anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Inositol
Trial phase: Phase 2
ATC code: A11HA07
SMILES: O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Powder form, 2g TID up to 6g TID

Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years
Trichotillomania (TTM) as the primary psychiatric diagnosis
Women's participation required negative results on a beta-human chorionic gonadotropin pregnancy test and stable use of a medically accepted form of contraception.
Signed informed consent before entry into the study.

Exclusion Criteria:

Unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screening visit
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
A need for medication other than ecopipam with possible psychotropic effects
Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as determined by the Structured Clinical Interview for DSM-IV
Current (past 12-months) DSM-IV substance abuse or dependence
Positive urine drug screen at screening
Initiation of cognitive behavior therapy within 3 months prior to study baseline
Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS
Any suicidality based on clinical interview
History of head injury or neurological disorder (such as seizures)
Any history of psychiatric hospitalization in the past year
Any history of a suicide attempt
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 4
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: induction onto buprenorphine/naloxone from opioid treatment

buprenorphine/naloxone: partial opioid agonist
Eligibility criteria:
Participants were recruited and enrolled at VACT West Haven, CT. Participants are aged 18 and older and have 3 months or more of continuous opioid therapy for chronic pain. Participants are actively prescribed 30-100mg of morphine equivalent opioid dose based on pharmacy records. Primary Care Providers will assent for patient participation.

Inclusion Criteria:

Aged 18 and older
3 months of continuous opioid therapy for chronic pain;
30-100 mg morphine equivalent daily opioid dose based on pharmacy records of standing and as needed opioids prescribed.
28 (out of 70) on the 7-item Brief Pain Inventory (BPI) functional interference subscale at screening
Numerical pain rating of 4 or greater (i.e., moderate pain or greater) at screening on the 11-point pain numerical rating scale (NRS)
Females must (a) be using birth control pills or depo provera injections, or have an intrauterine device; or (b) be post-menopausal, or (c) have undergone surgically sterilization.
Primary care provider's (PCP) assent for patient participation, ascertained via encrypted email or in-person query.

Exclusion Criteria:

DSM-IV defined substance use disorder, except nicotine dependence. Participants known to using marijuana, including those who are apparently legally authorized to use marijuana by non-VHA providers, will be excluded since opioid dose escalation in regular marijuana users is contraindicated.
Opioid therapy for palliative care
Participation in another investigational pharmaceutical trial within 30 days of screening
Pregnancy or lactation
Recently decompensated medical illness necessitating inpatient hospitalization (past 30 days)
Transaminases (aspartate aminotransferase/alanine aminotransferase) greater than five times the upper limit of normal within 90 days of assessment phase
Not well-controlled psychiatric symptoms at the time of physician assessment, including suicidal ideation or untreated psychosis; or recently decompensated psychiatric illness necessitating inpatient hospitalization (past 30 days).
Use of a moderate to strong CYP3A4 inhibitor
Intervention: Reserpine
Trial phase: Phase 4
ATC code: C02AA02 | C02AA52 | C02LA01 | C02LA51 | C02LA71
SMILES: [H][C@]12C[C@@H](OC(=O)c3cc(OC)c(OC)c(OC)c3)[C@H](OC)[C@@H](C(=O)OC)[C@@]1([H])C[C@]1([H])c3[nH]c4cc(OC)ccc4c3CCN1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: increase of up to 25% of current opioid dose

opioid dose escalation: up to 25% increase in patient's current opioid dose
Eligibility criteria:
Participants were recruited and enrolled at VACT West Haven, CT. Participants are aged 18 and older and have 3 months or more of continuous opioid therapy for chronic pain. Participants are actively prescribed 30-100mg of morphine equivalent opioid dose based on pharmacy records. Primary Care Providers will assent for patient participation.

Inclusion Criteria:

Aged 18 and older
3 months of continuous opioid therapy for chronic pain;
30-100 mg morphine equivalent daily opioid dose based on pharmacy records of standing and as needed opioids prescribed.
28 (out of 70) on the 7-item Brief Pain Inventory (BPI) functional interference subscale at screening
Numerical pain rating of 4 or greater (i.e., moderate pain or greater) at screening on the 11-point pain numerical rating scale (NRS)
Females must (a) be using birth control pills or depo provera injections, or have an intrauterine device; or (b) be post-menopausal, or (c) have undergone surgically sterilization.
Primary care provider's (PCP) assent for patient participation, ascertained via encrypted email or in-person query.

Exclusion Criteria:

DSM-IV defined substance use disorder, except nicotine dependence. Participants known to using marijuana, including those who are apparently legally authorized to use marijuana by non-VHA providers, will be excluded since opioid dose escalation in regular marijuana users is contraindicated.
Opioid therapy for palliative care
Participation in another investigational pharmaceutical trial within 30 days of screening
Pregnancy or lactation
Recently decompensated medical illness necessitating inpatient hospitalization (past 30 days)
Transaminases (aspartate aminotransferase/alanine aminotransferase) greater than five times the upper limit of normal within 90 days of assessment phase
Not well-controlled psychiatric symptoms at the time of physician assessment, including suicidal ideation or untreated psychosis; or recently decompensated psychiatric illness necessitating inpatient hospitalization (past 30 days).
Use of a moderate to strong CYP3A4 inhibitor
Intervention: Cyanocobalamin
Trial phase: Not Applicable
ATC code: B03AE01 | B03BA01 | B03BA51
SMILES: C/C1=C2/N=C(/C=C3\N=C(/C(C)=C4/[C@@H](CCC(N)=O)[C@](C)(CC(N)=O)[C@](C)([C@@H]5N=C1[C@](C)(CCC(=O)NC[C@@H](C)OP(=O)([O-])O[C@H]1[C@@H](O)[C@@H](n6cnc7cc(C)c(C)cc76)O[C@@H]1CO)[C@H]5CC(N)=O)N4[Co+]C#N)[C@@](C)(CC(N)=O)[C@@H]3CCC(N)=O)C(C)(C)[C@@H]2CCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 132
Group description: Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.

Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment.
Eligibility criteria:
Inclusion Criteria:

· Patients on Hemodialysis for at least 6 months

Patients on stable dose of epogen and iron supplementation for at least 1 month prior to B12 and MMA assay.

Exclusion Criteria:

· On B12 treatment

Hematological Cancer
Methotrexate use
Alcohol use greater then 2 drinks per day
Vegetarian Diet
Gastric Surgery
Inflammatory Bowel Disease
Pernicious Anemia
Recent transfusion
Intervention: Vandetanib
Trial phase: Phase 3
ATC code: L01EX04
SMILES: COc1cc2c(Nc3ccc(Br)cc3F)ncnc2cc1OCC1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Vandetanib 300 mg tablet, orally once daily until disease progression or death.
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumour biopsy.
Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced or metastatic differentiated (excluding minimally invasive follicular) thyroid cancer not amenable to surgical resection, external beam radiotherapy or local therapy.
Measurable disease defined as at least one lesion, not irradiated within 12 weeks of the date of randomisation, that can be accurately measured at baseline.
Participants must have experienced progression within 14 months and be RAI-refractory/resistant or unsuitable for RAI.
Thyroid-stimulating hormone (TSH) suppression below 0.5 mU/L is required.
World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
Negative pregnancy test (urine or serum) for female participants of childbearing potential.

Exclusion Criteria:

Inadequate organ function as defined by: (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 x upper limit of normal (ULN), or greater than 5.0 x ULN if judged by the Investigator to be related to liver metastases. (2) Serum bilirubin greater than 1.5 x ULN. This criterion does not apply to participants with known Gilbert's Disease. (3) Creatinine clearance <50 mL/min (calculated by Cockcroft-Gault formula).
Risk of prolonged interval between Q and T (QT) on an electrocardiogram (ECG) corrected for heart rate (QTc) as defined by: (1) Current therapy with any medication known to be associated with Torsades de pointes or potent inducers of cytochrome CYP3A4. (2) History of QT prolongation. (3) Congenital long QT syndrome. (4) QT interval corrected for heart rate by the Bazett's method (QTcB) correction unmeasurable or greater than 480 ms on screening ECG.
Previous therapy with approved or investigational tyrosine kinase or anti- vascular endothelial growth factor (VEGF) receptor inhibitors or targeted therapies (e.g. multi-targeted kinase inhibitors such as sorafenib, AMG-706, sunitinib, pazopanib, lenvatinib).
RAI therapy within 12 weeks prior to first dose of study drug, and radiation therapy other than RAI, including external beam, if not completed prior to randomization.
Intervention: Tauroursodeoxycholic acid
Trial phase: Not Applicable
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: 13
Group description: This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.

Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.
Eligibility criteria:
Inclusion Criteria:

HIV+
receiving protease inhibitor containing antiretroviral therapy for >6 months
Undetectable viral load

insulin resistant

impaired fasting glucose (fasting blood glucose>100mg/dl)
impaired glucose tolerance (blood glucose >140mg/dl at 2 hours during oral glucose tolerance testing).
abstained from medications that affect glucose (e.g. prednisone, growth hormone)
stable medications for >3 months

Exclusion Criteria:

weight loss of >5% of body weight in prior 6 months
active gastrointestinal disease (gallstones, pancreatitis, hepatitis, diarrhea)
use of anti-diabetic medications
cardiovascular disease (uncontrolled hypertension, heart attack, heart failure, prior endocarditis)
history of or active substance abuse
blood clotting disorder or taking medications that affect blood clotting (e.g. coumadin, warfarin)
pregnant, planning to become pregnant or lactating
unable to give informed consent
Intervention: Rivaroxaban
Trial phase: Phase 3
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2507
Group description: Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Eligibility criteria:
Inclusion Criteria:

Must have symptomatic heart failure for at least 3 months prior to Screening
Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization
Must have evidence of significant coronary artery disease
Must be medically stable in terms of their heart failure clinical status at the time of randomization
Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL (preferred assay) during the Screening period and before randomization

Exclusion Criteria:

Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event
Prior stroke within 90 days of randomization
Has been hospitalized for longer than 21 days during the index event
Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
Intervention: Vilazodone
Trial phase: Phase 3
ATC code: N06AX24
SMILES: N#Cc1ccc2[nH]cc(CCCCN3CCN(c4ccc5oc(C(N)=O)cc5c4)CC3)c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 175
Group description: 15 mg vilazodone tablets, once per day, oral administration
Eligibility criteria:
Inclusion Criteria:

Male or Female outpatients between 12-17 years of age
Primary diagnosis of major depressive disorder (MDD)
Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
History of suicidal behavior, or requires precaution against suicide
Not generally healthy medical condition
Seizure disorder
Intervention: Vilazodone
Trial phase: Phase 3
ATC code: N06AX24
SMILES: N#Cc1ccc2[nH]cc(CCCCN3CCN(c4ccc5oc(C(N)=O)cc5c4)CC3)c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 180
Group description: 30 mg vilazodone tablets, once per day, oral administration
Eligibility criteria:
Inclusion Criteria:

Male or Female outpatients between 12-17 years of age
Primary diagnosis of major depressive disorder (MDD)
Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
History of suicidal behavior, or requires precaution against suicide
Not generally healthy medical condition
Seizure disorder
Intervention: Sevoflurane
Trial phase: Phase 4
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 144
Group description: administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia

Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients
patients scheduled for orthognathic surgery

Exclusion Criteria:

severe cardiopulmonary disease
psychological disease
patients who cannot understand Korean
Intervention: Desflurane
Trial phase: Phase 4
ATC code: N01AB07
SMILES: FC(F)OC(F)C(F)(F)F
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 144
Group description: administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia

Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients
patients scheduled for orthognathic surgery

Exclusion Criteria:

severe cardiopulmonary disease
psychological disease
patients who cannot understand Korean
Intervention: Sitagliptin
Trial phase: Not Applicable
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: The dose of sitagliptin (Januvia®) 100 mg tablet will be taken orally each morning for 6 months.

Sitagliptin: The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria
Age ≥ 18y on date of consent
Pancreatic insufficiency
Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w/o fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia
For female subjects, negative urine pregnancy test at enrollment.

Exclusion Criteria:

Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia, (fasting glucose > 126 mg/dL)
History of clinically symptomatic pancreatitis within last year,
Prior lung or liver transplant,
Severe CF liver disease, as defined by portal hypertension,
Fundoplication-related dumping syndrome,
Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency),
Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to enrollment,
Treatment with oral or intravenous corticosteroids within 6 weeks of enrollment,
Hemoglobin <10g/dL, within 90 days of Visit 1 or at Screening,
Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine clearance < 50 mL/min (based on the Cockcroft-Gault formula) or potassium > 5.5mEq/L on non-hemolyzed specimen,
A history of anaphylaxis, angioedema or Stevens-Johnson syndrome,
Inability to perform study specific procedures (MMTT, GPA),
Subjects, who in study team opinion, may be non-compliant with study procedures.
Intervention: Lovenox
Trial phase: Phase 3
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 152
Group description: Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
Eligibility criteria:
Inclusion Criteria:

chronic renal failure on hemodialysis

Exclusion Criteria:

significant comorbidities that would prevent a patient from completing the trial
Intervention: Linaclotide
Trial phase: Phase 3
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: 416
Group description: Linaclotide 290 ug capsules, oral, once daily
Eligibility criteria:
Inclusion Criteria:

Patient has signed an Informed Consent Form(ICF).
Patient Must not be pregnant or breastfeeding and agree to use birth control
Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
Patient meets protocol-defined criteria for Irritable Bowel Syndrome with Constipation(IBS-C), including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria
Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from making any new, major life-style changes that may affect IBS-C symptoms

Exclusion Criteria:

Recent history of mushy or watery stools
Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
Surgery to the gastrointestinal tract
Usage of prohibited medications
Intervention: Cetirizine
Trial phase: Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
Eligibility criteria:
Inclusion Criteria:

positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

known contraindications or sensitivities to the study medication or its components
any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study