anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bupropion
Trial phase: Phase 2
ATC code: A08AA62 | N06AX12
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Contingent reinforcement plus bupropion
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications

Exclusion Criteria:

Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants
Intervention: Ziprasidone
Trial phase: Phase 3
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 331
Group description: Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
Eligibility criteria:
Inclusion Criteria:

Subjects who have successfully completed a ziprasidone clinical study
Patients not hospitalised in an acute psychiatric service
Written, informed consent to participation.
Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception (intrauterine device, implanted contraceptive, oral contraceptive or condom) must be initiated or continued

Exclusion Criteria:

Psychiatric:

Subjects at immediate risk of committing harm to self or others
Subjects requiring concurrent treatment with non-study antipsychotic agents
Subjects requiring treatment with antidepressants or mood stabilizers
General:
Subjects with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study
Acute or chronic heart disease
Clinically significant ECG abnormalities
Subjects with QTc >= 500 msec (subjects with QTc >= 450 msec and < 500 msec should be discussed with the cardiologist who is responsible for all of the centers involved)
Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments)
Subjects with serum K+ or Mg++ outside the normal range
Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator
Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times upper limit)
Pregnant or lactating women
Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends
Subjects unable or unlikely to follow the study protocol
Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds
Known hypersensitivity to ziprasidone or lactose
Intervention: Risperidone
Trial phase: Phase 4
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Study is double blind, placebo controlled. This is the subject group on active medication

Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW.
Eligibility criteria:
Inclusion Criteria:

Primary Diagnosis of Anorexia Nervosa
Female, age 12-21
Active in a level of care for AN at The Children's Hospital, Denver
As long as there is a primary dx of AN, co-morbid diagnoses may be included.
If taking an antidepressant, must be on a stable dose for 3 weeks prior to entering the study, and dose of antidepressant may not be changed during Phase 1 of the study.
If choosing to discontinue antidepressant medication, must be off the medication for 3 weeks prior to beginning the study.
If sexually active, must use birth control during the study and have a monthly pregnancy test.

Exclusion Criteria:

Previous enrollment in this study on a prior admission
Previous allergic reaction to risperidone or other atypical neuroleptic
Positive pregnancy test
Neurologic disorder other than benign essential tremor
Taking a psychotropic medication other than antidepressant and discontinuing the medication is not recommended.
Active hepatic or renal disease
Wards of the state
Males
Intervention: Ramipril
Trial phase: Phase 2 | Phase 3
ATC code: C09AA05 | C09BA05 | C09BB05 | C09BB07 | C09BX03 | C09BX05 | C10BX04 | C10BX06 | C10BX17 | C10BX18
SMILES: [H][C@@]12CCC[C@]1([H])N(C(=O)[C@H](C)N[C@@H](CCc1ccccc1)C(=O)OCC)[C@H](C(=O)O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 151
Group description: Angiotensin-converting enzyme inhibitor group
Eligibility criteria:
Inclusion Criteria:

Undergoing elective valvular heart surgery, coronary artery bypass grafting
If female, must be postmenopausal for at least 1 year, status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and willing to undergo urine beta-hcg testing prior to drug treatment and throughout the study

Exclusion Criteria

History of AF other than remote paroxysmal AF
Ejection fraction less than 30%
Evidence of coagulopathy (INR greater than 1.7 without warfarin therapy)
Emergency surgery
History of ACE inhibitor-induced angioedema
Low blood pressure (systolic blood pressure less than 100 mmHg and evidence of hypoperfusion)
Hyperkalemia (potassium level greater than 5.0 milliequivalents (mEq)/L at study entry)
Impaired kidney function (serum creatinine level greater than 1.6 mg/dl)
Any underlying or acute disease requiring regular medication that could possibly cause complications or make implementation of the study or interpretation of the study results difficult
Inability to discontinue current ACE inhibitor, AT1 receptor antagonist, or aldosterone receptor antagonist therapy
History of alcohol or drug abuse
Treatment with any investigational drug in the month prior to study entry
Mental condition that makes it impossible to understand the nature, scope and possible consequences of the study
Inability to comply with the study procedures (e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study)
Pregnant or breastfeeding
Intervention: Tiotropium
Trial phase: Phase 3
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2986
Group description: Once daily
Eligibility criteria:
Inclusion Criteria:

Written informed consent.
Male or female patients 40 years of age or older.
Smoking history of at least 10 pack years.
Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.

Exclusion Criteria:

Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
Myocardial infarction in past 6 months.
Unstable or life threatening arrhythmia in past year.
Hospitalization for NYHA heart failure class III or IV in past year.
Active tuberculosis.
Asthma.
Pulmonary resection.
Malignancy treated with radiation or chemotherapy in past 5 years.
Respiratory infection in 4 weeks prior to screening.
Known hypersensitivity to anticholinergic drugs or components.
Known moderate to severe renal impairment.
Known narrow angle glaucoma.
Significant symptomatic BPH or bladder neck obstruction.
Need for oxygen therapy >12 hr/day.
Use of oral corticosteroids at unstable doses or >10 mg/day.
Intervention: Oxaliplatin
Trial phase: Phase 2
ATC code: L01XA03
SMILES: NC1CCCCC1N.O=C([O-])C(=O)[O-].[Pt+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
Patients must have measurable disease
Age greater than or equal to 18 years
ECOG performance score of 0, 1, or 2
Absolute neutrophil count (ANC) > 1,500
Platelets > 100,000
Serum creatinine < 1.5mg/dL
Serum total bilirubin < 1.5mg/dL
Alkaline phosphatase < 3 times the upper limit of normal
SGOT/SGPT < 3 times the upper limit of normal
Patients must be recovered from the effects of any prior surgery or RT.
Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medications.

Exclusion Criteria:

Patients with an active infection > 38.5 degrees Celsius within 3 days of the first scheduled day of protocol treatment
Patients with active central nervous system (CNS) metastasis. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 2 weeks are eligible for the trial.
History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasm, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL
Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel
Patients who have had prior chemotherapy for lung cancer
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
Grade 2 peripheral neuropathy
Patients who are pregnant or lactating
Any other medical condition, including mental illness or substance abuse deemed by the investigator to be likely to interfere with the patients' ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
History of allogeneic transplant
Known HIV, hepatitis B or C (active, previously treated, or both)
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 224
Group description: 5-20 mg by mouth once daily for up to 26 weeks
Eligibility criteria:
Inclusion Criteria:

Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
Caregiver required.

Exclusion Criteria:

Have an uncontrolled, unstable clinically significant medical condition.
Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
Intervention: BENZOYL PEROXIDE
Trial phase: Phase 4
ATC code: D10AE01 | D10AE51
SMILES: O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 252
Group description: FDA approved drugs to treat blood pressure and cholesterol
Eligibility criteria:
Inclusion Criteria:

American Indian men and women 40 years of age or older
Type 2 DM (according to 1997 ADA criteria and/or previously diagnosed by former ADA or WHO criteria): fasting plasma glucose >= 7.0 mmol/L (126 mg/dL) or 2-hour glucose >= 11.0 mmol/L (>200 mg/dL) after a 75-gram oral glucose tolerance test.
LDL cholesterol >= 100 mg/dL. within the previous 12 months.
Systolic BP >= 130 mm Hg. within the previous 12 months.

Exclusion Criteria:

New York Heart Association Stage III- IV congestive heart failure.
SBP >180 mmHg (2% of population) or patients with known causes of hypertension.
History of angioedema.
Any medical condition that study physicians believe would interfere with study participation or evaluation of results.
Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
Serum hepatic transaminase levels 2X the upper limit of normal.
Participation in any clinical trial of any investigational medication within 3 months prior to this trial.
Renal insufficiency as indicated by serum creatinine >2.0 for women and >2.4 for men.
Diagnosis of primary hyperlipidemia in medical record.
Secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Patients on stable doses of thyroid replacement therapy will be eligible.
Presence of malignancy or history of any cancer except skin cancer within the past 5 years.
Pregnancy or lactation. Premenopausal women will be requested to use birth control methods throughout the study and provided educational materials about the risks of using the study medications during pregnancy.
Unable to obtain quantifiable carotid measure during screening examination.
Concomitant long term use of cyclosporins (Sandimmune), macrolide antibiotics (erythromycin -many generic and brand name forms, clarithromycin, Biaxin, and Zithromax), azole antifungals (itraconazole-Sporanox, ritonavir, Norvir, and nelfinavir (Viracept).

Orthostatic hypotension as defined by the following:

The individual has a measured fall of >20 mmHg in systolic BP upon standing associated with symptoms lasting more than one minute (or severe symptoms that would not allow further lowering of BP)
The standing systolic blood pressure is less than 90 mm.
Triglyceride level >350 mg/dl.
Severe aortic stenosis with valve area <=1.0 square cm.
Intervention: Basaglar
Trial phase: Phase 2
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: 6
Group description: open-label Insulin Glargine for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Patients between the ages of 18 - 75, inclusive
Diagnosed with type 2 diabetes
Hemoglobin A1c value greater than or equal to 8.0%
Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)
Overweight, obese (body mass index 25-45 kg/m2)

Exclusion Criteria:

Change of dose of lipid or blood pressure lowering therapy within past three months
Previous treatment with colesevelam for hyperlipidemia
Serum triglyceride greater than 500 mg/dL
Serum low density lipoprotein-cholesterol less than 60 mg/dL
Intervention: Zinc
Trial phase: Phase 2 | Phase 3
ATC code: C05AX04
SMILES: [Zn]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1314
Group description: Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water

Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
Eligibility criteria:
Inclusion Criteria:

Pneumonia: Child presenting with cough or difficult breathing and elevated respiratory rate.

Severe pneumonia: Child presenting with cough or difficult breathing and chest indrawing , but without any of the following danger signs:

not able to drink/breastfeed,
vomit everything,
has had convulsions,
is lethargic or unconscious.
Must be able to take Zinc

Exclusion Criteria:

The child requires special care for severe illness other than pneumonia
Severe malnutrition defined as being < 70% National Center for Health Statistics (NCHS) median weight for height
Presence of congenital heart disease
Documented tuberculosis
Any antibiotic treatment during the last 48 hours
The child was enrolled less than 6 months ago
Presence of dysentery
Cough for more than 14 days
Intervention: Zinc
Trial phase: Phase 2 | Phase 3
ATC code: C05AX04
SMILES: [Zn]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1314
Group description: Placebo

Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
Eligibility criteria:
Inclusion Criteria:

Pneumonia: Child presenting with cough or difficult breathing and elevated respiratory rate.

Severe pneumonia: Child presenting with cough or difficult breathing and chest indrawing , but without any of the following danger signs:

not able to drink/breastfeed,
vomit everything,
has had convulsions,
is lethargic or unconscious.
Must be able to take Zinc

Exclusion Criteria:

The child requires special care for severe illness other than pneumonia
Severe malnutrition defined as being < 70% National Center for Health Statistics (NCHS) median weight for height
Presence of congenital heart disease
Documented tuberculosis
Any antibiotic treatment during the last 48 hours
The child was enrolled less than 6 months ago
Presence of dysentery
Cough for more than 14 days
Intervention: Valsartan
Trial phase: Phase 4
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3031
Group description: For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of hypertension
Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH)

Exclusion Criteria:

Patients who have already been administered ARB
Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG)
Severe/malignant/secondary hypertensive patients
Pregnant women and women of childbearing potential
History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months
Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block
Severe renal impairment (Serum creatinine >3.0 mg/dl)
Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)
Intervention: SALICYLIC ACID
Trial phase: Phase 2 | Phase 3
ATC code: D01AE12 | N02BA04 | N02BA12 | S01BC08
SMILES: O=C(O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: All patients who met remission who were then transitioned to medications after the TMS trial was completed
Eligibility criteria:
Inclusion Criteria:

Diagnosis of major depression with a current episode
Hamilton Rating Scale for Depression score higher than 20
No response or intolerance to antidepressant medication in the current depressive episode

Exclusion Criteria:

Current use of antidepressants
Diagnosis of psychosis or anxiety disorder
Current substance abuse
Seizures or history of head trauma
Intervention: Guanfacine Hydrochloride
Trial phase: Phase 3
SMILES: Cl.NC(N)=NC(=O)Cc1c(Cl)cccc1Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 65
Group description: Guanfacine HCl once daily
Eligibility criteria:
Inclusion Criteria:

Subjects with a primary diagnosis of ADHD
Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
Subject is pregnant or lactating
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 415
Group description: 2.4 g/day QD
Eligibility criteria:
Inclusion Criteria:

previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

Exclusion Criteria:

proctitis
previous resective colonic surgery
Crohn's disease
hypersensitivity to salicylates
moderate/severe renal impairment
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 411
Group description: 1.6g/day administered 800 mg BID
Eligibility criteria:
Inclusion Criteria:

previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

Exclusion Criteria:

proctitis
previous resective colonic surgery
Crohn's disease
hypersensitivity to salicylates
moderate/severe renal impairment