anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: 33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.

Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
Eligibility criteria:
Inclusion Criteria:

Patients having sleeve gastrectomy
Surgeries performed by a particular surgeon - Dr. Sam Wasser
Body Mass Index greater than 35
American Society of Anesthesiologists Score II and III patients

Exclusion Criteria:

Patients having a different type of bariatric surgery including but not limited to duodenal switch, gastric bypass, hand-assisted laparoscopic sleeve gastrectomy
Sleeve gastrectomy's performed by other surgeons than Dr. Sam Wasser.
Pregnancy
Allergic to sugammadex, Zofran or scopolamine
Chronic Obstructive Pulmonary Disease or Asthma that is uncontrolled
American Society of Anesthesiologists Score I, IV, V patients
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Administration of intraosseous hypertonic saline

Intraosseous: Intraosseous administration of hypertonic saline

Hypertonic saline: Intraosseous administration of hypertonic saline
Eligibility criteria:
Inclusion Criteria:

NCCU patients in which osmotherapy with HTS is planned (standard of care
Does not already have a CVC or PICC.

Exclusion Criteria:

<18 years old
Known pregnancy
Long bone fracture in the targeted site
Proximity to prosthetic joint
Excessive tissue/absence of anatomical landmarks
History of osteopetrosis
Previous significant orthopedic procedure at site
Prosthetic limb or joint
IO catheter use in the past 48 hours of the target bone
Infection at the area of insertion
Hypersensitivity to lidocaine
Intervention: HYDROGEN PEROXIDE
Trial phase: Phase 2
ATC code: A01AB02 | D08AX01 | D11AX25 | S02AA06
SMILES: OO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: A-101 Topical Solution

A-101 Topical Solution: A-101 Topical Solution
Eligibility criteria:
Inclusion Criteria:

Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
Male or female ≥ 8 years old.
Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
Subject is non-pregnant and non-lactating.
Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target and Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.
Subject is willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

Subject has clinically atypical warts on the trunk or extremities.
Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
Subject has a history of Human Immunodeficiency Virus (HIV) infection
Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to Visit 1
Subject has a history of sensitivity to any of the ingredients in the study medications.
Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.
Intervention: Remifentanil
Trial phase: Phase 4
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Remifentanil will be administered to subjects during microelectrode recordings (MER).

Remifentanil: Remifentanyl will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
Eligibility criteria:
Inclusion Criteria:

All patients scheduled to undergo DBS electrode implantation surgery with MER that agree to participate in the experiment and sign an informed consent are candidates to participate in the study, unless one of the exclusion criteria is met

Exclusion Criteria:

Known or suspected obstructive sleep apnea.
Suspected difficult intubation.
Pregnancy (pregnancy test is standard care for women of childbearing age)
Under 18 years of age or over 85 years of age
Cognitive disability impairing understanding the experiment or signing the informed consent form.
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: 20
Group description: Propofol will be administered to subjects during MER.

Propofol: Propofol will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
Eligibility criteria:
Inclusion Criteria:

All patients scheduled to undergo DBS electrode implantation surgery with MER that agree to participate in the experiment and sign an informed consent are candidates to participate in the study, unless one of the exclusion criteria is met

Exclusion Criteria:

Known or suspected obstructive sleep apnea.
Suspected difficult intubation.
Pregnancy (pregnancy test is standard care for women of childbearing age)
Under 18 years of age or over 85 years of age
Cognitive disability impairing understanding the experiment or signing the informed consent form.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 100
Group description: Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.

Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
Eligibility criteria:
Inclusion Criteria:

Over age 18
English Speaking
Able to provide informed consent
Undergoing laparoscopic hysterectomy for benign indications

Exclusion Criteria:

Planned laparotomy incision
Planned procedure that requires dissection of the presacral space
Allergy to block medication (s)
Known or suspected malignancy
Non-English speaker
Intervention: Relamorelin
Trial phase: Phase 3
SMILES: NC(=O)C1(NC(=O)[C@H](Cc2ccccc2)NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@@H](Cc2csc3ccccc23)NC(=O)C2CCNCC2)CCNCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Type 1 or Type 2 diabetes mellitus
Meet the per protocol criteria of diabetic gastroparesis
Compliance with diary
Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating disorder at the time of Screening (Visit 1)
Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
History of gastrointestinal disorders that may be similar to gastroparesis
Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
Intervention: Nitrofurantoin
Trial phase: Phase 4
ATC code: J01XE01 | J01XE51
SMILES: O=C1CN(/N=C/c2ccc([N+](=O)[O-])o2)C(=O)N1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal

Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
Eligibility criteria:
Inclusion Criteria:

Age greater than 18
Creatinine clearance greater than 30 ml/min
Failed postoperative hospital voiding trial

Exclusion Criteria:

Pregnant
History of glucose-6-phosphate dehydrogenase deficiency
History of renal insufficiency, renal transplant, or nephropathy
Allergy to nitrofurantoin
History of recurrent UTI (defined as greater than two culture-proven infections in six months or three infections in one year)
Urinary Tract Infection (UTI) within 14 days one month of surgery
Non-English speaking
Urinary tract infection while Foley catheter is in place
On antibiotic therapy for other non-urological reasons
Sustained intraoperative bladder injury requiring prolonged catheterization greater than 5 days
Undergoing mesh excision from within the bladder, fistula repair, cystotomy repair, urethral diverticulectomy, sacral neuromodulation, urethral surgery, or any other procedure requiring prolonged catheterization and bladder decompression
Placement of a suprapubic catheter
Participants that request intermittent self-catheterization
Neurologic conditions affecting urinary tract system and normal voiding mechanisms
History of hepatic impairment due to prior nitrofurantoin use
Inability to provide consent/decisionally impaired
More than two in-office voiding trials
Intervention: CARBON DIOXIDE
Trial phase: Phase 4
ATC code: V03AN02
SMILES: O=C=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 90
Group description: in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy

Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air
Eligibility criteria:
Inclusion Criteria:

Pediatric gastroenterology patients aged 6 months through 21 years undergoing endoscopic procedures in the Stead Family Children's Hospital (SFCH) Lower Level 2 procedure room or the operating room in the SFCH who willingly consent/ascent to the study. These procedures will range from Esophagogastroduodenoscopy, Colonoscopy, and those having both Esophagogastroduodenoscopy and Colonoscopy.

Exclusion Criteria:

Non English speaking families who require the services of a translator Children outside the stipulated age range of study. Children in foster care homes or wards of the court. Children and parents who do not willingly consent to the study Children with history of bronchopulmonary dysplasia or other chronic respiratory compromise.
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: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Child-Pugh score of 5 or 6
Eligibility criteria:
Inclusion Criteria:

All subjects

Able to provide written informed consent to participate in this study after reading the ICF
Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements.
A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2

Hepatic impaired subjects (in addition)

A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment
Chronic and stable hepatic impairment

Healthy subjects (in addition)

Subject with normal hepatic function
Good health and free from clinically significant illness or disease

Exclusion Criteria:

All subjects

Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance
Subjects were previously administered MCI-186.
Positive urine drug screen (if not due to concomitant medication) or alcohol test
History of drug abuse
Presence of alcohol abuse
Presence of active infection requiring antibiotics
Positive test for human immunodeficiency virus (HIV) antigen/antibody
Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg
eGFR <60 mL/min/1.73m2

Hepatic impairment subject (in addition)

Subjects with severe ascites

Healthy subject (in addition)

History or presence of any parenchymal hepatic disease
Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)
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: Accepts Healthy Volunteers
Participants at risk: 8
Group description: normal hepatic function
Eligibility criteria:
Inclusion Criteria:

All subjects

Able to provide written informed consent to participate in this study after reading the ICF
Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements.
A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2

Hepatic impaired subjects (in addition)

A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment
Chronic and stable hepatic impairment

Healthy subjects (in addition)

Subject with normal hepatic function
Good health and free from clinically significant illness or disease

Exclusion Criteria:

All subjects

Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance
Subjects were previously administered MCI-186.
Positive urine drug screen (if not due to concomitant medication) or alcohol test
History of drug abuse
Presence of alcohol abuse
Presence of active infection requiring antibiotics
Positive test for human immunodeficiency virus (HIV) antigen/antibody
Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg
eGFR <60 mL/min/1.73m2

Hepatic impairment subject (in addition)

Subjects with severe ascites

Healthy subject (in addition)

History or presence of any parenchymal hepatic disease
Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)
Intervention: Zosyn
Trial phase: Phase 4
SMILES: CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.CCN1CCN(C(=O)NC(C(=O)NC2C(=O)N3C2SC(C)(C)C3C(=O)[O-])c2ccccc2)C(=O)C1=O.[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 82
Group description: piperacillin-tazobactam

Piperacillin, Tazobactam Drug Combination: Single drug therapy
Eligibility criteria:
Inclusion Criteria:

Postoperative Perforated Appendicitis (documented by intraoperative photo)
Postoperative Laparoscopic Appendectomy

Exclusion Criteria:

Nonperforated Gangrenous Appendicitis
Nonperforated Purulent Appendicitis
Open Appendectomy
Intervention: Tacrolimus
Trial phase: Phase 3
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Tacrolimus: immunosuppressive agent tacrolimus, given twice-daily
Eligibility criteria:
Inclusion Criteria:

1. Patients who are males or females aged 18-65 years. 2. Use of the following induction medications: basiliximab and rituximab. 2. Donors aged 18-65 years. 3. No prior organ transplant 4. Patients who are single-organ recipients (kidney only). 5. Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period.

6. Subject (recipient) is able to understand the consent form and give written informed consent

Exclusion Criteria:

Delayed graft function (please see above).
Known sensitivity or contraindication to alemtuzumab, Envarsus® XR, tacrolimus or MMF.
Use of the following induction medications: basiliximab and rituximab
Patient with significant or active infection.
Patients with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
Patients with PRA > 40%
Patients with current or historic donor specific antibodies
Body Mass Index (BMI) of < 18 or > 35
Patients who are pregnant or nursing mothers.
Patients whose life expectancy is severely limited by diseases other than renal disease.
Ongoing active substance abuse, drug or alcohol.
Major ongoing psychiatric illness or recent history of noncompliance.

Significant cardiovascular disease (e.g.):

Significant non-correctable coronary artery disease;
Ejection fraction below 30%;
History of recent myocardial infarction.
Malignancy within 3 years, excluding non-melanoma skin cancers.
Serologic evidence of infection with HIV or HBVs-Ag positive.
Patients with a screening/baseline total white blood cell count < 4,000/mm3; platelet count < 100,000/mm3; triglyceride > 400 mg/dl; total cholesterol > 300 mg/dl.
Investigational drug within 30 days prior to transplant surgery.
Anti-T cell therapy within 30 days prior to transplant surgery.
Diagnosis of atypical-Hemolytic Uremic Syndrome (aHUS).
Subjects transplanted with a Hepatitis C NAT-positive kidney.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia."

Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture
Eligibility criteria:
Inclusion Criteria:

Age 55 or older
Sustaining either an OTA/AO type 31A or 31B fracture undergoing ORIF or hemiarthroplasty
Able to consent
Isolated injury

Exclusion Criteria:

OTA/AO 31B1 (Impacted/slightly displaced)
Baseline dementia or cognitive deficit
Inability to consent
Chronic Opioid use
End stage liver disease with Model for End-Stage Liver Disease (MELD) greater than 20.
End stage renal disease as defined by patients requiring hemodialysis at least twice weekly
Polytrauma, defined as: concurrent upper or lower extremity fracture, pelvis fracture, spine fracture, rib fractures, or facial fractures, Blunt chest or abdominal trauma resulting in diagnosed organ injury, Head trauma resulting in intracranial bleed or diagnosed concussion
Allergy to amide-type local anesthetics
Prisoners (unlikely to be accessible for follow-up)
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Saline Solution (Sodium Chloride)

Sodium Chloride: Saline Injection
Eligibility criteria:
Inclusion Criteria:

Age 55 or older
Sustaining either an OTA/AO type 31A or 31B fracture undergoing ORIF or hemiarthroplasty
Able to consent
Isolated injury

Exclusion Criteria:

OTA/AO 31B1 (Impacted/slightly displaced)
Baseline dementia or cognitive deficit
Inability to consent
Chronic Opioid use
End stage liver disease with Model for End-Stage Liver Disease (MELD) greater than 20.
End stage renal disease as defined by patients requiring hemodialysis at least twice weekly
Polytrauma, defined as: concurrent upper or lower extremity fracture, pelvis fracture, spine fracture, rib fractures, or facial fractures, Blunt chest or abdominal trauma resulting in diagnosed organ injury, Head trauma resulting in intracranial bleed or diagnosed concussion
Allergy to amide-type local anesthetics
Prisoners (unlikely to be accessible for follow-up)
Intervention: Tazarotene
Trial phase: Phase 3
ATC code: D05AX05 | D05AX55
SMILES: CCOC(=O)c1ccc(C#Cc2ccc3c(c2)C(C)(C)CCS3)nc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 277
Group description: DFD-03 (0.1% tazarotene) Lotion

DFD-03: DFD-03 Lotion
Eligibility criteria:
Main Inclusion Criteria:

Subject must be at least 9 years of age.
A clinical diagnosis of mild to moderate facial acne vulgaris.
Inflammatory lesion count (papules and pustules) of at least 20 on the face, Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face and No more than 2 nodulocystic lesions on the face.
Females, regardless of childbearing potential, if sexually active, must be on or use an acceptable method of birth control.
Subject must be in good general health as determined by the investigator and supported by medical history, physical and Vital Signs exam.

Main Exclusion Criteria:

Females who are pregnant or lactating or planning to become pregnant.

Treatment with the following products:

Topical acne treatments or other topical facial medication on the treatment area.
Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne.
Systemic retinoid use.
Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping).
Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.
Treatment with an investigational product or device in the 30 days.
Known allergic reaction to retinoids or tazarotene.
Presence of any facial skin disease or condition that would interfere with the study or place the subject at unacceptable risk including sunburn, rosacea, seborrheic dermatitis, perioral dermatitis, lupus, dermatomyositis, psoriasis, eczema, squamous cell carcinoma, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis or any other facial disease or condition.
Subjects with a serious and/or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk.
Subjects who have been in another investigational trial within 30 days.