anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Mannitol
Trial phase: Phase 4
ATC code: A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04
SMILES: OCC(O)C(O)C(O)C(O)CO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Method of administration: irrigant during cystoscopy
Dose: 300cc during cystoscopy to visualize the ureters
Known adverse events: dysuria, polyuria, hyponatremia with excess absorption, potential increased risk of urinary tract infection
Contraindications when used as a genitourinary irrigation solution: anuria

Mannitol
Eligibility criteria:
Inclusion Criteria:

- Planned cystoscopy

Exclusion Criteria:

Women who are pregnant

Women with contraindications to pyridium, sodium fluorescein or mannitol:

Intra-operative administration of nitric oxide, prilocaine and sodium nitrite
Anuria
Women with creatinine greater than 1 or Cr Cl < 50ml/minute
Known allergy to pyridium, sodium fluorescein or mannitol.
Women with a known urologic anatomical anomaly
Intervention: OMECAMTIV MECARBIL
Trial phase: Phase 2
ATC code: C01CX10
SMILES: COC(=O)N1CCN(Cc2cccc(NC(=O)Nc3ccc(C)nc3)c2F)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Placebo for omecamtiv mecarbil BID
Eligibility criteria:
Inclusion Criteria:

Japanese male or female ≥ 20 years and ≤ 85 years of age
History of chronic stable heart failure (HF) with reduced ejection fraction, defined as requiring treatment for HF for a minimum of 4 weeks prior to screening
Treated for HF with optimal pharmacological therapy
Left ventricular ejection fraction ≤ 40% at screening

Exclusion Criteria:

Severe uncorrected valvular heart disease
Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
Acute myocardial infarction, unstable angina, or persistent angina at rest within 30 days prior to randomization
Systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg, or heart rate (HR) > 110 beats per minute (bpm) or HR < 50 bpm
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
Total bilirubin (TBL) ≥ 2x upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3x ULN Other Exclusion Criteria may apply.
Intervention: Naloxone
Trial phase: Phase 1 | Phase 2
ATC code: A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15
SMILES: C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: 3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps

intra-nasal naloxone: 3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
Eligibility criteria:
Inclusion Criteria:

Subjects are capable of giving informed consent.
Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.
Subject should be medication free, other than hormonal birth control, for 48 hours before through 24 hours after study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.

Exclusion Criteria:

Women who are pregnant.
Women who are breastfeeding.
Subject has a known hypersensitivity to naloxone.
Subject with hypertension
Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
Subject has taken or used any investigational drug or device in the 30 days prior to screening.
Subject has taken either prescribed or over the counter medication for 48 hours prior to study drug administration on either of the study days, other than hormonal birth control.
History of narcotic or heroin abuse.
Intervention: Petesicatib
Trial phase: Phase 2
SMILES: Cn1cc(-c2ccc(S(=O)(=O)[C@@H]3C[C@@H](C(=O)NC4(C#N)CC4)N(C(=O)C4(C(F)(F)F)CC4)C3)c(C(F)(F)F)c2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: RO5459072 at a dose of 100 milligrams (as capsules) was administered orally, 2 times a day, for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

A diagnosis of primary Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
ESSDAI score greater than or equal to (>/=) 5
ESSPRI score >/=5
Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening
Negative pregnancy test at screening and baseline (for women only)
Willing to comply with the study procedures and restrictions, including measures to prevent pregnancy and restrictions on sperm donation

Exclusion Criteria:

A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria
Severe complications of Sjogren's syndrome
Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy within 6 months prior to the screening visit
Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day
A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal, yeast or bacterial infection at screening
A history suggesting reduced immune function or any other conditions predisposing participants to serious infection
A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years
A diagnosis of fibromyalgia or significant depression
Having any concomitant disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the individual
Participation in an investigational drug or device study within 3 months prior to screening
Inability to comply with the study protocol for any other reason
Women who are lactating, breastfeeding or planning to nurse
Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein [P-gp]; sensitive substrates of CYP3A4 with a narrow therapeutic index)
Intervention: Sirolimus
Trial phase: Phase 1
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 38
Group description: M366 22.5 mg/975 mg tablet by mouth
Eligibility criteria:
Inclusion Criteria:

BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria:

Drug or alcohol dependence within the last 12 months (except nicotine)
Subjects who had ever been in treatment for substance use disorders (except smoking cessation
History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
History or presence of hypotension, judged to be clinically significant based on investigator judgement
Intervention: Sirolimus
Trial phase: Phase 1
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: M366 37.5 mg/1625 mg tablet by mouth
Eligibility criteria:
Inclusion Criteria:

BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria:

Drug or alcohol dependence within the last 12 months (except nicotine)
Subjects who had ever been in treatment for substance use disorders (except smoking cessation
History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
History or presence of hypotension, judged to be clinically significant based on investigator judgement
Intervention: Milrinone
Trial phase: Phase 2
ATC code: C01CE02
SMILES: Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.

Milrinone
Eligibility criteria:
Inclusion Criteria:

Subjects ≥ 18 years of age
Aneurysmal subarachnoid hemorrhage, proven on CT angiogram or digital subtraction angiography
Aneurysm treated, either by endovascular embolization or surgical clip ligation
Evidence of increased velocities on transcranial dopplers (TCDs) and/or radiographic evidence of vasospasm as seen on angiogram
Cerebral vasospasm as demonstrated by patient's clinical exam (new focal deficit or change in mental status not attributable to any other cause)

Exclusion Criteria:

Recurrent subarachnoid hemorrhage
Untreated ruptured aneurysm, for any reason
Patients who die prior to treatment for aneurysm
Patients who are not able to complete at least 6 months of follow-up
Patients who are admitted already in vasospasm (i.e. a delayed admission)
Creatinine clearance less than 20 ml/min
Women with a positive pregnancy test or who are lactating
Other comorbidity which may adversely affect patient outcome, at the discretion of the principal investigator
Intervention: Fingolimod
Trial phase: Phase 4
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 130
Group description: fingolimod 0.5 mg
Eligibility criteria:
Inclusion Criteria:

Written informed consent before any assessment was performed.
Randomized in study CFTY720DDE01 and received at least one dose of study drug (fingolimod) and completed the study.
Continuous intake of fingolimod after end of study CFTY720DDE01 with a maximum treatment interruption of 3 months in total before entering this study.
Parallel participation at study CFTY720DDE02 (Pangaea NIS) was allowed.

Exclusion criteriat:

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.
Patients with onset of an acute relapse had to postpone their evaluation until deemed stable from relapse by treating physician, but at least for 1 month since end of relapse.
Patients that received immunomodulating or immunosuppressive MS treatments other than fingolimod since completion of study CFTY720DDE01 as for example: Natalizumab,Alemtuzumab, Dimethyl fumarate, Teriflunomide, intravenous Immunoglobulins,Mitoxantrone, Methotrexate, Azathioprine or experimental immunomodulating-immunosuppressive therapies.
Intervention: Duavee
Trial phase: Phase 2
SMILES: CC12CCC3C(=CCc4cc(OS(=O)(=O)O)ccc43)C1CCC2=O.CC12CCC3c4ccc(OS(=O)(=O)O)cc4CCC3C1CCC2=O.CC12CCc3c(ccc4cc(OS(=O)(=O)O)ccc34)C1CCC2=O.Cc1c(-c2ccc(O)cc2)n(Cc2ccc(OCCN3CCCCCC3)cc2)c2ccc(O)cc12
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Participants asked to take Duavee for 6 months while on the study.

Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
Eligibility criteria:
Inclusion Criteria:

Women with vasomotor symptoms with a uterus who are postmenopausal or in late menopause transition
Body Mass Index (BMI) <36 kg/m2
Class I-III mammogram within 6 months of Random Periareolar Fine Needle Aspiration (RPFNA); If Class 0 or 4, must be resolved with additional procedures
If previously on oral contraceptives or hormone replacement, off for 8 weeks or more prior to baseline RPFNA; the exception is low dose vaginal hormones
Confirmed moderate risk of developing breast cancer
RPFNA results within study defined range
Kidney and liver function within study defined range
Willing and able to comply with study related procedures

Exclusion Criteria:

Previous biopsy showing evidence of breast cancer
Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke
History of renal or liver disease
Prior ovarian or endometrial cancer
Stopped or started hormone replacement within 8 weeks
Any other condition or intercurrent illness that in the opinion of the investigator makes the woman a poor candidate for RPFNA
Currently taking or have taken specific medications in the past 6 months
Participation on any chemoprevention trial within 6 months
Current illness which would make potential participant unsuitable for enrollment
Intervention: Fluoxetine
Trial phase: Phase 2
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 20 mg fluoxetine capsule by mouth once daily for 90 days

Fluoxetine
Eligibility criteria:
Inclusion Criteria:

MRI-confirmed acute ischemic stroke resulting in an isolated homonymous visual field loss.

Exclusion Criteria:

Known hypersensitivity to fluoxetine or other selective serotonin reuptake inhibitors
National Institutes of Health Stroke Scale score greater than 5
Premorbid modified Rankin Scale score greater than 2
Premorbid monocular or binocular visual field deficits
Premorbid retinopathy or optic neuropathy
Premorbid depression
History of cognitive impairment, dementia, or neurodegenerative disorder
History of seizure disorder
History of mania or hypomania
History of hyponatremia
History of angle-closure glaucoma or elevated intraocular pressure
Current alcohol abuse or impaired liver function
Current use of an antidepressant medication
Current use of a medication likely to have an adverse interaction with fluoxetine
Current use of a medication likely to impair post-stroke recovery
Contraindication to MRI
Pregnancy or lactation
Hemorrhagic transformation of the index stroke, resulting in mass effect
Enrollment in another clinical trial at the time of the index stroke
Intervention: Fentanyl
Trial phase: Not Applicable
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.

Fentanyl: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events.
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 2 years and less than 8 years at the time of randomization.
Weight greater than 6 kg.
American Society of Anesthesiologists (ASA) physical status of ASA I, II, or III (Appendix I).
Informed consent to participate from the parent or legally authorized guardian.
Scheduled for congenital cardiac bypass surgery.

Exclusion Criteria

Subjects will not be eligible to participate in the study if any of the following exclusion criteria apply:

History or a family (parent or sibling) history of malignant hyperthermia.
Known significant hepatic disorders determined by medical history, medical record documentation, physical examination, or laboratory tests obtained during the routine preoperative cardiac surgery evaluation or cardiology visit (International Normalized Ratio (INR)>1.5).
Emergency Cardiac Surgery.
History of chronic nausea and/or vomiting.
Currently receiving inotropic agents or using a pacemaker.
Prexisting long QTc interval of greater than 460ms determined by medical history, medical record documentation, or electrocardiogram obtained during the routine preoperative cardiac surgery evaluation.
History of documented pulmonary hypertension, respiratory dysfunction, or requirement of supplemental oxygen therapy.
History of opioid abuse, addiction, or tolerance.
Obesity defined as a body weight greater than 130% of the ideal weight.
Participation in another clinical trial or any study that may interfere with participation in this trial.
History of allergic reaction to methadone or fentanyl.
Intervention: Methadone
Trial phase: Not Applicable
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.

Methadone: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events.
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 2 years and less than 8 years at the time of randomization.
Weight greater than 6 kg.
American Society of Anesthesiologists (ASA) physical status of ASA I, II, or III (Appendix I).
Informed consent to participate from the parent or legally authorized guardian.
Scheduled for congenital cardiac bypass surgery.

Exclusion Criteria

Subjects will not be eligible to participate in the study if any of the following exclusion criteria apply:

History or a family (parent or sibling) history of malignant hyperthermia.
Known significant hepatic disorders determined by medical history, medical record documentation, physical examination, or laboratory tests obtained during the routine preoperative cardiac surgery evaluation or cardiology visit (International Normalized Ratio (INR)>1.5).
Emergency Cardiac Surgery.
History of chronic nausea and/or vomiting.
Currently receiving inotropic agents or using a pacemaker.
Prexisting long QTc interval of greater than 460ms determined by medical history, medical record documentation, or electrocardiogram obtained during the routine preoperative cardiac surgery evaluation.
History of documented pulmonary hypertension, respiratory dysfunction, or requirement of supplemental oxygen therapy.
History of opioid abuse, addiction, or tolerance.
Obesity defined as a body weight greater than 130% of the ideal weight.
Participation in another clinical trial or any study that may interfere with participation in this trial.
History of allergic reaction to methadone or fentanyl.
Intervention: Gadofosveset
Trial phase: Phase 4
ATC code: V08CA11
SMILES: O.O=C([O-])CN(CCN(CC(=O)[O-])CC(COP(=O)([O-])OC1CCC(c2ccccc2)(c2ccccc2)CC1)N(CC(=O)[O-])CC(=O)[O-])CC(=O)[O-].[Gd+3].[Na+].[Na+].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 17
Group description: gadofosveset, 0.03mmol/kg, one time bolus injection

gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds
Eligibility criteria:
Inclusion Criteria:

Male or female pediatric patients of all ethnicities (age newborn to 6 years) with known or suspected CHD with inconclusive echocardiographic exams and are referred for cardiovascular MRI for further evaluation of cardiac anatomy and function.
Written informed consent obtained from subject's legal representative/guardian(s) and ability for subject to comply with the requirements of the study

Exclusion Criteria:

Standard clinical contraindications to MRI, including subjects with cochlear implants and implanted cardiac devices
Subjects with past or current diagnosis of iron overload due to hereditary hemochromatosis or other causes (for subjects receiving Feraheme injection only).
Subjects with known hypersensitivity or allergy to iron oxide particles.
Subjects with renal insufficiency defined as estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73m2 (for subjects receiving Ablavar injection only).
Subjects who are critically ill at the time of MRI and for whom the period of general anesthesia and separation from the critical care nursery or intensive care unit poses added risk as deemed by referring cardiologists, cardiac surgeons or the managing radiologist (for Part II only).
Other medical conditions, in the judgment of the clinician investigator, that would increase the risks to the child related to participation in the study.