anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Victoza
Trial phase: Phase 2
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2
Stable body weight (less than 5% selfreported change within the last 3 months)

Exclusion Criteria:

Obesity induced by drug treatment
Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial
Type 1 or type 2 diabetes
Intervention: Orlistat
Trial phase: Phase 2
ATC code: A08AB01
SMILES: CCCCCCCCCCC[C@@H](C[C@@H]1OC(=O)[C@H]1CCCCCC)OC(=O)[C@H](CC(C)C)NC=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2
Stable body weight (less than 5% selfreported change within the last 3 months)

Exclusion Criteria:

Obesity induced by drug treatment
Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial
Type 1 or type 2 diabetes
Intervention: Artecom
Trial phase: Phase 3
SMILES: CC1CCC2C(C)C(OC(=O)CCC(=O)O)OC3OC4(C)CCC1C32OO4.COc1ccc2nc3cc(Cl)ccc3c(Nc3cc(CN4CCCC4)c(O)c(CN4CCCC4)c3)c2n1.O=P(O)(O)O.O=P(O)(O)O.O=P(O)(O)O.O=P(O)(O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 849
Group description: Pyronaridine artesunate (PA)

Pyronaridine artesunate: Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2)
Eligibility criteria:
Inclusion Criteria:

Male or female patients between the age of 3 and 60 years, inclusive.
Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.

Presence of acute uncomplicated P. falciparum mono-infection confirmed by:

Fever, as defined by axillary/tympanic temperature ≥ 37.5°C or oral/rectal temperature ≥ 38°C, or documented history of fever in the previous 24 hours and,
Positive microscopy of P. falciparum with parasite density between 1,000 and 100,000 asexual parasite count/μl of blood.
Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse.
Ability to swallow oral medication.

Exclusion Criteria:

Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000.
Mixed Plasmodium infection.
Severe vomiting or severe diarrhoea.
Known history or evidence of clinically significant disorders.
Presence of significant anaemia, as defined by Hb <8 g/dL.
Presence of febrile conditions caused by diseases other than malaria.
Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, lumefantrine or artesunate or other artemisinins.
Patients with known disturbances of electrolytes balance, e.g., hypokalaemia or hypomagnesaemia.
Use of any other antimalarial agent within 2 weeks prior to start of the study as evidenced by a positive urine test.
Female patients of child-bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.
Patients taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (flecainide, metoprol, imipramine, amitriptyline, clomipramine).
Received an investigational drug within the past 4 weeks.
Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen. (HBsAg) or Hepatitis C antibody (HCV Ab).
Known seropositive HIV antibody.
Liver function tests [ASAT/ALAT levels] >2.5 times the upper limit of normal range.
Known significant renal impairment as indicated by serum creatinine >1.4 mg/dL.
Intervention: Lumefantrine co-artemether
Trial phase: Phase 3
SMILES: CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.[H][C@]12O[C@H](OC)[C@H](C)[C@]3([H])CC[C@@H](C)[C@]4([H])CC[C@](C)(OO[C@]143)O2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 423
Group description: Arthemether lumefantrine (AL)

Coartem® (artemether lumefantrine): AL twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)
Eligibility criteria:
Inclusion Criteria:

Male or female patients between the age of 3 and 60 years, inclusive.
Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.

Presence of acute uncomplicated P. falciparum mono-infection confirmed by:

Fever, as defined by axillary/tympanic temperature ≥ 37.5°C or oral/rectal temperature ≥ 38°C, or documented history of fever in the previous 24 hours and,
Positive microscopy of P. falciparum with parasite density between 1,000 and 100,000 asexual parasite count/μl of blood.
Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse.
Ability to swallow oral medication.

Exclusion Criteria:

Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000.
Mixed Plasmodium infection.
Severe vomiting or severe diarrhoea.
Known history or evidence of clinically significant disorders.
Presence of significant anaemia, as defined by Hb <8 g/dL.
Presence of febrile conditions caused by diseases other than malaria.
Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, lumefantrine or artesunate or other artemisinins.
Patients with known disturbances of electrolytes balance, e.g., hypokalaemia or hypomagnesaemia.
Use of any other antimalarial agent within 2 weeks prior to start of the study as evidenced by a positive urine test.
Female patients of child-bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.
Patients taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (flecainide, metoprol, imipramine, amitriptyline, clomipramine).
Received an investigational drug within the past 4 weeks.
Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen. (HBsAg) or Hepatitis C antibody (HCV Ab).
Known seropositive HIV antibody.
Liver function tests [ASAT/ALAT levels] >2.5 times the upper limit of normal range.
Known significant renal impairment as indicated by serum creatinine >1.4 mg/dL.
Intervention: BENZOYL PEROXIDE
Trial phase: Phase 3
ATC code: D10AE01 | D10AE51
SMILES: O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 415
Group description: Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
Eligibility criteria:
Inclusion Criteria:

A clinical diagnosis of acne vulgaris with facial involvement.
A minimum of 20 but not more than 50 inflammatory lesions
A minimum of 30 but not more than 100 noninflammatory lesions
A score of 3 (Moderate) on the Investigator's Global Assessment Scale
Intervention: PF-00489791
Trial phase: Phase 2
SMILES: CCOCCn1nc(C(=O)NS(C)(=O)=O)c2nc(N(C)CC)nc(Nc3cc(C)ccn3)c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
Eligibility criteria:
Inclusion Criteria:

Males and/or Females of non-childbearing potential between 18 and 70 years of age
History of mild to moderate hypertension

Exclusion Criteria:

Type 1 or 2 diabetes on prescribed medications
Secondary, severe, or malignant hypertension
History of a significant cardiovascular event within the last 12 months of enrollment
Intervention: PF-00489791
Trial phase: Phase 2
SMILES: CCOCCn1nc(C(=O)NS(C)(=O)=O)c2nc(N(C)CC)nc(Nc3cc(C)ccn3)c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
Eligibility criteria:
Inclusion Criteria:

Males and/or Females of non-childbearing potential between 18 and 70 years of age
History of mild to moderate hypertension

Exclusion Criteria:

Type 1 or 2 diabetes on prescribed medications
Secondary, severe, or malignant hypertension
History of a significant cardiovascular event within the last 12 months of enrollment
Intervention: Arixtra
Trial phase: Phase 3
SMILES: COC1OC(COS(=O)(=O)[O-])C(OC2OC(C(=O)O)C(OC3OC(COS(=O)(=O)[O-])C(OC4OC(C(=O)O)C(OC5OC(COS(=O)(=O)[O-])C(O)C(O)C5NS(=O)(=O)[O-])C(O)C4O)C(OS(=O)(=O)[O-])C3NS(=O)(=O)[O-])C(O)C2OS(=O)(=O)[O-])C(O)C1NS(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Arixtra anti coagulation alone
Eligibility criteria:
Inclusion Criteria:

Documentation of cancer.
The disease may be a solid tumor, Lymphoma or Multiple Myeloma. Pathology reports will be documented in the patient's chart and included in the data.
Age > 18 years
An acute, radiographically confirmed, de novo Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
No past medical history of a prior thrombus or known thrombophilia

Exclusion Criteria

Patients are not eligible for this study if they receive therapeutic doses of any heparin for more than 72 hours before randomization 31.
Already receiving oral anticoagulant therapy 31.
Severe renal impairment, calculated using the Cockcroft-Gault formula, defined as a creatinine clearance <30 mL/min 31.
Platelet count of less than 50,000 per cubic millimeter
Bleeding from the gastrointestinal tract that requires blood transfusion (s), intracranial bleeding or retroperitoneal bleeding.
An indication for thrombolysis
Allergy to iodine
Hereditary thrombophilia
Pregnancy
Likelihood of noncompliance
It is contraindicated to anticoagulate patients with brain metastasis secondary to melanoma, choriocarcinoma, renal cell and medullary thyroid carcinoma. If these patients have a Venous Thromboembolism (VTE), it is standard of care for these patients to have a CT of their head to evaluate if there is metastasis to the brain before they are anticoagulated 38. If these patients do have brain metastasis, they will not be included in the study.
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: modafinil

modafinil: 200 milligrams daily dose
Eligibility criteria:
Inclusion Criteria:

adults age 18-54
diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
able to provide informed consent

Exclusion Criteria:

history of significant head injury or other neurological illness
active psychiatric illness requiring significant acute care
significant intellectual impairment (e.g. standardized full-scale IQ < 70)
history of medical illness or treatment that either interferes with experimental measures (e.g. cerebrovascular disease, anemias, etc.) or is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
significant active substance abuse
presence of ferromagnetic foreign body or prosthesis
active pregnancy
active treatment with medications that have drug interactions with modafinil
Intervention: Roflumilast
Trial phase: Phase 3
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 374
Group description: Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
Eligibility criteria:
Main Inclusion Criteria:

History of COPD for at least 12 months prior to baseline visit and chronic productive cough for 3 months in each of the 2 years prior to baseline visit
FEV1/FVC ratio (post-bronchodilator) ≤ 70%
FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
Treated with tiotropium for at least 3 months before enrollment
At least 28 puffs of rescue medication during last week prior to randomization

Main Exclusion Criteria:

COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
Intervention: Arformoterol Tartrate
Trial phase: Phase 4
SMILES: COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
Eligibility criteria:
Inclusion Criteria:

Male and female subjects must be at least 45 years old at the time of consent.
Subjects must have a pre-established primary clinical diagnosis of COPD.
Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit 1.
Subjects must have a FEV1 ≥ 0.70L at Visit 1.

Exclusion Criteria:

Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.
Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visit 1.
Intervention: Duloxetine
Trial phase: Phase 3
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 115
Group description: 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
Eligibility criteria:
Inclusion Criteria:

Male/Female outpatients 18 years of age with chronic low back pain
Females of child bearing potential must test negative on a pregnancy test at visit 1.

Exclusion Criteria:

Have a serious or unstable diseases of the heart or blood vessels, liver, kidney, lungs, or blood-related illness
Problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions
Psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study
Have acute liver injury (such as hepatitis) or severe cirrhosis
Have had previous exposure to duloxetine
Have a body mass index (BMI) over 40
Have a major depressive disorder
Require daily narcotics
Have suicidal risk
Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures
Intervention: Rosiglitazone
Trial phase: Phase 4
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: 4mg oral tablet once daily titrated to 8mg oral tablet once daily
Eligibility criteria:
Inclusion Criteria:

type 2 diabetes mellitus (prior clinical diagnosis and current use of hypoglycemic medical therapy or by new diagnosis according to ADA criteria) with at least one of the following:

prior diagnosis of cardiovascular disease (CAD, MI, revascularization, CVA/TIA, carotid or peripheral arterial disease)
at least one additional CVD risk factor (smoking, hypertension, hypercholesterolemia, albuminuria, family history of premature CAD, or documented hsCRP>3)

Exclusion Criteria:

treatment with a TZD within prior 6 months
documented intolerance to TZD
history or evidence of CHF
AST/ALT>3X upper limits of normal
creatinine >2.5
Intervention: Bexarotene
Trial phase: Phase 2
ATC code: L01XF03 | L01XX25
SMILES: C=C(c1ccc(C(=O)O)cc1)c1cc2c(cc1C)C(C)(C)CCC2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis (confirmed by bone marrow aspirate and/or biopsy) of 1 of the following:

Myelodysplastic syndromes of 1 of the following cell types:

Refractory anemia (RA) with ringed sideroblasts
Refractory cytopenia with multilineage dysplasia (RCMD)
RCMD and ringed sideroblasts
RA with excess blasts-1
RA with excess blasts-2
Myelodysplastic syndromes, unclassified
Chronic myelomonocytic leukemia

Relapsed or refractory acute myeloid leukemia (AML), meeting 1 of the following criteria:

Recurrent genetic abnormalities (11q23 [MLL] abnormalities)
Multilineage dysplasia
Therapy-related AML

Not otherwise categorized, including any of the following:

M0 minimally differentiated
M1 without maturation
M2 with maturation
M4 myelomonocytic leukemia
M5 monoblastic/monocytic leukemia
M6 erythroid leukemia
M7 megakaryoblastic leukemia
Newly diagnosed untreated AML allowed provided patient does not qualify for or refused potentially curative intensive chemotherapeutic regimens
No RA with 5q-syndrome
No peripheral leukemia with blast count > 30,000/mm³ (uncontrolled with hydroxyurea)
Relatively stable bone marrow function for > 7 days (i.e., no WBC doubling to > 10,000/mm^3)
No acute promyelocytic leukemia
No clinical symptoms of active CNS disease (if CNS disease is suspected, patient must have lumbar puncture with negative cytology)

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 1.6 mg/dL (unless secondary to hemolysis)
AST and ALT ≤ 4 times upper limit of normal (unless disease related)
Hemoglobin ≥ 8 g/dL (transfusions allowed)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
No untreated positive blood cultures or progressive infection as assessed by radiographic studies
No history of intolerance to sargramostim (GM-CSF)

PRIOR CONCURRENT THERAPY:

Recovered from prior therapy

At least 2 weeks since prior treatment for myeloid disorder, including any of the following:

Chemotherapy
Hematopoietic growth factors
Biologic therapy (e.g., monoclonal antibodies)
Hydroxyurea for patients with WBC > 10,000/mm^3 allowed
No concurrent vitamin A supplementation
No concurrent gemfibrozil
Intervention: Mycapssa
Trial phase: Phase 2 | Phase 3
ATC code: H01CB02
SMILES: CC(O)C(CO)NC(=O)C1CSSCC(NC(=O)C(N)Cc2ccccc2)C(=O)NC(Cc2ccccc2)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
Eligibility criteria:
Inclusion Criteria:

Age - 18 years and older
Diagnosis of Polycystic Liver Disease (PLD) associated with ADPKD or isolated Autosomal Dominant Polycystic liver Disease (ADPLD)
Severe PLD defined as a liver volume greater than 4000 mL or symptomatic disease due to mass effects from hepatic cysts
Not a candidate for or declining surgical intervention

Exclusion Criteria:

Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception
Creatinine greater than 3mg/dL or hemodialysis dependent
Cancer or major systemic disease that could prevent completion of the planned follow-up or interfere with data collection or interpretation
Uncontrolled diabetes mellitus as defined by blood glucose levels of greater than or equal to 250 mg/dL on 2 or more consecutive daily readings despite antidiabetic therapy
Neurologic/psychologic conditions preventing appropriate informed consent
Symptomatic gallstones or biliary sludge
Variceal bleeding or hepatic encephalopathy within prior 30 days
Uncontrolled hypertension (Systolic blood pressure greater than 160 mmHg; Diastolic blood pressure greater than 100 mmHg)
Current, or prior use of somatostatin analogue (octreotide, lanreotide) in past 6 months
History of significant adverse reaction to a somatostatin analogue
Intervention: FLUTICASONE PROPIONATE
Trial phase: Phase 2
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Drug

Flovent : 1760 mcg daily
Eligibility criteria:
Inclusion Criteria:

Signed informed consent for study by subject, or parent/guardian if subject is a minor. Assent will be obtained from all minors 11 years of age and older.
Histological findings on esophageal biopsy to include peak eosinophil density ≥ 24 per high power field (400x) in the proximal or distal esophagus validated by a pathologist at CCHMC.
Allergy evaluation including skin-prick testing with multiple food antigens to ensure elimination diet is not indicated.
Have undergone a minimum 3 months of elimination diet as indicated by skin-prick testing without detectable resolution by repeat endoscopy with biopsies demonstrating persistent EE OR subject/parental refusal to follow elimination diet. If the subject/parent refuses the elimination diet, they are eligible for this study.
Treatment with a proton-pump inhibitor for at least two months (rounded to nearest month) prior to endoscopy OR failure of histological improvement as defined by < 1 eosinophil per HPF after 2 month (rounded to nearest month) trial of proton pump inhibitor documented by prior endoscopy. The PPI must be used prior to endoscopy to rule out the possibility of GERD.

Exclusion Criteria:

History of poor tolerance to Fluticasone Propionate (FP), as defined as multiple episodes of oral candidiasis, hypothalamic-pituitary-adrenal axis suppression as evidenced by signs of Cushing syndrome, headaches, or increased respiratory infections during exposure to Flovent
Unable to cooperate with use of MDI
Pregnant females
Concurrent or recent (within 3 months) use of systemic corticosteroids.
Unable to swallow medicines (i.e., fed only by gastrostomy tube).
Comorbid eosinophilic disorders.
Previously treated with swallowed glucocorticoid for EE within 3 months of the screening visit. Nasal glucocorticoids taken for EE are permitted.