anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Famotidine
Trial phase: Phase 4
ATC code: A02BA03 | A02BA53
SMILES: NC(N)=Nc1nc(CSCCC(N)=NS(N)(=O)=O)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: 40 mg daily for 14 weeks
Eligibility criteria:
Inclusion Criteria:

Subject is age ≥ 18 years
Patient meets the criteria for laparoscopic gastric bypass surgery
Females only: Patient is willing to take a urine pregnancy test

Exclusion Criteria:

Subject allergic to omeprazole or famotidine
Patient receiving antifungal (i.e. ketoconazole or itraconazole)
Hepatic insufficiency
History of Crohns disease
History of Zollinger-Ellison disease
Patient received an investigational drug within 30 days of enrollment
Patient currently enrolled in another research project
Females Only: Pregnancy or plan on becoming pregnant during the next 14 weeks
Intervention: Voriconazole
Trial phase: Phase 1 | Phase 2
ATC code: J02AC03
SMILES: C[C@@H](c1ncncc1F)[C@](O)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Eligibility criteria:
Inclusion Criteria:

Presence of a corneal ulcer at presentation
Evidence of filamentous fungus on KOH (or Giemsa or any other stain) or culture
The patient must be able to verbalize a basic understanding of the study after it is explained to the patient, as determined by physician examiner. This understanding must include a commitment to return for follow-up visits.
Willingness to be treated as an in-patient or to be treated as an out-patient and come back every 48-72 hours to receive fresh medication for 3 weeks
Appropriate consent

Exclusion Criteria:

Overlying epithelial defect < 0.5 mm at its greatest width at presentation
Impending perforation
Evidence of bacteria on Gram stain at the time of enrollment
Evidence of acanthamoeba by stain
Evidence of herpetic keratitis by history or exam
Corneal scar not easily distinguishable from current ulcer
Age less than 16 years (before 16th birthday)
Bilateral ulcers
Previous penetrating keratoplasty in the affected eye
Pregnancy (by history or urine test) or breast-feeding (by history)
Acuity worse than 6/60 (20/200) in the fellow eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA 6/60 or better qualifies for enrollment)
Known allergy to study medications (antifungal or preservative)
No light perception in the affected eye
Not willing to participate
Intervention: Natamycin
Trial phase: Phase 1 | Phase 2
ATC code: A01AB10 | A07AA03 | D01AA02 | G01AA02 | S01AA10
SMILES: CC1CC=CC=CC=CC=CC(OC2OC(C)C(O)C(N)C2O)CC2OC(O)(CC(O)CC3OC3C=CC(=O)O1)CC(O)C2C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Eligibility criteria:
Inclusion Criteria:

Presence of a corneal ulcer at presentation
Evidence of filamentous fungus on KOH (or Giemsa or any other stain) or culture
The patient must be able to verbalize a basic understanding of the study after it is explained to the patient, as determined by physician examiner. This understanding must include a commitment to return for follow-up visits.
Willingness to be treated as an in-patient or to be treated as an out-patient and come back every 48-72 hours to receive fresh medication for 3 weeks
Appropriate consent

Exclusion Criteria:

Overlying epithelial defect < 0.5 mm at its greatest width at presentation
Impending perforation
Evidence of bacteria on Gram stain at the time of enrollment
Evidence of acanthamoeba by stain
Evidence of herpetic keratitis by history or exam
Corneal scar not easily distinguishable from current ulcer
Age less than 16 years (before 16th birthday)
Bilateral ulcers
Previous penetrating keratoplasty in the affected eye
Pregnancy (by history or urine test) or breast-feeding (by history)
Acuity worse than 6/60 (20/200) in the fellow eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA 6/60 or better qualifies for enrollment)
Known allergy to study medications (antifungal or preservative)
No light perception in the affected eye
Not willing to participate
Intervention: Utibron Neohaler
Trial phase: Phase 2
SMILES: CCc1cc2c(cc1CC)CC(NCC(O)c1ccc(O)c3[nH]c(=O)ccc13)C2.C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Eligibility criteria:
Inclusion Criteria:

Consented male or female adults aged ≥40 years
Moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2006)
Patients who have smoking history of at least 10 pack years
Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥30% and <80% of the predicted normal and post-bronchodilator FEV1/Forced vital capacity (FVC) <0.70 at Visit 1 and Visit 3

Exclusion Criteria:

Pregnant or nursing (lactating) women
Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening period
Patients who had a respiratory tract infection within 6 weeks of Visit 1 or at screening
Concomitant pulmonary disease, pulmonary tuberculosis (TB) (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
Any history of asthma
Patients who have clinically relevant lab abnormalities / conditions such as (but not limited to) long term prednisone therapy, unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding stable atrial fibrillation [AF]), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
Patients with a history of cardiac failure, life threatening arrhythmias (screening Holter) and acute ischemic changes (screening ECG)
Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval measured at screening (Visit 1) is prolonged (>450 ms for males or >470 for females)
History of malignancy of any organ system, treated or untreated within the past 5 years
Uncontrolled Type I / Type II Diabetes or blood glucose outside the normal range or Hemoglobin A1C (HbA1c) >8.0% of total hemoglobin measured at Visit 1

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Flurandrenolide
Trial phase: Phase 2
ATC code: D07AC07 | D07CC03
SMILES: CC1(C)O[C@@H]2C[C@H]3[C@@H]4C[C@H](F)C5=CC(=O)CC[C@]5(C)[C@H]4[C@@H](O)C[C@]3(C)[C@]2(C(=O)CO)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: 4 oz Haelan orally twice daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Anorexia (defined as > 30mm on a visual analog scale [VAS] of 0 to 100mm)
Weight loss (defined as weight loss > 5% within last 6 months)
Normal cognition (per treating physician's opinion)
Written informed consent
Advanced solid tumor (defined as locally recurrent or metastatic disease)
Patient must have perceived weight loss as a problem.
Able to maintain oral food intake within one week prior to enrollment in this study.

Exclusion Criteria:

Evidence of ascites (per treating physician's opinion).
Receiving supplementary tube feedings or parenteral nutrition
Known mechanical obstruction of the alimentary tract, or intractable vomiting
Add or change dose of the following medication within 2 weeks prior to this trial or during this trial: megestrol, corticosteroid, mirtazapine, metoclopramide and dronabinol, with the exception of pre-medication for chemotherapy (10-20 mg Decadron intavenous (IV) once and/or Reglan 10 mg IV x1 prior to chemotherapy).
Allergic to soy.
Positive pregnancy test for female patients of child-bearing potential. (Definition of child-bearing potential: not post-menopausal for past 12 months or nor surgically sterile)
Female patients with child bearing potential, but refuse to practice accepted methods of contraception (acceptable forms of contraception include: continuous abstinence, Depo-Provera shot, tubal ligation, NuvaRing vaginal ring, Ortho Evra skin patch, oral contraceptive, IUD-Mirena, vasectomy, male condom, diaphragm).
Weight less than 80 lb.
Patient who could not tolerate oral intake of 2 Oz. of Haelan during the taste test.
Diagnosed of breast cancer.
Intervention: Humalog
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)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)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: 170
Group description: Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Must have type 2 diabetes
Must be at least 18 years of age and less than 75 years of age
Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion Criteria:

Must not have used insulin on a regular basis during the past 2 years
Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
Must not have had more than one episode of severe hypoglycemia in the past 6 months
Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
Must not be pregnant or intend to get pregnant during the course of the study
Intervention: Basaglar
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(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: 167
Group description: Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Must have type 2 diabetes
Must be at least 18 years of age and less than 75 years of age
Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion Criteria:

Must not have used insulin on a regular basis during the past 2 years
Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
Must not have had more than one episode of severe hypoglycemia in the past 6 months
Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
Must not be pregnant or intend to get pregnant during the course of the study
Intervention: Fluciclovine (18F)
Trial phase: Phase 2
ATC code: V09IX12
SMILES: N[C@]1(C(=O)O)C[C@@H]([18F])C1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 128
Group description: All participants who received scans, including repeat scans, were monitored for adverse events.
Eligibility criteria:
STUDY NOW CLOSED for recruitment

Inclusion Criteria:

Patients must be 18 years of age or older.
Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease.
In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy.
Ability to lie still for PET scanning
Patients must be able to provide written informed consent.

Exclusion Criteria:

Age less than 18.
Greater than T3 disease in past
Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy.
Does not meet above criteria of suspicious PSA elevation
Inability to lie still for PET scanning
Cannot provide written informed consent.
Bone scan findings characteristic for metastatic prostate carcinoma
Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).
Intervention: Qsymia
Trial phase: Phase 3
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 109
Group description: Placebo
Eligibility criteria:
Inclusion Criteria:

70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
Informed Consent
Females of child-bearing potential must be using adequate contraception

Exclusion Criteria:

Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis
Obesity of known genetic or endocrine origin
Participation in a formal weight loss program or lifestyle intervention
Glaucoma or elevated intraocular pressure
Pregnancy or breastfeeding
Drug or Alcohol abuse
Smoking cessation within previous 3 months or plans to quit smoking during study
Eating disorders within past year
Cholelithiasis within past 6 months
Type 2 diabetes
Previous bariatric surgery
Bipolar disorder or psychosis
Steroid hormone therapy not stable for 3 months
Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
Intervention: Qsymia
Trial phase: Phase 3
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: 7.5 mg/46 mg phentermine/topiramate
Eligibility criteria:
Inclusion Criteria:

70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
Informed Consent
Females of child-bearing potential must be using adequate contraception

Exclusion Criteria:

Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis
Obesity of known genetic or endocrine origin
Participation in a formal weight loss program or lifestyle intervention
Glaucoma or elevated intraocular pressure
Pregnancy or breastfeeding
Drug or Alcohol abuse
Smoking cessation within previous 3 months or plans to quit smoking during study
Eating disorders within past year
Cholelithiasis within past 6 months
Type 2 diabetes
Previous bariatric surgery
Bipolar disorder or psychosis
Steroid hormone therapy not stable for 3 months
Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
Intervention: Medroxyprogesterone acetate
Trial phase: Not Applicable
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Subjects will receive Depo-Provera intramuscular injection.
Eligibility criteria:
Inclusion Criteria:

Women age 18 or older who are initiating Depo-Provera for contraception
English or Spanish-speaking
Have a negative urine pregnancy test

Exclusion Criteria:

Contraindications to either Depo-Provera or Femring (estrogen vaginal ring)
Have used Depo-Provera or Mirena in the prior 6 months
Have had an induced abortion, spontaneous abortion, or birth in prior 8 weeks
Intervention: Basaglar
Trial phase: Not Applicable
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: Child | Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Subjects randomized to treatment with insulins glargine and aspart
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed type 1 diabetes within 1 week of diagnosis
Age 6 - 18 years
Care provided at Children's Medical Center, Dallas

Exclusion Criteria:

Actual treatment with oral drugs influencing beta cell function or blood glucose levels (e.g. oral hypoglycemic agents)
Actual treatment with drugs influencing insulin sensitivity (e.g. Metformin, or systemic steroids)
Significant concomitant disease likely to interfere with glucose metabolism (children with active bacterial infections at the time of diagnosis must be cured prior to entry)
Expected poor compliance
Pregnancy
Any other condition that by the judgement of the investigator may be potentially harmful to the patients
Intervention: Focalin XR
Trial phase: Phase 4
SMILES: COC(=O)C(c1ccccc1)C1CCCC[NH2+]1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 86
Group description: Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
Eligibility criteria:
Inclusion Criteria:

Male and female subjects aged 6-12 years, inclusive.
Subjects meeting the DSM-IV criteria for ADHD of any type, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to screening visit (Concerta® 36 mg and 54 mg is allowable)

Exclusion Criteria:

Parent or guardian unable or unwilling to complete the Conner's ADHD/DSM-IV Scale for Parents (CADS-P) and the Daily Diary Card
Diagnosed with a tic disorder or Tourette's syndrome
History of seizure disorder
The presence of a known medical condition that would preclude the use of methylphenidate. A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease
ALT, AST, GGPT or serum creatinine greater then 2X the ULN at Screening
A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
Subjects who have participated in an investigational trial within the past 4 weeks (28 days) are excluded
Subjects who are currently taking antidepressants or other psychotropic medication
Subjects who have initiated psychotherapy during the three months prior to randomization
Subjects with a positive urine drug screen
Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate

Other protocol defined inclusion/exclusion criteria may apply