anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.

Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
Eligibility criteria:
Inclusion Criteria:

generally healthy [(i.e. ambulatory, not currently sick)]
between the ages of 18 and 65
smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
an expired carbon monoxide (CO) concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine >1000 ng/mL (NicAlert = 6).
interest in quitting smoking within the timeframe of the experiment.
ability to identify 4 personal smoking and 4 personal non-smoking places.
right handed as measured by a three-item scale used in our laboratory
own a smartphone

Exclusion Criteria:

immediate or no desire to quit smoking;
inability to attend all required experimental sessions;
use of other tobacco products or e-cigarettes more than 9 days in the past 30 days;
current alcohol or drug abuse;

positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and Phencyclidine(PCP)

marijuana will be tested for but will not be exclusionary;
participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded;
participants failing the toxicology screen will be allowed to re-screen once;
current use of nicotine replacement therapy or other smoking cessation treatment;
screening systolic BP greater than 140 (participants failing for blood pressure will be allowed to rescreen once)
screening diastolic BP greater than 90 (participants failing for blood pressure will be allowed to rescreen once)
screening heart rate greater than 100 (participants failing for heart rate will be allowed to rescreen once)
presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies)
report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems, heart disease, heart attack in the past 90 days, irregular heartbeat)
medical condition that may contraindicate participation in the opinion of the investigator and study physician.
current major psychiatric disease such as schizophrenia or schizoaffective disorder
currently pregnant, breast feeding or likely to become pregnant;
a quit attempt resulting in greater than 3 days of abstinence in the past 30 days
presence of conditions that would make MRI unsafe (e.g., pacemaker)
Intervention: Fluconazole
Trial phase: Phase 2
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 140
Group description: Vitamin C placebo will consist of an identical bag of 100mL normal saline (but with no vitamin C) and will be labeled "Vitamin C or Placebo". Placebo will be infused over 30 minutes as per the infusion instructions of the active vitamin and protected from light with a brown bag. Hydrocortisone placebo will be provided as an identical 3mL syringe as 1mL of normal saline.The thiamine placebo will be placed in a 50mL bag of Normal Saline labeled "Thiamine 200mg or Placebo" and run over 30 minutes (100mL/hr) Placebo patients will receive a matching 50mL bag of Normal Saline. All of these will be given for up to 4 days, or less if discharged from the ICU prior.

Sodium Chloride 0.9%: Placebo "Ascorbic Acid" 100mL IV piggyback every 6 hours, Placebo "Thiamine" 50mL IV piggyback every 12 hours, and Placebo "Hydrocortisone" IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days).
Eligibility criteria:
Inclusion Criteria:

i. Diagnosis of sepsis or septic shock within 12 hours of admission to the ICU ii. Informed consent as dictated by IRB and local practice. iii. Compliance with the 3 hour sepsis bundle

30ml/kg of intravenous crystalloid fluid (e.g.: sodium chloride 0.9%) for lactic acid >4 and/or systolic blood pressure <90mmHg / mean arterial pressure <65mmHg
Lactic acid level drawn
Broad spectrum antibiotics given after obtaining blood cultures

Exclusion Criteria:

i. Age < 18 years ii. Pregnant iii. DNR/DNI with limitations of care on admission iv. Patients with terminal end stage disease (i.e. stage IV cancer, end stage heart failure) that are unlikely to survive to hospital discharge v. Patients with a primary admitting diagnosis of an acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma [64-66] vi. Requirement for immediate surgery [64-66] vii. Patients with HIV and a CD4 < 50 mm2 [64-66] viii. Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.[39] ix. Patients with sepsis/septic shock transferred from another hospital x. Patients with features of sepsis/septic shock > 24 hours after admission
Intervention: Fluciclovine (18F)
Trial phase: Phase 4
ATC code: V09IX12
SMILES: N[C@]1(C(=O)O)C[C@@H]([18F])C1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study.

18F fluciclovine: Each subject will receive one IV dose of 18F fluciclovine for PET scanning

18F fluciclovine PET: Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner
Eligibility criteria:
Inclusion Criteria:

Female
18 years and older
Biopsy-proved cervical cancer or endometrial cancer within three months of study enrollment
Standard-of-care (SOC) FDG PET/CT exam performed within 30 days of study enrollment

Exclusion Criteria:

Female < 18 years old
No history of cervical cancer or endometrial cancer
Primary biopsy > 3 months of study enrollment
Systemic therapy or radiation therapy initiated
SOC FDG PET/CT exam performed > 30 days of study enrollment
Therapeutic procedures (chemotherapy, radiation therapy) have been initiated
Pregnancy or lactation
Claustrophobia or inability to tolerate the imaging procedure on the PET/MR scanner
Individual is not willing to give informed consent
Intervention: Tauroursodeoxycholic acid
Trial phase: Phase 1 | Phase 2
ATC code: A05AA05
SMILES: [H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])CC[C@]3(C)[C@@H]([C@H](C)CCC(=O)NCCS(=O)(=O)O)CC[C@@]3([H])[C@]1([H])[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.

Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Progressive MS based on Lublin Criteria
Low bile acid levels identified using targeted metabolomics analysis
On the same therapy for the past 6 months and not expected to switch therapy in the next 6 months
No relapse in the past 3 months

Exclusion Criteria:

No previous history of liver disease or cholecystectomy
No stage IV/V chronic kidney disease or other severe metabolic derangements (e.g. poorly controlled thyroid disease or diabetes)
BMI < 15 kg/m2 and BMI > 40 kg/m2
Female patients who are pregnant or nursing, or not willing to use contraception
Chronic antibiotic use
Corticosteroid treatment within the past 30 days
Known history of other neuroinflammatory, neurodegenerative or systemic autoimmune disease
Intervention: Chloraprep
Trial phase: Phase 2
SMILES: CC(C)O.NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)CC(O)C(O)C(O)CO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 319
Group description: Patients who are not in the intervention arm received the standard of care prior to a cesarean section. In the operating room the patient will receive an abdominal cleanse with 2% Chloraprep solution (2% chlorhexidine gluconate) in addition to routine IV antibiotics.

2% chlorhexidine gluconate cloth: applied to their abdomen
Eligibility criteria:
Inclusion Criteria:

Women at > 24 weeks gestation who are admitted in labor or admitted for induction of labor at Mount Sinai Hospital

Exclusion Criteria:

Allergy to chlorhexidine
Unplanned or emergency cesarean section
Women at <24 weeks gestation
Estimated fetal weight <500 grams
Fetal face presentation regardless of gestational age.
Intervention: Modafinil
Trial phase: Phase 2
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Modafinil 300 mg by mouth each day

Modafinil: Modafinil 300 mg by mouth daily
Eligibility criteria:
Inclusion Criteria:

Males and females age 18-65 meeting Diagnostic and Statistical Manual V criteria for moderate or severe AUD in the past year
Interested in cutting down or quitting
Able to provide voluntary informed consent
Have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 60 days
Stop signal reaction time on a stop signal task>233

Exclusion Criteria:

Severe neurological conditions (severe traumatic brain injury/stroke/active seizure disorder)
Heart disease [mitral valve prolapse, left ventricular hypertrophy, cardiac arrhythmias, angina, myocardial infarction, unstable angina, cardiac syncope or pre-syncope, any electrocardiogram (ECG) finding that suggests the presence of one of these conditions]
Uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure >100)
Heart rate greater than 70% of the maximum expected for age [0.70(220-age)]
Chronic renal or hepatic failure
Recent pancreatitis
Insulin-dependent diabetes
Other urgent medical problems
Elevated liver function tests (AST or ALT greater than 4 times normal; modafinil is metabolized primarily by the liver)
Schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last month
Current moderate or severe other substance use disorder (SUD) (except nicotine or marijuana)
Active legal problems with the potential to result in incarceration
Pregnancy or lactation, or child bearing age and not on birth control
Current daily use of anti-craving medications, stimulants, benzodiazepines, opiates, anti-psychotics; current daily use of tricyclic antidepressants, bupropion, monoamine oxidase inhibitors, serotonin and norepinephrine reuptake inhibitors, or therapeutic doses (for bipolar disorder) of mood stabilizers
Taking a medication contraindicated for use with modafinil
Intervention: Fexofenadine
Trial phase: Phase 2
ATC code: R06AX26
SMILES: CC(C)(C(=O)O)c1ccc(C(O)CCCN2CCC(C(O)(c3ccccc3)c3ccccc3)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Fexofenadine (180 mg) for 2 weeks
Eligibility criteria:
Inclusion Criteria:

A minimum 6-month history of heartburn and regurgitation, as their main symptom
Experience at least 3-4 days with episodes of heartburn or regurgitation per week
Female patients who are postmenopausal or using acceptable methods of birth control.

Exclusion Criteria (selected)

Esophageal stricture
Primary esophageal motility disorder
Systemic sclerosis
Active inflammatory bowel disease
Zollinger-Ellison syndrome
Active gastric or duodenal ulcer
Active infectious or inflammatory conditions of the small or large intestine
Malabsorption syndromes of the intestine
History of gastrointestinal cancer
Current active cancer
Prior gastric or intestinal surgery
Pregnant or breast feeding
Other serious psychiatric or medical disease
Intervention: Relamorelin
Trial phase: Phase 3
SMILES: NC(=O)C1(NC(=O)[C@H](Cc2ccccc2)NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@@H](Cc2csc3ccccc23)NC(=O)C2CCNCC2)CCNCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 155
Group description: Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Type 1 or Type 2 diabetes mellitus
Meet the per protocol criteria of diabetic gastroparesis
Compliance with diary
Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1)
Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
History of gastrointestinal disorders that may be similar to gastroparesis
Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
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: 419
Group description: During the 26-week open label part, all enrolled subjects will receive 30 mg BID doses of tenapanor. Investigators may decrease or increase the dose in 10 mg increments to a minimum of 10 g BIDor a maximum of 30 mg BID

Tenapanor: Active Drug
Eligibility criteria:
Inclusion Criteria:

Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods
Males must agree to avoid fathering a child and agree to use an appropriate method of contraception
Chronic maintenance hemodialysis 3x a week for at least 3 months
Chronic maintenance peritoneal dialysis for a minimum of 6 months
Kt/V ≥ 1.2 at most recent measurement prior to screening
Prescribed and taking at least 3 doses of phosphate binder per day
Serum phosphorus levels should be between 4.0 and 8.0 mg/dL at screening
Unchanged dose of vitamin D or calcimimetics for the last 4 weeks prior to screening
For enrollment in the study after at least 2 weeks of wash-out, subjects must have serum phosphorus levels of at least 6.0 mg/dL but not more than 10.0 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value after 2 or 3 weeks wash-out of phosphate binders

Exclusion Criteria:

Severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dL on phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening visit
Serum/plasma parathyroid hormone >1200 pg/mL
Clinical signs of hypovolemia at enrollment
History of IBD or IBS-D
Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period
Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator
Life expectancy <6 months
Previous exposure to tenapanor
Intervention: CID 11593706
Trial phase: Phase 3
SMILES: C=CCN.ClCC1CO1.O=C(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Subjects randomized into the active control group, for safety analysis, will receive sevelamer carbonate, open label, for the entire 52-week study period. Sevelamer carbonate will be dosed based on package insert instructions (standard of care)

Sevelamer Carbonate: Active control
Eligibility criteria:
Inclusion Criteria:

Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods
Males must agree to avoid fathering a child and agree to use an appropriate method of contraception
Chronic maintenance hemodialysis 3x a week for at least 3 months
Chronic maintenance peritoneal dialysis for a minimum of 6 months
Kt/V ≥ 1.2 at most recent measurement prior to screening
Prescribed and taking at least 3 doses of phosphate binder per day
Serum phosphorus levels should be between 4.0 and 8.0 mg/dL at screening
Unchanged dose of vitamin D or calcimimetics for the last 4 weeks prior to screening
For enrollment in the study after at least 2 weeks of wash-out, subjects must have serum phosphorus levels of at least 6.0 mg/dL but not more than 10.0 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value after 2 or 3 weeks wash-out of phosphate binders

Exclusion Criteria:

Severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dL on phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening visit
Serum/plasma parathyroid hormone >1200 pg/mL
Clinical signs of hypovolemia at enrollment
History of IBD or IBS-D
Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period
Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator
Life expectancy <6 months
Previous exposure to tenapanor
Intervention: Brexpiprazole
Trial phase: Phase 4
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.

Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
Eligibility criteria:
Inclusion Criteria:

Outpatient men and women ages 18-65
Bipolar I or II disorders, currently depressed mood state based on a SCID for DSM-5; Mixed features in DSM-5 are allowed, but those with a Young Mania Rating Scale score ≥ 15 will be excluded
Baseline MADRS score ≥ 20

Exclusion Criteria:

Mood disorders other than bipolar I or II disorders (e.g., bipolar NOS, or cyclothymic disorders, schizophrenia, schizoaffective disorder, or unipolar depression based on the SCID), other disorders, e.g. anxiety disorders, will be allowed
Current (last 14 days) treatment with an antipsychotic or antidepressant
History of neuroleptic malignant syndrome or tardive dyskinesia
Prior history of brexpiprazole use
Vulnerable populations (e.g., pregnant, nursing, cognitively impaired, incarcerated)
High risk for suicide defined as > 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
Severe or life-threatening medical condition, or laboratory or physical examination findings consistent with serious medical illness (e.g., dangerously abnormal electrolytes)
Moderate or severe hepatic or renal impairment based on medical history and laboratory analyses
Taking moderate or strong induces or inhibitors of CYP2D6 or CYP3A4
Intervention: Progesterone
Trial phase: Early Phase 1
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.

Progesterone: Progesterone capsule
Eligibility criteria:
Inclusion Criteria:

Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments and study procedures.
Age 18-45, with regular menses (every 25-35 days).
Report using cannabis at least 5 days per week, for at least the past year.
Consent to remain abstinent from alcohol for 12 hours prior to study visits, and all other drugs other than cannabis or nicotine for the duration of the study.
Consent to random assignment.

Exclusion Criteria:

Participants who are pregnant, nursing, amennorheic, or using oral contraceptives.
History of major medical illnesses; including liver diseases, abnormal vaginal bleeding, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the investigator deems as contraindicated for the patient to be in the study;
Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent/current psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder.
Current suicidal or homicidal risk. Any subject who endorses suicidal ideation will be seen by a licensed clinician in the Addiction Sciences Division who will determine the best course of action to ensure patient safety.
Known allergy to progesterone or peanuts (vehicle for micronized progesterone).
Unwilling or unable to maintain abstinence from alcohol 12 hours prior to study visits, and all other drugs other than cannabis or nicotine for the duration of the study.
Meet DSM-5 criteria for moderate to severe substance use disorder (other than nicotine, cannabis, or alcohol) within the past year.
Intervention: Lidocaine
Trial phase: Phase 2
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: 6
Group description: Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.

Lidocaine: Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.
Eligibility criteria:
Inclusion Criteria:

Complains of symptoms suggestive of post-dural puncture headache
Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
Fluent in written and spoken English

Exclusion Criteria:

Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
Those who refuse to consent to participate in the study
Patients who have had a failed epidural blood patch
Cognitive Impairment
Prisoner