anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Linagliptin
Trial phase: Phase 3
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: 631
Group description: Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Eligibility criteria:
Inclusion criteria:

Diabetes type 2, detectable C-peptide, HbA1c 7-10%
Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

Exclusion criteria:

Uncontrolled hyperglycemia during Run-in
Myocardial infarction, stroke or TIA within 3 months prior to informed consent
Liver impairment; gastric surgery; medical history of cancer in last 5 years
Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
Unsufficient birth control, pregnancy and nursing
Intervention: Quetiapine
Trial phase: Phase 2
ATC code: N05AH04
SMILES: OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Open label treatment with quetiapine

quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Between the ages of 18-65
Meets DSM-IV criteria for current cannabis dependence
Seeking treatment for cannabis dependence
Reports using cannabis an average of five days per week over the past 28 days
Capable of giving informed consent and complying with study procedures

Exclusion Criteria:

Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non-pharmacological intervention over the course of the study
Receiving prescribed psychotropic medication
Known history of allergy, intolerance, or hypersensitivity to quetiapine
Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men
Unstable medical conditions, such as poorly controlled diabetes or hypertension, which might make participation hazardous
Current DSM-IV diagnosis of substance dependence other than cannabis or nicotine dependence
Are legally mandated to participate in a substance use disorder treatment program
Increased risk for suicide
Diabetes (whether controlled or not), hyperglycemia (fasting glucose > 100 mg/dl), obesity (BMI > 30) and elevated lipids (cholesterol > 200 mg/dl; triglycerides > 150 mg/dl).
Intervention: Ondansetron
Trial phase: Phase 2
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Eligibility criteria:
Inclusion Criteria:

Patients greater than or equal to 18 years of age.
Patients with a diagnosis of acute myelogenous leukemia, high-risk myelodysplastic syndrome, chronic myelogenous leukemia in blast crisis or acute undifferentiated leukemia who will receive chemotherapy with regimens containing high-dose cytarabine (greater or equal 1g/m^2/d for at least 3 days).
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

Patients with emesis or grade 2 or 3 nausea present less than or equal to 24 hours before chemotherapy.
Patients with ongoing emesis due to any organic etiology
Patients with known hypersensitivity to the study drug or to 5-HT3 receptor antagonists
Patients receiving pimozide, terfenadine, astemizole, or cisapride
Intervention: Lacosamide
Trial phase: Phase 4
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks):

Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks):

200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks):

50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week
Eligibility criteria:
Inclusion Criteria:

Group 1:

Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures

Group 2:

Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days

Exclusion Criteria:

Previous use of Lacosamide
History of seizure disorder characterized primarily by isolated auras
History of primary generalized seizures
History of status epilepticus within last 12-months
History of cluster seizures during the 12 week period prior to Visit 1
Nonepileptic events, including pseudoseizures that could be confused with seizure
Lifetime history of suicide attempt or suicidal ideation in the past 6 months
Hypersensitivity to any component of Lacosamide
History of drug or alcohol abuse
History of an acute or subacutely progressive Central Nervous System (CNS) disease
Undergone cranial surgery within the last year prior to study entry
Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
Prior or concomitant Vigabatrin use
Intervention: Lacosamide
Trial phase: Phase 4
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 360
Group description: Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks):

Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks):

200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks):

50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week
Eligibility criteria:
Inclusion Criteria:

Group 1:

Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures

Group 2:

Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days

Exclusion Criteria:

Previous use of Lacosamide
History of seizure disorder characterized primarily by isolated auras
History of primary generalized seizures
History of status epilepticus within last 12-months
History of cluster seizures during the 12 week period prior to Visit 1
Nonepileptic events, including pseudoseizures that could be confused with seizure
Lifetime history of suicide attempt or suicidal ideation in the past 6 months
Hypersensitivity to any component of Lacosamide
History of drug or alcohol abuse
History of an acute or subacutely progressive Central Nervous System (CNS) disease
Undergone cranial surgery within the last year prior to study entry
Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
Prior or concomitant Vigabatrin use
Intervention: Tagatose
Trial phase: Phase 3
SMILES: O=C(CO)[C@@H](O)[C@@H](O)[C@H](O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: 15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetics in accordance with WHO.
Male and female patients, between 18 and 75 years of age.
Diabetic patients who are not on medication for the disease. Patients may be treated with diet and exercise.
Normal blood creatine clearance and normal liver function test results.
BMI less than or equal to 45kg/m2.

Exclusion Criteria:

Treatment with sulfonylurea (e.g., Glyburide, Glipizide, Glimepiride, Chlorpropamide, Tolazamide, Acetohexamide, or Tolbutamide), TZDs, metformin, acarbose, Byetta, insulin, and any antidiabetic medications within the prior 3 months.
Therapy with beta-blockers or thiazide diuretics within the prior 3 months.
Pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using inadequate contraceptive measure.
Documented gastrointestinal disease, or taking of medications likely to alter gut motility or absorption.
Receiving any investigational drug within 30 days of the baseline visit.
Intervention: Memantine
Trial phase: Phase 2
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years old
Primary Diagnosis of OCD
Physically healthy and females must be using effective contraception
At lease moderate OCD symptoms (Yale-Brown Obsessive-Compulsive Scale [YBOCS]score greater or equal to 16 prior to entering trial)
Able to provide consent

May be on or off selective reuptake inhibitor (SRI) medications

Patients on an SRI medication will be included if the dose is stable and adequate (or if they don't want to increase their dose [e.g. side effects] and have a history of prior SRI or CBT treatment meeting criteria for adequate trial)
Patients not on an SRI medication will be included if they they have failed at least 1 prior trial of standard OCD treatment (e.g. SRIs or CBT)

Exclusion Criteria:

Ongoing treatment with memantine
Patients planning to start CBT during the study period or those who have started CBT within 8 weeks prior to study enrollment
Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder.
Current major depressive disorder (patients must be free of the disorder for three months prior to enrollment). Patients will be excluded if they are moderately to severely depressed, but if they are mildly to moderately depressed they will be included (Hamilton Depression Rating Scale must be <18).
Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors).
Current eating disorder
Females who are pregnant or nursing
Severe renal insufficiency, severe hepatic impairment, or seizure disorder.
Documented history of hypersensitivity or intolerance to memantine.
Concomitant use of trimethoprim, N-methyl-D-aspartate receptor medications
Intervention: Cholecalciferol
Trial phase: Phase 4
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 40
Group description: IM Vitamin D3 3,00,000 Units single dose
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of tropical calcific pancreatitis established by history of abdominal pain or diabetes and evidence on ultrasound or CT scan of pancreatic ductal dilatation and intra-ductal stones

Exclusion Criteria:

History of alcohol intake or any secondary cause for chronic pancreatitis (hypercalcemia, hypertriglyceridemia, biliary tract stones)
History of hepatic or renal dysfunction or of current intake of drugs such as steroids, anticonvulsant drugs
Intervention: Cholecalciferol
Trial phase: Phase 4
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 40
Group description: IM vitamin D3 6,00,000 Units single dose
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of tropical calcific pancreatitis established by history of abdominal pain or diabetes and evidence on ultrasound or CT scan of pancreatic ductal dilatation and intra-ductal stones

Exclusion Criteria:

History of alcohol intake or any secondary cause for chronic pancreatitis (hypercalcemia, hypertriglyceridemia, biliary tract stones)
History of hepatic or renal dysfunction or of current intake of drugs such as steroids, anticonvulsant drugs
Intervention: Cholecalciferol
Trial phase: Phase 4
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Oral vitamin D3 500 Units/ day
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of tropical calcific pancreatitis established by history of abdominal pain or diabetes and evidence on ultrasound or CT scan of pancreatic ductal dilatation and intra-ductal stones

Exclusion Criteria:

History of alcohol intake or any secondary cause for chronic pancreatitis (hypercalcemia, hypertriglyceridemia, biliary tract stones)
History of hepatic or renal dysfunction or of current intake of drugs such as steroids, anticonvulsant drugs
Intervention: Testosterone
Trial phase: Phase 1
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Weekly testosterone treatment for a duration of 5 months
Eligibility criteria:
Inclusion Criteria:

Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).

Exclusion Criteria:

Medications such as anticoagulants (Coumadin) and glucocorticoids.
History of angina that occurs with exertion or at rest.
History of myocardial infarction within the last 12 months.
Failure to successfully complete an exercise stress test using the Bruce protocol. Subjects that demonstrate ≥ 0.1 mV horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ≥ 10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ≥ 10 PVC/min, or couplets) during the stress test will be excluded.
LDL cholesterol above 200 mg/dL.
History of prostatic cancer.
Elevated prostate specific antigen (PSA) above 4.0 µg/L, or severe benign prostatic hypertrophy (BPH) by history (frequent urination, reduced stream).
Serum total testosterone concentrations of greater than 500 ng/dL.
Subjects who engage in high intensity, elite training on a regular basis.
Major medical illness such as diabetes, chronic obstructive pulmonary disease, or sleep apnea.
Recent history of smoking tobacco.
Hematocrit greater than 51%.
Morbidly obese older men (BMI > 35).
Hypertension: Blood pressure on three consecutive measurements taken at one week intervals that has a systolic pressure ≥ 140 or a diastolic blood pressure ≥ 90. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.
History of hepatitis or a 3-fold elevation of liver function tests (Alk phos, ALT, AST).
Bone related disorders such as osteoporosis or parathyroid disease.
DEXA scans revealing lumbar spine T-scores of less than -2.5.
Subjects currently taking anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin.
Intervention: Oxaliplatin
Trial phase: Phase 4
ATC code: L01XA03
SMILES: NC1CCCCC1N.O=C([O-])C(=O)[O-].[Pt+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).
Eligibility criteria:
Inclusion Criteria:

Patients aged 21 and older.
Documented moderate to severe traumatic brain injury at least one year post injury.

Exclusion Criteria:

The only absolute exclusionary medication will be an anticoagulant (Coumadin) because of the risk of bleeding during the possible muscle biopsy procedure and daily injections of rhGH in the GH arm of the study.
Any subject with a history of hepatitis or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are uncertain of the effects of hormone replacement such as rhGH on the liver, so we will exclude any subjects with hepatitis. This exclusion applies only to subjects who would be enrolled in the GH arm of the study.
Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
Intervention: Cephalexin
Trial phase: Not Applicable
ATC code: J01DB01
SMILES: [H][C@]12SCC(C)=C(C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: keflex 500mg twice a day for five days

keflex: keflex 500 mg BID 5 days
Eligibility criteria:
Inclusion Criteria:

any individual who presents with a through-and-through laceration of the lip within twenty-four hours of injury

Exclusion Criteria:

patients less than eighteen years of age
pregnancy
currently taking antibiotics
animal or human bites
wounds greater than 24 hours old
diabetic patients
immune compromised patients
patients who require antibiotics for other sustained injuries
patients with an allergy to penicillin or cephalosporin will be excluded if randomized to the cephalexin treatment group
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: bimatoprost ophthalmic 0.03% solution
Eligibility criteria:
Inclusion Criteria:

African American/ethnic black
Adults at least 18 years of age
Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

Subjects with uneven lashes or longer on one side than the other
Any eye disease or abnormality
Eye surgery
Severe hyperpigmentation around the eye
Eyelash implants
Eyelash extension application
Any use of eyelash growth products within 6 months
Any use of prescription eyelash growth products
Treatments that may affect hair growth
Requiring eye drop medications for glaucoma
Intervention: Telapristone acetate
Trial phase: Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Proellex®: one (1) 25 mg capsule daily No data available
Eligibility criteria:
Inclusion Criteria:

Only subjects treated in the ZPE-201 study will be allowed to enter the extension study.
Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate.

Exclusion Criteria:

All other subjects
Intervention: Aminocaproic acid
Trial phase: Phase 4
ATC code: B02AA01
SMILES: NCCCCCC(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Patients will receive EACA before and during the surgical case.

Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.
Eligibility criteria:
Inclusion Criteria:

Undergoing thoracic and/or lumbar surgery for correction of adolescent idiopathic scoliosis, neuromuscular scoliosis, or adult deformity for correction of condition via posterior spinal fusion of 6 levels or greater.

Exclusion Criteria:

No renal dysfunction identified by elevated blood urea nitrogen (BUN) and creatinine (CR) or BUN to CR ratio greater than 20:1
Hold religious and/or other beliefs limiting blood transfusion
Currently use anti-coagulant medication or have past medical history leading to abnormal coagulation profile pre-operatively
Significant past medical history preventing the use of TXA or EACA described in the protocol
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Patients infused with normal saline before and during the surgical procedure as a placebo.

Normal Saline :
Eligibility criteria:
Inclusion Criteria:

Undergoing thoracic and/or lumbar surgery for correction of adolescent idiopathic scoliosis, neuromuscular scoliosis, or adult deformity for correction of condition via posterior spinal fusion of 6 levels or greater.

Exclusion Criteria:

No renal dysfunction identified by elevated blood urea nitrogen (BUN) and creatinine (CR) or BUN to CR ratio greater than 20:1
Hold religious and/or other beliefs limiting blood transfusion
Currently use anti-coagulant medication or have past medical history leading to abnormal coagulation profile pre-operatively
Significant past medical history preventing the use of TXA or EACA described in the protocol