anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Rocuronium
Trial phase: Phase 4
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 420
Group description: 0.6mg/kg
Eligibility criteria:
Inclusion Criteria:

indication for emergency intubation in intensive care
availability of qualified study physician

Exclusion Criteria:

contraindication against succinylcholine or rocuronium
indication for awake fibreoptic intubation
Intervention: Aclidinium Bromide
Trial phase: Phase 3
ATC code: R03AL05
SMILES: O=C(OC1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 600
Group description: Aclidinium bromide 200 μg once-daily by inhalation
Eligibility criteria:
Inclusion Criteria:

Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
Intervention: Methotrexate
Trial phase: Not Applicable
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Tacrolimus (TAC) And Methotrexate (MTX)
Eligibility criteria:
Inclusion Criteria:

- Patient must be going through a T cell-replete allogeneic transplant

Exclusion Criteria:

- A contraindication to the use of tacrolimus, mycophenolate, or methotrexate
Intervention: Aclidinium Bromide
Trial phase: Phase 3
ATC code: R03AL05
SMILES: O=C(OC1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 627
Group description: Aclidinium bromide 200 μg once-daily by inhalation
Eligibility criteria:
Inclusion Criteria:

Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Metformin pill
Eligibility criteria:
Inclusion Criteria:

Men and women aged 18 to 79
Type 2 diabetes, treated only by diet or oral drugs other than metformin
HbA1c greater than or equal to 7% and less than or equal to 10%
C-reactive protein greater than or equal to 2 mg/L

Exclusion Criteria:

Baseline use of metformin or insulin
Type 1 diabetes, history of ketoacidosis or positive anti-GAD antibody
History of congestive heart failure requiring drug therapy
Active liver disease
Kidney impairment
Recent initiation or change in dose of statins, fibric acid derivatives, angiotensin receptor blockers, nonsteroidal anti-inflammatory agents, or corticosteroids
Intervention: Nuvaring
Trial phase: Not Applicable
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: NuvaRing: Initiation of NuvaRing for contraception per package insert
Eligibility criteria:
Inclusion Criteria: 1) female aged 15 through 21 presenting for contraception; 2) willing to use the NuvaRing as their contraceptive method; 3) English-speaking; 4) up to date on routine health maintenance screening (pap smear within 3 years of initiation of sexual intercourse and Gonorrhea/ Chlamydia testing yearly or with each new partner); and 5) able to read and understand the consent form.

Exclusion Criteria: 1) are pregnant; 2) have a contraindication to hormonal contraception; 3) are unwilling to use NuvaRing as their contraceptive method; 4) are currently using any hormonal contraceptive or have used one within past 2 months; 5) have used emergency contraception in the past 7 days; 6) have had unprotected intercourse in the past 10 days; 7) have untreated Gonorrhea or Chlamydia; or 8) are unable to give informed consent because of psychiatric or cognitive problems.
Intervention: Nuvaring
Trial phase: Not Applicable
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
Eligibility criteria:
Inclusion Criteria: 1) female aged 15 through 21 presenting for contraception; 2) willing to use the NuvaRing as their contraceptive method; 3) English-speaking; 4) up to date on routine health maintenance screening (pap smear within 3 years of initiation of sexual intercourse and Gonorrhea/ Chlamydia testing yearly or with each new partner); and 5) able to read and understand the consent form.

Exclusion Criteria: 1) are pregnant; 2) have a contraindication to hormonal contraception; 3) are unwilling to use NuvaRing as their contraceptive method; 4) are currently using any hormonal contraceptive or have used one within past 2 months; 5) have used emergency contraception in the past 7 days; 6) have had unprotected intercourse in the past 10 days; 7) have untreated Gonorrhea or Chlamydia; or 8) are unable to give informed consent because of psychiatric or cognitive problems.
Intervention: Treprostinil
Trial phase: Phase 4
ATC code: B01AC21
SMILES: [H][C@@]12Cc3c(cccc3OCC(=O)O)C[C@]1([H])[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: All subjects received active treatment with treprostinil sodium.
Eligibility criteria:
Inclusion Criteria:

Age 18 to 70 years
Diagnosis of Idiopathic or Familial Pulmonary Arterial Hypertension (PAH)or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction (Grade of A or B on the Child-Pugh Classification Scale)or PAH associated with drug or toxins or CTEPH
WHO Class II-III
Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
Have central intravenous catheter
Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.
Mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.

Exclusion Criteria:

Nursing or pregnant woman
Have any other type of PAH due to conditions other than noted in the above inclusion criteria, including but not limited to PAH related to thrombotic or embolic disease
Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis)
Changes to chronic PAH therapy (i.e., new therapy added within last 30 days[including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil] or PAH medication discontinued within 7 days of study entry.
Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
Central venous line infection within the past 30 days.
Previous documented evidence of significant parenchymal lung disease
Evidence or history of left-sided heart disease
Musculoskeletal disorder or any other disease, which is thought to limit ambulation, or be connected to a machine that is not portable
Uncontrolled hypertension, chronic renal insufficiency, or active infection.
Use of investigational drug within past 30 days.
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: In labor, fever is identified, consent and randomization occurs, then acetaminophen is given.
Eligibility criteria:
Inclusion Criteria:

Term pregnancy
Singleton pregnancy
Pregnancy with cephalic presentation
Pregnancy in active phase labor
Fetal tachycardia

Exclusion Criteria:

Acetaminophen allergy
Clinical chorioamnionitis
Maternal fever
Non-reassuring fetal status or fetal heart rate abnormalities requiring cesarean delivery
Previous cesarean delivery
Multifetal gestation
Breech presentation
Known fetal anomaly
Known contraindication to vaginal delivery
Intervention: Tadalafil
Trial phase: Phase 2
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 99
Group description: 20 mg tadalafil tablet taken by mouth once a day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Exclusion Criteria:

Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
History of angina requiring treatment with nitrates.
Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.
Intervention: Nacom
Trial phase: Phase 4
SMILES: CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
Eligibility criteria:
Inclusion Criteria:

Male and female patients ages ≥ 30 and ≤ 80 years old.
A clinical diagnosis of idiopathic Parkinson's disease.
Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.

Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.

1 full tablet, and/or
1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
Must have a minimum UPDRS part II (ADL) score of 9.
Patients without dyskinesia or with mild dyskinesia.
Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.

Exclusion Criteria:

Previous or current use of entacapone.
History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
Unstable Parkinson's disease patients.
Patients who experience severe dyskinesia.

The following levodopa/carbidopa doses and strengths are not permitted:

Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.
Intervention: Sirolimus
Trial phase: Phase 1 | Phase 2
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Sirolimus treatment

sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)
Eligibility criteria:
Inclusion Criteria:

Age > 12 months and < 30 years at the time of study entry
Diagnosis of autoimmune cytopenias requiring treatment with medications
At least one of the following: Autoimmune Neutropenia, Autoimmune Hemolytic Anemia, and/or Autoimmune Thrombocytopenia
Must be proven autoimmune by either a documented autoantibody (positive direct anti globulin test, positive anti-neutrophil, and/or anti-platelet antibody) and/or a documented clinical response to immunosuppression
Autoimmune Cytopenias can be idiopathic (Idiopathic Thrombocytopenic Purpura (ITP), Autoimmune Hemolytic Anemia (AIHA), Autoimmune Neutropenia (AIN), or Evans syndrome) or secondary to one of following conditions: Lupus, Rheumatoid Arthritis (RA), ALPS (Autoimmune Lymphoproliferative Syndrome), or Inflammatory bowel disease (IBD)
Patients must have chronic disease diagnosed by either a documented cytopenia syndrome (Lupus, ALPS, RA, or IBD), or by having Evans syndrome defined as idiopathic destruction of multiple blood cell types, and/or by having disease >6 months
Patients must be refractory to or unable to tolerate standard front-line therapies for autoimmune cytopenias (corticosteroids and/or IVIG)
Patients may be taking second-line agents for autoimmune cytopenias (mycophenolate mofetil, cyclosporine, tacrolimus, mercaptopurine, and/or methotrexate) at time of study entry; however, attempts should be made to wean these agents. Patients may not stay on a combination of sirolimus and a calcineurin inhibitor for greater than 4 weeks
Informed consent/assent must be obtained prior to initiating treatment
Patient must be able to consume oral medication in the form of tablets or solution

Exclusion Criteria:

Pregnancy or breast feeding
Uncontrolled infection
Known allergy to Sirolimus or its components
Patients with a documented malignancy on therapy or not in remission
Patients who do not meet organ function requirements listed in protocol
Patients with a documented history of severe combined immunodeficiency or human immunodeficiency virus infection (HIV)
Intervention: Topiramate
Trial phase: Phase 4
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female patients, ages 10-18 years.
Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000).
Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16.
Subjects should be fluent in English.

Exclusion Criteria:

Female patients who are either pregnant or lactating.
Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
Any history of current or past diabetes that has been treated with pharmacological intervention.
Neurological disorders including epilepsy, stroke, or severe head trauma.
Clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG.
Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR).
Mental retardation (IQ <70).
History of hypersensitivity to or intolerance of olanzapine or topiramate.
Prior history of olanzapine or topiramate non-response or allergic reaction.
DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.
Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline Children's Depression Rating Scale suicide score of >3).
Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.
Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.
Intervention: Metformin
Trial phase: Not Applicable
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 and ≤ 65 years of age
HIV positive, on a stable combination antiretroviral regimen for > 6 months, including but not limited to either 2 nucleoside reverse transcriptase inhibitors (NRTI) and a non-nucleoside reverse transcriptase inhibitors (NNRTI) or protease inhibitor (PI), or a triple NRTI regimen
Ability and motivation to modify behavior and make lifestyle changes
NCEP-Adult Treatment Panel III defined metabolic syndrome, as defined by 3 out of 5 of the following: 1) Waist circumference greater than 102 cm (40 in) in men and 88 cm (35 in) in women, 2) Triglycerides ≥ 150 mg/dL or current anti-lipolytic drug treatment, 3) high-density lipoprotein less than 40mg/dL in men and 50 mg/dL in women, 4) Blood pressure ≥ 130/85 mmHg or current antihypertensive drug treatment, 5) Fasting glucose ≥ 100 mg/dL

Exclusion Criteria:

Any new serious opportunistic infection within the past 6 weeks
History of unstable angina, aortic stenosis, uncontrolled hypertension, severe neuropathy, arthritis or other contraindication to exercise
Current therapy with insulin or other diabetic agent, fasting blood sugar > 126
Requiring parenteral nutrition or parenteral glucocorticoid therapy or oral glucocorticoid therapy
Estrogen, progestational derivative, or ketoconazole use within 3 months
New antiretroviral regimen in the past 6 months
Serum creatinine > 1.5 mg/dL (males) and 1.4 mg/dL (females), serum glutamic pyruvic transaminase-liver function (SGPT), > 2.5 upper limit of normal (ULN), Lactate > 2.0 ULN, hemoglobin < 10.0 mg/dL
Current substance and/or alcohol abuse
Known hypersensitivity to Metformin
Congestive heart failure requiring pharmacologic treatment
Use of cimetidine or planned use during the study period
Hypertrophic obstructive cardiomyopathy
Pregnant or actively seeking pregnancy, breastfeeding
Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for < 3 months.
Presence of active AIDS including cancers
Current viral, bacterial or other infections (excluding HIV)
Weight loss in the past 3 months of greater than 10 pounds
Nitrates or other medications that can alter endothelial function
Contraindication to beta blocker or nitroglycerin use
Patients with previous allergic reactions to iodine-containing contrast media or to iodine
Intervention: Dalcetrapib
Trial phase: Phase 2
SMILES: CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 77
Group description: dalcetrapib (RO4607381): 900mg po daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

patients who have completed treatment on study NC19453.

Exclusion Criteria:

any significant lymph node abnormalities at the end of study NC19453.