anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Isovaleric Acid
Trial phase: Phase 3
SMILES: CC(C)CC(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: All participants who received IVA for 8 weeks in treatment period 1 or 2.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of CF based on protocol-specified clinical features and at least one of the following: increased sweat chloride level, identification of 2 CF causing mutations, or demonstration of abnormal nasal epithelial ion transport.
A 3849 + 10KB C→T or D1152H mutation on at least 1 CFTR allele.
FEV1 ≥40% of predicted and ≤105% of predicted at screening.

Exclusion Criteria:

A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation.
History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
Ongoing or prior participation in an investigational drug study within 30 days before the Screening Visit.
Protocol-specified abnormal laboratory values at the Screening Visit
For subjects <18 years of age at the Screening Visit, evidence of cataract/lens opacity determined to be clinically significant by the ophthalmologist or optometrist during the ophthalmologic examination (OE) at the Screening Visit.
Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A, including consumption of certain herbal medications and certain fruit and fruit juices, within 14 days before Day 1.
Pregnant, breastfeeding, or planning to become pregnant during the study.
Sexually active subjects of reproductive potential must be willing to use appropriate contraception.
Intervention: Midazolam
Trial phase: Phase 3
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 160
Group description: IV midazolam (1mg to 2mg max)

Midazolam: patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed
Eligibility criteria:
Inclusion Criteria:

Patients who are >18 years of age, who will give informed consent in receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their postoperative pain control.

Exclusion Criteria:

significant psychiatric disorder such as generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder; individuals who were incompetent to give informed consent; pregnant and/or breast feeding patients; any underlying coagulopathy, infection or other factors which would be a contraindication to receiving a peripheral nerve block; hypersensitivity to midazolam; and history of renal impairment. Patients who were extremely anxious (scores 50 and greater on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: Participants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months

Cholecalciferol: 5000 IU cholecalciferol with 1000 mg calcium citrate daily
Eligibility criteria:
Inclusion Criteria:

Age 25-45 years
Self-reported race/ethnicity African American
BMI ≥ 18 kg/m2
Total 25(OH)D levels < 20 ng/ml (50 nmol/L)
No use of vitamin D supplements within past 30 days of the screening visit
Able to provide written informed consent
Willing to take a vitamin D supplement daily for 3 months
Willing to return for follow-up visits to measure blood pressure and provide a blood sample to measure vitamin D and serum calcium
No current use of blood pressure lowering medications
Systolic blood pressure ≥ 100 mmHg and diastolic blood pressure ≥ 60 mmHg

Exclusion Criteria:

Medical history of chronic disease that affect gastrointestinal absorption of vitamin D: Crohn's disease, cystic fibrosis, and celiac disease
Use of medications which may affect total 25(OH)D levels: antiepileptic drugs, steroids, bile acid sequestrants, lipase inhibitors, orlistat
Current use of vitamin D supplements or use in past month and unwillingness to discontinue for at least 1 month prior to study enrollment
History of kidney stones or hypercalciuria
Fasting serum calcium ≥ 10.2 mg/dl
Average systolic blood pressure ≥ 140 mmHg
Average diastolic blood pressure ≥ 90 mmHg
Presence of type 1 diabetes mellitus, active malignancy, active thyroid disease or sarcoidosis
Pregnant or planning a pregnancy
Estimated glomerular filtration rate (based on serum creatinine level) is < 60 ml/min/1.73 m2 based on the Modification of Diet in Renal Disease formula
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 28
Group description: IV, Normal saline (placebo dose), one dose at <24 hours of age

Normal Saline: Single dose of normal saline, IV, given at less than 24 hours of age
Eligibility criteria:
Inclusion Criteria: Infants will be eligible for the MEND trial if they have a gestational age > 34 weeks by best obstetric estimate, are <24 hours old and have evidence of mild encephalopathy as defined by Shankaran et al based on a modified Sarnat examination performed at <6 hours of age.

History of an acute perinatal event (abruption, cord prolapsed, severe fetal heart rate abnormality, or meconium staining)
Infant is evaluated for hypothermia therapy and DOES NOT meet clinical criteria for TH.
Infant has an IV for clinical treatment

Exclusion Criteria:

Moderate/Severe encephalopathy on modified Sarnat examination at < 6 hours of age
Major congenital and/or chromosomal abnormalities
Prenatal diagnosis of brain abnormality or hydrocephalus
Severe growth restriction (< 3%)
Central venous hematocrit >65%, platelet count >600,000/dL, and/or neutropenia (ANC<500 μL)
ECMO
Infant judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
Intervention: Donepezil
Trial phase: Phase 4
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.

Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Alzheimer's Disease
Mini Mental State Examination score >15 / 30
Can swallow pills

Exclusion Criteria:

No other dementia due to Parkinson's disease, Lewy Body dementia, Normal Pressure Hydrocephalus, Fronto-temporal dementia, or prominent cerebral vascular accident
No prior or concurrent use of cholinesterase inhibitors
No prior or concurrent use of memantine hydrochloride
No other concurrent anticholinergic treatments
Intervention: Velpatasvir
Trial phase: Phase 3
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Willing and able to provide written informed consent
HCV RNA detected at screening
Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
Classification as treatment naïve or treatment experienced. Approximately 20% may be treatment-experienced.
Cirrhosis determination (approximately 20% may have cirrhosis)
Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day 1 prior to enrollment.
Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol
Lactating females must agree to discontinue nursing before the study drug is administered
Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Key Exclusion Criteria:

Current or prior history of any of the following:

Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
Liver transplantation
Hepatocellular carcinoma (HCC) (as determined by appropriate imaging at screening for those with cirrhosis) or current malignancy for which the patient is receiving treatment or which may interfere with individual's treatment, assessment or compliance with the protocol.
Screening laboratory parameters outside of defined threshold
Prior exposure to HCV NS5A inhibitor
Pregnant or nursing female
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Use of any prohibited concomitant medications as described in study protocol
Known hypersensitivity to VEL, SOF, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 83
Group description: intranasal administration of oxytocin

oxytocin: self-administration of oxytocin (nasal spray)
Eligibility criteria:
Inclusion Criteria:

Healthy subjects

Exclusion Criteria:

Subjects reported having any neurological problems, psychiatric illness or drug or alcohol abuse and none were currently taking any form of medication and had not drunk any caffeine-containing beverages on the day of the experiment.
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 300
Group description: Ondansetron (Zofran) is used for the treatment of nausea and vomiting.

Ondansetron: Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery.
Eligibility criteria:
Inclusion Criteria:

- Patients scheduled for elective surgery requiring general anesthesia

Exclusion Criteria:

Age less than 18 years
Adults unable to give primary consent
Pregnancy
Prisoners
Unable to access pericardial 6 acupressure point bilaterally post procedure
Allergy to Ondansetron
Intervention: SOMAPACITAN
Trial phase: Phase 3
ATC code: H01AC07
SMILES: C=C(CCCCCCCCCCCCCCCc1nnn[nH]1)NS(=O)(=O)CCCC(=O)NCCOCCOCC(=O)N[C@@H](CCC(=O)N[C@@H](CCC(=O)NCCOCCOCC(=O)N[C@@H](CCCCNC(=O)CSC[C@H](N)C(=O)O)C(N)=O)C(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Eligibility criteria:
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at screening - If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision 2/ Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's medical records - For subjects with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation
Intervention: Suvorexant
Trial phase: Not Applicable
ATC code: N05CJ01 | N05CM19
SMILES: [H][C@@]1(C)CCN(c2nc3cc(Cl)ccc3o2)CCN1C(=O)c1cc(C)ccc1-n1nccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: 10mg Suvorexant tablet h.s. for two consecutive nights

Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.
Eligibility criteria:
Inclusion Criteria:

Age 45-65 years
Any sex
Any race/ethnicity
Mini-Mental Status Examination score (MMSE) >=27
Sleep efficiency measured by actigraphy to determine good sleeper or poor sleeper

Exclusion Criteria:

Cognitive impairment as determined by history of MMSE < 27
Inability to speak or understand English
BMI >35
Any sleep disorders other than insomnia
history of sleep-disordered breathing
STOP-Bang score > 3
History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
Sleep schedule outside the range of bedtime 8PM-12AM and wake time 4AM-9AM
Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)
Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)
Stroke
Hepatic or renal impairment
Pulmonary disease (PI discretion)
Type 1 diabetes
HIV or AIDS
Neurologic or psychiatric disorder requiring medication (PI discretion)
Alcohol or tobacco use (PI discretion)
Use of sedating medications
Inability to get out of bed independently
Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways)
Abnormal physical examination
Current pregnancy
History of migraine headaches (PI discretion)
History of drug abuse in the past 6 months
Urinary or fecal incontinence
Difficulty sleeping in an unfamiliar environment (good sleep quality group only)
History or presence of any clinically significant medication condition, behavioral or psychiatric condition (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI is not a good candidate
Intervention: Suvorexant
Trial phase: Not Applicable
ATC code: N05CJ01 | N05CM19
SMILES: [H][C@@]1(C)CCN(c2nc3cc(Cl)ccc3o2)CCN1C(=O)c1cc(C)ccc1-n1nccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 20mg Suvorexant tablet h.s. for two consecutive nights

Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.
Eligibility criteria:
Inclusion Criteria:

Age 45-65 years
Any sex
Any race/ethnicity
Mini-Mental Status Examination score (MMSE) >=27
Sleep efficiency measured by actigraphy to determine good sleeper or poor sleeper

Exclusion Criteria:

Cognitive impairment as determined by history of MMSE < 27
Inability to speak or understand English
BMI >35
Any sleep disorders other than insomnia
history of sleep-disordered breathing
STOP-Bang score > 3
History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
Sleep schedule outside the range of bedtime 8PM-12AM and wake time 4AM-9AM
Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)
Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)
Stroke
Hepatic or renal impairment
Pulmonary disease (PI discretion)
Type 1 diabetes
HIV or AIDS
Neurologic or psychiatric disorder requiring medication (PI discretion)
Alcohol or tobacco use (PI discretion)
Use of sedating medications
Inability to get out of bed independently
Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways)
Abnormal physical examination
Current pregnancy
History of migraine headaches (PI discretion)
History of drug abuse in the past 6 months
Urinary or fecal incontinence
Difficulty sleeping in an unfamiliar environment (good sleep quality group only)
History or presence of any clinically significant medication condition, behavioral or psychiatric condition (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI is not a good candidate
Intervention: Methenamine Hippurate
Trial phase: Phase 4
SMILES: C1N2CN3CN1CN(C2)C3.O=C(O)CNC(=O)c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 47
Group description: Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.

Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs.
Eligibility criteria:
Inclusion Criteria:

recurrent UTI: at least 2 in the past 6 months or 3 in past year (culture positive)
must have been symptomatic with dysuria, urgency, frequency, suprapubic pain, hematuria, malodorous urine
treated for last UTI and negative urine culture on entry into study
English speaking

Exclusion Criteria:

pregnancy
urinary tract abnormalities (eg kidney stones)
acute pyelonephritis
renal insufficiency or failure
known allergy to medications
prophylaxis for post-coital recurrent UTIs
Intervention: Trimethoprim
Trial phase: Phase 4
ATC code: J01EA01 | J01EE01 | J01EE02 | J01EE03 | J01EE04 | J01EE05 | J01EE07 | J04AM08
SMILES: COc1cc(Cc2cnc(N)nc2N)cc(OC)c1OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 45
Group description: Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.

Trimethoprim: suppressive antibiotic.
Eligibility criteria:
Inclusion Criteria:

recurrent UTI: at least 2 in the past 6 months or 3 in past year (culture positive)
must have been symptomatic with dysuria, urgency, frequency, suprapubic pain, hematuria, malodorous urine
treated for last UTI and negative urine culture on entry into study
English speaking

Exclusion Criteria:

pregnancy
urinary tract abnormalities (eg kidney stones)
acute pyelonephritis
renal insufficiency or failure
known allergy to medications
prophylaxis for post-coital recurrent UTIs
Intervention: Linolenic Acid
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCCCCCCCC(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: 4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)

Fish oil: Fish oil supplementation
Eligibility criteria:
Inclusion Criteria:

≥ 18 or ≤ 45 years of age
Currently reporting daily cigarette use (≥ 1 CPD, no averages, must have daily use)
Between 6 and 36 weeks gestation

Exclusion Criteria:

Allergy to fish or seafood
Currently using fish oil supplements and unwilling to stop prior to and during the trial
Unstable psychiatric disease: Defined as requiring hospitalization or active medication changes (medication changes or up titration) within the preceding 3 months
Unstable pregnancy-related medical problems (pre-eclampsia, premature labor, threatened abortion, oligohydramnios, placenta previa, hyperemesis gravidarum, HELLP syndrome, Intrauterine growth restriction, cholestasis of pregnancy, Rh negative disease, gestational hypertension, placenta accreta)
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: 7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).

Ropivacaine: 0.5% ropivacaine
Eligibility criteria:
Inclusion Criteria:

Member of the Army on active duty status
Personal access to Internet
Anticipated stable assignment to installation for at least 2 months
Stable dosing for ≥3 months, if receiving psychotropic medications
Prior to enrollment, offered PTSD treatment using A-level modality (as defined by U.S. Army Medical Command (MEDCOM) policy 14-094; 18 Dec 2014).
PTSD Checklist - Civilian (PCL-C) score of 32 or greater at screening
Acceptable clinically indicated preoperative laboratory studies, per standard site-specific protocols

Exclusion Criteria:

Prior Stellate Ganglion Block (SGB)
Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)
Pregnancy (evaluated by urine test pre-procedure)
Current anticoagulant use
History of a bleeding disorder
Infection or mass at injection site
Myocardial infarction within 6 months of procedure
Phrenic or laryngeal nerve palsy (hoarseness)
History of glaucoma
History of schizophrenia, other psychotic disorder, bipolar disorder, or personality disorder (axis 2)
Moderate or severe traumatic brain injury
Symptoms of moderate to severe substance use disorder in past 30 days
Suicidal ideation in the past 2 months, documented by the M.I.N.I.-Plus Suicidality Items
Any ongoing other major life stressor or condition not listed here that the site Investigator believes clearly would place the participant at risk for injury or a poor outcome