anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Methylphenidate Hydrochloride
Trial phase: Phase 4
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 133
Group description: Methylphenidate extended-release capsules taken once daily.
Eligibility criteria:
Inclusion Criteria:

Patients with a physician-confirmed diagnosis of ADHD per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and the health care practitioner (HCP) has made the decision to prescribe an extended-release methylphenidate (ER MPH) product to the patient for potential improvement of symptoms throughout and later in the day, independent of this study.
Patient must be 12 years of age or older.
Patient must be eligible to receive Adhansia XR or osmotic- release oral delivery system methylphenidate ([OROS MPH] or Concerta) according to the US product labels; a patient must be eligible and willing to receive either drug, as randomization will assign them to a specific treatment group. Patient may be treatment-experienced or naïve to pharmacological therapy for ADHD, so long as all inclusion and no exclusion criteria are met.
Patient must be willing to take only the assigned study medication per HCP instructions based on FDA label guidance for treatment of their ADHD for the first 2 months of the study (i.e. full titration period). Patients should not be on any other medication, or starting any new non-medication treatment, proven to have effect on ADHD in the first two months of the study.

Exclusion Criteria:

Concurrent participation in an investigational study in which patient assessment and/or treatment may be dictated by a protocol.
Patients with a true allergy to methylphenidate (MPH), amphetamine (AMP), or sympathomimetic amines, history of serious adverse reactions to MPH or AMP or be known to be non-responsive to MPH or AMP treatment.
Patient is currently stable on their ADHD treatment regimen.
Female patients of child bearing potential who are pregnant, planning on becoming pregnant or breastfeeding.
Patient with any known conditions that are contraindicated for either Adhansia XR or OROS MPH (or Concerta) use, as documented in the US Full Prescribing Information, including patients with any known serious structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
Patients with a known sensitivity to the food dye tartrazine (Federal Food, Drug, and Cosmetic Yellow No. 5).

Suicidal Ideation

The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered at screening and at Month-2, Month-4, and Month-6, but also depends on the judgment of the HCP.
Inability or unwillingness of the patient (or parent/guardian if patient is a minor) to complete the study-required electronic questionnaires and provide required information through electronic means.
Intervention: Methylphenidate
Trial phase: Phase 4
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.
Eligibility criteria:
Inclusion Criteria:

Patients with a physician-confirmed diagnosis of ADHD per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and the health care practitioner (HCP) has made the decision to prescribe an extended-release methylphenidate (ER MPH) product to the patient for potential improvement of symptoms throughout and later in the day, independent of this study.
Patient must be 12 years of age or older.
Patient must be eligible to receive Adhansia XR or osmotic- release oral delivery system methylphenidate ([OROS MPH] or Concerta) according to the US product labels; a patient must be eligible and willing to receive either drug, as randomization will assign them to a specific treatment group. Patient may be treatment-experienced or naïve to pharmacological therapy for ADHD, so long as all inclusion and no exclusion criteria are met.
Patient must be willing to take only the assigned study medication per HCP instructions based on FDA label guidance for treatment of their ADHD for the first 2 months of the study (i.e. full titration period). Patients should not be on any other medication, or starting any new non-medication treatment, proven to have effect on ADHD in the first two months of the study.

Exclusion Criteria:

Concurrent participation in an investigational study in which patient assessment and/or treatment may be dictated by a protocol.
Patients with a true allergy to methylphenidate (MPH), amphetamine (AMP), or sympathomimetic amines, history of serious adverse reactions to MPH or AMP or be known to be non-responsive to MPH or AMP treatment.
Patient is currently stable on their ADHD treatment regimen.
Female patients of child bearing potential who are pregnant, planning on becoming pregnant or breastfeeding.
Patient with any known conditions that are contraindicated for either Adhansia XR or OROS MPH (or Concerta) use, as documented in the US Full Prescribing Information, including patients with any known serious structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
Patients with a known sensitivity to the food dye tartrazine (Federal Food, Drug, and Cosmetic Yellow No. 5).

Suicidal Ideation

The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered at screening and at Month-2, Month-4, and Month-6, but also depends on the judgment of the HCP.
Inability or unwillingness of the patient (or parent/guardian if patient is a minor) to complete the study-required electronic questionnaires and provide required information through electronic means.
Intervention: Simvastatin
Trial phase: Phase 4
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Following the baseline period, subject will be randomized to receive either simvastatin or an identical placebo at a dose of 40 mg/day for a period of 10 weeks.

Simvastatin 40mg: 40mg oral daily for 10 weeks
Eligibility criteria:
Inclusion

• Adults, age > 18 ys or < 80 yrs. Patients reporting complaints of statin-associated muscle symptoms, aches, weakness, cramps, or stiffness in the legs.

Exclusion Criteria

Patient who drink large quantities of grapefruit juice (> 1 quart daily).
Patients on the following drugs for which the FDA has issued restrictions for using simvastatin 40 mg daily do to an increased risk of severe muscle injury such as itraconazole, posaconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV-1 protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, amlodipine, ranolazine, and verapamil.
Patients with muscle-related pain that is not related to statin-use (e.g. muscle aches from strain or trauma) or remains unexplained.
Any patients with underlying non-statin related muscle disorders.
Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins.
Conditions of severe acute vascular stress (acute coronary syndrome, ischemic stroke, or major vascular surgery) within prior 3 months.
Any patients with a history of severe or life-threatening reactions to statins including rhabdomyolysis (defined as evidence of organ damage with CK >10,000 IU/L), CK elevation > 10 times the upper limit of normal, cognitive decline, transaminitis, or allergic reactions.
History of fibromyalgia or rheumatologic disease with symptoms that may be confounded with statin-related muscle complaints.
Patients unable to maintain their current activity level or planning to increase their activity level (e.g. new exercise regimen). Such changes may have acute effects on muscle metabolism.
Pregnant or breast-feeding women. Statins are teratogenic, and the effects of high magnetic fields on a fetus are unknown.
Women of reproductive age not on effective contraception. Adequate contraceptive measures include intrauterine device (IUD); bilateral tubal ligation; condom or diaphragm plus either contraceptive sponge, foam or jelly.
Any person with implanted metal, because of MRS safety.
Use of any active investigational drugs within 1 month or 5 half-lives, whichever is longer.
History of antibodies to HMGCoA.
Intervention: Rivaroxaban
Trial phase: Phase 3
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 599
Group description: Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
Eligibility criteria:
Inclusion Criteria:

Coronavirus Disease 2019 (COVID-19) positive diagnosis by locally obtained viral diagnostic test (example, polymerase chain reaction [PCR]). This may be nasal swab or saliva test or other available technology to demonstrate current infection
Confirm that participant is known to health system, with at least 1 contact in electronic medical records (EMR) prior to screening
Symptoms attributable to COVID-19 (example, fever, cough, loss of taste or smell, muscle aches, shortness of breath, fatigue)
Initial treatment plan does not include hospitalization
Presence of at least 1 additional risk factor: a) age more than or equal to (>=) 60 years; b) prior history of VTE; c) history of thrombophilia; d) history of coronary artery disease (CAD); e) history of peripheral artery disease (PAD); f) history of cerebrovascular disease or ischemic stroke; g) history of cancer (other than basal cell carcinoma) h) history of diabetes requiring medication; i) history of heart failure; j) body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter square (kg/m^2); k) D-dimer greater than (>) upper limit of normal for local laboratory (within 2 weeks of the date of the COVID-19 test and prior to randomization)

Exclusion Criteria:

Increased risk of bleeding such as a) significant bleeding in the last 3 months; b) active gastroduodenal ulcer in the last 3 months; c) history of bronchiectasis or pulmonary cavitation; d) need for dual antiplatelet therapy or anticoagulation; e) prior intracranial hemorrhage, f) known severe thrombocytopenia g) active cancer and undergoing treatment
Any illness or condition that in the opinion of the investigator would significantly increase the risk of bleeding (example recent trauma, recent surgery, severe uncontrolled hypertension, gastrointestinal cancer, renal failure requiring dialysis, severe liver disease, known bleeding diathesis)
Known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
Positive COVID-19 antibody or serology test after 2-week period of acute, symptomatic COVID-19 infection
Known diagnosis of triple positive (positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies) antiphospholipid syndrome
Intervention: Cyclobenzaprine Hydrochloride
Trial phase: Phase 3
SMILES: CN(C)CCC=C1c2ccccc2C=Cc2ccccc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 256
Group description: 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.

TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

The patient is male or female 18 to 65 years of age, inclusive.
The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.

Exclusion Criteria:

- History of or evidence for a diagnosis of borderline personality disorder (BPD).
Intervention: Droxidopa
Trial phase: Phase 4
ATC code: C01CA27
SMILES: N[C@H](C(=O)O)[C@H](O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: 100-600mg droxidopa TID

Droxidopa 100 MG [Northera]: droxidopa taken three times a day titrated up to a maximum of 600 mg.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of idiopathic Parkinson's Disease, meeting UK Brain Bank criteria for at least 3 years
Hoehn and Yahr (H&Y) stage I-III
Age between 30 and 80 years old (both inclusive)
Stable dosage of dopaminergic medications for at least 4 weeks
Orthostatic Hypotension, defined as a fall in systolic BP ≥ 20 mmHg or diastolic BP ≥ 10 mmHg within 3 minutes of standing
Willingness and ability to comply with scheduled visits

Exclusion Criteria:

Diabetes mellitus or other diseases potentially associated with autonomic dysfunction
Treatment with antihypertensive drugs or with alpha-adrenergic antagonists
Cognitive impairment, defined as a score < 24 at the Montreal Cognitive Assessment (MoCA)
Any atypical signs lowering the diagnostic certainty for PD
Lack of postural reflex defined as a score > 2 at the MDS-UPDRS item 3.12 (recover at the pull test)
Severe levodopa induced dyskinesia, defined as an MDS-UPDRS item 4.2 > 2 (functional impact of dyskinesia)
Intervention: Trimetazidine
Trial phase: Not Applicable
ATC code: C01EB15
SMILES: COc1ccc(CN2CCNCC2)c(OC)c1OC
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Treatment of trimetazidine in addition to standart therapy

Trimetazidine
Eligibility criteria:
Inclusion Criteria:

treated for atrial fibrillation with radiofrequency ablation
cardiac disease
providing written informed consent

Exclusion Criteria:

Congenital and acquired heart defects.
Acute coronary syndrome (unstable angina, myocardial infarction), myocardial revascularization during the previous 6 months
Transient ischemic attack, stroke in history.
Arterial hypertension (BP ≥160/100 мм. рт. ст.)
The risk of thromboembolic complications on a scale CHA2DS2-VASc> 2
Risk of hemorrhagic complications of anticoagulant therapy (HAS-BLED> 3 points on the scale).
Complications after RFA.
Chronic heart failure above III FC (NYHA), ejection fraction (EF) <40%.
Acute thrombophlebitis, complicated forms of varicose veins (thrombophlebitis, phlebothrombosis).
Pronounced atherosclerosis of peripheral arteries (intermittent claudication), requiring surgical intervention.
Violation of conductivity: AV-blockade 2-3 degrees, complete blockade of the bundle of the His bundle
The presence of an implanted pacemaker pacemaker / pacemaker with a resynchronization function/cardioverter-defibrillator)
Conduct RFA on AF earlier.
The presence of a history of syncopal states.
Diabetes mellitus type 1 and 2 in the stage of decompensation.
Acute conditions: infection, exacerbation of chronic diseases in a period of less than 1 month prior to the study; severe injury, surgical interventions other than RFA for a period of less than 2 months from the start of the study
Renal failure (creatinine levels above 300 µmol / L or 3.5 mg / dL).
Patient's refusal to participate in the study
Alcohol and drug abuse.
Peptic ulcer and duodenal ulcer in history.
Obesity, body mass index (BMI) ≥40 kg / m2
Intake of Trimetazidine MB and its analogues for 3 months. before inclusion in research.
The presence of any disease that, according to the doctor, prevents the inclusion of the patient in the study.
unable to understand study instructions
with considerable illness in the musculoskeletal system or with physical disability, which complicates exercise training
Intervention: 3-[5-(azetidine-1-carbonyl)pyrazin-2-yl]oxy-5-[(2S)-1-methoxypropan-2-yl]oxy-N-(5-methylpyrazin-2-yl)benzamide
Trial phase: Phase 2
SMILES: COCC(C)Oc1cc(Oc2cnc(C(=O)N3CCC3)cn2)cc(C(=O)Nc2cnc(C)cn2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: 50mg film-coated tablets at a dose of 100mg BID

AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
Eligibility criteria:
Inclusion Criteria:

Male or Female.
Aged 18 and older.
Have either Type I or Type II Diabetes Mellitus.
Hospitalised with suspected or confirmed novel coronavirus (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)) infection at time of enrolment, categorised as stage 3, 4 or 5 on the WHO Ordinal Scale for Clinical Improvement.
Blood glucose level at or above 4 mmol/L.
Able to take oral (tablet) formulation of medication.
Patient is able to provide written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

In the opinion of the clinical team, progression to intubation or mechanical ventilation is imminent and inevitable, within the next 24 hours, irrespective of the provision of treatments.
Patients admitted with primary suspected or proven Mycoplasma pneumoniae, Chlamydia pneumoniae and bacterial pneumonia, who acquired COVID-19 while hospitalized.
Treatment with immunomodulators or anti-rejection drugs within the last 3 months.
Pregnant or breast feeding.
Men, and women of child-bearing potential, unwilling to use highly effective contraception during their participation in the trial and for 2 weeks after study completion.
Anticipated transfer to another hospital which is not a study site within 72 hours.
Known sensitivity to any of the study medication/placebo excipients.
Prior dosing with AZD1656 on a previous clinical trial.
Patients admitted as a result of and receiving immediate treatment for an acute asthmatic attack, acute myocardial infarction, acute cerebrovascular event.
Any known non-COVID-19, non-diabetes related, serious condition which, in the opinion of the clinical team, makes the patient unsuitable for the trial.
Known history of drug or alcohol abuse within previous 12 months of screening.
Known history of HIV, hepatitis C or unresolved hepatitis B or severe liver disease.
Current or planned use of gemfibrozil or any other strong inhibitors of CYP2C8.
Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecule treatment(s) within 30 days or 5 half-lives (whichever is longer) prior to enrolment into this study, or containing biological treatment(s) within 3 months prior to entry into this study.
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 20 mL saline

EXPAREL (bupivacaine liposome injectable suspension)
Eligibility criteria:
Inclusion Criteria:

Healthy adult male or female volunteers ages 18 or older
American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
Able to provide informed consent, adhere to the study schedule, and complete all study assessments
Body Mass Index (BMI) ≥18 and ≤40 kg/m2

Exclusion Criteria:

Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, nonsteroidal anti-inflammatory drugs [NSAIDs])
Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion, may confound the post dosing assessments
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
Previous participation in an EXPAREL study
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
Currently pregnant, nursing, or planning to become pregnant during the study
Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study.
Currently on a neuromodulating agent neuroleptic agent (e.g., gabapentin, pregabalin [Lyrica], duloxetine [Cymbalta], etc.)
Inadequate sensory function on the foot (monofilament test)
Chronic opioid use within 30 days prior to randomization (average ≥30 oral morphine equivalents/day)
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 3
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: subjects randomized to this treatment arm will receive 40 mL (100 mg) 0.25% bupivacaine HCl.

Bupivacaine Hydrochloride: 0.25% bupivacaine
Eligibility criteria:
Inclusion Criteria:

Healthy adult male or female volunteers ages 18 or older
American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
Able to provide informed consent, adhere to the study schedule, and complete all study assessments
Body Mass Index (BMI) ≥18 and ≤40 kg/m2

Exclusion Criteria:

Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, nonsteroidal anti-inflammatory drugs [NSAIDs])
Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion, may confound the post dosing assessments
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
Previous participation in an EXPAREL study
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
Currently pregnant, nursing, or planning to become pregnant during the study
Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study.
Currently on a neuromodulating agent neuroleptic agent (e.g., gabapentin, pregabalin [Lyrica], duloxetine [Cymbalta], etc.)
Inadequate sensory function on the foot (monofilament test)
Chronic opioid use within 30 days prior to randomization (average ≥30 oral morphine equivalents/day)