anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ezetimibe
Trial phase: Phase 4
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: ezetimibe, 10 mg/day, for 7 weeks
Eligibility criteria:
Inclusion Criteria:

male, non-smoker, 21-75 years of age
female, non-smoker, 40-75 years of age
post-menopausal women, as defined by lack of menses for at least 2 years and age >55, OR history of documented bilateral oophorectomy, confirmed with an elevated FSH at screening
low-density lipoprotein (LDL) concentration between 130-200 mg/dL.
triglyceride (TG) concentration <350 mg/dL, inclusive
high-density lipoprotein (HDL) between 30-60 mg/dL for men and 40 -70 mg/dL for women
ability to give informed consent

Exclusion Criteria:

Subject has history of diabetes mellitus, active hepatitis, gall bladder disease, gastric or ileal bypass surgery, irritable bowel syndrome, and gastrointestinal disorder/condition associated with malabsorption, or clinically significant abnormalities on screening (prestudy) physical examination of laboratory tests.
Screening laboratory tests with hematocrit <30%, aspartate aminotransferase/alanine aminotransferase (AST/ALT) >2*upper limit of normal, abnormal thyroid-stimulating hormone (TSH), fasting glucose >=126mg/dL
renal impairment with creatinine clearance (CRCl)<80ml/min
treatment within the last 2 months with drugs known to alter lipid metabolism including beta blockers, thiazide diuretics, bile acid resins, statins, ezetimibe, niacin, fibrates, plant stanol esters (eg Benecol,phyto sterols) and fishoils
history of known coronary heart disease (CHD), stroke or prior revascularization procedure or peripheral vascular disease
history of allergy to egg or soy products
current or recent (past 12 months) of drug abuse or alcohol abuse. Alcohol use must be limited to no more than 2 drinks/day (1 drink=12 oz beer, 5 oz wine, or 1.5 oz hard liquor). Subject must be willing to avoid large day-to-day fluctuations in alcohol intake.
participation in another clinical trial or exposure to any investigational agent within 30 days prior to Visit 1
Individual has a condition the Principal Investigator believes would interfere with his/her ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results, or put the subject at undue risk
Intervention: FLORBETAPIR
Trial phase: Phase 2
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 184
Group description: All subjects receiving florbetapir F 18 injection
Eligibility criteria:
Inclusion Criteria AD:

Male or female >=50 years of age
Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24

Inclusion Criteria MCI:

Male or female >=50 years of age
Have a Clinical Dementia Rating (CDR) of 0.5
MMSE >24

Normal subjects:

Male or female >=50 years of age
MMSE >=29
Normal on psychometric test battery at screening
Provide informed consent

Exclusion Criteria:

Have a history or current diagnosis of other neurologic disease
Have had or currently have a diagnosis of other neurodegenerative disease
Have participated in experimental therapy targeted to amyloid plaque
Intervention: Atomoxetine
Trial phase: Not Applicable
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: 40mg atomoxetine twice a day for 2 weeks

atomoxetine :
Eligibility criteria:
Inclusion Criteria:

History of TBI
Moderate to severe TBI as indicated by Glasgow Coma Score (GCS) score of 12 or less; or Post Traumatic Amnesia (PTA) of seven days or more
at least one year post injury
between the ages of 18-65 (inclusive)
symptoms consistent with attentional dysfunction
consent to participate in study

Exclusion Criteria:

history of any conditions that would prohibit standard neuropsychological testing
non-English speaking (to the extent that would limit ability to complete study measures)
prior history of significant psychiatric illness requiring hospitalization
epilepsy
cardiovascular disease or risks including: dysrhythmias, angina, myocardial infarction, uncontrolled hypertension, valvular heart disease including mitral valve prolapse
use of any monoamine oxidase inhibitor or any other drug affecting brain monoamine concentrations
severe renal or hepatic impairment
pregnant or lactating
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits

Exclusion Criteria:

Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:

Six months or more (immediately prior to Screening Visit) without a menstrual period, or
Prior hysterectomy, or
Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
Documented endometriosis or active pelvic inflammatory disease (PID);
Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;

Use of prohibited concomitant medications:

Depo-Provera use must cease ten months prior to first dose of study drug, or
GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits

Exclusion Criteria:

Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:

Six months or more (immediately prior to Screening Visit) without a menstrual period, or
Prior hysterectomy, or
Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
Documented endometriosis or active pelvic inflammatory disease (PID);
Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;

Use of prohibited concomitant medications:

Depo-Provera use must cease ten months prior to first dose of study drug, or
GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Intervention: Sugammadex
Trial phase: Phase 3
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
ASA class 1-3
Creatinine clearance (CLcr) < 30 mL/min and no anticipated clinical

indication for high flux hemodialysis during first 24 hours after

sugammadex administration (for renally impaired group) or CLcr >= 80

mL/min (for control group)

-Scheduled for a surgical procedure under general anesthesia with propofol

requiring neuromuscular relaxation with the use of rocuronium

Scheduled for a surgical procedure in supine position
Written informed consent

Exclusion Criteria:

- Subjects known or suspected to have neuromuscular disorders impairing

neuromuscular blockade and/or significant hepatic dysfunction

Subjects scheduled for renal transplant surgery
Subjects known or suspected to have a (family) history of malignant

hyperthermia

-Subjects known or suspected to have an allergy to narcotics, muscle

relaxants or other medication used during general anesthesia

Subjects receiving fusidic acid, toremifene and/or flucloxacillin
Subjects who have already participated in a sugammadex trial
Subjects who have participated in another clinical trial, not pre-approved

by the sponsor, within 30 days of entering into 19.4.328 (P05769)

Female subjects who are pregnant
Female subjects who are breast-feeding
Intervention: Sugammadex
Trial phase: Phase 3
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
ASA class 1-3
Creatinine clearance (CLcr) < 30 mL/min and no anticipated clinical

indication for high flux hemodialysis during first 24 hours after

sugammadex administration (for renally impaired group) or CLcr >= 80

mL/min (for control group)

-Scheduled for a surgical procedure under general anesthesia with propofol

requiring neuromuscular relaxation with the use of rocuronium

Scheduled for a surgical procedure in supine position
Written informed consent

Exclusion Criteria:

- Subjects known or suspected to have neuromuscular disorders impairing

neuromuscular blockade and/or significant hepatic dysfunction

Subjects scheduled for renal transplant surgery
Subjects known or suspected to have a (family) history of malignant

hyperthermia

-Subjects known or suspected to have an allergy to narcotics, muscle

relaxants or other medication used during general anesthesia

Subjects receiving fusidic acid, toremifene and/or flucloxacillin
Subjects who have already participated in a sugammadex trial
Subjects who have participated in another clinical trial, not pre-approved

by the sponsor, within 30 days of entering into 19.4.328 (P05769)

Female subjects who are pregnant
Female subjects who are breast-feeding
Intervention: Citalopram
Trial phase: Not Applicable
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Escitalopram 20mg qd
Eligibility criteria:
Inclusion Criteria:

Age:40~90 years
Education:not illiterate
Clinical Dementia Rating (CDR):0.5~2
Modified Hachinski Ischemic Score (Rosen et al., 1979):less than 4
Dementia according to DSM-IV criteria
Probable Alzheimer's disease according to NINCDS-ADRDA criteria
Current ongoing donepezil medication at stable doses (5 ~ 10 mg/day) for at least 2 months

Exclusion criteria:

Evidence of delirium, confusion or altered consciousness
Evidence of Parkinson's disease, stroke, brain tumor and normal pressure hydrocephalus
Evidence of infectious or inflammatory brain disease
Evidence of serious cerebrovascular diseases
Current major depressive disorder or other major psychiatric illnesses
Evidence of serious or unstable medical illnesses which can significantly change cognitive state
History of alcohol or other substance dependence
Any antidepressant medications within the previous 4 weeks
Absence of a reliable and cooperative collateral informant
Any conditions which prohibit MRI scan, such as presence of pacemaker or cerebrovascular clip, and claustrophobia
Evidence of focal brain lesions on MRI including lacunes and white matter hyperintensity lesions of grade 2 or more by Fazeka scale
Intervention: Metformin Hydrochloride
Trial phase: Not Applicable
SMILES: CN(C)C(=N)N=C(N)N.Cl
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration

Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months
Eligibility criteria:
Inclusion Criteria:

Premenopausal women between 18-45 years of age and BMI less than 42
Diagnosed with PCOS as defined by the Rotterdam criteria, which is a combination of any two of the following three criteria: 1) chronic oligo- or amenorrhea (<8 menstrual periods annually); 2) biochemical or clinical androgen excess; and 3) polycystic ovaries on ultrasonography -Normal thyroid function tests and serum prolactin; and exclusion of 21 alpha hydroxylase deficiency by a fasting 17 alpha hydroxyprogesterone less than 200 ng/dl -In acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20,urinanalysis) -Able to provide signed, witnessed informed consent -Able to comply with study requirements

Exclusion Criteria:

-Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary, cardiac,renal,hepatic,neurologic,psychiatric,infectious,neoplastic and malignant disease (other than non-melanoma skin cancer) -Current use of oral contraceptives; use of fertility drugs within 6 months of study -Current or recent use (within 3 months prior to study entry) of metformin -Documented or suspected recent (within one year)history of drug abuse or alcoholism -Ingestion of any investigational drug within two months prior to study onset.
Intervention: Bromfenac Sodium
Trial phase: Phase 3
SMILES: Nc1c(CC(=O)[O-])cccc1C(=O)c1ccc(Br)cc1.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
Eligibility criteria:
Inclusion Criteria:

Scheduled for cataract surgery

Exclusion Criteria:

Known hypersensitivity to bromfenac and salicylates
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 343
Group description: 750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
Eligibility criteria:
Inclusion Criteria:

Subjects ≥ 18 years of age and able to give informed consent
Iron deficiency is the primary etiology of anemia
Screening Visit central laboratory Hemoglobin (Hgb) ≤ 11g/dL
Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL when TSAT was ≤ 30%

Exclusion Criteria:

Previous participation in a FCM trial
Known hypersensitivity reaction to FCM
Requires dialysis for treatment of chronic kidney disease
Current anemia not attributed to iron deficiency
Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
Anticipated need for surgery
AST or ALT greater than 1.5 times the upper limit of normal
Received an investigational drug within 30 days of screening
Pregnant or sexually-active females who are not willing to use an effective form of birth control
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: 15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
Eligibility criteria:
Inclusion Criteria:

Subjects ≥18 years of age and able to give informed consent
Iron deficiency is the primary etiology of anemia
History of intolerance or an unsatisfactory response to oral iron
Screening Visit central laboratory Hgb ≤11 g/dL
Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria:

Previous participation in a FCM trial
Known hypersensitivity reaction to FCM or iron dextran
Requires dialysis for treatment of chronic kidney disease
Current anemia not attributed to iron deficiency
Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
Anticipated need for surgery during the 30 day period prior to screening or during the study period
AST or ALT greater than 1.5 times the upper limit of normal
Received an investigational drug within 30 days of screening
Women who are breastfeeding
Pregnant or sexually-active females who are not willing to use an effective form of birth control
Intervention: Conferon
Trial phase: Phase 3
SMILES: O=S(=O)(O)O.[Fe]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Eligibility criteria:
Inclusion Criteria:

Subjects ≥18 years of age and able to give informed consent
Iron deficiency is the primary etiology of anemia
History of intolerance or an unsatisfactory response to oral iron
Screening Visit central laboratory Hgb ≤11 g/dL
Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria:

Previous participation in a FCM trial
Known hypersensitivity reaction to FCM or iron dextran
Requires dialysis for treatment of chronic kidney disease
Current anemia not attributed to iron deficiency
Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
Anticipated need for surgery during the 30 day period prior to screening or during the study period
AST or ALT greater than 1.5 times the upper limit of normal
Received an investigational drug within 30 days of screening
Women who are breastfeeding
Pregnant or sexually-active females who are not willing to use an effective form of birth control
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 366
Group description: Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
Eligibility criteria:
Inclusion Criteria:

Subjects ≥18 years of age and able to give informed consent
Iron deficiency is the primary etiology of anemia
Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria:

Previous participation in a FCM trial
Known hypersensitivity reaction to FCM
Requires dialysis for treatment of chronic kidney disease
Current anemia not attributed to iron deficiency
Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
Anticipated need for surgery requiring general anesthesia 30 days prior to screening or during the study period
AST of ALT greater than 1.5 times the upper limit of normal
Received an investigational drug within 30 days of screening
Pregnant or sexually-active females who are not able to use an effective form of birth control
Intervention: Bromfenac
Trial phase: Phase 3
ATC code: S01BC11
SMILES: Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
Eligibility criteria:
Inclusion Criteria:

Scheduled for cataract surgery

Exclusion Criteria:

Known hypersensitivity to bromfenac and salicylates
Intervention: Ephedrine
Trial phase: Phase 3
ATC code: A08AA56 | C01CA26 | R01AA03 | R01AB05 | R01BA02 | R01BA52 | R03CA02 | S01FB02
SMILES: CN[C@@H](C)[C@@H](O)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Placebo

Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day
Eligibility criteria:
Inclusion Criteria:

Age 18 to 65.
History of allergic rhinitis.
The ability to be placed on placebo without significant compromise in the quality of life.
General good health.
Ability to comply with the protocol and sign an informed consent.
Have daytime sleepiness by history.
Have poor sleep by history.
Have fatigue by history.
Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite) with correlating symptoms.

Exclusion Criteria:

Age fewer than 18 or over 65 years.
A history of sleep apnea.
Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma.
Non-allergic rhinitis.
Hypertension
Diabetes Mellitus
Inability to tolerate pseudoephedrine
Significant other diseases as determined by the investigator.
Use of a research medication within 30 days.
Use of a nasal steroid or topical antihistamine or decongestant within 30 days.
Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or H2-blockers.
Excessive use of alcohol or drug abuse.
Inability to stop medication use during run-in period.
Use of an oral antihistamine within 1 week of enrollment.
Failed to have benefit when pseudoephedrine was used for rhinitis or asthma in the past