anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Migalastat Hydrochloride
Trial phase: Phase 3
SMILES: Cl.OCC1NCC(O)C(O)C1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 21
Group description: Migalastat was administered every other day for 12 months.
Eligibility criteria:
Key Inclusion Criteria

Willing and able to provide written consent or assent (participant and parent/legal guardian, as applicable)
Male or female between 12 and <18 years of age diagnosed with Fabry disease
Confirmed, amenable GLA variant
Participant weighed at least 45 kg (99 pounds) at screening
Participant had never been treated with ERT or had not received ERT for 14 days prior to screening
Participant had at least 1 complication (such as, laboratory abnormality and/or sign/symptom) of Fabry disease
Participant was able to swallow study medication whole

Key Exclusion Criteria

Had moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <60 milliliter/minute/1.73 meter squared (m^2) at screening)
Had advanced kidney disease requiring dialysis or kidney transplantation
History of allergy or sensitivity to study medication (including excipients) or other iminosugars (for example, miglustat, miglitol)
Had received any gene therapy at any time or anticipated starting gene therapy during the study period
Required treatment with Glyset (miglitol) and/or Zavesca (miglustat) within 6 months before screening or throughout the study
Required treatment with Replagal (agalsidase alfa), or Fabrazyme (agalsidase beta) within 14 days before screening or throughout the study
Participant was treated or had been treated with any investigational/experimental drug, biologic or device within 30 days before screening
Any intercurrent illness or condition or concomitant medication use considered to be a contraindication at screening or baseline or that may have precluded the participant from fulfilling the protocol requirements or suggested to the investigator that the potential participant may have had an unacceptable risk by participating in this study
Pregnant or breast-feeding or planned to become pregnant during the study period
Otherwise unsuitable for the study in the opinion of the investigator
Intervention: AQX-1125
Trial phase: Phase 2
SMILES: C=C1CC[C@H]2[C@H](CN)[C@@H]([C@@]3(C)CC[C@H](O)C[C@@H]3CO)CC[C@]12C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: AQX-1125 200 mg

AQX-1125 200 mg: Synthetic SHIP1 activator
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent and the willingness and ability to comply with all aspects of the study requirements
Males, ≥18 and ≤80 years of age at Screening Visit 1
Have pain or discomfort in the pelvic region for at least 3 months in the last 6 months, in the absence of a urinary tract infection or other pelvic/urological cause, and have a physician diagnosis of CP/CPPS (NIH Prostatitis Category III)
Subjects must agree to use a condom for sexual intercourse from Screening Visit 1 until at least 90 days after the last dose of study drug, unless they have been surgically sterilized (vasectomy) for a minimum of 6 months
Must be capable of voiding independently for 30 days prior to screening

Exclusion Criteria:

Diagnosis of NIH Prostatitis Categories I (acute prostatitis) or II (chronic bacterial) prostatitis
Diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) with symptoms of pain, pressure, or discomfort perceived to be related to the bladder, and associated lower urinary symptoms for >6 weeks in the absence of infection or other identifiable causes
Relief of pelvic pain after voiding
Post-void residual volume >150 mL
Have had an unresolved (positive bacterial urine culture) urinary tract infection within 8 weeks (inclusive) prior to Screening Visit 1
History of previous prostate or bladder intervention within 1 month of Screening Visit 1, history of microwave therapy, transurethral resection of the prostate, transurethral radiofrequency thermotherapy, transurethral incision of the prostate, transurethral needle ablation, transurethral laser vaporization of the prostate, Urolift®, Rezum, and other urological interventions within 6 months of Screening Visit 1
Unilateral testicular or scrotal pain as the sole symptom of CP/CPPS
Ongoing, symptomatic urethral stricture disease
Neurologic disease or disorder affecting the bladder, ability to void spontaneously, or directly contributing to urinary symptoms (e.g., multiple sclerosis, autonomic neuropathy)
Severe, excruciating pain during rectal exam (i.e. an "inability to perform the exam")
History of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years
Any prior history of pelvic cancer (e.g., colorectal, genitourinary) or treatment (radiation or chemotherapy) thereof
Major surgery within 3 months prior to Screening Visit 1
Have any other condition/disease which, in the opinion of the Investigator, could compromise subject safety or interfere with the subject's participation in the study or in the evaluation of the study results.
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: 5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery.
Eligibility criteria:
Inclusion Criteria:

Pregnant patients who require a scheduled or non-urgent cesarean birth
Patient able to receive neuraxial analgesia
Patient able to give verbal and written consent for both cesarean birth and study

Exclusion Criteria:

Patients requiring emergent cesarean birth
Patients allergic to lidocaine or adhesive
Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth
Patients using chronic oral neuromodulators
Patients with cardiac disease or using anti-arrhythmic agents
Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus.
Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.
Intervention: Ketamine
Trial phase: Phase 1 | Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes
Eligibility criteria:
Inclusion Criteria:

Age between 18 years 65 years.
Females of childbearing age must have a negative urine pregnancy test at baseline and use an effective method of contraception during the study.
Diagnosis of MS (according to the 2010 McDonald criteria).
Ambulatory (at least 20 feet using bilateral assistance).
Fatigue reportedly present and screening modified fatigue impact scale (MFIS) score >33.
Internet and email access and able to use a computer or tablet

Exclusion Criteria:

Beck Depression Inventory (BDI) score of more than 30.
Neurodegenerative disorders other than relapsing or progressive MS.
Breastfeeding or pregnant.
History of coronary artery disease or congestive heart failure.
Uncontrolled hypertension at screening (history of high blood pressure and screening systolic blood pressure >160 or diastolic blood pressure>100).
History of severe liver disease, including cirrhosis.
Terminal medical conditions.
Currently treated for active malignancy.
Alcohol or substance abuse in the past year (except marijuana or other cannabinoids).
A history of intolerance or allergic or anaphylactic reaction to ketamine or midazolam
Clinically unstable medical or psychiatric disorders that require acute treatment as determined by the PI.
History of severe or untreated coronary artery disease or history of congestive heart failure.
History of prior ischemic or hemorrhagic stroke and cerebral vascular aneurysms.
History of recurrent seizures or epilepsy.
Taking any disallowed therapy(ies) as noted in Appendix 2 of the protocol.
Intervention: Midazolam
Trial phase: Phase 1 | Phase 2
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
Eligibility criteria:
Inclusion Criteria:

Age between 18 years 65 years.
Females of childbearing age must have a negative urine pregnancy test at baseline and use an effective method of contraception during the study.
Diagnosis of MS (according to the 2010 McDonald criteria).
Ambulatory (at least 20 feet using bilateral assistance).
Fatigue reportedly present and screening modified fatigue impact scale (MFIS) score >33.
Internet and email access and able to use a computer or tablet

Exclusion Criteria:

Beck Depression Inventory (BDI) score of more than 30.
Neurodegenerative disorders other than relapsing or progressive MS.
Breastfeeding or pregnant.
History of coronary artery disease or congestive heart failure.
Uncontrolled hypertension at screening (history of high blood pressure and screening systolic blood pressure >160 or diastolic blood pressure>100).
History of severe liver disease, including cirrhosis.
Terminal medical conditions.
Currently treated for active malignancy.
Alcohol or substance abuse in the past year (except marijuana or other cannabinoids).
A history of intolerance or allergic or anaphylactic reaction to ketamine or midazolam
Clinically unstable medical or psychiatric disorders that require acute treatment as determined by the PI.
History of severe or untreated coronary artery disease or history of congestive heart failure.
History of prior ischemic or hemorrhagic stroke and cerebral vascular aneurysms.
History of recurrent seizures or epilepsy.
Taking any disallowed therapy(ies) as noted in Appendix 2 of the protocol.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: This arm will receive Saline along with Bupivacaine

Saline: Saline injection used as control
Eligibility criteria:
Inclusion Criteria:

Men and women sixty-five years of age and older with isolated intracapsular hip fractures undergoing hemi arthroplasty through a posterior approach with the ability to consent to the study.

Exclusion Criteria:

Under sixty-five years of age, extracapsular hip fracture, suffer from any form of cognitive compromise that leaves them unable to consent, or if they are treated with any surgical modality other than hip hemiarthroplasty.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: This arm will receive Exparel along with Bupivacaine

Bupivacaine liposome: A long-acting liposomal bupivacaine
Eligibility criteria:
Inclusion Criteria:

Men and women sixty-five years of age and older with isolated intracapsular hip fractures undergoing hemi arthroplasty through a posterior approach with the ability to consent to the study.

Exclusion Criteria:

Under sixty-five years of age, extracapsular hip fracture, suffer from any form of cognitive compromise that leaves them unable to consent, or if they are treated with any surgical modality other than hip hemiarthroplasty.
Intervention: NITROUS OXIDE
Trial phase: Phase 3
ATC code: N01AX13 | N01AX63
SMILES: [N-]=[N+]=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Patients will receive nitrous oxide during the version procedure.

Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device
Eligibility criteria:
Inclusion Criteria:

Female 18 years or greater
Scheduled to undergo external cephalic version due to singleton breech presentation
Not scheduled to have spinal or epidural anesthesia during the version procedure
American Society of Anesthesiology (ASA) Physical Status 1, 2 or 3.
Able to provide informed consent and adhere to study protocol

Exclusion Criteria:

Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of exposure to nitrous oxide or complicate the subject's post-procedural course.
Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures.
Intervention: Vancomycin
Trial phase: Phase 2 | Phase 3
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Will receive 15mg/kg based on actual body weight (maximum of 2g) of vancomycin via the systemic route at a rate of 15mg/kg as per hospital guidelines. Systemic IV vancomycin is given via a forearm vein, given over an infusion timed to finish immediately prior to surgery.

Vancomycin: Antibiotic
Eligibility criteria:
Inclusion Criteria

Primary Total Knee Arthroplasty for osteoarthritis Informed consent given

Exclusion Criteria

Current or treatment with IV Vancomycin within preceding 7 days Previous hypersensitivity to vancomycin Significant cardiac or respiratory abnormality Patient has contraindications to IO vascular access using the EZ-IO
Intervention: Vancomycin
Trial phase: Phase 2 | Phase 3
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Will have the limb exsanguinated and an above knee tourniquet inflated to 300 mmHg. Immediately following tourniquet inflation, Group B will receive 500mg of vancomycin, via an EZ-IO intraosseous cannula. The vancomycin would be administered in 150ml of saline solution. The intraosseous cannula would be placed into the epiphysis of the proximal tibia. The tourniquet will be left inflated for 10 minutes following completion of the IORA injection then deflated.

Vancomycin: Antibiotic
Eligibility criteria:
Inclusion Criteria

Primary Total Knee Arthroplasty for osteoarthritis Informed consent given

Exclusion Criteria

Current or treatment with IV Vancomycin within preceding 7 days Previous hypersensitivity to vancomycin Significant cardiac or respiratory abnormality Patient has contraindications to IO vascular access using the EZ-IO
Intervention: Triheptanoin
Trial phase: Phase 1 | Phase 2
ATC code: A16AX17
SMILES: CCCCCCC(=O)OCC(COC(=O)CCCCCC)OC(=O)CCCCCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: Standard care for 1 month, then standard care and Triheptanoin for 5 months.

Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease.
Eligibility criteria:
Inclusion Criteria:

Lab supported probable or more definite ALS by El Escorial Criteria
Age greater than or equal to 18 years
Willing and able to provide informed consent
On riluzole at a stable dose for at least 30d or not taking this
On Radicava at a stable dose for at least 30d or not taking this
Life expectancy at least 6 months
Currently managed on a reasonably stable diet, avoidance of fasting, carnitine or medium chain triglyceride (MCT) oils
Must stop any other experimental ALS treatment for at least 30 days prior to screening
If sexually active, must agree to use contraceptive or abstinence for duration of treatment with triheptanoin
Females of child bearing age must have negative pregnancy test at screening

Exclusion Criteria:

Unwilling or unable to provide informed consent
Previous intolerance or adverse reaction to triheptanoin or MCT
Conditions that will prohibit MRI scanning (metal in eye, some surgical implants, claustrophobia, inability to lie supine)
Have any other co-morbid conditions that in the opinion of the study investigator, places the participant at increased risk of complications, interferes with study participation or compliance, or confounds study objectives
Intervention: Triheptanoin
Trial phase: Phase 1 | Phase 2
ATC code: A16AX17
SMILES: CCCCCCC(=O)OCC(COC(=O)CCCCCC)OC(=O)CCCCCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: Standard care and Triheptanoin for 6 months.

Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease.
Eligibility criteria:
Inclusion Criteria:

Lab supported probable or more definite ALS by El Escorial Criteria
Age greater than or equal to 18 years
Willing and able to provide informed consent
On riluzole at a stable dose for at least 30d or not taking this
On Radicava at a stable dose for at least 30d or not taking this
Life expectancy at least 6 months
Currently managed on a reasonably stable diet, avoidance of fasting, carnitine or medium chain triglyceride (MCT) oils
Must stop any other experimental ALS treatment for at least 30 days prior to screening
If sexually active, must agree to use contraceptive or abstinence for duration of treatment with triheptanoin
Females of child bearing age must have negative pregnancy test at screening

Exclusion Criteria:

Unwilling or unable to provide informed consent
Previous intolerance or adverse reaction to triheptanoin or MCT
Conditions that will prohibit MRI scanning (metal in eye, some surgical implants, claustrophobia, inability to lie supine)
Have any other co-morbid conditions that in the opinion of the study investigator, places the participant at increased risk of complications, interferes with study participation or compliance, or confounds study objectives
Intervention: Labetalol
Trial phase: Phase 4
ATC code: C07AG01 | C07BG01 | C07CG01
SMILES: CC(CCc1ccccc1)NCC(O)c1ccc(O)c(C(N)=O)c1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 55
Group description: intravenous medication 20mg, 40mg, 80 mg

Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol.
Eligibility criteria:
Inclusion Criteria:

pregnant patients from 20 weeks to up to 6 weeks postpartum
between the ages of 18-55.
persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic.

Exclusion Criteria:

multiple gestation
patients with non-reassuring fetal heart rate (category 3)
patients with abruptio placenta
patients with renal impairment
history of heart failure
history of cardiac arrhythmia
use of anti-hypertensive medications in the past 24 hours
patients with allergies or medical contraindications to labetalol or nifedipine.
Intervention: Nifedipine
Trial phase: Phase 4
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: Oral medication 10mg and 20mg

Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed.
Eligibility criteria:
Inclusion Criteria:

pregnant patients from 20 weeks to up to 6 weeks postpartum
between the ages of 18-55.
persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic.

Exclusion Criteria:

multiple gestation
patients with non-reassuring fetal heart rate (category 3)
patients with abruptio placenta
patients with renal impairment
history of heart failure
history of cardiac arrhythmia
use of anti-hypertensive medications in the past 24 hours
patients with allergies or medical contraindications to labetalol or nifedipine.
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.
Eligibility criteria:
Inclusion Criteria:

Men and women
Ages 18-65
Have schizophrenia or schizoaffective disorder
Would like to quit smoking within the next 6 months
Have smoked at least 10 cigarettes per day in the past year
Have breath CO level > 10 ppm
Able to speak, read and comprehend English well enough to complete study procedures

Exclusion Criteria:

Pregnant, breast-feeding, or unwilling to use medically-approved contraception
Currently using varenicline, bupropion or nicotine replacement therapy for smoking cessation
Medical disease that would preclude participation
Unstable psychiatric conditions
Body mass index (BMI) < 15 or > 38 kg/m2
Past-month suicidal intention, with or without a specific plan
Positive urine drug screen or breath alcohol level > 0.01% at screening
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 91
Group description: Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
Eligibility criteria:
Inclusion Criteria:

Robotic or Video-Assisted Lung Resection for All Indications

Exclusion Criteria:

Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
Extra-Thoracic Procedures
Hypersensitivity to Amide Local Analgesia
Cardiac Conduction Abnormalities
Hepatic Dysfunction
Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage