anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: CID 163342991
Trial phase: Phase 3
SMILES: CC(=CC(=O)OCCCCCCCCC(=O)[O-])CC1OCC(CC2OC2C(C)C(C)O)C(O)C1O.CC(=CC(=O)OCCCCCCCCC(=O)[O-])CC1OCC(CC2OC2C(C)C(C)O)C(O)C1O.[Ca+2]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 219
Group description: Mupirocin Calcium: mupirocin cream
Eligibility criteria:
Inclusion Criteria:

Males or non-pregnant females aged 18 months or older.
Must have a secondarily infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.
Must have a positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
Must have a positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
Must have a Skin Infection Rating Scale (SIRS) total score for the secondarily infected traumatic skin lesion of at least 8 at baseline.
Must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, and be able to complete the study.
Must be in general good health and free from any clinically significant disease, other than secondarily infected traumatic skin lesion(s), that might interfere with the study evaluations.

Exclusion Criteria:

Subjects who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
Presence of any dermatological disorder that may interfere with evaluation of the subject's secondarily infected traumatic skin lesion(s).
Presence of bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.
Presence of secondarily infected bite or puncture wound.
Presence of systemic signs or symptoms of infection (fever defined as an oral temperature greater than 101°F or 38.3°C).
Requirement for surgical intervention for treatment of the infection prior to study entry.
Presence of cutaneous herpes simplex infections.
Use of any topical corticosteroid, topical antibiotic, or topical antifungal, on the secondarily infected target lesion, within 48 hours prior to Visit 1/Day 1.
Use of systemic antibiotics or systemic corticosteroids within 7 days of Visit 1/Day 1.
Primary or secondary immunodeficiency.
Diagnosed Diabetes Mellitus (controlled or uncontrolled).
Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments.
History of hypersensitivity or allergy to mupirocin and/or any ingredient in the study medication.
Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
Subjects who, in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
Intervention: CID 163342991
Trial phase: Phase 3
SMILES: CC(=CC(=O)OCCCCCCCCC(=O)[O-])CC1OCC(CC2OC2C(C)C(C)O)C(O)C1O.CC(=CC(=O)OCCCCCCCCC(=O)[O-])CC1OCC(CC2OC2C(C)C(C)O)C(O)C1O.[Ca+2]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 219
Group description: Mupirocin Calcium: Reference mupirocin cream
Eligibility criteria:
Inclusion Criteria:

Males or non-pregnant females aged 18 months or older.
Must have a secondarily infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.
Must have a positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
Must have a positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
Must have a Skin Infection Rating Scale (SIRS) total score for the secondarily infected traumatic skin lesion of at least 8 at baseline.
Must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, and be able to complete the study.
Must be in general good health and free from any clinically significant disease, other than secondarily infected traumatic skin lesion(s), that might interfere with the study evaluations.

Exclusion Criteria:

Subjects who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
Presence of any dermatological disorder that may interfere with evaluation of the subject's secondarily infected traumatic skin lesion(s).
Presence of bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.
Presence of secondarily infected bite or puncture wound.
Presence of systemic signs or symptoms of infection (fever defined as an oral temperature greater than 101°F or 38.3°C).
Requirement for surgical intervention for treatment of the infection prior to study entry.
Presence of cutaneous herpes simplex infections.
Use of any topical corticosteroid, topical antibiotic, or topical antifungal, on the secondarily infected target lesion, within 48 hours prior to Visit 1/Day 1.
Use of systemic antibiotics or systemic corticosteroids within 7 days of Visit 1/Day 1.
Primary or secondary immunodeficiency.
Diagnosed Diabetes Mellitus (controlled or uncontrolled).
Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments.
History of hypersensitivity or allergy to mupirocin and/or any ingredient in the study medication.
Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
Subjects who, in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
Intervention: Serine
Trial phase: Phase 2
SMILES: NC(CO)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of schizophrenia for the past 2 years
Patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (PANSS) total score of 70-110
Patients currently treated with one antipsychotic medication

Exclusion Criteria:

Patients who, in the opinion of the Investigator, have a history of antipsychotic treatment resistance
Patients currently taking clozapine
History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first Screening Visit
Patients with positive blood screen for human immunodeficiency virus (HIV) antibody and/or hepatitis B virus surface antigen
Patients with history of renal disease or those taking medications to treat renal disease
Intervention: Serine
Trial phase: Phase 2
SMILES: NC(CO)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of schizophrenia for the past 2 years
Patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (PANSS) total score of 70-110
Patients currently treated with one antipsychotic medication

Exclusion Criteria:

Patients who, in the opinion of the Investigator, have a history of antipsychotic treatment resistance
Patients currently taking clozapine
History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first Screening Visit
Patients with positive blood screen for human immunodeficiency virus (HIV) antibody and/or hepatitis B virus surface antigen
Patients with history of renal disease or those taking medications to treat renal disease
Intervention: Serine
Trial phase: Phase 2
SMILES: NC(CO)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 78
Group description: Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of schizophrenia for the past 2 years
Patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (PANSS) total score of 70-110
Patients currently treated with one antipsychotic medication

Exclusion Criteria:

Patients who, in the opinion of the Investigator, have a history of antipsychotic treatment resistance
Patients currently taking clozapine
History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first Screening Visit
Patients with positive blood screen for human immunodeficiency virus (HIV) antibody and/or hepatitis B virus surface antigen
Patients with history of renal disease or those taking medications to treat renal disease
Intervention: Omadacycline
Trial phase: Phase 1
ATC code: J01AA15 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)cc(CNCC(C)(C)C)c(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
Eligibility criteria:
Inclusion Criteria:

Male or female participants, age 18 or older who have signed the informed consent form
Must have a qualifying community-acquired bacterial pneumonia
Has disease severity such that oral antibiotics therapy is appropriate
Participants must not be pregnant at the time of enrollment
Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Must be able to swallow tablets and comply with all of the requirements of the study

Exclusion Criteria:

Has received more than 24 hours of a potentially effective systemic antibacterial therapy within the 72 hours prior to the first dose of test article
Known or suspected infection caused by a pathogen that may be resistant to test article
Participants who reside in a long-term care or nursing home
Evidence of empyema
Evidence of significant immunological disease
Evidence of liver impairment or disease
Evidence of unstable cardiac disease
Severe renal disease or requirement for dialysis
Evidence of septic shock
Has a history of hypersensitivity or allergic reaction to any tetracycline
Has received an investigational drug within the past 30 days
Participants who are pregnant or nursing
Unable or unwilling to comply with the protocol requirements
Intervention: Qzj1I2EN1V
Trial phase: Phase 1 | Phase 2
SMILES: C=CC(=O)N1CCN(c2ncnc3c(F)c(-c4ccc(F)c5sc(N)nc45)c(Cl)cc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
Eligibility criteria:
Inclusion Criteria:

Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not respond to at least 1 line of standard therapy and has spread to other part(s) of the body
For phase II, participants must be willing to have new tumor tissue biopsies (doctor removes a small amount of tissue) during the study if it does not cause undue risks to health
Participants must be willing to use highly effective birth control
Participants must have adequate organ function
Participants must be able to swallow capsules

Exclusion Criteria:

Participants must not have certain infections such as hepatitis or tuberculosis or HIV that is not well controlled
Participants must not have another serious medical condition including a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
Participants must not have cancer of the central nervous system that is not stable
Participants must not be pregnant or breastfeeding
Participants must not use herbal supplements
Intervention: Qzj1I2EN1V
Trial phase: Phase 1 | Phase 2
SMILES: C=CC(=O)N1CCN(c2ncnc3c(F)c(-c4ccc(F)c5sc(N)nc45)c(Cl)cc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
Eligibility criteria:
Inclusion Criteria:

Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not respond to at least 1 line of standard therapy and has spread to other part(s) of the body
For phase II, participants must be willing to have new tumor tissue biopsies (doctor removes a small amount of tissue) during the study if it does not cause undue risks to health
Participants must be willing to use highly effective birth control
Participants must have adequate organ function
Participants must be able to swallow capsules

Exclusion Criteria:

Participants must not have certain infections such as hepatitis or tuberculosis or HIV that is not well controlled
Participants must not have another serious medical condition including a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
Participants must not have cancer of the central nervous system that is not stable
Participants must not be pregnant or breastfeeding
Participants must not use herbal supplements
Intervention: Edaravone
Trial phase: Phase 3
ATC code: N07XX14
SMILES: CC1=NN(c2ccccc2)C(=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: MT-1186 105mg (2 weeks On/Off)
Eligibility criteria:
Inclusion Criteria:

Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed
Subjects will be diagnosed with Definite ALS, Probable ALS, Probable laboratory-supported ALS, or Possible ALS according to the El Escorial revised criteria for the diagnosis of ALS.
Subjects will be living and functioning independently (eg, able to eat, excrete, ambulate independently without assistance of others). The use of supportive tools and adaptive utensil is allowed
Subjects will have a baseline forced vital capacity percentage (%FVC) ≥ 70%.
Subjects whose first symptom of ALS occurred within 3 years of the time of providing written informed consent.

Exclusion Criteria:

Subjects who have the presence or history of any clinically significant disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator.
Subjects of childbearing potential unwilling to use acceptable method of contraception from the screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period.
Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).
Subjects who have a significant risk of suicidality. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the 3 months before the screening visit.
Subjects who have ALT or AST elevations greater than 2 times the ULN at screening.
Subjects with a Glomerular Filtration Rate (GFR) <30 mL/Min Per 1.73 m2.
Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.
Subjects with hereditary fructose intolerance.
Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer before providing informed consent for the present study.
Subjects who are unable to take their medications orally.
Intervention: Doxycycline
Trial phase: Phase 4
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Participants who received Doxycycline, 100 mg twice a day for 2 months in either the first or second intervention period of the study
Eligibility criteria:
Inclusion Criteria:

Diagnosis of definite HHT by the Curacao criteria or genetic diagnosis of HHT
Epistaxis severity during observation month at least moderate by Epistaxis Severity Score (ESS) evaluation
For female participants, a negative pregnancy test at Day -1 and agree to use birth control during treatment and for 28 days following cessation of Doxycycline

Exclusion Criteria:

Use of medication(s) contraindicated with doxycycline use within 14 days prior to the study (including barbiturates, tegretol, dilantin, warfarin, isotretinoin)
Intervention: Lidocaine
Trial phase: Early Phase 1
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack
Eligibility criteria:
Inclusion Criteria: ADHD

Exclusion Criteria for both arms:

known adverse reactions to lidocaine
epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism;
treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers;
generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness);
mouth sores;
Ehlers Danlos syndrome, and
red hair.
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: 20
Group description: Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).

Dextenza: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
Eligibility criteria:
Inclusion Criteria:

Progressive keratoconus with planned corneal cross-linking in one or both eyes
Age 18 years and older
Ability to provide informed consent for procedures
Ability to attend scheduled follow up visits

Exclusion Criteria:

Age less than 18
Pregnancy/currently breast-feeding
Inability to provide informed consent
Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
Punctal stenosis
Previous corneal transplant surgery
Systemic concomitant use of controlled substance for pain management (i.e. oxycodone)
Concurrent use of topical steroid eye drops
Systemic, topical or intravitreal steroid use within 1 month of baseline
Active history of chronic or recurrent inflammatory eye disease in either eye
History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
Intervention: PREDNISOLONE ACETATE
Trial phase: Phase 4
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.

Prednisolone Acetate: post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
Eligibility criteria:
Inclusion Criteria:

Progressive keratoconus with planned corneal cross-linking in one or both eyes
Age 18 years and older
Ability to provide informed consent for procedures
Ability to attend scheduled follow up visits

Exclusion Criteria:

Age less than 18
Pregnancy/currently breast-feeding
Inability to provide informed consent
Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
Punctal stenosis
Previous corneal transplant surgery
Systemic concomitant use of controlled substance for pain management (i.e. oxycodone)
Concurrent use of topical steroid eye drops
Systemic, topical or intravitreal steroid use within 1 month of baseline
Active history of chronic or recurrent inflammatory eye disease in either eye
History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
Intervention: Acthargel
Trial phase: Phase 4
SMILES: CSCCC(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(N)CO)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(Cc1ccccc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NCC(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)N1CCCC1C(=O)NC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)N1CCCC1C(=O)NC(CC(N)=O)C(=O)NCC(=O)NC(C)C(=O)NC(CCC(=O)O)C(=O)NC(CC(=O)O)C(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)NC(C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(Cc1ccccc1)C(=O)N1CCCC1C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)O)C(C)C)C(C)C)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
Eligibility criteria:
Inclusion Criteria:

Has severe or recalcitrant keratitis
Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis
If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6)
Has normal eyelids, and protocol-defined physical and medical eye attributes
Agrees to avoid wearing contact lenses during the trial

Exclusion Criteria:

Is pregnant or breast-feeding
Is defined as vulnerable, or is employed by, or related to anyone involved in the study
Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis