anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acetaminophen
Trial phase: Phase 1 | Phase 2
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Topical 1% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel
Eligibility criteria:
Inclusion Criteria:

Healthy subjects must be between 18 and 50 years of age.
Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
No history of chronic itch or pain.
Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
Must abstain from the use of moisturizers on the arms 24 hours before study visits.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease.
Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
Use of emollients on the arms a week prior to the study and throughout the study.
Known allergies to acetaminophen and cowhage.
Pregnant women. (Women of child bearing potential will undergo an hCG pregnancy test).
Currently incarcerated.
Intervention: ISLATRAVIR
Trial phase: Phase 2
SMILES: C#C[C@]1(CO)O[C@@H](n2cnc3c(N)nc(F)nc32)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 97
Group description: Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
Eligibility criteria:
Inclusion Criteria:

Is in general good health with acceptable laboratory values at screening
Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
Has low risk of HIV infection, within 12 months prior to screening visit or the rescreening visit (if applicable)
Use contraceptives consistent with local regulations
Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP)
A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.

Exclusion Criteria:

Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has an active diagnosis of hepatitis due to any cause
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 30 days prior to Day

1 through the duration of the study.

Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to Day1 through the duration of the study.
Has previously been randomized in a study and received islatravir (MK-8591).
Female is expecting to conceive or donate eggs at any time during the study
Has QTc interval (using Fridericia correction) >450 msec (for males) or >460 msec (for females) or deemed clinically abnormal by the investigator.
Intervention: Delafloxacin
Trial phase: Phase 3
ATC code: J01MA23
SMILES: Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Delafloxacin IV with the option to switch to delafloxacin OS
Eligibility criteria:
Inclusion Criteria:

Male or female patients aged more than 18 years.
Patients with a history of cardiothoracic / related leg or abdominal surgery, occurred within 30 days and no implant is left in place, and a diagnosis of superficial or deep SSI according to the CDC definition.
The severity of infection requires an IV treatment and patient hospitalization according to the Investigator's judgment.

Exclusion Criteria:

Previous IV antimicrobial therapy exceeding 24-hour duration during 72 hours prior to first dose.
Any infection expected to require systemic antimicrobial agents other than study treatment(s).
Medical history of significant hypersensitivity or allergic reaction or contraindication to the study drugs
Medical history of central nervous system (CNS) disorders
Medical history of myasthenia gravis.
Medical history of C. difficile diarrhea.
Organ-space infection.
Complicated Intra-Abdominal Infection (cIAI)
Chronic or underlying conditions at site of infection that may complicate the assessment of clinical response or would interfere with SSI healing.
Underlying disease leading to deep immunosuppressive status.
End-stage renal disease, CrCl <15 mL/min.
Intervention: Sirolimus
Trial phase: Early Phase 1
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Rapamycin ointment will be applied to one keloid on the subject

Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin
Eligibility criteria:
Inclusion Criteria:

Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to
Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable
Cognitive functioning sufficient to provide informed consent
Physically able to apply ointment to keloids daily
Able to attend monthly clinic visits for 6 months

Exclusion Criteria:

Diagnosis of diabetes
Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months
Local area steroidal treatment within the past 3 months
History of allergy to rapamycin of petrolatum-based products
Intervention: Naropin
Trial phase: Phase 4
SMILES: CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients.

ropivicaine 0.2%: 2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
Eligibility criteria:
Inclusion criteria:

Age > 18
Able to consent for themselves
Undergoing a head and neck surgery at UAB with reconstruction using either a forearm free flap or a fibula free flap

Exclusion criteria:

Age < 18
Unable to consent for themselves
Non-English speakers
Non-resectable tumor
Have a known opioid tolerance, or are on a home opioid regimen for a chronic condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new cancer diagnosis will be allowed).
Patients with known hepatic failure, renal failure, or sulfa allergy, as determined by standard of care labs drawn within 30 days of enrollment
Intervention: Sunitinib Malate
Trial phase: Phase 2
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(C=C2C(=O)Nc3ccc(F)cc32)c1C.O=C(O)CC(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.

GB-102: Intravitreal injection of GB-102
Eligibility criteria:
Inclusion Criteria:

Males or females ≥ 21 years of age
Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
Demonstrated response to prior anti-VEGF treatment since diagnosis
BCVA of 31 letters or better

Exclusion Criteria:

History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
Uncontrolled hypertension, diabetes mellitus or IOP
Chronic renal disease
Intervention: Sunitinib Malate
Trial phase: Phase 2
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(C=C2C(=O)Nc3ccc(F)cc32)c1C.O=C(O)CC(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.

GB-102: Intravitreal injection of GB-102
Eligibility criteria:
Inclusion Criteria:

Males or females ≥ 21 years of age
Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
Demonstrated response to prior anti-VEGF treatment since diagnosis
BCVA of 31 letters or better

Exclusion Criteria:

History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
Uncontrolled hypertension, diabetes mellitus or IOP
Chronic renal disease
Intervention: Lofexidine
Trial phase: Phase 4
ATC code: N07BC04
SMILES: CC(Oc1c(Cl)cccc1Cl)C1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily.

Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily
Eligibility criteria:
Inclusion Criteria:

Age 18 to 70 years.
Chronic lumbar spine pain for ≥ 3 months duration.
Scheduled for elective lumbar spine surgery.
Daily morphine equivalent dose between 50 mg and 200 mg.

Exclusion Criteria:

Cancer-related pain.
Medical or surgical conditions that could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, cardiac disease, inflammatory bowel disease, renal or hepatic impairment, vascular disease, and history of anaphylaxis. Patients may be excluded for other comorbid medical or surgical conditions based on the physician investigator's discretion.
History of schizophrenia or other chronic psychiatric disorder that could be adversely impacted by opioid tapering or use of lofexidine. Patients may be excluded for other comorbid mental health conditions based on the physician investigator's discretion.
Neurological condition that impair functioning in an ambulatory setting or could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, Parkinson's disease, amyotrophic lateral sclerosis, or a dementing illness. Patients may be excluded for other neurological conditions based on the physician investigator's discretion.
Active substance abuse disorder.
Inability to function in an ambulatory care setting due to severe deconditioning requiring use of supportive gait aids including a cane or walker. Patients may be excluded for other functional problems based on the physician investigator's discretion.
History of adverse effects attributed to opioid tapering or lofexidine use.
Use of medications from drug classes known to have adverse interactions with lofexidine including, but not exclusively limited to, beta-blockers, calcium channel blockers, alpha 1 and 2 receptor antagonists, tricyclic antidepressants, benzodiazepines, and selective serotonin reuptake inhibitors. Patients may be excluded for use of other medications based on the physician investigator's and research pharmacy's discretion.
Intervention: Fentanyl
Trial phase: Phase 1 | Phase 2
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Experimental visit with Fentanyl administration
Eligibility criteria:
Inclusion Criteria:

Healthy
Non-obese (body mass index less than 30 kg/m2)
Body mass greater than or equal to 65 kg

Exclusion Criteria:

Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
Any known history of renal or hepatic insufficiency/disease
Pregnancy or breast feeding
Current smokers, as well as individuals who regularly smoked within the past 3 years
Positive urine drug screen
Currently taking pain modifying medication(s)
Intervention: CALCIUM CHLORIDE
Trial phase: Phase 2
ATC code: A11GB01 | A12AA07 | B05XA07 | G04BA03
SMILES: [Ca+2].[Cl-].[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 397
Group description: The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.

Calcium Chloride: Calcium chloride 5 mmol
Eligibility criteria:
Inclusion Criteria:

Out-of-hospital cardiac arrest
Age ≥ 18 years
Received at least one dose of adrenaline

Exclusion Criteria:

Traumatic cardiac arrest - including drowning and external asphyxia (e.g., hanging, strangulation, or foreign object airway obstruction)
Known or strongly suspected pregnancy
Prior enrollment in the trial
Received adrenaline during cardiac arrest before arrival of prehospital personnel with the study drug
Clinical indication for calcium administration during the cardiac arrest
Intervention: Ivarmacitinib
Trial phase: Phase 2
SMILES: [H][C@@]12C[C@@H](N(C)c3ncnc4[nH]ccc34)C[C@]1([H])CN(C(=O)Nc1nc(OC)ns1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.

Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Eligibility criteria:
Inclusion Criteria:

Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
Moderate to severe atopic dermatitis
Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion Criteria:

Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)
Intervention: Ivarmacitinib
Trial phase: Phase 2
SMILES: [H][C@@]12C[C@@H](N(C)c3ncnc4[nH]ccc34)C[C@]1([H])CN(C(=O)Nc1nc(OC)ns1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.

Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Eligibility criteria:
Inclusion Criteria:

Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
Moderate to severe atopic dermatitis
Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion Criteria:

Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)
Intervention: Ivarmacitinib
Trial phase: Phase 2
SMILES: [H][C@@]12C[C@@H](N(C)c3ncnc4[nH]ccc34)C[C@]1([H])CN(C(=O)Nc1nc(OC)ns1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.

Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Eligibility criteria:
Inclusion Criteria:

Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
Moderate to severe atopic dermatitis
Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion Criteria:

Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery.

Rectal acetaminophen: Rectal 1300mg
Eligibility criteria:
Inclusion Criteria:

Willing to consent
Amendable to receive either rectal or intravenous acetaminophen
Planned hospital stay for at least 24 hours.

Exclusion Criteria:

Patients unable to provide informed consent
Patients with a history of regular opioid use prior to surgery based on their current home medication list
Patients who have required regular opioid intake for the 7 days preceding surgery
Patients with known hypersensitivity to acetaminophen
Patients with a baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limits
Unable to complete procedure as planned.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery.

Intravenous acetaminophen: Intravenous 1000mg
Eligibility criteria:
Inclusion Criteria:

Willing to consent
Amendable to receive either rectal or intravenous acetaminophen
Planned hospital stay for at least 24 hours.

Exclusion Criteria:

Patients unable to provide informed consent
Patients with a history of regular opioid use prior to surgery based on their current home medication list
Patients who have required regular opioid intake for the 7 days preceding surgery
Patients with known hypersensitivity to acetaminophen
Patients with a baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limits
Unable to complete procedure as planned.