anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Zuranolone
Trial phase: Phase 2
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Participants received SAGE-217, 30 mg, oral solution, once daily for 14 days, as tolerated.
Eligibility criteria:
Inclusion Criteria:

Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

Exclusion Criteria:

Participant has a history of suicide attempt
Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time
Participant has active psychosis
Participant has a medical history of seizures
Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Intervention: Zuranolone
Trial phase: Phase 2
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.
Eligibility criteria:
Inclusion Criteria:

Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

Exclusion Criteria:

Participant has a history of suicide attempt
Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time
Participant has active psychosis
Participant has a medical history of seizures
Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Intervention: Natrii lactatis solutio composita
Trial phase: Phase 3
SMILES: CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Each 100 mL of Lactated Ringer's Injection USP contains:

Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs

Lactated Ringer: IV infusion of lactated ringer throughout surgery.
Eligibility criteria:
Inclusion Criteria:

Major surgical procedure requiring arterial access

Exclusion Criteria:

Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.
Intervention: Empagliflozin
Trial phase: Phase 3
ATC code: A10BD19 | A10BD20 | A10BD27 | A10BK03
SMILES: OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2996
Group description: 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Eligibility criteria:
Inclusion criteria:

Male or female patient, age >= 18 years at screening. For Japan only: Age >=20 years at screening
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
Stable dose of oral diuretics, if prescribed
Signed and dated written ICF (informed consent form)
Further inclusion criteria apply

Exclusion criteria:

Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
Heart transplant recipient or listed for heart transplant
Acute decompensated HF (Heart Failure)
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
Symptomatic hypotension and/or a SBP < 100 mmHg
Indication of liver disease,
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
History of ketoacidosis
Current use or prior use of a SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
Currently enrolled in another investigational device or drug trial
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Further exclusion criteria may apply
Intervention: Empagliflozin
Trial phase: Phase 3
ATC code: A10BD19 | A10BD20 | A10BD27 | A10BK03
SMILES: OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1863
Group description: Film-coated tablet of 10 milligram (mg) Empagliflozin was administered orally once daily.
Eligibility criteria:
Inclusion criteria:

Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening

Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)

If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
Signed and dated written ICF (Informed Consent Form)
Further inclusion criteria apply

Exclusion criteria:

Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
Heart transplant recipient, or listed for heart transplant
Acute decompensated HF
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
Symptomatic hypotension and/or a SBP < 100 mmHg
Indication of liver disease
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
History of ketoacidosis
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
Currently enrolled in another investigational device or drug study
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Further exclusion criteria apply
Intervention: Clonidine Hydrochloride
Trial phase: Phase 4
SMILES: Cl.Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.

extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
Eligibility criteria:
Inclusion Criteria:

meet SCID criteria for bipolar disorder, type I, Mania with YMRS > 15
No significant improvement in symptoms after three or more days of hospitalization
documented medical evaluation without identified acute or serious medical illness
negative pregnancy test in women of child-bearing age

Exclusion Criteria:

involuntary commitment or lack of capacity to provide informed consent
low blood pressure
Intervention: Paclitaxel
Trial phase: Phase 2
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
Eligibility criteria:
Inclusion Criteria:

Male; 18 years of age and older
Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned radical prostatectomy; appropriate for treatment with paclitaxel therapy
ECOG of 0 or 1

Laboratory requirements:

WBC >2500/mm3
Neutrophil >1500/mm3
Hemoglobin >10 mg/dL
Platelet >100,000/ mm3
AST and ALT <2.5 x ULN
Total bilirubin <1.5 x ULN
Creatinine <2 mg/dL
Normal PT/INR and PTT;
Willing to use appropriate contraception from time of NanoPac® injection until prostatectomy
Willing to receive an mpMRI

Exclusion Criteria:

Evidence of locally advanced or metastatic disease;
Prostate size ≥ 50 cc
Prior prostatectomy
Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) prior to surgery
Treatment with a prior investigational agent within 30 days of first dose of investigational medication
Any previous local treatment of the prostate (i.e. radiation)
Any other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule
Known sensitivity to any of the study medication components
History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.
Intervention: Paclitaxel
Trial phase: Phase 2
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
Eligibility criteria:
Inclusion Criteria:

Male; 18 years of age and older
Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned radical prostatectomy; appropriate for treatment with paclitaxel therapy
ECOG of 0 or 1

Laboratory requirements:

WBC >2500/mm3
Neutrophil >1500/mm3
Hemoglobin >10 mg/dL
Platelet >100,000/ mm3
AST and ALT <2.5 x ULN
Total bilirubin <1.5 x ULN
Creatinine <2 mg/dL
Normal PT/INR and PTT;
Willing to use appropriate contraception from time of NanoPac® injection until prostatectomy
Willing to receive an mpMRI

Exclusion Criteria:

Evidence of locally advanced or metastatic disease;
Prostate size ≥ 50 cc
Prior prostatectomy
Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) prior to surgery
Treatment with a prior investigational agent within 30 days of first dose of investigational medication
Any previous local treatment of the prostate (i.e. radiation)
Any other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule
Known sensitivity to any of the study medication components
History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.
Intervention: FLUCICLOVINE
Trial phase: Phase 2
SMILES: N[C@]1(C(=O)O)C[C@@H](F)C1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC positron emission tomography (PET)-computerized tomography (CT)(PET-CT) scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.
Eligibility criteria:
Inclusion Criteria:

High-risk prostate cancer patients eligible for standard of care surgery

At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen (PSA) >20, as per clinical assessment and routine guidelines
Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or sodium fluoride (NaF) PET)

Exclusion Criteria:

Definitive findings of systemic metastasis on conventional imaging.
Intervention: Zoledronic acid
Trial phase: Phase 4
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Zoledronate: administrated at baseline.

Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site.
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women (postmenopausal for at least two years)
Men above 50 years
Treatment for at least two years with denosumab
Last denosumab injection less than five months ago

Exclusion Criteria:

Low-energy vertebral fracture at any time
Low-energy hip fracture within the last 12 months
BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)
Alendronate treatment for more than three years prior to denosumab treatment
Ongoing treatment with glucocorticoids
Metabolic bone disease
Hormone replacement therapy
Cancer
Estimated glomerular filtration rate (eGFR) < 35 mL/min
Allergy to zoledronic acid
Hypocalcaemia
Contraindications for zoledronic acid according to the SPC
Intervention: Zoledronic acid
Trial phase: Phase 4
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Zoledronate: administrated depending on increase in s-CTX (above 1.26 ug/l) or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 3.

Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site.
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women (postmenopausal for at least two years)
Men above 50 years
Treatment for at least two years with denosumab
Last denosumab injection less than five months ago

Exclusion Criteria:

Low-energy vertebral fracture at any time
Low-energy hip fracture within the last 12 months
BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)
Alendronate treatment for more than three years prior to denosumab treatment
Ongoing treatment with glucocorticoids
Metabolic bone disease
Hormone replacement therapy
Cancer
Estimated glomerular filtration rate (eGFR) < 35 mL/min
Allergy to zoledronic acid
Hypocalcaemia
Contraindications for zoledronic acid according to the SPC
Intervention: Zoledronic acid
Trial phase: Phase 4
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Zoledronate: administrated depending on increase in s-CTX (above 1.26 ug/l), decrease in BMD (more than 5% at any site), or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 6.

Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site.
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women (postmenopausal for at least two years)
Men above 50 years
Treatment for at least two years with denosumab
Last denosumab injection less than five months ago

Exclusion Criteria:

Low-energy vertebral fracture at any time
Low-energy hip fracture within the last 12 months
BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)
Alendronate treatment for more than three years prior to denosumab treatment
Ongoing treatment with glucocorticoids
Metabolic bone disease
Hormone replacement therapy
Cancer
Estimated glomerular filtration rate (eGFR) < 35 mL/min
Allergy to zoledronic acid
Hypocalcaemia
Contraindications for zoledronic acid according to the SPC
Intervention: Ketamine Hydrochloride
Trial phase: Phase 2
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O.Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.
Eligibility criteria:
Inclusion Criteria:

Healthy subjects (absence of disease) 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 48 hours prior to the study visits.
Must abstain from the use of moisturizers on the arms the day of study visit.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease or a painful condition.
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 48 hours prior to the study visits (e.g. antihistamines, anesthetics, anti-inflammatories, opioids, neuroleptics, etc.).
Use of emollients on the volar aspects of the forearms arms on the day of the study visit.
Use of anti-depressants, anti-psychotics, and illicit drugs.
Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
Known history of anaphylactic shock, or allergy to cowhage and/or known adverse reactions to lidocaine (or other local anesthetics of the amide type), ketamine or amitriptyline.
Intervention: Amitriptyline Hydrochloride
Trial phase: Phase 2
SMILES: CN(C)CCC=C1c2ccccc2CCc2ccccc21.Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Amitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.
Eligibility criteria:
Inclusion Criteria:

Healthy subjects (absence of disease) 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 48 hours prior to the study visits.
Must abstain from the use of moisturizers on the arms the day of study visit.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease or a painful condition.
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 48 hours prior to the study visits (e.g. antihistamines, anesthetics, anti-inflammatories, opioids, neuroleptics, etc.).
Use of emollients on the volar aspects of the forearms arms on the day of the study visit.
Use of anti-depressants, anti-psychotics, and illicit drugs.
Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
Known history of anaphylactic shock, or allergy to cowhage and/or known adverse reactions to lidocaine (or other local anesthetics of the amide type), ketamine or amitriptyline.
Intervention: Lidocaine Hydrochloride
Trial phase: Phase 2
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.
Eligibility criteria:
Inclusion Criteria:

Healthy subjects (absence of disease) 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 48 hours prior to the study visits.
Must abstain from the use of moisturizers on the arms the day of study visit.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease or a painful condition.
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 48 hours prior to the study visits (e.g. antihistamines, anesthetics, anti-inflammatories, opioids, neuroleptics, etc.).
Use of emollients on the volar aspects of the forearms arms on the day of the study visit.
Use of anti-depressants, anti-psychotics, and illicit drugs.
Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
Known history of anaphylactic shock, or allergy to cowhage and/or known adverse reactions to lidocaine (or other local anesthetics of the amide type), ketamine or amitriptyline.