anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 148
Group description: (group 1) 1 gram IV acetaminophen every 8 hours for three doses

Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours
Eligibility criteria:
Inclusion Criteria:

Parturients 18 years
Elective Cesarean delivery
Spinal anesthesia
Able to consent to the study and participate in the follow-up.

Exclusion Criteria:

Weight under 50 kgs
Allergy to acetaminophen
General anesthesia
Urgent or emergent cases
Bleeding diathesis or other coagulopathy
G6PD deficiency
Liver disease
Substance abuse or dependence
HELLP syndrome
Thrombocytopenia or platelet dysfunction
History or active gastrointestinal bleeding
Acute kidney injury or chronic renal insufficiency
Contraindication/refusal to spinal anesthesia
Chronic pain
Chronic narcotic use
Illicit drug use
Allergy to any study related medications.
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 148
Group description: (group 2) 1 gram oral acetaminophen every 8 hours for three doses

Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours
Eligibility criteria:
Inclusion Criteria:

Parturients 18 years
Elective Cesarean delivery
Spinal anesthesia
Able to consent to the study and participate in the follow-up.

Exclusion Criteria:

Weight under 50 kgs
Allergy to acetaminophen
General anesthesia
Urgent or emergent cases
Bleeding diathesis or other coagulopathy
G6PD deficiency
Liver disease
Substance abuse or dependence
HELLP syndrome
Thrombocytopenia or platelet dysfunction
History or active gastrointestinal bleeding
Acute kidney injury or chronic renal insufficiency
Contraindication/refusal to spinal anesthesia
Chronic pain
Chronic narcotic use
Illicit drug use
Allergy to any study related medications.
Intervention: Tafenoquine
Trial phase: Phase 2
ATC code: P01BA07
SMILES: COc1cc(C)c2c(Oc3cccc(C(F)(F)F)c3)c(OC)cc(NC(C)CCCN)c2n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 104
Group description: Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.

Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Healthy male or female volunteers who provided informed consent (a healthy volunteer was defined as one who was free of ailments that might cause difficulty in evaluating drug efficacy or adverse experiences).
Subjects aged 18-55 years.
Subjects planning to reside in the study area for the entire study duration of approximately 70 weeks

Exclusion Criteria:

Subjects with positive parasitaemia following halofantrine treatment for radical cure.
Subjects with any medical condition which, in the opinion of the investigator, made the subject unsuitable to enter the study.
Subjects with personal or family history of seizures.
Female subjects with a positive serum beta-HCG5 (tested during screening and within 48 hours of first drug administration and approximately monthly thereafter).
Women who were pregnant or lactating or who in the opinion of the investigator were at risk of becoming pregnant.
Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and haematology values. Subjects who had demonstrated hypersensitivity to any of the study drugs especially to any other 8-aminoquinolines.
Subjects unwilling to report for drug administration or blood drawing during the 70 week duration of the study.
Subjects with G6PD deficiency.
Subjects with laboratory guideline values for exclusion: haemoglobin <10 gm/dL, platelets <80,000/mm3, WBC <3000ul3, creatinine or ALT more than twice the upper limit of normal for age.
Subjects with an abnormal ECG, particularly an extended QTc interval > 0.42 seconds.
Subjects taking any other anti-malarial product, or who had taken an antimalarial drug other than halofantrine within the previous two weeks.
Subjects who had received an investigational drug (a new chemical entity not registered for use) within 30 days or 5 half-lives whichever was the longer.
Subjects with a history of psychiatric disorder.
Intervention: Perflubutane
Trial phase: Phase 4
SMILES: FC(F)(F)C(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 178
Group description: 48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.

SHAPE measurement (Sonazoid ultrasoud contrast agent): Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.
Eligibility criteria:
Inclusion Criteria:

Be scheduled for trans-jugular liver biopsy the day of the ultrasound procedure.
Be at least 21 years of age.
Be medically stable.
If a female of child-bearing potential, must have a negative pregnancy test.
Be conscious and able to comply with study procedures.
Have read and signed the IRB-approved Informed Consent form for participating in the study.

Exclusion Criteria:

Females who are pregnant or nursing.
Patients not scheduled for trans-jugular liver biopsy
Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 h afterwards,.
Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
Patients with pulmonary hypertension or unstable cardiopulmonary conditions
Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment.
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
Patients on life support or in a critical care unit.
Patients with unstable occlusive disease (e.g., crescendo angina)
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
Patients with uncontrolled congestive heart failure (NYHA Class IV)
Patients with recent cerebral hemorrhage.
Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of SONAZOID).
Patients with congenital heart defects.
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
Patients with respiratory distress syndrome
Patients with thrombosis within the hepatic, portal, or mesenteric veins.
Intervention: Cephalosporin
Trial phase: Not Applicable
SMILES: C=C1CSC(C(NC(=O)CCCCC(N)C(=O)O)C(=O)O)N=C1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.

After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.

Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.

After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.
Eligibility criteria:
Inclusion Criteria:

grade I Tokyo guideline for acute cholecystitis
grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation

Exclusion Criteria:

chronic cholecystitis
gallbladder polyp or gallbladder cancer
the patient who underwent reduced port surgery
the patient who underwent common bile duct exploration during the operation
the patient who underwent concurrent operation
the patient who had past history of upper abdominal surgery
the patient who had a immunodeficiency state
the case which had a suspicion of delayed bile leakage
the case which had a incomplete cystic duct ligation
the patient who underwent open conversion surgery during the operation
the patient who had a high risk of bleeding
Intervention: Treprostinil
Trial phase: Not Applicable
ATC code: B01AC21
SMILES: [H][C@@]12Cc3c(cccc3OCC(=O)O)C[C@]1([H])[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Saline administration via subcutaneous infusion.
Eligibility criteria:
Inclusion Criteria:

Pediatric patient undergoing Fontan operation and/or pre-Fontan cardiac catheterization at Lucile Packard Children's Hospital (LPCH)

Exclusion Criteria:

Platelet count < 50K (treprostinil can act as a platelet inhibitor and this may place patient at additional risk of bleeding if already thrombocytopenic)
Dermatologic condition that renders the patient unable to tolerate a subcutaneous infusion (can still take part in inhaled vasodilator testing during cardiac catheterization)
Currently receiving any vasodilator therapy specifically for the purpose of pulmonary vasodilation (phosphodiesterase type 5 inhibitor, endothelia receptor antagonist and/or prostacyclin).
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Male
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.
Eligibility criteria:
Inclusion Criteria:

Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery who's parents are requesting circumcision. Eligibility includes

Apgar score at 5 minutes >7
birthweight greater than 2.4 kg
Age of at least 10 hours
At least one void.

Exclusion Criteria:

Newborns of substance abusing mothers.
Newborns with any contraindications to routine circumcision, anatomical or hematologic.
Intervention: Metformin
Trial phase: Early Phase 1
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 83
Group description: 83 patients will continue metformin until end of 1st trimester (14 weeks gestation)

Metformin: 83 patients will continue metformin until end of 1st trimester
Eligibility criteria:
Inclusion Criteria:

Age : 25 - 35.

Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )

At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination.
Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations.
Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking.
Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.

Exclusion Criteria:

patients with other causes of infertility other than PCOS
contraindications to metformin : liver impairment , renal failure.
Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.
Intervention: Metformin
Trial phase: Early Phase 1
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 83
Group description: 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)

Metformin: 83 patients will continue metformin until end of 1st trimester
Eligibility criteria:
Inclusion Criteria:

Age : 25 - 35.

Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )

At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination.
Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations.
Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking.
Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.

Exclusion Criteria:

patients with other causes of infertility other than PCOS
contraindications to metformin : liver impairment , renal failure.
Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM

Metformin: 500 mg po after baseline testing of heart rate
Eligibility criteria:
Inclusion Criteria:

EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for fibromyalgia or previous/current exposure to antipsychotic medications

Exclusion Criteria:

recent infection,
renal failure,
pre-existing cardiac disease,
chronic obstructive pulmonary disease
inability to participate in informed consent,
lack of transport to return home from study site,
severe fasting intolerance or hypoglycemia,
history of stroke-alike episode,
uncontrolled migraine or cyclic vomiting,
diabetes on insulin or sulfonylurea,
non-English speaker,
medications with strong effects on baseline heart rate variability
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM

Metformin: 500 mg po after baseline testing of heart rate
Eligibility criteria:
Inclusion Criteria:

EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for fibromyalgia or previous/current exposure to antipsychotic medications

Exclusion Criteria:

recent infection,
renal failure,
pre-existing cardiac disease,
chronic obstructive pulmonary disease
inability to participate in informed consent,
lack of transport to return home from study site,
severe fasting intolerance or hypoglycemia,
history of stroke-alike episode,
uncontrolled migraine or cyclic vomiting,
diabetes on insulin or sulfonylurea,
non-English speaker,
medications with strong effects on baseline heart rate variability
Intervention: MECRYLATE
Trial phase: Phase 4
SMILES: C=C(C#N)C(=O)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.

cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
Eligibility criteria:
Inclusion Criteria:

Age of 20 to 80 years
Cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within 24 h of bleeding
Stable hemodynamic condition for at least 3 days after cyanoacrylate injection

Exclusion Criteria:

Previous treatment of gastric varices, including endoscopic therapy, transjugular intrahepatic porto-systemic shunt, or surgery
Contraindications to non-selective beta-blockers or cyanoacrylate injection
Serum total bilirubin >10 mg/dL
Grade III/IV hepatic encephalopathy
Hepato-renal syndrome
Severe heart failure (NYHA Fc III/IV)
Chronic kidney disease under renal replacement therapy
Refractory ascites
Malignancy other than hepatocellular carcinoma
Pregnancy
Pacemaker use
Refusal to participate
Intervention: Avycaz
Trial phase: Phase 4
SMILES: CC(C)(ON=C(C(=O)NC1C(=O)N2C(C(=O)[O-])=C(C[n+]3ccccc3)CSC12)c1csc(N)n1)C(=O)O.NC(=O)C1CCC2CN1C(=O)N2OS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Ceftazidime/avibactam 2.5gm IV q8h for 3 doses

Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
Eligibility criteria:
Inclusion Criteria:

Diagnosis of CF based on positive sweat chloride or know CF mutation
Age > 17 years
Able to spontaneously expectorate sputum

Exclusion Criteria:

Any clinically significant laboratory abnormality
Presence of an ongoing acute pulmonary exacerbation
Pregnancy
Serious past allergy to a beta-lactam antibiotic
Intervention: Fentanyl
Trial phase: Phase 2
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.
Eligibility criteria:
Inclusion Criteria:

Patients with advanced cancer (locally advanced, metastatic, recurrent and/or incurable cancer).
Opioid tolerant, taking daily doses of strong opioid pain medication in the past 1 week.
On strong opioid intravenous continuous infusion MEDD >=70 mg/day at the time of enrollment.
Inpatient at MD Anderson seen by palliative care team.
Background cancer pain that is <=3/10 in the last 24 hours.
Breakthrough cancer pain that is >=4/10 in the last 24 hours.
Stable pain control defined as rescue doses <=6 in last 24 hours.
Age >=18
Ability to communicate in English

Exclusion Criteria:

Memorial Delirium Assessment Scale >13/30
History of opioid abuse
CAGE positivity (>=2/4)
Allergy to fentanyl
Grade 2 or higher oral mucositis
Unable/unwilling to sign consent
Intervention: Vortioxetine
Trial phase: Phase 2
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.

Vortioxetine: Medication currently approved for major depression.
Eligibility criteria:
Inclusion Criteria:

Men and women age 18-65;
Primary diagnosis of Binge eating disorder;
At least 3 binge eating days per week for the 2 weeks before the baseline visit;
Ability to understand and sign the consent form.

Exclusion Criteria:

Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination (history of medical illness which is currently stable is allowed such as diabetes well controlled, treated hypothyroidism, hypertension, etc)
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
Past 12-month DSM-5 major psychiatric disorder (psychotic disorder, bipolar disorder, major depressive disorder)
Past 6-month alcohol or substance use disorders
Illegal substance use based on urine toxicology screening
Initiation of psychological or weight-loss interventions within 3 months of screening
Use of any other prescription psychotropic medication (except an as needed hypnotic or as needed benzodiazepine)
Previous treatment with Vortioxetine
Currently taking over the counter weight loss medications. If willing to stop these medications, the participant will not be excluded based on this criterion.

10) Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Intervention: Rocuronium
Trial phase: Phase 4
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 109
Group description: rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches

Rocuronium
Eligibility criteria:
Inclusion Criteria:

ASA I-III
BMI > 34 kg/m2
Elective bariatric surgery.

Exclusion Criteria:

Known or suspected neuromuscular disorders impairing neuromuscular function
Allergies to muscle relaxants, anesthetics or narcotics
A(family) history of malignant hyperthermia
Women who are or may be pregnant or are currently breast feeding
Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.
Intervention: Rocuronium
Trial phase: Phase 4
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 109
Group description: rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches

Rocuronium
Eligibility criteria:
Inclusion Criteria:

ASA I-III
BMI > 34 kg/m2
Elective bariatric surgery.

Exclusion Criteria:

Known or suspected neuromuscular disorders impairing neuromuscular function
Allergies to muscle relaxants, anesthetics or narcotics
A(family) history of malignant hyperthermia
Women who are or may be pregnant or are currently breast feeding
Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.
Intervention: Carmellose sodium
Trial phase: Phase 3
SMILES: CC(=O)O.O=CC(O)C(O)C(O)C(O)CO.[Na]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Eligibility criteria:
Inclusion Criteria:

Used artificial tears for dry eye
Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
Herpes keratitis in the last 6 months
Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months