anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 160
Group description: Ibuprofen 10 mg/kg oral single dose
Eligibility criteria:
Inclusion Criteria:

Children with migraine without aura (MoA) diagnosed according to the criteria for pediatric age of the International Classification of Headache Disorders (IHS-2)
aged from 5 to 18 years
at least four attacks /month

Exclusion Criteria:

mental retardation (IQ <70)
genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome)
hypothyroidism
psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD),
neuromuscular disorders,
epilepsy,
obesity (BMI>95 percentiles),
liver or renal diseases,
gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn;
hypersensitivity to medication studies.
Intervention: Bupivacaine
Trial phase: Phase 4
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: 2
Group description: in this group, plain bupivacaine will be used to block femoral and sciatic nerve

Bupivacaine
Eligibility criteria:
Inclusion Criteria:

age 18-75, no contraindication to regional anesthesia

Exclusion Criteria:

peripheral neuropathy
Intervention: Bupivacaine
Trial phase: Not Applicable
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: 5
Group description: Control

Bupivacaine
Eligibility criteria:
Inclusion Criteria:

age 18-75, no contraindication to regional anesthesia,

Exclusion Criteria:

opioid user, chronic pain conditions, peripheral neuropathy
Intervention: Bupivacaine
Trial phase: Phase 4
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: 4
Group description: Plain bupivacaine

Bupivacaine: Control
Eligibility criteria:
Inclusion Criteria:

Age 18-75
foot surgery
no contraindication to regional anesthesia

Exclusion Criteria:

opioid dependent
chronic pain condition
peripheral neuropathy
Intervention: Dutasteride
Trial phase: Phase 4
ATC code: G04CA52 | G04CB02
SMILES: [H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1([H])C(=O)Nc1cc(C(F)(F)F)ccc1C(F)(F)F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: 4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Dutasteride
Eligibility criteria:
Inclusion Criteria:

an average weekly ethanol consumption of at least 24 standard drinks;
be able to read English at the 8th grade or higher level;
no evidence of significant cognitive impairment;
be willing to provide signed, informed consent to participate in the study (including a willingness to stop or reduce drinking to non-hazardous levels);
be willing to nominate an individual who will know the patient's whereabouts to facilitate follow up during the study

Exclusion Criteria:

history of significant alcohol withdrawal symptoms (e.g. substantial tremor, autonomic changes, perceptual distortions, seizures, delirium, or hallucinations);
current Diagnostic and Statistical Manual Version IV (DSM-IV) diagnosis of Alcohol Dependence who on clinical examination by a physician, are deemed to be too severely alcohol dependent to permit them to participate in a placebo-controlled study (e.g. evidence of serious adverse medical or psychiatric effects that are exacerbated by heavy drinking and would, for safety reasons, lead the physician to urge the patient to be totally abstinent and engage in an empirically supported treatment).
current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation,(we will not exclude patients with hypertension, diabetes mellitus, asthma or other common medical conditions, if these are adequately controlled and the patient has an ongoing relationship with a primary care provider)
serious psychiatric illness on the basis of history or psychiatric examination (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mental disorder, current clinically significant eating disorder, or substantial suicide or violence risk);
current DSM-IV diagnosis of drug dependence (other than nicotine dependence);
currently taking psychotropics other than medication for depression/anxiety disorder (with stable dose for at least 4 weeks),medications for treatment of Attention Deficit/Hyperactivity Disorder (with stable dose for at least 4 weeks), a non-benzodiazepine sleep medication or a low dose of benzodiazepine equivalent to 2 mg clonazepam or lorazepam per day;
are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 150
Group description: 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm

Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement
Eligibility criteria:
Inclusion Criteria:

Males or females > 18 y.o.
Ability to speak, read, an/or understand English
Ability to communicate a level of pain via the specified pain scale
A written order exists for an intravenous peripheral catheter insertion for the patient

Exclusion Criteria:

Lidocaine allergy
Buffered lidocaine allergy
Benzyl alcohol allergy
Non-English speaking
Non-responsive or unable to understand or report pain score (ex. intubated in the ICU)
Inability to place catheter
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 130
Group description: 4,000 IU of VD3 for one year

Vitamin D3: 4,000 IU of VD3 for at least one year
Eligibility criteria:
Inclusion Criteria:

Male 19 - 90 years old - Low-grade prostate cancer
Clinical Stage T1C or T2a
Serum PSA < 10.0 ng/ml
Gleason Score < or = to 6 (either architectural pattern < or = to 3)
Decision to monitor prostate cancer in Active Surveillance
Serum creatinine < 2.0 mg/dL
Serum phosphorus > 2.3 and < 4.8 mg/dL
Serum calcium > 8.5 and < 10.5 mg/dL
Must be capable of giving consent to participate in the study

Exclusion Criteria:

Any concurrent malignancy, except non-melanoma skin cancer
History of sarcoidosis
History of Primary Hyperparathyroidism
History of hypercalcemia
Vitamin D supplementation > 2,000 IU daily
Lithium medication
Intervention: Theophylline
Trial phase: Not Applicable
ATC code: R03DA04 | R03DA20 | R03DA54 | R03DA74 | R03DB04
SMILES: Cn1c(=O)c2[nH]cnc2n(C)c1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Patients will receive aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.

Theophylline drug levels will be monitored daily for 4 days. Target theophylline level is 5-7mcg/ml. Aminophylline dosing will be adjusted in order to achieve desired levels as stated in the study protocol.
Eligibility criteria:
Inclusion Criteria:

Pediatric kidney transplant recipients less than 21 years of age
Patients undergoing deceased donor (DD) kidney transplants

Exclusion Criteria:

Known history of non-sinus tachycardia
Multiple organ transplants recipients
Severe liver dysfunction
graft was placed on pump after harvesting
Intervention: Budesonide and formoterol fumarate dihydrate
Trial phase: Phase 4
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1.COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo

Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.

Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.
Eligibility criteria:
Inclusion Criteria:

Outpatients subjects of either sex between ages 40-80 years, with a diagnosis of COPD. COPD will be characterized as the presence of airflow obstruction with an FEV1/FVC < 0.7 (Forced Expiratory Volume at one second / Forced Vital Capacity) and a FEV1 (Forced Expiratory Volume at one second ) 80% of predicted. All patients must have lung hyperinflation as demonstrated by an increase of ≥100 ml after the administration of budesonide/formoterol. All patients must have a cigarette smoking history of more than 10 pack-years, and be able to perform all the specified procedures as required by the protocol.

Exclusion Criteria:

Patients with other significant diseases (recent < 6 weeks COPD exacerbation) that could place the patient at risk because of participation in the study, or which may influence the results of the study or the patients' ability to participate in the study.
All patients with a recent (<1 year) history of myocardial infarction, or with a recent history of heart failure (NYHA class III and IV, pulmonary edema, or patients with cardiac arrhythmias.
Patients on daytime oxygen therapy.
Patients with known active tuberculosis.
Patients with a history of active cancer except for non-metastatic skin cancer.
Patients who have undergone thoracotomy, sternotomy, major cardiopulmonary intervention (lung resection, open heart surgery, etc), or other procedure in the 6 months prior to evaluation likely to cause instability of pulmonary status.
Patients with upper respiratory infection in the past six weeks.
Intervention: Divalproex Sodium
Trial phase: Not Applicable
SMILES: CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
Eligibility criteria:
Inclusion Criteria:

Veteran
history of closed-head traumatic brain injury (TBI) at least one year prior to enrollment
symptoms of affective lability such as mood swings, irritability, frustration and anxiety
currently using alcohol

Exclusion Criteria:

history of Axis I bipolar disorder or anxiety disorder prior to the TBI
skull opened either surgically or traumatically
history of stroke
current diagnosis or past history of major psychosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
active liver disease
evidence of the alcohol amnesic syndrome
history of seizure disorder other than those caused by ethanol withdrawal
any type of dementia
current suicidal/homicidal ideations
symptomatic thiamine, folate or Vitamin B-12 deficiency
HIV positive
any medical conditions that would constitute contraindications to treatment with divalproex sodium
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 3
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
Eligibility criteria:
Inclusion Criteria:

18 to 65 years of age
Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
Fixed home/place of residence and can be reached by telephone
On a stable dose of antipsychotic medications
Able to swallow capsules

Exclusion Criteria:

-Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
Treated with clozapine in past 30 days
Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
Uncontrolled hypertension
History of thyroid disorder that has not been stabilized on thyroid medication
Glaucoma
Pregnant or nursing
Subject has received an investigational product or participated in a clinical study within 30 days
Intervention: Betamethasone
Trial phase: Phase 4
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: 8
Group description: Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks

Taclonex Topical Suspension: topical medication for psoriasis
Eligibility criteria:
Inclusion Criteria:

Subjects age 18 years and older with stable plaque psoriasis of duration of at least 6 months.
Subject must be currently using a stable dose, with stable disease severity, of a single non-biologic systemic psoriasis medication (methotrexate or acitretin) for at least 2 months.
Subject must be planning to continue current systemic agent, and standard of care monitoring for that medication
All labs required for methotrexate or acitretin will be done according to standard of care.
If a woman, before entry she must be: Postmenopausal, or practicing a highly effective method of birth control
Women of childbearing potential must have a negative urine pregnancy test prior to randomization
Subject must be able and willing to provide written informed consent to participate.

Exclusion Criteria:

Non-plaque psoriasis (pustular, erythrodermic, or guttate).
Use of excluded therapies: phototherapy use currently or in the 4 weeks prior to baseline, use of more than 1 systemic therapy in the 2 months prior to baseline, use of topical steroid, tar preparation, or vitamin D analog in the 4 weeks prior to baseline.
Subjects who are currently taking or have taken in the past 60 days, for any reason, any medication that, in the opinion of the investigator, suppressed the immune response. This may include but is not limited to systemic steroids, azathioprine, cyclosporine, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system.
Subjects with any use at any time in the past of Taclonex topical suspension or Taclonex ointment
Subjects who are pregnant, nursing, or plan on becoming pregnant during the course of the study.
Presence of any unstable medical or psychiatric condition that, in the opinion of the investigator, could impair subject compliance.
Subject has any active infection within 30 days prior to baseline.
Known or suspected disorders of calcium metabolism
Known or suspected severe kidney or liver disease.
Known or suspected hypersensitivity to component(s) of the investigational products.
Intervention: Ponatinib
Trial phase: Phase 2 | Phase 3
ATC code: L01EA05 | L01XE24
SMILES: Cc1ccc(C(=O)Nc2ccc(CN3CCN(C)CC3)c(C(F)(F)F)c2)cc1C#Cc1cnc2cccnn12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Ponatinib taken by mouth daily

ponatinib
Eligibility criteria:
Inclusion Criteria:

Measurable disease
Documented evidence of disease progression following most recent therapy
Estimated life expectancy greater than 12 weeks

Exclusion Criteria:

Pregnant or breastfeeding
Prior chemotherapy or brain radiotherapy within 4 weeks of entering study
Receiving other investigational agents
Untreated or progressive brain metastases
Prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to ponatinib
Known HIV positive on combination antiretroviral therapy
Clinically uncontrolled hypertension
Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence for at least 5 years
Active or uncontrolled clinically significant infection
Chronic GI disease that may affect bioavailability of ponatinib
History of significant bleeding disorder unrelated to cancer
Uncontrolled intercurrent illness
Clinically significant ventricular arrythmia
History of chronic pancreatitis, alcohol abuse or uncontrolled hypertriglyceridemia
Intervention: Sulindac
Trial phase: Phase 2
ATC code: M01AB02
SMILES: CC1=C(CC(=O)O)c2cc(F)ccc2/C1=C\c1ccc([S+](C)[O-])cc1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will receive 150 mg of sulindac twice daily for 12 months. They will receive up to 4 MRI within 12 months and two breast biopsies.
Eligibility criteria:
Inclusion Criteria:

Eligibility criteria will include: Postmenopausal women with of first incidence of early stage (stages 0 - III) hormone receptor positive breast cancer stabilized on anastrozole therapy for at least 3 months
Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of 12 months
Patients must have an unaffected, non-irradiated contralateral breast with a baseline breast density score of > 25% as measured by standard digital mammography (BIRADs score > 2) or magnetic resonance imaging (MRI) performed within 12 months of randomization to the study
A willingness to follow the study protocol, as indicated by provision of informed consent to participate
A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted)
Normal renal function as determined by a serum creatinine < upper limit of normal
No known contraindication to NSAID use
Normotensive or controlled blood pressure (< 140/90) on a single anti-hypertensive medication

Exclusion Criteria:

Current or anticipated need for daily aspirin or NSAID use including aspirin for cardiovascular protection
Known intolerance to NSAIDs
Age > 75 years
History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA)
Diabetes requiring drug therapy
Current smoker
History of Uncontrolled hypertension
Blood pressure > 140/90 at baseline by home monitoring
History of GI ulcers, chronic GERD, or GI bleeding in the past 5 years
History of a bleeding diathesis or current anticoagulant therapy
Daily therapy with H2 blockers or protein pump inhibitors
History of claustrophobia
Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses.
Intervention: AZILSARTAN
Trial phase: Not Applicable
SMILES: CCOc1nc2cccc(C(=O)O)c2n1Cc1ccc(-c2ccccc2-c2noc(=O)[nH]2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 359
Group description: Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks

Azilsartan: Azilsartan 20mg/day
Eligibility criteria:
Inclusion Criteria:

Grade I or II essential hypertension
The sitting systolic blood pressure is in term of 140-179 mmHg, or sitting diastolic blood pressure is in term of 90-109 mmHg at the both two time points at the beginning of the observation period and at the beginning of a treatment period (Week0)
20 years old or older at the time of the informed consent
Able to give written informed consent before participating in the research
Therapeutic category during the observation period: Ambulatory

Exclusion Criteria:

Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180 mmHg or sitting diastolic blood pressure greater than or equal to 110 mmHg), malignant hypertension
More than 2 kinds of antihypertensive agents for treatment on the hypertension
History of taking following medicines within 2 weeks before start of the observation period.

When subject with taking any of the following medicine at the time of informed consent is included, stop to take the medicine for determined period after the informed consent.

I. Antihypertensive agents II. Antianginal agents III. Antiarrhythmic agents (except single time use of the lidocaine hydrochloride formulation for anesthesia) IV. Digitalis products

Less than 130 mmHg of mean 24-hour systolic blood pressure and less than 80 mmHg of mean 24-hour diastolic blood pressure at the start of the observation period.
History of following circulatory-related diseases or symptoms within 24 weeks before start of the observation period.

I. Cardiac disease: Myocardial infarction, coronary artery revascularization II. Cerebrovascular-disease: cerebral infarction, cerebral hemorrhage, transient ischemic attack III. Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema

History or complication with the following circulatory-related diseases; Valvular stenosis, atrial fibrillation, pharmacotherapy-required angina, congestion heart failure, or cardiac arrhythmia, or arteriosclerosis obliterans with symptoms of intermittent claudication et al
Day / night reversal
History of hypersensitivity or allergy to Azilsartan, Amlodipine, or related drugs
Participant in any other clinical research
Pregnant, possible to being pregnant, or lactating woman
Mal-control of blood pressure during informed consent to taking antihypertensive agent
Any those the investigator or other researchers consider as unsuitable