anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 144
Group description: 5-ASA (5-Aminosalicylate)

5-ASA (5-Aminosalicylate): 500 mg tablet
Eligibility criteria:
Inclusion Criteria for Active phase:

Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients.
Extent of colonic involvement confirmed within the past 36 months
UCDAI score of at least 3 but not greater than 8 and a score of at least 1 for endoscopy
Screening tests to rule out any abnormalities in stool, heart or kidney.
Male or non-pregnant females between 18 to 75 years.
Women of childbearing potential to use efficacious contraception as judged by the investigator.
Written informed consent given.

Inclusion Criteria for Maintenance phase:

Newly recruited subjects with documented mild to moderate UC entering the Run-in Phase: in clinical remission for at least 1 month and for a maximum of 3 years, and receiving 5-ASA 1.4 to 2.5 g/day for maintenance of quiescent disease
Subjects from Active Phase: meeting remission criteria after the 8-week active period
Extent of colonic involvement confirmed within the past 36 months by colonoscopy
In complete remission at entry into the Maintenance Phase, defined as i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings; and iv) a Physician's Global Assessment (PGA) score of 0 or 1
Screening tests to rule out any abnormalities in stool, heart or kidney.

Exclusion Criteria:

Use of 5-ASA products at a dose >2.5g/day within 7 days prior to entry.
Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of Inflammatory Bowel Disease
Infectious diseases, parasites, bacterial pathogens
Allergy to aspirin or salicylate
Liver or kidney abnormalities
Alcohol or drug abuse
Pregnancy
Cancer
Bleeding disorders, ulcers, autoimmune diseases
Mental disorders
Participation in clinical trial in last 30 days
Inability to fill in diary cards / comply with protocol requirements
Intervention: Norepinephrine
Trial phase: Phase 3
ATC code: C01CA03
SMILES: NC[C@H](O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 252
Group description: Patients that get NE infusion
Eligibility criteria:
Inclusion Criteria:

Patients are transferred to our medical intensive care unit from the emergency room (ER), general medical floors, and from outside hospitals.
Patients were eligible if they were greater than 18 years of age
Presented with a diagnosis of SIRS plus a suspected or documented source of infection.

Exclusion Criteria:

Patients were not eligible if they were found to have hypovolemic and/or hemorrhagic etiologies of their vasodilatory shock or another etiology of their SIRS.
Intervention: PALIPERIDONE PALMITATE
Trial phase: Phase 3
SMILES: CCCCCCCCCCCCCCCC(=O)OC1CCCn2c1nc(C)c(CCN1CCC(c3noc4cc(F)ccc34)CC1)c2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 229
Group description: Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
Eligibility criteria:
Inclusion Criteria:

Participants who meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
A total Positive and Negative Syndrome Scale (PANSS) score between 60 and 120, inclusive, at screening and baseline
Body mass index (BMI) of equal to or greater than 17.0 kilogram per meter square (kg/m^2)
Female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study
Be capable of self-administering study medication (applies to oral supplementation) or have assistance with study medication administration consistently available throughout the first 4 weeks of the study Exclusion Criteria:
A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
A decrease of at least 25 percent in the total PANSS score between screening and baseline
Participants who have previously participated in this study
A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
Intervention: Risperidone
Trial phase: Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 223
Group description: Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
Eligibility criteria:
Inclusion Criteria:

Participants who meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
A total Positive and Negative Syndrome Scale (PANSS) score between 60 and 120, inclusive, at screening and baseline
Body mass index (BMI) of equal to or greater than 17.0 kilogram per meter square (kg/m^2)
Female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study
Be capable of self-administering study medication (applies to oral supplementation) or have assistance with study medication administration consistently available throughout the first 4 weeks of the study Exclusion Criteria:
A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
A decrease of at least 25 percent in the total PANSS score between screening and baseline
Participants who have previously participated in this study
A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
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: 16
Group description: Two (4mL) doses of sterile saline
Eligibility criteria:
Inclusion Criteria:

Subjects (men or women) at least 18 years and less than 75 years of age and
Ischemic discomfort ≥20 minutes and ≤6 hours of duration and
ST elevation ≥1mm (≥0.1mV) in two contiguous limb leads OR ≥2mm (≥0.2mV) in two contiguous precordial leads and
Occluded infarct-related artery (TIMI Flow Grade 0 or 1) at the time of coronary angiography and
Planned primary PCI within 2 hours of hospital presentation and
Planned or concomitant use of aspirin, clopidogrel, unfractionated heparin, and Glycoprotein IIb/IIIa inhibition with intent to stent the infarct-related artery and
Informed consent able to be obtained

Exclusion Criteria:

CLINICAL

Age ≥75 years
Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation.
Uncontrolled hypertension (SBP >180 OR DBP >110) at time of enrollment.
Cardiac arrest or arrhythmia requiring chest compressions or cardiopulmonary resuscitation.
Known pregnancy.

BIOCHEMICAL

Known thrombocytopenia (platelet count <100,000)
Known severe renal insufficiency (creatinine >4.0 mg/dL).

INCREASED BLEEDING RISK

Active internal bleeding
Recent (<3 months) gastrointestinal hemorrhage
Recent intracranial or intraspinal surgery, trauma, major surgery, or biopsy of a parenchymal organ (< 1 month)
Known coagulopathy, platelet disorder, or history of thrombocytopenia
Current warfarin therapy
Known neoplasm
Any known history of transient ischemic attack, cerebrovascular accident, or active intracranial pathology including arteriovenous malformation or aneurysm

MEDICATIONS

Administration of a fibrinolytic agent within 72 hours
Known allergy or contraindication to fibrinolytics OR aspirin OR heparin OR clopidogrel

ANGIOGRAPHIC

Left Main Coronary artery culprit lesion
Ostial culprit lesion (ostium of LAD, LCX, or RCA).
Lesion in non-native coronary artery (e.g. saphenous vein graft, arterial conduit graft)
Subjects requiring urgent coronary artery bypass grafting
Intervention: Hydrochlorothiazide
Trial phase: Phase 2
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: No
Participants at risk: 15
Group description: hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months

nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg
Eligibility criteria:
Inclusion Criteria:

60 years or older
Hypertension
Cognitive criteria: score either 10 or less out of 15 for the executive clock draw test 1 (CLOX1) or less than or equal to 1 standard deviation from the corresponding age specific mean on the immediate memory subtest

Exclusion Criteria:

Intolerance to ACEI or ARB
History of congestive heart failure
History of diabetes mellitus
History of stroke (less than 6 months)
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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily
Eligibility criteria:
Inclusion Criteria:

Healthy volunteer
Age 18-40 years

Exclusion Criteria:

Any continuous medication
Any significant disease
Hypotension or hypertension
Allergy to licorice or hydrochlorothiazide
Pregnancy and breast feeding
Fear of needles and previous difficult blood samplings
Substance abuse
Participation in another clinical drug trial within 1 month of enrollment
Intervention: rhEPO
Trial phase: Phase 3
SMILES: COC1C(O)CC(=O)OC(C)CC=CC=CC(OC2CC(C)(O)C(O)C(C)O2)C(C)CC(CCO)C1OC1OC(C)C(OC2CC(C)(O)C(O)C(C)O2)C(N(C)C)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
Eligibility criteria:
Inclusion Criteria:

chronic renal anemia;
continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
regular hemodialysis for greater than or equal to (>=) 3 months

Exclusion Criteria:

transfusion of red blood cells during previous 2 months
poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;
Intervention: Fesoterodine Fumarate
Trial phase: Phase 4
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1C(CCN(C(C)C)C(C)C)c1ccccc1.O=C(O)C=CC(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Toviaz 4mg to 8mg

Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
Eligibility criteria:
Patients will be selected by the investigator and sub-investigator's patient population, and physician referrals. All patients will meet the inclusion/ exclusion criteria.

Inclusion Criteria

Male ≥40 years of age
Clinical signs and symptoms of frequency and urgency, enlarged prostate and urodynamic study consistent with overactive bladder.
IPSS >12, with IPSS QoL > 3 at screening visit.
Ability and willingness to correctly complete the micturition diary and all the trial related questionnaires comply with scheduled visits and comply with trial procedures.
Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.
Procedure to treat BOO by TURP or PVP greater than or equal to 1 month ago.

Exclusion Criteria

A known history of interstitial cystitis, uninvestigated hematuria, or bladder outlet obstruction due to: mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
Evidence of Urinary Tract Infection according to local standard of care.
Expectation of initiating treatment during the duration of this study with - any drug treatment for OAB, any drugs with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects.
Use of any electrostimulation within the 30 days before randomization, or the expectation to initiate such therapy during the study.
Any condition which, in the opinion of the investigator, makes the patient unstable, or with contraindications for inclusion, e.g., uncontrolled narrow-angled glaucoma, urinary retention, preplanned prostate surgery, or gastric retention.
Significant hepatic or renal disease, defined as twice the upper limit of the reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine.
Use of any other investigational drug in the 2 months preceding visit 1.
History of postural hypotension or syncope in the judgement of the investigator based on local standards of care.
Alcohol and/or any other drug abuse in the opinion of the investigator.
Medications such as erythromycin, Biaxin (Clarithromycin), Sporanox (itraconazole), Nizoral (ketoconazole), Neoral and Sandimmune (cyclosporine), Velban (vinblastine) and miconazole.
Non-medication treatments such as bio-feedback or other bladder training exercises.
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Patients who had completed the preceding study and demonstrated drug efficacy were the target.

Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days.
Eligibility criteria:
Inclusion Criteria:

Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
Subjects have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
Subjects who were enrolled in and have completed Study 003 and who meet the following criteria for demonstration of drug efficacy

Subjects demonstrating drug efficacy:

Those subjects who completed Study 003 whose score for CGI-BP Change From Preceding Phase (mania) at the time of evaluation on Day 21 of Study 003 (completion) was between 1 (Very much improved) and 3 (Minimally improved)

Exclusion Criteria:

Subjects presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:

Delirium, dementia, amnestic disorder, or other cognitive disorders
Schizophrenia or other psychotic disorder
Personality disorder
Subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
Subjects who represent a significant risk of committing suicide
Subjects known to have a complication of allergy to aripiprazole or other quinolinone-skeleton compounds
Subjects with a complication of neuroleptic malignant syndrome
Subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
Subjects with a complication of paralytic ileus
Subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy
Subjects with a complication of diabetes
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
Eligibility criteria:
Inclusion Criteria:

Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
Patients have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
Patients who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
Patients with a YMRS total score of 16 or more

Exclusion Criteria:

Patients presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:

Delirium, dementia, amnestic disorder, or other cognitive disorders
Schizophrenia or other psychotic disorder
Personality disorder
Patients experiencing their first manic or mixed episode
Patients whose current manic episode has lasted for more than 4 weeks
Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders, but including abuse of benzodiazepines)
Patients who have received ECT treatment within 8 weeks prior to informed consent
Patients who are expected to require administration of ultrashort-acting or short-acting benzodiazepine receptor agonist hypnotics and antianxiety drugs (See (1) of 4.2.2) at doses exceeding the equivalent of 15 mg/day of diazepam (Only for those patients using such drugs)
Patients at significant risk of developing a severe adverse event. Patients who have a medical condition that would interfere with assessments of safety or efficacy during the course of the trial, or who have a history of such a condition.

Patients who have received any of the following treatments during the screening period

Reserpine
Levodopa, dopamine receptor stimulants
Monoamine oxidase inhibitors
Psychostimulants
Thyroid hormones, antithyroid drugs
Corticosteroids (other than topical preparations)
Adrenaline
All other investigational or unapproved agents
ECT
Light therapy
Patients judged to have a diabetic blood glucose level (judgment based on use of a self-monitoring blood glucose meter permissible), or patients whose HbA1c is 6.5% or higher
Patients with a history or a complication of diabetes
Intervention: Givinostat
Trial phase: Phase 2
ATC code: M09AX14
SMILES: CCN(CC)Cc1ccc2cc(COC(=O)Nc3ccc(C(=O)NO)cc3)ccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.

ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
Eligibility criteria:
Inclusion Criteria:

Signed Informed Consent Form
Male or female, age ≥ 18 years
Confirmed diagnosis of PV/ET/MF according to the revised World Health Organisation criteria
JAK-2 V617F positivity
In need of cytoreductive therapy when hydroxyurea is not indicated (e.g. young patients) or when refractoriness to the drug is documented

Exclusion Criteria:

Active bacterial or fungal infection requiring antimicrobial treatment on Day 1
Patients of childbearing potential without a negative pregnancy test prior to initiation of the study drug
Pregnancy or lactation
A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval > 450 ms, according to Bazett's correction formula - see appendix G for the formula)
The use of concomitant medications that prolong the QT/QTc interval (see appendix F for full list)
Concomitant acute coronary syndromes; uncontrolled hypertension
New York Heart Association (NYHA) Grade II or greater congestive heart failure
History of any cardiac arrhythmia requiring medication (irrespective of its severity)
A history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Active Epstein Barr Virus (EBV) infection (i.e. positive serology IgM)
Known HIV infection
Active hepatitis B and/or C infection
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
Eastern Cooperative Oncology Group (ECOG) performance status 3 or greater
Platelets count <100x109/L within 14 days before enrolment
Absolute neutrophil count <1.2x109/L within 14 days before enrolment
Percentage of blast cells in peripheral blood >10% within 14 days before enrolment
Serum creatinine >2xULN (Upper limit of normal)
Total serum bilirubin >1.5xULN
Serum AST (aspartate aminotransferase) / ALT (alanine aminotransferase) > 3xULN
Interferon alpha within 14 days before enrolment
Hydroxyurea within 14 days before enrolment
Anagrelide within 7 days before enrolment
Any other investigational drug within 28 days before enrolment