anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Diphenhydramine
Trial phase: Phase 3
ATC code: D04AA32 | D04AA33 | R06AA02 | R06AA52
SMILES: CN(C)CCOC(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: 25 mg diphenhydramine capsule, generic, sourced from Major Pharmaceuticals will be given orally 30-60 minutes prior to ocrelizumab infusion.

antihistamine: prophylaxis
Eligibility criteria:
Inclusion Criteria:

Male or female patient with relapsing or progressive forms of Multiple Sclerosis (MS), age 18 to 70 inclusive at the time of consent.
Able to understand the purpose, responsibilities and risks of the study and provide signed informed consent.
Naïve to ocrelizumab (OCR) and will receive OCR as part of standard of care for MS treatment.
No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
Estimated Expanded Disability Status Scale (EDSS) of ≤ 6.5 at screening.
Female patients of childbearing potential must practice effective contraception and continue contraception during the study.

Exclusion Criteria:

Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
Evidence of active hepatitis B infection at screening.
Patients with untreated hepatitis C, or tuberculosis. Patients who have history of Progressive multifocal leukoencephalopathy (PML) or known to be Human Immunodeficiency Virus (HIV) positive, per standard care.
Any persistent or severe infection.
Pregnancy or lactation.
Significant, uncontrolled somatic disease or severe depression in the last year.
Current use of immunosuppressive medication, lymphocyte-depleting agents, or lymphocyte-trafficking blockers.
Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study.
Any known allergy or inability to tolerate diphenhydramine or cetirizine.
Intervention: ICOSAPENT ETHYL
Trial phase: Phase 2
SMILES: CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 2g Vascepa capsules twice daily with meals

icosapent ethyl: Encapsulated omega-3 acid ethyl esters
Eligibility criteria:
Inclusion Criteria:

Male or female, ≥18 y of age
Judged to be in generally good health
Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening
Body mass index of ≥20.0 kg/m2
No clinically significant findings in a 12-lead ECG or physical examination
Willing and able to undergo the scheduled study procedures
Understands study procedures and signs forms documenting informed consent to participate in the study

Exclusion Criteria:

Laboratory test result of clinical significance
Uncontrolled hypertension
Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder
History of human immunodeficiency virus, hepatitis B or hepatitis C infection
Used any medication intended to alter the lipid profile within 4 weeks of the first qualification visit
Active systemic infection
A condition the Investigator believes would interfere subject ability to provide informed consent and/or comply with the study protocol
Intervention: Chlordiazepoxide
Trial phase: Phase 4
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm.

Control: Patients randomized to the control will receive a placebo
Eligibility criteria:
Inclusion Criteria:

Any patient undergoing primary total knee arthroplasty for osteoarthritis
Age ≥ 18 years old
Willingness to undergo randomization and return for all scheduled visits

Exclusion Criteria:

Age > 80 years old
American Society of Anesthesiologists (ASA) Score ≥ 4
Other supplemental vitamin D or Calcium use including their analogs: ergocalciferol, calcitriol, dihydrotachysterol, and paricalcitol
Current cancer
Malabsorption syndromes
Inability to take medications orally
Renal impairment defined as a glomerular filtration rate (GFR) < 30 mL/minute or creatinine >1.3 mg/dL
History of hypercalcemia defined as albumin-corrected hypercalcemia >12 mg/dL
Intervention: Tenalisib
Trial phase: Phase 2
SMILES: CC[C@H](Nc1ncnc2[nH]cnc12)c1oc2ccccc2c(=O)c1-c1cccc(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally
Eligibility criteria:
Inclusion Criteria:

Patients with diagnosis of B-cell CLL
Disease status defined as refractory to or relapsed after at least one prior therapy.
Presence of measurable lymphadenopathy presence of > 1 nodal lesion
ECOG performance status ≤ 2.
Adequate bone marrow, liver, and renal function

Exclusion Criteria:

Richter's (large cell) transformation, or PLL transformation.
Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
Prior exposure to drug that inhibits PI3K
Patient with ASCT/Allo-SCT receiving treatment for active GVHD.
Ongoing severe systemic bacterial, fungal or viral infection.
Central nervous system (CNS) involvement of leukemia or lymphoma.
Ongoing immunosuppressive therapy including systemic corticosteroids.
Known history of severe liver injury as judge by investigator.
Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
Women who are pregnant or lactating.

Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV) infection iv. active CMV infection

-
Intervention: Paclitaxel
Trial phase: Phase 2
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.

NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age;

Histopathologically proven adenocarcinoma of the prostate:

Localized cancer;
Subjects with tumors classified as <T3 per TNM classification, Gleason score≥ 6;
Prostate tumor must be able to be visualized on mpMRI;
Already considered to be candidate for radical prostatectomy;
Considered appropriate for treatment with paclitaxel therapy;

Laboratory requirements:

WBC >2500/mm3
Neutrophil >1500/mm3
Hemoglobin >10 mg/dL
Platelet >100,000/ mm3
AST and ALT <2.5 x ULN
Total bilirubin <1.5 x ULN
Calculated creatinine clearance ≥ 30 ml/min
Normal PT/INR and PTT;
ECOG of 0 or 1;
International Prostate Symptom Score (I-PSS) less than or equal to 20;
If sexually active, willing to use double condoms from time of NanoPac injection until prostatectomy;
Agree to all study procedures and provide signed informed consent;

Exclusion Criteria:

Evidence of locally advanced or metastatic disease;
Prostate size ≥ 50 cc;
Prior prostatectomy, including surgery for any benign condition (such as TURP);
Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) while on study prior to surgery;
Treatment with a prior investigational medication within 30 days of first dose of study agent;
Any previous local treatment of the prostate (e.g. radiation, HIFU, cryotherapy, Focal Irreversible Electroporation, Photodynamic Therapy, Laser Induced Thermometry);
Any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule;
Known sensitivity to any of the study agent components;
History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.
Intervention: Empagliflozin
Trial phase: Phase 3
ATC code: A10BD19 | A10BD20 | A10BD27 | A10BK03
SMILES: OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks.

Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years and ≤75 years old at Visit 1;
Chinese patient with diagnosis of Type 2 diabetes prior to Visit 1;

A stable treatment with premixed Insulin (≥ 20IU/day) or basal insulin (≥ 16 IU/day) for at least 12 weeks prior to enrolment with or without up to two OADs

With maximum insulin dose of ≤ 1 unit/kg/day. Acceptable basal insulins should have duration of action up to 24 h such as insulin Degludec, insulin glargin, insulin detemir or NPH (neutral protamine hagedorn) insulin; Acceptable pre-mixed insulins could be once or twice daily posology only. The total insulin dose should not be changed by more than 20% of the baseline value within the 12 weeks prior to randomisation (Visit 3). Both human insulin & insulin analogue are acceptable;
If the patient is taking OADs, regimen has to be unchanged for at least 12 weeks prior to randomization (Visit 3);
If the patient is taking metformin, stable dose (at least 1500 mg daily or maximum tolerated dose) must be maintained for at least 12 weeks without dose adjustments prior to randomization (Visit 3);
HbA1c ≥7.5% and ≤11.0% at Visit 1;
Fasting C-peptide: >0.5 ng/mL (>166pmol/L) at Visit 1；
18.5 kg/m2 ≤ BMI ≤ 45 kg/m2 at Visit 1;
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial;
Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion Criteria:

Diagnosis of Type 1 diabetes;
Patients receiving MDI insulin or insulin pump treatment;
eGFR <45ml/min/1.73m2 calculated based on MDRD formula;
Uncontrolled hyperglycemia [glucose level >13. 9 mmol/l after an overnight fast during placebo run-in];
Severe hypoglycemia episode (event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions) within 6 months prior to Visit 1;
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. Myocardial infarction, stroke or transient ischaemic attack within 3 months prior to Visit 1;
Bariatric surgery;
Further criteria apply
Intervention: Empagliflozin
Trial phase: Phase 3
ATC code: A10BD19 | A10BD20 | A10BD27 | A10BK03
SMILES: OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks.

Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years and ≤75 years old at Visit 1;
Chinese patient with diagnosis of Type 2 diabetes prior to Visit 1;

A stable treatment with premixed Insulin (≥ 20IU/day) or basal insulin (≥ 16 IU/day) for at least 12 weeks prior to enrolment with or without up to two OADs

With maximum insulin dose of ≤ 1 unit/kg/day. Acceptable basal insulins should have duration of action up to 24 h such as insulin Degludec, insulin glargin, insulin detemir or NPH (neutral protamine hagedorn) insulin; Acceptable pre-mixed insulins could be once or twice daily posology only. The total insulin dose should not be changed by more than 20% of the baseline value within the 12 weeks prior to randomisation (Visit 3). Both human insulin & insulin analogue are acceptable;
If the patient is taking OADs, regimen has to be unchanged for at least 12 weeks prior to randomization (Visit 3);
If the patient is taking metformin, stable dose (at least 1500 mg daily or maximum tolerated dose) must be maintained for at least 12 weeks without dose adjustments prior to randomization (Visit 3);
HbA1c ≥7.5% and ≤11.0% at Visit 1;
Fasting C-peptide: >0.5 ng/mL (>166pmol/L) at Visit 1；
18.5 kg/m2 ≤ BMI ≤ 45 kg/m2 at Visit 1;
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial;
Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion Criteria:

Diagnosis of Type 1 diabetes;
Patients receiving MDI insulin or insulin pump treatment;
eGFR <45ml/min/1.73m2 calculated based on MDRD formula;
Uncontrolled hyperglycemia [glucose level >13. 9 mmol/l after an overnight fast during placebo run-in];
Severe hypoglycemia episode (event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions) within 6 months prior to Visit 1;
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. Myocardial infarction, stroke or transient ischaemic attack within 3 months prior to Visit 1;
Bariatric surgery;
Further criteria apply
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: Sublingual film containing 120 Micrograms dexmedetomidine

Sublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)
Eligibility criteria:
Inclusion Criteria:

A subject will be eligible for inclusion in the study if he or she meets the following criteria:

Male and female patients between the ages of 18 to 75 years, inclusive.
Patients who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Patients who read, understand, and provide written informed consent.
Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

A subject will be excluded from the study if he or she meets the following criteria:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines, hypnotics and anti-psychotic drugs in the 4 hours before study treatment.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
Patients who are judged to be at significant risk of suicide
Female patients who have a positive pregnancy test at screening or are breastfeeding.
Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Sublingual film containing 180 Micrograms dexmedetomidine

Sublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)
Eligibility criteria:
Inclusion Criteria:

A subject will be eligible for inclusion in the study if he or she meets the following criteria:

Male and female patients between the ages of 18 to 75 years, inclusive.
Patients who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Patients who read, understand, and provide written informed consent.
Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

A subject will be excluded from the study if he or she meets the following criteria:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines, hypnotics and anti-psychotic drugs in the 4 hours before study treatment.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
Patients who are judged to be at significant risk of suicide
Female patients who have a positive pregnancy test at screening or are breastfeeding.
Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Sublingual film containing 180 Micrograms Dexmedetomidine

Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
Eligibility criteria:
Inclusion Criteria:

Male and female patients between the ages of 18 to 75 years, inclusive.
Patients who have met DSM-5 criteria for bipolar I or II disorder.
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Patients who read, understand and provide written informed consent.
Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
Patients who are judged to be at significant risk of suicide.
Female patients who have a positive pregnancy test at screening or are breastfeeding.
Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.