anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: CID 118984462
Trial phase: Phase 3
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(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=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: 233
Group description: Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for at least 6 months
Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
BMI (Body Mass Index) below or equal to 45.0 kg/m^2

Exclusion Criteria:

Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide
Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
Intervention: Ergocalciferol
Trial phase: Phase 2
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

HIV infected
HIV-RNA < 400 copies/ml at study entry and for 12 wks. prior
25-hydroxyvitamin D level <20
On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry

Exclusion Criteria:

Pregnancy or Breast Feeding
Diabetes
Creatinine Clearance <50
Any active infectious or inflammatory condition
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 within 6 months prior to study entry
Intervention: Elocon
Trial phase: Phase 4
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 34
Group description: One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Eligibility criteria:
Inclusion Criteria:

2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.

Exclusion Criteria:

adenoids hypertrophy < 50% of posterior choanae

recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.
Intervention: Ramosetron
Trial phase: Phase 4
SMILES: Cn1cc(C(=O)[C@@H]2CCc3[nH]cnc3C2)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
Eligibility criteria:
Inclusion Criteria:

Diagnosis of primary osteoarthritis, knee
Scheduled for elective total knee arthroplasty
Signed written informed consent

Exclusion Criteria:

Refusing participate
Contraindication to regional anesthesia
Severe impairment of bowel motility
administration of other antiemetics within 24hours before surgery
systemic steroid within 24hours before surgery
history of cardiovascular & respiratory disease
renal & hepatic failure
Intervention: Bisoprolol
Trial phase: Phase 4
ATC code: C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05
SMILES: CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
Eligibility criteria:
Inclusion Criteria:

>18 years of age and <80 years of age
Chronic heart failure subjects with stable clinical condition
New York Heart Association (NYHA) functional classification II-III
Left ventricular ejection fraction (LVEF) ≤45%

Exclusion Criteria:

NYHA functional classification IV
Acute myocardial infarction, Unstable Angina Pectoris, Coronary artery bypass graft, Percutaneous coronary intervention (PCI), Valve surgery in the preceding 3 months
Hypersensitivity to bisoprolol or any of the Concor excipients
Subjects with over mild valvular stenosis and severe(Grade III/IV) pulmonary insufficiency
Systolic Blood Pressure <90 millimeters of mercury (mmHg) at screening
Resting Heart Rate <55 beats per minute (bpm) confirmed by electrocardiogram (ECG) at screening
Subjects who are taking concomitant drug which can have drug-drug interaction (DDI) with bisoprolol
Woman of childbearing age without effective contraception measures, or who are pregnant or lactating
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 167
Group description: Oral administration. Once per day.
Eligibility criteria:
Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
Patients in their first episode of psychosis
Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
Substance abuse or dependence within the prior 3 months
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 169
Group description: Oral administration. Once per day.
Eligibility criteria:
Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
Patients in their first episode of psychosis
Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
Substance abuse or dependence within the prior 3 months
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 586
Group description: Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients and corresponding caregivers who have provided informed consents prior to any study specific procedures.
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.
Intervention: Regadenoson
Trial phase: Phase 4
ATC code: C01EB21
SMILES: CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Regadenoson Rubidium-82 Positron Emission Tomography

Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Clinically indicated N-13 ammonia PET study or ten healthy volunteers
Known coronary artery disease (prior percutaneous coronary intervention, prior coronary artery bypass surgery or Q wave MI on ECG) or intermediate to high pretest likelihood of CAD
Able to exercise on a treadmill
Able and willing to provide informed consent to participate in the study

Exclusion Criteria:

Contraindications to exercise stress testing such as, unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure < 90 or > 200 mmHg, respectively), or > 1st degree atrioventricular block in the absence of a functioning pacemaker.
Subject requires emergent cardiac medical intervention or catheterization after the clinical study.
Documented myocardial infarction (MI) ≤ 30 days prior to enrollment.
History of percutaneous coronary intervention (PCI) ≤ 4weeks prior to enrollment.
History of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment.
History of heart transplantation.
Allergy or intolerance to aminophylline or regadenoson
Known severe or oxygen dependent bronchoconstrictive or bronchospastic lung disease [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.].
Severe LV dysfunction, with ejection fraction of < 30%
Serious non-cardiac medical illness (e.g., disseminated malignancy, severe neurological dysfunction at time of baseline PET study) or a social situation which will preclude research study participation
History of Seizures.
Intervention: Ketoconazole
Trial phase: Phase 3
ATC code: D01AC08 | G01AF11 | G01AF20 | H02CA03 | J02AB02
SMILES: CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 234
Group description: Ketoconazole 2% cream (formulation F126)
Eligibility criteria:
Inclusion Criteria:

Be co-operative, reliable and sufficiently competent to grade and record symptoms as requested
have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy
Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study and have a negative urine pregnancy test at screening (applies to women only)
Sign an informed consent form indicating an understanding of the purpose of and procedures required for the study and willingness to participate in the study

Exclusion Criteria:

Have complicated Tinea pedis defined as confluent, diffuse moccasin type tinea pedis of the entire plantar surface (undersurface of foot), onychomycosis (fungal nail infection)
other dermatomycosis (fungal skin infection) requiring active treatment
Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication
Have a history of disallowed therapies including oral (by mouth) antifungal treatments within the previous 6 weeks, recent use (within 2 weeks of the study start) of topical antifungal agent, immunosuppressive or radiation therapy within the previous 4 weeks, recent use (within 2 weeks prior to screening) of other oral antibiotics, systemic corticosteroids or topical corticosteroids or antibiotics applied to the feet
Be HIV-positive (testing will not be performed)
Have uncontrolled diabetes mellitus or peripheral vascular disease requiring active treatment
Intervention: Ketoconazole
Trial phase: Phase 3
ATC code: D01AC08 | G01AF11 | G01AF20 | H02CA03 | J02AB02
SMILES: CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 230
Group description: Ketoconazole 2% cream (formulation F012) (Nizoral)
Eligibility criteria:
Inclusion Criteria:

Be co-operative, reliable and sufficiently competent to grade and record symptoms as requested
have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy
Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study and have a negative urine pregnancy test at screening (applies to women only)
Sign an informed consent form indicating an understanding of the purpose of and procedures required for the study and willingness to participate in the study

Exclusion Criteria:

Have complicated Tinea pedis defined as confluent, diffuse moccasin type tinea pedis of the entire plantar surface (undersurface of foot), onychomycosis (fungal nail infection)
other dermatomycosis (fungal skin infection) requiring active treatment
Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication
Have a history of disallowed therapies including oral (by mouth) antifungal treatments within the previous 6 weeks, recent use (within 2 weeks of the study start) of topical antifungal agent, immunosuppressive or radiation therapy within the previous 4 weeks, recent use (within 2 weeks prior to screening) of other oral antibiotics, systemic corticosteroids or topical corticosteroids or antibiotics applied to the feet
Be HIV-positive (testing will not be performed)
Have uncontrolled diabetes mellitus or peripheral vascular disease requiring active treatment
Intervention: Bupropion Hydrochloride
Trial phase: Phase 2
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.

Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
Eligibility criteria:
Inclusion Criteria:

Male or female subjects, 18-75 years old
Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria
Smoking at least 10 cigarettes per day
Weight of at least 100 lbs (45.4 kg)
Motivation to quit smoking
Stabilized psychotic symptoms
Provision of informed consent for testing and treatment

Exclusion Criteria:

Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder
Seizure disorder, recent withdrawal from alcohol or anxiolytics
History of bulimia nervosa, anorexia nervosa, or dementia
History of depression, panic, or bipolar disorders
Pregnancy or lactation
Prior use of varenicline or bupropion HCl within three months prior to initiation of the study
Current use of other smoking cessation treatments
Regular use of non-cigarette tobacco products (> than once/week)
Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6 months
Patients with suicidal ideations or plans
Florid psychosis or increasing psychosis following varenicline or bupropion HCl treatment
History of, or current, alcohol dependence/abuse
Current use of monoamine oxidase inhibitors (MAOI)
Intervention: Hexose
Trial phase: Not Applicable
ATC code: V04CE01 | V06DC01
SMILES: OCC1OC(O)C(O)C(O)C1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.

D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally.
Eligibility criteria:
Inclusion Criteria:

2-21 years old
Biopsy proven FSGS or minimal change with steroid resistance
Presence of FSPF (defined as permeability activity >0.5)
Presence of nephrotic range proteinuria (urine protein: creatinine ratio >2) at the time of enrollment.
Persistent nephrotic range proteinuria despite being on stable immunosuppressive medications (cyclosporine, tacrolimus or mycophenolate mofetil) for at least 12 weeks and/or persistent nephrotic range proteinuria despite being on stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for 12 weeks.
Stable serum creatinine (change of less than 0.3 mg/dl) in the prior 3 months.
Schwartz estimated (e) glomerular filtration rate (GFR) >60ml/min/1.73m2

Exclusion Criteria:

Secondary FSGS
Onset of nephrotic syndrome in infancy.
Presence of acute renal failure (as defined by acute kidney injury criteria) at the time of enrollment. These children can be enrolled 1 month after resolution of acute renal failure (ARF).
Decreasing renal function (persistent increase in serum creatinine of greater than 0.3 mg/dl over baseline in the prior 3 months).
Use of another investigational drug
Pregnant or unable to comply with contraceptive measures in females of child bearing age
eGFR < 60 ml/min per 1.73 m2
Children with Galactosemia
Children with type 1 or 2 diabetes
Intervention: Iron sucrose
Trial phase: Phase 3
ATC code: B03AB02 | V03AE05
SMILES: O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
Eligibility criteria:
Key Inclusion Criteria include:

Males and females ≥18 years of age

Participants with IDA defined as having:

Hemoglobin <10.0 g/deciliter (dL)
Transferrin saturation (TSAT) <20%
Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

History of allergy to IV iron
Allergy to two or more classes of drugs
Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute(min)/1.73 square meter (m^2)
Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
Hemoglobin ≤7.0 g/dL
Serum ferritin >600 nanogram/mL
Intervention: Travoprost
Trial phase: Phase 2
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: TRAVATAN 0.004% once daily
Eligibility criteria:
Inclusion Criteria:

either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension

meets the following IOP entry criteria:

Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

females of childbearing potential not meeting protocol conditions
angle grade less than Grade 2 in either eye
cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
severe central visual field loss in either eye
any abnormality preventing reliable applanation tonometry in either eye
hypersensitivity to prostaglandin analogues or to any component of the study medication