anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: VEROSUDIL
Trial phase: Phase 2
SMILES: CN(C)C(C(=O)Nc1ccc2c(=O)[nH]ccc2c1)c1ccsc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 0.7% Rho-Kinase Inhibitor

AR-12286
Eligibility criteria:
Inclusion Criteria:

50-85 y.o.
Male and Female
Exfoliation Syndrome and ocular hypertension or mild or moderate exfoliative glaucoma
IOP ≥22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart
No previous intraocular surgery except clear cornea phacoemulsification
Corrected visual acuity in both eyes ≥20/50 in the eligible eye
Not more than 6 diopters spherical equivalent on the study eye
Not more than 3 diopters cylinder equivalent on the study eye
Have given written informed consent, prior to any investigational procedures
Ability to attend for the 6-month duration of the study

Exclusion Criteria:

Open angle glaucoma other than exfoliative glaucoma
Closed angle glaucoma (primary or secondary)
Intraocular pressure >30 mm Hg
Severe exfoliation glaucoma
Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics
Previous intraocular surgery except clear cornea phacoemulsification
Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study
Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study)
Any abnormality preventing reliable applanation tonometry of either eye
Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study
Changes of systemic medication that could have a substantial effect on IOP anticipated during the study
Participation in any investigational study within the past 30 days
Inability to perform reliable VF testing
Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary
Self-reported poor compliance to treatment
Reluctance to return for scheduled follow-up visits
Patients not able to understand the nature of the study
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 4
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Office based treatment of opioid dependence with buprenorphine/naloxone

Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
Eligibility criteria:
Inclusion Criteria:

HIV positive
Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use disorder
Urine drug screen positive for opioids
Interested in receiving treatment for opioid dependence
Age at least 18 years old
Willing to practice an effective method of birth control, if female

Exclusion Criteria:

Known hypersensitivity to buprenorphine or naloxone
aspartate aminotransferase (AST) & alanine aminotransferase (ALT) > 5x upper limit
Currently pregnant or breastfeeding
Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection, psychosis) that precludes safe participation in the opinion of study physician
Methadone maintenance treatment within 30 days of consent
Intervention: Baclofen
Trial phase: Phase 2
ATC code: M03BX01
SMILES: NCC(CC(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Eligibility criteria:
Inclusion Criteria:

Adults (>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals
Patient placed on AWS watch protocol by admitting physicians.

Exclusion Criteria:

Unable to provide informed consent
Unable to take swallow oral medications (tube-fed patients are to be excluded)
Admitted for AWS or with Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score >8 at baseline
No alcohol intake for ≥ 48 hours or AUDIT score <12 at baseline
Baclofen use at baseline
Baclofen sensitivity
Hospital discharge anticipated in within 48 hours
Pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential)
Other active drug dependence (except tobacco)
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Normal saline

Normal saline
Eligibility criteria:
Inclusion Criteria:

Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.

Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.

Exclusion Criteria:

allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females and < 12g/dl in males).
Intervention: Caffeine
Trial phase: Phase 2
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Eligibility criteria:
Inclusion Criteria:

Admitted to study hospital pediatric intensive care unit (PICU),
One month to 16 years of age,
Exhibits Acute Hypoxemic Respiratory Failure as defined as: PaO2/FiO2 ≤ 300 or SpO2/FiO2 ≤ 260, No evidence of cardiac dysfunction, Mechanically ventilated,
Require artificial nutrition,
Anticipate placement of central venous line within 24 hours of admission

Exclusion Criteria:

Premature infants and neonates < 37 weeks corrected gestational age,
Transfer patient on an established enteral or parenteral nutritional regimen,
Known allergy to lactulose or mannitol,
Pregnant,
Admit BMI >30,
Thoracic trauma, abdominal trauma, and/or active intracranial bleeding,
Anuric renal failure, previous bowel surgery and/or short gut syndrome,
Cannot be enterally fed within 24 hours of admission according to the admitting physician,
On extracorporeal membrane oxygenation (ECMO),
Expected survival <24 hours or limitations to aggressive ICU care (DNR),
Receiving active CPR when admitted to the PICU,
A pre-existing bronchopleural fistula,
Previously enrolled and randomized into this protocol,
Actively enrolled in another clinical trial which at the discretion of the PI would conflict with this study.
Intervention: Caffeine
Trial phase: Phase 2
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Eligibility criteria:
Inclusion Criteria:

Admitted to study hospital pediatric intensive care unit (PICU),
One month to 16 years of age,
Exhibits Acute Hypoxemic Respiratory Failure as defined as: PaO2/FiO2 ≤ 300 or SpO2/FiO2 ≤ 260, No evidence of cardiac dysfunction, Mechanically ventilated,
Require artificial nutrition,
Anticipate placement of central venous line within 24 hours of admission

Exclusion Criteria:

Premature infants and neonates < 37 weeks corrected gestational age,
Transfer patient on an established enteral or parenteral nutritional regimen,
Known allergy to lactulose or mannitol,
Pregnant,
Admit BMI >30,
Thoracic trauma, abdominal trauma, and/or active intracranial bleeding,
Anuric renal failure, previous bowel surgery and/or short gut syndrome,
Cannot be enterally fed within 24 hours of admission according to the admitting physician,
On extracorporeal membrane oxygenation (ECMO),
Expected survival <24 hours or limitations to aggressive ICU care (DNR),
Receiving active CPR when admitted to the PICU,
A pre-existing bronchopleural fistula,
Previously enrolled and randomized into this protocol,
Actively enrolled in another clinical trial which at the discretion of the PI would conflict with this study.
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: 800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
Eligibility criteria:
Inclusion Criteria:

undergoing laparoscopic cholecystectomy under general anesthesia
American Society of Anesthesiologists status of 1, 2 or 3 (as determined by the anesthesiologists)
not pregnant of breast feeding

Exclusion Criteria:

cognitively impaired
using antipsychotic drugs
chronic use of steroids or opioids
subject has received COX inhibitors within 3 days if surgery
subjects for whom opiates, benzodiazepines and COX inhibitors are contraindicated
subjects with a history of bleeding disorders or peptic ulcer disease
Intervention: Gemcitabine
Trial phase: Not Applicable
ATC code: L01BC05
SMILES: Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.
Eligibility criteria:
Inclusion Criteria:

Cytologic or histologic proof of adenocarcinoma of the pancreas is required. Patients with Islet cell tumors are not eligible.
Patients do not have known metastases.
Patients must have potentially resectable or borderline resectable pancreatic cancer and have agreed to undergo surgical resection at MD Anderson Cancer Center if operable. They will have undergone staging (physical examination, chest x-ray, contrast enhanced CT or MRI (if CT contraindicated) and/or angiogram) to determine resectability.
Patients have completed radiation and chemotherapy with either fluoropyrimidines (5-FU or capecitabine) or gemcitabine as a radiosensitizing agent as part of their preoperative therapy. Previous systemic chemotherapy alone is not allowed. Preoperative therapy will be completed at least 4 weeks prior to surgery.
Patients with Karnofsky performance status > 70 are eligible.
There will be no upper age restriction. Patients less than 18 years of age are excluded from the protocol because adenocarcinoma of the pancreas is rarely seen in the pediatric population.
Adequate renal and bone marrow function: Leukocytes >= 3,000/uL; Absolute neutrophil count >= 1,500/uL; Platelets >= 100,000/Ul; Serum creatinine <= 2.0 mg/dL; Creatinine clearance >= 60 ml/min (calculated by the Cockcroft -Gault equation)
Adequate Hepatic function (endoscopic or percutaneous drainage as needed): Total bilirubin < = 3 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) <= 5 X institutional ULN
Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude administration of gemcitabine. Patients with uncontrolled congestive heart failure, unstable angina and myocardial infarction within 3 months will be excluded.
Patient is not pregnant. Women of childbearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) and refrain from breast-feeding, as specified in the informed consent.
Patients must sign a study-specific consent form.

Exclusion Criteria:

Major cardiovascular or pulmonary comorbidity that precludes use of general anesthesia (NYHA [New York Heart Association] Class III and IV).
Identification of metastatic disease.
Patients with a known hypersensitivity to Gemcitabine.
Pregnant women
Inability to comply with study and/or follow-up procedures.
Patients < 18 years of age.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.

Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies
Eligibility criteria:
Inclusion Criteria:

Male or female greater than 18 years of age
Admission to the hospital for an infected wound
Diabetic, ischemic, neuropathic, venous, surgical wounds, any anatomical location
Subjects requiring serial (more than 1) operative debridement

Exclusion Criteria:

Pregnancy
Patients with exposed bowel, brain matter, spinal cord
Patients with exposed peripheral bypass grafts
Known allergy or sensitivity to Prontosan or components of NPWT
Known allergy or sensitivity to adhesives
Uncontrolled bleeding disorders/coagulopathy
Wounds that tunnel to unexposed areas
Malignancy
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Bupivicaine .03ml to each nare

Bupivacaine: intervention
Eligibility criteria:
Inclusion Criteria:

are 18 - 65 years of age
present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region)
have a normal neurological exams

Exclusion Criteria:

are less than 18 years old or greater than 65
have any focal neurological dysfunction signs or symptoms
have a posterior/occipital/cervicogenic source predominance of headache
are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches
have self treated with pain medication or anti-emetic 4 hours prior to arrival
have a history of peripheral vascular disease, cancer, or HIV infection
are known to be pregnant
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 640
Group description: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).

Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes.
Eligibility criteria:
Inclusion Criteria:

Primary total knee replacmeent
Osteoarthritis
Unilateral

Exclusion Criteria:

Revision surgery
Donated preoperative autologous blood
On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
Preoperative hepatic or renal dysfunction
Diagnosis of inflammatory disease
Diagnosis of inflammatory arthritis
Pregnant
Breastfeeding
Preoperative hemoglobin <10g/dL
International Normalized Ratio>1.4
Abnormal Partial Thromboplastin Time
Preoperative platelet count of <150,000mm^3
Creatinine > 1.4
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 640
Group description: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Eligibility criteria:
Inclusion Criteria:

Primary total knee replacmeent
Osteoarthritis
Unilateral

Exclusion Criteria:

Revision surgery
Donated preoperative autologous blood
On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
Preoperative hepatic or renal dysfunction
Diagnosis of inflammatory disease
Diagnosis of inflammatory arthritis
Pregnant
Breastfeeding
Preoperative hemoglobin <10g/dL
International Normalized Ratio>1.4
Abnormal Partial Thromboplastin Time
Preoperative platelet count of <150,000mm^3
Creatinine > 1.4
Intervention: Succinylcholine
Trial phase: Phase 4
ATC code: M03AB01
SMILES: C[N+](C)(C)CCOC(=O)CCC(=O)OCC[N+](C)(C)C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 91
Group description: Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.
Eligibility criteria:
Inclusion Criteria:

pregnant women undergoing Cesarean section under general anesthesia
at least 18 years of age
results of a physical and laboratory preoperative examination within normal limits or clinically acceptable limits for the study
written informed consent

Exclusion Criteria:

urgent Cesarean section
multiple pregnancy
abnormal placentation
prematurity (<34 weeks)
severe fetal hypoxia
history of severe pre-existing disease
hypersensitivity or allergy to rocuronium or sugammadex

Discontinuation Criteria:

a subject's choice to end participation in the study
a subject meets any exclusion criteria during the study or equivalent criteria
lost to follow up
the investigator feels that it's in the subject's best interest to discontinue the study
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 68
Group description: Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
Eligibility criteria:
Inclusion Criteria:

Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-IV-TR
Male and female patients aged 13-17 years
Patients completing the 031-09-003 study
Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study
Inpatient or outpatient status

Exclusion Criteria:

Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR
Patients who have been compulsorily admitted to hospital
Patients with mental retardation
Patients with thyroid disorder
Patients who fall under a contraindication listed in the ABILIFY package insert
Patients with a serious hepatic, renal, cardiac or hematopoietic disorder
Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy
Patients with a history or a complication of diabetes and patients who fall under any of the following: fasting blood glucose level ≧ 126 mg/dL, non-fasting blood glucose level ≧ 200 mg/dL, HbA1c ≧ 6.5%
Patients with a history or a complication of suicide attempt, suicidal thought or self-harm
Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS
Patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus
Patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
Patients with a history or a complication of water intoxication
Patients with Parkinson's disease
Pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. However, women of childbearing potential who are practicing an appropriate method of contraception (refer to 8.6) and have a negative pregnancy test result are eligible for inclusion in this study.
Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator