anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Magnesium Sulfate
Trial phase: Not Applicable
ATC code: A06AD04 | A12CC02 | B05XA05 | D11AX05 | V04CC02
SMILES: O=S(=O)([O-])[O-].[Mg+2]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour

Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.
Eligibility criteria:
Inclusion Criteria:

- vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.

Exclusion Criteria:

- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress
Intervention: Divalproex Sodium
Trial phase: Phase 4
SMILES: CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Depakote ER up to 1500 mg/day
Eligibility criteria:
Inclusion Criteria:

Bipolar I, II or NOS currently suffering from depression
Both: both female and male participants are being studied
Adults 18 years and older of any race

Exclusion Criteria:

Schizophrenia or schizoaffective disorder and other disorders excluded at the discretion of the investigator's discretion
Substance dependence within the past 3 months and abuse within the past 2 weeks prior to study.
Positive screen for psychoactive drugs, stimulants or drugs of abuse (excluding marijuana, as long as dependence and abuse are ruled out according to DSM-IV)
Significant risk harm to self or others based on history and mental status exam
Clinically significant or unstable medical condition
Unstable thyroid pathology and treatment initiated or altered within the past 3 months
Clinically significant abnormal laboratory test results, vital signs, as judged by the investigators
Women pregnant or nursing, or WOCBP who do not use adequate contraception or who are judged to be unreliable in their use of contraception
Subjects who failed (because of inefficacy or adverse effects) an adequate trial of Depakote; eligible patient's may not have received Depakote within 30 days of screen
Intervention: Memantine
Trial phase: Not Applicable
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patients are randomized 1:1, memantine treatment is for 2 days before ECT for a total of 30 days
Eligibility criteria:
Inclusion Criteria::

Meets DSM-IV criteria for Major Depressive Disorder
18 to 75 years of age and able to provide legal consent
Referred to Stanford ECT service by treating physician for unilateral electroconvulsive therapy with inpatient hospitalization
Competed process for consenting to the clinical use of ECT according to California State law
Females of childbearing potential will be required to use a double-barrier method of contraception, which includes foam and either condom and diaphragm, IUD, and/or implant during study.&#xA; Exclusion Criteria:- Treatment with ECT in the 6 months prior to screening
Meets criteria for drug or alcohol abuse or dependence in the 6 months prior to screening
Use of alcohol or illegal drugs within seven days of randomization or during study. Patients may be excluded for use during a period greater than 7 days, per study physician's discretion
Presence of unstable or untreated cardiovascular disease, hypertension, or endocrine disorder as determined by the investigator
use of antipsychotic, antidepressant, or other prescription medications unless dose is stable for at least 7 days prior to randomization.
Use of any investigational treatment within 30 days of randomization
Previous allergic reaction to memantine or drugs of similar chemical structure.
Women who are pregnant or breastfeeding are not advised to participate in the research study
Any neurological disorder or organic brain condition that would confound neurocognitive testing
Intervention: Fenofibrate
Trial phase: Not Applicable
ATC code: C10AB05 | C10BA03 | C10BA04 | C10BA09 | C10BA12
SMILES: CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: 160 mg daily for 12 weeks

Fenofibrate
Eligibility criteria:
Inclusion Criteria:

Insulin Resistant Triglyceride 150 mg/dL or greater or triglyceride HDL-C ratio 3 or greater BMI 25-35

Exclusion Criteria:

Diabetes Mellitus History of gall stones History of CHF History of CAD Severe anemia,kidney, or liver disease
Intervention: Rosiglitazone
Trial phase: Not Applicable
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks

Rosiglitazone
Eligibility criteria:
Inclusion Criteria:

Insulin Resistant Triglyceride 150 mg/dL or greater or triglyceride HDL-C ratio 3 or greater BMI 25-35

Exclusion Criteria:

Diabetes Mellitus History of gall stones History of CHF History of CAD Severe anemia,kidney, or liver disease
Intervention: Cefotaxime
Trial phase: Phase 1
ATC code: J01DD01
SMILES: [H][C@]12SCC(COC(C)=O)=C(C(=O)O)N1C(=O)[C@H]2NC(=O)/C(=N\OC)c1csc(N)n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
Eligibility criteria:
Inclusion Criteria:

Previous participation in the "SOPHIE" study;
Has a specific genotype for OAT3

Exclusion Criteria:

Under 18 years old or over 45 years old;
Pregnant (pregnancy status in female subjects will be determined by a urine pregnancy test before study drug administration);
They report a prior history of any allergic reaction to cephalosporin antibiotic, or severe hypersensitivity to penicillin;
Has a prior history of renal or hepatic dysfunction (renal and hepatic function will also be determined for each subject with prescreening blood tests);
Taking a medication that could confound study results (such as known substrates or inhibitors of OATs);
They do not consent to participate in the study.
Intervention: Montelukast
Trial phase: Phase 4
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Treated for 4 months with montelukast 4 mg per day

Montelukast
Eligibility criteria:
Inclusion Criteria:

Adults 18 to 50 years of age.
Male or female, who are not pregnant or lactating.
Common cold symptoms for less than 24 hours.
At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, sneezing and malaise.

Exclusion Criteria:

Investigational medication in past 30 days.
Known hypersensitivity to any ingredients in study medication.
History of asthma or other chronic diseases.
Females of childbearing potential who are not using a medically acceptable form of birth control.
Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
Females with a positive urinary HCG test.
Patients with a positive rapid antigen test for streptococcal infection.
Common cold symptoms for more than 24 hours.
Patients who are users of illicit drugs.
Patients who are on rifampin or phenobarbital.
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: 68
Group description: Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
Eligibility criteria:
Inclusion Criteria:

18-65 years old
Diagnosed with Schizophrenia or Schizoaffective disorder
Ability to visit the doctor's office for scheduled visits

Exclusion Criteria:

Women who are pregnant or breastfeeding
Have a body mass index (BMI) greater than 40
Have diabetes, heart disease or any other unstable illness
Have known positive human immunodeficiency virus (HIV)
Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics
Intervention: Risperidone
Trial phase: Phase 4
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
Eligibility criteria:
Inclusion Criteria:

18-65 years old
Diagnosed with Schizophrenia or Schizoaffective disorder
Ability to visit the doctor's office for scheduled visits

Exclusion Criteria:

Women who are pregnant or breastfeeding
Have a body mass index (BMI) greater than 40
Have diabetes, heart disease or any other unstable illness
Have known positive human immunodeficiency virus (HIV)
Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics
Intervention: Atomoxetine
Trial phase: Phase 3
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 228
Group description: 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
Eligibility criteria:
Inclusion Criteria:

Patients who met all of the disease diagnostic and study criteria at Visit 2 of previous placebo-controlled study, completed the study
Patients wish to enter into this study

Exclusion Criteria:

Patients whose families anticipate a move outside the geographic range of the investigative site, or who plan extended travel inconsistent with the recommended visit interval
Intervention: Gemcitabine
Trial phase: Phase 3
ATC code: L01BC05
SMILES: Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 166
Group description: Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
Eligibility criteria:
Inclusion Criteria:

Clinical evidence of superficial transitional cell carcinoma of the bladder
Males or females at least 18 years of age
Karnofsky Performance Status greater than or equal to 70%
Patient compliance and geographic proximity that allow adequate follow-up
Female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during the study. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment.
Signed informed consent.

Exclusion Criteria:

Clinical evidence of muscle-invasive or locally advanced bladder cancer
Clinical evidence of upper urinary tract tumor
Distant metastases
Other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy
Severe concomitant psychiatric disease
Febrile, active infection
Other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)
Intervention: Atomoxetine
Trial phase: Phase 3
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 100
Group description: Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Eligibility criteria:
Inclusion Criteria:

Child or adolescent patients must be at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for ADHD. For the purposes of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL. Patients must also have an ADHDRS-IV-Parent:Inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit 2. In addition, they must have a CGI-ADHD-S score 4 at both Visit 1 and Visit 2.
Patients must have a newly diagnosed case of ADHD. Newly diagnosed case of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or International Statistical Classification of Diseases and Related Health Problems [World Health Organisation; 10th Revision] [ICD 10] criteria) within 3 months prior to Visit 1.

Exclusion Criteria:

Patients with history of ADHD diagnosis longer than 3 months prior to Visit 1. Diagnosis of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or ICD 10 criteria) and has registered it in medical records or verbally informed parents about this diagnosis.
Patients who weigh less than 20 kg at study entry (Visit 1). If a patient's weight changes after Visit 1 to a value outside of the stated range, the patient will still be eligible, and the weight should be rounded to the nearest value within the above range for dosing purposes.
Intervention: VALPROIC ACID
Trial phase: Phase 4
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Eligibility criteria:
Inclusion Criteria:

Must have a diagnosis of schizophrenia as confirmed by the MINI
Must be on antipsychotic medication
Must be age 50 year or older
Must be capable of providing written informed consent for study participation. In situations where individuals have guardians of person, guardian and subject must both provide written consent; and
Must live in the Northeast Ohio area.

Exclusion Criteria:

A primary psychiatric DSM Axis I diagnosis other than schizophrenia
Actively abusing substances; or
Medically unstable.
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Abilify (Children With Symptoms of Mania Study)
Eligibility criteria:
Inclusion Criteria:

Outpatients ages 4-9 years (inclusive)
Patients who are anticipated to have a Young Mania Rating Scale (Young et al. 1978) of 15 or higher at baseline
Meet DSM-IV criteria for bipolar disorder type 1 or 2, cyclothymia, or bipolar disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment (K-SADS-PL supplemented with mood disorder sections from the WASH-U K-SADS) (Geller et al., 2001; Kaufman et al., 1997) and a clinical interview with a child and adolescent psychiatrist.

Exclusion Criteria:

Patients who have a history of intolerance to APZ at doses of 0.1mg/kg/day
Patients who have experienced a manic episode with a documented APZ dose as monotherapy treatment of 0.2 mg/kg/day
Patients with an active neurological/medical disorder for which treatment with APZ would be contraindicated
Patients with clinical evidence of autistic disorder, Asperger's disorder, Rett's syndrome or other pervasive developmental disorders
Patients with clinical evidence of mental retardation
Patients who are known to be allergic or hypersensitive to aripiprazole
Patients who are unable to swallow pills/capsules
Patients for whom the need for hospitalization during the course of the study appears likely
Patients who have a general medical or neurological condition (including clinically significant abnormalities on screening laboratories) that may be considered to be the etiology of the patient's mood disorder
Patients who have a general medical or neurological condition for which treatment with an atypical antipsychotic would be contraindicated (e.g. tardive dyskinesia)
Patients who have a general medical or neurological condition that could interfere with the interpretation of clinical response to APZ treatment
Patients taking psychotropic agents (other than psychostimulants) within one week of baseline (2 weeks for fluoxetine; 3 days for psychostimulants)
Intervention: Ciprofloxacin
Trial phase: Not Applicable
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 137
Group description: Ciprofloxacin 250 mg BID X 3 days
Eligibility criteria:
Inclusion Criteria:

Nonpregnant females in good general health with symptoms of acute cystitis

Exclusion Criteria:

Pregnant,lactating, or not regularly contracepting: known anatomic abnormalities of the urinary tract; use of prophylactic antibiotics; history of allergy or intolerance to any of the study drugs; recent (>2 weeks)exposure to an oral or parenteral antimicrobial; or history of UTI in the previous 1 month
Intervention: Cefpodoxime
Trial phase: Not Applicable
ATC code: J01DD13
SMILES: COCC1=C(C(=O)O)N2C(=O)C(NC(=O)C(=NOC)c3csc(N)n3)C2SC1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 137
Group description: Cefpodoxime 100 mg BID X 3 days
Eligibility criteria:
Inclusion Criteria:

Nonpregnant females in good general health with symptoms of acute cystitis

Exclusion Criteria:

Pregnant,lactating, or not regularly contracepting: known anatomic abnormalities of the urinary tract; use of prophylactic antibiotics; history of allergy or intolerance to any of the study drugs; recent (>2 weeks)exposure to an oral or parenteral antimicrobial; or history of UTI in the previous 1 month
Intervention: GLUTAMINE
Trial phase: Phase 3
ATC code: A16AA03
SMILES: NC(=O)CCC(N)C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 10 grams three times a day (orally) for four days and then stop

glutamine: 10 grams three times a day (orally) for four days and then stop
Eligibility criteria:
Inclusion Criteria:

Patients must have histologically or cytologically confirmed breast cancer, Stage I, II, III or IV or other solid tumors.
Patients must be receiving weekly paclitaxel or nab-paclitaxel chemotherapy or have recently completed paclitaxel or nab-paclitaxel chemotherapy and have at least a Grade I peripheral neuropathy (see Appendix A) because of therapy.
Because no dosing or adverse event data are currently available on the use of glutamine in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
ECOG performance status <1 (Karnofsky >90%).
Life expectancy of greater than 3 months.
Patients must have sufficient organ and marrow function so that paclitaxel treatment can be administered.
The effects of glutamine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have experienced prior neuropathies not associated with chemotherapy
Patients may not be receiving any other investigational agents.
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
There are no known allergies associated with glutamine.
Uncontrolled intercurrent illness that render the patient ineligible to receive paclitaxel chemotherapy.
Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with glutamine. Breastfeeding should also be discontinued if the mother is treated with glutamine.
Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with glutamine. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
Concurrent chemotherapy with another drug known to cause neuropathy (CDDP or CBDCA or oxaliplatin) are excluded.
Intervention: Ovral
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2185
Group description: Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
Eligibility criteria:
Inclusion Criteria:

Premenopausal
Not pregnant or breastfeeding
Sexually active at risk of pregnancy

Exclusion Criteria:

Any contraindication to the use of oral contraceptives
Pregnancy within the last 3 months
Smoking > 10 cigarettes per day
Intervention: Temozolomide
Trial phase: Phase 2
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
Eligibility criteria:
Inclusion Criteria:

Pathologic evidence of a malignant glioma.
Tissue block or unstained slides must be available for MGMT analysis.
Age 18-70
KPS > 50
Granulocyte count >1.5 X 109/L
Platelet count >99 X 109/L
SGOT < 2.5X upper limit of normal (ULN).
Serum creatinine < 2X ULN.
Bilirubin < 2X ULN.
All patients must sign written informed consent.

Exclusion Criteria:

Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
Any prior experimental therapy for glioma.
Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
Serious medical or psychiatric illness that would in the opinion of the investigator would interfere with the prescribed treatment.
Pregnant or breast feeding women.
Refusal to use effective contraception.