anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Upadacitinib
Trial phase: Phase 3
ATC code: L04AA44 | L04AF03
SMILES: CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of CD for at least 3 months prior to Baseline.
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
If female, participant must meet the contraception recommendations.

Exclusion Criteria:

Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
Participant with ostomy or ileoanal pouch.
Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
Screening laboratory and other protocol pre-specified analyses show abnormal results.
Intervention: Upadacitinib
Trial phase: Phase 3
ATC code: L04AA44 | L04AF03
SMILES: CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of CD for at least 3 months prior to Baseline.
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
If female, participant must meet the contraception recommendations.

Exclusion Criteria:

Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
Participant with ostomy or ileoanal pouch.
Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
Screening laboratory and other protocol pre-specified analyses show abnormal results.
Intervention: Pemafibrate
Trial phase: Phase 3
ATC code: C10AB12
SMILES: CC[C@@H](Oc1cccc(CN(CCCOc2ccc(OC)cc2)c2nc3ccccc3o2)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: .2 mg pemafibrate orally BID

Pemafibrate: 0.2 mg orally BID - twice daily
Eligibility criteria:
Inclusion Criteria:

Already randomized at US or Canadian sites in the PROMINENT study
Ability to cooperate with dilated ophthalmic examination and imaging procedures

At least one eye meets the following study eye inclusion criteria:

Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity level between 20 and 53 (minimal to severe non-proliferative diabetic retinopathy (NPDR)), inclusive, on color fundus photographs confirmed by central Reading Center grading.

Exclusion Criteria:

Study eye exclusion criteria are:

a. Neovascularization present. b. Current central-involved diabetic macular edema (DME based on optical coherence tomography (OCT) central subfield thickness (CST) i. Zeiss Cirrus: CST ≥ 290µm in women or ≥ 305µm in men ii. Heidelberg Spectralis: CST ≥ 305µm in women or ≥ 320µm in men c. Known major non-diabetic intraocular pathology that in the opinion of the investigator would substantially and adversely affect visual acuity or lead to ocular neovascularization during the course of the study d. Anticipated need for intravitreous anti-vascular endothelial growth factor (VEGF), intravitreous corticosteroid, or pan-retinal photocoagulation (PRP) in the next 6 months following randomization e. History of intravitreous anti-VEGF or corticosteroid treatment within the prior year for any indication.

f. History of intraocular surgery within prior 4 months or anticipated within the next 6 months following randomization g. Any history of PRP or vitrectomy h. History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to screening i. Aphakia j. Known substantial media opacities that would preclude successful imaging
Intervention: Propranolol
Trial phase: Phase 2
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 121
Group description: After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of propranolol 2mg of IV push
Eligibility criteria:
Inclusion Criteria:

Nulliparous women undergoing induction of labor
>37 weeks' gestational age
Non-anomalous, singleton cephalic presenting fetus.

Exclusion Criteria:

Multiple gestations, known fetal anomalies
Maternal cardiac or hypertensive disease
Chronic beta blocker use
Bronchial asthma
Maternal or fetal indication for immediate delivery.
Intervention: ABROCITINIB
Trial phase: Phase 3
ATC code: D11AH08
SMILES: CCCS(=O)(=O)N[C@H]1C[C@@H](N(C)c2ncnc3[nH]ccc23)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 156
Group description: Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Eligibility criteria:
Inclusion Criteria:

12 years of age or older with a minimum body weight of 40 kg
Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4)
Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Prior treatment with JAK inhibitors
Other active nonAD inflammatory skin diseases or conditions affecting skin
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Intervention: ABROCITINIB
Trial phase: Phase 3
ATC code: D11AH08
SMILES: CCCS(=O)(=O)N[C@H]1C[C@@H](N(C)c2ncnc3[nH]ccc23)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 154
Group description: Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Eligibility criteria:
Inclusion Criteria:

12 years of age or older with a minimum body weight of 40 kg
Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4)
Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Prior treatment with JAK inhibitors
Other active nonAD inflammatory skin diseases or conditions affecting skin
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Intervention: Lente
Trial phase: Phase 4
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(CC3C=NC=N3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(CC3C=NC=N3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C.[Zn]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin

NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL.
Eligibility criteria:
Inclusion Criteria:

Patients between 18 and 100 years old.
History of type 2 diabetes mellitus (DM2) or that upon admission is diagnosed by values of glycated haemoglobin (HbA1) > 6.5%
Fasting central glucose before randomization between 140mg/dl and 400mg/dl
Non-critical patients hospitalized in the service of Internal Medicine (MI), General Surgery (CG) and Traumatology (TyO).
Patients receiving a diabetic diet orally
Treated with diet alone, o any combination of oral anti-diabetic agents or insulin treatment with any dosage before admission.

Exclusion Criteria:

Parenteral nutrition
Hyperglycemia without a known history of diabetes
Impaired renal function (glomerular filtration rate less than 30)
Diabetic ketoacidosis and hyperosmolar state
Type 1 Diabetes mellitus
Pregnancy
Patients on treatment with more than 10mg prednisone or steroid boluses.
Known hypopituitarism or adrenal insufficiency
Hyperglycaemia due to stress (negative antecedent of DM2, hyperglycemia and HbA1 <6.5)
Severe liver disease (Child-Pugh C score)
Acute pancreatitis
Patients with sepsis or multiple organ failure
Candidates for intensive care unit
Intervention: 4-chloro-N-[(1R)-1-[4-(6-fluoroquinolin-4-yl)cyclohexyl]ethyl]benzamide
Trial phase: Phase 1 | Phase 2
SMILES: CC(NC(=O)c1ccc(Cl)cc1)C1CCC(c2ccnc3ccc(F)cc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Eligibility criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1
Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting if such a therapy exists
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Ability to swallow tablets
Adequate bone marrow and organ function, as defined by the protocol

Exclusion Criteria:

Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)
Ocular melanoma
Any significant acute or chronic medical illness
Prior malignancy
Other active malignancy requiring concurrent intervention
Prior organ allograft or allogeneic bone marrow transplantation
Participants with active, known, or suspected autoimmune disease
Requirement for daily supplemental oxygen
Uncontrolled or significant cardiovascular disease
Pre-existing liver disease
Gastrointestinal disease known to interfere with absorption

Other protocol defined inclusion/exclusion criteria could apply
Intervention: Alvimopan
Trial phase: Phase 2
ATC code: A06AH02
SMILES: C[C@H]1CN(C[C@H](Cc2ccccc2)C(=O)NCC(=O)O)CC[C@@]1(C)c1cccc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Alvimopan: alvimopan pill
Eligibility criteria:
Inclusion Criteria:

Ability to understand and the willingness to sign a written informed consent.
Scheduled to undergo open (non-minimally invasive) CRS/HIPEC.
Scheduled to receive postoperative pain management with intravenous opioids.
Age > 18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Women of child-bearing potential with negative pregnancy test prior to initiating study drug dosing.

Exclusion Criteria:

Greater than 7 days of consecutive opioid use immediately prior to scheduled surgery.
Child-Pugh Class C hepatic impairment.
End-stage renal disease (GFR < 15 mL/min/1.73 m2 and/or on peritoneal dialysis or hemodialysis).
Complete mechanical bowel obstruction.
Contraindication or inability to tolerate oral medication postoperatively.
Presence of gastrointestinal ostomy after CRS/HIPEC.
Pancreatic or gastric anastomosis performed during CRS/HIPEC.
History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition as alvimopan at the treating investigators discretion.
Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e. uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
History of myocardial infarction in the 12 months prior to scheduled surgery.
Pregnant or nursing.
Intervention: Rapastinel
Trial phase: Phase 2
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for MDD
Current major Depressive episode of at least 4 weeks and not exceeding 24 months in duration at visit 1
Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 1 month before Visit 1.

Lifetime history or currently meet DSM-5 criteria for:

Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study.
Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
Prior participation in any investigational study of rapastinel/GLYX-13
Intervention: Lorcaserin
Trial phase: Phase 4
ATC code: A08AA11
SMILES: C[C@H]1CNCCc2ccc(Cl)cc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.

Belviq: Belviq is an oral drug.
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) 28-40

Exclusion Criteria:

Any clinically significant or relevant medical condition, including:
Diabetes
Uncontrolled Hypertension
Heart disease
Bleeding disorder
Kidney or liver dysfunction
Neurologic disease
Psychiatric or eating disorders
Pregnancy or breastfeeding
Use of tobacco or opiates
History of alcohol or drug abuse
Recent weight change +/- 5%
Medications that affect body weight
Intervention: Gallium Ga-68 gozetotide
Trial phase: Phase 3
ATC code: V09IX14
SMILES: O=C([O-])CCc1ccc(O)c(CN(CCN(CC(=O)[O-])Cc2cc(CCC(=O)NCCCCCC(=O)NCCCC[C@H](NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)ccc2O)CC(=O)[O-])c1.[68Ga+3]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 346
Group description: PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Eligibility criteria:
Inclusion Criteria

Histopathologically proven prostate adenocarcinoma.

Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy

PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.

Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy

Nadir + greater than or equal to 2 ng/mL rise in PSA
Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
Age >= 18.
Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

Unable to lie flat, still or tolerate a PET scan.
Concomitant investigational therapy.
Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
Intervention: Ciprofloxacin
Trial phase: Phase 3
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 827
Group description: Ciprofloxacin 250 mg PO administered twice daily for 3 days

Ciprofloxacin: Treatment of uncomplicated urinary tract infection
Eligibility criteria:
Inclusion Criteria:

Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)
Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain

A mid-stream urine specimen with:

a dipstick analysis positive for nitrite AND
evidence of pyuria as defined by either:

i. a dipstick analysis positive for leukocyte esterase ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine iii. White blood cell count ≥10 cells/high-powered field in the sediment of a spun urine

Has given written informed consent to participate in the study.

Exclusion Criteria:

Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI
Patients with ileal loops or urinary stoma
Patients with an indwelling urinary catheter in the previous 30 days
Patients with paraplegia
Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
Any history of trauma to the pelvis or urinary tract
Patient's urine culture, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
Known history of creatinine clearance <50 mL/min
Patients known to have liver disease
Patients who are pregnant, or females of child-bearing age unable to take adequate contraceptive precautions
Patients with uncontrolled diabetes mellitus
Patients with history of blood dyscrasias
Patients with history of uric acid kidney stones
Patients with acute gouty attack
Patients on chronic methotrexate therapy
Patient known to be immunocompromised
Patients with a known history of myasthenia gravis
Patients who require concomitant administration of tizanidine or valproic acid
Patients with a history of allergy or hypersensitivity to carbapenems, beta-lactams, quinolones or probenecid
Patient is considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
History of seizures
Use of any other investigational drug in the 30 days prior to the study