anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: FLORBETAPIR
Trial phase: Phase 2
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Cognitively normal (CN) subjects.

florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Eligibility criteria:
Inclusion Criteria:

AD:

Male or female >= 50 years of age
Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
Have a caregiver who can report on their mental status and activities of daily living (ADL)
Give informed consent or have a caregiver give consent with subject assent.

FTD:

Male or female >= 45 years of age
Meet consensus criteria for FTD and have mild to moderate disease severity. Have a caregiver who can report on their mental status and ADL
Give informed consent or have a caregiver give consent with subject assent.

CN:

Male or female >= 45 years of age
Have and MMSE >= 29
Give informed consent

Exclusion Criteria:

Have a history or a current clinically significant neurologic disease (other than AD or FTD, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a diagnosis of mixed dementia
Evidence from MRI or other biomarkers that suggests an etiology of dementia other than AD or FTD, as applicable or in the case of CN subjects evidence indicating the presence of AD, FTD or other types of neurologic pathology
Have current clinically significant cardiovascular disease, screening ECG abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, cancer or infectious disease
Have a recent history of alcohol or substance abuse or dependence
Women of childbearing potential who are not permanently surgically sterile, or are not refraining from sexual activity while not using adequate contraception.
Require medications with a narrow therapeutic window, are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
Have ever participated in a study with an amyloid targeting agent
Have had a radiopharmaceutical imaging or treatment procedure within 7 days of the imaging, other than as defined in the protocol
Intervention: FLORBETAPIR
Trial phase: Phase 2
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Subjects with Alzheimer's disease (AD).

florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Eligibility criteria:
Inclusion Criteria:

AD:

Male or female >= 50 years of age
Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
Have a caregiver who can report on their mental status and activities of daily living (ADL)
Give informed consent or have a caregiver give consent with subject assent.

FTD:

Male or female >= 45 years of age
Meet consensus criteria for FTD and have mild to moderate disease severity. Have a caregiver who can report on their mental status and ADL
Give informed consent or have a caregiver give consent with subject assent.

CN:

Male or female >= 45 years of age
Have and MMSE >= 29
Give informed consent

Exclusion Criteria:

Have a history or a current clinically significant neurologic disease (other than AD or FTD, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a diagnosis of mixed dementia
Evidence from MRI or other biomarkers that suggests an etiology of dementia other than AD or FTD, as applicable or in the case of CN subjects evidence indicating the presence of AD, FTD or other types of neurologic pathology
Have current clinically significant cardiovascular disease, screening ECG abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, cancer or infectious disease
Have a recent history of alcohol or substance abuse or dependence
Women of childbearing potential who are not permanently surgically sterile, or are not refraining from sexual activity while not using adequate contraception.
Require medications with a narrow therapeutic window, are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
Have ever participated in a study with an amyloid targeting agent
Have had a radiopharmaceutical imaging or treatment procedure within 7 days of the imaging, other than as defined in the protocol
Intervention: Tolvaptan
Trial phase: Phase 4
ATC code: C03XA01
SMILES: Cc1ccccc1C(=O)Nc1ccc(C(=O)N2CCCC(O)c3cc(Cl)ccc32)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Subjects will receive 15 mg Tolvaptan once daily.
Eligibility criteria:
Inclusion Criteria:

Cirrhosis
Screening within 24 hours of admission
Na level less than 130mEq/L
Presence of fluid overload with either history of ascites or edema
Cr < 2.0mg/dl
Planned length of stay after randomization of at least 24 hours
Anticipated survival of at least 8 days
Ability to provide informed consent

Exclusion Criteria:

Hospitalization greater than 24 hours at screening
Depletional hyponatremia
Hyponatremia due to hyperglycemia
Acute and transient hyponatremia associated with head trauma or post-operative states
Hyponatremia due to primary polydipsia, adrenal insufficiency, or hypothyroidism
Urgent need for treatment of hyponatremia with saline or hypertonic saline
Treatment with demeclocycline, lithium chloride, and urea
Cr greater than 2.0mg/dl
Stage 3 or 4 hepatic encephalopathy
Inability to provide informed consent
Planned discharge within 24 hours
Anticipated survival less than 8 days
GI bleeding within one month of enrollment
Intervention: CLOBETASOL PROPIONATE
Trial phase: Phase 4
ATC code: D07AD01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Clobex Spray
Eligibility criteria:
Inclusion Criteria:

Subjects 18 years of age or older.
Subjects with a board certified dermatologist clinical diagnosis of active moderate to severe psoriasis lesions affecting up to 20% of the body surface area at the baseline visit, and in the opinion of the investigator, is otherwise a good candidate for treatment with clobetasol propionate 0.05% spray.
Subjects with a target lesion of at least 1 cm x 1 cm
Subjects who agree to be photographed at each visit

Exclusion Criteria:

Subjects with any condition or presentation that may, in the opinion of the investigator, may put the subject at risk, may confound study results, or may interfere with participation in the study.
Subjects with any known allergies to any of the ingredients listed on the test article label or surgical ink.
Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast feed during the course of the trial.
Subjects that are relatives of the investigator, or are themselves or a relative of any study staff or any Galderma employee.
Subjects who have participated in an investigational study within 30 days of enrollment; participated in biologic investigational studies within 90 days of enrollment, or subjects planning to participate in any other interventional clinical research study while enrolled in this trial.
Intervention: Bisphenol A
Trial phase: Not Applicable
SMILES: CC(C)(c1ccc(O)cc1)c1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.

Laboratory biomarker analysis will be performed.

(RS)2-(3-benzoylphenyl)-propionic acid: Given PO

laboratory biomarker analysis: Correlative studies
Eligibility criteria:
Inclusion Criteria:

Axillary lymph node dissection within the preceding 12 months

Exclusion Criteria:

Patients with active cancer
Patients with lymphedema
Infection or bleeding tendency
Patients with medical contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including history of allergies, know gastrointestinal intolerance
Other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate
Persons not competent to consent
Patients on aspirin therapy
Minors (< 18 years of age)
Pregnant and/or lactating women
Males
Intervention: Filgotinib
Trial phase: Phase 2
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Eligibility criteria:
Inclusion Criteria:

male or female subjects who are ≥18 years of age on the day of signing informed consent,
have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,

have ≥6 swollen joints (from a 66-joint count) and

≥8 tender joints (from a 68-joint count) at Screening and at Baseline,

Screening serum c-reactive protein ≥ 0.7 x upper limit of laboratory normal range (ULN),
have shown an inadequate response in terms of either lack of efficacy or toxicity to MTX,
have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period.

Exclusion Criteria:

current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening,
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Intervention: Filgotinib
Trial phase: Phase 2
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Eligibility criteria:
Inclusion Criteria:

male or female subjects who are ≥18 years of age on the day of signing informed consent,
have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,

have ≥6 swollen joints (from a 66-joint count) and

≥8 tender joints (from a 68-joint count) at Screening and at Baseline,

Screening serum c-reactive protein ≥ 0.7 x upper limit of laboratory normal range (ULN),
have shown an inadequate response in terms of either lack of efficacy or toxicity to MTX,
have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period.

Exclusion Criteria:

current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening,
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Intervention: Filgotinib
Trial phase: Phase 2
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Eligibility criteria:
Inclusion Criteria:

male or female subjects who are ≥18 years of age on the day of signing informed consent,
have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,

have ≥6 swollen joints (from a 66-joint count) and

≥8 tender joints (from a 68-joint count) at Screening and at Baseline,

Screening serum c-reactive protein ≥ 0.7 x upper limit of laboratory normal range (ULN),
have shown an inadequate response in terms of either lack of efficacy or toxicity to MTX,
have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period.

Exclusion Criteria:

current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening,
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Intervention: ASPIRIN
Trial phase: Phase 4
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.

Aspirin: 81 mg daily for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Participants from the GeneSTAR cohort
Unaffected with no overt coronary artery disease or serious vascular event (stroke or peripheral vascular disease diagnosis
Women who are postmenopausal.
Women who use a reliable contraceptive method; a reliable contraceptive method will be defined as personal history of tubal ligation, ongoing use of intra-uterine device, or ongoing use of oral contraceptive pills.

Exclusion Criteria:

Presence of any CAD or stroke, transient ischemic attacks, peripheral arterial disease
Persons taking aspirin, NSAIDS, or any anti-coagulants who are medically unable to stop them for a two week pre-trial
A history of allergy to aspirin or clopidogrel
Weight < 60kg
Age < 45 and > 75 years of age
A history of recent or any active bleeding
Serious or current co-morbidity (AIDS, cancer)
Pregnant women as determined by urine dipstick pregnancy test
Any aneurysms on cranial magnetic resonance imaging/magnetic resonance angiography (obtained recently in the GeneSTAR participants)
Blood pressure above >=159/95mmHg
History of a gastric or duodenal ulcer, or significant gastrointestinal disease, like regional enteritis
Mental incompetence to make a decision to participate (developmentally disabled, and persons with diagnosed psychiatric disorders-documented in primary care records).
Intervention: Naltrexone
Trial phase: Phase 1 | Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone

Naltrexone
Eligibility criteria:
Inclusion Criteria:

Adult, aged 18-49.
Currently maintained on buprenorphine, with a clinically acceptable interest in tapering or discontinuing it
Willingness to switch over to naltrexone
In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.
Able to give informed consent and comply with study procedures,
Currently on 2 mg or less of buprenorphine.
Voluntarily seeking treatment for opioid dependence.

Exclusion Criteria:

Significant current suicidal risk or 1 or more suicide attempts within the past year
History of accidental drug overdose in the last three years defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV organic mental disorder, psychotic disorder, or bipolar disorder with mania
History of allergic reaction, adverse reaction, or sensitivity to any study medication.
Acute hepatitis with SGOT or SGPT > 3 times the upper end of the laboratory normal range (chronic hepatitis is acceptable as we have found naltrexone treatment well tolerate and safe among patients with chronic hepatitis)
Currently prescribed or regularly taking opioids for chronic pain
Current participation in another intensive psychotherapy or substance abuse treatment program, or participation in another treatment study.
Opioid dependence is not well-managed, and characterized by relapses, slips, or missed doses
Concurrent treatment with psychotropic medications which may interact adversely with naltrexone, such as duloxetine and valproic acid.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 250
Group description: According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.

Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid
Eligibility criteria:
Inclusion Criteria:

Gender; male/ female
Age: ≥ 18 year

Elective cardiac surgical patients

Coronary artery bypass graft (CABG) (conventional, E.CCO)
Aortic valve replacement (AVR) (conventional)
Mitral valve replacement (MVR)/ Mitral valve repairment (MPL) (conventional)
Tricuspid valve replacement (TVR) / Tricuspid valve repairment (TPL)
Bentall
Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/Maze)

Exclusion Criteria:

MVR/MPL (minimal invasive, Port Access Surgery)
Maze (minimal invasive, via Thoracoscopy)
AVR (minimal invasive, via mini Sternotomy)
off-pump procedures
Emergency operations
Patient with increased or decreased blooding tendency (FV leiden, prot C, S deficiency, anti-thrombin deficiency, prothrombin mutation)
Intervention: Teriflunomide
Trial phase: Phase 4
ATC code: L04AA31
SMILES: C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1000
Group description: Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Eligibility criteria:
Inclusion criteria:

Participants with a relapsing form of multiple sclerosis (RMS) having signed written informed consent.

Exclusion criteria:

According to local labelling,
Less than 18 years of age,
Current or history of receiving teriflunomide,
Previous treatment with leflunomide within 6 months prior to baseline,
Participants with preexisting acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN),
Known history of active tuberculosis (TB) or latent TB infection, either diagnosed by standard medical practice or guidelines (including skin or blood test, chest X-ray, or as appropriate per local practice),
Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections,
Women who were pregnant or breast-feeding,
Female participants with a positive pregnancy test at screening or women of child-bearing potential who did not agree to use reliable contraception throughout the course of the study,
Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study,

Additional exclusion criteria applicable for Europe (EU) countries (in accordance with contraindications of EU summary of product characteristics [SmPC]):

Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia,
Participants with severe active infection until resolution,
Participants with severe renal impairment undergoing dialysis, because insufficient clinical experience was available in this participant group,
Participants with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Hypersensitivity to the active substance or to any of the excipients,
Other additional contraindications per local labeling.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Elobixibat
Trial phase: Phase 3
ATC code: A06AX09
SMILES: CCCCC1(CCCC)CN(c2ccccc2)c2cc(SC)c(OCC(=O)N[C@@H](C(=O)NCC(=O)O)c3ccccc3)cc2S(=O)(=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 409
Group description: Elobixibat 10 mg

Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.
Eligibility criteria:
Inclusion Criteria:

Has completed double-blind treatment in either of the lead-in efficacy trials, 000079 or 000080.
The patient reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all trial visits and assessments.
The patient agrees to refrain from making any new, major lifestyle changes that may affect CIC symptoms (i.e., starting a new diet, changing an exercise plan) from the time of signing the ICF through to the last trial visit.

Exclusion Criteria:

The patient has been withdrawn/discontinued from the 000079 or 000080 trials.
The patient is not willing to abide by the restrictions for intake of prohibited medication.

Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who have a positive urine pregnancy test at Visit 1, or who do not agree to use one of the following methods of birth control from the day of signing the ICF until 30 days after the final dose of trial drug are excluded:

Transdermal patch
Established use of oral, injected or implanted hormonal methods of contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
True sexual abstinence: when this is in line with the preferred and usual lifestyle of the patient.
The patients is considered by the Investigator to be unsuitable to participate in the trial for any other reason.