anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: Child
Healthy volunteers: No
Participants at risk: 64
Group description: Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion.Subjects will receive an injection of this buffered 2% lidocaine with 1:100,000 epinephrine on one occasion; they will be randomized to this group. After a minimum of one week, subjects will receive the alternate solution.

We will use 8.4% Sodium Bicarbonate manufactured by Hospira, Inc. Lake Forest, IL

Buffered Lidocaine: Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion. 8.4% Sodium Bicarbonate will be used.
Eligibility criteria:
Inclusion Criteria:

Patients requiring restorative or surgical dental treatment on two occasions on opposite sides of the mouth; either both maxillary or both mandibular quadrant/sextant involving comparable teeth/areas
Patients able to undergo dental treatment in the dental clinic without general anesthesia, sedation, or anxiolysis
Patients 4-17 years of age
Patients classified as ASA I or ASA II
Patients of parents who can read, write and give consent in English

Exclusion Criteria:

Patients with allergy to local anesthetic
Patients who are pregnant or nursing
Patients with cardiac concerns or contraindications to epinephrine
Patients unable to undergo dental treatment in the clinic for behavior or medical reasons
Patients requiring anxiolysis, sedation, or general anesthesia
Patients unable to keep dental appointments or return for dental appointments
Patients who do not meet inclusion criteria
Patients who experience a missed block (IANB) during injection
Intervention: Buprenorphine
Trial phase: Phase 4
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator (either 100mg or 300 mg) for up to 5 total injections

Sublocade: SUBLOCADE to be administered approximately every 4 weeks per local standard of care
Eligibility criteria:
Inclusion Criteria:

Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
Completed the EOT Visit for the INDV-6000-403 Study.
Is an appropriate candidate in the opinion of the Investigator or medically qualified sub-Investigator.

Exclusion Criteria:

Subject compliance issues during participation in the INDV-6000-403 study which, in the opinion of the Investigator, could potentially compromise subject safety.
Subjects who are unable, in the opinion of the Investigator or Indivior, to comply fully with the study requirements including those who are currently incarcerated or pending incarceration legal action.
Intervention: ASCORBIC ACID
Trial phase: Phase 1 | Phase 2
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Senolytic treatment in 5 individuals with early AD to determine levels of drug that reach the central nervous system (CNS) by collecting cerebral spinal fluid (CSF), and begin collecting initial data on target engagement of senescent cells, AD-related markers, and AD-relevant outcomes for future trials.

Dasatinib + Quercetin: Intermittent D+Q administered for 2 days on/14 days off for 12 weeks (6 cycles)
Eligibility criteria:
Inclusion Criteria:

Age 65 years or above.
Clinical diagnosis of AD (MoCA 10-20 and Clinical Dementia Rating Scale/CDR = 1) on a stable dose of cholinesterase inhibitors for at least three months
Body Mass Index (BMI) within range of 19 - 35 kg/ m2
Labs: Normal blood cell counts without clinically significant excursions (WBCs: 4,500-10,500 cells/mcL; absolute neutrophil count: 1,800-8,700 cells/mcL; platelets: 140-450 K/uL; hemoglobin 12.0-17.5 grams/dL); liver and renal function (AST 10-40 IU/L, total bilirubin 0.1-1.4 mg/dl); cholesterol (<240 mg/dl), triglycerides (<300 mg/dl), and glucose control (HbA1c < 7%). PT/PTT/INR within normal limits
Participants must be accompanied by a Legally Authorized Representative designated to sign informed consent and to provide study partner reported outcomes at all remaining visits
Participants must have no plans to travel over the next 4-5 months that interfere with study visits following consent

Exclusion Criteria:

Hearing, vision, or motor deficits despite corrective devices;
Alcohol or drug abuse;
MRI contraindications;
Myocardial infarction, angina, stroke or transient ischemic attack in the past 6 months; QT interval >440 on ECG will not be enrolled. Chronic heart failure will be exclusionary;
Participants with coagulation disorders;
Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments;
Uncontrolled diabetes (HbA1c > 7% or the current use of insulin);
Current or chronic history of liver disease, or known hepatic or biliary abnormalities;
Use of anti-arrhythmic medications known to cause QTc prolongation, anti-platelet or anti-coagulant medication;
Current use of quinolone antibiotics.
Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg).
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.
History of or MRI-positive for any space occupying lesion, including mass effect or abnormal intracranial pressure, which would indicate contraindication to lumbar puncture
Intervention: Tacrolimus
Trial phase: Phase 3
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Tacrolimus as maintenance immunosuppression

Tacrolimus: Tacrolimus (FK / Prograf) titrated to a goal trough of 6 - 8 ng/ml
Eligibility criteria:
Inclusion Criteria:

Liver transplant recipients >= 18 years old
Normal baseline renal dysfunction (GFR > 60 mL/min)
Rabbit anti-thymocyte globulin (rATG) induction (cumulative dose 1.5 - 5 mg/kg)
Indication for transplant: ethanol, hepatitis C, or nonalcoholic steatohepatitis or any combination of these

Exclusion Criteria:

Increased risk of rejection: autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, positive crossmatch, retransplantation
Incompletely healed incision or other wound healing issues at time of randomization
Multiple or previous organ transplantation
Severe, uncontrolled hypercholesterolemia (> 9mmol/L) or hypertriglyceridemia (>8.5 mmol/L) in the 6 months prior to transplantation
Insurance company unwilling to pay for the cost of the everolimus or patient does not qualify for the Novartis Patient Assistance Program.
Pregnant women
Unable to provide informed consent
Intervention: Everolimus
Trial phase: Phase 3
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Everolimus monotherapy maintenance immunosuppression

Everolimus: Everolimus monotherapy - target trough levels 4 - 8 ng/ml as maintenance immunosuppression
Eligibility criteria:
Inclusion Criteria:

Liver transplant recipients >= 18 years old
Normal baseline renal dysfunction (GFR > 60 mL/min)
Rabbit anti-thymocyte globulin (rATG) induction (cumulative dose 1.5 - 5 mg/kg)
Indication for transplant: ethanol, hepatitis C, or nonalcoholic steatohepatitis or any combination of these

Exclusion Criteria:

Increased risk of rejection: autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, positive crossmatch, retransplantation
Incompletely healed incision or other wound healing issues at time of randomization
Multiple or previous organ transplantation
Severe, uncontrolled hypercholesterolemia (> 9mmol/L) or hypertriglyceridemia (>8.5 mmol/L) in the 6 months prior to transplantation
Insurance company unwilling to pay for the cost of the everolimus or patient does not qualify for the Novartis Patient Assistance Program.
Pregnant women
Unable to provide informed consent
Intervention: Budesonide
Trial phase: Phase 2
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.

Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.
Eligibility criteria:
Inclusion Criteria:

Pediatric patients older than 30 days and up to 18 years of age admitted to the PICU with a diagnosis of PARDS enrolled within 72 hours of diagnosis.
Patients requiring invasive mechanical ventilation.
Criteria of PARDS as defined by the Pediatric Acute Lung Injury Consensus Conference (PALICC), on June 2015 in Pediatric Critical Care Journal

Exclusion Criteria:

Patients with diffuse alveolar hemorrhage.
Patients terminally ill with limitation of care or in hospice care.
Patients receiving inhaled steroids or systemic steroids as chronic therapy before admission.
Patients with high dose systemic steroids for anti-inflammatory purposes. The investigators will not exclude patients receiving hydrocortisone for shock.
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Single intra-articular (IA) injection of FX006 32 mg

FX006 32 mg: Extended-release 32 mg FX006 IA injection
Eligibility criteria:
Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Patients 40 to 80 years of age, inclusive, on the day of consent
Body Mass Index (BMI) ≤ 40 kg/m^2
Has a documented clinical diagnosis of unilateral or bilateral hip OA for at least six months
Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by local read of X-ray obtained during Screening or ≤ 6 months of Screening visit
Has clinically significant pain in the index hip

Exclusion Criteria:

Has a history of hypersensitivity to triamcinolone acetonide, PLGA or lidocaine
Is receiving anticoagulants (including warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin, ritonavir or cobicistat)
Has had any previous surgery on the index hip
Presence of surgical hardware or other foreign body in the index hip
Has a history of infection of the index hip
Has a diagnosis of other disorders in the index hip that can cause pain
Has received any intra-articular injection in the index hip of corticosteroids, investigational (including FX006) or marketed (including Zilretta®) within the 3 months prior to Screening
Has had trauma to the index hip in the past 3 months requiring immobilization
Has a history or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis), or of ocular herpes simplex
Has within the past 3 months received corticosteroids by mouth, or by parenteral injection. Multiple courses or chronic intermittent use of inhaled, intranasal, or topical steroids is also exclusionary. Single courses of 14 days or less by those routes are permitted
Has, at screening, or any time prior to day of scheduled injection (Day 1), clinical suspicion of local or systemic infection, including any infection in the index leg.
Has a history of or active significant concomitant illness (known or suspected)
Any bacterial or viral infection requiring parental antibiotics within 4 weeks of Day 1 or oral antibiotics within 2 weeks of Day 1
Is a woman who is pregnant, nursing, lactating, or plans to become pregnant during the study
Is a man who plans to conceive during the study
Intervention: Epinephrine
Trial phase: Phase 4
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Epinephrine in the submucosal injection fluid (1:200,000)

Epinephrine: Epinephrine in the submucosal injection fluid
Eligibility criteria:
Inclusion Criteria

Patients aged 18 years and over
Patients scheduled for treatment of large (≥ 20 mm) colorectal polyps
Able to sign informed consent

Exclusion Criteria

Patients previously enrolled in the study
Pedunculated polyps
Polyps not amenable to endoscopic resection
Patients allergic or sensitive to epinephrine
Patients with coronary artery disease who have had a myocardial infarction in the past year, or had coronary stenting in the past year, or had angina in the past year.
Patients electing anesthesia other than monitored anesthesia care with propofol (MAC) for colonoscopy
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Licogliflozin monotherapy arm: licogliflozin 30 mg tablet (+ placebo matching tropifexor capsule), once daily orally
Eligibility criteria:
Inclusion Criteria:

Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following:

NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation and ballooning and
Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria

Exclusion Criteria:

Type 1 diabetes mellitus
Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at screening
HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas

Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:

Platelet count < LLN (see Central laboratory manual).
Serum albumin < LLN (see Central laboratory manual).
International Normalized Ratio (INR) > ULN (see Central laboratory manual).
ALT or AST > 5× ULN (confirmed by 2 values during screening).
Total bilirubin > ULN (see Central laboratory manual) (confirmed by 2 values during screening), including Gilbert's syndrome.
Alkaline phosphatase > 300 IU/L (confirmed by 2 values during screening).
History of esophageal varices, ascites or hepatic encephalopathy
Splenomegaly
MELD score >12
Intervention: Betamethasone
Trial phase: Phase 1 | Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection.

Dexamethasone 4mg: 1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 60 minutes after injection.
Eligibility criteria:
Inclusion Criteria:

Adults age ≥ 18

Exclusion Criteria:

Pregnancy
Presence of a disease that affects HPA axis function
Current use of medications that affect cortisol secretion, such as opioid pain medication, anti-fungal agents, anti-epileptic agents, and glucocorticoids, including hydrocortisone, prednisone, dexamethasone, steroid-containing inhalers, and steroid injected into the joints
History of adverse event related to use of glucocorticoids
Intervention: Ertugliflozin
Trial phase: Phase 4
ATC code: A10BD23 | A10BD24 | A10BK04
SMILES: CCOc1ccc(Cc2cc([C@]34OC[C@](CO)(O3)[C@@H](O)[C@H](O)[C@H]4O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Ertugliflozin 5 mg tablet once a day for 12 weeks

Ertugliflozin 5 mg: Ertugliflozin 5 mg once a day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Age > 18 years old but < 75 years old
No HF hospitalization within 6 months
Overweight or Obesity defined as BMI > 29 but < 42
History of insulin resistance or T2DM and on oral diabetes agents other than SGLT2i (HgbA1c > 5.8% and < 10.5%)
EF calculated based on a recent echo/cath/nuclear study at screening (pre-enrollment) > 50%
Stable HFpEF (HF with preserved ejection fraction) medications use of 3 months with no plans to changes or add medications for at least 12 weeks course of the study)

Exclusion Criteria:

Acute HFpEF hospitalization within 6 months of enrollment.
CKD stage 4 or 5 (eGFR < 30 ml/min by CKD-EPI equation).
Other known causes of HF including poorly controlled hypertension (SBP >160 mm Hg) or ischemic cardiomyopathy (etc).
Anemia (Hgb < 11.0 mg/dL for women and < 12.0 mg/dL for men) or severe thrombocytopenia (platelets < 50,000 mm3)
Anticipated changing of HF medication during anticipated study period.
HFREF (LV EF < 50%).
Acute coronary syndrome, transient ischemic attack, CVA or critical limb ischemia during the last 6 months or coronary/peripheral revascularization within the last 3 months. Severe life threatening illness or live expectancy < 6 months.
Contraindications to MRI (metallic implants, severe claustrophobia) or treadmill exercise (limb amputation, severe osteoarthritis or equivalent functional mechanical limitation).
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.

Bupivacaine: Bupivacaine Hcl 0.25% Inj
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo laparoscopic gastric sleeve gastrectomy
18-65 years of age
BMI> 35 kg/m2.

Exclusion Criteria:

Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
Contraindication/allergy to acetaminophen or ketorolac
History of substance abuse or chronic opioid use
Coagulopathy
Patients receiving systemic anticoagulation
Local infection
ASA 4
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.

Bupivacaine: Bupivacaine Hcl 0.25% Inj
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo laparoscopic gastric sleeve gastrectomy
18-65 years of age
BMI> 35 kg/m2.

Exclusion Criteria:

Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
Contraindication/allergy to acetaminophen or ketorolac
History of substance abuse or chronic opioid use
Coagulopathy
Patients receiving systemic anticoagulation
Local infection
ASA 4
Intervention: Lmp7-IN-1
Trial phase: Phase 1
SMILES: O=C(NC(Cc1coc2ccccc12)B(O)O)C1CC2CCC1O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.
Eligibility criteria:
Inclusion Criteria:

Participants having Eastern Co-operative Oncology Group (ECOG) Performance Status less than or equals to (<=) 1
Adequate hematological, hepatic and renal function as defined in the protocol
Participant must have measurable disease of Multiple Myeloma (MM) and received greater than (>) 3 prior lines of therapy for MM including a Proteasome Inhibitors (PI), an Immunomodulatory Imide Drug (IMiD) and an anti-CD38 mAb or who are refractory to at least PI agent (carfilzomib or bortezomib) and IMiD according to the International Myeloma Working Group (IMWG) criteria
Participant must have documented evidence progressive disease as defined by the IMWG criteria either on or after their last regimen
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Any condition, including any uncontrolled disease state that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.
An active second malignancy or evidence of disease of cancer (other than MM) before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).
Cerebrovascular accident/stroke (< 6 months prior enrollment) or neurologic instability per clinical evaluation due to tumor involvement of the Central Nervous System
Diagnosis of fever within 1 week prior to study intervention administration
Part B: Participants planning to undergo a stem cell transplant should not be enrolled to reduce disease burden prior to transplant.
Other protocol defined exclusion criteria could apply