anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: TESTOSTERONE UNDECANOATE
Trial phase: Phase 4
SMILES: CCCCCCCCCCC(=O)O[C@H]1CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Participants in this group will receive Jatenzo for 26 consecutive weeks.

Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Eligibility criteria:
Inclusion Criteria:

Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
Males between 18 and 65 years of age.
Documented diagnosis of testosterone deficiency.
Prior treatment with testosterone therapy at the time of enrollment with adequate control of low testosterone symptoms. Serum total testosterone < 300 ng/dL on 2 measurements prior to the initiation of testosterone therapy. Patients must have completed an adequate washout period following prior testosterone therapy (4 weeks for gels and injection based therapies and 16 weeks for subcutaneous pellets).
Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

History of significant sensitivity or allergy to androgens or product excipients.
Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up or abnormal ECG.
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points.
Body mass index (BMI) ≥ 40 kg/m2.

Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:

Baseline hemoglobin > 16 g/dL
Hematocrit < 35% or > 50%
Poorly controlled blood pressure as defined by Systolic Blood Pressure (SBP) >150 or Diastolic Blood Pressure (DBP) > 90 on two separate measurements
Concurrent use of any prohibited medications that can affect testosterone levels or metabolism.
History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
History of stroke or myocardial infarction within the past 5 years.
History of, or current or suspected, prostate or breast cancer.
History of, or current or suspected, pituitary abnormality.
History of diagnosed, severe, untreated, obstructive sleep apnea.
History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
Inability to understand and provide written informed consent for the study.
Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Jatenzo
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 100
Group description: Lyrica (Pregabalin) 75mg PO 2 hours before the operation

Dexdor (Dexmedetomidine) 0.8µg/kg/h IV Per-operative / Post-operative

Ketalar (Ketamine) Bolus (0.5mg/kg) + 0.3mg/kg/h IV Per-operative until stop propofol

Linisol (Lidocain) Bolus (1.5mg/kg) + 1.3mg/kg/h IV Per-operatiive until 12h post-op

Magnesium Sulphate Induction (25mg/kg) + 25mg/kg weaning ECC IV Per-operative

Fentanyl 2.5µg/kg IV Per-operative

Paracetamol 4x1g /24u IV Post-operative

Tradonal (Tramadol) 100mg IV 4/d IV Post-operative in case of Break through pain

Oxynorm (Oxycodon) 5-10mg 4-6/d PO Post-operative in case of Break through pain

Dexmedetomidine: The use of multimodal painkillers pre, per and postoperative
Eligibility criteria:
Inclusion Criteria:

Patients undergoing first time cardiac surgery by median sternotomy
Elective surgery or semi-urgent: there needs to be time to provide 1 hour before surgery the intake of pregabalin
≥ 18 years for men
Women who are in menopause
Possibility to communicate with the patient to score pain and comfort
Signed Informed Consent, signed by subject able and willing to provide written informed consent for study participation

Exclusion Criteria:

Urgent surgery
Women who are in premenopause
Hypersensitivity to any of the study medication
In case of direct postoperative revision the patient is NOT excluded.
Intervention: Opioid
Trial phase: Phase 4
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1.CCOC(=O)C1(c2ccccc2)CCN(C)CC1.COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Opioid Analgesic: Patients will be provided a prescription for low dose opioids for 5 days postoperatively (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) to be taken every 6 hours as needed for pain. Refills may be provided (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) if requested by the patient at the providers discretion. In addition, patients will also be prescribed Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily and a muscle relaxer (Methocarbamol 750mg BID or Flexeril 5-10 mg TID) as needed for spasms. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.
Eligibility criteria:
Inclusion Criteria:

Radiographic evidence of degenerative cervical spine disease
Failure of conservative therapy
Age ≥18 years
Skeletal maturity.

Exclusion Criteria:

Preoperative chronic opioid use as determined by self report (>45 out of past 90 days)
History of chronic kidney disease
Revision cervical spine surgery
Concurrent posterior cervical fusion
Does the patient have an intolerance to NSAIDs (non-steroidal anti-inflammatory drugs)?
Does the patient have any preexisting health condition the study physician believes will be exacerbated by participating in this study?
Intervention: Iron
Trial phase: Phase 4
ATC code: A11AA01 | B03AE01 | B03AE02 | B03AE03 | B03AE04
SMILES: [Fe]
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning.
Eligibility criteria:
Inclusion Criteria:

Age 9 years or greater and less than age 22 years
Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score >100
Iron deficiency anemia, defined as both hemoglobin <12 g/dL and ferritin <15 ng/mL within 7 days of enrollment.

Exclusion Criteria:

non-uterine cause of vaginal bleeding
pregnancy
chronic kidney disease
serology confirmed celiac disease
active gastrointestinal blood loss
active malignancy
inability to follow-up at Texas Children's Hospital
receipt of intravenous iron within 30 days prior to enrollment
allergy or known inability to tolerate oral iron
Intervention: Iron
Trial phase: Phase 4
ATC code: A11AA01 | B03AE01 | B03AE02 | B03AE03 | B03AE04
SMILES: [Fe]
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
Eligibility criteria:
Inclusion Criteria:

Age 9 years or greater and less than age 22 years
Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score >100
Iron deficiency anemia, defined as both hemoglobin <12 g/dL and ferritin <15 ng/mL within 7 days of enrollment.

Exclusion Criteria:

non-uterine cause of vaginal bleeding
pregnancy
chronic kidney disease
serology confirmed celiac disease
active gastrointestinal blood loss
active malignancy
inability to follow-up at Texas Children's Hospital
receipt of intravenous iron within 30 days prior to enrollment
allergy or known inability to tolerate oral iron
Intervention: Finerenone
Trial phase: Phase 2
ATC code: C03DA05
SMILES: CCOc1ncc(C)c2c1[C@H](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 951
Group description: Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.
Eligibility criteria:
Inclusion Criteria:

This study will only include participants who were enrolled in the FIGARO-DKD study (NCT02545049) and had received up to 20 mg finerenone or placebo for ≥24 months.
For each participant, pharmacokinetic (PK) plasma samples from Visit 3 and at least 2 other Visits (Visit 5, Visit 8, Visit 11) must be available on storage from the main study FIGARO-DKD.

Exclusion Criteria:

Participants which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD.
Participants which were not part of the full analysis set (FAS) of FIGARO-DKD.
Participants with known fatal outcome.
Participants with baseline estimated glomerular filtration rate (eGFR) ≤25 mL/min/1.73m^2.
Participants with low baseline risk (normal albuminuria and eGFR≥60 mL/min/1.73m^2).
Sponsor request (after discussion with the investigator), for reasons such as a significant protocol deviation.
Intervention: Pirtobrutinib
Trial phase: Phase 3
ATC code: L01EL05
SMILES: COc1ccc(F)cc1C(=O)NCc1ccc(-c2nn([C@@H](C)C(F)(F)F)c(N)c2C(N)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Eligibility criteria:
Inclusion Criteria:

Study participant must be at least 19 years of age at the time of signing the informed consent
Study participant must be a Korean adult with a diagnosis of moderate to severe psoriasis (PSO)
Study participant must have had plaque PSO for at least 6 months prior to the Screening Visit
Study participant must have Psoriasis Area and Severity Index (PASI) ≥12 and body surface area (BSA) affected by PSO ≥10% and Investigator's Global Assessment (IGA) score ≥3 on a 5-point scale
Study participant must be a candidate for systemic PSO therapy and/or phototherapy
Study participant agrees not to change their usual sun exposure during the course of the study and to use ultraviolet A/ultraviolet B sunscreens if unavoidable exposure occurs
A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a female of childbearing potential (FOCBP) OR A FOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 20 weeks after the last dose of study treatment

Exclusion Criteria:

Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections
Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Study participant has a presence of active suicidal ideation or positive suicide behavior
Study participant has a presence of moderately severe major depression or severe major depression
Subject has a known hypersensitivity to any excipients of bimekizumab
Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
Intervention: Brinzolamide
Trial phase: Phase 3
ATC code: G01AE10 | S01EC04 | S01EC54
SMILES: CCN[C@H]1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 297
Group description: Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Eligibility criteria:
Inclusion Criteria:

Male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.
Provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure.
Be able and willing to follow study instructions and complete all required visits.
Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.

Exclusion Criteria:

Subjects with angle closure glaucoma
Females who are pregnant, breast feeding, or planning a pregnancy.
Females of childbearing potential who do not agree to utilize an adequate form of contraception.
Current, or past history of, severe hepatic or renal impairment
Current, or history within 2 months prior to baseline of, significant ocular disease
Functionally significant visual field loss
Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
Subjects currently in another clinical trial
Intervention: Brinzolamide
Trial phase: Phase 3
ATC code: G01AE10 | S01EC04 | S01EC54
SMILES: CCN[C@H]1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 300
Group description: Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Eligibility criteria:
Inclusion Criteria:

Male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.
Provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure.
Be able and willing to follow study instructions and complete all required visits.
Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.

Exclusion Criteria:

Subjects with angle closure glaucoma
Females who are pregnant, breast feeding, or planning a pregnancy.
Females of childbearing potential who do not agree to utilize an adequate form of contraception.
Current, or past history of, severe hepatic or renal impairment
Current, or history within 2 months prior to baseline of, significant ocular disease
Functionally significant visual field loss
Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
Subjects currently in another clinical trial
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
Eligibility criteria:
Inclusion Criteria:

Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
Have a history of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

Have Diabetes Mellitus
Have a self-reported change in body weight >5 kg within 3 months prior to screening
Have obesity induced by other endocrinological disorders
Have had a history of chronic or acute pancreatitis
Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years
Have any lifetime history of a suicide attempt
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Intervention: ALK-4290
Trial phase: Phase 2
SMILES: Cc1cc(C(=O)N(C)C)cc(NC(=O)[C@H]2CCC(=O)N2C2CCN(Cc3ccc(Cl)c(C)c3)CC2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Subjects will receive AKST4290, 400mg twice daily, for 24 weeks

AKST4290: Oral AKST4290
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years.
Type 1 or type 2 DM.
BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.
Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).

Exclusion Criteria:

Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.
PRP or grid laser within 1000 microns of the foveal center.
Center-InvolvedI-Diabetic Macular Edema (CI-DME) on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).
Prior Intraocular of periocular steroid Injection
Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.
History of vitreoretinal surgery.
History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
History of DME or DR treatment with laser or intraocular injections of medication.
Medical history or condition that, in the opinion of the investigator would preclude participation in the study.
Clinically relevant abnormal laboratory value at Screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the Screening phase).
Malignancy for which the participant has undergone resection, radiation, or chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed).
Concurrent participation in another interventional clinical trial; prior clinical trial participants must have been off study agents for at least 30 days for small molecules, 4 months for disease modifying therapies, and 1 year for vaccine or immunotherapy trials prior to Screening.
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Intravenous Lidocaine: Patient will receive intravenous lidocaine 1.0-1.5 mg/kg/hour for 48 hours post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
Eligibility criteria:
Inclusion Criteria:

Unilateral renal transplant

Exclusion Criteria:

History of chronic pain, chronic opioid use, or opioid use disorder
Cardiac arrythmia, cardiac failure
Hepatic Failure
Local anesthetic allergy (allergy to lidocaine and ropivacaine)
Complicated surgical course including intraoperative damage to other organs (bowel)
Return to operating room within 72hours
Intervention: Ferrous Sulfate
Trial phase: Phase 4
ATC code: B03AA07
SMILES: O=S(=O)([O-])[O-].[Fe+2]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.

Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.

Ferrous sulfate: one tablet 325 milligrams three times a day
Eligibility criteria:
Inclusion Criteria:

Delivery at our institution
Hemoglobin below 9 g/dl in postpartum day 1
Singleton gestation

Exclusion Criteria:

Diagnosis of malabsorptive disorder or history of gastric bypass procedure
Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)
Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure
Patient has received blood transfusion or there is a plan to transfuse
Lactose intolerance
Intervention: Conferon
Trial phase: Phase 4
SMILES: O=S(=O)(O)O.[Fe]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.

Oral placebo will be given by mouth for a total of 6 weeks TID.

Iron dextran: 1000 mg intravenous infusion
Eligibility criteria:
Inclusion Criteria:

Delivery at our institution
Hemoglobin below 9 g/dl in postpartum day 1
Singleton gestation

Exclusion Criteria:

Diagnosis of malabsorptive disorder or history of gastric bypass procedure
Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)
Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure
Patient has received blood transfusion or there is a plan to transfuse
Lactose intolerance