anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Simvastatin
Trial phase: Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Simvastatin 40 mg for 24-28 weeks
Eligibility criteria:
DISEASE CHARACTERISTICS:

History of histologically confirmed breast cancer, meeting 1 of the following staging criteria:

Ductal carcinoma in situ
Stage I-III invasive breast cancer

At least 3 months since completion of all intended local and systemic therapy, including mastectomy or lumpectomy with or without radiotherapy, adjuvant chemotherapy, and/or endocrine therapy

May have declined recommended treatment provided all treatment intended/agreed upon by the patient and treating physician was completed ≥ 3 months ago

At least 1 healthy intact breast

No prior radiotherapy or mastectomy
Prior biopsies allowed
Any hormone-receptor status

PATIENT CHARACTERISTICS:

Female
Pre- or post-menopausal
ECOG performance status 0-2
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception
No active liver disease
AST and ALT ≤ 3 times upper limit of normal
Creatinine clearance ≥ 30 mL/min
No prior hypersensitivity to any 3-hydroxyl-3-methylglutaryl-Coenzyme A (HMG-CoA) reductase inhibitor or any of its components
No other concurrent infectious, inflammatory, or autoimmune diseases (at the discretion of principal investigator)

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

No daily alcohol use > 3 standard drinks per day

Standard drink defined as 10 grams of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor
No selective estrogen receptor modulator or aromatase inhibitor within the past 3 months
No hormone replacement therapy (HRT) within the past 3 months

No prior estrogen and/or progesterone HRT ≥ 5 years in duration

Vaginal estrogen preparations allowed
No concurrent HRT
No other cholesterol-lowering drug, including a statin, within the past 3 months
No concurrent itraconazole, ketoconazole, nefazodone, cyclosporine, HIV protease inhibitors, clarithromycin, erythromycin, mibefradil, carbamazepine, bosentan, chaparral, amiodarone, or verapamil
No concurrent daily grapefruit juice consumption > 8 ounces per day
No other concurrent agents or therapies intended to treat or prevent in situ or invasive breast cancer
Intervention: Daptomycin
Trial phase: Phase 2
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis of cancer

Diagnosis of neutropenic fever

Temperature > 38.3°C once OR ≥ 38°C twice within 12 hours

Absolute neutrophil count < 500/mm^³ and ≥ 1 of the following:

Mucositis
Concurrent skin or soft tissue infection
Indwelling catheter and/or suspected catheter infection
Recent quinolone prophylaxis
Positive blood cultures for gram-positive cocci before final identification or other documented gram-positive pathogen
Colonization with β-lactam resistant gram-positive organisms (commonly the nares or the skin)
Hypotension, tachycardia, narrowed pulse pressures, tachypnea, or other signs of cardiovascular compromise
Expected duration of neutropenia ≥ 3 days
No known infection with daptomycin-resistant organism or gram-negative organism and not yet meeting criteria for the addition of gram-positive antimicrobial therapy
No suspected meningitis or osteomyelitis
No documented or suspected gram-positive pneumonia
No suspected or proven endocarditis

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy ≥ 2 weeks
Creatinine clearance ≥ 50 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double-method contraception
No known sensitivity to daptomycin or product excipients
No history of or concurrent rhabdomyolysis
No HIV positivity
No psychiatric disorders that would preclude study compliance

No signs or symptoms of myopathy with creatine phosphokinase (CPK) elevation > 1,000 U/L (5 times upper limit of normal [ULN])

No CPK elevations > 10 times ULN in patients with no signs or symptoms of myopathy

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 7 days since prior daptomycin or other antibiotic agents covering gram-positive organisms
No concurrent hemodialysis or continuous ambulatory peritoneal dialysis
No concurrent succinylcholine, ethanol, fludrocortisone, olanzapine, or pioglitazone
No concurrent hydroxymethyl glutaryl (HMG) coenzyme A (HMG CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin)
Concurrent therapy for gram-negative bacterial infection allowed
Intervention: Morphine
Trial phase: Not Applicable
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 98
Group description: DepoDur Injection
Eligibility criteria:
Inclusion Criteria:

All mentally competent patients over the age of 18 undergoing lumbar surgery at L3-S1 who would be expected to be hospitalized for greater than 48 hours would be eligible for this study.

Exclusion Criteria:

Patients less than 18 years old, those not able to give consent, prisoners, patients with allergies to narcotic analgesics, and pregnant women will be excluded.

Women who are pregnant or are not practicing medically acceptable contraception (a pregnancy test is used pre-operatively as part of standard of care).

Patients who experience complications during the surgery (e.g., major hemorrhage, dural puncture) will not receive the study drug.
Intervention: Remifentanil
Trial phase: Phase 4
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
Eligibility criteria:
Inclusion Criteria:

Consenting adult patients (age >50 years) undergoing carotid endarterectomy with general anesthesia.

Exclusion Criteria:

Receiving another alpha 2-adrenoreceptor agonist;
Contraindication to dexmedetomidine, including allergy;
Current hepatic disease (liver function tests > twice upper limit of normal);
Renal insufficiency, as defined by a creatinine > 2.0 mg/dL;
Mentally impairment, including dementia or delirium;
Heart block ;
Sick sinus syndrome;
Atrial fibrillation with a low ventricular response (< 50 bpm);
Absolute or relative hypovolemia;
Prior stroke;
Severe left-ventricular dysfunction
Intervention: Oxaliplatin
Trial phase: Phase 2
ATC code: L01XA03
SMILES: NC1CCCCC1N.O=C([O-])C(=O)[O-].[Pt+2]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
Eligibility criteria:
Inclusion Criteria:

Previously histologically confirmed aggressive lymphomas, defined according to WHO classification (except Burkitt's lymphoma, lymphoblastic lymphoma)
Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease
Performance status (ECOG) ≤3
Age ≤ 75
Treated with at least one CHOP or CHOP-derived doxorubicin containing regimen
At least one or more uni-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination
Adequate organ functions defined as; ANC > 1,500/ul, platelet > 75,000/ul, transaminases < 3 X upper normal values; bilirubin < 2 mg%
Written informed consent approved by Institutional Review Board

Exclusion Criteria:

Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
Serious co-morbid diseases
Pregnancy or breast-feeding
Intervention: MYCOPHENOLATE MOFETIL
Trial phase: Not Applicable
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days
Eligibility criteria:
Inclusion Criteria:

ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age.
Patients must be 30 to 180 days (1 to 6 months) post-transplant to be eligible.
Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen.
Patients with renal insufficiency (history of renal insufficiency or renal failure in the past, patients on hemodialysis, patients with a rising creatinine post-transplant).
Patients with biopsy-proven acute cellular rejection (mild, moderate, or severe based on Rejection Activity Index (RAI) as graded by pathologists at UPMC) or repeated bouts of rejection (greater than 2 episodes within a 30 day period).
Patients with tacrolimus- or cyclosporine-induced neurotoxicity.
Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period.

Exclusion Criteria:

Multi-organ transplant patients.
HIV positive patients.
Living-related liver transplant recipients
Pregnant patients and nursing mothers.
Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment.
Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.
Evidence of drug and/or alcohol abuse.
Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves
Intervention: Ramelteon
Trial phase: Phase 4
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
Eligibility criteria:
Inclusion Criteria:

Female patients aged 21-60 years old
Have a negative serum or urine pregnancy test for women of child-bearing potential
Have a three-month or longer history of insomnia
Self-report < 6.5 hours of total sleep time, in addition to a sleep efficiency of less than 85%, averaged over two weeks of screening
A score of less than 60 on the Zung Self-Rating Depression Scale
Self-report bedtimes that do not vary by more than two hours on five nights per week
Have completed chemotherapy for breast cancer less than two years prior to study drug administration
Have completed chemotherapy for breast cancer for at least two months prior to screening visit
Patients that are receiving Herceptin are eligible for study enrollment
Have completed radiation therapy for breast cancer for at least two months prior to screening visit
ECOG (Eastern Cooperative Oncology Group)score of 0-1
Be able to read, understand, and provide written informed consent before enrolling in the study
Must be willing to comply with all study visits and comply with daily phone calls to the IVRS throughout the study
Agree to participate for the entire study period (about two months)

Exclusion Criteria:

Metastatic disease
Pregnant or lactating female
Self-reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly
Self-reports use of products containing nicotine of greater than 15 cigarettes daily or cannot avoid products containing nicotine during sleep periods
Current use of any of the following medications, and cannot discontinue these medications for the duration of the study: Hypnotic medication, Anti-convulsants, Anxiolytics, Narcotic analgesics, Medications or supplements containing Melatonin, Ketaconazole and Fluconazole
Currently taking fluvoxamine, brand name Luvox
Have symptoms consistent with the diagnosis of any other sleep disorder other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless legs syndrome)
Currently on night or rotating shift work
Self-reports habitual napping of greater than one hour accumulated sleep on 4 or more days per week
Has a psychiatric illness that interferes with normal sleep-wake function (e.g. major depression, post-traumatic stress disorder)
A score of 60 or greater on the Zung Self-Rating Depression Scale
Has current unstable medical disorder, such as symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or other serious medical condition as determined by the Investigator
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: 20
Group description: rosiglitazone 4mg/day
Eligibility criteria:
Inclusion Criteria:

Male or female
Age 18-65 years
Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
Well established compliance with out-patient medications
Current treatment with clozapine for a minimum of one year
Evidence of insulin resistance: impaired fasting glucose (glucose ≥100 mg/dl) or hyperinsulinemia (fasting insulin ≥ 15 ng/dl) or a HOMA-IR (homeostasis model assessment for insulin resistance) (fasting glucose X fasting insulin/22.5) ≥2 or a SI (insulin sensitivity index)

Exclusion Criteria:

Inability to provide informed consent
Current substance abuse
Significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine > 1.5), anemia (Hemoglobin < 11.0 gm/dL) or psychiatrically unstable
Severe hepatic impairment, active liver disease or increased serum transaminase levels (ALT>2.0X upper limit of normal) If at any time, ALT increases to 2X ULN, the subject's participation in the study will be terminated.
Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
Treatment with agents that induce weight loss
History of diabetes mellitus or thyroid disease
Current treatment with an oral hypoglycemic agent or insulin
Known hypersensitivity to rosiglitazone or any of its components
Fasting Glucose >126 mg/dL11. Treatment with other atypical antipsychotic agents thought to impair glucose metabolism (olanzapine) or low potency conventional agents (thioridazine, chlorpromazine)
Intervention: Olanzapine
Trial phase: Phase 4
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Remain on risperidone or olanzapine.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder
Currently receiving antipsychotic therapy with risperidone or olanzapine
Overweight

Exclusion Criteria:

Diagnosis of diabetes
Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to study entry
Refractory schizophrenia or schizoaffective disorder
Currently receiving therapy with clozapine
No stable residence and phone number for 90 days prior to study entry
Prior unsuccessful treatment with ziprasidone
Intolerance to ziprasidone
Intervention: Ziprasidone
Trial phase: Phase 4
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder
Currently receiving antipsychotic therapy with risperidone or olanzapine
Overweight

Exclusion Criteria:

Diagnosis of diabetes
Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to study entry
Refractory schizophrenia or schizoaffective disorder
Currently receiving therapy with clozapine
No stable residence and phone number for 90 days prior to study entry
Prior unsuccessful treatment with ziprasidone
Intolerance to ziprasidone
Intervention: Salsalate
Trial phase: Phase 4
ATC code: N02BA06
SMILES: O=C(Oc1ccccc1C(=O)O)c1ccccc1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Salsalate (3g/day) for 7 days
Eligibility criteria:
INCLUSION CRITERIA:

Age: Greater than 18 and less than 45 years.

Number: 44 completed studies (22 placebo, 22 Salsalate).

Sex: 22 Males and 22 Females.

BMI: Greater than or equal to 30 kg.m(2)

EXCLUSION CRITERIA:

Age below 18 or above 45 years to minimize the risk of glucose clamp.
Diabetes mellitus (as per 75 g OGTT, WHO 1999 criteria)
Cardiovascular disease including: abnormal EKG, personal history of coronary heart disease;symptomatic angina pectoris or cardiac insufficiency as defined by NYHA; classification as functional class III or IV.
Systolic blood pressure greater than 160mmHG and/or diastolic blood pressure greater than 100 mmHg and/or on antihypertensive therapy or resting heart rate greater than 90 bpm.
Hematological disorder, including prolonged prothrombin time (normal range 10.9-12.9 sec) and partial thromboplastin time (24-36 sec) and thrombocytopenia (less than 150,000 mm(3)).
Respiratory disease (including influenza, asthma)
Allergies (including hay fever)
Gastrointestinal (including peptic ulcer), hepatic or renal disease (ALT and AST greater than 3-fold above upper limit of normal range, creatinine greater than 1.3 mg/dl).
Alcoholism, alcohol-induced autonomic neuropathy.
Any endocrinological disorder, including hypopituitarism/pituitary dysfunctions or lesions, hypo/hyperthyroidism, insulinoma.
CNS disease
Psychosis or personal history of any psychiatric disorder.
Taking medications within one month prior to beginning the study, including medications known to have pharmacological interactions with salicylates or that may affect insulin sensitivity and secretion (including salicylates, COX 1 and COX 2 inhibitors, warfarin, Beta-Blockers, phenothiazines, antidepressants, antiarrhythmic drugs, antimuscarinic drugs).
Acute inflammation as assessed by history, physical and laboratory examination (subjects with C-reactive protein 2 standard deviations above the population mean will not be admitted). The population mean was calculated from subjects admitted at our research unit.
Pregnant or lactating females or females on hormonal contraceptives.
History of metabolic acidosis.
Allergy to aspirin, other salicylates, or bleeding diathesis or currently on oral anticoagulants.
Any current viral illness.
Active cancer within 5 years prior to screening for the study.
Positive urine drug screening test.
Inability to provide informed consent.
Smokers
Intervention: Losartan
Trial phase: Phase 3
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Subjects received losartan
Eligibility criteria:
INCLUSION CRITERIA:

Volunteers from the Gila River Indian Community who meet the eligibility criteria will be invited to participate.

To be eligible for participation in the study, subjects must meet the following criteria:

Aged 18-65.
Diagnosis of type 2 diabetes greater than or equal to 5 years.
Serum creatinine concentration less than to 1.4 mg/dl.
Serum potassium concentration less than or equal to 5.5 milliequivalents (mEq)/L.
At least 2 of 3 weekly screening urinary albumin-to-creatinine ratios less than 300 mg/g. All screening tests are to be within 3 months of enrollment.
Willingness, after receiving a thorough explanation of the study, to participate.

EXCLUSION CRITERIA:

Subjects will be excluded for the following reasons:

Clinically significant disorders of the liver, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, pulmonary diseases, renal-urinary disorders, gastrointestinal disorders, or hematocrit levels less than or equal to 30 percent in women or less than or equal to 35 percent in men.
Renovascular or malignant hypertension; uncontrolled hypertension despite treatment with three antihypertensive drugs; or hypertension that is being treated with antihypertensive medicines and the primary care physician or the patient refuses to adopt the blood pressure treatment regimen outlined in the study protocol.
Hematuria of unknown etiology.
Chronic debilitating disorders with or without treatment that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate efficacy of treatment.
Currently receiving a drug regimen that includes: steroids, immunosuppressants, or investigational new drugs.
Pregnancy. Women of childbearing potential must have a negative pregnancy test prior to entry and every three months during the study.
Evidence of inability to empty the bladder.
Hypersensitivity to angiotensin-converting enzyme inhibitors (ACEi), ARBs, or iodine.
Bleeding disorders, since kidney biopsies could not be performed safely in these individuals.
Massive obesity with body mass index greater than or equal to 45 kg/m(2).
Non-diabetic renal disease.
Conditions that are likely to interfere with informed consent or compliance with the protocol.
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Ptavastatin 4 mg once daily
Eligibility criteria:
Inclusion Criteria:

Completed NK-104-304 (NCT 00309738)
Hypercholesterolemia or combined dyslipidemia
2 or more risk factors for coronary heart disease (CHD)

Exclusion Criteria:

Withdrawn or terminated from NK-104-304 (00309738)
Intervention: Simvastatin
Trial phase: Phase 3
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Simvastatin 40 mg or 80 mg once daily
Eligibility criteria:
Inclusion Criteria:

Completed NK-104-304 (NCT 00309738)
Hypercholesterolemia or combined dyslipidemia
2 or more risk factors for coronary heart disease (CHD)

Exclusion Criteria:

Withdrawn or terminated from NK-104-304 (00309738)
Intervention: Atorvastatin
Trial phase: Phase 3
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Atorvastatin 40 mg once daily
Eligibility criteria:
Inclusion Criteria:

Type II diabetes mellitus
Combined dyslipidemia
Completed NK-104-305 (NCT00309751)

Exclusion Criteria:

Withdrawal from NK-104-305 (NCT00309751)