anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Aminolevulinic Acid
Trial phase: Phase 1
ATC code: L01XD04
SMILES: NCC(=O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure.

Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none

Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
Eligibility criteria:
Inclusion Criteria:

Adults at least 18 years old.
Subjects must be able to read, sign, and understand the informed consent
Subjects have at least 4 and no more than 20 clinically typical, visible actinic keratoses in the target treatment area on the face or scalp.
Subject must be willing to forego any other treatments for AK in the treatment area on the face or scalp, during the study period, and for 14 days prior to screening; including cryotherapy, topical 5-fluorouracil, imiquimod, and ingenol mebutate.
Subjects who have previously received PDT must undergo at least an 8-week washout period prior to enrollment in study.
Subject must be willing and able to participate in the study and to comply with all study requirements including concomitant medication and other treatment restrictions, and telephone interview.
If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study. Women who are pregnant, lactating, or planning to become pregnant during the study period are excluded from the study.

Exclusion Criteria:

Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
Subjects with any medical condition that, in the opinion of the investigator, makes the patient unsuitable for the trial.
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Sugammadex 4 mg/kg at the end surgery

Sugammadex: Sugammadex injection
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years;
American Society of Anesthesiologists (ASA) physical status 1-3;
Scheduled for catheter-based neurointerventional procedures including coiling and stent insertion;
General anesthesia.

Exclusion Criteria:

Suspected difficult intubation;
Neuromuscular disorder;
Renal impairment creatinine ≥ 2 mg /dl;
Hepatic dysfunction;
History of malignant hyperthermia;
Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;
Perioperative respiratory infections and/or pneumonia;
Intubated or unresponsive;
Pregnancy or breastfeeding.
Intervention: Timolol
Trial phase: Phase 4
ATC code: C07AA06 | C07BA06 | C07DA06 | S01ED01 | S01ED51
SMILES: [H][C@](O)(CNC(C)(C)C)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once.

Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ocular hypertension, primary open angle glaucoma, or normal tension glaucoma in the study eye(s)
Age 18-90
Best corrected visual acuity of 20/60 or better

Exclusion Criteria:

Current use of either brimonidine or timolol

Other disease, ophthalmic or systemic, that is likely to significantly affect the OCT test in the study eye(s) including:

More than moderate grade cataract that significantly reducing OCTA scan signal level
Macular degeneration other than mild drusen or pigmentary changes
Diabetic retinopathy other than mild background non proliferative retinopathy
Prior or current macular edema
Prior laser treatment to the retina
Prior retinal detachment
Prior central serous retinopathy
Prior retinal vein or artery occlusion
Prior inflammatory retinopathy or choroidopathy
Keratoconus or other corneal ectasia
Corneal scarring in central 4 mm
Prior penetrating keratoplasty
Ischemic optic neuropathy
Dementia beyond early/mild memory loss
History of cerebrovascular accident
History of severe carotid stenosis
History of previous ocular surgery other than non-complicated cataract extraction
Intervention: Brimonidine
Trial phase: Phase 4
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.

Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ocular hypertension, primary open angle glaucoma, or normal tension glaucoma in the study eye(s)
Age 18-90
Best corrected visual acuity of 20/60 or better

Exclusion Criteria:

Current use of either brimonidine or timolol

Other disease, ophthalmic or systemic, that is likely to significantly affect the OCT test in the study eye(s) including:

More than moderate grade cataract that significantly reducing OCTA scan signal level
Macular degeneration other than mild drusen or pigmentary changes
Diabetic retinopathy other than mild background non proliferative retinopathy
Prior or current macular edema
Prior laser treatment to the retina
Prior retinal detachment
Prior central serous retinopathy
Prior retinal vein or artery occlusion
Prior inflammatory retinopathy or choroidopathy
Keratoconus or other corneal ectasia
Corneal scarring in central 4 mm
Prior penetrating keratoplasty
Ischemic optic neuropathy
Dementia beyond early/mild memory loss
History of cerebrovascular accident
History of severe carotid stenosis
History of previous ocular surgery other than non-complicated cataract extraction
Intervention: Meloxicam
Trial phase: Phase 3
ATC code: M01AC06 | M01AC56 | N01BB59
SMILES: Cc1cnc(NC(=O)C2=C(O)c3ccccc3S(=O)(=O)N2C)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: N1539 (meloxicam injection for IV use) 30 mg every 24 hours

N1539: Once Daily
Eligibility criteria:
Inclusion Criteria:

Voluntarily provide written informed consent.
Be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection and/or anastomosis.
ASA physical status category 1, 2, or 3.
Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study.
Have a body mass index <40 kg/m^2

Exclusion Criteria:

Have a known allergy or hypersensitivity to any study treatment.
Planned surgical procedure includes a resection beyond the peritoneal reflection, is related to an acute bout of diverticulitis, or is associated with an emergency procedure.
Have a history of myocardial infarction within the preceding 12 months.
Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation.
Have active or recent (within 6 months) gastrointestinal ulceration or bleeding, with exception of events related to an ulcerative colitis diagnosis.
Have a known bleeding disorder which may be worsened with the administration of an NSAID.
Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within 48 hours prior to surgery.
Have previously received N1539/IV meloxicam or received any investigational product within 30 days before dosing with study medication.
Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.
Intervention: Chlorthalidone
Trial phase: Phase 2
ATC code: C03BA04 | C03BB04 | C03EA06 | G01AE10
SMILES: NS(=O)(=O)c1cc(C2(O)NC(=O)c3ccccc32)ccc1Cl
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks

Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of T1D
Age 12-21 years
Tanner Stage 2 or greater pubertal development
Urine calcium excretion ≥ 4 mg/kg/day
Able to swallow pills

Exclusion Criteria:

BMI > 99th percentile for age (<18 years) or BMI >35 kg/m2 (≥ 18 years)

Coexistent conditions that may affect calcium metabolism including:

celiac disease
Graves' Disease
Addison's disease
hypo- or hyperparathyroidism

History of diabetes related complications including:

neuropathy
retinopathy
nephropathy
gastroparesis
History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within the past month
History of any diuretic use within the past month

Laboratory abnormalities on screening bloodwork including:

estimated glomerular filtration rate <90 mL/min per 1.73 m2 of body surface area
serum calcium >10.5 mg/dL
serum potassium <3.5 mmol/L
Systolic or diastolic blood pressure <5th percentile for age and sex50 for age <18 years or systolic <90 mmHg or diastolic blood pressure <60 mmHG for age ≥18 years
Intervention: Ifetroban
Trial phase: Phase 2
SMILES: CCCCCNC(=O)c1coc([C@H]2[C@@H](Cc3ccccc3CCC(=O)O)[C@@H]3CC[C@H]2O3)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Subjects with AERD who received Ifetroban
Eligibility criteria:
Inclusion Criteria:

History of AERD, defined as meeting the diagnostic triad with:

History of physician-diagnosed asthma and
History of physician-diagnosed nasal polyposis and
History of pathognomonic reactions aspirin or other nonselective cyclooxygenase (COX) inhibitors.
Stable asthma (post-bronchodilator forced expiratory volume at one second (FEV1) of ≥70%, no glucocorticoid burst for at least 2 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 6 months)
Age between 18 and 70 years
No current smoking (not more than one instance of smoking in the last 3 months)
Non-pregnant

Exclusion Criteria:

Hypersensitivity to montelukast
Current use of zileuton
History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
Current use of any NSAIDs aside from the aspirin provided during the study
Current use of beta blockers
Use of any biologics within the last 4 months prior to initiating the study
Intervention: CID 12303048
Trial phase: Phase 2
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: 2% chlorhexidine gluconate cloth
Eligibility criteria:
Inclusion Criteria:

Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.
Intervention: Avatrombopag
Trial phase: Phase 3
ATC code: B02BX08
SMILES: O=C(Nc1nc(-c2cc(Cl)cs2)c(N2CCN(C3CCCCC3)CC2)s1)c1cnc(N2CCC(C(=O)O)CC2)c(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Open-label: oral avatrombopag

Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure.
Eligibility criteria:
Inclusion Criteria:

Men and women greater than or equal to 18 years of age;

A mean baseline platelet count between:

50 × 10^9/L and <100 × 10^9/L for non-chronic liver disease participants
50 × 10^9/L and <75 × 10^9/L for participants with chronic liver disease;
Participant is scheduled to undergo operations to critical sites (eg, eye surgery, neurosurgery) or operations with a high risk of bleeding (eg, major abdominal surgery), or, in the opinion of the Investigator, would otherwise require a pre-operative platelet transfusion to prevent bleeding

Exclusion Criteria:

Participant with a history of arterial or venous thrombosis within 6 months of baseline;
Participant with known portal vein blood flow velocity rate <10 cm/second or previous portal vein thrombosis within 6 months of baseline;
Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Baseline Visit;
Use of erythropoietin-stimulating agents;
Participant has a known medical history of genetic prothrombotic syndromes; or
Participant has abnormal hemoglobin levels or prothrombin time/international normalized ratio
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers ages 18 years and ≤ 75 years.
Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide stools and blood samples.

Exclusion Criteria:

Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or gluten sensitivity
Previous abdominal surgery
Currently pregnant or nursing
Had H. Pylori Infection
Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia
Currently consuming herbs or probiotics
Intervention: Caprolactone
Trial phase: Phase 2
SMILES: O=C1CCCCCO1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule

Polycap: Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule
Eligibility criteria:
Inclusion Criteria:

Above the age of 18 years; male or female
Stroke/TIA diagnosis no greater than two months before enrollment. Ischemic strokes including lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible -
Subjects with stroke may present with at least one of the following additional conditions: Documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension >140/90mmHg or previous treatment with anti-hypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
Legally competent to sign informed consent

Exclusion Criteria:

Unable to sign informed consent
Contraindications to any of the components of the polypill
Hemorrhagic stroke
Severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care
Severe congestive cardiac failure (NYHA III-IV)
Severe renal disease, eGFR <30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient
Cancer diagnosis or treatment in past 2 years
Need for oral anticoagulation at the time of randomization or planned in the future months
Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)
Nursing/pregnant mothers
Do not agree to the filing, forwarding and use of his/her pseudonymized data.
Intervention: CID 12303048
Trial phase: Phase 1
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Chlorhexidine Gluconate: 2% CHG
Eligibility criteria:
Inclusion Criteria:

Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were:

non- or ex-smokers
body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg
negative pregnancy test for female subjects
healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)
Intervention: EXENATIDE
Trial phase: Phase 4
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.

Exenatide: Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period
Eligibility criteria:
Inclusion Criteria:

Health Status: Type 2 Diabetes Mellitus according to ADA criteria (subjects must be in good general health as determined by physical exam, medical history, blood chemistry-CBC, TSH, T4, EKG and urinalysis)
BMI: 21-45kg/m
HbA1C>7.0% and <10.5%
Medication: Drug naïve and/or on a stable dose of metformin and/or sulfonylurea (more than 3 months)

Exclusion Criteria:

Health Status: Type 1 Diabetics
Proliferative diabetic retinopathy
Plasma Creatinine greater than 1.4mg/dL in females or greater than 1.5mg/dL in males, or 24 hour urine albumin excretion greater than 300mg/dL
Medication: Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)
Intervention: Dapagliflozin
Trial phase: Phase 4
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.

Dapagliflozin: Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
Eligibility criteria:
Inclusion Criteria:

Health Status: Type 2 Diabetes Mellitus according to ADA criteria (subjects must be in good general health as determined by physical exam, medical history, blood chemistry-CBC, TSH, T4, EKG and urinalysis)
BMI: 21-45kg/m
HbA1C>7.0% and <10.5%
Medication: Drug naïve and/or on a stable dose of metformin and/or sulfonylurea (more than 3 months)

Exclusion Criteria:

Health Status: Type 1 Diabetics
Proliferative diabetic retinopathy
Plasma Creatinine greater than 1.4mg/dL in females or greater than 1.5mg/dL in males, or 24 hour urine albumin excretion greater than 300mg/dL
Medication: Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)
Intervention: Ketorolac
Trial phase: Phase 2
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Patients receiving scheduled ketorolac postoperatively

Ketorolac
Eligibility criteria:
Inclusion Criteria:

Patients undergoing hysterectomy

Exclusion Criteria:

Coronary Artery Disease
Peptic Ulcer Disease
Chronic Renal Disease
Liver disease
Alcohol Abuse
Daily narcotic usage
Narcotic use 24 hours prior to surgery
Crohn's Disease
History of myocardial infarction
History of stroke
Preoperative hematocrit less than 24
Asthma
Ulcerative Colitis
Diverticulitis
Aspirin Allergy
Sulfonamide Allergy
Pre-operative pain score of greater than 3
Patients undergoing procedures that may involve bowel resection or bowel reanastomosis.
Allergy to any non-steroidal anti-inflammatory drug
Cardiac anomaly or disease
Congestive Heart Failure
Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib
Eligibility criteria:
Inclusion Criteria:

Patients undergoing hysterectomy

Exclusion Criteria:

Coronary Artery Disease
Peptic Ulcer Disease
Chronic Renal Disease
Liver disease
Alcohol Abuse
Daily narcotic usage
Narcotic use 24 hours prior to surgery
Crohn's Disease
History of myocardial infarction
History of stroke
Preoperative hematocrit less than 24
Asthma
Ulcerative Colitis
Diverticulitis
Aspirin Allergy
Sulfonamide Allergy
Pre-operative pain score of greater than 3
Patients undergoing procedures that may involve bowel resection or bowel reanastomosis.
Allergy to any non-steroidal anti-inflammatory drug
Cardiac anomaly or disease
Congestive Heart Failure
Intervention: Metoclopramide
Trial phase: Phase 2
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: A one-time dose of promotility agent (2 mL of Metoclopramide 5 MG/ML Injectable Solution in 8 mL saline IV) will be administered at the time of GJ placement. After administration of the pro-motility drug, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.

Metoclopramide 5 MG/ML Injectable Solution: A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement.
Eligibility criteria:
Inclusion Criteria:

18 years old or older
undergoing de novo GJ placement as part of their routine clinical care

Exclusion Criteria:

Patient pregnant

Contraindications to metoclopramide including:

allergic reaction
pheochromocytoma
QTc prolongation
history of seizure disorder
extrapyramidal symptoms