anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ferumoxides
Trial phase: Phase 2
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Intravenous injection of Feraheme, 5 mg Fe/kg

Feraheme: 5 mg Fe/kg iv

MR Scan: Standard of Care
Eligibility criteria:
INCLUSION CRITERIA

Age 10 to 21 years
Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis
Informed consent with assent as appropriate.

EXCLUSION CRITERIA

Contraindication to MRI
Presence of metal implants
Need for sedation or anesthesia
Claustrophobia
Hemosiderosis or hemochromatosis
History of allergic reactions to similar compounds will be obtained and patients with positive history of allergic reactions will be excluded from the study
Females who are pregnancy or nursing
Intervention: Nabiximols
Trial phase: Phase 3
ATC code: N02BG10
SMILES: C=C(C)C1CCC(C)=CC1c1c(O)cc(CCCCC)cc1O.CCCCCc1cc(O)c2c(c1)OC(C)(C)C1CCC(C)=CC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 660
Group description: Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
Eligibility criteria:
Inclusion Criteria:

Participant had completed the parent study within the last seven days
Willing and able to give written informed consent
Willing and able to comply with all study requirements

Exclusion Criteria:

The participant was using cannabis or cannabinoid based medications, other than the parent study investigational medicinal product (IMP), and was unwilling to abstain for the duration of the study
Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
Any known or suspected history of a substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer), current heavy alcohol consumption (more than 60 grams [g] of pure alcohol per day for men, and more than 40 g of pure alcohol per day for women), current use of an illicit drug or current non-prescribed use of any prescription drug
Had poorly controlled epilepsy or recurrent seizures (for example, one or more seizure during the last year)
Had experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction
Had significantly impaired renal function
Had significantly impaired hepatic function at the "end of treatment" visit of the parent study
Female participants of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom should not have been used in conjunction with a female condom as this may not have proven effective)
Intervention: Calcitriol
Trial phase: Not Applicable
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Treatment with cholecalciferol 400 IU daily at home.

Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Serum 25-hydroxyvitamin D level <20 ng/ml (<50 nmol/L)
Diagnosed with atopic dermatitis by a CHW pediatric dermatologist
Age 1-18 years old
Primary residence in Milwaukee County
Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis [SCORAD] score greater than 15)
On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)
Intervention: Calcitriol
Trial phase: Not Applicable
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.

Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Serum 25-hydroxyvitamin D level <20 ng/ml (<50 nmol/L)
Diagnosed with atopic dermatitis by a CHW pediatric dermatologist
Age 1-18 years old
Primary residence in Milwaukee County
Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis [SCORAD] score greater than 15)
On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)
Intervention: Methylphenidate Hydrochloride
Trial phase: Phase 3
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 298
Group description: All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).
Eligibility criteria:
Inclusion Criteria:

1. Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)

Exclusion Criteria:

Patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments.
Patients who during the core study developed cardiovascular disorders.
Pregnant women.
Patients who developed seizures during the core study.
Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
Diagnosis or family history of Tourette's syndrome.
Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Sitagliptin
Trial phase: Phase 2
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Exclusion Criteria:

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.
Intervention: Zeven
Trial phase: Phase 3
ATC code: J01XA04
SMILES: CNC1C(=O)NC2Cc3ccc(cc3)Oc3cc4cc(c3OC3OC(C(=O)O)C(O)C(O)C3NC(=O)CCCCCCCCC(C)C)Oc3ccc(cc3Cl)C(O)C3NC(=O)C(NC(=O)C4NC(=O)C(NC2=O)c2cc(cc(O)c2Cl)Oc2cc1ccc2O)c1ccc(O)c(c1)-c1c(OC2OC(CO)C(O)C(O)C2O)cc(O)cc1C(C(=O)NCCCN(C)C)NC3=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 284
Group description: Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
Eligibility criteria:
Inclusion Criteria:

Male or female patients 18 - 85 years of age.
Signed and dated informed consent document.
Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection.
Requires a minimum of 3 days of IV therapy.
Patient willing and able to comply with study procedures.

Exclusion Criteria:

Patients presenting with any of the following:

A contra-indication to any required study drug.
Pregnant or nursing females.
Sustained shock.
Participation in another study of an investigational drug or device within 30 days.
Receipt of a systemically or topically administered antibiotic within 14 days prior to randomization, except receipt of a single dose of a short-acting antibacterial drug 3 or more days prior to randomization.
Infection due to a dalbavancin or vancomycin-resistant organism.
Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection.
Exclusively gram-negative bacterial or a fungal ABSSSI.
Venous catheter infection.
Infection of a diabetic foot ulcer or a decubitus ulcer.
Device-related infections.
Gram-negative bacteremia.
Infected burns.
Infected limb with critical ischemia.
Superficial/simple skin and skin structure infections.
Concomitant condition requiring non-study antibacterial therapy.
ABSSSI requiring therapy for longer than 14 days.
Adjunctive therapy with hyperbaric oxygen.
More than 2 surgical interventions for ABSSSI anticipated.
Chronic inflammatory condition precluding assessment of clinical response.
Absolute neutrophil count < 500 cells/mm3.
Human immunodeficiency virus (HIV) infection with a CD4 cell count < 200 cells/mm3.
Recent bone marrow transplant, > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy.
Life expectancy less than 3 months.
Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
Prior participation in the study.
Intervention: Brivaracetam
Trial phase: Phase 3
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 766
Group description: Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
Eligibility criteria:
Inclusion Criteria:

Subject completed the Treatment Period of N01358 or the evaluation period of N01258
Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible

Exclusion Criteria:

Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
Poor compliance with the visit schedule or medication intake in the previous BRV study
Planned participation in any other clinical study of another investigational drug or device during this study
Pregnant or lactating woman
Any medical condition which, in the Investigator's opinion, warrants exclusion
Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: RDX5791: Capsule, QD
Eligibility criteria:
Inclusion Criteria:

Subject meets Rome III criteria for IBS-C
If > 50 years old, colonoscopy evaluation within 10 years
All ages, negative colonoscopy if any "warning symptoms"
Active disease during 2-week screening period
Compliant with IVRS

Exclusion Criteria:

Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria
Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
Use of medications that are known to affect stool consistency
Subject has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments or prevent completion of study
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: RDX5791: Capsule, QD
Eligibility criteria:
Inclusion Criteria:

Subject meets Rome III criteria for IBS-C
If > 50 years old, colonoscopy evaluation within 10 years
All ages, negative colonoscopy if any "warning symptoms"
Active disease during 2-week screening period
Compliant with IVRS

Exclusion Criteria:

Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria
Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
Use of medications that are known to affect stool consistency
Subject has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments or prevent completion of study
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: 9
Group description: Strattera 10-30 mg b.i.d.

Strattera: 10-30 mg b.i.d. for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Parkinson's disease
Respond to levodopa therapy

Exclusion Criteria:

Dementia
Psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or ADD/ADHD
Any clinically unstable disease such as cancer, HIV/AIDS, heart condition, liver disease, kidney or renal failure or others that might require hospitalization
Evidence for another neurological disease (history of seizures, Alzheimer disease, multiple sclerosis or other movement disorders);
Currently using any of the study drugs;
Colorblindness
Intervention: Rivastigmine
Trial phase: Phase 4
ATC code: N06DA03
SMILES: CCN(C)C(=O)Oc1cccc([C@H](C)N(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Exelon 1.5-4.5 mg b.i.d.

Exelon: 1.5-4.5 mg b.i.d. for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Parkinson's disease
Respond to levodopa therapy

Exclusion Criteria:

Dementia
Psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or ADD/ADHD
Any clinically unstable disease such as cancer, HIV/AIDS, heart condition, liver disease, kidney or renal failure or others that might require hospitalization
Evidence for another neurological disease (history of seizures, Alzheimer disease, multiple sclerosis or other movement disorders);
Currently using any of the study drugs;
Colorblindness
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Varenicline: Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.
Eligibility criteria:
Inclusion Criteria:

Subjects will be diagnosed with Parkinson Disease (PD) by the United Kingdom (UK) Brain Bank criteria.
Subjects will have to be at least stage 2 on the Hoehn and Yahr staging system of PD and have a history of at least 1 fall or near fall in the last 6 months
Subjects must have a stable medication regimen.
All subjects will be over the age of 40 in an attempt to exclude inherited forms of parkinsonism.
Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG are within normal limits (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit).

Exclusion Criteria:

Hoehn and Yahr stage V subjects.
Subjects with a history of major psychiatric disorder, deep brain stimulation surgery, recent cerebral trauma, cardiac arrhythmia, or renal insufficiency.
A cardiovascular procedure in the last 5 years (eg, percutaneous transluminal coronary angioplasty) or have cardiovascular instability (including myocardial infarction or unstable angina). Other cardiovascular exclusions include uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, peripheral vascular disease with prior amputation, or severe congestive heart failure (New York Heart Association class III or IV).
Concurrent treatment with any monoamine oxidase inhibitors (MAOIs), bupropion (Wellbutrin), or nicotine patches.
Dementia or other psychiatric illness that prevents the patient from giving informed consent (Folstein Mini Mental Status Exam score less than 25).
Concurrent treatment with trihexyphenidyl (Artane) or benztropine mesylate (Cogentin).
Significant degree of dysphagia, by history.
Legal incapacity or limited legal capacity.
Presence of severe renal disease (BUN 50% greater than normal or creatinine clearance <60 mL/min) or hepatic disease.
Abnormal creatine kinase and/or platelet count in the past 6 months (as determined by lab reports obtained from primary care physicians or conducted at baseline).
Use of varenicline within the previous 30 days.
Women of childbearing potential who are pregnant at the time of screening or who will not use adequate protection during participation of the study.
Allergy/sensitivity to the drug or its formulations.
Concurrent participation in another clinical study.
Active substance or tobacco use or dependence.
Moderate or severe chronic obstructive pulmonary disease.
Serious illness (requiring systemic treatment/or hospitalization) until the subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 60 days prior to study entry.
Inability or unwillingness of the subject or legal guardian/representative to give written informed consent.
Intervention: Atorvastatin
Trial phase: Phase 4
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: 41
Group description: After the subject take PET CT, he or she is randomized to either " Atorvastatin 20 mg" group or " Atorvastatin 20 mg+ Pioglitazone 30 mg". The " Atorvastatin 20 mg" group is to take atorvastatin 20 mg and take follow up PET CT in 3 months

Atorvastatin 20mg: 20 mg QD for 3 months
Eligibility criteria:
Inclusion Criteria:

The subject who has undergone percutaneous coronary intervention due to coronary artery disease ( stable angina or unstable angina)
The subject described above who has atherosclerotic plaque in his/her carotid artery by carotid ultrasonography
The subject who or a legal representative agrees to the clinical trial and gives written permission to the IRB-approved form.

Exclusion Criteria:

The subjets who have taken statins or thiazolidinedione with 4 weeks
Marked elevated liver enzyme ( more than 2.5 fold compared to reference range)
Renal insufficiency patients ( serum creatinine more than 2 mg/dl)
Congestive heart failure ( NYHA class 2-4)
Acue myocardial infarction
Unstable angina with ST segment deviation
Pregnancy
The subjects enrolled in another studies
Intervention: Ranolazine
Trial phase: Not Applicable
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: 147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.

Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.

500-1,000 mg po bid for 2 weeks Placebo: 500-1,000 mg po bid for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Men or women age >18 from diverse racial/ethnic groups;
Competent to give informed consent;
Patients with chronic angina or its equivalent;
Coronary angiogram revealing MCD with no obstructive CAD (epicardial coronary stenosis <50% luminal diameter stenosis);
Left ventricular ejection fraction > or = 45%;
Objective evidence of ischemia by noninvasive methods such as exercise stress test, stress Echo, MRI, or SPECT;
Patients with 10% myocardial ischemia by Cardiac magnetic resonance imaging (CMRI) myocardial perfusion reserve index ≤ 2.0 or abnormal coronary reactivity testing (CFR < 2.5, or ACH response of no dilation or constriction, determined by local site read).

Exclusion Criteria:

Acute coronary syndrome (defined by WHO), cardiogenic shock or requiring inotropic or intra-aortic balloon support;
Planned percutaneous coronary intervention or CABG or established obstructive CAD with ischemia eligible for revascularization, acute MI;
Prior non-cardiac illness with an estimated life expectancy <4 years;
Unable to give informed consent;
Allergy or contra-indication to CMRI testing, including renal failure, claustrophobia, and asthma, uncontrolled moderate hypertension (sitting blood pressure >160/95mmHg with measurements recorded on at least 2 occasions), conditions likely to influence outcomes: Severe lung, creatinine >1.8 or CrCl ≤ 50ml/min) or hepatic disease;
Surgically uncorrected significant congenital or valvular heart disease and other disease likely to be fatal or require frequent hospitalization within the next six months;
Adherence or retention reasons;
Unwilling to complete follow-up evaluation including repeat testing, documented obstructive hypertrophic cardiomyopathy;
Aortic stenosis (valve area <1.5cm);
LV dysfunction (ejection fraction ≤35%);
History of significant cocaine or amphetamine abuse;
Taking potent CYP3A4 inhibitors (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir);
Women who are pregnant.