anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fluorescein Sodium
Trial phase: Phase 4
SMILES: O=C([O-])c1ccccc1-c1c2ccc(=O)cc-2oc2cc([O-])ccc12.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 136
Group description: All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older.
Diagnosed by preoperative imaging modalities to have a brain tumor or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.
The patient is determined by a board certified Neurosurgeon (above mentioned neurosurgeons) to benefit from the application of Fluorescein Sodium intraoperatively
Patient or legally authorized representative provides written informed consent to enroll in this study.

Exclusion Criteria:

Known allergic reaction to Fluorescein Sodium.
Children.
Prisoners.
Students.
Infection of the central nervous system or other sites.
Hemodynamic instability or significant impairments in circulation.
Concomitant treatment with other investigational drugs.
Any uncontrolled condition unrelated to the neurosurgical disease.
History of psychiatric, additive, or any other disorder that compromises the ability to provide informed consent or comply with study protocols.
Participation on other clinical trials during the last thirty days.
Pregnant patients.
Patients unable to discontinue medications that affect Fluorescein metabolism.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
Eligibility criteria:
Inclusion Criteria:

-Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.

Exclusion Criteria:

Patients with baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limit of normal would be excluded.
Patients with baseline CrCl <30.
Patients that require intensive postoperative care and delayed extubation will typically require additional sedation which would impede adequate evaluation of the two study pain regimens as they are designed to be patient controlled.
Patients with complications unrelated to the pain regimens that prolong their stay would be excluded from the evaluation of hospital stay and cost effectiveness analyses. Examples would include but are not limited to pre-renal azotemia and acute renal failure; pneumonia; venous thromboembolism; or need for re-exploration laparotomy.
Allergy to acetaminophen would exclude those patients set to enter the experimental IV acetaminophen study arm. One exception would be if the allergy were trivial and related to route of administration such as mild nausea with oral acetaminophen.
Patients that undergo a bowel resection during surgery as it may adversely effect return of bowel function
Patients that have required regular opioid intake for the 7 days preceding surgery.
NSAIDs within 8 hours of surgery.
Chronic steroid use with the exception of low-dose inhaled steroid formulations.
Chronic alcohol or drug abuse.
Patients currently pregnant.
Patients unable to provide informed consent.
Age >85
Any physical, medical, and mental condition that would make participation in the study inadvisable.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Acetaminophen 325 mg and Hydrocodone 5 mg

Acetaminophen/Hydrocodone: Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18
Male or Female (non-pregnant)
Elective, soft tissue hand surgery indicated based on diagnosis made by either clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination of the two (carpal tunnel release, trigger finger release, first dorsal compartment release, ganglion cyst excision, second extensor compartment release)
Subjects are capable of giving informed consent

Exclusion Criteria:

Allergy to study medication
Any pre-existing pain condition requiring analgesia
Fibromyalgia
Recent upper gastrointestinal bleeding
Coagulopathy (primary or medication-related)
Renal impairment
Liver disease
Pregnancy
Patients who consent to the study but require unexpected admission, including those requiring admission resulting from operative complications, will be excluded before randomization
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: A regimen with traditional drugs only

Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetics diagnosed for at least 6 months
Patients ages ≥ 65 years and older
Active patients in the Bay West Endocrinology practice
Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12%
Eligible for randomization to either treatment group
Patients willing to follow either treatment arm including regimen using one or more injectables
Patients to have an English Reading Level of Grade 6 or above
Patients residing at home

Exclusion Criteria:

Unwilling to use a regimen that may contain using one or more injections
Using short acting insulin prior to the study
Using GLP-1 in past 10 weeks
History of hypoglycemia unawareness or episodes needing emergency intervention
End-stage renal disease
Dementia
Blindness
Terminal illness
Intervention: Lenalidomide
Trial phase: Phase 2
ATC code: L04AX04
SMILES: Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
Eligibility criteria:
Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
Age > = 18 years at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Must have confirmed diagnosis of plasma cell disorder.
Patients with prior thalidomide or CC-5013 (lenalidomide) use are eligible but these agents must have been discontinued at least 4 weeks prior to treatment in this study.
All previous cancer therapy, including chemotherapy, and dexamethsone must have been discontinued at least 4 weeks prior to treatment in this study. Patients with recent radiation, hormonal therapy and surgery are eligible.
Patients must not have received prior Hepatitis B vaccination.
Patient should be negative for antibody against HbSAg.
ANC >= 1000, Platelets >= 75,000.
Women of childbearing potential (WCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active WCBP must agree to use two of the following adequate forms of contraception throughout the entire study (tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner). A WCBP must agree to have pregnancy tests 4 weeks after her last dose of lenalidomide. Due to the short duration of drug therapy, abstinence would also be a reasonable option.

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or lactating females.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Concurrent use of other anti-cancer agents or treatments.
Known HIV, HBV and HCV positivity.
Clinically significant autoimmune disease.
Serious intercurrent illness such as active infection requiring IV antibiotics, significant cardiac or pulmonary disease.
Psychiatric disorder, alcohol or illicit drug use.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.
Eligibility criteria:
Inclusion Criteria:

Women between the ages of 18 and 70 years
Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
Scheduled to undergo major vaginal reconstruction
Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.

Exclusion Criteria:

Allergy to acetaminophen
Liver disease (chronic or active)
Chronic alcohol use (>1 drink/day)
Bleeding diathesis
Renal disease
Opiate dependent or daily use
History of chronic pain
Mental or cognitive disorder preventing patient to accurately verbalize pain levels
Undergoing abdominal or laparoscopic procedures at the time of surgery
Allergy to hydromorphone
Surgery is not performed under general anesthesia
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.
Eligibility criteria:
Inclusion Criteria:

Women between the ages of 18 and 70 years
Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
Scheduled to undergo major vaginal reconstruction
Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.

Exclusion Criteria:

Allergy to acetaminophen
Liver disease (chronic or active)
Chronic alcohol use (>1 drink/day)
Bleeding diathesis
Renal disease
Opiate dependent or daily use
History of chronic pain
Mental or cognitive disorder preventing patient to accurately verbalize pain levels
Undergoing abdominal or laparoscopic procedures at the time of surgery
Allergy to hydromorphone
Surgery is not performed under general anesthesia
Intervention: Hydrocortisone
Trial phase: Phase 4
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 23
Group description: Patients randomized to the hydrocortisone arm will receive a 2 mg/kg hydrocortisone IV bolus on enrolment followed by 1 mg/kg of hydrocortisone IV q6h until the patient has not had an escalation in therapy for at least 12 hours. If the patient meets these criteria their hydrocortisone will be weaned to 1 mg/kg every 8 hours which will be continued until they are off all vasoactive infusions for 12 hours. If following the initial hydrocortisone wean, the patient requires fluid boluses and/or an increase in their vasoactive infusion(s), their hydrocortisone will be increased back to 1 mg/kg of hydrocortisone IV q6h until they meet stability criteria again. Duration of treatment will range from a minimum of 20 hours to a maximum of 7 days of study drug.

Hydrocortisone: Hydrocortisone will be made up as a 10 mg/ml solution so the volume of added fluid will be very small (2 to 10 mls even for the initial dose of 2 mg/kg).
Eligibility criteria:
Inclusion Criteria:

Children newborn to 17 years
On any dose of any vasoactive infusion for between 1 to 6 hours

Exclusion Criteria:

Patients who have known or suspected hypothalamic, pituitary or adrenal disease
Patients who are currently receiving steroids for the treatment of shock/suspected shock prior to randomization
Patients who are expected to have treatment withdrawn
Patients who are premature infants (<38 weeks corrected gestational age)
Patients who are pregnant
Patients post cardiac surgery
Patient who received their first dose of vasoactive infusion >24 hours after PICU admission
Patient who is no longer on vasoactive infusion at the time of study enrollment, and/or is expected to no longer be on vasoactive infusion at the time the first dose of study drug will be administered
Patients for whom primary cardiogenic shock is strongly suspected
Patients for whom spinal shock is strongly suspected
Patients for whom hemorrhagic or hypovolemic shock is strongly suspected
Patients who were previously enrolled in the STRIPES study
Patients who receive a vasoactive agent for reasons not related to shock
Physician refusal
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 132
Group description: Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18 years
Scheduled cesarean section delivery
Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine Associates
Singleton pregnancy
Term delivery (greater than or equal to 37 weeks)
Spinal/epidural anesthesia with epidural analgesia (duramorph)
Use of pfannenstiel incision

Exclusion Criteria:

Weight less than 50 kg
Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS)
Multiple gestation pregnancy
Cesarean section for pre-term delivery (less than 37 weeks)
Fetal anomalies
Inability to use epidural duramorph at time of procedure
General anesthesia used
Vertical skin incision
Opioid addiction
Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)
Intervention: Fentanyl
Trial phase: Phase 4
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 78
Group description: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.

Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Eligibility criteria:
Inclusion Criteria:

1) Supracondylar fracture (2) Age 2-17 years (3) American Society of Anesthesiologists Status 1 -3 (4) Scheduled for closed reduction with percutaneous pinning under general anesthesia

Exclusion Criteria:

Pulseless extremity
Compromised neurologic status on exam (specifically assessment of radial, ulnar, and median nerve)
Known allergy to local anesthetics (7) Not scheduled for closed reduction with percutaneous pinning under general anesthesia
Bleeding diathesis
American Society of Anesthesiologist (ASA) status 4 or higher.
Sleep apnea by polysomnography
Intervention: Haloperidol
Trial phase: Phase 4
ATC code: N05AD01
SMILES: O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Eligibility criteria:
Inclusion Criteria:

Previous diagnosis of GP including those without formal gastric emptying studies.
Patients presenting with unresolving nausea, vomiting, and abdominal pain that is attributable to their GP.

Exclusion Criteria:

History of QT prolongation or presence on a 12 leads electrocardiogram.
Presence of concomitant acute abdominal pathology including but not limited to hepatobiliary disease, ischemia, and abdominal aneurysm.
Prisoners
Hypotension (systolic blood pressure below 90 mm Hg)
Pregnant women
Patients who are cognitively impaired and/or unable to consent for the study
Age <18
Allergy to haloperidol
Intervention: Abemaciclib
Trial phase: Phase 1
ATC code: L01EF03
SMILES: CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Single oral dose of LY2835219 given with a standard meal in one of three study periods.

LY2835219: Administered orally.
Eligibility criteria:
Inclusion Criteria:

Healthy sterile males or surgically sterile or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
Are able to eat a high-fat, high-calorie meal

Exclusion Criteria:

Participated in a clinical trial involving investigational product within 30 days
Abnormal blood pressure
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have donated blood of more than 500 milliliter (mL) within the last month
Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C
Intervention: Abemaciclib
Trial phase: Phase 1
ATC code: L01EF03
SMILES: CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Single oral dose of LY2835219 given with no food in one of three periods.

LY2835219: Administered orally.
Eligibility criteria:
Inclusion Criteria:

Healthy sterile males or surgically sterile or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
Are able to eat a high-fat, high-calorie meal

Exclusion Criteria:

Participated in a clinical trial involving investigational product within 30 days
Abnormal blood pressure
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have donated blood of more than 500 milliliter (mL) within the last month
Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C
Intervention: Abemaciclib
Trial phase: Phase 1
ATC code: L01EF03
SMILES: CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Single oral dose of LY2835219 given with a high fat meal in one of three periods.

LY2835219: Administered orally.
Eligibility criteria:
Inclusion Criteria:

Healthy sterile males or surgically sterile or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
Are able to eat a high-fat, high-calorie meal

Exclusion Criteria:

Participated in a clinical trial involving investigational product within 30 days
Abnormal blood pressure
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have donated blood of more than 500 milliliter (mL) within the last month
Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C