anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Atorvastatin
Trial phase: Phase 3
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
Eligibility criteria:
Inclusion Criteria:

Greater than 25 y/o
No occurrence of intra- or post-operative cardiopulmonary arrest
Not consuming drugs affecting atrial rhythm
Having sinus rhythm before surgery
Lack of paroxysmal atrial fibrillation history
Only undergo heart valve surgery
Lack of considerable heart ischemia needed atorvastatin use
Routine cares in ward, post-operative ward, and intensive care unit were done

Exclusion Criteria:

Lesser than 25 y/o
History of atrial fibrillation
History of taking anti-arrhythmic drugs
History of implementing pacemakers
Severe heart failure
Renal failure
Hepatic failure
Severe pulmonary diseases
Heart block or bradyarrhythmia
Routine cares in ward, post-operative ward, and intensive care unit were not done
Performing concomitant cardiac surgery except valve repair
Having considerable heart ischemia needed atorvastatin use
Intervention: Eovist
Trial phase: Phase 3
SMILES: CCOc1ccc(CC(CN(CCN(CC(=O)[O-])CC(=O)[O-])CC(=O)[O-])N(CC(=O)[O-])CC(=O)[O-])cc1.[Gd+3].[Na+].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
Eligibility criteria:
Inclusion Criteria:

Age 0-2 months (must be gestational age 37 to 41 weeks)
Scheduled to undergo routine contrast-enhanced liver MRI
Able to comly with the study procedures

Exclusion Criteria:

Scheduled for any intervention (except lumbar puncture and bone marrow aspiration) during the study period
If receiving chemotherapy, may have a change in treatment during the study period
Contraindication for MRI
Renal insufficiency (estimated glomerular filtration rate < 80% of age-adjusted normal mean value using the Schwartz formula)
Acute renal failure
Clinically relevant abnormal laboratory parameter, ie, greater than 3 times the upper limit of the normal range, in particular, liver enzymes and renal function. (Note: if elevations in liver enzyme levels are consistent with the underlying hepatobiliary disease, then the subject may be enrolled.)
Intervention: Mirabegron
Trial phase: Phase 4
ATC code: G04BD12
SMILES: Nc1nc(CC(=O)Nc2ccc(CCNC[C@H](O)c3ccccc3)cc2)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily

Mirabegron: see detailed information in associated Arm Description
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of Multiple Sclerosis (MS) (no sub-type restrictions)
Age ≥18
No change in disease modifying therapy in 60 days.
Patient willing and able to complete micturition diary
Urinary urgency (8 or more entries of bladder urgency score ≥2) in 72hr voiding diary recorded during screening period
Micturition frequency ≥ 8 / day or incontinence ≥ 2 episodes in 72 hour voiding diary recorded during screening period
At least 36 hours of voiding activity recorded in 72 hour voiding diary during screening period
Non-antimuscarinic medications that are likely to influence bladder function may not be initiated between screening and study completion. They may be continued with no dose changes during the study.
Discontinued use of antimuscarinics at least two weeks prior to screening
Able to give informed consent

Exclusion Criteria:

Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures)
Multiple Sclerosis exacerbation within 30 days of screening
Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing
Screening blood pressure > 165 systolic or 100 diastolic
History of allergy to Mirabegron
Screening post-void residual > 200ml
Evidence of urinary tract infection at screening
Evidence of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
Intravesical botulinum toxin treatment within the previous six months of screening.
Presence of InterStim device
Use of indwelling catheter or self-catheterization
Concurrent use of thioridazine(Mellaril® or Mellaril-S®, flecainide (Tambocor®), propafenone (Rythmol®) or digoxin (Lanoxin®)
Concurrent use of antimuscarinics: oxybutynin (Ditropan®, Ditropan XL ®), tolterodine (Detrol®, Detrol LA®), fesoterodine extended-release (Toviaz®), solifenacin (Vesicare®), trospium (Sanctura®, Sanctura XR®), darifenacin extended release (Enablex®)
Screening estimated glomerular filtration rate (eGFR) < 60, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal
Any other serious and/or unstable medical condition
Intervention: Tranexamic acid
Trial phase: Phase 3
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 447
Group description: 1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
Eligibility criteria:
Inclusion Criteria:

Blunt or penetrating injured patients at risk of bleeding being transported via air or ground medical services from the scene of injury or from referring hospital to a definitive trauma center that is participating in the trial AND
Within 2 hours of time of injury AND

Hypotension (Systolic Blood Pressure (SBP) < 90mmHg)

At scene of injury or during air or ground medical transport
Documented at referring hospital prior to air or ground medical transport arrival

OR

Tachycardia (heart rate >110 beats per minute)

At scene of injury or during air or ground medical transport
Documented at referring hospital prior to air or ground medical transport arrival

Exclusion Criteria:

Age > 90 or < 18 years of age
Inability to obtain intravenous access or intraosseous
Documented (radiographic evidence) cervical cord injury with motor deficit
Known prisoner
Known pregnancy
Traumatic arrest with > 5 minutes CPR without return of vital signs
Penetrating cranial injury
Traumatic brain injury with brain matter exposed
Isolated drowning or hanging victims
Wearing an opt out bracelet.
Isolated fall from standing
Patient or Family Objection at scene
Intervention: Injectafer
Trial phase: Phase 4
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 99
Group description: 2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg

Injectafer: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg
Eligibility criteria:
Inclusion Criteria:

Signed informed consent
Male or female subjects ≥ 18 years of age with clinical diagnosis of IDA secondary to IBD or Gastric Bypass
Screening Hemoglobin (Hb) ≤ 11g/dL
Screening Ferritin ≤ 100 ng/mL
Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study

Exclusion Criteria:

Hypersensitivity reaction to any component of IV Injectafer or oral iron
Requires dialysis for treatment of chronic kidney disease (CKD)
During the 30 day period prior to screening has been treated with IV iron
No evidence of iron deficiency
During the 30 day period prior to screening has been treated with a red blood cell transfusion.
Any non-viral infection
Known positive hepatitis with evidence of active disease
Received an investigational drug within 30 days of screening
Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary
Alcohol or drug abuse within the past 6 months
Hemochromatosis or other iron storage disorders
Pregnant
Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with the study requirements
Intervention: Brimonidine
Trial phase: Phase 2
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 154
Group description: 400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
Eligibility criteria:
Inclusion Criteria:

Geographic atrophy due to age-related macular degeneration in the study eye
Visual acuity better than or equal to 20/125 Snellen equivalent in the study eye and 20/200 Snellen equivalent in the fellow eye.

Exclusion Criteria:

Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in the last 3 months
Infections in either eye in the last 3 months
Intervention: Acetylcysteine
Trial phase: Not Applicable
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).
Eligibility criteria:
Inclusion Criteria:

subjects were aged 18-80 years old;
a diagnosis of idiopathic or post-infective bronchiectasis was made;
patients had at least two exacerbations in the past year and were in a stable state for at least 4 weeks prior to the primary enrollment.

Exclusion Criteria:

Patients were excluded if they fulfilled any of the following criteria: current smokers; cigarette smoking within 6 months; cystic fibrosis or other etiologies (such as immunodeficiency, allergic bronchopulmonary aspergillosis, traction bronchiectasis caused by emphysema, advanced pulmonary fibrosis, etc.); pulmonary function test results showing a forced expiratory volume in 1 s (FEV1) ≤ 30% of the predicted value; a history of severe cardiovascular or neurological disease; comorbidity with liver disease, kidney disease, malignant tumor, gastric ulcer, or intestinal malabsorption; a known allergy to N-acetylcysteine; pregnancy or lactation (for women); a history of prior macrolide use of more than 1 week; and poor compliance.
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 160
Group description: Drug treatment
Eligibility criteria:
Inclusion Criteria:

Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber lens
Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion Criteria:

Any intraocular inflammation in the study eye present during the screening slit lamp examination
Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
Any intraocular inflammation in the study eye present during the screening slit lamp examination
Intervention: Apixaban
Trial phase: Phase 4
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: apixaban 5 mg or 2.5 mg po bid

apixaban: 5 po or 2.5 po bid.
Eligibility criteria:
Inclusion Criteria:

Eligible patients with atrial fibrillation or flutter
Age 18-84 years
Willingness to participate in the study and ability to sign informed consent.

Exclusion Criteria:

Atrial fibrillation due to a reversible cause
moderate or severe mitral stenosis
conditions other than atrial fibrillation that require anticoagulation (e.g., a prosthetic heart valve)
A need for aspirin at a dose of >165 mg a day or for both aspirin and P2Y-inhibitor
Serious bleeding event in the previous 6 months or a high risk of bleeding (eg, active peptic ulcer disease)
a platelet count of <100,000/mm3 or hemoglobin level of <10 g/dL
stroke within the previous 10 days
documented hemorrhagic tendencies, or blood dyscrasias
Renal insufficiency (serum creatinine level of 12.5 mg per deciliter or calculated creatinine clearance of <50 ml per minute)
Weight in excess of 325 pounds
Resting hypotension (systolic blood pressure of <90mmHg) or resting hypertension (systolic blood pressure of >170mmHg or diastolic blood pressure of >110 mmHg)
History of active malignancy requiring concurrent chemotherapy
Known allergy to iodinated contrast material
pregnancy, women of childbearing potential unwilling to use adequate contraception.
Intervention: Warfarin
Trial phase: Phase 4
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: warfarin with target INR of 2-3

warfarin
Eligibility criteria:
Inclusion Criteria:

Eligible patients with atrial fibrillation or flutter
Age 18-84 years
Willingness to participate in the study and ability to sign informed consent.

Exclusion Criteria:

Atrial fibrillation due to a reversible cause
moderate or severe mitral stenosis
conditions other than atrial fibrillation that require anticoagulation (e.g., a prosthetic heart valve)
A need for aspirin at a dose of >165 mg a day or for both aspirin and P2Y-inhibitor
Serious bleeding event in the previous 6 months or a high risk of bleeding (eg, active peptic ulcer disease)
a platelet count of <100,000/mm3 or hemoglobin level of <10 g/dL
stroke within the previous 10 days
documented hemorrhagic tendencies, or blood dyscrasias
Renal insufficiency (serum creatinine level of 12.5 mg per deciliter or calculated creatinine clearance of <50 ml per minute)
Weight in excess of 325 pounds
Resting hypotension (systolic blood pressure of <90mmHg) or resting hypertension (systolic blood pressure of >170mmHg or diastolic blood pressure of >110 mmHg)
History of active malignancy requiring concurrent chemotherapy
Known allergy to iodinated contrast material
pregnancy, women of childbearing potential unwilling to use adequate contraception.
Intervention: Ozenoxacin
Trial phase: Phase 3
ATC code: D06AX14
SMILES: CNc1ncc(-c2ccc3c(=O)c(C(=O)O)cn(C4CC4)c3c2C)cc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 412
Group description: ozenoxacin cream 1%

Ozenoxacin
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients < 12 years the total area will not exceed a maximum of 2% of the body surface area.
Total Skin Infection Rating Scale (SIRS) score of at least 3, including pus/exudate score of at least 1

Exclusion Criteria:

Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)
Intervention: Ataluren
Trial phase: Phase 3
ATC code: M09AX03
SMILES: O=C(O)c1cccc(-c2noc(-c3ccccc3F)n2)c1
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 218
Group description: Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for up to 144 weeks.
Eligibility criteria:
Inclusion Criteria:

Completion of study treatment in the previous Phase 3, double-blind study (PTC124-GD-020-DMD).
Evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial. Note: If the study candidate is considered a child under local regulation, a parent or legal guardian must provide written consent prior to initiation of study screening procedures and the study candidate may be required to provide written assent. The rules of the responsible Institutional Review Board/Independent Ethic Committee (IRB/IEC) regarding whether 1 or both parents must provide consent and the appropriate ages for obtaining consent and assent from the participant should be followed.
In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the period of study drug administration and 6-week follow-up period.
Willingness and ability to comply with scheduled visits, ataluren administration plan, study procedures, laboratory tests, and study restrictions.

Exclusion Criteria:

Known hypersensitivity to any of the ingredients or excipients of the study drug (Litesse® UltraTM [refined polydextrose], polyethylene glycol 3350, Lutrol® micro F127 [poloxamer 407], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla, Cab-O-Sil® M5P [colloidal silica], and magnesium stearate).
Ongoing participation in any other therapeutic clinical trial.
Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, electrocardiogram (ECG) findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
Intervention: Cannabidiol
Trial phase: Phase 3
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Participants received 20 mg/kg/day of GWP42003-P administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Eligibility criteria:
Key Inclusion Criteria:

Participants were male or female aged between 2 and 18 years (inclusive).
Participants had a documented history of Dravet Syndrome that was not completely controlled by current antiepileptic drugs.
Participants took one or more antiepileptic drugs at a dose that had been stable for at least four weeks.
All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) were stable for four weeks prior to screening and participants were willing to maintain a stable regimen throughout the study.

Key Exclusion Criteria:

Participants had clinically significant unstable medical conditions other than epilepsy.
Participants had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization, other than epilepsy.
Participants were currently using or had in the past used recreational or medicinal cannabis or synthetic cannabinoid based medications (including Sativex®) within the three months prior to study entry and were unwilling to abstain for the duration for the study.
Participants had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
Participants had been part of a previous clinical trial involving another investigational product in the previous six months.
There were plans for the participants to travel outside their country of residence during the study.
Participants previously randomized into this study. In particular, participants who participated in Part A of the study could not enter Part B.
Intervention: Ruxolitinib
Trial phase: Phase 2
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: All participants received ruxolitinib.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of PMF, PPV MF or PET-MF, irrespective of JAK2 mutational status according to the 2008 revised International Standard Criteria
Peripheral blast count < 10%
Requires therapy for MF in the opinion of the investigator
Received prior monotherapy treatment with ruxolitinib for at least 12 consecutive weeks and experienced treatment interruption because of lossof response or adverse event
Patients adhering to the Screening phase assessments and undergoing a a ruxolitinib-free washout period of a minimum of 1 week and a maximum of 8 weeks
ECOG performance status 0, 1, 2, or 3
Adequate bone marrow function
Written informed consent

Exclusion Criteria:

Patients not initially responding (primary resistance) to ruxolitinib therapy
Patients who underwent a splenectomy or spleen radiation
Patients currently scheduled for bone marrow transplant
Patients who have discontinued ruxolitinib < 14 days prior to screening
Patients who are not able to receive a starting dose of ruxolitinib of at least 15 mg total daily dose
Leukemic transformation
Inadequate renal function
Presence of clinically meaningful active bacterial, fungal, parasitic or viral infection which requires therapy
Previous history of Progressive Multifocal Leuko-encephalopathy (PML)
Clinically significant cardiac disease or significant concurrent medical condition
Intervention: Ticagrelor
Trial phase: Phase 1 | Phase 2
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 53
Group description: All participants will switch from clopidogrel to ticagrelor for two weeks
Eligibility criteria:
Inclusion Criteria:

Patients with diagnosis of CLI (Rutherford class IV, V and VI) on continuous dual antiplatelet therapy with aspirin 81 mg and clopidogrel 75 mg daily for at least 14+2 days .

Exclusion Criteria:

Chronic use of nonsteroidal anti-inflammatory drugs, thrombocytopenia (platelet count <100 × 103/μl), hemoglobin <10 g/dL, use of an oral anticoagulant (warfarin) or low molecular weight heparin within 14 days, GPIIb/IIIa inhibitors, or fibrinolytic drugs within 30 days. Pregnancy, <18 or >80 years of age, current smoking (>1 pack per day), concomitant therapy with strong cytochrome P450 3A inhibitors or inducers within 14 days, concomitant antithrombotic therapy other than aspirin within 14 days, hypercoaguable states. History of medication non-compliance, drug or alcohol abuse within 2 years. Acute coronary syndrome or coronary drug-eluting stenting within 1 year. Peripheral vascular revascularization procedures (surgical or endovascular) and/or amputation within one month. Contraindications for ticagrelor including: hypersensitivity to ticagrelor or any of the excipients, Active pathological bleeding, History of intracranial hemorrhage and Severe hepatic impairment.