anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Alectinib
Trial phase: Phase 1
ATC code: L01ED03 | L01XE36
SMILES: CCc1cc2c(cc1N1CCC(N3CCOCC3)CC1)C(C)(C)c1[nH]c3cc(C#N)ccc3c1C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants with severe hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 mg on Day 1.
Eligibility criteria:
Inclusion Criteria:

All Participants

Body mass index between 18 to 35 kilograms per square meter (kg/m^2) inclusive and weight greater than (>) 50 kilograms (kg)
Female participants must be surgically sterile or post-menopausal
Male participants and their partners of child-bearing potential must be willing to use 2 effective methods of contraception, one of which must be a barrier method

Participants with Hepatic Impairment

- Documented chronic stable liver disease (Child-Pugh Class A, B or C)

Exclusion Criteria:

All Participants

Pregnant or lactating women, males with female partners who are pregnant or lactating, or women of child bearing potential
Positive test for drugs of abuse or alcohol
Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to study drug administration
History of hypersensitivity to any of the additives in the alectinib formulation
Participants under judicial supervision, guardianship, or curatorship
History of severe drug-related allergic reactions or drug-induced hepatotoxicity

Healthy Participants

Use of any medications (prescription or over-the-counter), within 2 weeks or 5 half-lives (whichever longer) prior to study drug administration
Use of any herbal supplements or any metabolic inducers within 4 weeks, or 5 half-lives (whichever is longer) prior to study drug administration

Participants with Hepatic Impairment

Positive screening test for human immunodeficiency virus (HIV)
History of liver transplantation
Hepatocellular carcinoma or acute liver disease
Severe ascites at screening or admission to the clinic
Recent history (past 2 years) or current severe hepatic encephalopathy (Grade 3 or higher)
Any evidence of progressive liver disease within the last 4 weeks
Presence of surgically created or transjugular intrahepatic portal systemic shunts
Intervention: Alectinib
Trial phase: Phase 1
ATC code: L01ED03 | L01XE36
SMILES: CCc1cc2c(cc1N1CCC(N3CCOCC3)CC1)C(C)(C)c1[nH]c3cc(C#N)ccc3c1C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Participants with normal hepatic function received alectinib at a single oral dose of 300 mg on Day 1.
Eligibility criteria:
Inclusion Criteria:

All Participants

Body mass index between 18 to 35 kilograms per square meter (kg/m^2) inclusive and weight greater than (>) 50 kilograms (kg)
Female participants must be surgically sterile or post-menopausal
Male participants and their partners of child-bearing potential must be willing to use 2 effective methods of contraception, one of which must be a barrier method

Participants with Hepatic Impairment

- Documented chronic stable liver disease (Child-Pugh Class A, B or C)

Exclusion Criteria:

All Participants

Pregnant or lactating women, males with female partners who are pregnant or lactating, or women of child bearing potential
Positive test for drugs of abuse or alcohol
Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to study drug administration
History of hypersensitivity to any of the additives in the alectinib formulation
Participants under judicial supervision, guardianship, or curatorship
History of severe drug-related allergic reactions or drug-induced hepatotoxicity

Healthy Participants

Use of any medications (prescription or over-the-counter), within 2 weeks or 5 half-lives (whichever longer) prior to study drug administration
Use of any herbal supplements or any metabolic inducers within 4 weeks, or 5 half-lives (whichever is longer) prior to study drug administration

Participants with Hepatic Impairment

Positive screening test for human immunodeficiency virus (HIV)
History of liver transplantation
Hepatocellular carcinoma or acute liver disease
Severe ascites at screening or admission to the clinic
Recent history (past 2 years) or current severe hepatic encephalopathy (Grade 3 or higher)
Any evidence of progressive liver disease within the last 4 weeks
Presence of surgically created or transjugular intrahepatic portal systemic shunts
Intervention: Chlorogenic Acid
Trial phase: Phase 2
SMILES: O=C(/C=C/c1ccc(O)c(O)c1)O[C@@H]1C[C@](O)(C(=O)O)C[C@@H](O)[C@H]1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.

Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
Eligibility criteria:
Inclusion Criteria:

BMI: 30.0-34.99 kg / m2.
Diagnosis of IGT (OGTT Values between 140mg / dl and 199mg / dl.
Written informed consent.
Body weight stable over the last 3 months.
Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.
Women who are not contemplated get pregnant within the next 6 months.

Exclusion Criteria:

Women pregnant or breastfeeding.
Physical or mental disability that makes it impossible to perform the intervention.
Diagnosis of Hypertension or heart failure.
Smokers.
Untreated thyroid disease.
Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).
Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.
Diagnosis of renal disease or creatinine > 1.5 mg / dl.
Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.
Total Cholesterol ≥ 280 mg/dL.
Triglycerids ≥ 300 mg/dL.
Known allergy to calcined magnesia or Chorogenic acid.
Intervention: Tenapanor
Trial phase: Phase 3
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 307
Group description: Tenapanor

Tenapanor
Eligibility criteria:
Inclusion Criteria:

18 to 75 years old
Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception.
Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization
Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS
A colonoscopy based on AGA guidelines; every 10 years at ≥ 50 years old, or the occurrence of any warning signs

Exclusion Criteria:

Functional diarrhea as defined by Rome III criteria
IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction, ischemic colitis or carcinoid syndrome.
Subject has a history or current evidence of laxative abuse (in the clinical judgment of the physician)
Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal) or renal impairment (serum creatinine > 2mg/dL)
Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy (unless within 60 days of screening visit)
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)

Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission.
Eligibility criteria:
Inclusion Criteria:

Age range: over 18 years old
Capacity to consent
Diagnosis of MDD and suffering from a major depressive episode
Score of at least 22 on the MADRS

Exclusion Criteria:

Significant active physical illness, particularly those that may affect the brain
Need for use of medication during the study that will interact with the study medication. Need to start medication that will affect study results (anti epileptics, antidepressants, beta blockers, medications with serotonergic or GABAergic modes of action)
Patients considered at significant risk for suicide
Patient is unlikely to be able to tolerate medication washout or the ~3 week interval (5 for fluoxetine) following washout (drug free period). Medication washouts will be supervised by a study physician.
For females: Pregnancy, currently lactating; planning to conceive during the course of study participation, or abortion in the past two months.
Coumadin treatment within 10 days of PET scanning
Any MRI contraindications, including metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
Bipolar Disorder
Current psychosis
High potential for excessive drug/alcohol use during the treatment period (excluding nicotine or cannabis)
Currently taking effective antidepressant
Currently taking an effective antidepressant
Prior intolerance escitalopram (ESC) for ≥ 4 weeks taking ≥ ⅔ Physician's Desk Reference (PDR) maximal dose
Significant neurological deficits
Electroconvulsive Therapy (ECT) within the past 6 months
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.

Lidocaine
Eligibility criteria:
Inclusion Criteria:

All adult patients undergoing elective open or laparoscopic total pancreatectomies and pancreatoduodenectomies (i.e., Whipple procedure), and participating in the Enhanced Recovery Protocol (ERP) at Mayo Clinic in Florida.
Age 18 - 80 years old
American Society of Anesthesiologist (ASA) class I - III
BMI < 40
Ability to understand and read English

Exclusion Criteria:

Not able or willing to sign consent
Intolerance or allergy to opioids, NSAIDS, acetaminophen, or amide-type local anesthetics (i.e., lidocaine).
History of epilepsy or currently receiving treatment for seizures
Severe hepatic insufficiency (Child-Pugh Score C)
Renal insufficiency (creatinine clearance less than 30 mL/minute)
Advance heart failure (NY Heart failure stage 3 or greater; Ejection function <30%)
Cardiac arrhythmias: 2nd and 3rd degree heart block, sick sinus syndrome, symptomatic bradyarrhythmias, Wolff-Parkinson-White (WPW) syndrome, or Stokes-Adams syndrome; Left bundle branch block or bifascicular block; Not to exclude patients the following conditions unless clinical circumstance dictate: Atrial fibrillation or atrial fluTter; Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers
Patients on anti-arrhythmic therapy (i.e., digoxin, amiodarone, flecainide, lidocaine, sotalol, etc.). Not to exclude patients on beta blockers (i.e., metoprolol, atenolol, etc.) unless clinical circumstance dictate
Patients with active psychiatric disorders or cognitive dysfunction
Pregnancy or lactating
Enucleation, central, and distal pancreatectomy
Opioid tolerance (defined as consumption of greater than 30 mg of oxycodone per day)
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 64
Group description: Patients will be administered optimal dosing of Omeprazole 20 mg for 4 weeks starting at week 2. Rescue antacid use is permitted. Total duration of 6 weeks.

Optimal Dosing of Omeprazole: Omeprazole 20 mg
Eligibility criteria:
Inclusion Criteria:

≥ 18 years old
taking omeprazole 20 mg
episodic heartburn at least 3 times per week
provides consent and be willing to complete study questionnaires
read, speak and write English

Exclusion Criteria:

weight loss (alarm symptom)
normal esophagogastroduodenoscopy (EGD) in last one year
pregnant or women planning on becoming pregnant at any time during the study
history of Barrett's esophagus
prior esophageal strictures
intolerance/allergy to study medications
patients on plavix or a history of upper gastrointestinal surgery
investigators or their immediate family (spouse, children, sibling)
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
Eligibility criteria:
Inclusion Criteria:

English-speaking adults at least 18 years old.
Subjects must be scheduled for an excision of forehead skin due to any etiology, with a same day, single stage closure planned as the most likely surgical repair.
Subjects must be able to read, sign, and understand the informed consent.
Subject is willing and able to participate in the study as an outpatient, making several visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.

Exclusion Criteria:

Subjects with an unstable medical condition as deemed by the clinical investigator, including review of the subject's prior and current medications.
Subjects with Myasthenia gravis, Lambert-Eaton Syndrome or other neuromuscular disorder.
Subjects taking medications that may alter the function of neuromuscular junctions (i.e. aminoglycoside antibiotics)
Women who are pregnant, lactating, or planning to become pregnant during the study period.
Subjects who have a history of keloids.
Known allergy to botulinum toxin.
Subjects who are not able to be closed with a same day, single stage technique.
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 51
Group description: Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.

Propofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.
Eligibility criteria:
Inclusion Criteria:

treated for at least 6 weeks with ACEIs or ARB
undergoing elective surgery under general endotracheal anesthesia
ASA Physical Class I or II

Exclusion Criteria:

BMI >45kg/m^2
taking both ACEI and ARB
history of difficult intubation in the past
require rapid sequence induction and intubation
uncontrolled baseline blood pressure (SBP>180mmHg or DBP >110 mmHg) at anesthesia preoperative clinic visit
contraindication to the use of propofol or methohexital
significant coronary artery disease
history of systolic heart failure
history of renal failure (creatine level >2 mg/dL)
Intervention: Methohexital
Trial phase: Not Applicable
ATC code: N01AF01 | N05CA15 | N05CB01
SMILES: C=CCC1(C(C)C#CCC)C(=O)NC(=O)N(C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 51
Group description: Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.

Methohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.
Eligibility criteria:
Inclusion Criteria:

treated for at least 6 weeks with ACEIs or ARB
undergoing elective surgery under general endotracheal anesthesia
ASA Physical Class I or II

Exclusion Criteria:

BMI >45kg/m^2
taking both ACEI and ARB
history of difficult intubation in the past
require rapid sequence induction and intubation
uncontrolled baseline blood pressure (SBP>180mmHg or DBP >110 mmHg) at anesthesia preoperative clinic visit
contraindication to the use of propofol or methohexital
significant coronary artery disease
history of systolic heart failure
history of renal failure (creatine level >2 mg/dL)
Intervention: Colchicine
Trial phase: Phase 2
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Colchicine 0.6 mg daily by mouth

Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Eligibility criteria:
Inclusion Criteria:

Patients of either gender who are 21 years of age (no upper age limit), HIV positive and taking stable ART (no change in ART regimen in last 3 months),
HIV viral load <100 copies/mL (plasma HIV RNA concentration),
Abnormal CEF at baseline (<7ml/min change in CBF during IHE as compared to resting value).

Exclusion Criteria:

Patients unable to understand the risks, benefits, and alternatives of participation and give meaningful consent,
Patients with contraindications to MRI such as implanted metallic objects (pre-existing cardiac pacemakers, cerebral clips) or indwelling metallic projectiles,
History of clinical CAD, including acute coronary syndrome, myocardial infarction or revascularization,
Resting ECG with evidence of Q wave myocardial infarction,
Pregnant women,
Recent history, within the past 3 months, of cocaine or heroin use,
Moderate or greater renal impairment (estimated glomerular filtration rate <45ml/min),
Moderate-severe hepatic disease (elevation in hepatic transaminases >3x upper limit of normal),
Leukopenia (<3000/mm3) or thrombocytopenia (<100,000/mm3),
CD4<200 cell/mm3,
Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease,
Requirement for, or intolerance to, colchicine,
Women of childbearing potential (even if using oral contraceptive agents) or intention to breastfeed,
Chronic, continuous use of oral or IV steroid therapy or other immunosuppressive or biologic response modifiers or anti-inflammatory agents (chronic NSAIDs or acetylsalicylic acid (ASA) >81mg daily),
History of chronic pericardial effusion, pleural effusion, ascites or peripheral neuropathy manifested by both signs and symptoms,
Taking protease inhibitors (PI), cobicistat, or CYP3A4 inhibitors.
Intervention: Bombesin (68Ga)
Trial phase: Phase 2 | Phase 3
SMILES: CC(C)CC(NC(=O)CC(O)C(CC(C)C)NC(=O)C(Cc1cnc[nH]1)NC(=O)CNC(=O)C(NC(=O)C(C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(Cc1ccccc1)NC(=O)CN1CCC(NC(=O)CN2CCN(CC(=O)[O-])CCN(CC(=O)[O-])CCN(CC(=O)[O-])CC2)CC1)C(C)C)C(N)=O.[Ga+3]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Patients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention.

68Ga-RM2: Imaging with PET/MRI

Magnetic Resonance Imaging: Imaging with 68Ga-RM2 PET/MRI

Positron Emission Tomography: Imaging with 68Ga-RM2 PET/MRI
Eligibility criteria:
Inclusion Criteria:

Biopsy proven prostate adenocarcinoma

Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy

Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation

PSA greater than 0.2 ng/mL measured 6-13 weeks after RP
Confirmatory persistent PSA greater than 0.2 ng/mL

Post-radiation therapy - American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition

Nadir plus (+) greater than or equal to 2 ng/mL rise in PSA
No evidence of metastatic disease on conventional imaging, including a negative bone scan for skeletal metastasis and negative contrast-enhanced CT
Able to provide written consent
Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

Exclusion Criteria:

Unable to provide informed consent
Inability to lie still for the entire imaging time
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
Metallic implants