anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fluticasone
Trial phase: Phase 2
ATC code: D07AC17 | R01AD08 | R01AD58 | R03AK06 | R03AK11 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
Eligibility criteria:
Inclusion Criteria:

40 years and older
Clinical diagnosis of COPD for greater than one year
History of cigarette smoking

Exclusion Criteria:

Other lung diseases (not including COPD), such as asthma
A condition that could interfere with your ability to perform exercise tests
Intervention: Tiotropium
Trial phase: Phase 3
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1952
Group description: Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Eligibility criteria:
Inclusion Criteria:

Male or female
At least 40 years old
Smoker or ex-smoker
Smoking history > 10 pack-years
Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion Criteria:

Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
History of asthma or allergic conditions.
Malignancy requiring treatment within past 5 years
Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
Known active tuberculosis
Known hypersensitivity to anticholinergic drugs.
Intervention: Motexafin gadolinium
Trial phase: Phase 2
SMILES: CC(=O)[O-].CC(=O)[O-].CCc1c(CC)c2cc3nc(cnc4cc(OCCOCCOCCOC)c(OCCOCCOCCOC)cc4ncc4nc(cc1[n-]2)C(CCCO)=C4C)C(C)=C3CCCO.[Gd+3]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

motexafin gadolinium: Given IV

2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy
Eligibility criteria:
Inclusion Criteria:

Diagnosis of intrinsic pontine glioma (brain stem glioma)

Clinical and radiographic (MRI) evidence of tumors that diffusely involve the brain stem (i.e., tumors that intrinsically [> 50% intra-axial] involve the pons or pons and medulla, pons and midbrain, or entire brain stem) allowed
Tumor may contiguously involve the thalamus or upper cervical cord
No more than 1 lesion/mass present at diagnosis
Karnofsky performance status (PS) 60-100% (age > 16 years) OR Lansky PS 60-100% (age ≤ 16 years)
Life expectancy ≥ 8 weeks
Absolute neutrophil count ≥ 1,000/mm³
Platelet count ≥ 100,000/mm³ (transfusion independent)
Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal for age/gender (0.4-1.7 mg/dL)
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT < 1.5 times ULN

No known glucose-6-phosphate dehydrogenase (G6PD) deficiency

If family history suggestive of congenital hemolytic anemia, patient must be screened for G6PD with G6PD activity test prior to study entry
No biliary obstruction
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior definitive therapy for this specific tumor
No prior cranial radiotherapy
Concurrent steroids and anticonvulsants allowed
No concurrent proton therapy
No concurrent intensity-modulated radiotherapy
No concurrent anticancer chemotherapy
No concurrent immunomodulating agents
Intervention: Levothyroxine
Trial phase: Phase 3
ATC code: C10AX01 | H03AA01 | H03AA51
SMILES: N[C@@H](Cc1cc(I)c(Oc2cc(I)c(O)c(I)c2)c(I)c1)C(=O)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 265
Group description: 50 µg of Levothyroxine for participants with hypothyroxinemia

Levothyroxine: Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery.
Eligibility criteria:
Inclusion Criteria:

Subclinical Hypothyroidism as defined by an elevated TSH (≥ 3.00 mU/L) and a free-T4 in the normal range (i.e. 0.86 to 1.90 ng/dL) or Hypothyroxinemia as defined by a TSH in the normal range (0.08 to 2.99 micrometers (mU)/L) and a low free-T4 (<0.86 ng/dL)
Singleton Pregnancy
Gestational age at randomization between 8 weeks 0 days and 20 weeks 6 days

Exclusion Criteria:

Major fetal anomaly or demise
Planned termination of the pregnancy
History of thyroid cancer or current thyroid disease requiring medication
Diabetes, on medication (insulin, glyburide)
Collagen vascular disease (autoimmune disease), such as lupus, scleroderma and polymyalgia rheumatica, on medication
Receiving anticoagulant therapy
Depression, currently on treatment with tricyclics or selective serotonin reuptake inhibitors (SSRIs)

Other known serious maternal medical complications including:

Chronic hypertension requiring antihypertensive medication (including diuretics)
Epilepsy or other seizure disorder, on medication
Active or chronic liver disease (acute hepatitis, chronic active hepatitis) with persistently abnormal liver enzymes
Cancer (including melanoma but excluding other skin cancers)
Heart disease (tachyrhythmia, class II or greater heart disease or on heart medication). Mitral valve prolapse without arrhythmia is not an exclusion.
Asthma, on oral corticosteroids
Known illicit drug or alcohol abuse during current pregnancy
Delivery at a non-network hospital
Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy
Unwilling or unable to commit to 5 year follow-up of the infant
Intervention: Atenolol
Trial phase: Phase 2 | Phase 3
ATC code: C07AB03 | C07BB03 | C07CB03 | C07CB53 | C07DB01 | C07FB03
SMILES: CC(C)NCC(O)COc1ccc(CC(N)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 58
Group description: A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
Eligibility criteria:
Inclusion Criteria:

At least 18 ys old
Male or female with no child bearing potential
Seated blood pressure diastolic 90-115 mm Hg
Left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women
Informed consent

Exclusion Criteria:

Coronary artery disease, heart failure or other significant cardiac disorder
Cerebrovascular accident within the past 6 months
A seated systolic blood pressure above 200 mm Hg
Significant renal disease, collagen or vascular disease, or gastrointestinal condition
Significant allergy or intolerance to study drug
Alcohol or drug abuse
Uncontrolled diabetes mellitus
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)

Gabapentin: 300 mg. capsules

Dosage schedule for weeks 1 and 2 and weeks 12 and 13:

day 1 you will take 1 capsule for the day
day 2 you will take 1 capsule 2 times for that day
days 3-6 you will take 1 capsule 3 times for those days
days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
days 13-14 you will take 2 capsules 3 times each day
continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
at completion of study treatment you will titrate off study drug over a weeks time.
Eligibility criteria:
Inclusion Criteria:

All women, ages 18 years and older with the diagnosis of vulvodynia or VVS (by Friedrich's criteria), who present to the University of Iowa Vulvar Vaginal Disease Clinic.

Exclusion Criteria:

Vulvar Vaginal Disease clinic patients who are pregnant, less than 3 months postpartum, breast-feeding, non-English speaking, or have contraindication to use of gabapentin due to allergy or renal disease (serum creatinine level greater than 1.4).
Intervention: Clotrimazole
Trial phase: Phase 3
ATC code: A01AB18 | D01AC01 | G01AF02 | G01AF20
SMILES: Clc1ccccc1C(c1ccccc1)(c1ccccc1)n1ccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 287
Group description: Clotrimazole troches, 10 mg, 5 times per day for 14 days
Eligibility criteria:
Inclusion Criteria:

Patients with clinical picture of oropharyngeal candidiasis
Confirmation of oropharyngeal candidiasis by candida culture positive
HIV-positive patients
Patients 18 years of age

Exclusion Criteria:

Patients with signs or symptoms of systemic candidiasis
Patients with signs or symptoms of esophagitis
Pregnant or breast-feeding women
Patients who have taken systemic antifungals within the past 30 days
Patients who have taken local antifungals within the past 7 days
Intervention: Basaglar
Trial phase: Phase 4
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: 122
Group description: Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
Eligibility criteria:
Inclusion Criteria:

Diabetes Mellitus, Type 2 on oral agents
Age > 30 years

Exclusion Criteria:

Severe Asthma, severe Chronic Obstructive Pulmonary Disease
Smoking
Intervention: Nabiximols
Trial phase: Phase 3
ATC code: N02BG10
SMILES: C=C(C)C1CCC(C)=CC1c1c(O)cc(CCCCC)cc1O.CCCCCc1cc(O)c2c(c1)OC(C)(C)C1CCC(C)=CC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
Eligibility criteria:
Inclusion Criteria:

Any disease sub-type of MS of at least two years duration
Central neuropathic pain (CNP) of at least three months and expected to remain stable for the study duration
Moderate CNP defined by NRS pain score at baseline sum to at least 24
Subject established on or previously tried and failed analgesic therapy for CNP
If receiving disease modifying medications, stable dose for 3 months and maintained for study duration

Exclusion Criteria:

Subjects whose identified pain is likely to be nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic in origin, or due to trigeminal neuralgia.
Other non central neuropathic pain of a severity which is likely to interfere with the patients assessment of CNP
medical history suggests subject is likely to relapse/remit during course of study
history of schizophrenia (including family history), other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with MS
known or suspected history of alcohol abuse, epilepsy or recurrent seizures or hypersensitivity to cannabinoids
travel outside of the country of residence planned during the study
significant cardiac, renal or hepatic impairment
subjects with current recreational cannabis, medicinal cannabis or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration of the study
Intervention: Betamethasone
Trial phase: Phase 2
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: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Dexamethasone 0.01% (0.5mg/5 mL) oral rinse solution in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration.
Eligibility criteria:
INCLUSION CRITERIA:

History of allogeneic hematopoietic stem cell transplantation within 60-90 days of enrollment.
Age 12 or older.
Ability to rinse and expectorate study medication rather than swallow it.
Ability and willingness to come to Clinical Center for follow-up appointments and at the time of development of symptoms/signs suggestive of oral GVHD.

EXCLUSION CRITERIA:

Clinically significant oral chronic GVHD at the time of the screening.
Active viral or fungal infection involving oral cavity not resolving by day 90.
Platelet count less than 20,000/ml at the time of the screening appointment.
Life expectancy less than 4 months at the time of enrollment.
Documented hypersensitivity to dexamethasone.
Pregnancy or lactation.
Inability to understand the investigational nature of the study.
Inability to provide informed consent.
Intervention: Sertraline
Trial phase: Phase 4
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: Participants will receive treatment with sertraline

Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
Eligibility criteria:
Inclusion Criteria:

For people with PTSD:

Meets DSM-IV criteria for PTSD
Medically healthy
Right handed
Learned English prior to age 5
Agrees to use an effective form of contraception throughout the study

For healthy controls:

Medically healthy
Right handed
Has experienced a qualifying traumatic event
Does not meet DSM-IV criteria for present or past PTSD
Learned English prior to age 5
Agrees to use an effective form of contraception throughout the study

Exclusion Criteria:

For people with PTSD:

Meets DSM-IV criteria for panic disorder within 6 months prior to study entry
Current suicide risk
History of DSM-IV diagnosis of any the following conditions: schizophrenia, bipolar mood disorder, obsessive compulsive disorder (including trichotillomania), or eating disorder
Meets DSM-IV criteria for substance use or dependence within the 6 months prior to study entry
Any substance abuse within 2 weeks prior to study entry
Score of greater than 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D) with depressive symptoms secondary to PTSD
Current participation in cognitive behavioral psychotherapy that is specifically designed to treat PTSD
Concomitant psychoactive medications
History of cerebrovascular accident (CVA) or any disorder that causes chronic neurological problems
Medical illness with central nervous system (CNS) involvement or currently taking medication that affects the CNS
Unstable general medical illness requiring intervention (e.g., HIV infection)
Pregnant, breastfeeding, or plans to become pregnant
Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets, surgical prostheses, surgical clips, or pins
History of gastric bypass surgery

For healthy controls:

Any history of generalized anxiety disorder or panic disorder
Any history of psychotic disorder, bipolar disorder, or cyclothymia
Any history of substance abuse or dependence within the 6 months prior to study entry
Any substance use within 2 weeks prior to study entry
Any other Axis I disorder within the year prior to study entry, including obsessive-compulsive disorder and trichotillomania
Unstable general medical illness requiring intervention (e.g., HIV infection)
Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets, surgical prostheses, surgical clips, or pins
Concomitant psychoactive medications
Patients with a history of cerebrovascular accident (CVA) or any disorder that causes chronic neurological problems
Medical illness with central nervous system (CNS) involvement or currently taking medication that affects the CNS
Cognitive impairment or severe Axis II disorder that will likely affect participation in the study
Pregnant, breastfeeding, or plans to become pregnant
Intervention: Ticagrelor
Trial phase: Phase 3
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9333
Group description: Ticagrelor 90 mg twice daily dose (BD)
Eligibility criteria:
Inclusion Criteria:

Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Exclusion Criteria:

Persons with moderate or severe liver disease
Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
Persons who are being treated with blood clotting agents that cannot be stopped
Intervention: Clopidogrel
Trial phase: Phase 3
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9291
Group description: Clopidogrel 75 mg once daily dose (ODD)
Eligibility criteria:
Inclusion Criteria:

Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Exclusion Criteria:

Persons with moderate or severe liver disease
Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
Persons who are being treated with blood clotting agents that cannot be stopped
Intervention: Entacapone
Trial phase: Phase 4
ATC code: N04BX02
SMILES: CCN(CC)C(=O)/C(C#N)=C/c1cc(O)c(O)c([N+](=O)[O-])c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
Eligibility criteria:
Inclusion Criteria:

Male and female patients ages ≥ 30 and ≤ 80 years old.
A clinical diagnosis of idiopathic Parkinson's disease.
Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.

Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.

1 full tablet, and/or
1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
Must have a minimum UPDRS part II (ADL) score of 9.
Patients without dyskinesia or with mild dyskinesia.
Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.

Exclusion Criteria:

Previous or current use of entacapone.
History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
Unstable Parkinson's disease patients.
Patients who experience severe dyskinesia.

The following levodopa/carbidopa doses and strengths are not permitted:

Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.