anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bimatoprost
Trial phase: Phase 2
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: 13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months.
Eligibility criteria:
Inclusion Criteria:

Completed FSV5-002 study.
Written informed consent prior to any study procedure.
Willingness to comply with the visit schedule.

Exclusion Criteria:

Participation in an investigational drug or device study other than FSV5-002 within the past 6 months or anticipated participation during the study period.
Subjects who will require contact lens use during the study period.
Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.
Intervention: Etonogestrel
Trial phase: Not Applicable
ATC code: G03AC08
SMILES: [H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC(=C)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 100
Group description: Subjects randomized to receive Implanon immediately post-partum.

Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.
Eligibility criteria:
Inclusion Criteria:

English speaking
Aged 18-45 at enrollment (inclusive)
Immediately postpartum of a live singleton infant, 37 weeks gestation, at HUP
Desiring to delay another pregnancy for 6 months
Willing and able to follow the study protocol

Exclusion Criteria:

Breastfeeding during study participation
Plans for relocation outside of Philadelphia in the next six months
Plans for use of weight loss medication or diet pills in the next six months
Women who wish to start Implanon ® or DMPA prior to discharge but who do not want to be randomized. 5. Issues or concerns in the judgment of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
Intervention: delta-(L-alpha-Aminoadipoyl)-L-cysteinyl-glycine
Trial phase: Not Applicable
ATC code: G03GA01
SMILES: NC(CCCC(=O)NC(CS)C(=O)NCC(=O)O)C(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
Blood samples will be obtained at T = -0.5, 0, and +24 hours.
Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
Eligibility criteria:
Inclusion Criteria:

Subjects will be determined to have PCOS based on clinical history of irregular menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on ultrasound
Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start
Subjects will be determined to be normal controls if they have a clinical history of regular periods

Exclusion Criteria:

Women with hemoglobin less than 11 gm/dl at screening evaluation
Women with untreated thyroid abnormalities
Pregnant women or women who are nursing
Women with BMI > 37
Women with known sensitivity to the agents being used
Women with diabetes, or renal, liver, or heart disease
Intervention: Ranolazine
Trial phase: Phase 2
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Participants receiving 500mg twice a day for 2 weeks then 1000mg twice daily of ranolazine for 10 weeks
Eligibility criteria:
Inclusion Criteria:

History of typical angina or effort-induced anginal symptoms and are currently experiencing angina at least once per week
Abnormal stress ECG, exercise stress imaging, or pharmacological stress imaging
Non-obstructive coronary artery disease as defined by lesion stenosis ≤ 50% in any artery as visualized by diagnostic angiography

Exclusion Criteria:

Inability to provide informed consent
Active Myocardial Infarction
History of coronary artery bypass grafting
Diagnosis of other specific cardiac disease such as severe valvular heart disease, cardiomyopathy, or variant angina
Left Ventricular Ejection Fraction (LVEF) < 30%
Known renal insufficiency (CrCl < 30 mL/min) or on dialysis
Contraindications to the use of Ranolazine
Intervention: Tofacitinib
Trial phase: Phase 2
ATC code: L04AA29
SMILES: C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects must have moderate to severe rheumatoid arthritis inadequately controlled by methotrexate as defined by the American College of Rheumatology (ACR) classification criteria for Rheumatoid arthritis, painful and swollen joint counts and C-reactive protein (CRP).
Screening CRP >3 mg/L or CDAI score > 10 at screening or at baseline before vaccination.
Subjects must have active disease at screening and baseline.
Must be at least 50 years of age or older.

Exclusion Criteria:

History of receiving any varicella-zoster virus vaccine
Receipt of any vaccines within 6 weeks of first dose of study treatment.
Subjects with current infections or history of infections.
History of recurrent (more than one episode) of herpes zoster or disseminated (a single episode) of herpes zoster or disseminated (a single episode) of herpes simplex.
Intervention: Brimonidine
Trial phase: Phase 4
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%
Eligibility criteria:
Inclusion Criteria:

Male or Female
18 years of age and older
Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline
Female subjects of childbearing potential must practice a reliable method of contraception throughout the study
Moderate or severe rosacea with an Investigator Global Assessment (IGA) score of 3 or 4
Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization forms

Exclusion Criteria:

Female subjects who are pregnant, breast feeding or who are of childbearing potential and not practicing a reliable method of birthcontrol
History of hypersensitivity or idiosyncratic reaction to any component of the test medications
Subjects who have not completed the proper wash-out periods for prohibited medications and/or procedures
Medical condition that contraindicates the subject's participation in the study
Alcohol or drug abuse is evident within the past 5 years
History of poor cooperation, non-compliance with medical treatment, unreliability
Participation in an investigational drug study within 30 days of the Baseline visit
Intervention: Ranolazine
Trial phase: Phase 2
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Ranolazine 500mg tablet

500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks

Ranolazine: Ranolazine 500mg tablet

500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks
Eligibility criteria:
Inclusion Criteria:

Stable patients >= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)
At least 1 indeterminate stenosis (20-80%), fractional flow reserve (FFR) >=0.8 and PCI deferred

Exclusion Criteria:

Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month
acute coronary syndrome or cardiogenic shock
use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)
use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)
liver cirrhosis
sever renal insufficience (i.e. creatinine clearance < 30mL/min/1.73 m2)
QTc > 500 milliseconds
Intervention: Secnidazole
Trial phase: Phase 2
ATC code: J01RA07 | P01AB07
SMILES: Cc1ncc([N+](=O)[O-])n1CC(C)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Administered orally

SYM-1219
Eligibility criteria:
Inclusion Criteria:

Are females at least 18 years of age in good general health who are not menopausal.
Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
Off-white (milky or gray), thin, homogeneous vaginal discharge
Vaginal pH ≥ 4.7
Presence of clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount
A positive 10% KOH Whiff test.
Have a Gram stain slide Nugent score ≥ 4 at the Baseline visit (Day 1)

Exclusion Criteria:

Are pregnant, lactating, or planning to become pregnant during the study.
Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex.
Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline visit (Day 1).
Intervention: Secnidazole
Trial phase: Phase 2
ATC code: J01RA07 | P01AB07
SMILES: Cc1ncc([N+](=O)[O-])n1CC(C)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Administered orally

SYM-1219
Eligibility criteria:
Inclusion Criteria:

Are females at least 18 years of age in good general health who are not menopausal.
Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
Off-white (milky or gray), thin, homogeneous vaginal discharge
Vaginal pH ≥ 4.7
Presence of clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount
A positive 10% KOH Whiff test.
Have a Gram stain slide Nugent score ≥ 4 at the Baseline visit (Day 1)

Exclusion Criteria:

Are pregnant, lactating, or planning to become pregnant during the study.
Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex.
Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline visit (Day 1).
Intervention: EZOGABINE
Trial phase: Phase 2
ATC code: N03AX21
SMILES: CCOC(=O)Nc1ccc(NCc2ccc(F)cc2)cc1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
Eligibility criteria:
Inclusion Criteria:

Male or female participants, 18-65 years of age;
Current diagnosis of major depressive disorder according as determined by a psychiatrist and confirmed with The Mini-International Neuropsychiatric Interview (MINI);
At least moderate depression severity as defined by a score of >= 21 on the Montgomery-Asberg Depression Rating Scale (MADRS);
At least a moderate level of anhedonia based on a Snaith-Hamilton Pleasure Scale (SHAPS) score ≥ 20;
If female of childbearing potential, must agree to use of a medically accepted form of contraception, or else agree to abstinent;
Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

Exclusion Criteria:

Lifetime diagnosis of schizophrenia or any psychotic disorder, bipolar disorder, obsessive compulsive disorder or pervasive developmental disorders or mental retardation;
Diagnosis of a substance use disorder within the past 6 months (excluding substance use disorder in sustained remission)
Female participants who are pregnant, nursing, for may become pregnant;
Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
Clinically significant abnormalities of laboratories, physical examination, or ECG;
Prolonged QT Interval at screening, operationalized as a QTc of > 480 ms at baseline;
Hypokalemia (potassium value less than 3.5mEq/L) or hypomagnesemia (magnesium value less than 1.6mEq/L) at baseline;
A history of retinal abnormalities (ie, pigment changes, retinal dystrophy) or findings of retinal pathology on ophthalmological exam at baseline
Antidepressant medication within 2 weeks of start of treatment (4 weeks for fluoxetine)*
Other psychotropic medication, including antipsychotics and mood stabilizers within 2 weeks of start of treatment; subjects will be allowed to remain on a stable dose of zolpidem 10 mg nightly for sleep or a benzodiazepine as needed for sleep or anxiety (dosage equivalent to lorazepam 1 mg daily or less)
No current or recent significantly elevated risk of self-harm or violence as determined by the PI.
For subjects who may participate in the MRI portion of the study, claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, and inability to lie still for 1 hour or more.
Intervention: Selurampanel
Trial phase: Phase 2
SMILES: CC(C)c1cc2[nH]c(=O)n(NS(C)(=O)=O)c(=O)c2cc1-c1ccnn1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
Eligibility criteria:
Inclusion Criteria:

Written informed consent had to be obtained before any assessment was performed;
Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;
Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days
At least 1 year had to have elapsed since the patient received his or her last dose of BGG492.

Exclusion Criteria:

- There were no exclusion criteria for this study. All patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments
Intervention: OXYTOCIN
Trial phase: Phase 4
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.

pitocin
Eligibility criteria:
Inclusion Criteria:

Patients with a singleton pregnancy
Term pregnancy (> 37 weeks gestation)
Age ≥ 18 years
Bishop score < 5
Contractions < 6/hr
Reassuring fetal heart tracing

Exclusion Criteria:

Rupture of membranes
Antepartum bleeding
Fetal death
Placenta previa or low lying placenta
Active genital herpes infection
Previous use of an induction or preinduction agent during the current pregnancy
EFW >4500 grams
Non reassuring fetal testing
Inability to pass foley through cervix
Prior cesarean section
Intervention: OXYTOCIN
Trial phase: Phase 4
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.

pitocin
Eligibility criteria:
Inclusion Criteria:

Patients with a singleton pregnancy
Term pregnancy (> 37 weeks gestation)
Age ≥ 18 years
Bishop score < 5
Contractions < 6/hr
Reassuring fetal heart tracing

Exclusion Criteria:

Rupture of membranes
Antepartum bleeding
Fetal death
Placenta previa or low lying placenta
Active genital herpes infection
Previous use of an induction or preinduction agent during the current pregnancy
EFW >4500 grams
Non reassuring fetal testing
Inability to pass foley through cervix
Prior cesarean section
Intervention: Modafinil
Trial phase: Phase 2 | Phase 3
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Eligibility criteria:
Inclusion Criteria:

Receiving standard-of-care therapy for nocturia based on assessment by study physician
Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.
Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary
Epworth Sleepiness Scale Score of at least 10
Clinical Global Impression of Sleepiness at least Moderate
Age 18-90 years inclusive

Exclusion Criteria:

Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment
Sleep disorders other than nocturia based on history and screening assessment
Unstable medical or psychiatry conditions
Medical or psychiatric conditions affecting sleep/wake or urologic function
Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram
Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram
History of substance abuse or dependence in the last year
Regular consumption of over 800 mg of caffeine use
Shift-work in the 3 months prior to or during the study
Intervention: Iron (III) oxide adipate
Trial phase: Phase 2
SMILES: O=C([O-])CCCCC(=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: PT20 400 mg tid (1.2 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Eligibility criteria:
Inclusion Criteria:

Men or women aged 18 90 years
Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
Subject must have the most recent serum phosphate measurement, taken during the 28 days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

Exclusion Criteria:

Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days prior to the start of Screening (Visit 1) is < 18 mg/dL.
Subject has, in the opinion of the investigator, severe chronic lung disease and/or carbon dioxide retention.
Intervention: Iron (III) oxide adipate
Trial phase: Phase 2
SMILES: O=C([O-])CCCCC(=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: PT20 800 mg tid (2.4 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Eligibility criteria:
Inclusion Criteria:

Men or women aged 18 90 years
Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
Subject must have the most recent serum phosphate measurement, taken during the 28 days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

Exclusion Criteria:

Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days prior to the start of Screening (Visit 1) is < 18 mg/dL.
Subject has, in the opinion of the investigator, severe chronic lung disease and/or carbon dioxide retention.
Intervention: Iron (III) oxide adipate
Trial phase: Phase 2
SMILES: O=C([O-])CCCCC(=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: PT20 1600 mg tid (4.8 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Eligibility criteria:
Inclusion Criteria:

Men or women aged 18 90 years
Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
Subject must have the most recent serum phosphate measurement, taken during the 28 days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

Exclusion Criteria:

Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days prior to the start of Screening (Visit 1) is < 18 mg/dL.
Subject has, in the opinion of the investigator, severe chronic lung disease and/or carbon dioxide retention.
Intervention: Iron (III) oxide adipate
Trial phase: Phase 2
SMILES: O=C([O-])CCCCC(=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: PT20 3200 mg tid (9.6 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Eligibility criteria:
Inclusion Criteria:

Men or women aged 18 90 years
Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
Subject must have the most recent serum phosphate measurement, taken during the 28 days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

Exclusion Criteria:

Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days prior to the start of Screening (Visit 1) is < 18 mg/dL.
Subject has, in the opinion of the investigator, severe chronic lung disease and/or carbon dioxide retention.