anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Desogestrel and ethinyl estradiol
Trial phase: Phase 4
SMILES: C#CC1(O)CCC2C3CCC4=CCCCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Apri (or generic equivalent - Reclipsen) (30µg/d EE, 150 µg/d desogestrel) is a monophasic dosing regimen of 21 active and 7 placebo pills. On Day 1 of the Intervention, participants in the COC group will begin taking the COC pill. Each participant in this group will ingest active pills from the first pack each day for the first 21 days. Pills ingested on days 22 through 28 are placebo pills. A second pill pack will begin on day 29 and pills with active ingredients will be ingested from the second pack each day for days 29-49. On day 50, the participants will immediately begin a 3rd pill pack, if the post-study testing is still occurring, and will ingest a pill with active ingredients from the third pack for days 50-56 (or for as long as the post-study testing is occurring).
Eligibility criteria:
Inclusion Criteria:

Female
Age 18-30 yrs
BMI 18-29 kg/m2
Non-smoking
Not using hormonal contraceptives for at least 6 months prior
Not currently pregnant nor intending to become pregnant in the next 6 months
Not lactating
No apparent metabolic, endocrine, musculoskeletal, or severe psychiatric disease
Willing to adhere to maintenance of current exercise training and diet and remain weight stable (±2 kg) during study
Variable physical activity acceptable, but mode must be primarily weight bearing
At least 9 menses in past 12 months
Willing to quit taking any current nutritional supplements and take Calcium and Vitamin D supplements for the duration of the study.
If 21 or older, a normal Pap smear must be confirmed.

Exclusion Criteria:

Non-weight bearing exercise as primary mode of physical activity
Known or suspected metabolic or endocrine disease
Pregnant
Currently consuming large amounts of soy products
Regular consumption of grapefruit juice
Current clinical eating disorder or other axis 1 psychiatric or bipolar disorders
Oral or hormonal contraceptive use in the last 6 months
Currently amenorrheic
Hyperparathyroidism
Liver or renal disease
Evidence of malabsorption or skeletal disorder
Thyroid abnormalities (controlled hypothyroidism acceptable)
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDS)
Taking medications known to have interactions with contraceptive therapy
Division I Athlete, on or off season
Other Exclusion Criteria proposed by the World Health Organization COC Contraindications (Grossman, 2011)
Intervention: Icosapent
Trial phase: Phase 4
SMILES: CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.

Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).
Eligibility criteria:
Inclusion Criteria:

Over 18 years and under 90 years old.
Patients who have received radiotherapy after being diagnosed with head and neck cancer and currently are diagnosticated of mandibular osteoradionecrosis (any clinical stage)
Follow-up for at least a year after the radiation treatment is completed.
Absence of tumor at the time of recruitment.
Patients with the capacity to give informed consent

Exclusion Criteria:

Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).
Patients taking oral anticoagulants (acenocoumarol, warfarin).
Known hemorrhagic/coagulation disorder.
Vitamin K deficiency due to any cause.
Use of estrogens oral contraceptives.
Serious bleeding or extensive retinal hemorrhage.
Ischaemic heart diseases, including recent Myocardial Infarction.
Serious cardiac arrhythmia.
Severe LIVER DISEASE.
Severe renal failure (creatinine clearance <30 mL/min).
Hypotension.
Female patients who are pregnant or lactating
Any other situation or condition that, in the opinion of the INVESTIGATOR, may interfere with optimal PARTICIPATION in the study.
Intervention: Triamcinolone
Trial phase: Not Applicable
ATC code: A01AC01 | C05AA12 | D07AB09 | D07BB03 | D07CB01 | D07XB02 | H02AB08 | R01AD11 | R03BA06 | S01BA05 | S02CA04
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.

A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).

Kenalog: Intravaginal pelvic floor injection one series
Eligibility criteria:
Inclusion Criteria:

Provide informed consent
Healthy women > age 18 regardless of menopausal status
Willing and able to fill out study questionnaires. In patients that are unable to read, the research nurse will be available to assist.
High-tone pelvic floor dysfunction on vaginal exam
A pelvic pain score of > 4 on screening Visual Analog Scale (VAS)
Pain perceived to be in the pelvis that has been present for at least 3 months.

Exclusion Criteria:

Patients that have had Botox to the bladder within the last 8 months
Patients that have had Botox outside the bladder of > 160 u within the last 12 weeks.
Patients that have had transvaginal trigger point injections of any form (Botox or steroid) in the last 3 months
Pregnancy
Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the study period that could be deemed unsafe in combination with study medication as judged by the investigators.
Any evidence of vaginitis on wet mount slide at initial visit that is untreated.
Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
Any indication/condition/medication that the investigators identify as contraindicated in conjunction with study medication.
Systolic blood pressure > 160 mm Hg on screening blood pressure
Heart rate > 110 beats/minute on screening heart rate
Intervention: Oseltamivir
Trial phase: Phase 3
ATC code: J05AH02
SMILES: CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 23
Group description: Age appropriate oral dose of Oseltamivir BID for 5 days:

Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects < 13 years - weight-based dose as a capsule or oral suspension.
Eligibility criteria:
Key Inclusion Criteria:

Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) or rectal temperature ≥ 101.3ºF (≥ 38.5ºC) with at least one respiratory symptom (cough or rhinitis) OR Positive influenza determined by PCR or Rapid Antigen Test
Onset of symptoms no more than 72 hours before presentation for screening for subjects < 2 years old.

Key Exclusion Criteria:

Pregnant or breast-feeding females
Development of symptoms while hospitalized
Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications
Presence of immunocompromised status
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: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: 200micrograms of epinephrine group

High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
Eligibility criteria:
Inclusion Criteria:

Non-emergent repeat cesarean section
Neuraxial anesthesia as the planned primary anesthetic
Informed consent obtained
Females age 18-50

Exclusion Criteria:

Emergency cesarean section
Anesthetic other than neuraxial
Allergy to local anesthetics, morphine, or epinephrine
Pre-existing sensory/motor deficit
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: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: 0.2ml saline

No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
Eligibility criteria:
Inclusion Criteria:

Non-emergent repeat cesarean section
Neuraxial anesthesia as the planned primary anesthetic
Informed consent obtained
Females age 18-50

Exclusion Criteria:

Emergency cesarean section
Anesthetic other than neuraxial
Allergy to local anesthetics, morphine, or epinephrine
Pre-existing sensory/motor deficit
Intervention: Apixaban
Trial phase: Phase 3
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 250
Group description: Participants will be administered apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase
Eligibility criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

New diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia
Planned 3-4 drug systemic induction chemotherapy with a corticosteroid, vincristine and a single dose or multiple doses of asparaginase, with or without daunorubicin
Functioning Central Venous Access Device
Must be able to tolerate oral medication or have it administered via an Nasogastric tube (NGT) or GT tube
Males and females,age 1 year(365 days) to < 18 (17 years and 364 days) years.

Exclusion Criteria:

Subjects scheduled to have > 3 Lumbar Punctures over the course of the study treatment period
Prior history of documented DVT or PE in the past 3 months
Known inherited bleeding disorder or coagulopathy
Major surgery [excluding Central Venous Access Device (CVAD) replacement and bone marrow aspiration and non-open biopsy] within the last 7 days prior to enrollment that may be associated with a risk of bleeding. Open biopsy is considered a major surgery.
Uncontrolled severe hypertension at enrollment. Severe hypertension is defined as a systolic or diastolic blood pressure (BP) > 5 mm Hg above the 95th percentile as defined by the National High Blood Pressure Education Program Working Group (NHBPEP) established guidelines for the definition of normal and elevated blood pressure in children
Extreme hyperleukocytosis, white blood cell (WBC) counts over 200 x 109/L (200,000/microL) at the time of enrollment
Liver dysfunction manifested by SGTP (ALT) > 5X Upper limit of normal (ULN) and/or Aspartate aminotransferase (AST) >5 X ULN and/or direct (conjugated) bilirubin > 2X ULN
Renal function < 30% of normal for age and size as determined by the Schwartz formula
International normalized ratio (INR) > 1.4 and activated partial thromboplastin time (aPTT) > 3 seconds above the upper limit of normal for age, within 1 week prior to enrollment.
History of allergy to apixaban or Factor Xa inhibitors
History of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents
History of any significant drug allergy (such as anaphylaxis or hepatotoxicity
Any investigational drug being administered during the study

Other protocol inclusion/exclusion criteria may apply
Intervention: Silodosin
Trial phase: Phase 4
ATC code: G04CA04
SMILES: C[C@H](Cc1cc2c(c(C(N)=O)c1)N(CCCO)CC2)NCCOc1ccccc1OCC(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Subjects in the Silodosin Group will be given silodosin 8 mg tablets, one tablet to be taken PO each day for two weeks.

Silodosin: 8mg tablet, 1 tab PO daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Adults age 18 to 70 years
Non-diabetic
Unilateral ureteral calculus 4 to 10 mm visible on CT scan within the ureter
Serum creatinine level within normal range
Ability to tolerate oral fluids and oral pain medication
Ability to make informed medical decisions regarding consent
Willingness to follow up in the ER in two weeks

Exclusion Criteria:

Adults unable to consent
Age <18
Signs of infection including Temperature >38º C or Urinalysis with any of the following: Positive Leukocyte Esterase, Positive Nitrates, or White Blood Cell Count >5/hfp in the setting of a positive urine culture (defined as a single isolated bacterial species population of >100,000 CFU)
Patients with chronic pain already undergoing treatment with narcotic medications
Patients already taking an alpha adrenergic antagonist medication
Pregnant women
Prisoners
No working phone number
Intervention: Tamsulosin
Trial phase: Phase 4
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Subjects in the Tamsulosin Group will be given tamsulosin 0.4 mg tablets, one tablet to be taken PO each day for two weeks.

Tamsulosin: 0.4 mg Tab, 1 tab PO daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Adults age 18 to 70 years
Non-diabetic
Unilateral ureteral calculus 4 to 10 mm visible on CT scan within the ureter
Serum creatinine level within normal range
Ability to tolerate oral fluids and oral pain medication
Ability to make informed medical decisions regarding consent
Willingness to follow up in the ER in two weeks

Exclusion Criteria:

Adults unable to consent
Age <18
Signs of infection including Temperature >38º C or Urinalysis with any of the following: Positive Leukocyte Esterase, Positive Nitrates, or White Blood Cell Count >5/hfp in the setting of a positive urine culture (defined as a single isolated bacterial species population of >100,000 CFU)
Patients with chronic pain already undergoing treatment with narcotic medications
Patients already taking an alpha adrenergic antagonist medication
Pregnant women
Prisoners
No working phone number
Intervention: Sodium Hypochlorite
Trial phase: Phase 3
ATC code: D08AX07
SMILES: [Na+].[O-]Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
Eligibility criteria:
Inclusion Criteria:

Head and neck cancer who plan to undergo radiation therapy to the head and neck region
At least 18 years of age
Able to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Prior radiation therapy to the head and neck region or prior chemotherapy for head and neck cancer (induction chemotherapy NOT excluded)
The physician-approved radiation treatment plan indicates a maximum prescription dose of less than 45 Gy
Scleroderma or discoid lupus
Intervention: Promega
Trial phase: Phase 2 | Phase 3
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.

Omegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs.
Eligibility criteria:
Inclusion Criteria:

Live in or temporarily relocate to Oklahoma
Age less than 18 years, both sexes, all races
Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
Are not currently enrolled in another lipid emulsion study

Exclusion Criteria:

Known food allergy to fish
Known metabolic disorder of lipid metabolism
Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
Medical condition likely to result in death in the next 30 days
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Length of intervention: 16 weeks atorvastatin: Atorvastatin is an oral cholesterol-lowering medication commonly referred to as statin therapy.
Eligibility criteria:
Inclusion Criteria:

early diffuse scleroderma (< 3 years from the first scleroderma-related symptom)
Raynaud phenomenon
no use of lipid-lowering medication within 60 days

Exclusion Criteria:

pregnancy
renal or kidney dysfunction (creatinine < 2.0 mg/dL or creatinine clearance < 60 c/min)
diabetes mellitus
known cardiovascular disease or a prior history of stroke
history of liver disease
new or changed dose of calcium channel blockers (CCB) and angiotensin receptor blockers (ARBs) in the last 4 weeks
known allergy or adverse reaction to the atorvastatin or another statin drug
Intervention: Cromolyn Sodium
Trial phase: Phase 4
SMILES: O=C([O-])c1cc(=O)c2c(OCC(O)COc3cccc4oc(C(=O)[O-])cc(=O)c34)cccc2o1.[Na+].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Subjects randomized to the experimental arm will receive oral cromolyn sodium. The dose will be per current package insert for oral cromolyn:

Subjects 2-12 years of age - 100 mg (1 ampule) 4 times daily Subjects 13-18 years of age - 200 mg (2 ampules) 4 times daily

oral cromolyn sodium: Oral cromolyn sodium
Eligibility criteria:
Inclusion Criteria:

Diagnosis of eosinophilic esophagitis

Exclusion Criteria:

Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period.
Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline).
Evidence of pathologic eosinophilia in other locations in the GI tract.
Participation in another research protocol
Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)
Intervention: Linagliptin
Trial phase: Phase 4
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Patients will be treated for 12 weeks with Linagliptin 5mg once daily.

Linagliptin
Eligibility criteria:
Inclusion Criteria:

Age 20-80 years inclusive. Type 2 diabetes BMI ≥30 kg/m2 Subjects on statins, ACE inhibitors, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the course of study.

HbA1c ≤ 8.0%

Exclusion Criteria:

- Use of GLP-1 agonists or DPP-IV therapy in the last 3 months. History of Pancreatitis. Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and hypertriglyceridemia.

Subjects who are taking antiplatelet or anticoagulant medications will be excluded from the fat biopsy portion of the study.

Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks Hepatic disease (liver function tests more than 3 times the upper limit of normal) Renal impairment (serum eGFR <30 ml/min) Any other life-threatening, non-cardiac disease Uncontrolled hypertension (BP > 160/100 mm of Hg) Congestive Heart Failure class III or IV. Use of an investigational agent or therapeutic regimen within 30 days of study Participation in any other concurrent clinical trial
Intervention: Vilazodone
Trial phase: Phase 3
ATC code: N06AX24
SMILES: N#Cc1ccc2[nH]cc(CCCCN3CCN(c4ccc5oc(C(N)=O)cc5c4)CC3)c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 187
Group description: Vilazodone tablets 15-30 mg. Oral administration, once per day.
Eligibility criteria:
Inclusion Criteria:

Male or Female outpatients between 7-17 years of age
Primary diagnosis of Major Depressive Disorder (MDD)
Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
History of suicidal behavior, or requires precaution against suicide
Not generally healthy medical condition
Seizure disorder
Intervention: Losartan
Trial phase: Phase 2
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <95th percentile

Losartan: Standard dosing
Eligibility criteria:
Inclusion Criteria:

Pts with HbSS or SB0 thalassemia
Hypertension from clinic BP readings (defined by NHLBI BP tables)
Abnormal nocturnal dipping (systolic or diastolic) as defined by <10% dip or abnormal nocturnal BP load (>25% of sleep BP readings >95th percentile as defined by AHA ABPM guidelines)
Signed Informed Consent

Exclusion Criteria:

Patient already on BP lowering medication
Hyperkalemia
Pregnancy
Intervention: Losartan
Trial phase: Phase 2
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <75th percentile

Losartan: Experimental dosing
Eligibility criteria:
Inclusion Criteria:

Pts with HbSS or SB0 thalassemia
Hypertension from clinic BP readings (defined by NHLBI BP tables)
Abnormal nocturnal dipping (systolic or diastolic) as defined by <10% dip or abnormal nocturnal BP load (>25% of sleep BP readings >95th percentile as defined by AHA ABPM guidelines)
Signed Informed Consent

Exclusion Criteria:

Patient already on BP lowering medication
Hyperkalemia
Pregnancy
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 127
Group description: TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes

Tranexamic Acid: see arm/group descriptions
Eligibility criteria:
Inclusion Criteria:

Adult patients over age of 18 undergoing elective total primary knee arthroplasty under spinal anesthesia.

Exclusion Criteria:

Previous adverse reaction to tranexamic acid
Congenital or acquired coagulation disorders
Preoperative platelet count of less than 100,000/microliter or INR> 1.4
History of deep venous thrombosis, pulmonary embolism or cerebrovascular accident
Patients with acquired defective color vision
Renal insufficiency (Glomerular filtration rate <20 ml/min)
Severe liver disease
Coronary stents
Pregnant patients
Main anesthetic other than spinal anesthesia