anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Prasugrel
Trial phase: Phase 3
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 343
Group description: dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Eligibility criteria:
Inclusion Criteria:

all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria:

pregnancy
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: 38
Group description: 5% lidoderm patch
Eligibility criteria:
Inclusion Criteria:

Male or Female 18 years or older of age
Pain in the location of the lower back
Pain duration for a minimum of 6 months on a continuous basis
Pain intensity of at least 3 out of 10 on most days of the week over the past six months
Manifestations of radicular element of pain: radiation below knee (examples towards thigh, buttocks).
Right handedness

Exclusion Criteria:

Applying for or currently receiving workers' compensation or disability status.
Back pain secondary to spinal cord injury
Back pain secondary to any systemic condition (e.g ankylosing spondylitis0
Diabetes mellitus
Back pain secondary to tumors.
Standard MRI criteria re: claustrophobia, metal objects etc.
Subjects with cognitive deficits such as dementia, psychiatric illness including depression with a BDI score of more than 19 (moderate to severe depression), history of brain injury, history of chronic disease
Pregnant and/or lactating women
Left handedness
Active cancer
Other serious painful condition (e.g., arthritis)
Intervention: Opicapone
Trial phase: Phase 1
ATC code: N04BX04
SMILES: Cc1c(Cl)c(C)[n+]([O-])c(Cl)c1-c1noc(-c2cc(O)c(O)c([N+](=O)[O-])c2)n1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).

BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
Eligibility criteria:
Inclusion Criteria:

Healthy Caucasian male subjects, 40-55 years of age.
Sitting blood pressure and pulse rate within a clinically acceptable range for the purposes of the study, i.e.: BP: 100 - 160 mmHg systolic, 50 - 95 mmHg diastolic and pulse rate: 50 - 100 bpm. Blood pressure and pulse were to be measured after 3 minutes resting in a sitting position.
Subject body mass index was to be between 18 and 28 kg/m2
Normal 12-lead ECG
Ability to communicate well with the investigator and comply with the requirements of the entire study.
The subject had given his written informed consent to participate in the study.

Exclusion Criteria:

History of serious adverse reactions or hypersensitivity to any drug.
Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
History of alcohol or drug abuse in the last 5 years.
Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug.
Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested.
Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a donor.
Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
Symptoms of a significant somatic or mental illness in the 4 week period preceding drug administration.
History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
Positive results from the HIV serology.
Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) values must be within the normal range.
Positive results of the drug screening.
Known hypersensitivity to BIA 9-1067.
Heavy smokers, i.e., more than 10 cigarettes per day
Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation)
Subject who had more than 4 flights (with more than 2 hours flight time) within the last year prior to the administration of the drug.
Intervention: Sufentanil
Trial phase: Phase 4
ATC code: N01AH03
SMILES: CCC(=O)N(c1ccccc1)C1(COC)CCN(CCc2cccs2)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
Eligibility criteria:
Inclusion Criteria:

female 18 to 40 Years
class ASA 1 and 2
candidates for elective cesarean section

Exclusion Criteria:

renal failure
liver failure
cardiac disorder
coagulopathy
hepatomegaly
splenomegaly
drug sensitivity and abuse
morbid obesity
smoking
history of post operative nausea and vomiting
motion sickness
local hypoesthesia
Intervention: Sufentanil
Trial phase: Phase 4
ATC code: N01AH03
SMILES: CCC(=O)N(c1ccccc1)C1(COC)CCN(CCc2cccs2)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: In control group we add 1cc salin to 20cc bupivacain in TAP block
Eligibility criteria:
Inclusion Criteria:

female 18 to 40 Years
class ASA 1 and 2
candidates for elective cesarean section

Exclusion Criteria:

renal failure
liver failure
cardiac disorder
coagulopathy
hepatomegaly
splenomegaly
drug sensitivity and abuse
morbid obesity
smoking
history of post operative nausea and vomiting
motion sickness
local hypoesthesia
Intervention: Blonanserin
Trial phase: Phase 3
SMILES: CCN1CCN(c2cc(-c3ccc(F)cc3)c3c(n2)CCCCCC3)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 130
Group description: Participants received 8-24mg tablet orally twice daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia
Patients are 18≤age<65 years of age on the day when informed consent is obtained.
Subject had a PANSS total score ≥70 and 120≥ at Screening
Subject had a score ≥4 on the PANSS at Screening and Baseline.
Subjects are willing and able to comply with study protocol including treatment in hospital.
Subjects or their legal guardians have signed the written informed consent form.

Exclusion Criteria:

The subject was treatment with other Investigate product within 30 days.
Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.
Subject had a history of treatment with clozapine within 28 days.
Subject With parkinson disease,etc
Intervention: Risperidone
Trial phase: Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Participants received 2-6mg tablet orally twice daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia
Patients are 18≤age<65 years of age on the day when informed consent is obtained.
Subject had a PANSS total score ≥70 and 120≥ at Screening
Subject had a score ≥4 on the PANSS at Screening and Baseline.
Subjects are willing and able to comply with study protocol including treatment in hospital.
Subjects or their legal guardians have signed the written informed consent form.

Exclusion Criteria:

The subject was treatment with other Investigate product within 30 days.
Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.
Subject had a history of treatment with clozapine within 28 days.
Subject With parkinson disease,etc
Intervention: Glimepiride
Trial phase: Phase 2
ATC code: A10BB12 | A10BD04 | A10BD06
SMILES: CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

Subjects with recent cardiovascular events, those with evidence of diabetic complications
Intervention: Simvastatin
Trial phase: Phase 2
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: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated

Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
Eligibility criteria:
Inclusion Criteria:

male gender
ages 18-64
at least one vitiligo skin lesion measuring at least 2x2 cm in size
willing and able to understand and sign informed consent
able to complete study and comply with study procedures

Exclusion Criteria:

history of segmental vitiligo
allergy to statin medications
use of statin medications due to cardiac risks.
use of any medications contraindicated with use of simvastatin
use of topical vitiligo treatments in past 4 weeks
use of laser or light-based vitiligo treatments within the past 8 weeks
treatment with immunomodulating oral medications in the past 4 weeks
use of statin medications in the past 8 weeks
evidence of hepatic dysfunction, personal or family history of non-alcoholic steatotic hepatitis, or personal history of hepatitis
evidence of renal dysfunction
history of myopathy or rhabdomyolysis, or elevated baseline creatinine kinase
recent history of alcohol or drug abuse
history of diabetes
untreated hypothyroidism
other conditions that require the use of interfering topical or systemic therapy
other current conditions that might interfere with study assessments such as, but not limited to, atopic dermatitis and psoriasis
clinically significant abnormal findings or conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1 | Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Eligibility criteria:
Inclusion Criteria:

Painful osteoarthritis in the study knee
Able to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study

Exclusion Criteria:

Chronic pain conditions other than knee osteoarthritis
Presence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year
Surgery to the study knee within 24 weeks
Treatment with hyaluronic acid in the study knee within 24 weeks
Treatment with corticosteroids in the study knee within 12 weeks
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Previous treatment with botulinum toxin of any serotype for any reason
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: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
Eligibility criteria:
Inclusion Criterion:

Patients scheduled for elective or urgent CABG of two to six vessels

Exclusion Criteria:

Preoperative:

Hemoglobin of less than 110g/L
Under 18 years of age
Body mass less than 75kg
Presence of an intra-aortic balloon pump
Emergency surgery, requiring operative intervention within 24 hours of consultation to the cardiac surgery team
Need for cardiac surgical intervention in addition to planned CABG (with the exception of patent foramen ovale closure)
Ejection fraction (EF) of less than 50%, as determined by echocardiogram or angiography
Pulmonary hypertension with pulmonary artery pressures greater than 60mmHg (as estimated by right ventricular systolic pressure (RVSP))
Presence of infectious endocarditis
Hepatic failure with impaired liver function, including International Normalized Ratio (INR) greater than 1.5
Known diagnosed bleeding disorder
History of heparin induced thrombocytopenia and thrombosis (HITT)
Renal failure with pre-operative creatinine greater than 200ml/min or oliguria with urine output less than 10ml/hour
Allergy to tranexamic acid
Pregnancy

Intraoperative:

Discovery of infectious endocarditis
Need for cardiac surgical intervention in addition to planned coronary CABG
Development of allergic reaction to tranexamic acid following intravenous infusion
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Normal saline (70mL)
Eligibility criteria:
Inclusion Criterion:

Patients scheduled for elective or urgent CABG of two to six vessels

Exclusion Criteria:

Preoperative:

Hemoglobin of less than 110g/L
Under 18 years of age
Body mass less than 75kg
Presence of an intra-aortic balloon pump
Emergency surgery, requiring operative intervention within 24 hours of consultation to the cardiac surgery team
Need for cardiac surgical intervention in addition to planned CABG (with the exception of patent foramen ovale closure)
Ejection fraction (EF) of less than 50%, as determined by echocardiogram or angiography
Pulmonary hypertension with pulmonary artery pressures greater than 60mmHg (as estimated by right ventricular systolic pressure (RVSP))
Presence of infectious endocarditis
Hepatic failure with impaired liver function, including International Normalized Ratio (INR) greater than 1.5
Known diagnosed bleeding disorder
History of heparin induced thrombocytopenia and thrombosis (HITT)
Renal failure with pre-operative creatinine greater than 200ml/min or oliguria with urine output less than 10ml/hour
Allergy to tranexamic acid
Pregnancy

Intraoperative:

Discovery of infectious endocarditis
Need for cardiac surgical intervention in addition to planned coronary CABG
Development of allergic reaction to tranexamic acid following intravenous infusion
Intervention: Bivalirudin
Trial phase: Phase 4
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1829
Group description: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour

Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Eligibility criteria:
Inclusion Criteria:

All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial

Exclusion Criteria:

≤ 18 years of age
Known intolerance, hypersensitivity or contraindication to any trial medication
Active bleeding at presentation
Artificial ventilation, reduced conscious level or other factors precluding the administration of oral antiplatelet therapy
Previous enrolment in this trial
Intervention: Aliskiren
Trial phase: Phase 4
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Aliskiren: Drug therapy has been started with an initial 2 weeks on Aliskiren 150 mg followed by a titration to 300 mg Aliskiren if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
Eligibility criteria:
Inclusion Criteria:

Tolerance to study drugs
Age > 18 years
Arteria hypertension stage 1-2 (blood pressure: 140/90 and 180/110 mm Hg)
Normal renal function
Availability to give informed consent

Exclusion Criteria:

Intolerance to study drugs
Renal artery stenosis
Hyperkalaemia > 5.0 mmol/l
Contra-indications to the use of PAH, inulin or Lithium
Asthma
Pychiatric illness
No estimated easy vascular venous access for placement of two peripherical venous catheters in forearms
Contra-indication to MRI-imaging: Claustrophobia or Pacemaker or other implanted metal device
Intervention: Hydrochlorothiazide
Trial phase: Phase 4
ATC code: C03AA03 | C03AB03 | C03AX01 | C03EA01 | C09BX03 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA52 | C09XA54 | G01AE10
SMILES: NS(=O)(=O)c1cc2c(cc1Cl)NCNS2(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Hydrochlorothiazide: Drug therapy has been started with an initial 2 weeks HCTZ 12.5 mg followed by a titration to 25 mg HCTZ if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.

No side effect were observed and all patients finished the sudy in this treatment arm
Eligibility criteria:
Inclusion Criteria:

Tolerance to study drugs
Age > 18 years
Arteria hypertension stage 1-2 (blood pressure: 140/90 and 180/110 mm Hg)
Normal renal function
Availability to give informed consent

Exclusion Criteria:

Intolerance to study drugs
Renal artery stenosis
Hyperkalaemia > 5.0 mmol/l
Contra-indications to the use of PAH, inulin or Lithium
Asthma
Pychiatric illness
No estimated easy vascular venous access for placement of two peripherical venous catheters in forearms
Contra-indication to MRI-imaging: Claustrophobia or Pacemaker or other implanted metal device
Intervention: Tedizolid
Trial phase: Phase 2
ATC code: J01XX11
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](CO)OC4=O)cc3F)cn2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: TR701 FA: 1 tablet 200 mg once daily
Eligibility criteria:
Inclusion Criteria:

Male or female patients ≥ 18 years of age
Suspected or documented gram-positive infection from baseline Gram stain or culture.
Cellulitis/erysipelas or major cutaneous abscesses at Screening

Exclusion Criteria:

Postsurgical or open wound infections
Severe sepsis or septic shock
Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (< 75 cm2 or area of suppuration not surrounded by cellulitis/erythema), and impetiginous lesions
Infections associated with, or in close proximity to, a prosthetic device
Known bacteremia or osteomyelitis at time of screening
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: 0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.

0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
Eligibility criteria:
Inclusion Criteria:

Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent

Exclusion Criteria:

Hyponatremia <130 mmol/L; acute myocardial infarction or stroke in previous 7 days; cardiac transplant; ventricular arrhythmia; unstable angina; use of pressors/midodrine; enrollment in conflicting research study; institutionalized individuals; pregnancy; prisoners; documented allergy to mannitol
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 26
Group description: MECP2 mutation positive subjects randomized to receive dextromethorphan(DM) at baseline
Eligibility criteria:
Inclusion Criteria:

males and females who have classic or atypical RTT with a proven mutation in the MECP2 gene;
subjects must be between one year - 10 years of age.

Exclusion Criteria:

those without an established mutation in the MECP2 gene;
those with mutations in the MECP2 gene but who have had brain resection or surgical intervention; for example, tumor, hydrocephalus, severe head trauma; or, an associated severe medical illnesses such as vasculopathies, malignancies, diabetes, thyroid dysfunction, etc;
those on medications that could interact with DM, e.g. MAO inhibitors, SSRI, sibutramine etc. to avoid a serotonin syndrome; quinidine and drugs metabolized by the CYP450 isoform CYP2D6 (e.g. amiodarone, haloperidol, propafenone, thioridazine);
those proven to be intermediate or slow metabolizers of DM;
those with reported adverse reactions to DM;
those whose pregnancy test is positive;
those showing poor compliance with any aspect of the study;
foster children.