anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: CID 3081884
Trial phase: Not Applicable
ATC code: L03AX13
SMILES: CC(=O)O.CC(N)C(=O)O.NC(CCC(=O)O)C(=O)O.NC(Cc1ccc(O)cc1)C(=O)O.NCCCCC(N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.

Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
Eligibility criteria:
Inclusion Criteria:

Patients diagnosed with clinically definite MS according to the McDonald criteria
Have a Gd enhancing lesion using 1.5T standard protocol and/or an acute relapse
Age 18-65
Have a relapsing-remitting (RR) disease course or clinically isolated syndrome (CIS) with high risk of conversion to clinically definite (CD) MS (presence of >9 T2 lesions in addition to 1 Gd lesion)
Have EDSS scores less than or equal to 5.5
Have disease duration of 3 months to 30 years
None of the exclusion criteria

Exclusion Criteria:

Previous immunomodulatory or immunosuppressant treatment during the 30 days prior to day 0 of the study with the following agents (e.g., IFN-β, GA, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
Intervention: Desmopressin
Trial phase: Phase 3
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

Male and Female 50 years or older
Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion Criteria:

CHF
Diabetes
Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency
Incontinence
Illness requiring steroids
Current or past urologic malignancy
Nephrotic Syndrome
Unexplained pelvic masses
Urinary bladder neurological dysfunction
Urinary bladder surgery or radiotherapy
Sleep Apnea
Pregnant or breast feeding
Intervention: Desmopressin
Trial phase: Phase 3
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

Male and female 50 years or older
Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion Criteria:

CHF
Diabetes
Diabetes Insipidus
Renal Insufficiency
Hepatic Insufficiency
Incontinence
Illness requiring steroids
Current or past urologic malignancy
Nephrotic Syndrome
Unexplained pelvic masses
Urinary bladder neurological dysfunction
Urinary bladder surgery or radiotherapy
Sleep Apnea
Pregnant or breast feeding
Intervention: Olanzapine
Trial phase: Phase 2
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
Eligibility criteria:
Inclusion Criteria:

Age 18-85
NIHSS score 8-20
Stroke is ischemic in origin, supratentorial, and radiologically confirmed
Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered
Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits
Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
Female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study

Exclusion Criteria:

Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
Patients who have received tissue plasminogen activator (tPA)following the index stroke
Patients classified as comatose
Women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control
Serum hemoglobin > 16 grams(g)/deciliter (dL)(males) or > 14 g/dL (females); or platelet count > 400,000/cubic millimeters(mm3)
Advanced liver, kidney, cardiac, or pulmonary disease
Elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (AST) or alanine transaminase (ALT),creatinine, or prostate-specific antigen (PSA) levels
Patients with a known history of hypercoagulability
Expected survival < 1 year
Allergy or other contraindication to hCG or EPO
A known diagnosis of cancer in the previous 5 years
Uncontrolled hypertension
Use of either hCG or epoetin alfa within the previous 90 days
Any condition known to elevate hCG
Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS)≥ 2
Any patients not living independently
Any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial
With the exception of the qualifying stroke, any other stroke within the previous 3 months
Patients who cannot take anti-platelet or anti-coagulant therapy
Pre-existing and active major psychiatric or other chronic neurological disease
Alcohol abuse or have a history of substance abuse or dependency within 12 months prior to the study
Currently participating in another investigational study
Intervention: Olanzapine
Trial phase: Phase 2
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
Eligibility criteria:
Inclusion Criteria:

Age 18-85
NIHSS score 8-20
Stroke is ischemic in origin, supratentorial, and radiologically confirmed
Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered
Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits
Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
Female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study

Exclusion Criteria:

Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
Patients who have received tissue plasminogen activator (tPA)following the index stroke
Patients classified as comatose
Women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control
Serum hemoglobin > 16 grams(g)/deciliter (dL)(males) or > 14 g/dL (females); or platelet count > 400,000/cubic millimeters(mm3)
Advanced liver, kidney, cardiac, or pulmonary disease
Elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (AST) or alanine transaminase (ALT),creatinine, or prostate-specific antigen (PSA) levels
Patients with a known history of hypercoagulability
Expected survival < 1 year
Allergy or other contraindication to hCG or EPO
A known diagnosis of cancer in the previous 5 years
Uncontrolled hypertension
Use of either hCG or epoetin alfa within the previous 90 days
Any condition known to elevate hCG
Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS)≥ 2
Any patients not living independently
Any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial
With the exception of the qualifying stroke, any other stroke within the previous 3 months
Patients who cannot take anti-platelet or anti-coagulant therapy
Pre-existing and active major psychiatric or other chronic neurological disease
Alcohol abuse or have a history of substance abuse or dependency within 12 months prior to the study
Currently participating in another investigational study
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesia physical status class I & II
Age > 20 and < 70 years
Robot- assisted endoscopic thyroidectomy

Exclusion Criteria:

Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
Body mass index ≥ 40 kg/m2
History of seizure disorder
Current therapy with pregabalin, gabapentin, or any opioid
Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
Insulin-dependent diabetes mellitus
Renal insufficiency (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2)
Intervention: Healon
Trial phase: Phase 4
SMILES: CC(=O)NC1C(O)OC(CO)C(O)C1OC1OC(C(=O)O)C(OC2OC(CO)C(O)C(OC3OC(C(=O)O)C(O)C(O)C3O)C2NC(C)=O)C(O)C1O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: sodium hyaluronate 0.18%
Eligibility criteria:
Inclusion Criteria:

Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
Be likely to complete the entire course of study and to comply with appropriate instructions

Exclusion Criteria:

Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
Have uncontrolled systemic disease
Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
Have anticipated contact lens wear during the study
Have an active ocular infection
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 241
Group description: Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours
Eligibility criteria:
Inclusion Criteria:

CABG, CABG + Valve, or Valve surgery
Use of cardiopulmonary bypass

Exclusion Criteria:

Less than 50 years of age
History of diabetes
History of symptomatic cerebrovascular disease (e.g. prior stroke) with residual deficit
Alcoholism (> 2 drinks/day)
History of psychiatric illness (any clinical diagnoses requiring therapy)
History of drug abuse (any illicit drug use in the past 3 months)
Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
Severe pulmonary insufficiency (requiring home oxygen therapy)
Renal failure (baseline serum creatinine > 2.0 mg/dl)
Pregnant women
Unable to read and thus unable to complete the cognitive testing
Score < 24 on a baseline Mini Mental State examination (MMSE) or greater than or equal to 27 on the baseline Center for Epidemiological Studies Depression (CES-D) Scale -
Intervention: Lapatinib
Trial phase: Phase 2
ATC code: L01EH01 | L01XE07
SMILES: CS(=O)(=O)CCNCc1ccc(-c2ccc3ncnc(Nc4ccc(OCc5cccc(F)c5)c(Cl)c4)c3c2)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.

Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.
Eligibility criteria:
Inclusion Criteria:

Patients with nonfunctioning adenomas who have undergone at least one prior surgical resection and have demonstrated recurrence on MRI
Patients with prolactinomas who are resistant to dopamine agonist therapy
Patients with malignant pituitary tumors
Patients with visual field deficits and/or compression of the optic chiasm must be stable for at least 6 months

Exclusion Criteria:

Patients with compromised visual fields and/or compression of the optic chiasm on MRI that has not been stable for last 6 months.
Patients that have reduced left ventricular ejection fraction less than 50%
Patients with moderate to severe hepatic impairment
Patients that are pregnant or lactating
Patients under the age of 18
Active hepatitis
Known previous HIV Positive
Concurrent cancers
Life expectancy less than one year
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: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 88
Group description: 40 mg. Simvastatin/day

Simvastatin: 40 mg Simvastatin/day
Eligibility criteria:
Inclusion Criteria:

Parent diagnosed with Alzheimer's disease
Age 40-72

Exclusion Criteria:

Active liver disease
History of adverse reaction to statins
Contraindication to lumbar puncture
Elevated creatine kinase and creatinine lab values
Use of medications known to interact with statins
History of dementia or mild cognitive impairment
Currently pregnant or planning to become pregnant
Use of large quantities of grapefruit juice (more than 1 quart per day)
Contraindications to MRI (for MRI sub-study)
Currently on cholesterol-lowering medication or use in past 4 months
History of heart attack, heart problems, stroke and/or diabetes
Drinking more than a quart of grapefruit juice per day
Metal implants, or metal debris in body (MRI)
List of medications that interact with simvastatin
Intervention: Raltegravir
Trial phase: Phase 4
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
Eligibility criteria:
Inclusion Criteria:

provision of written, informed consent
HIV-infected adults at least 18 years of age
receiving stable ART including TDF and a r/PI for the previous 6 months
no prior PI genotypic resistance or known replication of HIV in patients receiving a PI
plasma HIV RNA < 50 copies/ml for at least the previous 3 months

spine or neck of femur t-score ≤ -1.0 (i.e. WHO-defined osteopenia) measured by dual energy x-ray absorptiometry (DEXA)

Exclusion Criteria:

participation in any other clinical trial (unless approved by the study PI)
use of TDF for previously active chronic hepatitis B infection
receiving or requiring therapy for low BMD (including prior fragility fracture)
using oral corticosteroids or inhaled fluticasone
virological failure on, or intolerance to, RAL
contra-indication to RAL therapy (see appendix 2)
breast-feeding
pregnancy
secondary, endocrinological cause of low BMD:25-hydroxy vitamin D deficiency, hypogonadism: a)symptomatic b)asymptomatic defined by total testosterone > 25% below lower limit of reference range and/or luteinizing hormone > 2 x upper limit of normal (ULN),untreated hypothyroidism or hyperparathyroidism according to local reference ranges
Intervention: Ertapenem
Trial phase: Phase 4
ATC code: J01DH03
SMILES: [H][C@@]1(SC2=C(C(=O)O)N3C(=O)[C@]([H])([C@@H](C)O)[C@@]3([H])[C@H]2C)CN[C@]([H])(C(=O)Nc2cccc(C(=O)O)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: All patients will receive ertapenem 500 mg IV once.
Eligibility criteria:
i. Inclusion criteria Adult patients (≥ 18 years), non-infected (afebrile, lack of constitutional symptoms and no leukocytosis), on a stable PD regimen (at least one month) are eligible for participation. Both patients with and without residual renal function will be studied. Non-anuric patients concurrently receiving medications with the potential to inhibit active tubular secretion will be allowed to enter the study after a 2-week washout period. These medications include H2-antagonists, trimethoprim, or probenecid. The patient and their physician at the Hortense and Louis Rubin Dialysis Center will contacted if any medication needs to be discontinued.

ii. Exclusion criteria Patients will be ineligible for the study if they have had peritonitis within the previous 4 weeks, clinical signs or symptoms of active infection, elevated white blood cell count, or treatment with any antibiotic within the previous 2 weeks. Patients with a hemoglobin (hgb) < 11 g/dL will be ineligible for study inclusion. Patients with stated or documented allergies to beta-lactams medications will not be eligible. Pregnant or breastfeeding women will not be eligible for inclusion. All women of child-bearing age will need to yield a serum hCG ≤ 5 mIU/mL within 2 weeks of the scheduled study day. Patients taking valproic acid will also be excluded.
Intervention: Entecavir
Trial phase: Phase 4
ATC code: J05AF10
SMILES: C=C1[C@H](CO)[C@@H](O)C[C@@H]1n1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Participants received entecavir 0.5 mg orally once daily for 48 weeks.
Eligibility criteria:
Inclusion Criteria:

Adult patients, >=18 and </= 65 years of age
HBeAg positive chronic hepatitis B
Pre-treatment with entecavir for 9-36 months

Exclusion Criteria:

Antiviral, antineoplastic or immunomodulatory treatment
Co-infection with active hepatitis A, C or D, or HIV
Evidence of decompensated liver disease
History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Drug

Circadin: Prolonged Release melatonin (Circadin) 2mg tablets
Eligibility criteria:
Inclusion Criteria:

Written informed consent as dictated by local legal circumstances.
Age range: adult patients between 50-85 years of age.
Gender: men and women. Women of child bearing potential or within two years of the menopause must have a negative urine pregnancy test at the Screening Visit.
A documented history of confirmed Alzheimer's disease
Dementia severity: MMSE score > 15,
Stable AChE inhibitor dose for 2 months prior to Screening visit.
Stable medications for non-excluded concurrent medical conditions for four weeks prior to the screening visit.
Stable doses of B12 and/or Folic acid supplements for at least 3 months prior to enrollment and throughout the study.
Cranial image: no evidence of focal disease to account for dementia (established by CT, PET or MRI). If there is no such available scan (CT, PET or MRI), one must be performed prior to enrollment.
Health: Physically acceptable for the study with no pathology likely to occur during or immediately after the study, as confirmed by medical history and exam and ECG.
Clinical laboratory values must be within normal limits, or judged not clinically significant by the investigator.
Residence: Stable home situation with no planned move during the 28-week investigational period.
A family member or a regular caregiver that will be available for visits and will ensure compliance. The caregiver must speak fluent Hebrew, Russian or English.
Ability to ingest oral medication and participate in all scheduled evaluations.
Ability to spend 2 daily hours outdoors exposed to sunlight.

Exclusion Criteria:

Severe agitation.
Unstable medical condition, mental retardation.
moderate to severe depression as defined by DSM-IV
Use of benzodiazepines or other hypnotics during the study and the preceding four weeks.
Use of Circadin® during the two weeks prior to study enrollment.
Pharmacological immunosuppression.
Participation in a clinical trial with any investigational agent within two months prior to study enrollment.
Alcoholism.
Known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists.
Patients with rare hereditary problems of galactose intolerance, the LAPP lactose deficiency or glucose mal absorption.
Renal Failure with creatinine >150 micromol/l.
Hepatic Failure with ASAT; ALAT; GGT levels above three times the upper normal limit.
Clinically significant abnormal laboratory findings which have not been approved by the Safety Officer (sponsor)
Other serious diseases that could interfere with patient assessment.
Caregivers who are unwilling or unable to give informed consent or otherwise fulfill requirements of the study.
Untreated B12 and/or Folic acid deficiency.
Intervention: Atazanavir
Trial phase: Phase 4
ATC code: J05AE08 | J05AR15 | J05AR23
SMILES: COC(=O)N[C@H](C(=O)N[C@@H](Cc1ccccc1)[C@@H](O)CN(Cc1ccc(-c2ccccn2)cc1)NC(=O)[C@@H](NC(=O)OC)C(C)(C)C)C(C)(C)C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Boosted atazanavir was switched for the PI or NNRTI in the patients regimen

Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
Eligibility criteria:
Inclusion Criteria:

HIV positive children with elevated lipid levels
on stable HAART for at least 3 months (defined to be on the same regimen with viral load < 1000 for 6 months prior to baseline visit).
Weight equal to or greater than 25kg
Able to swallow pills or willing to learn

Exclusion Criteria:

Patients with underlying hepatitis B or C viral infections
Previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of Reyataz® (atazanavir).

Taking other medications that are highly dependent on CYP3A or UGT1A1 for clearance

Ergot medicines: dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45®, ergotrate maleate, Methergine®, and others (used for migraine headaches).
Orap® (pimozide, used for Tourette's disorder).
Propulsid® (cisapride, used for certain stomach problems).
Triazolam, also known as Halcion® (used for insomnia).
Midazolam, also known as Versed® (used for sedation), when taken by mouth.
Camptosar® (irinotecan, used for cancer).
Crixivan® (indinavir, used for HIV infection).
Cholesterol-lowering medicines Mevacor® (lovastatin) or Zocor® (simvastatin).
Rifampin (also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®).
St. John's wort (Hypericum perforatum), an herbal product sold as a dietary supplement,
Viramune® (nevirapine, used for HIV infection).
Vfend® (voriconazole).
Patients with grade 3 or higher elevations in transaminases (> 10 X ULN)
Women of Childbearing Potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
Women who are pregnant or breastfeeding.
Women with a positive pregnancy test.