anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Denintuzumab mafodotin
Trial phase: Phase 2
SMILES: CCC(C)C(C(CC(=O)N1CCCC1C(OC)C(C)C(=O)NC(Cc1ccccc1)C(=O)O)OC)N(C)C(=O)C(NC(=O)C(C(C)C)N(C)C(=O)CCCCCN1C(=O)CC(SCC(N)C(=O)O)C1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Intravenous Immunoglobulin
Eligibility criteria:
Inclusion Criteria:

Diagnosis of probable Alzheimer's disease (AD) of mild to moderate severity (as determined by a Mini Mental State Examination (MMSE) score of 14 - 26 inclusive).
Ability to give informed consent, designate a decision-maker or have an already recognized decision-maker (such as a legal guardian or health care proxy).
Ability to comply with testing and infusion regimen.
An able caregiver willing to participate (such as a spouse, child, other relative, close friend, aide or other professional caregiver closely involved in helping the patient take care of himself/herself).
Venous access suitable for repeated infusion and phlebotomy.
On stable doses of approved AD medications for at least 3 months.
As applicable, on stable doses of psychoactive medications (e.g. antidepressants, antipsychotics) for at least 6 weeks.
Neuroimaging performed after symptom onset consistent with the patient's diagnosis.
Clinical laboratory values within normal limits or if abnormal, judged clinically insignificant by the Principal Investigator.
Women who want to take part in this study must either be post-menopausal, surgically sterilized or agree to avoid becoming pregnant during the entire period of their participation in this study.

Exclusion Criteria:

Non-Alzheimer dementia.
Active renal disease.
Abnormally high serum viscosity levels.
Immunoglobulin A (IgA) deficiency.
Untreated congestive heart failure, unstable angina or a history of recent myocardial infarction.
Unstable arrhythmia.
Untreated or poorly controlled hypercholesterolemia.
Untreated or poorly controlled hypertension.
Poorly controlled diabetes.
Thrombosis (central or peripheral) in the past year.
Modified Hachinski score > 5.
Active cancer diagnosis, except basal cell carcinoma.
Active autoimmune or neuroimmunologic disorder.
History of IVIg treatment in past 6 months.
Untreated major depression or other major psychiatric disorders.
Known coagulopathy or platelet counts < 100,000.
Positive serology for Hepatitis B or C, or HIV.
Active migraines or frequent headaches (3 or more times per week).
Taking immunosuppressive drugs.
Chronic (more than thrice weekly) use of non-steroidal anti-inflammatory drugs (NSAIDs), excluding aspirin 81 milligrams daily.
Received an investigational treatment for AD within 3 months of study entry.
A history of or current disorder or disease that in a physician co-investigator's judgment may impede the subject's participation in the study, pose immoderate risk to the patient or confound the results of the study
Intervention: Voriconazole
Trial phase: Phase 4
ATC code: J02AC03
SMILES: C[C@@H](c1ncncc1F)[C@](O)(Cn1cncn1)c1ccc(F)cc1F
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
Eligibility criteria:
Inclusion Criteria:

Subjects must be willing and able to provide informed consent.
Subjects must be willing and able to be confined at the Clinical Research Unit as required by the protocol.

Exclusion Criteria:

Subjects with any condition affecting drug absorption.
Intervention: Lovastatin
Trial phase: Phase 2
ATC code: C10AA02 | C10BA01
SMILES: [H][C@@]12C(=C[C@H](C)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of RA as defined by 1987 American College of Rheumatology (ACR) criteria
Functional Class I, II, or III RA as defined by 1987 ACR criteria
Serum C-reactive protein (CRP) measurement of greater than 5 mg/L
Mildly active disease with at least one swollen and two tender joints, but no more than six swollen and eight tender joints
If on corticosteroids, dose must be stable and 10 mg/day prednisone (or equivalent) or less for at least 4 weeks prior to study entry
If on DMARD, dose must be stable for at least 4 weeks (methotrexate, leflunomide, azathioprine, etanercept, adalimumab, anakinra) or at least 3 months (hydroxychloroquine, gold, or abatacept)
Willing to use acceptable means of contraception

Exclusion Criteria:

Serum creatinine level greater than 1.5 mg/dL
Currently taking a statin or have taken a statin within 12 weeks of study entry
History of an adverse reaction to a statin
Active or recent infection within 4 weeks of study entry
Myositis or an unexplained elevation in creatine phosphokinase (CPK)
Joint replacement surgery within 60 days of study entry or plan to undergo joint replacement surgery during the course of the study
Intra-articular cortisone injections within 4 weeks of study entry
Chronic disorders other than RA affecting the joints, including systemic lupus erythematosus (SLE), psoriatic arthritis, gout, scleroderma, or known reactive arthritis (Reiter's syndrome)
HIV infection
Hepatitis B surface antigen positive
Hepatitis C antibody positive
Treatment with infliximab within 12 weeks of study entry
Treatment with rituximab
Treatment with medications known to be metabolized by the cytochrome P3A4 pathway. More information about this criterion can be found in the protocol.
Require amiodarone or verapamil
Investigational drug or treatment during the 4 weeks or seven half-lives prior to study entry
History of alcohol abuse
History of liver disease, current liver disease (e.g., hepatitis, cirrhosis), or abnormal liver function (AST or ALT greater than 2 times the upper limit of normal [ULN])
Any condition that, in the opinion of the investigator, may interfere with the study
Pregnancy or breastfeeding
Intervention: Atomoxetine
Trial phase: Phase 4
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Participants will receive 40-80mgs of atomoxetine orally once daily.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of idiopathic Parkinson's disease
IDS score greater than 21
Mini-Mental State Examination (MMSE) score greater than 15

Exclusion Criteria:

Recent deep brain stimulation
Currently participating in an antidepressant trial at a less than adequate dose and duration
Severe depression or depression with suicide ideation
History of liver toxicity
Unstable medical disease or comorbid psychiatric disease
Intervention: Erythromycin
Trial phase: Phase 2
ATC code: D10AF02 | D10AF52 | J01FA01 | S01AA17
SMILES: CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(O)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: Subjects with Bulimia Nervosa will take erythromycin.

Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Meets criteria for bulimia nervosa
Duration of illness is greater than 1 year
Self-induces vomiting
Weighs 80%-120 % of ideal weight

Exclusion Criteria:

Significant medical illness
Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by American Psychiatric Association criteria
Moderate to severe depression, as defined by a score greater than 18 on the Hamilton Depression Scales
Current diagnosis of organic mental disorder, factitious disorder, or malingering
History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with assessment or compliance with the study procedures
At risk for suicide
Current psychotropic medications and current medications that affect GI function or that inhibit or induce cytochrome three A gene expression
Currently pregnant, lactating, or planning to become pregnant
Drug or alcohol abuse within the 3 months prior to study entry
Abnormal EKG at baseline or 1 week following each upward dosage adjustment
Anemia
Known intolerance to erythromycin, or related antibiotics
Abnormal results on liver function tests
Electrolyte abnormalities
Intervention: Bupropion
Trial phase: Phase 3
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: 73
Group description: participants in this arm receive bupropion

Bupropion: 300 mg QD
Eligibility criteria:
Inclusion Criteria:

Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry
Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at time of study entry
Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry

Exclusion Criteria:

History of seizures, head trauma and/or severe hepatic cirrhosis
Current use of medications known to affect smoking behavior and/or cessation
Use of tricyclic antidepressant medication and monoamine oxidase inhibitors
Major depressive disorder within the month prior to study entry
Eating disorder within the year prior to study entry
History of bipolar or psychotic disorder
Pregnant or breastfeeding
Unstable serious medical disorder
History of migraines
Currently using smokeless tobacco, pipes, or cigars
Intervention: Testosterone
Trial phase: Phase 4
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
Eligibility criteria:
Inclusion Criteria:

Male
30-65 years old
Taking at least one serotonergic antidepressant at adequate dose for at least six weeks but still meeting DSM-IV criteria for major depressive disorder within the past year
HAM-D score >12

Exclusion Criteria:

Current suicidal ideation
Substance abuse or dependence within the past year
Current or past psychotic symptoms
A history of bipolar disorder
A prostate-specific antigen (PSA) level greater than 4.0 ng/ml
Other clinically significant medical condition
A history of failing to show any clinically significant response to two or more adequate trials of different antidepressants.
Intervention: Morphine
Trial phase: Phase 2 | Phase 3
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 46
Group description: 0.05 mg/kg IV morphine
Eligibility criteria:
Inclusion Criteria:

Age greater than 65 years
Pain with onset within 7 days
ED attending physician's judgment that patient's pain warrants use of parenteral opioids
Normal mental status

Exclusion Criteria:

Prior use of methadone
Use of other opioids or tramadol within past seven days
Prior adverse reaction to morphine or hydromorphone
Chronic pain syndrome
Alcohol intoxication
Systolic Blood Pressure <90 mm Hg
Use of monoamine oxidase (MAO) inhibitors in past 30 days
Elderly patients with a capnometry reading of greater than 46
Intervention: Hydromorphone
Trial phase: Phase 2 | Phase 3
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: 0.0075 mg/kg IV hydromorphone
Eligibility criteria:
Inclusion Criteria:

Age greater than 65 years
Pain with onset within 7 days
ED attending physician's judgment that patient's pain warrants use of parenteral opioids
Normal mental status

Exclusion Criteria:

Prior use of methadone
Use of other opioids or tramadol within past seven days
Prior adverse reaction to morphine or hydromorphone
Chronic pain syndrome
Alcohol intoxication
Systolic Blood Pressure <90 mm Hg
Use of monoamine oxidase (MAO) inhibitors in past 30 days
Elderly patients with a capnometry reading of greater than 46
Intervention: Hydromorphone
Trial phase: Phase 2
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 269
Group description: 2 mg IV hydromorphone administered over 2-3 minutes

2 mg IV hydromorphone
Eligibility criteria:
Inclusion Criteria:

Age greater than 21 years
Age less than 65 years of age
Pain with onset within 7 days
ED attending physician's judgment that patient's pain warrants use of morphine
Normal mental status

Exclusion Criteria:

Prior use of methadone
Use of other opioids or tramadol within past seven days
Prior adverse reaction to hydromorphone.
Chronic pain syndrome
Alcohol intoxication
SBP <90 mm Hg
Use of MAO inhibitors in past 30 days
C02 measurement greater than 46
Intervention: Memantine
Trial phase: Phase 4
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: 14
Group description: Daily dose Memantine

Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.
Eligibility criteria:
Inclusion Criteria:: 1) age 18 - 65; 2) satisfy DSM-IV-TR criteria for Bipolar Disorder and Major Depressive Episode; 3) Lamotrigine Inadequate-Response: Defined as already treated with at least 100 mg of lamotrigine for at least 4 weeks but 17 item HDRS rating > 15; 4) give informed consent as approved by local IRB; 5) if on other antidepressants or mood stabilizers on stable dose for the past 4 weeks.

Exclusion Criteria:1) comorbid psychotic disorder such as schizophrenia or schizoaffective disorder; 2) significant suicidal or homicidal risk; 3) clinically significant medical illness; 4) allergy or intolerance to lamotrigine or memantine; 5) pregnancy, planning to be pregnant or not using adequate contraception; 6) satisfy criteria for substance dependence within 6 months prior to start of the study; and 7) on any medication with significant adverse interaction with either lamotrigine or memantine.
Intervention: Sitagliptin Phosphate
Trial phase: Phase 3
SMILES: NC(CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F.O=P(O)(O)O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
Eligibility criteria:
Inclusion Criteria:

Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise
Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit

Exclusion Criteria:

Patients with type 1 diabetes
History of ketoacidosis or requires insulin use
Alanine aminotransferase / aspartate aminotransferase > 2.5 X ULN, triglycerides > 600 mg/dL, creatinine clearance < 35 mL/min
Fasting plasma glucose consistently > 260 mg/dL
Poorly controlled hypertension
Intervention: Qlaira
Trial phase: Phase 3
SMILES: CC12CCC3=C4CCC(=O)C=C4CCC3C1CCC2(O)CC#N.CCCCC(=O)OC1CCC2C3CCc4cc(O)ccc4C3CCC12C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 145
Group description: A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
Eligibility criteria:
Inclusion Criteria:

Women 18 years or older
And with a diagnosis of dysfunctional uterine bleeding without organic pathology
And with at least one of the following symptoms: prolonged, frequent or excessive bleeding.

Exclusion Criteria:

The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Women with a history of endometrial ablation or dilatation and curettage within 2 months prior to study start will be excluded.
Intervention: Aripiprazole
Trial phase: Phase 2
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 14
Group description: aripiprazole monotherapy
Eligibility criteria:
Inclusion Criteria:

Males and Females ages 6-17
A diagnosis of Autism, Asperger's Disorder, or Pervasive Developmental Disorder - not otherwise specified (PDD NOS)
Medically healthy
Ability to give assent
Significant tantrums, aggression, self-injurious behavior and/or agitation by achieving a score of 18 or higher on the Aberrant Behavior Checklist-irritability subscale and a score of moderate or higher on the Clinical Global Impressions-Severity Scale.

Exclusion Criteria:

Co-morbid serious mental illness.
Intelligence Quotient (IQ) <50, based on verified records of cognitive testing performed within 2 years of enrollment. In event that suitable records of prior testing are unavailable, IQ will be estimated using the Wechsler Abbreviated Scale of Intelligence (WASI, 1999 Harcourt Assessment, Inc.).
Significant active medical and/or neurological illness.
Subjects that require other psychotropic medications such as antidepressants, mood stabilizers, anticonvulsants, stimulants, sedatives, or other antipsychotic medications in order to maintain clinical stability.
Active substance abuse/dependence based upon history and urine toxicology screen.
Inability to have blood drawn at baseline and termination visits.
Known allergy or hypersensitivity to aripiprazole or its ingredients.
Patients clinically stable on current medications.
Intervention: ALBUTEROL
Trial phase: Phase 3
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 95
Group description: Participants received albuterol
Eligibility criteria:
Inclusion Criteria:

Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening
Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
Ability to perform spirometry
Demonstrate 12% airways reversibility

Exclusion Criteria:

Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases
Intervention: Dinoprostone
Trial phase: Phase 3
ATC code: G02AD02
SMILES: CCCCC[C@H](O)/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1C/C=C\CCCC(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 436
Group description: Cervidil 10 mg vaginal insert over a period of up to 24h
Eligibility criteria:
Inclusion Criteria:

Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor

Exclusion Criteria:

No uterine scar (no previous delivery by cesarean section)
No multiple gestation
No condition that disallows use of prostaglandins for induction of labor
No more than 3 previous vaginal births beyond 24 weeks gestation
Intervention: Enzastaurin
Trial phase: Phase 2
SMILES: Cn1cc(C2=C(c3cn(C4CCN(Cc5ccccn5)CC4)c4ccccc34)C(=O)NC2=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
Eligibility criteria:
Inclusion Criteria:

You must have previously participated in and finished Study H6Q-LC-JCAV (JCAV), Study H6Q-LC-JCAY (JCAY), or other enzastaurin clinical pharmacology and biopharmaceutics studies. If you have had any other cancer treatment (chemotherapy, radiation, anti-cancer hormone therapy), you must have completed it at least 4 weeks ago before you can enroll in this study.
You must have a cancer for which no other therapy exists that can prolong your life. This may include participants with treated, stable brain cancer.
You must have lesions (areas of cancer in your body) that your doctor can either measure or detect.
You either must not be able to become pregnant, (because you've had surgery ["tubes tied" or hysterectomy], you've gone through menopause, or you've had previous radiation for cancer that made you sterile) or your potential to become pregnant must be reduced by the use of an approved birth control method (including intrauterine or barrier devices) during and for 3 to 6 months following the study.
You can be either male or female, and must be at least 18 years old.

Exclusion Criteria:

You must not have received treatment within the last 30 days with a drug other than enzastaurin that is still experimental (this means it has not received approval to be prescribed, except in a clinical trial).
You must not be pregnant or breastfeeding.
You must not have central nervous system (CNS) tumors (tumors in your brain and spinal cord). (However, participants who have stable CNS tumors and are taking steroid medication may be included.)
You must not have another serious disorder, including active infections that will interfere with your participation in the study.
You must not have a second cancer in addition to your primary cancer. Participants with adequately treated skin cancer or who have had another cancer in the past, but have been cancer free for more than 2 years, are eligible.
Intervention: Glimepiride
Trial phase: Phase 2
ATC code: A10BB12 | A10BD04 | A10BD06
SMILES: CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: Patients randomized to receive treatment with Glimepiride
Eligibility criteria:
Inclusion criteria:

Inclusion_Criteria:

Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
HbA1c 7.5 10.0% at screening for patients treated with metformin alone
HbA1c 7.5 10.0% at beginning of the placebo run-in phase
Age > 21 and < 75 years
MI > 25 and < 40 kg/m2 (Body Mass Index)

Exclusion criteria:

Exclusion_Criteria:

Clinically relevant cardiovascular disease
Impaired hepatic function
Renal insufficiency or impaired renal function
Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Treatment with insulin within 3 months prior to screening