anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Propofol
Trial phase: Phase 2
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
Eligibility criteria:
Inclusion Criteria:

Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Exclusion Criteria:

American Society of Anesthesiologists (ASA) grade III, IV V and VI
Baseline oxygen saturation<90% (room air)
Body Mass Index (BMI) >=35
Intervention: Propofol
Trial phase: Phase 2
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
Eligibility criteria:
Inclusion Criteria:

Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Exclusion Criteria:

American Society of Anesthesiologists (ASA) grade III, IV V and VI
Baseline oxygen saturation<90% (room air)
Body Mass Index (BMI) >=35
Intervention: Propofol
Trial phase: Phase 2
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
Eligibility criteria:
Inclusion Criteria:

Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Exclusion Criteria:

American Society of Anesthesiologists (ASA) grade III, IV V and VI
Baseline oxygen saturation<90% (room air)
Body Mass Index (BMI) >=35
Intervention: Propofol
Trial phase: Phase 2
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
Eligibility criteria:
Inclusion Criteria:

Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Exclusion Criteria:

American Society of Anesthesiologists (ASA) grade III, IV V and VI
Baseline oxygen saturation<90% (room air)
Body Mass Index (BMI) >=35
Intervention: Propofol
Trial phase: Phase 2
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
Eligibility criteria:
Inclusion Criteria:

Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Exclusion Criteria:

American Society of Anesthesiologists (ASA) grade III, IV V and VI
Baseline oxygen saturation<90% (room air)
Body Mass Index (BMI) >=35
Intervention: Propofol
Trial phase: Phase 2
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
Eligibility criteria:
Inclusion Criteria:

Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Exclusion Criteria:

American Society of Anesthesiologists (ASA) grade III, IV V and VI
Baseline oxygen saturation<90% (room air)
Body Mass Index (BMI) >=35
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 224
Group description: normal saline injected into bilateral Crow's Feet Line areas on Day 1.
Eligibility criteria:
Inclusion Criteria:

Moderate to severe Crow's Feet Lines
Have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses OK)

Exclusion Criteria:

Current or previous botulinum toxin treatment of any serotype
Facial laser or light treatment, microdermabrasion or superficial peels within 3 months
Oral retinoid therapy within 1 year
Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery)
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 306
Group description: Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
Eligibility criteria:
Inclusion Criteria:

Moderate to severe Crow's Feet Lines and Frown Lines
Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK)

Exclusion Criteria:

Current or previous botulinum toxin treatment of any serotype
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
Oral retinoid therapy within one year
Intervention: Amlodipine
Trial phase: Phase 4
ATC code: C07FB07 | C07FB12 | C07FB13 | C08CA01 | C08CA17 | C08CA51 | C08GA02 | C09BB03 | C09BB04 | C09BB07 | C09BB13 | C09BX01 | C09BX03 | C09BX04 | C09DB01 | C09DB02 | C09DB04 | C09DB05 | C09DB06 | C09DB07 | C09DB09 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA53 | C09XA54 | C10BX03 | C10BX07 | C10BX09 | C10BX11 | C10BX14 | C10BX18 | C10BX19
SMILES: CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 159
Group description: Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
Eligibility criteria:
Inclusion Criteria:

Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3):
(1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0)
(2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
(3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2
Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3):
(1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris
(2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
(3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2

Exclusion Criteria:

Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg.
Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated
Intervention: Lincomycin
Trial phase: Phase 4
ATC code: J01FF02
SMILES: [H][C@@]1(C(=O)N[C@@H]([C@H]2O[C@H](SC)[C@H](O)[C@@H](O)[C@H]2O)[C@@H](C)O)C[C@@H](CCC)CN1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Lacosamide: Subjects randomized to lacosamide according to the following schedule:

Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
Eligibility criteria:
Inclusion Criteria:

Subjects must meet the following inclusion criteria to be eligible for the study.

Subject can provide written informed consent and is willing to comply with study procedures.
Subject is at least 18 years of age.
Subject has focal epilepsy with classifiable seizures according to the International Classification of Epileptic Seizures, 1981.11
Subject is deemed to be an appropriate candidate for LCM adjunctive therapy.
Subject has been maintained on a stable dose of 1 or 2 marketed AEDs for at least 4 weeks.

Exclusion Criteria:

Subjects must meet the following exclusion criteria to be eligible for the study.

Subject has a history of a moderate or severe sleep apnea (apnea-hypopnea index [AHI] > 15), severe insomnia (habitual sleep duration < 4 hours) or narcolepsy.
Subject has a score on the Sleep Apnea Scale of the Sleep Disorders Questionnaire (SA/SDQ) at screening of 32 or higher (female) and 36 or higher (male).
Subject is currently participating or has participated within the last 2 months in a trial of an investigational drug or experimental device.
Subject has seizures or seizures clusters that are not quantifiable.
Subject has 6 or more seizures (excluding auras) in the 2-week Baseline Phase.
Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism or excretion.
Subject has any medical or psychiatric condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the - Subject has a history of alcohol or drug abuse within the previous 2 years.
Subject has an acute or sub-acutely progressive central nervous system disease.
Subject is pregnant, breastfeeding or of childbearing age and not surgically sterile or practicing an acceptable form of contraception (barrier contraception, surgically sterilized, IUD, abstinence) for the duration of the trial.
Intervention: Bromfenac
Trial phase: Phase 1 | Phase 2
ATC code: S01BC11
SMILES: Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
Eligibility criteria:
Inclusion Criteria:

Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
Meet the best corrected visual acuity score requirement
Meet the IOP requirement
Additional inclusion criteria also apply

Exclusion Criteria:

Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
Additional exclusion criteria also apply
Intervention: Bromfenac
Trial phase: Phase 1 | Phase 2
ATC code: S01BC11
SMILES: Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
Eligibility criteria:
Inclusion Criteria:

Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
Meet the best corrected visual acuity score requirement
Meet the IOP requirement
Additional inclusion criteria also apply

Exclusion Criteria:

Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
Additional exclusion criteria also apply
Intervention: Bromfenac Sodium Sesquihydrate
Trial phase: Phase 1 | Phase 2
SMILES: Nc1c(CC(=O)[O-])cccc1C(=O)c1ccc(Br)cc1.Nc1c(CC(=O)[O-])cccc1C(=O)c1ccc(Br)cc1.O.O.O.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Xibrom™: Xibrom dosed BID
Eligibility criteria:
Inclusion Criteria:

Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
Meet the best corrected visual acuity score requirement
Meet the IOP requirement
Additional inclusion criteria also apply

Exclusion Criteria:

Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
Additional exclusion criteria also apply
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Target controlled infusion anesthesia with propofol for induction and maintenance.
Eligibility criteria:
Inclusion Criteria

Men or women, aged from 18 to 65
ASA (American Society of Anesthesiologists) physical status (a requirement of the subject's physical status): I or II
Body mass index (weight/height^2) from 16 to 30 kg/m^2
Elective laparoscopic surgery requiring general anesthesia managed with endotracheal intubation
Duration of anesthesia use will be greater than or equal to 1 hour, but less than 3 hours in length.

Exclusion Criteria

Hypersensitivity or unusual response to any halogenated anesthetics.
History of significant cardiovascular, pulmonary, hepatic, renal, central nervous system or muscular disease.
Pre-operative cognitive dysfunction or disabling neuropsychiatric disorders.
Need for emergency surgery or surgery requiring additional regional anesthetic techniques.
Need for intracranial surgery, cardio-surgery or thoracic surgery.
Subjects inability to cooperate with the anesthetist before administration of the anesthetic agent.
Personal or familial history of malignant hyperthermia.
Females who are either pregnant or breast feeding.
Intervention: CID 11593706
Trial phase: Phase 3
SMILES: C=CCN.ClCC1CO1.O=C(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: 2400 mg (3 pills) with each meal

sevelamer carbonate : 2400 mg with each meal for 4 weeks
Eligibility criteria:
Inclusion Criteria:

eGFR < 60 ml/min
age at least 18 years

Exclusion Criteria:

any primary parathyroid disease
Intervention: Tetrabenazine
Trial phase: Phase 1 | Phase 2
ATC code: N07XX06 | N07XX16
SMILES: COc1cc2c(cc1OC)C1CC(=O)C(CC(C)C)CN1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Active 10% FBR containing bioadhesive gel

Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

No adverse events
Eligibility criteria:
Inclusion Criteria:

Ages: 21 to 80
Microscopically confirmed premalignant oral epithelial disease
No previous history of cancer (with the exception of basal cell carcinoma of the skin)
Tobacco free for at least six weeks prior to entrance in the trial and remain tobacco-free for the three month duration of the study
Availability for necessary study follow-up evaluations (every 10 to 14 days during the trial)
Capable of providing informed consent.

Exclusion Criteria:

Previous history of cancer (with the exception of basal cell carcinoma of the skin)
Current use of tobacco products or refusal to remain tobacco-free for the three month duration of the study
Lack of microscopically confirmed premalignant oral epithelial changes
Microscopic diagnosis of oral squamous cell carcinoma
Previous history of radiation therapy on same side of the head and neck region
History of allergy to any kind of berry
Women who are determined to be pregnant or plan to be pregnant during the trial
Women who are nursing.
Intervention: Prednisone
Trial phase: Phase 1
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: All participants who received at least one dose of prednisone
Eligibility criteria:
Inclusion Criteria:

Has a clinical history of mild to moderate asthma for at least 6 months, but otherwise is in good health
Participant with allergic rhinitis and asthma has a history of nonseasonal airway symptoms in response to aeroallergens OR has seasonal symptoms but can be evaluated out-of-season
Is clinically stable and free of respiratory infection or change in allergen exposure for at least 4 weeks prior to start of study

Exclusion Criteria:

Has intolerance to the study drug, inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication
Has intolerance to lidocaine/lignocaine, sedatives, atropine or glycopyrrolate, or any other medication associated with bronchoscopy
Has taken oral parenteral corticosteroids within 8 weeks or inhaled corticosteroids/nasal corticosteroids within 5 weeks of screening and/or during the study
Has recent (4 weeks) or ongoing upper or lower respiratory tract infection
Has active allergic rhinitis at screening
Has received a vaccination within 3 weeks of screening
Intervention: Phenylephrine and ketorolac injection
Trial phase: Phase 2
SMILES: CNCC(O)c1cccc(O)c1.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 56
Group description: OMS302 Solution

OMS302 Solution
Eligibility criteria:
Inclusion Criteria:

Competent and willing to voluntarily provide informed consent
18 years of age or older
In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia
Other inclusion criteria to be evaluated by the investigator

Exclusion Criteria:

No allergies to the medications and/or the active ingredients of any of the study medications
No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery
No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
Other exclusion criteria to be evaluated by the investigator
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 42
Group description: 3 mg of nasal nicotine will be administered postoperatively.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) class 2-3
Non-smokers, defined as not smoking (not even a puff) for at least one year preoperatively, and having smoked less than 100 cigarettes throughout their life or remote history of smoking with complete tobacco abstinence (not even a puff) for at least 10 years
Scheduled for elective laparoscopic bariatric surgery (other than gastric banding or sleeve resection bariatric surgeries as these are outpatient procedures) requiring general anesthesia.

Exclusion Criteria:

Regular use of opioid medications in the past year, any prior use of sustained release opioid medications, or history of substance abuse with opioids
History of previous psychiatric hospitalizations
Allergy to nicotine
Previous bariatric surgery or previous foregut surgery
Pregnant or lactating female (per usual surgical routine)
Contraindications for receiving ketorolac (elevated creatinine)
Unstable angina, severe uncontrolled hypertension, serious cardiac dysrhythmias (tachyarrhythmias, atrial fibrillation), or vasospastic diseases (Buerger's disease, Raynaud's phenomena)
Unable to provide informed consent to participate in the study
Contraindication to the proposed antiemetics.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 47
Group description: 1 ml of nasal normal saline spray will be administered postoperatively.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) class 2-3
Non-smokers, defined as not smoking (not even a puff) for at least one year preoperatively, and having smoked less than 100 cigarettes throughout their life or remote history of smoking with complete tobacco abstinence (not even a puff) for at least 10 years
Scheduled for elective laparoscopic bariatric surgery (other than gastric banding or sleeve resection bariatric surgeries as these are outpatient procedures) requiring general anesthesia.

Exclusion Criteria:

Regular use of opioid medications in the past year, any prior use of sustained release opioid medications, or history of substance abuse with opioids
History of previous psychiatric hospitalizations
Allergy to nicotine
Previous bariatric surgery or previous foregut surgery
Pregnant or lactating female (per usual surgical routine)
Contraindications for receiving ketorolac (elevated creatinine)
Unstable angina, severe uncontrolled hypertension, serious cardiac dysrhythmias (tachyarrhythmias, atrial fibrillation), or vasospastic diseases (Buerger's disease, Raynaud's phenomena)
Unable to provide informed consent to participate in the study
Contraindication to the proposed antiemetics.
Intervention: Vorinostat
Trial phase: Phase 2
ATC code: L01XH01
SMILES: O=C(CCCCCCC(=O)Nc1ccccc1)NO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Eligibility criteria:
Inclusion Criteria:

Stage I-III invasive breast cancer
Awaiting surgery or neoadjuvant treatment
ECOG performance status 0, 1 or 2
Adequate organ function
Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study)

Exclusion Criteria:

Prior or current treatment of any kind for the current breast cancer
Current use of any other investigational drugs
Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness