anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 51
Group description: At the start of surgery, patients in the control arm will receive D5% Normal Saline + 20 meq/L KCl at maintenance IVF. After 24 hours, standard IVF, not containing NaHCO3 or Na acetate will be administered for the duration of the PICU stay as required, determined by the clinicians primarily caring for the patient postoperatively.

Sodium Chloride
Eligibility criteria:
Inclusion Criteria:

Subjects age ≤18 years
Subjects scheduled for cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the Schwartz formula
Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved)
Subjects with known metabolic disorder
Premature infants born <30 weeks gestation and <30 days old due to risk of intraventricular hemorrhage

Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.
Intervention: Azithromycin
Trial phase: Phase 4
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 97047
Group description: Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.

In Niger during year 3, all communities will be offered azithroymcin.

Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
Eligibility criteria:
Inclusion Criteria:

Communities

The community location in target district.
The community leader consents to participation in the trial
The community's estimated population is between 200-2,000 people.
The community is not in an urban area.

Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census.

Exclusion Criteria:

Individuals

- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Intervention: Ruxolitinib
Trial phase: Phase 2
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Regularly transfused adult patients with thalassemia and spleen enlargement
Eligibility criteria:
Inclusion Criteria:

Patients with thalassemia on a regular and stable transfusion regimen (at least 2 RBC units within every 4-week interval for 24 weeks prior to Screening) and anticipated to receive the same transfusion regimen during the study.
Patients with spleen enlargement at Screening, defined as spleen palpable below the costal margin and spleen volume of ≥ 450 cm3 as confirmed by MRI (or CT scan in applicable patients).
Patients need to be on iron chelation treatment (deferoxamine or deferasirox) for at least four weeks prior to Screening

Exclusion Criteria:

Splenectomy prior to or planned during the study
Active serious bacterial, mycobacterial, fungal, parasitic or viral infection which requires therapy (e.g., pneumonia, tuberculosis, systemic mycosis, herpes zoster)
Hemoglobin <65 g/L (<4.0 mmol/L) at Screening
Platelet count <75×109/L, absolute neutrophils count < 1.5×109/L at Screening.
Estimated MDRD < 30 mL/min/1.73 m2 at Screening.
ALT (SGPT) levels >5 times ULN at Screening.
Hepatocellular disease such as hepatitis B (presence of HBs antigen), hepatitis C (presence of HCV RNA), liver cirrhosis.
HIV positivity
Intervention: Cefazolin
Trial phase: Phase 4
ATC code: J01DB04
SMILES: [H][C@]12SCC(CSc3nnc(C)s3)=C(C(=O)O)N1C(=O)[C@H]2NC(=O)Cn1cnnn1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 3g cefazolin provided via IV push 30-60 minutes prior to skin incision
Eligibility criteria:
Inclusion Criteria:

Patients at term (>37 weeks) undergoing a cesarean delivery at Women's Pavilion at Miller Children's Hospital and University of California, Irvine.

Exclusion Criteria:

pre-gestational diabetes
chronic hypertension
collagen vascular disease
renal impairment
multiple gestation
contraindications to Cefazolin administration (known anaphylactic reaction to penicillin's or known cephalosporin allergy)
any exposure to cephalosporins in one week prior to cesarean section
need for emergent cesarean delivery or diagnosis of chorioamnionitis
Intervention: Apremilast
Trial phase: Phase 1
ATC code: L04AA32
SMILES: CCOc1cc([C@@H](CS(C)(=O)=O)N2C(=O)c3cccc(NC(C)=O)c3C2=O)ccc1OC
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.

CC100
Eligibility criteria:
Inclusion Criteria:

Men must practice a reliable method of birth control during study and for 2 weeks following study. Women must be non-fertile or post-menopausal.

Exclusion Criteria:

Have serious or unstable illnesses as determined by the investigator.
Have current or a history of asthma, or severe drug allergies or pollen allergy.
Have used medications (except for calcium supplements or externally applied eye drops or antibiotics) within 30 days prior to dosing or are expected to use other medications during the study.
Have had serious infectious disease affecting the brain within the preceding 5 years; or have known or existing evidence of serious infection.
Have laboratory test values that are considered clinically significant as determined by the investigator.
Have ECG abnormalities that are clinically significant.
Have donated blood (a pint or more) or received an experimental drug within 30 days prior to dosing.
Have a history of chronic alcohol or drug abuse within the past 2 years.
Intervention: Methylphenidate
Trial phase: Phase 1 | Phase 2
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Patients will receive IV methylphenidate following general anesthesia
Eligibility criteria:
Inclusion Criteria:

Age 18-75 years
American Society of Anesthesiologists classification 1 or 2
Scheduled to undergo a pancreaticoduodenectomy or distal pancreatectomy at Massachusetts General Hospital

Exclusion Criteria:

American Society of Anesthesiologists physical status classification of 3 or beyond.
Intervention: Tranexamic acid
Trial phase: Not Applicable
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.

Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
Eligibility criteria:
Inclusion Criteria:

Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach

Exclusion Criteria:

Revision surgery
Surgery occurring more than 2 weeks post-injury
History of blood dyscrasia or renal insufficiency
History of any thromboembolic disease
Pregnancy or nursing, color vision defects
History of retinal detachment/degeneration
Intracranial hemorrhage
Hypersensitivity to tranexamic acid
Contraceptive Use (estrogens/progestins)
FEIBA (anti-inhibitor coagulant complex) use
Intervention: FLORBETAPIR
Trial phase: Phase 4
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 241
Group description: 241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.

florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice.
Eligibility criteria:
Inclusion Criteria:

- Scan obtained for clinical reasons

Exclusion Criteria:

- None
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: See Placebo Intervention Description

Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U).

45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U
Eligibility criteria:
Inclusion Criteria:

Patients 18 and older with a tibial plafond fracture to be treated by a staged protocol involving primary external fixation and definitive fixation within 3 weeks from the injury.

(Non-definitive, interval procedures such as repeat irrigation and debridement and fibular fixation are allowed.)

Exclusion Criteria:

Younger than 18 years of age
Significant traumatic brain injury or cognitive disability that would interfere with post-operative rehabilitation and study questionnaires
Nerve, vascular, or tendon injury of the lower leg: injury to the tibial or peroneal motor nerves, injury to the posterior tibial artery requiring repair, or laceration of tendons that are involved in plantar flexion or dorsiflexion of the ankle which require repair
History of prior lower extremity fracture to the tibia or ankle of the affected limb.
Incarcerated patients.
Patients unable or unwilling to return for follow-up examination.
Pregnant or lactating patients.
History of disease affecting the neuromuscular junction (ex: myasthenia gravis).
Use of aminoglycoside antibiotics at the time of definitive fixation.
Ipsilateral foot injury that will impair dorsiflexion exercises: Lisfranc injuries, fractures or dislocations of the talus, calcaneus, navicular, cuboid, cuneiforms, or metatarsals (phalanx fractures or dislocations will not be excluded).
Patients receiving Botulinum Toxin A for other reasons.
Patients with a known hypersensitivity to Botulinum toxin A.
Gustilo Anderson type III B and C.
Patients with a weight greater than 115 kg - to ensure proper injection locations
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.

All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.

Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.

Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
Eligibility criteria:
Inclusion Criteria:

Subject must be 18 years and older.
Subject carries Fibromyalgia diagnosis based on American College of Rheumatology criteria.
Fibromyalgia patients who are gamma-aminobutyric acid (GABA)-analogue (gabapentin or pregabalin) naïve, or those who have been on gamma-aminobutyric acid (GABA)-analogue, but discontinued due to side effects or having difficulty maintaining dosing schedule due to multiple doses per day, or those who are currently on immediate release gamma-aminobutyric acid-analogue (GABA).
Able to distinguish pain from fibromyalgia and pain from other sources. (subjects with other rheumatic disease or medical conditions that contributed to the symptoms of fibromyalgia will be excluded)
Subject pain scores >4 on Numeric pain rating scale (NPRS)

Exclusion Criteria:

Creatinine clearance of < 30mg/ml
Pain from Traumatic injury or structural or regional rheumatic disease
Unstable medical or psychiatric illness
Lifetime history of psychosis, hypomania, or mania.
Epilepsy, or dementia
Substance abuse in the last 6 months
Suicidal tendencies
Pregnant or breastfeeding
Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
Subjects who are, in the opinion of the principle investigator, are treatment refractory
Treatment with investigational drug within 30 days of screening.
Concomitant medication exclusions consisted of medications or herbal agents with Central Nervous System (CNS) effects with exception of episodic use of sedating antihistamines
Subject who are on more than one additional class of concomitant fibromyalgia medications i.e. non-selective serotonin reuptake inhibitor (SSRI) antidepressants, topicals, opioids.
Intervention: Baclofen
Trial phase: Phase 3
ATC code: M03BX01
SMILES: NCC(CC(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Baclofen 10mg by mouth three times daily

Baclofen: Treatment arm: baclofen 10mg tid
Eligibility criteria:
Inclusion Criteria:

Adults age 21-100 admitted to medical floors at Denver Health
Patients placed on SEWS protocol by admitting physicians (at risk for AWS).

Exclusion Criteria:

Unable to provide informed consent
Unable to take oral medications
admitted for AWS or with SEWS score >7 at baseline
no alcohol intake for ≥ 48 hours
baclofen use at baseline
baclofen sensitivity
hospital discharge anticipated in within 48 hours
pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
other active drug dependence (except tobacco)
taking a medication known to interact with baclofen.
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: Accepts Healthy Volunteers
Participants at risk: 51
Group description: 30 milliliters (ml) of 0.5% marcaine with epinephrine

Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Eligibility criteria:
Inclusion Criteria:

Elective colon resection for both benign and malignant disease
Laparoscopic, robotic and open techniques

Exclusion Criteria:

emergent colon cases
cases preformed by surgeons other than Dr. Raman or Dr. Kraemer
pregnant patients
patients currently breast feeding
patients under the age of 18
other patients unable to give informed consent
bupivacaine use within 96 hours
allergy to amide anesthetics
prisoners
caution will be used in patients with renal or hepatic failure.
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: Accepts Healthy Volunteers
Participants at risk: 51
Group description: exparel 20ml, diluted with 10ml sterile saline for total of 30ml

Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Eligibility criteria:
Inclusion Criteria:

Elective colon resection for both benign and malignant disease
Laparoscopic, robotic and open techniques

Exclusion Criteria:

emergent colon cases
cases preformed by surgeons other than Dr. Raman or Dr. Kraemer
pregnant patients
patients currently breast feeding
patients under the age of 18
other patients unable to give informed consent
bupivacaine use within 96 hours
allergy to amide anesthetics
prisoners
caution will be used in patients with renal or hepatic failure.
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
Eligibility criteria:
Inclusion Criteria:

Hospitalised for chest pain and potential acute coronary syndrome.
Onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of ≥ 10 min duration at rest and at least 2 of the following: ST segment changes on electrocardiogram (ECG) indicative of ischemia, or Positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction.
Females must be either surgically sterile or post-menopausal.
Activated Clotting Time (ACT) </= 300 at the time of study treatment

Exclusion Criteria:

Participation in another clinical study with an investigational product during the last 30 days.
Current acute complication of percutaneous coronary intervention or coronary bypass surgery.
Any contraindication to ticagrelor, clopidogrel or bivalirudin.
ST elevation myocardial infraction within 24 hours of study entry.
Any indications for oral anticoagulation or aspirin dose other than 75 to 100 milligrams (mg) daily.
Planned use of omeprazole or esomeprazole.
Patients with known bleeding or coagulation disorders; patients requiring dialysis; patients who have an inability to swallow medication.
Patients with known bleeding diathesis or coagulation disorder; history of intracranial bleed.
Use of Intravenous (IV) heparin less than 2 hours before procedure.
Sustained uncontrolled high blood pressure
Intervention: Clopidogrel
Trial phase: Phase 4
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
Eligibility criteria:
Inclusion Criteria:

Hospitalised for chest pain and potential acute coronary syndrome.
Onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of ≥ 10 min duration at rest and at least 2 of the following: ST segment changes on electrocardiogram (ECG) indicative of ischemia, or Positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction.
Females must be either surgically sterile or post-menopausal.
Activated Clotting Time (ACT) </= 300 at the time of study treatment

Exclusion Criteria:

Participation in another clinical study with an investigational product during the last 30 days.
Current acute complication of percutaneous coronary intervention or coronary bypass surgery.
Any contraindication to ticagrelor, clopidogrel or bivalirudin.
ST elevation myocardial infraction within 24 hours of study entry.
Any indications for oral anticoagulation or aspirin dose other than 75 to 100 milligrams (mg) daily.
Planned use of omeprazole or esomeprazole.
Patients with known bleeding or coagulation disorders; patients requiring dialysis; patients who have an inability to swallow medication.
Patients with known bleeding diathesis or coagulation disorder; history of intracranial bleed.
Use of Intravenous (IV) heparin less than 2 hours before procedure.
Sustained uncontrolled high blood pressure
Intervention: Futibatinib
Trial phase: Phase 1 | Phase 2
ATC code: L01EN04
SMILES: C=CC(=O)N1CC[C@H](n2nc(C#Cc3cc(OC)cc(OC)c3)c3c(N)ncnc32)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 24 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent
Age ≥ 18 years of age
Has histologically or cytologically confirmed, locally advanced or metastatic cancer

The following specific criteria for each study portion

Phase 1 (Dose Escalation):

Patients with any type of solid tumor
Disease progression following standard therapies or intolerant to prior standard therapies

Phase 1 (Dose Expansion)

Have at least one FGF/FGFR aberration
Disease progression following standard therapies or were intolerant to prior standard therapies (including prior FGFR inhibitors).
Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or Response Assessment in Neuro-Oncology criteria (2010) for brain tumors.

Patients with any of the following tumor types

Patients with intrahepatic or extrahepatic CCA harboring FGFR2 gene fusions or other FGFR2 aberrations
Patients with primary CNS tumors
Patients with advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
Patients with breast cancer or gastric cancer
Patients with other solid tumor types harboring FGFR gene fusions or activating mutations
Patients with solid tumor types and other FGF/FGFR alterations not listed above

Phase 2

Patients with iCCA and FGFR2 gene rearrangements (incl fusions)
Have been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy
Must have documentation of radiographic progression of disease
No prior FGFR inhibitor
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ function.

Exclusion Criteria:

History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.
History and/or current evidence of clinically significant ectopic mineralization/calcification.
History and/or current evidence of clinically significant retinal disorder
A serious illness or medical condition(s)
Pregnant or breast-feeding female