anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Single dose containing 125 mg of celecoxib in 10 ml solution

DFN-15 (Celecoxib Oral Solution) 125 mg: Oral Solution
Eligibility criteria:
Inclusion Criteria:

Subjects scheduled to undergo elective bilateral lower (mandibular) third molar extraction under local anesthesia.
Subjects must be generally healthy, ambulatory, able to understand and willing to comply with study procedures, study restrictions, assessments, and requirements per the discretion of the investigator.
Subjects must voluntarily sign written informed consent prior to any study-specific procedures.
Subjects must have a body mass index (BMI) greater than or equal to 19.0 to less than or equal to 35.0

Exclusion Criteria:

History of migraine or frequent headaches, low back pain, or other acute or chronic pain conditions.
Acute illness or unresolved local infection prior to surgery that can interfere with the conduct of the study.
Positive results on urine drug screen or alcohol breath test indicative of illicit drug (Cocaine Metabolites, Marijuana (THC), MDMA (Ecstasy) and Phencyclidine) or alcohol abuse at screening and/or prior to extraction procedure.
Positive results for the following (prescription included): Amphetamines, Barbiturates, Benzodiazepines, Methadone, Methamphetamine, Opiates, Oxycodone, and Tricyclic Antidepressants.
Frequent use of nicotine-containing products.
Excessive intake of caffeine-containing foods or beverages within 48 hours prior to surgery.
Routinely uses pain medication.
Currently taking any corticosteroid chronically (except for an inhaled steroid for pulmonary disease, and local topical or ophthalmic steroid) or has taken systemic corticosteroids within 4 weeks of the proposed date of surgery.
Currently taking central nervous system active drugs such as hypnotics, sedatives, monoamine oxidase inhibitors, sympathomimetic amines, benzodiazepines, tricyclic antidepressants, or serotonin norepinephrine reuptake inhibitors, and anticonvulsants for pain.
Donated blood products or had blood loss greater than 500 mL 30 days prior to Screening or between Screening and surgery.
Member or relative of study staff or the Sponsor directly involved in the study.
Previous participation in this study.
Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30 days prior to the Screening visit.
Currently receiving or have received within 7 days prior to investigational product administration in the study, any drug (s) that is metabolized by hepatic microsomal enzyme CYP 2D6.
Clinically significant disease or disorder which may put the subject at risk, influence the results or the subject's ability to participate in the study.
Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Single dose containing 250 mg of celecoxib in 10 ml solution

DFN-15 (Celecoxib Oral Solution) 250 mg: Oral Solution
Eligibility criteria:
Inclusion Criteria:

Subjects scheduled to undergo elective bilateral lower (mandibular) third molar extraction under local anesthesia.
Subjects must be generally healthy, ambulatory, able to understand and willing to comply with study procedures, study restrictions, assessments, and requirements per the discretion of the investigator.
Subjects must voluntarily sign written informed consent prior to any study-specific procedures.
Subjects must have a body mass index (BMI) greater than or equal to 19.0 to less than or equal to 35.0

Exclusion Criteria:

History of migraine or frequent headaches, low back pain, or other acute or chronic pain conditions.
Acute illness or unresolved local infection prior to surgery that can interfere with the conduct of the study.
Positive results on urine drug screen or alcohol breath test indicative of illicit drug (Cocaine Metabolites, Marijuana (THC), MDMA (Ecstasy) and Phencyclidine) or alcohol abuse at screening and/or prior to extraction procedure.
Positive results for the following (prescription included): Amphetamines, Barbiturates, Benzodiazepines, Methadone, Methamphetamine, Opiates, Oxycodone, and Tricyclic Antidepressants.
Frequent use of nicotine-containing products.
Excessive intake of caffeine-containing foods or beverages within 48 hours prior to surgery.
Routinely uses pain medication.
Currently taking any corticosteroid chronically (except for an inhaled steroid for pulmonary disease, and local topical or ophthalmic steroid) or has taken systemic corticosteroids within 4 weeks of the proposed date of surgery.
Currently taking central nervous system active drugs such as hypnotics, sedatives, monoamine oxidase inhibitors, sympathomimetic amines, benzodiazepines, tricyclic antidepressants, or serotonin norepinephrine reuptake inhibitors, and anticonvulsants for pain.
Donated blood products or had blood loss greater than 500 mL 30 days prior to Screening or between Screening and surgery.
Member or relative of study staff or the Sponsor directly involved in the study.
Previous participation in this study.
Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30 days prior to the Screening visit.
Currently receiving or have received within 7 days prior to investigational product administration in the study, any drug (s) that is metabolized by hepatic microsomal enzyme CYP 2D6.
Clinically significant disease or disorder which may put the subject at risk, influence the results or the subject's ability to participate in the study.
Intervention: Furosemide
Trial phase: Phase 2
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 192
Group description: Oral furosemide 20 mg/day for a total of 5 consecutive doses.

Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily
Eligibility criteria:
Inclusion Criteria:

Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum
Gestational hypertension
Pre-eclampsia with or without severe features
Superimposed pre-eclampsia with or without severe features
New diagnosis of HDP within 24 hours from delivery
Postpartum, delivery ≥ 20 weeks estimated gestational age
Age ≥18 years old

Exclusion Criteria:

History of allergic reaction to furosemide
High risk comorbidities for which treatment may be indicated or contraindicated: class C or higher diabetes mellitus, chronic kidney disease or baseline creatinine >1.2, cardiac disorders including cardiomyopathy, congenital heart disease, angina or coronary heart disease, rheumatic disease (lupus), sickle cell disease
Baseline labs with K <3
Use of furosemide or other diuretics antepartum or intrapartum
Use of ototoxic agents including aminoglycosides (ie, Gentamicin for >1 dose), cephalosporins (ie Ancef >1 dose),
Patient unstable for protocol per investigator's judgement
Intervention: ALK-4290
Trial phase: Phase 2
SMILES: Cc1cc(C(=O)N(C)C)cc(NC(=O)[C@H]2CCC(=O)N2C2CCN(Cc3ccc(Cl)c(C)c3)CC2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: ALK4290 800 mg daily
Eligibility criteria:
Inclusion Criteria:

Men and women with newly diagnosed active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye:

No prior treatment for wAMD in the study eye and no current or planned concomitant intravitreal anti-VEGF treatment in the fellow eye
Central subfield retinal thickness ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
Presence of SRF and/or IRF on SD-OCT
Any active CNV with subfoveal leakage as determined by FA
Total lesion size not greater than 12 disc areas on FA
If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA
No subfoveal fibrosis or atrophy on FA
BCVA letter score, as measured by ETDRS in the study eye, between 70 and 24 letters, inclusive, at screening
Patients 50 years of age or older at screening visit 1
Body mass index (BMI) between18 and ≤ 40 at screening visit 1
Female subjects must not be pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry.
Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions

Exclusion Criteria:

Previous participation in any studies of investigational drugs within 1 month preceding screening visit
Any form of macular degeneration that is not age-related (e.g., Best's disease, Stargardt's disease, Sorsby's disease, etc.)
Additional eye disease in the study eye that could compromise BCVA (i.e., uncontrolled glaucoma (intraocular pressure > 24) with visual field loss, clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, monocular vision, or genetic disorders such as retinitis pigmentosa; high myopia > 8 diopters)
The presence of polypoidal choroidal vasculopathy (PCV) or retinal angiomatous proliferation (RAP) in the study eye
Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with fundus photography/FA or SD-OCT
Intraocular surgery in the study eye within 3 months prior to screening
Aphakia or total absence of the posterior capsule (yttrium aluminum garnet (YAG) laser capsulotomy permitted, a minimum of 1 month prior to enrollment) in the study eye
Intervention: ALK-4290
Trial phase: Phase 2
SMILES: Cc1cc(C(=O)N(C)C)cc(NC(=O)[C@H]2CCC(=O)N2C2CCN(Cc3ccc(Cl)c(C)c3)CC2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: ALK4290 800 mg daily (400 mg tablet twice a day)

ALK4290: ALK4290 400 mg tablet twice a day
Eligibility criteria:
Inclusion Criteria:

Men and women with refractory active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye:

Persistent exudation of SRF and IRF as documented by SD-OCT and absence of improvement in visual acuity following monthly IVT anti-VEGF therapy of at least 3 months; subject must have received their last IVT anti-VEGF injection 30 to 90 days prior to the initial screening visit
Central subfield retinal thickness ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
Total lesion size not greater than 12 disc areas on FA
If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA
No subfoveal fibrosis or atrophy on FA
BCVA letter score, as measured by ETDRS in the study eye, between 70 and 24 letters, inclusive, at screening
Patients 50 years of age or older at screening visit 1
Body mass index (BMI) between18 and ≤ 40 at screening visit 1
Female subjects must not be pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in the study, she should inform her treating physician immediately
Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions

Exclusion Criteria:

Treatment with IVT anti-VEGF therapy within 30 days preceding screening visit in the study eye and/or planned concomitant IVT anti-VEGF treatment in the fellow eye during the study period
Previous participation in any studies of investigational drugs within 1 month preceding screening visit
Any form of macular degeneration that is not age-related (e.g., Best's disease, Stargardt's disease, Sorsby's disease, etc.)
Additional eye disease in the study eye that could compromise BCVA (i.e., uncontrolled glaucoma (intraocular pressure > 24) with visual field loss, clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, monocular vision, or genetic disorders such as retinitis pigmentosa; high myopia > 8 diopters)
Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with fundus photography/FA or SD-OCT
Intraocular surgery in the study eye within 3 months prior to screening
Aphakia or total absence of the posterior capsule (yttrium aluminum garnet (YAG) laser capsulotomy permitted, a minimum of 1 month prior to enrollment) in the study eye
Intervention: Mitomycin
Trial phase: Phase 2
ATC code: L01DC03
SMILES: [H][C@]12N[C@@]1([H])CN1C3=C(C(=O)C(N)=C(C)C3=O)[C@@H](COC(N)=O)[C@]12OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: 6 once-weekly intravesical instillations of UGN-102.
Eligibility criteria:
Inclusion Criteria:

Willing and able to sign an informed consent and comply with the protocol.
Has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 6 weeks of screening.

Is at intermediate risk of recurrence, defined as having 1 or 2 of the following:

Presence of multiple tumors;
Solitary tumor > 3 cm;
Recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).
Has negative voiding cytology for high grade (HG) disease at or within 6 weeks of enrollment.
Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the participant is female or the female partner of a male participant and is of childbearing potential (defined as premenopausal women who have not been sterilized).

Has adequate organ and bone marrow function as determined by routine laboratory tests as below:

Leukocytes ≥ 3,000 per μL;
Absolute neutrophil count ≥ 1,500 per μL;
Platelets ≥ 100,000 per μL;
Hemoglobin ≥ 9.0 g/dL;
Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
Alkaline phosphatase ≤ 2.5 × ULN;
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.

Has no evidence of active urinary tract infection (UTI) at Screening and Baseline visits.

In the case of symptomatic UTI, the patient will be treated with a full course of antibiotics, and study drug will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of study drug is left to the discretion of the Principal Investigator (PI).

Exclusion Criteria:

History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.
Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 2 years.
History of HG papillary UC in the past 2 years.
Known allergy or sensitivity to mitomycin.
Clinically significant urethral stricture that would preclude passage of a urethral catheter.
History of pelvic radiotherapy.

History of:

Neurogenic bladder;
Active urinary retention;
Any other condition that would prohibit normal voiding.
Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract urothelial carcinoma (UTUC).
Has participated in a study with an investigational agent or device within 30 days of enrollment.
History of prior treatment with an intravesical chemotherapeutic agent with the exception of a single dose of chemotherapy immediately after any previous transurethral resection of bladder tumors (TURBT).
Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 145
Group description: Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria:

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Lifetime history of meeting DSM-5 criteria for:
Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant suicide risk, as judged by the Investigator
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 147
Group description: Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria:

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Lifetime history of meeting DSM-5 criteria for:
Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant suicide risk, as judged by the Investigator
Intervention: Oteseconazole
Trial phase: Phase 3
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 217
Group description: 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
Eligibility criteria:
Key Inclusion Criteria:

3 or more episodes of acute VVC in the past 12 months
Positive KOH or Gram stain test
Total vulvovaginal signs and symptoms score of ≥3 at screening visit
Total vulvovaginal signs and symptoms score of <3 at baseline visit
Must be able to swallow pills

Key Exclusion Criteria:

Presence or a history of another vaginal or vulvar condition(s)
Evidence of major organ system disease
History of cervical cancer
Poorly controlled diabetes mellitus
Pregnant
Recent use of topical or systemic antifungal or antibacterial drugs
Recent use of immunosuppressive or systemic corticosteroid therapies
Intervention: Oteseconazole
Trial phase: Phase 3
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 217
Group description: 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
Eligibility criteria:
Key Inclusion Criteria:

3 or more episodes of acute VVC in the past 12 months
Positive KOH or Gram stain
Total vulvovaginal signs and symptoms score of ≥3 at screening visit
Total vulvovaginal signs and symptoms score of <3 at baseline visit
Must be able to swallow pills

Key Exclusion Criteria:

Presence or a history of another vaginal or vulvar condition(s)
Evidence of major organ system disease
History of cervical cancer
Poorly controlled diabetes mellitus
Pregnant
Recent use of topical or systemic antifungal or antibacterial drugs
Recent use of immunosuppressive or systemic corticosteroid therapies
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Lactate Ringer's (LR, 273mOsm/L) is commonly used at our facility as our isotonic standard irrigation solution and will serve as the control to be evaluated against a hyperosmolar (1.9%, 600mOsm) solution.

Normal saline: Lactate Ringer's (LR, 273mOsm/L)
Eligibility criteria:
Inclusion Criteria:

Adult patients (18 years of age or greater) undergoing arthroscopic knee surgery who are willing and able to consent.

Exclusion Criteria:

Current pregnancy or breastfeeding
Unable to give consent
Prisoner
Mentally Disabled