anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Phenobarbital
Trial phase: Phase 4
ATC code: N03AA02 | N05CB01
SMILES: CCC1(c2ccccc2)C(=O)NC(=O)NC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: Phenobarbital, 4-5 mg/kg/day, for 4 months

phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
Eligibility criteria:
Inclusion Criteria:

Birth at > 34 weeks' gestation
Neonatal seizures (clinical, electrographic or both), with onset in the first 120 hours after birth and resolution within 7 days of onset
Parental informed consent

Exclusion Criteria:

Birth at < 34 weeks' gestation
If the attending neonatologist attributes the seizures solely to a transient abnormality, easily correctable and unlikely to recur (eg, transient electrolyte abnormalities). If the attending neonatologist cannot be contacted, the site PI will be asked to review the available information and judge whether the infant is eligible.
If the infant has been diagnosed with or there is a strong suspicion of an inborn error of metabolism, significant brain malformation, microcephaly (< 3 %ile), or a chromosomal abnormality which, in the absence of seizures, is known to be independently associated with an increased likelihood of cognitive impairment
If the infant has been diagnosed with an intrauterine viral infection
If the infant is not expected to survive to discharge
Intervention: EXENATIDE
Trial phase: Not Applicable
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: No
Participants at risk: 20
Group description: 5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study

Exenatide: refer to Arm detail
Eligibility criteria:
Inclusion Criteria:

Male or female subjects ≥18 and ≤75 years of age
Clinical diagnosis of type 2 diabetes
Diabetes duration ≥ 1 year
HbA1c ≥7.0%
Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)

Exclusion Criteria:

Previously treated with insulin or incretin-based therapy
Treated with a thiazolidinedione within past 6 weeks
Taken oral or injected prednisone or cortisone medications in the previous 30 days
Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)
eGFR (Estimated Glomerular Filtration Rate) <30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)
ALT(Alanine Transaminase) > 2x Upper Limit of Normal (ULN)
Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study
Currently pregnant or planning pregnancy during the study period
Unable to follow the study protocol
Unable to speak, read and write in English
Uncontrolled hyperglycemia with HbA1c > 9% on metformin or >8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy
At the investigator's discretion for other medical or psychological reasons
Intervention: Basaglar
Trial phase: Not Applicable
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Insulin Glargine: refer to Arm detail
Eligibility criteria:
Inclusion Criteria:

Male or female subjects ≥18 and ≤75 years of age
Clinical diagnosis of type 2 diabetes
Diabetes duration ≥ 1 year
HbA1c ≥7.0%
Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)

Exclusion Criteria:

Previously treated with insulin or incretin-based therapy
Treated with a thiazolidinedione within past 6 weeks
Taken oral or injected prednisone or cortisone medications in the previous 30 days
Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)
eGFR (Estimated Glomerular Filtration Rate) <30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)
ALT(Alanine Transaminase) > 2x Upper Limit of Normal (ULN)
Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study
Currently pregnant or planning pregnancy during the study period
Unable to follow the study protocol
Unable to speak, read and write in English
Uncontrolled hyperglycemia with HbA1c > 9% on metformin or >8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy
At the investigator's discretion for other medical or psychological reasons
Intervention: N-Vinyl-2-pyrrolidone
Trial phase: Phase 2
SMILES: C=CN1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Eye drops in Single Dose Unit

Povidone: Eye drops Single dose unit

1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
Eligibility criteria:
Inclusion Criteria:

-Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye

Exclusion Criteria:

Monophtalmia
Eyelid dysfunction
Facial paralysis.
Severe dry eye syndrome.
Ocular metaplasia.
Filamentous keratitis
Schirmer test < 5 mm.
Best far corrected visual acuity < 1/10.
Intervention: Azithromycin
Trial phase: Phase 2
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Eye drops Single dose unit

Azithromycin: Eye drops, Dosage : 1.5%

1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
Eligibility criteria:
Inclusion Criteria:

-Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye

Exclusion Criteria:

Monophtalmia
Eyelid dysfunction
Facial paralysis.
Severe dry eye syndrome.
Ocular metaplasia.
Filamentous keratitis
Schirmer test < 5 mm.
Best far corrected visual acuity < 1/10.
Intervention: Trospium chloride
Trial phase: Phase 4
SMILES: O=C(OC1CC2CCC(C1)[N+]21CCCC1)C(O)(c1ccccc1)c1ccccc1.[Cl-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 162
Group description: Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
Eligibility criteria:
Inclusion Criteria:

Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification
Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence
Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).

Exclusion Criteria:

Predominant stress or insensate incontinence
History of neurogenic bladder
Two urinary tract infections in the last six months
Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)
Donated >500mL blood in the 30 days prior to the screening visit
Intervention: MESALAMINE
Trial phase: Phase 4
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth).
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.
Stable antiretroviral therapy for at least 6 months.
Screening CD4+ T cell count below 350 cells/mm3
All available CD4+ T cell counts in the last year and at screening <350 cells/mm3
Screening plasma HIV RNA levels below level of detection (< 40 copies RNA/mL).
All available plasma HIV RNA levels within past year below the level of detection. Isolated detectable values < 500 c/ml are allowed if HIV RNA levels before and after this time point are undetectable.
>90% adherence to therapy within the preceding 30 days, as determined by self-report.
Both male and female subjects are eligible. Females of childbearing potential must have negative pregnancy test at screening and agree to use a double-barrier method of contraception during the study.

Exclusion Criteria:

Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
Exposure to any immunomodulatory drug in the past 16 weeks.
Active hepatitis C or hepatitis B which will require treatment in the subsequent 24 weeks.
Screening absolute neutrophil count <1,000 cells/mm3, platelet count <50,000 cells/mm3, Hgb < 8mg/dL
Pancreatitis or lipase greater than 2 times the upper limit of normal.
Renal insufficiency with creatinine clearance less than 50 ml/min
Elevated transaminases greater than 2.5 times the upper limit of normal.
Evidence of decompensated cirrhosis, heart failure.
Pregnant or breastfeeding women
Intervention: Micafungin
Trial phase: Phase 4
ATC code: J02AX05
SMILES: CCCCCOc1ccc(-c2cc(-c3ccc(C(=O)N[C@H]4C[C@@H](O)[C@@H](O)NC(=O)[C@@H]5[C@@H](O)[C@@H](C)CN5C(=O)[C@H]([C@H](O)CC(N)=O)NC(=O)[C@H]([C@H](O)[C@@H](O)c5ccc(O)c(OS(=O)(=O)O)c5)NC(=O)[C@@H]5C[C@@H](O)CN5C(=O)[C@H]([C@@H](C)O)NC4=O)cc3)no2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Micafungin: 100 mg IV infusion over 1 hour
Eligibility criteria:
Inclusion Criteria:

Male and female subjects
18 years or older
All racial and ethnic origins
English or Spanish speaking

Exclusion Criteria:

Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of micafungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of micafungin, so that the pregnancy and post-partum state would be a confounding variable.

Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
Creatinine Clearance < 70 ml/min as estimated by the Cockcroft-Gault equation
History of allergies to echinocandins
Echinocandins are contraindicated for any reason
Volunteers unwilling to comply with study procedures.
Suspected or documented systemic fungal infection.
Intervention: Micafungin
Trial phase: Phase 4
ATC code: J02AX05
SMILES: CCCCCOc1ccc(-c2cc(-c3ccc(C(=O)N[C@H]4C[C@@H](O)[C@@H](O)NC(=O)[C@@H]5[C@@H](O)[C@@H](C)CN5C(=O)[C@H]([C@H](O)CC(N)=O)NC(=O)[C@H]([C@H](O)[C@@H](O)c5ccc(O)c(OS(=O)(=O)O)c5)NC(=O)[C@@H]5C[C@@H](O)CN5C(=O)[C@H]([C@@H](C)O)NC4=O)cc3)no2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Micafungin: 300 mg IV infusion over 1 hour
Eligibility criteria:
Inclusion Criteria:

Male and female subjects
18 years or older
All racial and ethnic origins
English or Spanish speaking

Exclusion Criteria:

Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of micafungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of micafungin, so that the pregnancy and post-partum state would be a confounding variable.

Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
Creatinine Clearance < 70 ml/min as estimated by the Cockcroft-Gault equation
History of allergies to echinocandins
Echinocandins are contraindicated for any reason
Volunteers unwilling to comply with study procedures.
Suspected or documented systemic fungal infection.
Intervention: Betamethasone
Trial phase: Not Applicable
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
Eligibility criteria:
Inclusion Criteria:

male veterans enrolled to receive care through the VA North Texas Healthcare System
diagnosis of combat-related PTSD

Exclusion Criteria:

Hypersensitivity to dexamethasone
Current use of steroids
Current psychosis
Organic Brain Damage
Current major depressive disorder with melancholic features
Substance dependence in the last 3 months
Prominent suicidal or homicidal features
Medical conditions: diabetes, uncontrolled hypertension, severe congestive heart failure, hepatic failure, or any other contraindicated medical condition (such as HPA Axis disease, Addison's Disease or Cushing's Disease).
Veterans taking medication with established drug interactions with dexamethasone
Intervention: Modafinil
Trial phase: Phase 2
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
Eligibility criteria:
Inclusion Criteria:

Have a diagnosis of cancer.
Be able to understand written and spoken English
Be able to swallow medication
Have preferred sleep phase between 7:30 pm and 11:00 am
Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study period
Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted
Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment
Have completed chemotherapy and or radiation not less than one month ago. Note: Both types of treatment must be completed at least one month ago if patient receives chemotherapy and radiation therapy and there is no outer limit to how long ago treatments were completed.)
Report insomnia on the SDS-CL at a frequency of at least 3 days a week

Exclusion Criteria:

Have ever taken modafinil or had CBT-I therapy. CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component.
Have an unstable medical or psychiatric illness (Axis I-current or within the last 5 years)
Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension
Be presently taking an anticoagulant or a corticosteroid
Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert®] or similar psycho stimulants) within the past 30 days
Be currently pregnant or nursing
Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score >=2 or an Alcohol Use Disorders Identification Test (AUDIT) score >=13
Have surgery planned within the study period
Have have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the "Often" or "Frequently" level.
Intervention: Flutemetamol
Trial phase: Phase 3
ATC code: V09AX04
SMILES: CNc1ccc(-c2nc3ccc(O)cc3s2)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: [18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
Eligibility criteria:
Inclusion Criteria:

The subject is at least 50 years of age.
The subjects' general health is adequate to comply with study procedures.
The subject has been scheduled for a shunt placement procedure for the treatment of NPH.

Exclusion Criteria:

The subject has a contraindication for MRI or PET.
The subject is pregnant or lactating.
The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
The subject has participated in any clinical study using an investigational agent within 30 days of dosing.
Intervention: Solifenacin
Trial phase: Phase 4
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 175
Group description: Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Symptoms of overactive bladder (OAB), including urinary frequency, urgency or urge incontinence, for greater than or equal to 3 months
Urodynamic diagnosis of detrusor overactivity (DO)
Either naïve to anti-muscarinic treatment (i.e. no prior history of use of anti-muscarinic agents) or 6-months anti-muscarinic treatment free (i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit
Bladder post-void residual volume of less than 30 ml
Available to complete the study

Exclusion Criteria:

History of stress urinary incontinence, urethral sphincter incompetence or neurogenic detrusor overactivity
History, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II)
History of urinary tract operation within 6 months prior to screening
Indwelling catheter or permanent catheter fitted
History of pelvic area radiotherapy treatment
Uncontrolled diabetes mellitus
History of fibromyalgia
Post-partum or breast-feeding within 3 months prior to screening visit
Either pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants or injectable contraceptives)
Positive pre-study hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV) result at time of screening
History of drug and / or alcohol abuse at time of screening
History of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions
Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment or who are on treatment with a potent cytochrome p450 (CYP) 3A4 inhibitor, e.g. Ketoconazole
Currently dosing with medication(s) intended to treat overactive bladder symptoms or has a history of non-drug treatment, such as electrical therapy, magnetic field stimulation, pelvic floor treatment or bladder training intended to treat overactive bladder symptoms within 6 months prior to screening, as described in the list of prohibited medications
Currently receiving or has a history of treatment with alpha blockers, botulinum toxin (cosmetic use is acceptable), resiniferatoxin or pelvic floor muscle relaxants within 9 months prior to screening
Participated in any clinical study less than or equal to 3 months prior to screening
Intervention: Lansoprazole
Trial phase: Phase 4
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months

dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months
Eligibility criteria:
Patients who have undergone ablation for Barrett's Esophagus (BE) and High Grade Dysplasia (HGD) or Low Grade Dysplasia (LGD) with Photodynamic Therapy (PDT)/Radiofrequency ablation and endoscopic mucosal resection who have no endoscopic and histologic evidence of specialized intestinal metaplasia on biopsies from the esophagus on two successive endoscopies post ablation will be offered enrollment in the study.

Inclusion criteria:

Absence of intestinal metaplasia on endoscopy (under Narrow Band Imaging) and on histology (from biopsies taken from gastroesophageal junction and distal esophagus) on two successive surveillance endoscopies.
Able to consent to study
Males and females age 18-90
Life expectancy of 5 years or greater.

Exclusion criteria:

Pregnancy
Inability to consent for the procedure
Anticoagulation therapy precluding performance of ambulatory pH monitoring and/or biopsies
Intolerance to proton pump inhibitors
Elevation in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), (liver enzymes), bilirubin or alkaline phosphatase more than five times the upper limit of normal.