anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 233
Group description: Pitavastatin 4 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and females (18-75 years of age)
At least two cardiovascular disease risk factors
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus
Abnormal pancreatic, liver or renal function
Abnormal serum creatine kinase (CK) above the pre-specified level
Intervention: Simvastatin
Trial phase: Phase 3
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: Simvastatin 40 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and females (18-75 years of age)
At least two cardiovascular disease risk factors
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus
Abnormal pancreatic, liver or renal function
Abnormal serum creatine kinase (CK) above the pre-specified level
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 275
Group description: Pitavastatin 4 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and females (ages 18-75 years)
Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
Must have been following a restrictive diet
Diagnosis of combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus
Abnormal pancreatic, liver, or renal function
Abnormal serum creatine kinase (CK) above the pre-specified level
Significant heart disease
Intervention: Atorvastatin
Trial phase: Phase 3
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: 137
Group description: Atorvastatin 20 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and females (ages 18-75 years)
Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
Must have been following a restrictive diet
Diagnosis of combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus
Abnormal pancreatic, liver, or renal function
Abnormal serum creatine kinase (CK) above the pre-specified level
Significant heart disease
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 311
Group description: Pitavastatin 2 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and females (18-75 years)
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
Conditions which may cause secondary dyslipidemia.
Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)
Abnormal serum creatine kinase (CK) above the pre-specified level
Abnormal pancreatic, liver or renal function
Significant heart disease
Intervention: Simvastatin
Trial phase: Phase 3
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Simvastatin 20 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and females (18-75 years)
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
Conditions which may cause secondary dyslipidemia.
Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)
Abnormal serum creatine kinase (CK) above the pre-specified level
Abnormal pancreatic, liver or renal function
Significant heart disease
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 320
Group description: Pitavastatin 4 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and females (18-75 years)
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
Conditions which may cause secondary dyslipidemia.
Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)
Abnormal serum creatine kinase (CK) above the pre-specified level
Abnormal pancreatic, liver or renal function
Significant heart disease
Intervention: Simvastatin
Trial phase: Phase 3
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: Simvastatn 40 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and females (18-75 years)
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
Conditions which may cause secondary dyslipidemia.
Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)
Abnormal serum creatine kinase (CK) above the pre-specified level
Abnormal pancreatic, liver or renal function
Significant heart disease
Intervention: Aggrenox
Trial phase: Phase 3
SMILES: CC(=O)Oc1ccccc1C(=O)O.OCCN(CCO)c1nc(N2CCCCC2)c2nc(N(CCO)CCO)nc(N3CCCCC3)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 655
Group description: Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
Eligibility criteria:
Inclusion Criteria:

Patients with a diagnosis of cerebral infarction (excluding cardiogenic cerebral embolism) who meet the diagnostic criteria based on the National Institute of Neurological Disorders and Stroke (NINDS) ad hoc committee's classification of cerebrovascular disease III.

Patients who have had an onset of cerebral infarction, the time of which is known, between 1 week and 6 months before the time of enrolment (including first and recurrent cerebral infarctions)
Patients who are 50 years or older
Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator
Patients with a finding corresponding to the responsible focus confirmed by head X-ray computerised tomography (CT) or magnetic resonance imaging (MRI)

Patients who have at least two of the following risk factors:

diabetes
hypertension (systolic blood pressure is 140 mmHg or higher or diastolic blood pressure is 90 mmHg or higher) or under treatment of hypertension
smoker (at the time of onset of cerebral infarction)
obesity (Body mass index (BMI) is more than 25 kg/m2)
previous vascular disease (stroke, acute myocardial infarction or peripheral arterial disease before the onset of cerebral infarction)
end-organ damage (retinopathy, left ventricular hypertrophy (LVH) or microalbuminuria)
hyperlipidaemia

Exclusion Criteria:

Patients with a diagnosis of brain disorders with a bleeding risk such as brain haemorrhage, subarachnoid haemorrhage, cerebral arteriovenous (AV) malformation, cerebral AV aneurysms and brain tumours
Patients with complications of cardiac disorders (atrial fibrillation, mitral valve stenosis, severe cardiac valve disorders) that may provide an embolic source for cerebral embolism
Patients having had acute coronary syndromes (acute myocardial infarction, unstable angina) within 6 months after enrolment in this study
Patient with hypersensitivity to dipyridamole preparations
Patients with a history of drug allergy to acetylsalicylic acid (ASA) or aspirin asthma
Patients with a history of peptic ulcer
Patients having undergone arterial reconstruction after development of cerebral infarction
Patients with very severe impairment (4 or 5 on Modified Rankin Scale)
Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract, vitreous haemorrhage, etc.)
Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or diastolic blood pressure is 110 mmHg or higher)
Patients with complications such as serious cardiac, renal and hepatic disorders
Patients with a malignant tumour or having had a tumour treatment in the past 5 years
Women who are or may be pregnant or lactating women
Intervention: Thymosin Beta 4
Trial phase: Phase 2
SMILES: CCC(C)C(NC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(CCSC)NC(=O)C(CC(=O)O)NC(=O)C1CCCN1C(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(C)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(Cc1ccccc1)C(=O)NC(CC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CC(N)=O)C(=O)N1CCCC1C(=O)NC(CC(C)C)C(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CCC(=O)O)C(=O)NC(C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CCC(N)=O)C(=O)NC(C)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)O)C(C)CC)C(C)O)C(C)O)C(C)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days

Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days
Eligibility criteria:
Inclusion Criteria:

Informed Consent form signed by the patient or patient's legal representative; also, if the patient is under the age of majority but capable of providing assent, signed assent from the patient
Diagnosis of junctional or dystrophic EB.
Patients who present with Hallopeau-Siemens subtype may be enrolled.
At least one active, unroofed EB erosion on the limb or on the trunk.
Lesion size 5 to 50 cm2, inclusive.
Stable lesion present for 14-60 days before enrollment.
More that one member in a family can be enrolled as long as that member is treated to a different cohort with an assurance that the study medication will not be shared.
No clinically significant abnormalities (Grade 2 or higher on the National Cancer Institute [NCI] toxicity scale) on Screening laboratory tests, except for the following specific laboratory threshold result: albumin must be 2 g/dL or higher; hemoglobin must be 8 g/dL or higher.

Exclusion Criteria:

Clinical evidence of local infection of the index (targeted) lesion.
Use of any investigational drug within the 30 days before enrollment.
Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.
Use of systemic or topical steroidal therapy within the 30 days before enrollment.Inhaled steroids are allowed.
Use of systemic antibiotics within the 7 days before enrollment.
Current or former malignancy.
Arterial or venous disorder resulting in ulcerated wounds.
Diabetes mellitus.
Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)
Intervention: 1-Propanol
Trial phase: Phase 2
ATC code: D08AX03 | D08AX53
SMILES: CCCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: 20 mg daily of policosanol

Policosanol : 20 mg of policosanol in capsular form daily
Eligibility criteria:
Inclusion Criteria:

CD4 count > 250 Plasma HIV RNA < 50,000 Currently receiving HAART age 18-60 total cholesterol between 200-240 or triglycerides between 150-400 or LDL cholesterol > 160

Exclusion Criteria:

kidney or liver disease current use of lipid-lowering drugs pregnancy lactation

-
Intervention: Roflumilast
Trial phase: Phase 3
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 466
Group description: Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
Eligibility criteria:
Main Inclusion Criteria:

History of COPD for at least 12 months prior to baseline visit
FEV1/FVC ratio (post-bronchodilator) ≤ 70%
FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted

Main Exclusion Criteria:

COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
Intervention: Milnacipran
Trial phase: Phase 3
ATC code: N06AX17 | N06AX28
SMILES: CCN(CC)C(=O)C1(c2ccccc2)CC1CN
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 516
Group description: Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
Eligibility criteria:
Inclusion Criteria:

diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

psychiatric illness,
depression,
suicidal risk,
substance abuse,
pulmonary dysfunction,
renal impairment,
active cardiac disease,
liver disease,
autoimmune disease,
cancer,
inflammatory bowel disease
Intervention: Dronabinol
Trial phase: Phase 1
ATC code: A04AD10
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)Oc1cc(CCCCC)cc(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
Eligibility criteria:
Inclusion Criteria:

Patients with histologically confirmed diagnosis of primary malignant brain tumor (grade 3 or 4)
Karnofsky greater than or equal to 80%
Life expectancy greater than or equal to 6 months
Patients must be undergoing one of the following chemotherapy administrations: Temozolomide; Lomustine (CCNU) or Irinotecan or Camptosar (CPT-11)
Patients must give written informed consent
Patients must have aspartate aminotransferase (AST), alanine transaminase (ALT), total serum bilirubin, and alkaline phosphatase less than 2 times upper limits of normal laboratory values, performed within 14 days prior to initiation of study
For women, negative risk of pregnancy through standard chemotherapy screening procedures inclusive of pregnancy test, menopause or surgical procedure
Patient must have social support with caregiver daily monitoring for side effects

Exclusion Criteria:

Premorbid central nervous system (CNS) diagnosis (cerebral vascular accident (CVA), closed head injury (CHI), multiple sclerosis (MS)
Patients with global aphesis limiting the informed consent process
Patients with unmanaged psychiatric disease
Patients with history of drug addiction or recent illicit drug usage within the last 3 months
Patients with hypersensitivity to dronabinol, marijuana or sesame seed oil
Patients must not be taking an concomitant meds contraindicated with Dronabinol (including anxiolytics, sedative, hypnotics, barbiturates, general anesthetics, monoamine oxidase inhibitors [MAOIs], opiate agonists, phenothiazines, sedating H1 blockers, skeletal muscle relaxants and sympathomimetics)
Patients who have hepatic enzyme elevation of greater than two times upper limits of normal laboratory values for AST, ALT, total serum bilirubin or alkaline phosphatase
Pregnant or breastfeeding women
Women of childbearing potential who are not using an effective method of contraception (oral contraceptives, female and/or male barrier devices, spermicidal agents, or surgical procedures inhibiting contraception)
Patients who live alone
Intervention: Buprenorphine
Trial phase: Phase 3
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: 46
Group description: Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Eligibility criteria:
Inclusion Criteria:

clinical evidence of stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.

Exclusion Criteria:

receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 334
Group description: 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
Eligibility criteria:
Inclusion Criteria:

Blunt trauma
Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)*

Age 15 years or older or 50 kg or more

Patients who met the inclusion criteria above and did not meet the exclusion criteria below but who had systolic blood pressure (SBP) ≤70 or SBP>70 and SBP≤90 and heart rate (HR)≥108 were included in the Hypertonic Resuscitation following Traumatic Injury study that focused on shock patients who may or may not have a traumatic brain injury (TBI). In other words, patients with both TBI and shock would not be included in this study of TBI patients without shock at the time of enrollment.

Exclusion Criteria:

Known or suspected pregnancy
Age younger than 15 years or less than 50 kg if age unknown
Ongoing pre-hospital cardiopulmonary resuscitation (CPR)
Administration of more than 2L crystalloid or any colloid or blood products
Severe hypothermia (T less than 28C)
Drowning or asphyxia due to hanging
Burns TBSA more than 20%
Isolated penetrating injury to the head
Inability to obtain pre-hospital intravenous access
Time of call received at dispatch to study intervention more than four hours
Known prisoners
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 573
Group description: 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
Eligibility criteria:
Inclusion Criteria:

Blunt trauma
Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)*

Age 15 years or older or 50 kg or more

Patients who met the inclusion criteria above and did not meet the exclusion criteria below but who had systolic blood pressure (SBP) ≤70 or SBP>70 and SBP≤90 and heart rate (HR)≥108 were included in the Hypertonic Resuscitation following Traumatic Injury study that focused on shock patients who may or may not have a traumatic brain injury (TBI). In other words, patients with both TBI and shock would not be included in this study of TBI patients without shock at the time of enrollment.

Exclusion Criteria:

Known or suspected pregnancy
Age younger than 15 years or less than 50 kg if age unknown
Ongoing pre-hospital cardiopulmonary resuscitation (CPR)
Administration of more than 2L crystalloid or any colloid or blood products
Severe hypothermia (T less than 28C)
Drowning or asphyxia due to hanging
Burns TBSA more than 20%
Isolated penetrating injury to the head
Inability to obtain pre-hospital intravenous access
Time of call received at dispatch to study intervention more than four hours
Known prisoners
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 256
Group description: 7.5% hypertonic saline (HS) 250ml dose
Eligibility criteria:
Inclusion Criteria:

Blunt or penetrating trauma
Prehospital Systolic Blood Pressure (SBP) <= 70;OR
Prehospital SBP 71-90 AND Hear Rate (HR) ≥108
15 years of age or older, or 50kg or more if age unknown

Exclusion Criteria:

Known or suspected pregnancy
Age younger than 15 or less than 50kg if age unknown
Ongoing prehospital cardiopulmonary resuscitation (CPR)
Administration of more than 2000cc crystalloid or any colloid or blood products
Severe hypothermia (suspected Temperature less than 28 degrees celsius)
Drowning or asphyxia due to hanging
Burns Total Body Surface Area (TBSA) more than 20%
Isolated penetrating injury to the head
Inability to obtain prehospital intravenous access
Time of call received at dispatch to study intervention greater than four hours
Known prisoners
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 376
Group description: 0.9% normal saline 250 ml dose as placebo
Eligibility criteria:
Inclusion Criteria:

Blunt or penetrating trauma
Prehospital Systolic Blood Pressure (SBP) <= 70;OR
Prehospital SBP 71-90 AND Hear Rate (HR) ≥108
15 years of age or older, or 50kg or more if age unknown

Exclusion Criteria:

Known or suspected pregnancy
Age younger than 15 or less than 50kg if age unknown
Ongoing prehospital cardiopulmonary resuscitation (CPR)
Administration of more than 2000cc crystalloid or any colloid or blood products
Severe hypothermia (suspected Temperature less than 28 degrees celsius)
Drowning or asphyxia due to hanging
Burns Total Body Surface Area (TBSA) more than 20%
Isolated penetrating injury to the head
Inability to obtain prehospital intravenous access
Time of call received at dispatch to study intervention greater than four hours
Known prisoners