anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Milrinone
Trial phase: Phase 2
ATC code: C01CE02
SMILES: Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Patients assigned to the milrinone group will receive a bolus of 50 mcg/kg followed by an infusion of 0.5 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.

milrinone: Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted
Eligibility criteria:
Inclusion Criteria:

Patients undergoing an elective, primary Fontan operation at Children's Hospital Boston.

Exclusion Criteria:

Revision surgery for failing Fontan circulation.
Preoperative serum creatinine > 1.5 mg/dL or chronic dialysis.
The attending surgeon, cardiac anesthesiologist, or cardiac intensivist has a compelling indication to initiate either nesiritide or milrinone outside of the confines of the study.
Intervention: 7H
Trial phase: Not Applicable
SMILES: CC(=O)O.O=CC(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 114
Group description: Carboxymethylcellulose based artificial tear
Eligibility criteria:
Inclusion Criteria:

Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters

Exclusion Criteria:

Dry eye signs and symptoms
Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
Pregnancy or planning pregnancy
Uncontrolled systemic disease
Use of systemic medications affecting dry eye
Intervention: Ibandronate
Trial phase: Phase 4
ATC code: M05BA06 | M05BB09
SMILES: CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Eligibility criteria:
Inclusion Criteria:

post-menopausal women, 50-85 years of age;
any inflammatory rheumatoid disease including polymyalgia rheumatica;
receiving treatment with 5-15 mg/day of prednisolone.

Exclusion Criteria:

previous treatment with an iv bisphosphonate at any time;
previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;
treatment with parathyroid hormone in last 2 years;
inability to stand or sit in an upright position for at least 60 minutes;
inability to swallow a tablet whole;
history of major gastrointestinal disease.
Intervention: Ibandronate
Trial phase: Phase 4
ATC code: M05BA06 | M05BB09
SMILES: CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 357
Group description: Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
Eligibility criteria:
Inclusion Criteria:

ambulatory, post-menopausal women with osteoporosis;
eligible for bisphosphonate treatment;
naïve to bisphosphonate therapy, or lapsed users (last bisphosphonate intake greater than or equal to [>=] 6 months ago).

Exclusion Criteria:

inability to stand or sit upright for at least 60 minutes;
inability to swallow a tablet whole;
hypersensitivity to bisphosphonates;
treatment with drugs, or presence of active disease, known to influence bone metabolism;
history of upper gastrointestinal disease.
Intervention: Ibandronate
Trial phase: Phase 3
ATC code: M05BA06 | M05BB09
SMILES: CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 640
Group description: Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
Eligibility criteria:
Inclusion Criteria:

post-menopausal women;
>=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.

Exclusion Criteria:

inability to stand or sit in an upright position for at least 60 minutes;
hypersensitivity to bisphosphonates;
treatment with other drugs affecting bone metabolism;
abnormalities of the oesophagus, which delay oesophageal emptying.
Intervention: Fesoterodine
Trial phase: Phase 3
ATC code: G04BD11
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 471
Group description: Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
Eligibility criteria:
Inclusion Criteria:

Men aged 40 years and above.
On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

Exclusion Criteria:

Contraindication to fesoterodine (antimuscarinics).
Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
Eligibility criteria:
Inclusion Criteria:

Greater than or equal to 18 years old
Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose >140 mg/dL OR impaired fasting glucose: fasting glucose > or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c > or = 5.7%
Abdominal obesity: waist circumference >102 cm (men) and >88 cm (women)
Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study

Exclusion Criteria:

Type 2 diabetes
Current use of glycemic control medications within one month of randomization
Fasting glucose >126 mg/dL
Current use of weight loss medication
Previous weight loss surgery
History of severe gastrointestinal disease
Standard clinical contraindications to exenatide or metformin therapy
Unstable angina
Heart failure
Stroke or coronary artery bypass graft within 3 months of screening
Women who are currently pregnant or planning to become pregnant
Breastfeeding women
Clinically significant liver disease
Creatinine > 1.5 mg/dL
Hepatic function greater than 3 times upper limit of normal
Patients who are mentally incompetent and cannot sign a Patient Informed Consent
Intervention: Domperidone
Trial phase: Not Applicable
ATC code: A03FA03
SMILES: O=c1[nH]c2ccccc2n1CCCN1CCC(n2c(=O)[nH]c3cc(Cl)ccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants ranged from 18-65 years of age. Gender composition was 60$% female and 40% male.
Eligibility criteria:
Inclusion Criteria:

gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
signed informed consent

Exclusion Criteria:

serious cardiac arrhythmias
clinically significant bradycardia, sinus node dysfunction, or heart block.
prolonged QTc
clinically significant electrolyte disorders.
gastrointestinal hemorrhage or obstruction.
prolactinoma
pregnant or breast feeding female
known allergy to domperidone.
Intervention: Sirolimus
Trial phase: Phase 4
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Oral sirolimus plus bare metal stent implantation
Eligibility criteria:
Inclusion Criteria:

Indication of revascularization
De novo lesions
Native vessels
Suitable for stent placement

Exclusion Criteria:

Acute myocardial infarction within the last 24 hours
In stent restenosis
Previous percutaneous coronary intervention within the last 6 months
Intervention: Bortezomib
Trial phase: Not Applicable
ATC code: L01XG01 | L01XX32
SMILES: CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
Eligibility criteria:
Inclusion Criteria:

Patients with myeloma who had relapsed after one prior treatment and who have demonstrated resistance to their last treatment, who are candidate to receive Velcade and had normal PT and PTT, will be evaluated for inclusion in the present study.

Exclusion Criteria:

Previous history of venous thromboembolism, myocardial infarction, stroke, TIA
Hypercoagulable state (deficit ATIII, Factor V Leiden, deficit protein S, deficit protein C, prothrombin gene mutation), antiphospholipid syndrome.
Von Willebrand disease, inherited platelet abnormalities.
Familiar history of hypercoagulable state.
Anticoagulant therapy, aspirin, non-steroidal anti-inflammatory drugs, beta blockers, tricyclic antidepressant, hormone replacement therapy, BCPs, and all other agents able to interfere with platelet function in the previous two weeks.
Non-secretory MM, unless the patient has measurable lesions on CT, MRI and/or PET.
Intervention: Mardepodect
Trial phase: Phase 2
SMILES: Cn1cc(-c2ccncc2)c(-c2ccc(OCc3ccc4ccccc4n3)cc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Eligibility criteria:
Inclusion Criteria:

Have a current diagnosis of schizophrenia.
Increase in symptoms over the past 2-4 weeks.
Willing to remain inpatients for the duration of the trial.

Exclusion Criteria:

Evidence or history of clinically significant medical problems.
Females of childbearing potential.
A primary psychiatric diagnosis other than schizophrenia.
A diagnosis of substance abuse or dependence in the last 6 months.
Intervention: Methadone
Trial phase: Phase 2
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
Eligibility criteria:
Inclusion Criteria:

Must have a telephone
Age: patient must be 18 years or older and less than 70 years of age
Life expectancy of 3 months or greater
No prior use of step-3 opioids (step 2 opioids are allowed)
Provision of informed consent
Score of 26 or greater on Mini-Mental Status Exam (MMSE) (to be done by investigator if there is question about mental status)
Nonmalignant pain will be excluded; however, if the patient has both malignant and nonmalignant pain, entry into the trial will be determined by the predominant site of pain
Moderate to severe cancer related pain that requires the use of step-3 opioids
Normal renal function
There will be no exclusionary criteria based on Karnofsky score
Must live no more than 1 hour away from clinic
Patient must have pain severity of 5-7/10 on a 0-10 pain scale

Exclusion Criteria:

Nursing home patients
Obvious cognitive dysfunction
Intractable nausea or vomiting
A true allergy or intolerance to opioids
Unstable renal function
Undergoing therapeutic procedures likely to influence pain during the study period
Gastrointestinal pathology or surgery that influences absorption of morphine or methadone
Must not have had treatment with radiotherapy, chemotherapy or radionuclides in the last 30 days
History of drug seeking behavior
Respiratory compromise
Treatment with bisphosphonates within the last month
Use of MAO inhibitors
Drugs that interfere with CYP34A or CYP2D6
Drugs that interfere with morphine metabolism
Retroviral therapies
Active radiation or antineoplastic therapies
Hepatic dysfunction
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Study will exclude women who are pregnant and/or nursing
Women who are of child bearing potential must have a negative urine pregnancy test
Patients with a recent substance abuse history will be excluded
Patients with major depression will be excluded
Intervention: Spironolactone
Trial phase: Phase 4
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone.

spironolactone: spironolactone 50 mg daily for 6 months
Eligibility criteria:
Inclusion Criteria:

18 years or older
Nonischemic dilated cardiomyopathy
Left ventricular ejection fraction 35% or less
Stable heart failure symptoms
Able to undergo both positron emission tomography and magnetic resonance imaging with gadolinium
Able to tolerate treatment with spironolactone

Exclusion Criteria:

Serum potassium >5.0
Serum creatinine >2.5
Contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.
Intervention: Alfuzosin
Trial phase: Phase 3
ATC code: G04CA01 | G04CA51
SMILES: COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
Eligibility criteria:
Inclusion Criteria:

Children and adolescents of either gender 2 - 16 years of age with a detrusor Leak Point Pressure (LPP) of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis either Society of Fetal Urology (SFU) grade 1, 2 or 3 due to neuropathic bladder dysfunction.

Exclusion Criteria:

Hydronephrosis of non-neuropathic etiology.
Urological surgery in the last 4 months prior to the study.
Urethral dilatation in the last 3 months prior to the baseline urodynamic assessment.
α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment.
Detrusor injections of botulinum toxin in the last 6 months.
Urological diseases/conditions other than functional bladder obstruction of neuropathic etiology, that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele).
History of intolerance to α-blocker therapy.
Orthostatic hypotension.
History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Intervention: Perflutren
Trial phase: Not Applicable
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Contrast-enhanced sonography

perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Eligibility criteria:
Inclusion Criteria:

Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment
Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter
Patient is stable and is to be managed conservatively (i.e. non-surgically)
18 years of age or older
Ability and willingness to provide written informed consent

Exclusion Criteria:

Known or suspected cardiac shunt(s)
Known sensitivity to octafluoropropane
Pregnant or breastfeeding
Intervention: Imiquimod
Trial phase: Not Applicable
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Healthy individuals with PWS (n = 24) were treated with PDL and then randomized to apply post treatment Imiquimod 5% cream for 8 weeks for 57 PWS sites (multiple sites per patient)
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Port Wine Stain birthmark
Male and female subjects of any age who are in good health.
Fitzpatrick skin type I-VI

Exclusion Criteria:

Pregnant or lactating
History of cutaneous photosensitivity
History of hypersensitivity to imiquimod 5% cream or any of its components
History of photodermatoses
Intervention: Amiodarone
Trial phase: Not Applicable
ATC code: C01BD01
SMILES: CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 342
Group description: Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing cardiac surgery that was expected to include cross-clamping of the aorta

Exclusion Criteria:

Women wishing to become pregnant within 6 months of surgery
Allergy to amiodarone
History of organ dysfunction due to previous amiodarone use
Patients who require more than mild systemic hypothermia (<32 degrees C) during cardiopulmonary bypass
Patients who require more than one bypass run or more than one period of aortic cross-clamping
Intervention: Hydrocortisone
Trial phase: Phase 2
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
Eligibility criteria:
Inclusion Criteria:

Age < 1 month
Postoperative
Inotrope score > 20 x > 4 hrs [epinephrine: (mcg/kg/min) x 100 + norepinephrine: (mcg/kg/min) x 100 + phenylephrine: (mcg/kg/min) x 100 + vasopressin: (units/kg/hr) x 100 + milrinone: (mcg/kg/min) x 15 + dopamine: (mcg/kg/min) x 1 + dobutamine: (mcg/kg/min) x 1 + calcium chloride: (mg/kg/hr) x 1]

Exclusion Criteria:

Age > 1 month
Documented sepsis
Preoperative use of steroids > 1 wk
Intervention: LITHIUM CARBONATE
Trial phase: Phase 4
SMILES: O=C([O-])[O-].[Li+].[Li+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 140
Group description: Lithium Carbonate: 300 to 2400 mg
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria for Axis I bipolar II disorder
Meets DSM-IV criteria for Axis I major depressive episode
Score of 16 on 17-item HAM-D rating scale
Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry
Willing to use an effective form of birth control throughout the study

Exclusion Criteria:

History of mania
Current primary Axis I diagnosis other than bipolar II disorder
Alcohol or drug dependence within 3 months prior to study entry
Contraindication to treatment with venlafaxine or lithium
Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris)
Pregnant or breastfeeding
Experiencing suicidal thoughts
Requires hospitalization
Requires concurrent neuroleptic or MS therapy
Requires concurrent AD therapy
Current psychotic features
Inadequate trial of therapy at the time of initial screening visit
History of intolerance to either venlafaxine or lithium
Unlikely to participate in a 36-week trial
Presence of apparent secondary gain
Intervention: Fluoxetine
Trial phase: Not Applicable
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Recovered anorexia

Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
Eligibility criteria:
Inclusion Criteria:

Recovered from Anorexia Nervosa
Not taking medication for emotional problems
Regular menstrual cycle

Exclusion Criteria:

Women who are pregnant or nursing
Psychoactive medications in the past 30 days
Neurological disorders.
Intervention: Dopamine
Trial phase: Phase 3
ATC code: C01CA04
SMILES: NCCc1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 252
Group description: Patients that get DA infusion
Eligibility criteria:
Inclusion Criteria:

Patients are transferred to our medical intensive care unit from the emergency room (ER), general medical floors, and from outside hospitals.
Patients were eligible if they were greater than 18 years of age
Presented with a diagnosis of SIRS plus a suspected or documented source of infection.

Exclusion Criteria:

Patients were not eligible if they were found to have hypovolemic and/or hemorrhagic etiologies of their vasodilatory shock or another etiology of their SIRS.
Intervention: Imiquimod
Trial phase: Phase 3
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 160
Group description: 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
Eligibility criteria:
Inclusion Criteria:

In good general health
Have 5 to 20 AKs on the face or balding scalp
Negative urine pregnancy test (for women who are able to become pregnant)
Willing to make frequent visits to the study center during treatment and follow-up periods.

Exclusion Criteria:

Women who are pregnant, lactating or planning to become pregnant during the study.
Have had a medical event within 90 days of the first visit (such as; stroke, heart attack).
Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.