anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Buprenorphine/samidorphan
Trial phase: Phase 3
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.NC(=O)c1ccc2c(c1O)C13CCN(CC4CC4)C(C2)C1(O)CCC(=O)C3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 175
Group description: All subjects assigned to ALKS 5461

Sublingual tablets

ALKS 5461: samidorphan + buprenorphine administered sublingually
Eligibility criteria:
Inclusion Criteria:

Completed study ALK5461-217
Be willing to abide by the contraception requirements as outlined in the study protocol
Be willing and able to follow the study procedures and visits as outlined in the protocol
Additional criteria may apply

Exclusion Criteria:

Pregnant, planning to become pregnant, or breastfeeding
A positive urine drug test for drugs of abuse
Poses a current suicide risk
Additional criteria may apply
Intervention: Frovatriptan
Trial phase: Not Applicable
ATC code: N02CC07
SMILES: CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 37
Group description: Receiving D5W

D5W
Eligibility criteria:
Inclusion Criteria:

Age >18 years old and <100 years old.
Patients seen in the Emergency Department at Henry Ford Macomb hospital.
Patients that are A+Ox3.
Patients who have typical presentation for renal colic.

Exclusion Criteria:

Age <18 years.
Patients with a history of dementia, acute delirium or altered mental status.
Patients with inability to consent to study or inability to fill questionnaire independently.
Patients with chronic kidney disease and allergies to study drugs.
Patients that are pregnant (women who are of child-bearing potential will be screened with a urine BHCG).
Patients with stroke activation or symptoms.
Patients with trauma activations.
Patients over the age of 100 years old are excluded as they make up a small percentage of the population and may become identifiable because of their age.
Imaging study does not show evidence of ureteral stone.
Intervention: Ketamine Hydrochloride
Trial phase: Phase 4
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O.Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Ketamine trials
Eligibility criteria:
Inclusion Criteria:

18-45 years of age
Healthy
Non-obese (body mass index less than 30 kg/m2)
Body mass greater than or equal to 65 kg

Exclusion Criteria:

Subjects not in the defined age range
Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
Any known history of renal or hepatic insufficiency/disease
Pregnancy or breast feeding
Body mass less than 65 kg
Current smokers, as well as individuals who regularly smoked within the past 3 years
Positive urine drug screen
Currently taking pain modifying medication(s)
Intervention: Povidone iodine
Trial phase: Phase 2 | Phase 3
SMILES: C=CN1CCCC1=O.II
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Subjects will receive vaginal preparation with povidine-iodine.

Povidine-iodine: Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.
Eligibility criteria:
Intervention Group (vaginal preparation)

Inclusion Criteria:

Pregnant women admitted for cesarean delivery
Gestational age greater than or equal to 34 weeks

Exclusion Criteria:

Rupture of membranes or active labor
Chorioamnionitis (prior to enrollment)
Recent (within 4 weeks) antibiotic exposure
Maternal HIV infection or immunocompromised state
Known allergy to shellfish, iodine, or chlorhexidine
Intervention: Hydrocodone Bitartrate
Trial phase: Phase 1
SMILES: COc1ccc2c3c1OC1C(=O)CCC4C(C2)N(C)CCC314.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state
Eligibility criteria:
Inclusion Criteria:

Males and/or females between the ages of 19 and 55 years, inclusive.

Females of childbearing potential were using one of the following acceptable birth control methods:

Intrauterine device (IUD) in place for at least 3 months prior to study;
Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through 30 days beyond study completion;
Stable hormonal contraceptive for at least 3 months prior to study through 30 days beyond completion of study;

Abstinence was not an acceptable form of contraception.

Females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 3 months prior to study) or postmenopausal <2 years. An FSH >40 mIU/mL was obtained and in the record.

Good general health was determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measures.
Within 15% of Ideal Body Weight as defined by the 1983 Metropolitan Life chart.
Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 1 year.
Able to read, understand, and sign the informed consent after the nature of the study had been explained.
Negative finding on tests for Hepatitis B and C antigen as well as HIV and pregnancy test (if female).
Negative urine screen for drugs of abuse and alcohol at screening and the first check in.
Non-alcohol or drug abuser - for alcohol, defined as history of less then 4 drinks daily.

Exclusion Criteria:

Clinically significant abnormalities detected by medical history, physical, ECG, or clinical laboratory findings (as determined by the Principal Investigator). Any disease or condition which impacted absorption, distribution, metabolism, or elimination of the study drugs.
Females who were pregnant or nursing.
History of hypersensitivity reaction to the study drugs or related compounds, such as other opioids.
Receipt of an investigational drug within 1 month prior to study enrollment.
Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior study enrollment.
Known or suspected use of illicit drugs (including codeine or hydrocodone, etc.).
The use of any medication on a chronic basis with the exception of oral contraceptives for women of childbearing potential. An appropriate drug-free period for prescription or over-the-counter (OTC) drugs provided to washout any especially long half-life drugs.
Consumption of alcohol within 48 hours prior to each dosing period.
Consumption of grapefruit 14 days prior to dosing and throughout the study.
Hemoglobin value < 12 g/dL. If a subject's hemoglobin dropped below 11.0 g/dL the subject was dropped from the study at the Principal Investigator's discretion.
Intervention: Glycerin
Trial phase: Phase 4
ATC code: A06AG04 | A06AX01
SMILES: OCC(O)CO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: 27 women randomized to Glycerin suppository

Glycerin Suppository: Glycerine rectal suppository
Eligibility criteria:
Inclusion Criteria:

between ages 18 and 75,
undergoing level I total laparoscopic or robot-assisted hysterectomy with or without bilateral salpingo-oophorectomy, cystoscopy, lysis of adhesions, or surgical treatment of endometriosis

Exclusion Criteria:

contraindications to the use of B&O (i.e. glaucoma, severe hepatic or renal disease, bronchial asthma, history of narcotic idiosyncracies, respiratory depression, convulsive disorders, acute alcoholism or delirium tremens, or regular use of an anticholinergic medication (twice per week or more frequently)
additional surgical procedures being performed
Intervention: Iron sucrose
Trial phase: Phase 4
ATC code: B03AB02 | V03AE05
SMILES: O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 88
Group description: Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
Eligibility criteria:
Inclusion Criteria:

All prevalent haemodialysis patients, established for greater than 3 months

Exclusion Criteria:

Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active infection Active malignancy Frail with either frequent hospital admissions or unable to follow trial protocol due to differing target haemoglobin
Intervention: Chlordiazepoxide
Trial phase: Phase 2
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 20
Group description: 9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)

Heparin: Medication administered to dwell in central venous catheter
Eligibility criteria:
Inclusion Criteria:

Age 0 - ≤ 18 years old
PICU admission
CVC placed within 72 hours of enrollment (tunneled such as peripherally inserted central catheter (PICC), Broviac or Hickman, or untunneled) and in place during hospitalization

Exclusion Criteria:

Pregnancy
Non-English-speaking subjects and/or parent/guardian
Platelet count < 20,000
Active CVC infection-defined as positive blood culture from the in -situ CVC at time of enrollment
Current radiographically confirmed VTE
Currently receiving treatment doses of anticoagulation (heparin infusion >15U/kg/hr, enoxaparin injections >=2mg/kg/day or >=60mg/day)
CVC diameter <1.9 Fr
Current or previous diagnosis of Heparin Induced Thrombocytopenia or allergy to heparin or t-PA
Med-a-port catheters
Intervention: Zuranolone
Trial phase: Phase 3
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 192
Group description: Participants self-administered SAGE-217 30 mg capsules, orally, once daily in the evening with food for 14 days.
Eligibility criteria:
Inclusion Criteria:

Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32 and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at screening and Day 1 (prior to dosing).

Exclusion Criteria:

Participant had active psychosis.
Participant had attempted suicide associated with the current episode of MDD.
Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Intervention: Zuranolone
Trial phase: Phase 2
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Participants self-administered SAGE-217, 30 mg, oral capsule, QD, in the evening, from Day 1 to Day 14.
Eligibility criteria:
Inclusion Criteria:

1. Participant had a documented history of hypomanic or manic episode and a diagnosis of bipolar I or bipolar II disorder with a current major depressive episode.

Exclusion Criteria:

Participant had a history of suicide attempt.
Participant had current suicidal ideation with plans.
Participant had a history of rapid cycling bipolar disorder.
Intervention: Elocon
Trial phase: Phase 4
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.

Mometasone Nasal Spray: Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.
Eligibility criteria:
Inclusion Criteria:

12-weeks or longer of two or more of the following signs and symptom consistent with CRS:

mucopurulent drainage(anterior, posterior, or both)
nasal obstruction (congestion)
facial pain-pressure-fullness
and decreased sense of smell

AND inflammation documented by one or more of the following findings:

purulent mucus or edema in the middle meatus or ethmoid region
radiographic imaging showing inflammation of the paranasal sinuses.

Exclusion Criteria:

inability to speak or understand English
nasal polyps
history of nasal or sinus surgery
comorbid mucociliary conditions
dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease
history of oral or systematic antibiotic use in the past 2 weeks
history of allergy to MF or other topical steroids
pregnant or breastfeeding
participants with a baseline SNOT-22 score of 9 or less will be excluded due to inability to achieve a minimally clinically improved difference pre- and post-intervention.
Intervention: Ornithine phenylacetate
Trial phase: Phase 2
SMILES: NCCCC(N)C(=O)O.O=C(O)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
Eligibility criteria:
Key Inclusion Criteria:

A potential participant may only be included if (at screening), he/she:

Understands the study and has signed informed consent
Is an adult, not pregnant or lactating
Has cirrhosis of the liver
Has had 1 instance of HE within 12 months
Has hyperammonaemia defined as ≥37 μmol/L at screening

Key Exclusion Criteria:

A potential participant will be excluded if (at screening), he/she:

Has contraindicated allergies
Expects liver transplant within 1 month
Has had a liver shunt within the last 3 months
Has inadequate kidney, gastrointestinal, or cardiac function

Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:

the safety and well-being of the participant or potential offspring
the safety of study staff
the analysis of results
Intervention: CID 118984462
Trial phase: Phase 2
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 132
Group description: Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):

dipeptidyl peptidase-4 (DPP-4) inhibitors
sodium-glucose cotransporter (SGLT-2) inhibitors
biguanides
alpha-glucosidase inhibitors
sulfonlyureas
HbA1c value of 6.5% to 10%, inclusive
Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

Exclusion Criteria:

Type 1 diabetes mellitus or latent autoimmune diabetes
Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2
Active or untreated malignancy
Chronic (>14 days) systemic glucocorticoid therapy
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 252
Group description: During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).

Cariprazine: Cariprazine supplied in capsules
Eligibility criteria:
Inclusion Criteria:

Written informed consent has been obtained.
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
Patient must be an outpatient at the time of Visit 1 (Screening).
Patient meets the DSM-5 criteria for MDD based on SCID-5, with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
Diagnosis of MDD confirmed through a formal adjudication process.
Patient demonstrates ability to follow study instructions and likely to complete all required visits.
Patient must have an inadequate response, as measured by the modified ATRQ, to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
Male and female patients must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.
Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria:

Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.
Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 252
Group description: During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).

Cariprazine: Cariprazine supplied in capsules
Eligibility criteria:
Inclusion Criteria:

Written informed consent has been obtained.
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
Patient must be an outpatient at the time of Visit 1 (Screening).
Patient meets the DSM-5 criteria for MDD based on SCID-5, with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
Diagnosis of MDD confirmed through a formal adjudication process.
Patient demonstrates ability to follow study instructions and likely to complete all required visits.
Patient must have an inadequate response, as measured by the modified ATRQ, to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
Male and female patients must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.
Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria:

Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.
Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.