anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nitric Oxide
Trial phase: Phase 2
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.

Nitric Oxide: Delivered as a footbath
Eligibility criteria:
Inclusion Criteria:

Positive clinical findings for moccasin, interdigital or bullous tinea pedis as determined by direct clinical examination
Must have a clinical symptom severity score of at least 20 on a possible 64 point scale
Written informed consent must be obtained from the subject.
Must ≥ 19 years of age, for study sites located in British Columbia. For other locations the subject must be ≥ 18 years of age, unless local laws dictate otherwise.
Must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial.
Must agree to take measures to avoid pregnancy during the 31 day study period

Exclusion Criteria:

Has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation.
Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator could compromise the integrity of the study.
Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®), tolnaftate, haloprogin), Zeasorb, antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1) on or immediately around the area under evaluation.
Use of systemic corticosteroids in the preceding 7 days respectively, of screening visit (Day 1)
Use of systemic antifungals in the preceding 7 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (GrisPEG®), butoconazole, terconazole, Potassium iodide)
Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
Is pregnant or is a nursing mother
Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
Is < 19 years of age, for study sites located in British Columbia. For other locations subject is < 18 years of age, unless local laws dictate otherwise.
Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. Such conditions may include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy
Intervention: Biotin
Trial phase: Not Applicable
ATC code: A11HA05
SMILES: [H][C@]12CS[C@@H](CCCCC(=O)O)[C@@]1([H])NC(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Subjects receive 1 capsule per day containing either 100 mg Fe.

supplement: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 1 capsule per day containing either 100 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.
Eligibility criteria:
Inclusion Criteria:

Eligible subjects were anemia men or women aged over 20 years old with Hb<=12 g/dl.

Exclusion Criteria:

Subjects were excluded if subjects had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. Subjects were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: 1ml of Normal Saline will be given intravenously with the administering of the spinal dose

Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose
Eligibility criteria:
Inclusion Criteria:

Pregnant
American Society of Anesthesiologists risk classification I and II
Age > 18 years
Non-laboring
Patients with elective cesarean sections

Exclusion Criteria:

Non- English speakers
Height < 4' 11"
BMI >40 Kg/ mm
Antiemetic drug use in the 24 hours prior to cesarean delivery,
Hypertensive diseases of pregnancy
Chronic hypertension receiving antihypertensive treatment
Any other physical or psychiatric condition that may impair their ability to cooperate with study data collection.
Intervention: Glycopyrrolate
Trial phase: Phase 4
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose

Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
Eligibility criteria:
Inclusion Criteria:

Pregnant
American Society of Anesthesiologists risk classification I and II
Age > 18 years
Non-laboring
Patients with elective cesarean sections

Exclusion Criteria:

Non- English speakers
Height < 4' 11"
BMI >40 Kg/ mm
Antiemetic drug use in the 24 hours prior to cesarean delivery,
Hypertensive diseases of pregnancy
Chronic hypertension receiving antihypertensive treatment
Any other physical or psychiatric condition that may impair their ability to cooperate with study data collection.
Intervention: Ubrogepant
Trial phase: Phase 3
ATC code: N02CD04
SMILES: C[C@@H]1[C@H](c2ccccc2)C[C@H](NC(=O)c2cnc3c(c2)C[C@@]2(C3)C(=O)Nc3ncccc32)C(=O)N1CC(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 409
Group description: Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
Eligibility criteria:
Inclusion Criteria:

-Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).

Exclusion Criteria:

Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities
Requirement for a medication during the study that is on the list of prohibited medications.
Intervention: Netarsudil
Trial phase: Phase 2
ATC code: S01EE51 | S01EX05
SMILES: Cc1ccc(C(=O)OCc2ccc([C@@H](CN)C(=O)Nc3ccc4cnccc4c3)cc2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: 1 drop in each eye (OU) daily in the evening (PM)
Eligibility criteria:
Inclusion Criteria:

18 years of age or older.
Ocular hypertension or open-angle glaucoma in both eyes.
Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both eyes.
Corrected visual acuity in each eye equivalent to 20/200 or better.
Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles.
Intraocular pressure ≥ 30 mmHg.
Use of ocular medications within 30 days.
Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination.
Previous eye surgery (other than cataract).
Ocular trauma within 6 months.
Clinically significant ocular disease that might interfere with the study.
Central corneal thickness greater than 620 µm.
Intervention: Brexpiprazole
Trial phase: Phase 1
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: OPC-34712 (4 mg) orally disintegrating tablet is administered with water.
Eligibility criteria:
Inclusion Criteria:

Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria:

Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator or sponsor may place the subject at risk or interfere with outcome variables, including drug absorption, distribution, metabolism, and excretion
History of serious mental disorder
History of drug or alcohol abuse within 2 years prior to screening
History of any significant drug allergy
Use of an investigational drug within 120 days prior to the first dosing of trial drug
Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
History of major surgery of the digestive tract (excluding appendectomy)
Any subject who, in the opinion of the investigator, should not participate in the trial
Intervention: Brexpiprazole
Trial phase: Phase 1
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: OPC-34712 (4 mg) orally disintegrating tablet is administered without water.
Eligibility criteria:
Inclusion Criteria:

Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria:

Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator or sponsor may place the subject at risk or interfere with outcome variables, including drug absorption, distribution, metabolism, and excretion
History of serious mental disorder
History of drug or alcohol abuse within 2 years prior to screening
History of any significant drug allergy
Use of an investigational drug within 120 days prior to the first dosing of trial drug
Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
History of major surgery of the digestive tract (excluding appendectomy)
Any subject who, in the opinion of the investigator, should not participate in the trial
Intervention: Brexpiprazole
Trial phase: Phase 1
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: OPC-34712 (4 mg) conventional tablet is administered with water.
Eligibility criteria:
Inclusion Criteria:

Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria:

Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator or sponsor may place the subject at risk or interfere with outcome variables, including drug absorption, distribution, metabolism, and excretion
History of serious mental disorder
History of drug or alcohol abuse within 2 years prior to screening
History of any significant drug allergy
Use of an investigational drug within 120 days prior to the first dosing of trial drug
Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
History of major surgery of the digestive tract (excluding appendectomy)
Any subject who, in the opinion of the investigator, should not participate in the trial
Intervention: Ethanol
Trial phase: Not Applicable
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Three servings per day of epicatechin-rich (75 mg daily) cocoa beverages for six months.

Cocoa
Eligibility criteria:
Inclusion Criteria:

All participants will be age 60 and older.
All participants will have PAD. PAD will be defined as follows. First, an ABI < 0.90 at baseline is an inclusion criterion for PAD. Second, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD will be eligible.

Exclusion Criteria:

Above- or below-knee amputation.
Critical limb ischemia.
Wheelchair-bound or requiring a cane or walker to ambulate.
Walking is limited by a symptom other than PAD.
Baseline six-minute walk value of <500 feet or >1,600 feet
Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months.
Planned revascularization or major surgery during the next six months.
Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. [NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.]
Mini-Mental Status Examination (MMSE) score < 23 or dementia.
Unwilling to attend three visits in one week for final outcome measures.
Allergy to chocolate.
Unwilling or unable to consume products manufactured on the same equipment that processes peanuts, tree nuts, egg, wheat, soy, and milk.
Use of cocoa-containing dietary supplements.
Unwilling to give up major dietary sources of epicatechin during the study.
Symptoms of heart failure or angina that limit walking activity more than ischemic leg symptoms, increase in angina, or angia at rest (i.e. unstable angina).
Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.]
Non-English speaking, a visual impairment that limits walking ability.
In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
Intervention: Omadacycline
Trial phase: Phase 3
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: 368
Group description: Participants received omadacycline 450 milligrams (mg) orally every 24 hours (q24h) for 2 doses, followed by 300 mg orally q24h. The total treatment duration was 7 to 14 days. Participants received active omadacycline tablets and over-encapsulated linezolid placebo tablets.
Eligibility criteria:
Inclusion Criteria:

Patients, ages 18 years or older who have signed the informed consent
Has a qualifying skin and skin structure infection
Female patients 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

Exclusion Criteria:

Infections where the outcome is strongly influenced by factors other than protocol-defined treatments and procedures, or that require antibacterial treatment for greater than 14 days
Evidence of significant immunological 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 linezolid
Has received an investigational drug within the past 30 days
Women who are pregnant or nursing
Intervention: Linezolid
Trial phase: Phase 3
ATC code: J01XX08
SMILES: CC(=O)NC[C@H]1CN(c2ccc(N3CCOCC3)c(F)c2)C(=O)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 367
Group description: Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets.
Eligibility criteria:
Inclusion Criteria:

Patients, ages 18 years or older who have signed the informed consent
Has a qualifying skin and skin structure infection
Female patients 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

Exclusion Criteria:

Infections where the outcome is strongly influenced by factors other than protocol-defined treatments and procedures, or that require antibacterial treatment for greater than 14 days
Evidence of significant immunological 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 linezolid
Has received an investigational drug within the past 30 days
Women who are pregnant or nursing
Intervention: Valbenazine
Trial phase: Phase 2
ATC code: N07XX13
SMILES: COc1cc2c(cc1OC)[C@H]1C[C@@H](OC(=O)[C@@H](N)C(C)C)[C@H](CC(C)C)CN1CC2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Adolescents (12 to 17 years of age) received valbenazine 20 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 40 mg or continue with the participant's current dose for the remainder of the treatment period.
Eligibility criteria:
Inclusion Criteria:

Have participated in and completed the NBI-98854-1501 (T-Force Green) or NBI-98854-1505 (T-Forward) Phase 2 study
Have a clinical diagnosis of Tourette Syndrome (TS)
If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
Adolescent and adult subjects (12 to 64 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen. Subjects who are on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates, or psychostimulants (for subjects with comorbid ADHD) are allowed to participate in the study
Be in good general health

Exclusion Criteria:

Have an active, clinically significant unstable medical condition within 1 month prior to screening
Have a known history of long QT syndrome or cardiac arrhythmia
Have a known history of neuroleptic malignant syndrome
Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
Have a blood loss ≥250 mL or donated blood within 56 days prior to screening (subjects 6 to 17 years of age); have a blood loss ≥550 mL or donated blood within 30 days prior to screening (subjects 18 to 64 years of age)
Have a known history of substance dependence, substance (drug) or alcohol abuse
Have a significant risk of suicidal or violent behavior
Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
Intervention: Valbenazine
Trial phase: Phase 2
ATC code: N07XX13
SMILES: COc1cc2c(cc1OC)[C@H]1C[C@@H](OC(=O)[C@@H](N)C(C)C)[C@H](CC(C)C)CN1CC2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Adults (18 to 64 years of age) received valbenazine 40 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 80 mg or continue with the participant's current dose for the remainder of the treatment period.
Eligibility criteria:
Inclusion Criteria:

Have participated in and completed the NBI-98854-1501 (T-Force Green) or NBI-98854-1505 (T-Forward) Phase 2 study
Have a clinical diagnosis of Tourette Syndrome (TS)
If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
Adolescent and adult subjects (12 to 64 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen. Subjects who are on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates, or psychostimulants (for subjects with comorbid ADHD) are allowed to participate in the study
Be in good general health

Exclusion Criteria:

Have an active, clinically significant unstable medical condition within 1 month prior to screening
Have a known history of long QT syndrome or cardiac arrhythmia
Have a known history of neuroleptic malignant syndrome
Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
Have a blood loss ≥250 mL or donated blood within 56 days prior to screening (subjects 6 to 17 years of age); have a blood loss ≥550 mL or donated blood within 30 days prior to screening (subjects 18 to 64 years of age)
Have a known history of substance dependence, substance (drug) or alcohol abuse
Have a significant risk of suicidal or violent behavior
Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study