anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Izilendustat
Trial phase: Phase 2
SMILES: CC(C)(C)OC(=O)N1CCN(Cc2ccn(Cc3ccc(Cl)cc3)c(=O)c2O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: PCP GB004 480 mg QD for oral administration for 36 weeks
Eligibility criteria:
Inclusion Criteria:

Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.

Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:

prednisone ≤ 20 mg/day or equivalent or
beclomethasone ≤ 5 mg/day or
budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day

Exclusion Criteria:

Prior approved biologic therapy used for the treatment of UC.
Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.
Azathioprine, or 6-mercaptopurine within 1 day of Day 1.

NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
Intervention: Izilendustat
Trial phase: Phase 2
SMILES: CC(C)(C)OC(=O)N1CCN(Cc2ccn(Cc3ccc(Cl)cc3)c(=O)c2O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: PCP GB004 480 mg BID for oral administration for 36 weeks
Eligibility criteria:
Inclusion Criteria:

Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.

Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:

prednisone ≤ 20 mg/day or equivalent or
beclomethasone ≤ 5 mg/day or
budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day

Exclusion Criteria:

Prior approved biologic therapy used for the treatment of UC.
Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.
Azathioprine, or 6-mercaptopurine within 1 day of Day 1.

NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
Intervention: Izilendustat
Trial phase: Phase 2
SMILES: CC(C)(C)OC(=O)N1CCN(Cc2ccn(Cc3ccc(Cl)cc3)c(=O)c2O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 130
Group description: OLE GB004 480 mg BID for oral administration for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.

Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:

prednisone ≤ 20 mg/day or equivalent or
beclomethasone ≤ 5 mg/day or
budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day

Exclusion Criteria:

Prior approved biologic therapy used for the treatment of UC.
Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.
Azathioprine, or 6-mercaptopurine within 1 day of Day 1.

NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
Intervention: Rifaximin
Trial phase: Phase 1 | Phase 2
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Rifaximin 550 mg (Standard dose for IBS-D)

Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged 18-75 years old inclusive

Onset of clinical symptoms for IBS-D occurring at least 6 months and, in order to progress to treatment phase, meet the following:

Has abdominal pain, on average, ≥1 day per week in previous 3 months, associated with ≥2 of the following: (1) Related to defecation, (2) Associated with a change in stool frequency, or (3) Associated with a change in form (appearance) of stool.
Fits Rome IV criteria for IBS with diarrhea (IBS-D), which is defined by >25% of abnormal bowel movements with Bristol stool form types 6 or 7 (loose, watery stool) and <25% of abnormal bowel movements with Bristol stool form types 1 or 2 (hard, lumpy stool).
Colonoscopy must have been completed within the past 10 years
Subjects are capable of understanding the requirements of the study, are willing to comply with all the study procedures, and are willing to attend all study visits

All subjects (male and female) shall agree to use an acceptable method of contraception throughout their participation in the study. Acceptable methods of contraception include:

Double barrier methods (condom with spermicidal jelly or a diaphragm with spermicide),
Hormonal methods (e. g. oral contraceptives, patches or medroxyprogesterone acetate),
An intrauterine device (IUD) with a documented failure rate of less than 1% per year.
Abstinence or partner(s) with a vasectomy may be considered an acceptable method of contraception at the discretion of the investigator.
Female subjects who have been surgically sterilized (e.g. hysterectomy or bilateral tubal ligation) or who are postmenopausal (total cessation of menses for >1 year) will not be considered "females of childbearing potential".

Exclusion Criteria:

Use of any oral antibiotics in the last two months
Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)
Subjects with known pelvic floor dysfunction
Pregnancy
Nursing mothers
Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures
History of bowel obstruction
History of inflammatory bowel disease or celiac disease
History of HIV
Cirrhosis
IBS-C/chronic idiopathic constipation
Poorly controlled diabetes or thyroid disease
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.

Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
Eligibility criteria:
Inclusion Criteria

Patients older than 18 years old
Patients undergoing scheduled primary anatomic total shoulder arthroplasty
Patients undergoing scheduled primary reverse total shoulder arthroplasty
Patients who consent to be randomized

Preoperative use of anticoagulant or antiplatelet therapy within 10 days prior to surgery:

Coumadin (Warfarin)
Heparin
Low molecular weight heparin
Factor Xa inhibitors
Apixaban (Eliquis)
Rivarixaban (Xatelto)
Edoxaban (Savaysa)
Dabigatran (Pradaxa)
Clopidogrel (Plavix)
Prasugrel (Effient)
Ticagrelor (Brilinta)

Exclusion Criteria

Patients younger than 18
Patients who are pregnant* or breast-feeding women
Patients who are allergic to tranexamic acid
Patients scheduled for revision total shoulder arthroplasty
Patients with proximal humerus fracture or fracture sequelae
Patients who use estrogen containing medications (i.e. oral contraceptive pills)
Patients who have acquired disturbances of color vision

Patients with a history of any of the following diagnosis: '

Subarachnoid hemorrhage
Active intravascular clotting
Severe pulmonary disease (FEV <50% normal)
Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)
(Renal impairment serum creatinine > 1.5 times the upper limit of normal NYU)
Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
Patients who refuse blood products
Patients undergoing hormone replacement therapy
Patients with diagnosed or self-reported cognitive dysfunction;
Patients who are unable to understand or follow instructions;
Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
Patients with BMI over 50
Any patient that the investigators feel cannot comply with all study related procedures.
Intervention: l-Alanyl-l-glutamine
Trial phase: Phase 3
ATC code: B05XB02
SMILES: CC(N)C(=O)NC(CCC(N)=O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw

L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
Eligibility criteria:
Inclusion Criteria:

Patients with coronary heart disease indicated for elective coronary artery bypass grafting under cardiopulmonary bypass
Patients with left ventricle ejection fraction 31% -50% confirmed by echocardiography or radio nuclear study.
Patients age ≥18 years
Never had heart surgery before
Agree to participate in the study and signed informed consent

Exclusion Criteria:

Emergency coronary artery grafting bypass
Having additional procedures other than coronary artery bypass grafting
History of myocardial infarction with onset less than 3 months
Patients with serum creatinine level more than 2 g/dL
Patients with ALT/AST levels more than 1.5 times the upper limit of normal value
Required to use intra-aortic balloon pump pre-operatively
History of stroke with onset less than 3 months
History of pre-operative atrial fibrillation
History of heart conduction problem and/or using a pacemaker
Patients with HIV
Contraindications to pulmonary artery catheter insertion

Drop out Criteria

Experiencing stroke after surgery
Experiencing surgery related complication (haemorrhage) requiring re operation
Requiring continuous veno-venous hemofiltration or haemodialysis after surgery
Delayed sternal closure
Aortic cross clamp duration more than 120 minutes and/or cardiopulmonary bypass time more than 180 minutes
Intervention: Sufentanil
Trial phase: Phase 4
ATC code: N01AH03
SMILES: CCC(=O)N(c1ccccc1)C1(COC)CCN(CCc2cccs2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: 30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia.

Sufentanil: 30 µg tablet of sublingual sufentanil
Eligibility criteria:
Inclusion Criteria:

Adults aged 18 years or older;
Scheduled for elective knee arthroscopy without anticipated ligamentous repair;
Planned general anesthesia without a regional block or wound infiltration with local anesthesia;
Planned day-of-surgery discharge.

Exclusion Criteria:

Opioid tolerance defined by ≥15 mg of oral morphine daily or equianalgesic dose of another opioid within 30 days of surgery;
Known hypersensitivity to sufentanil or components of DSUVIA;
Patients with an allergy or hypersensitivity to opioids;
Pregnancy or actively breastfeeding;
Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug;
Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
Intervention: Daunorubicin
Trial phase: Phase 2
ATC code: L01DB02 | L01XY01
SMILES: COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)C[C@@](O)(C(C)=O)C[C@@H]3O[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Patients in this arm will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.

Daunorubicin: Eligible patients with relapsed and/or refractory acute leukemia will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Patients with pathologically confirmed ALL or AML, whose disease is refractory to two induction therapeutic attempts, or who are in 2nd or greater relapse, or who are in 1st relapse or refractory to a single therapeutic attempt but are unable to receive intensive therapy at the time of consent.
All prior upfront therapies including bone marrow transplant are acceptable. Pulse steroids (of 5 days duration or less in the prior month) administered as part of a routine maintenance therapy are acceptable.
Age 1 to 21 years of age, inclusive
Established central catheter IV access

Exclusion Criteria:

Females who are known to be pregnant or lactating
Any Grade 3 or higher Cardiac Disorder per CTCAE version 5
Patients with echocardiographic evidence of cardiomyopathy (shortening fraction <27% or ejection fraction <50%)
Uncontrolled sepsis
Absolute Blast Count >50 x10(3)/mcL at enrollment or on day 1 of study
Direct hyperbilirubinemia >5mg/dL
Grade 3 or higher anaphylaxis to daunorubicin
Non-English speaking
Patients, who in the opinion of the PI, are unable to tolerate any study-specific procedures
Patients who have received cyclosporine, tacrolimus or other agents to prevent or treat graft-vs-host disease post bone marrow transplant in the last 14 days
Concurrent investigational drugs or other chemotherapeutic agents (excluding hydroxyurea), immunotherapies or biosimilars during the 5 days of daunorubicin.
Prior cumulative doses of anthracyclines will not be an exclusion regardless of the total cumulative dose previously received.
Intervention: Ioflupane I-123
Trial phase: Phase 1
ATC code: V09AB03
SMILES: COC(=O)C1C(c2ccc(I)cc2)CC2CCC1N2CCCF
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration.
Eligibility criteria:
Inclusion Criteria:

Chinese male or female who has agreed to sign and date the written informed consent form
Age 18-70 years
Body mass index (BMI) of 18-30 kg/m^2
General good state of health as judged by a qualified physician after completing physical examination
Fit, co-operative, and able to provide consent

Exclusion Criteria:

Sensitivity to DaTSCAN™ ioflupane (123I) injection or any of its ingredients
A history of motor disturbances
A history of pulmonary, cardiovascular, neurological, renal or hepatic, hormonal or coagulation disorders or hyperthyroidism
A history of drug, alcohol, or solvent abuse
The subject has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening
Radionuclide injection within a minimum of 5 radioactive half-lives prior to screening
Use of any medication (except paracetamol [acetaminophen] or oral contraceptive), including traditional Chinese medicine, within 2 weeks prior to the imaging visit
Classification as a radiation worker
Women of child-bearing potential not accepting a highly effective method of birth control (A woman is considered of child-bearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Postmenopausal is defined as 12 months with no menses without an alternative medical cause, in International Council on Harmonisation (ICH) M3 (R2); A highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner, in ICH M3 (R2).
Pregnant or lactating women
Intervention: SULFUR HEXAFLUORIDE
Trial phase: Phase 4
ATC code: V08DA05
SMILES: FS(F)(F)(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS),

Lumason: 2.4 mL per lesion
Eligibility criteria:
Inclusion Criteria:

Adult (≥18 years of age) patients with diagnosed HCC (via imaging, biopsy, or combination of imaging and biochemical markers), who are treated with their first round of TACE.
Sex: male or female
BMI ≤ 40

Exclusion Criteria:

Children (<18), pregnant patients
Patients who do not speak English
Patients with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason.
Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
Patients who have a prior non-contrast ultrasound, within last 3 months (at time of consent), where the tumor could not be seen - most commonly due to severe steatosis or obesity.
Pregnant or nursing woman
Patients who do not plan to get their follow-up CT/MRI at Hershey Medical Center.
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Sugammadex: Subjects who are randomized to into the sugammadex arm (Arm I) will receive sugammadex for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm II (neostigmine group).
Eligibility criteria:
Inclusion Criteria:

obese (body mass index [BMI] >30 kg/m2)
diagnosis of obstructive sleep apnea (OSA) (with or without continuous positive airway pressure [CPAP] use)
scheduled for surgery requiring general anesthesia and neuromuscular blockade

Exclusion Criteria:

history of hepatic, renal, or cardiovascular and/or cerebrovascular dysfunction
history of difficult tracheal intubation
history of adverse reaction to anesthesia
history of adverse reaction to rocuronium, sugammadex, and/or neostigmine/glycopyrrolate
Intervention: Neostigmine
Trial phase: Phase 4
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Neostigmine: Subjects who are randomized into the neostigmine arm (Arm II) will receive neostigmine for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm I (sugammadex group).
Eligibility criteria:
Inclusion Criteria:

obese (body mass index [BMI] >30 kg/m2)
diagnosis of obstructive sleep apnea (OSA) (with or without continuous positive airway pressure [CPAP] use)
scheduled for surgery requiring general anesthesia and neuromuscular blockade

Exclusion Criteria:

history of hepatic, renal, or cardiovascular and/or cerebrovascular dysfunction
history of difficult tracheal intubation
history of adverse reaction to anesthesia
history of adverse reaction to rocuronium, sugammadex, and/or neostigmine/glycopyrrolate
Intervention: Trans sodium crocetinate
Trial phase: Phase 1 | Phase 2
SMILES: CC(C=CC=C(C)C(=O)[O-])=CC=CC=C(C)C=CC=C(C)C(=O)[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: 0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days

Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
Eligibility criteria:
Inclusion Criteria:

Hospitalized subjects with confirmed SARS-CoV-2 infection and hypoxemia, defined as SpO2 < 94% on room air or requiring supplemental oxygen
Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to enrollment.
WHO ordinal scale score of 3, 4 or 5 at baseline
Male or non-pregnant female adult ≥18 years of age at time of enrolment.
Subject (or legally authorized representative (LAR)) provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Illness of any duration
Women of childbearing potential must have a negative blood pregnancy test at the screening/baseline visit (Day 1) and agree to use a double method of birth control through 30 days after the last dose of study drug.

Exclusion Criteria:

Intubated and mechanically ventilated at baseline
Receiving extracorporeal membrane oxygenation (ECMO) at baseline
Severe organ dysfunction (SOFA score > 10)
Patient or LAR unable to provide written informed consent
ALT/AST > 3 times the upper limit of normal or serum bilirubin > 1.5 times the upper limit of normal
Estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) formula < 30 mL/min/1.73 m^2 or on dialysis
Pregnancy or breast feeding.
Anticipated transfer to another hospital which is not a study site within 72 hours.
Allergy to any study medication