anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM FLUORIDE
Trial phase: Phase 2
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: An oral rinse given to pediatric patients in routine practice within the standard of care.

Sodium Fluoride (.05%): 30 second oral rinse expectorate of 10mL of solution
Eligibility criteria:
Inclusion Criteria:

Patients presenting to the dental clinic for routine dental treatment (including recall exams, new patient exams, and operative appointments) who are American Society of Anesthesia (ASA) class I or II
Cooperative patients classified as 3 or 4 according to the Frankl Behavioral Rating Scale,
No known allergies or sensitivities to products or ingredients being tested
Had untreated cavities
Nothing to eat/drink for 1 hour prior to dental appointment

Exclusion Criteria:

Patients who are ASA class III, IV, V or VI
Known allergies or sensitivities to any of the mouth rinses or any of the ingredients in the mouth rinses to be tested
Non-English speaking parent/participant
Patient presenting to the clinic as a walk in or emergency appointment
Patient experiencing any pain or sensitivity
Precooperative or uncooperative behavior or behavior classified as 1 or 2 according to the Frankl Behavioral Rating Scale
Intervention: Ledipasvir
Trial phase: Phase 3
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
Eligibility criteria:
Key Inclusion Criteria:

HCV RNA > 15 IU/mL at screening
HCV genotype 1 or 4
Chronic HCV infection (≥ 6 months)
Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± pegylated interferon (PEG)
Cirrhotic and non-cirrhotic as determined by standard methods
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors
Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF
Pregnant or nursing female or male with pregnant female partner
Coinfection with HIV or hepatitis B virus
Current or prior history of clinical hepatic decompensation
Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Timbetasin acetate
Trial phase: Phase 3
SMILES: CC(=O)O.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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: It is a preservative-free, sterile eye drop solution containing Tβ4

RGN-259: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Be male or female of any race, at least 18 years of age
Have provided verbal and written informed consent.
Be able and willing to follow instructions, including participation in all study assessments and visits;
Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use an adequate method of birth control throughout the study period.

Exclusion Criteria:

Have any clinically significant slit lamp findings at Visit 1 that in the opinion of the investigator may interfere with the study parameters;
Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergy that requires treatment
Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the investigator, is the primary cause of the persistent epithelial defect;
Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g. follicular conjunctivitis) not related to NK
Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the study;
Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior to Visit 1 or anticipates use of contact lenses during the study period;
Have an uncontrolled systemic disease that in the opinion of the investigator may interfere with the study parameters;
Anticipate a change in immunosuppressive therapy during the course of the study;
Intervention: Lumateperone
Trial phase: Phase 3
ATC code: N05AD10
SMILES: CN1CCN2c3c(cccc31)C1CN(CCCC(=O)c3ccc(F)cc3)CCC12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 176
Group description: Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks

Lumateperone 28 mg
Eligibility criteria:
Inclusion Criteria:

male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
experiencing a current major depressive episode
treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms

Exclusion Criteria:

any subject unable to provide informed consent
any female subject who is pregnant or breastfeeding
any subject judged to be medically inappropriate for study participation
Intervention: Lumateperone
Trial phase: Phase 3
ATC code: N05AD10
SMILES: CN1CCN2c3c(cccc31)C1CN(CCCC(=O)c3ccc(F)cc3)CCC12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 177
Group description: Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks

Lumateperone 42 mg
Eligibility criteria:
Inclusion Criteria:

male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
experiencing a current major depressive episode
treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms

Exclusion Criteria:

any subject unable to provide informed consent
any female subject who is pregnant or breastfeeding
any subject judged to be medically inappropriate for study participation
Intervention: Vancomycin
Trial phase: Phase 3
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 300
Group description: vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance

vancomycin: Active comparator
Eligibility criteria:
Inclusion Criteria:

written informed consent;
≥18 years of age;
a bacterial infection of the skin with a lesion size area of at least 75 cm2;
a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
infected diabetic foot ulcers;
infected decubitus ulcers;
necrotizing fasciitis or gangrene;
uncomplicated skin or skin structure infection;
infections associated with a prosthetic device;
suspected or confirmed osteomyelitis;
conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.
Intervention: Lumefantrine co-artemether
Trial phase: Not Applicable
SMILES: CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.[H][C@]12O[C@H](OC)[C@H](C)[C@]3([H])CC[C@@H](C)[C@]4([H])CC[C@](C)(OO[C@]143)O2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 79
Group description: Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.

Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.
Eligibility criteria:
Inclusion Criteria:

>= 5 years
body weight < 120kg
documented fever (axillary temperature ≥37.5o C) or history of fever in the previous 48 hours in the absence of other obvious causes of fever, such as pneumonia, middle ear infection, etc.
monoinfection by P. falciparum with parasitemia between 250 and 200,000 asexual parasites/µl, as determined by swab and thick peripheral blood smear microscopic exam
patient or parent/caregiver able to comprehend and sign informed consent or permission form
patients aged 7-17 years able to provide assent, patients aged 5-6 years do not require assent
willingness to return to the clinic and/or accept home visits for regular check-ups during the 28-day follow-up period
hemoglobin level ≥8 g/dl

Exclusion Criteria

presence of malaria danger signs (inability to drink, vomiting (more than twice in the previous 24 hours), recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand up); presence of signs of severe malaria (altered level of consciousness, psychomotor alteration, seizure, torpor and irreversible coma), severe anemia (hematocrit < 15% or clinical signs, hemoglobin <5 g/dl), renal failure (serum creatinine > 3 mg/dl or clinical signs), pulmonary edema, hypoglycemia (blood glucose < 40 mg/dl or clinical signs), shock (systolic blood pressure < 70 mmHg for adults; < 50 mmHg for children), spontaneous hemorrhage/disseminated intravascular coagulation, repeated generalized seizures, acidemia/acidosis (clinical signs), macroscopic hemoglobinuria, and jaundice.
history of chronic or severe underlying diseases (e.g. heart, renal or liver diseases, HIV/AIDS, tuberculosis, malnourishment)
history of hypersensitivity to AL
current pregnancy (history of current pregnancy or positive pregnancy test)
use of any antimalarial drug in the previous 30 days.
Intervention: Utibron Neohaler
Trial phase: Phase 4
SMILES: CCc1cc2c(cc1CC)CC(NCC(O)c1ccc(O)c3[nH]c(=O)ccc13)C2.C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 527
Group description: 110/50 μg capsules o.d. for inhalation
Eligibility criteria:
Inclusion Criteria:

Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.
Male and female adults aged ≥ 40 years.
Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines.
Patients with a post-bronchodilator FEV1 ≥40 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 µg of salbutamol).
Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at screening.
Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).

Exclusion Criteria:

Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) .
Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Brexanolone
Trial phase: Phase 2
ATC code: N06AX29
SMILES: CC(=O)C1CCC2C3CCC4CC(O)CCC4(C)C3CCC12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Subjects will receive and intravenous infusion of Allopregnanolone at escalating doses of 2mg, 4mg, and 6mg once weekly over a three week period. The highest dose tolerated without sedation will be held stable for the remaining weekly infusions, for a total of 12 infusions.
Eligibility criteria:
Inclusion Criteria

Fragile X premutation carrier status (55 to 200 CGG repeats in FMR1),
Diagnosis of FXTAS including an intention tremor and/or ataxia and/or deficits on the BDS-2 demonstrating executive function deficits.

Exclusion Criteria

other genetic problems in addition to the premutation
a history of significant brain trauma
significant substance abuse
inability to follow the protocol
liver or kidney disease
heart failure
active cancer
other serious systemic disease
current use of phenytoin
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 352
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, at least 18 years of age at time of screening.
Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.
Chronic HCV infection.
Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).
Subjects must be non-cirrhotic.

Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:

HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.

OR

On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Chronic HIV type 2 (HIV-2) infection.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 351
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, at least 18 years of age at time of screening.
Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.
Chronic HCV infection.
Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).
Subjects must be non-cirrhotic.

Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:

HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.

OR

On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Chronic HIV type 2 (HIV-2) infection.
Intervention: Budesonide
Trial phase: Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 103
Group description: Budesonide inhaler as experimental treatment along with placebo pill.

Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness
Eligibility criteria:
Inclusion Criteria:

Male and Female
Sea level-dwelling hikers
Between ages 18-65

Exclusion Criteria:

History of allergy to acetazolamide or budesonide (or other corticosteroids)
Taken NSAIDs, acetazolamide, or corticosteroids in the one week prior to study enrollment.
Hazardous medical conditions which precludes the ability to moderately hike to high altitude including: sickle cell anemia, asthma, or COPD, severe anemia, or severe coronary arterial disease.
Pregnancy or suspected pregnancy.
Participants who are younger than 18 years of age and more than 65
Sleep above 4'000 elevation in the preceding 1 week.
History of asthma or COPD
Current symptoms of an acute upper respiratory illness.
Unable to complete a moderately strenuous hike at high altitude.
Intervention: Acetazolamide
Trial phase: Phase 3
ATC code: G01AE10 | S01EC01
SMILES: CC(=O)Nc1nnc(S(N)(=O)=O)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 103
Group description: Acetazolimide pill as active comparator along with sham inhaler.

Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness
Eligibility criteria:
Inclusion Criteria:

Male and Female
Sea level-dwelling hikers
Between ages 18-65

Exclusion Criteria:

History of allergy to acetazolamide or budesonide (or other corticosteroids)
Taken NSAIDs, acetazolamide, or corticosteroids in the one week prior to study enrollment.
Hazardous medical conditions which precludes the ability to moderately hike to high altitude including: sickle cell anemia, asthma, or COPD, severe anemia, or severe coronary arterial disease.
Pregnancy or suspected pregnancy.
Participants who are younger than 18 years of age and more than 65
Sleep above 4'000 elevation in the preceding 1 week.
History of asthma or COPD
Current symptoms of an acute upper respiratory illness.
Unable to complete a moderately strenuous hike at high altitude.
Intervention: Hydromorphone Hydrochloride
Trial phase: Not Applicable
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(=O)CCC3C1C5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
Eligibility criteria:
Inclusion Criteria:

Admission to trauma service at Beaumont Hospital, Royal Oak, Michigan
Two or more rib fractures in an anatomic pattern feasible for nerve blockade (unilateral or bilateral)
Age greater than or equal to 18 years
Ability to comprehend and endorse an informed consent

Exclusion Criteria:

Patients who are pregnant or breastfeeding
Patients intubated before placement of continuous infusion catheter
Any significant concomitant injuries potentially confounding for evaluation of the effectiveness of analgesia (eg., traumatic brain injury)
History of an allergic reaction to local anesthetic
Use of other regional anesthetics before evaluation (epidural or paravertebral nerve blockade)
International Normalized Ratio (INR) > 2.0
Inability to obtain informed consent
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Control group will receive Normal saline over 15 minutes at the beginning of surgical closure

Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Eligibility criteria:
Inclusion Criteria:

Patients must be undergoing open bariatric surgery at WVUH-ruby hospital. - They must be ASA class 1, 2 and 3.
Consented individuals.
They must be between the age of 18 to 55.

Exclusion Criteria:

History of bradycardia or tachy-brady syndrome HR<45.
1st degree heart block or higher.
Patient refusal.
On pain medication for any reason for more than 24 hrs within 2 weeks of procedure.
Allergy to medication.
History of alcohol or drug abuse.
History of Cardiac/ liver/ kidney disease