anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hydroxocobalamin
Trial phase: Phase 2
ATC code: B03BA03 | B03BA53 | V03AB33
SMILES: CC1=C2N=C(C=C3N=C(C(C)=C4[N-]C(C(CC(N)=O)C4(C)CCC(=O)NCC(C)OP(=O)([O-])OC4C(CO)OC(n5cnc6cc(C)c(C)cc65)C4O)C4(C)N=C1C(CCC(N)=O)C4(C)CC(N)=O)C(CCC(N)=O)C3(C)C)C(CCC(N)=O)C2(C)CC(N)=O.[Co+3].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV

Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.

Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Eligibility criteria:
Inclusion Criteria:

Any patient for whom we are able to obtain consent ahead of their procedure
Patients presenting for a procedure in which cardiopulmonary bypass will be required
Considered high risk for vasoplegic syndrome
Has no contraindications to arterial line or PA catheter placement
Develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary bypass.

Exclusion Criteria:

Age<18 years
Known pregnancy or patients without a documented pregnancy test if not menopausal.
Known prior anaphylactic or allergic reaction to B12a
CKD stage 4 or worse
ECMO (extracorporeal membrane oxygenation) prior to study consent.
Patients currently on cardiopulmonary bypass
Intervention: Azithromycin
Trial phase: Phase 2
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: 8 weeks of Azithromycin (250 mg) capsule once daily by mouth

Azithromycin: 8 weeks of Azithromycin (250 mg) once daily by mouth
Eligibility criteria:
Inclusion criteria (All participants):

Age 18 - 55 years
Able to provide informed consent
Smoking history < 10 pack-years

Inclusion Criteria for subjects with poorly controlled asthma

Methacholine PC20 < 16 mg/ml or PD 20 < 400 mcg/ml or albuterol response > 12% on FEV1 after 4 puffs of albuterol
Currently prescribed ICS + LABA
Meet definition for Th2-low asthma: peripheral blood eosinophil count < 300 and exhaled nitric oxide level < 30 ppb.

Exclusion Criteria (All participants)

History of allergy or intolerance to any medications used in this study

Medication exclusions:

Current use of medications that prolong QTc interval
Current use of omalizumab or other ant-IgE therapies
Current use of anti-IL 5 therapies
Current use of anticoagulants
Prednsione or other oral steroids within past 3 months
Pregnancy or lactation, or plans to become pregnant
Other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema)
Pre-existing liver disease by history
Smoking within the last 6 months
Exacerbation of asthma in past 3 months
Affected by a hearing disorder
Clinically significant medical condition (e.g., heart failure, seizure disorder) which may in-crease risk as determined by study investigator
Corrected QT interval > 450 msec. Patients with known cardiac history or prolonged QT interval on a screening EKG are excluded given the small but real potential for macrolide-related side effects
Intervention: Betamethasone
Trial phase: Phase 3
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: 388
Group description: Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)

Dose and regimen: 1 drop - 4 times a day for 14 days
Eligibility criteria:
Inclusion Criteria prior to surgery:

Signed written informed consent
Male or female, age ≥40 years
Scheduled senile or presenile cataract surgery
Willing to interrupt the use of contact lenses for the entire duration of the study
Able and willing to follow study procedures

Female patients must be postmenopausal, surgically sterile or must agree to use an effective method of contraception

Inclusion criteria following surgery:

Surgery completed without complications

Exclusion Criteria:

Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations
Patients undergoing bilateral cataract surgery
Patients under treatment with prostaglandin analogues or intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs
Systemic diseases that may interfere with the results of the study
Any condition that could interfere with correct instillation of eye drops
Ocular surgery in the study eye (including laser surgery) in the 3 months before screening
Monocular patients
Visual Acuity < 20/80 of the contralateral eye measured as ETDRS or Snellen
Contraindications to ocular treatment with Tobradex®, Maxidex® or levofloxacin/dexamethasone
Hypersensitivity to the study product or its excipients
Participation in other clinical studies within at least 5 half-lives of the Investigational Medicinal Product (IMP) used in the previous studies
Pregnancy or breastfeeding
Intervention: Bimiralisib
Trial phase: Phase 2
SMILES: Nc1cc(C(F)(F)F)c(-c2nc(N3CCOCC3)nc(N3CCOCC3)n2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Bimiralisib capsules orally

Bimiralisib: Bimiralisib capsules
Eligibility criteria:
Inclusion Criteria:

Histologically or cytological confirmed diagnosis of Head and Neck Squameous Cell Carcinoma, for which no standard curative or life prolonging therapy is available
Available CLIA-certified sequencing results of the NOTCH gene in Head and Neck Squameous Cell Carcinoma (HNSCC) tumor material. The tumor must harbor a NOTCH1 LOF mutation as confirmed by central review (MD Anderson Cancer Center, MDACC)
ECOG performance status of ≤ 2
Adequate bone marrow, liver, and renal functions
Measurable disease according to RECIST version 1.1
Patients of reproductive potential must agree to use effective contraception from screening until 90 days after discontinuing study treatment.

Exclusion Criteria:

Has received any anti-cancer treatment including hormonal and investigational agents within 21 days prior to first dose of bimiralisib.
Major surgery within 28 days prior to first dose of bimiralisib or persisting side effects that have not improved to NCI-CTCAE grade 1 or better.
Pregnant or nursing (lactating) women.
Poorly controlled diabetes mellitus, steroid-induced diabetes mellitus
Has other active malignancies that require systemic treatment.
Has a known history of HIV infection

Any of the following cardiac abnormalities:

History of, or current, documented congestive heart failure (New York heart association functional classification iii - iv), documented cardiomyopathy
Symptomatic (NYHA class II or higher) left ventricular ejection fraction (LVEF) < 40% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (echo)
Myocardial infarction ≤ 6 months prior to enrolment
Unstable angina pectoris
Serious uncontrolled cardiac arrhythmia
Symptomatic pericarditis
Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
Patient has a history of non-compliance to medical regimen or inability to grant consent.
Medically documented history of an active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or ≥ CTCAE grade 3 anxiety
History of interstitial pneumonitis or patients who require chronic oxygen supplementation.
Intervention: Ofloxacin
Trial phase: Phase 2
ATC code: A02BD10 | J01MA01 | J01MA12 | J01RA05 | J01RA09 | S01AE01 | S01AE05 | S02AA16
SMILES: CC1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.

Administration route: ocular instillation

Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).
Eligibility criteria:
Inclusion Criteria:

Written informed consent
Male or female patients, aged ≥40 years
Patient undergoing phacoemulsification
Corneal thickness between 450 μm and 600 μm as measured by means of pachymetry
Corneal integrity confirmed by means of fluorescein test
Adequate pupil dilation assessed at screening
Female patients of childbearing potential must have a negative pregnancy test
Ability to fully understand all study procedures

Exclusion Criteria:

Corneal epithelium integrity not confirmed by fluorescein test
History of corneal disease or dystrophy
History of ocular trauma with corneal damage
History of acute ocular inflammation (including uveitis) in the 6 months prior to screening
Previous ocular surgery (including laser treatment)
Glaucoma
Treatment with an ophthalmic investigational drug in the 3 months prior to screening
Treatment with any topical ocular drug within 12 hours before start of cataract surgery other than study drugs and instillation of topical anaesthetic within 10 minutes before start of surgery
Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery
Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery
Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone
Pregnant or lactating women
Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life, or who have previously participated in this trial
Intervention: Betamethasone
Trial phase: Phase 2
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: 41
Group description: Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.

Administration route: ocular instillation

Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).
Eligibility criteria:
Inclusion Criteria:

Written informed consent
Male or female patients, aged ≥40 years
Patient undergoing phacoemulsification
Corneal thickness between 450 μm and 600 μm as measured by means of pachymetry
Corneal integrity confirmed by means of fluorescein test
Adequate pupil dilation assessed at screening
Female patients of childbearing potential must have a negative pregnancy test
Ability to fully understand all study procedures

Exclusion Criteria:

Corneal epithelium integrity not confirmed by fluorescein test
History of corneal disease or dystrophy
History of ocular trauma with corneal damage
History of acute ocular inflammation (including uveitis) in the 6 months prior to screening
Previous ocular surgery (including laser treatment)
Glaucoma
Treatment with an ophthalmic investigational drug in the 3 months prior to screening
Treatment with any topical ocular drug within 12 hours before start of cataract surgery other than study drugs and instillation of topical anaesthetic within 10 minutes before start of surgery
Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery
Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery
Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone
Pregnant or lactating women
Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life, or who have previously participated in this trial
Intervention: Glycopyrrolate
Trial phase: Not Applicable
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Participants undergoing neck procedures

Intraoperative Video Laryngoscopy: The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures.

Glycopyrrolate: 0.004mg/kg as per routine prior to intubation
Eligibility criteria:
Inclusion Criteria:

Age 18 and older with capacity to make all medical decisions
Medical indication for partial or total thyroidectomy, re-operative parathyroidectomy, or neck dissection

Exclusion Criteria:

Patients who are under the age of 18
Patients who are not able to make medical decisions or consent to research
Intervention: PESAMPATOR
Trial phase: Phase 2
SMILES: CC(C)S(=O)(=O)N[C@H]1COC[C@H]1Oc1ccc(-c2ccc(C#N)s2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Otherwise healthy participant with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), diagnosis of schizophrenia of at least 2 years' duration as confirmed by the mini-international neuropsychiatric interview (MINI) 7.0.2 for Psychotic Disorders.
Evidence of stable schizophrenia symptomatology ≥12 weeks (e.g., no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of schizophrenia symptoms).
Participants must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for ≥8 weeks prior to Baseline/Day 1, including concomitant psychotropic medication. Doses of background atypical antipsychotics should be within the recommended dose range listed in the approved product labeling of the country where the study is being conducted.
SCI-PANSS: No more than moderate-severe rating (score ≤5) on delusions, hallucinatory behavior, grandiosity, suspiciousness / persecution, and hostility (i.e. PANSS, positive symptom items P1, P3, P5, P6, P7); or unusual thought content (G9); and no more than a moderate rating (score ≤4) on conceptual disorganization (P2).

Key Exclusion Criteria:

Participation in a trial using any component or version of the MATRICS Consensus Cognitive Battery (MCCB) or the University of California, San Diego (UCSD) Performance-Based Skills Assessment test within the previous 6 months.
Participation in cognitive remediation therapy within 6 months prior to randomization.
Screening MCCB Working Memory Domain T-score ≥60.
Current DSM-5 diagnosis of schizoaffective disorder on the MINI 7.0.2 for Psychotic Disorders.
Current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and/or generalized anxiety disorder on the MINI 7.0.2 for Psychotic Disorders.
Lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, and/or binge-eating disorder on the MINI 7.0.2 for Psychotic Disorders.
Meets the DSM-5 diagnosis of moderate or severe substance use disorder (excluding nicotine dependence) within 12 months of screening on the MINI 7.0.2 for Psychotic Disorders interview.
DSM-5 diagnosis of Intellectual Disability (intellectual developmental disorder).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: PESAMPATOR
Trial phase: Phase 2
SMILES: CC(C)S(=O)(=O)N[C@H]1COC[C@H]1Oc1ccc(-c2ccc(C#N)s2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Otherwise healthy participant with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), diagnosis of schizophrenia of at least 2 years' duration as confirmed by the mini-international neuropsychiatric interview (MINI) 7.0.2 for Psychotic Disorders.
Evidence of stable schizophrenia symptomatology ≥12 weeks (e.g., no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of schizophrenia symptoms).
Participants must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for ≥8 weeks prior to Baseline/Day 1, including concomitant psychotropic medication. Doses of background atypical antipsychotics should be within the recommended dose range listed in the approved product labeling of the country where the study is being conducted.
SCI-PANSS: No more than moderate-severe rating (score ≤5) on delusions, hallucinatory behavior, grandiosity, suspiciousness / persecution, and hostility (i.e. PANSS, positive symptom items P1, P3, P5, P6, P7); or unusual thought content (G9); and no more than a moderate rating (score ≤4) on conceptual disorganization (P2).

Key Exclusion Criteria:

Participation in a trial using any component or version of the MATRICS Consensus Cognitive Battery (MCCB) or the University of California, San Diego (UCSD) Performance-Based Skills Assessment test within the previous 6 months.
Participation in cognitive remediation therapy within 6 months prior to randomization.
Screening MCCB Working Memory Domain T-score ≥60.
Current DSM-5 diagnosis of schizoaffective disorder on the MINI 7.0.2 for Psychotic Disorders.
Current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and/or generalized anxiety disorder on the MINI 7.0.2 for Psychotic Disorders.
Lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, and/or binge-eating disorder on the MINI 7.0.2 for Psychotic Disorders.
Meets the DSM-5 diagnosis of moderate or severe substance use disorder (excluding nicotine dependence) within 12 months of screening on the MINI 7.0.2 for Psychotic Disorders interview.
DSM-5 diagnosis of Intellectual Disability (intellectual developmental disorder).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Contezolid acefosamil
Trial phase: Phase 2
SMILES: CC(=O)OP(=O)([O-])N(CC1CN(c2cc(F)c(N3C=CC(=O)CC3)c(F)c2F)C(=O)O1)c1ccon1.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h
Eligibility criteria:
Inclusion Criteria:

Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
Diagnosed with cellulitis/erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

Uncomplicated skin infections
Severe sepsis or septic shock
ABSSSI solely due to Gram-negative pathogens
Prior systemic antibiotics within 96 hours of randomization
Intervention: Lorazepam
Trial phase: Phase 2
ATC code: N05BA06 | N05BA56
SMILES: O=C1Nc2ccc(Cl)cc2C(c2ccccc2Cl)=NC1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.

Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.
Eligibility criteria:
Inclusion Criteria:

Adults between the ages of 18-65
Sustained a physical injury with a pain score ≥ 5 on the numeric rating scale [NRS] from 0- 10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable"
Expected to be in the ED for at least 2 hours, in a private treatment room
Ownership of a cell phone with text messaging capabilities
Emergency Department admission assessment confirmed subject is not suicidal.

Exclusion Criteria:

Non-English speaking
Not medically suitable for lorazepam per treating MD (e.g. medical condition where benzodiazepines are contraindicated or may be unsafe)
Not alert and oriented
Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
Seeking treatment due to a mental health or substance use disorder
History of chronic opioid use
Prescribed opioid or benzodiazepine use within the past 24 hours
Alcohol use within the past 12 hours or medical history of alcoholism.
Clinical indication for open-label benzodiazepine administration in the ED.
Any use of recreational narcotics throughout lifetime
Sensitivity or allergy or intolerance to opioids or benzodiazepines
Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
Prisoner
Intervention: Omadacycline
Trial phase: Phase 2
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
Eligibility criteria:
Inclusion Criteria:

Female participants, age 18-65 years who have signed the informed consent form
Must have a qualifying acute pyelonephritis
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 comply with all of the requirements of the study

Exclusion Criteria:

Males
Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
Infections that require antibacterial treatment for greater than 14 days
Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
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 or to levofloxacin
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