anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pomaglumetad methionil
Trial phase: Phase 1
SMILES: CSCCC(N)C(=O)NC1(C(=O)O)CS(=O)(=O)C2C(C(=O)O)C21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Pomaglumetad Methionil 40mg, one dose, one time
Eligibility criteria:
Inclusion Criteria:

Men and women between 18 and 60 years of age, any race
Primary, current Axis I diagnosis of post traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria
Able to provide written informed consent

Exclusion Criteria:

Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia, schizoaffective disorder, bipolar disorder
History of moderate or severe traumatic brain injury (TBI) with loss of consciousness
Lifetime history of seizure disorder
Current diagnosis of obsessive-compulsive disorder (OCD)
Current diagnosis of bulimia nervosa or anorexia nervosa; or substance use disorder
Alcohol or drug abuse in the past 90 days, or dependence in the past year.
Individuals with a cumulative lifetime history of intravenous substance abuse longer than 1 year.
Severe dissociation, defined as a Clinician Administered Dissociative States Scale (CADSS) score greater than 60 at baseline
Patients with creatinine clearance <60 milliliters (mL)/min (moderate renal impairment)
Current pregnancy or breast feeding; medical conditions that could interfere with correct interpretation of study data, i.e., individuals with the following medical conditions will be excluded: cancer in the past year, stroke, heart attack, angina, neurological disease (multiple sclerosis, epilepsy, Parkinson's disease), central nervous system (CNS) lesions including TBI with loss of consciousness, dementing illness, and/or liver or kidney disease. Patients with QT interval >450 msec (males) and >470 msec (females).
Participants who have started new medication regimen for PTSD within 3 months prior to study start and subjects taking fluoxetine
Current suicidality defined by emergent Columbia Suicide Severity Rating Scale (CSSRS)-defined suicidal behavior, a suicidal ideation score of 5 (indicating active suicidal ideation with specific plan and some level of intent) or 4 (indicating active suicidal ideation with some intent to act, without specific plan) on the CSSRS or in the absence of a CSSRS suicidal ideation score of 5 or 4 or CSSRS-defined suicidal behavior, if the investigator determines the patient to have a significant short-term risk for a suicide attempt.
Individuals with active suicidal risk, active self-mutilation or aggressive behavior with threatening behavior toward others within the past year, as judged by the Principal Investigator
Pregnant or lactating women
Legal and Financial: Current legal proceedings resulting from the traumatic events. People whose continued receipt of financial benefits is contingent upon maintaining PTSD symptoms or who are waiting for a decision concerning the receipt of financial benefits based upon PTSD symptoms
Intervention: Sertraline
Trial phase: Not Applicable
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper

Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper
Eligibility criteria:
Inclusion Criteria:

Past history of depression or postpartum depression
Singleton gestation
Delivery > 34 weeks gestation
No current clinical evidence of depression
Able to read and understand written English language

Exclusion Criteria:

Multiple gestation
Delivery prior to 34 weeks
Delivery outside of Cooper University Hospital
Major fetal anomaly or fetal demise
Current use of antidepressants
Evidence of active depression at antepartum evaluation
Edinburgh Postpartum Depression scale of >12 prior to discharge from the hospital
Maternal age < 18 years
Infant in Neonatal Intensive Care Unit (NICU) at time of patient discharge from hospital
Known or suspected allergy to Sertraline
Intervention: Pantoprazole
Trial phase: Not Applicable
ATC code: A02BC02 | A02BD04 | A02BD11
SMILES: COc1ccnc(CS(=O)c2nc3ccc(OC(F)F)cc3[nH]2)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB

Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
Eligibility criteria:
Inclusion Criteria:

Adult, 18 years and older; Upper GI bleed confirmed by endoscopy

Exclusion Criteria:

Intensive Care Unit admission, Emergency endoscopic intervention required to control bleeding, Malignant appearing ulcers as determined by endoscopy, Previous documented treatment with twice daily PPI for other indication, Receiving twice daily PPI therapy prior to admission
Intervention: Pantoprazole
Trial phase: Not Applicable
ATC code: A02BC02 | A02BD04 | A02BD11
SMILES: COc1ccnc(CS(=O)c2nc3ccc(OC(F)F)cc3[nH]2)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB

Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
Eligibility criteria:
Inclusion Criteria:

Adult, 18 years and older; Upper GI bleed confirmed by endoscopy

Exclusion Criteria:

Intensive Care Unit admission, Emergency endoscopic intervention required to control bleeding, Malignant appearing ulcers as determined by endoscopy, Previous documented treatment with twice daily PPI for other indication, Receiving twice daily PPI therapy prior to admission
Intervention: Chlorthalidone
Trial phase: Phase 2
ATC code: C03BA04 | C03BB04 | C03EA06 | G01AE10
SMILES: NS(=O)(=O)c1cc(C2(O)NC(=O)c3ccccc32)ccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: 25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks

Chlorthalidone
Eligibility criteria:
Inclusion Criteria:

Age 30 to 80 years old;
Systolic blood pressures between 110 to 150 mmHg and/or diastolic blood pressure between 80-99 mmHg;
Ability to give informed consent.

Exclusion Criteria:

Pregnancy;
Intolerance to study protocols;
Acute cardiovascular events within the previous 6 months;
Impaired renal function [estimated glomerular filtration rate (GFR) < 45 ml/min/1.73m^2];
Current or recent treatment with systemic glucocorticoid therapy (within 1 month of enrollment);
Current use of anti-hypertensive medication (except calcium channel blockers and beta blockers);
Diabetes mellitus requiring medical therapy;
Morbid obesity (BMI > 45);
Prior adverse reaction to a thiazide or spironolactone;
Claustrophobia preventing the patient from having an MRI or other contraindications to MRI;
Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase > 1.5x upper limit of normal range);
Current illicit drug use;

Sexually active women of childbearing potential** who are unwilling to practice adequate contraception during the study [adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly].

Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Intervention: OXYTOCIN
Trial phase: Early Phase 1
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: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
Eligibility criteria:
Inclusion Criteria:

Adults ages 18-64
Good medical health
Ability to understand and speak English

Exclusion Criteria:

Pregnancy
Medical Illnesses: Moderate or severe acute or chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy, influenza).
Cardiovascular risk factors: History of hypertension with baseline blood pressure above 140 mm Hg (systolic) over 90 mm Hg (diastolic). Also any history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).
CNS disease: Known history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central nervous system disease, or history of head trauma which resulted in a persistent neurologic deficit or loss of consciousness > 3 minutes.
Medication status: Individuals on stable doses of a neuroleptic and/or an antidepressant medication for at least the past 6 weeks will be allowed to participate in this study. The use of other psychotropic medications will not be allowed. Females taking contraceptive hormones will not be able to participate in the study.
A history of seizures or current use of anticonvulsants; history of head injury with loss of consciousness
Intervention: Bupropion
Trial phase: Phase 4
ATC code: A08AA62 | N06AX12
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Bupropion sustained release (SR) 150 mg orally twice per week

Bupropion: Antidepressant
Eligibility criteria:
Inclusion Criteria:

age 30-70 yrs;
have patent and non-infected arteriovenous fistula or graft;
are receiving maintenance HD 3 times per week lasting for 3-4 hours;
serum albumin of ≥ 3.2 g/dl, serum phosphate of <6.5 mg/dl, and serum hemoglobin of ≥9 mg/dl in consecutive two blood tests as per the National Kidney Foundation Disease Outcomes Quality Initiative (NKF KDOQI) guidelines [subjects failing screening due to blood test will be allowed to be re-screened in 30 days];
receiving stable or maintenance dose of iron or erythropoietin-stimulating agents, statins, angiotension receptor blockers and/or angiotension converting enzyme inhibitors, phosphate binders, vitamin D receptor analogs as these agents may influence cytokines proposed in the study;
meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD;
have a Ham-D score > 17

Exclusion Criteria:

meet DSM-IV criteria for Bipolar Disorder or other psychotic disorder in the month prior to screening;
are taking antidepressants, anti-anxiety medications, or hypnotics (including Zyban for smoking cessation);
having failed to respond to or tolerate bupropion or fluoxetine in the past
allergic to fluoxetine or bupropion
known history of HIV/AIDS; No testing will be conducted for screening purposes
known history of alcohol or drug abuse or dependence within the month prior to screening based on clinical records;
history of myocardial infarction or heart failure within one month of screening or a history of seizures or stroke at any point;
history of chronic liver disease and diagnosis of hepatic encephalopathy based on clinical records;
currently diagnosed with cancer or receiving any cancer treatment;
history of any infection within the last 2 weeks ;
currently taking any antibiotics, anti-inflammatory, and immune-modulator agents;
recorded noncompliance with dialysis schedules; and
currently participating in clinical or behavioral intervention studies.
recorded noncompliance with dialysis schedules; and
currently participating in clinical or behavioral intervention studies
Intervention: Lorazepam
Trial phase: Phase 3
ATC code: N05BA06 | N05BA56
SMILES: O=C1Nc2ccc(Cl)cc2C(c2ccccc2Cl)=NC1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.
Eligibility criteria:
Inclusion Criteria:

Subjects with status epilepticus or repetitive status epilepticus / cluster seizure who have seizures that can be evaluated by investigator's visual observations based on motor symptoms or who have seizures that can be evaluated by EEG.
Subjects with status epilepticus accompanied by generalized seizure, partial seizure or secondarily generalized seizure lasting 5 minutes or longer
Subjects with repetitive status epilepticus / cluster seizure accompanied by not less than 3 consecutive episodes of generalized seizure, partial seizure or secondarily generalized seizure in 1 hour.
Subjects not younger than 3 months (either gender is eligible for the study)

Exclusion Criteria:

Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal
Subjects with known history of hypersensitivity to lorazepam or benzodiazepine
Subjects with a known history of benzodiazepine abuse.
Subjects currently receiving lorazepam
Subjects with angle-closure glaucoma
Subjects with myasthenia gravis
Subjects with either of aspartate transaminase, alanine transaminase, total bilirubin, blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of normal of the institutional reference value (if the data is available)
Subjects with white blood cell count less than 3000/mm3 or neutrophil count less than 1500/mm3 at screening visit (if the data is available)
Intervention: Senna
Trial phase: Not Applicable
ATC code: A06AB06 | A06AB56
SMILES: O=C(O)c1cc(O)c2c(c1)C(C1c3cc(C(=O)O)cc(O)c3C(=O)c3c(OC4OC(CO)C(O)C(O)C4O)cccc31)c1cccc(OC3OC(CO)C(O)C(O)C3O)c1C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients who received Senna
Eligibility criteria:
Inclusion Criteria:

Males and females 18 - 70 years of age. Diagnosed with CIC according to Rome III criteria. Coherent and mentally competent patient to understand and consent for the trial Unremarkable colonoscopy done in past 5 years

Exclusion Criteria:

Significant diarrhea (defined as loose or watery stool and or more than three bowel movements daily associated with urgency more than 25% of the days in preceding 3 months) Untreated hypothyroidism Organic or structural disease as the cause of patient's symptoms (stricture or tumor) Diseases that affect bowel transit time (Gastroparesis, short bowel syndrome) Evidence of cathartic colon History of alcohol, laxative abuse or illicit drug use Pregnant or lactating women Planning pregnancy or become pregnant during study period Concomitant use of any medication that could alter gastrointestinal motility (Calcium channel blockers, Narcotics, anticholinergics, calcium and aluminium containing antacids, phenothiazines, ferrous sulfate)
Intervention: Linaclotide
Trial phase: Not Applicable
ATC code: A06AX04
SMILES: CC1NC(=O)C2CCCN2C(=O)C(CC(N)=O)NC(=O)C2CSSCC(N)C(=O)NC3CSSCC(NC1=O)C(=O)NC(C(C)O)C(=O)NCC(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)O)CSSCC(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCC(=O)O)NC3=O)C(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients who received Linzess
Eligibility criteria:
Inclusion Criteria:

Males and females 18 - 70 years of age. Diagnosed with CIC according to Rome III criteria. Coherent and mentally competent patient to understand and consent for the trial Unremarkable colonoscopy done in past 5 years

Exclusion Criteria:

Significant diarrhea (defined as loose or watery stool and or more than three bowel movements daily associated with urgency more than 25% of the days in preceding 3 months) Untreated hypothyroidism Organic or structural disease as the cause of patient's symptoms (stricture or tumor) Diseases that affect bowel transit time (Gastroparesis, short bowel syndrome) Evidence of cathartic colon History of alcohol, laxative abuse or illicit drug use Pregnant or lactating women Planning pregnancy or become pregnant during study period Concomitant use of any medication that could alter gastrointestinal motility (Calcium channel blockers, Narcotics, anticholinergics, calcium and aluminium containing antacids, phenothiazines, ferrous sulfate)
Intervention: Clonidine
Trial phase: Not Applicable
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Epidural clonidine injection

Clonidine
Eligibility criteria:
Inclusion Criteria:

Subject has clinical diagnosis of low back due to intervertebral disc disease, spinal stenosis or herniated disc
Subject has average pain score (VAS) at least 5
Subject has persistent pain despite conservative care
Subjects has experienced pain for at least 1 month
18 years of age or older when written informed consent is obtained
Signed Institutional Review Board (IRB) approved informed consent form

Exclusion Criteria:

Allergy to clonidine, dexamethasone, ropivicaine or lidocaine
Coagulopathy
Active Infection
Serious neurologic deficit
Subject is pregnant or planning on becoming pregnant during the course of the study
Subject is member of a vulnerable population
Investigator suspects substance abuse that might confound the study results
Subject has unresolved major issues of secondary gain (as determined by the investigator)
Subject exhibits major psychiatric morbidity, untreated or refractory to treatment as determined by the investigator
Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: In Part 1, 4 participants were allocated to this arm and received one 2mg nicotine film.

Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
Eligibility criteria:
Inclusion Criteria:

Aged 18 - 55
Smoke >9 cigarettes/day for at least the past 12 months
Able to understand and consent to study procedures
Able to read and write in English
Exhaled Carbon Monoxide <12 ppm at in-person screening

Exclusion Criteria:

Unstable or significant medical conditions and conditions such as elevated blood pressure (Systolic >140 mm Hg or diastolic >90mm Hg at baseline), COPD and those that are likely to affect biomarker data such as kidney or liver disease.
Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label.
More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes or inpatient treatment for these in the past 6 months.
Use of non-cigarette nicotine delivery product in the prior week (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco).
Use of an FDA approved cessation medication in past week (any NRT, Chantix, Wellbutrin)
Women who are pregnant (verified by urine pregnancy test at visit), trying to become pregnant (not using a medically acceptable form of birth control for at least one month prior to visit i.e., oral contraceptives, intrauterine device, double barrier), or nursing.
Uncontrolled serious psychiatric illness or inpatient treatment in the past 6 months.
Unwillingness to provide blood samples or history of repeatedly fainting during blood draws
Any previous adverse reaction to NRT.
Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol.
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: In Part 1, 4 participants were allocated to this arm and received one 4mg nicotine film.

Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
Eligibility criteria:
Inclusion Criteria:

Aged 18 - 55
Smoke >9 cigarettes/day for at least the past 12 months
Able to understand and consent to study procedures
Able to read and write in English
Exhaled Carbon Monoxide <12 ppm at in-person screening

Exclusion Criteria:

Unstable or significant medical conditions and conditions such as elevated blood pressure (Systolic >140 mm Hg or diastolic >90mm Hg at baseline), COPD and those that are likely to affect biomarker data such as kidney or liver disease.
Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label.
More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes or inpatient treatment for these in the past 6 months.
Use of non-cigarette nicotine delivery product in the prior week (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco).
Use of an FDA approved cessation medication in past week (any NRT, Chantix, Wellbutrin)
Women who are pregnant (verified by urine pregnancy test at visit), trying to become pregnant (not using a medically acceptable form of birth control for at least one month prior to visit i.e., oral contraceptives, intrauterine device, double barrier), or nursing.
Uncontrolled serious psychiatric illness or inpatient treatment in the past 6 months.
Unwillingness to provide blood samples or history of repeatedly fainting during blood draws
Any previous adverse reaction to NRT.
Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol.