anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cyclobenzaprine Hydrochloride
Trial phase: Phase 3
SMILES: CN(C)CCC=C1c2ccccc2C=Cc2ccccc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 248
Group description: 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.

TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

The patient is male or female 18 to 65 years of age, inclusive.
The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol specified range.

Exclusion Criteria:

History of or evidence for a diagnosis of borderline personality disorder (BPD).
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: One 0.5mg/kg intravenous dose of ketamine

Ketamine: administered 1 week prior to a laboratory-induced stress
Eligibility criteria:
Inclusion Criteria:

Males and females aged 18-45 years;
Does not meet for any current or past psychiatric diagnoses as defined by DSM-V criteria;
Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

Exclusion Criteria:

Any current or lifetime psychiatric disorder as determined by the Structured Clinical Interview for DSM-V Axis Disorders (SCID-5);
Concomitant use of any medication with central nervous system activity, including treatment with antidepressants (classified as SSRIs, SNRIs, Atypical Antidepressants, TCAs);
Any unstable medical illnesses including hepatic, renal impairment, gastroenterologic (including gastro-esophageal reflux disease), respiratory (including obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics), cardiovascular (including ischemic heart disease and uncontrolled hypertension), endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
Hypertension (systolic BP >160 mm Hg or diastolic BP >90 mm Hg) at screening or immediately prior to treatment with ketamine/midazolam;
Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG; clinically significant is defined by an abnormality that suggests a disease and/or organ toxicity that is new or has worsened from screening, or if the abnormality is of a degree that requires additional active management (e.g., further diagnostic investigation).
Patients who have a positive urine toxicology test for illicit substances at screening and on the treatment day.
Previous recreational use of PCP or ketamine.
Subjects who have received ketamine in the past.
Intervention: Midazolam
Trial phase: Phase 2
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: One 0.045mg/kg intravenous dose of midazolam

Midazolam: administered 1 week prior to a laboratory-induced stress
Eligibility criteria:
Inclusion Criteria:

Males and females aged 18-45 years;
Does not meet for any current or past psychiatric diagnoses as defined by DSM-V criteria;
Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

Exclusion Criteria:

Any current or lifetime psychiatric disorder as determined by the Structured Clinical Interview for DSM-V Axis Disorders (SCID-5);
Concomitant use of any medication with central nervous system activity, including treatment with antidepressants (classified as SSRIs, SNRIs, Atypical Antidepressants, TCAs);
Any unstable medical illnesses including hepatic, renal impairment, gastroenterologic (including gastro-esophageal reflux disease), respiratory (including obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics), cardiovascular (including ischemic heart disease and uncontrolled hypertension), endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
Hypertension (systolic BP >160 mm Hg or diastolic BP >90 mm Hg) at screening or immediately prior to treatment with ketamine/midazolam;
Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG; clinically significant is defined by an abnormality that suggests a disease and/or organ toxicity that is new or has worsened from screening, or if the abnormality is of a degree that requires additional active management (e.g., further diagnostic investigation).
Patients who have a positive urine toxicology test for illicit substances at screening and on the treatment day.
Previous recreational use of PCP or ketamine.
Subjects who have received ketamine in the past.
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 10 mg cetirizine tablet, generic, sourced from Mylan Pharmaceuticals will be given orally 30-60 minutes prior to ocrelizumab infusion.

antihistamine: prophylaxis
Eligibility criteria:
Inclusion Criteria:

Male or female patient with relapsing or progressive forms of Multiple Sclerosis (MS), age 18 to 70 inclusive at the time of consent.
Able to understand the purpose, responsibilities and risks of the study and provide signed informed consent.
Naïve to ocrelizumab (OCR) and will receive OCR as part of standard of care for MS treatment.
No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
Estimated Expanded Disability Status Scale (EDSS) of ≤ 6.5 at screening.
Female patients of childbearing potential must practice effective contraception and continue contraception during the study.

Exclusion Criteria:

Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
Evidence of active hepatitis B infection at screening.
Patients with untreated hepatitis C, or tuberculosis. Patients who have history of Progressive multifocal leukoencephalopathy (PML) or known to be Human Immunodeficiency Virus (HIV) positive, per standard care.
Any persistent or severe infection.
Pregnancy or lactation.
Significant, uncontrolled somatic disease or severe depression in the last year.
Current use of immunosuppressive medication, lymphocyte-depleting agents, or lymphocyte-trafficking blockers.
Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study.
Any known allergy or inability to tolerate diphenhydramine or cetirizine.
Intervention: Edaravone
Trial phase: Phase 1
ATC code: N07XX14
SMILES: CC1=NN(c2ccccc2)C(=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: ALS patients receive the edaravone oral suspension.
Eligibility criteria:
Inclusion Criteria:

The key criteria are listed below.

Patients aged between 20 and 75 years at the time of informed consent
Japanese patients
Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie House criteria
Patients who can consent to contraception
Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

The key criteria are listed below.

Patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy
Patients undergoing treatment for malignancy
Patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except ALS) and infections requiring antibiotics. Patients who have a problem in general condition and are judged ineligible by the Investigator
Body mass index (BMI) of <18.0 or >30.0, or a body weight of <50 kg
Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
Intervention: Prednisone
Trial phase: Phase 4
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone

Allosure: Monthly monitoring of dd-cfDNA levels in blood

Immunosuppression reduction: Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results

Trugraf: Monthly monitoring of Trugraf result
Eligibility criteria:
Inclusion Criteria:

Age minimum 18 years
Written informed consent
Single kidney transplant recipient (i.e. no combined organ transplants)
Treated with de novo belatacept since transplantation (i.e. no previous use of calcineurin inhibitor or mTOR inhibitor for the current transplant)
At least 1 year after transplantation or after initiation of belatacept
Stable renal function (eGFR > 40 ml/min continuously during previous 6 months)
Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA < 1%; for Trugraf this corresponds to "TX" signature)
No history of BK viremia in current allograft

Exclusion Criteria:

History of biopsy-proven acute rejection
Presence of donor-specific antibodies (at any MFI)
Spot urine protein/creatinine ratio > 0.5 g/g
Intervention: Calcitriol
Trial phase: Phase 4
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.

Vitamin D: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
Eligibility criteria:
Inclusion Criteria:

Any patient undergoing primary total knee arthroplasty for osteoarthritis
Age ≥ 18 years old
Willingness to undergo randomization and return for all scheduled visits

Exclusion Criteria:

Age > 80 years old
American Society of Anesthesiologists (ASA) Score ≥ 4
Other supplemental vitamin D or Calcium use including their analogs: ergocalciferol, calcitriol, dihydrotachysterol, and paricalcitol
Current cancer
Malabsorption syndromes
Inability to take medications orally
Renal impairment defined as a glomerular filtration rate (GFR) < 30 mL/minute or creatinine >1.3 mg/dL
History of hypercalcemia defined as albumin-corrected hypercalcemia >12 mg/dL
Intervention: Sufentanil
Trial phase: Phase 4
ATC code: N01AH03
SMILES: CCC(=O)N(c1ccccc1)C1(COC)CCN(CCc2cccs2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Single dose of sublingual sufentanil for acute pain.

Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet
Eligibility criteria:
Inclusion Criteria:

undergoing outpatient ambulatory surgery
recipient of general anesthesia
pain score of 4 or greater in the PACU

Exclusion Criteria:

non-english speaking patients
cancer surgeries
patients who have allergy or intolerance to the study drugs or derivatives
patients on chronic opioids (defined as daily opioids for 3 months or longer)
Intervention: Trofinetide
Trial phase: Phase 3
SMILES: C[C@@]1(C(=O)N[C@@H](CCC(=O)O)C(=O)O)CCCN1C(=O)CN
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Trofinetide solution of 30-60 mL based on the subject's weight at Baseline, administered twice daily by mouth or gastrostomy tube (G-tube)

Trofinetide: Trofinetide solution administered based on the subject's weight at Baseline, twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Female subjects 5 to 20 years of age, inclusive, at Screening
Body weight ≥12 kg at Screening
Can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube
Has classic/typical Rett syndrome (RTT)
Has a documented disease-causing mutation in the MECP2 gene
Has a stable pattern of seizures, or has had no seizures, within 8 weeks of Screening
Subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter or must agree to use acceptable methods of contraception. Subject must not be pregnant or breastfeeding.
The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments
Subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to Screening

Exclusion Criteria:

Has been treated with insulin within 12 weeks of Baseline
Has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study
Has a history of, or current, cerebrovascular disease or brain trauma
Has significant, uncorrected visual or uncorrected hearing impairment
Has a history of, or current, malignancy
Has a known history or symptoms of long QT syndrome

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance.
Eligibility criteria:
Inclusion Criteria:

Written consent to participate in the study
Symptoms consistent with greater trochanteric bursitis for greater than or equal to 3 months prior to screening (patient reported is acceptable)
Pain in hip for greater than 15 days over the last month (as reported by the patient).
Hip bursitis as determined by clinical examination and clinical features. Where Magnetic Resonance Imaging (MRI) data is available, it will be used to confirm the bursitis diagnosis. Also, pain relief in subjects that have been treated with bursal injections containing an anesthetic (such as ropivacaine) is in itself indicative of bursitis.
Body mass index (BMI) less than or equal to 40 kg/m2
Ambulatory and in good general health
Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.
Willing to abstain from use of protocol-restricted medications during the study

Exclusion Criteria:

Hip Arthroplasty
Hip osteoarthritis, iliopsoas bursitis, reactive arthritis,rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of local infection around the bursa.
Lack of pain relief with the intrabursal treatments containing an anesthetic
Intra-bursal treatment of any bursa with any of the following agents within three (3) months of screening: any corticosteroid preparation (investigational or marketed, including FX006); and/or six (6) months for any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).
Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of screening.
Females who are pregnant or nursing or plan to become pregnant during the study; women who plan to conceive
Intervention: SILVER DIAMMINE FLUORIDE
Trial phase: Phase 2
SMILES: N.N.[Ag+].[F-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: 38% silver diamine fluoride, topical, 1 drop, single application

38% silver diamine fluoride: Topical application of SDF to teeth
Eligibility criteria:
Inclusion Criteria:

18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications

Exclusion Criteria:

pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride
Intervention: SILVER DIAMMINE FLUORIDE
Trial phase: Phase 2
SMILES: N.N.[Ag+].[F-]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 59
Group description: 38% silver diamine fluoride, topical, 1 drop, single application

Silver Diamine Fluoride: 38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7
Eligibility criteria:
Inclusion Criteria:

Healthy.
At least one carious lesion.

Exclusion Criteria:

Oral mucositis
Any ulcerative lesions
Hypersensitivity to silver
Hypersensitivity to fluoride.
SDF treatment within 3 months.
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.

Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
Eligibility criteria:
Inclusion Criteria:

Patients who present to Wake Forest Baptist Medical Center for a direct current cardioversion for treatment of paroxysmal or persistent atrial fibrillation as well as atrial flutter.

Exclusion Criteria:

Patients with sedation for transesophageal echocardiogram within 30 minutes of DCCV
Hemodynamically compromised patients (as defined by hypotension <90/50 mmHg, altered mental status, shock, ischemic chest discomfort, or heart failure)
Intervention: Methohexital
Trial phase: Phase 4
ATC code: N01AF01 | N05CA15 | N05CB01
SMILES: C=CCC1(C(C)C#CCC)C(=O)NC(=O)N(C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.

Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
Eligibility criteria:
Inclusion Criteria:

Patients who present to Wake Forest Baptist Medical Center for a direct current cardioversion for treatment of paroxysmal or persistent atrial fibrillation as well as atrial flutter.

Exclusion Criteria:

Patients with sedation for transesophageal echocardiogram within 30 minutes of DCCV
Hemodynamically compromised patients (as defined by hypotension <90/50 mmHg, altered mental status, shock, ischemic chest discomfort, or heart failure)
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: As this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically 600mg of oral cannabidiol once daily for 3 consecutive days.

Cannabidiol 600mg: All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opioid use disorder, severe
Currently in treatment with methadone or buprenorphine

Exclusion Criteria:

Requiring level of care higher than outpatient treatment for alcohol, sedative/hypnotics, or stimulants
Any current mood episode requiring level of care higher than outpatient treatment
History of psychotic disorder or bipolar disorder
Currently pregnant
Hepatic liver enzymes greater than 3x upper normal limit
Hypersensitivity to cannabinoids or sesame oil (cannabidiol solution comes in sesame oil emulsion)
Currently taking any medications with known significant pharmacokinetic interactions with CBD