anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Silibinin
Trial phase: Phase 2
ATC code: A05BA03
SMILES: COc1cc(C2Oc3cc(C4Oc5cc(O)cc(O)c5C(=O)C4O)ccc3OC2CO)ccc1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump

Silibinin: 20 mg/kg/day IV
Eligibility criteria:
Inclusion Criteria:

Signed Informed Consent(s) for clinical trial participation (due to the potential critical status of the subject upon presentation, consent may need to be obtained from Legally Authorized Representative (LAR) per sites consenting policy and ICH/GCP guidance) Signed Informed Consent for Clinical Trial participation
History of eating foraged mushrooms
Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain, nausea, vomiting, and / or watery diarrhea) usually 24-48 hours after of mushroom ingestion
Liver function tests suggestive of amatoxin poisoning: AST or ALT above the institutions upper limit of normal after mushroom ingestion

Exclusion criteria:

1. Evidence of significant medical illness or any other abnormal laboratory finding that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in, and completion of the study or could preclude the evaluation of the subject's response.
Intervention: Dexmedetomidine
Trial phase: Not Applicable
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days

Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
Eligibility criteria:
Inclusion Criteria:

Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
Informed consent within 36 hours of qualifying for the study.

Exclusion Criteria:

Patients < 18 years of age or > 85 years of age.
Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
Patients with alcohol withdrawal not requiring ICU admission.
Patients receiving epidural administration of medication(s).
Comatose patients by metabolic or neurologic affectation.
Patients with active myocardial ischemia or second- or third-degree heart block.
Moribund state with planned withdrawal of life support.
Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).
Pregnant females or females suspected of being pregnant
Intervention: Dexmedetomidine
Trial phase: Not Applicable
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days

Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
Eligibility criteria:
Inclusion Criteria:

Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
Informed consent within 36 hours of qualifying for the study.

Exclusion Criteria:

Patients < 18 years of age or > 85 years of age.
Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
Patients with alcohol withdrawal not requiring ICU admission.
Patients receiving epidural administration of medication(s).
Comatose patients by metabolic or neurologic affectation.
Patients with active myocardial ischemia or second- or third-degree heart block.
Moribund state with planned withdrawal of life support.
Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).
Pregnant females or females suspected of being pregnant
Intervention: Zoledronic acid
Trial phase: Phase 3
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: 110
Group description: aclasta group

zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period
Eligibility criteria:
Inclusion Criteria:

Patient who agree to clinical trial
Patient who are more than 18 years of age
Osteonecrosis of the femoral head
Steinberg stage I, II non traumatic osteonecrosis of femoral head
Necrotic area of > 30% (HJ Kim et al )
JIC (Japanese Investigation Committee): C1 or C2 lateral lesion (by X-ray or MRI)

Exclusion Criteria:

Patients who are pregnant (patients who are of child bearing potential who are not practicing a reliable contraceptive method (oral, subcutaneous, mechanical, or surgical contraception)
Patients who have contraindicated condition to zoledronic acid such as chronic renal failure (calculated creatinine clearance less than 35.0 ml/min), severe heart disease such as atrial fibrillation, sensitive to bisphosphonates and hypocalcemia (serum calcium less than 8 mg/dl or 2.0 mmol/L)
Patients who have collapsed lesion including subchonral fracture
Patients who have multiple lesion of osteonecrosis of femoral head
Patients who received other kinds of bisphophonates or anabolic agents before zoledronic acid use
Patients with any medical or psychiatric condition which, in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial per protocol
Patients who are considered potentially unreliable and patients who may not reliably attend study visits
Intervention: Lidocaine Hydrochloride
Trial phase: Not Applicable
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 506
Group description: Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
Eligibility criteria:
Inclusion Criteria:

Patients included are >18 years old, referred to Endoscopy Clinic for an ERCP for any well established indication such as: biliary strictures, benign and malignant hepato-pancreato-biliary tumors, chronic pancreatitis, and suspected sphincter of Oddi dysfunction

Exclusion Criteria:

Known sensitivity to lidocaine or contrast agent
History of seizure disorder
History of cardiac arrhythmia (tachyarrhythmia, bradyarrhythmia, cardiac conduction defects, prolonged QT syndrome)
History of congestive heart failure
Active acute pancreatitis before procedure
Planned biliary stent removal without pancreatogram
Pregnancy
Incarcerated individuals
Less than 18 years of age
Previous sphincterotomy
Inability to give informed consent
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: eslicarbazepine acetate : once-daily oral tablet
Eligibility criteria:
Inclusion Criteria:

written informed consent signed by patient
aged 18 years or more
documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening
at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified)
excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests
post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method)

Exclusion Criteria:

only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures) that are not video-EEG documented
primarily generalised epilepsy
known rapid progressive neurological disorder; history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening
seizures of psychogenic origin within the last 2 years
history of schizophrenia or suicide attempt
currently on or with exposure to felbamate or oxcarbazepine more within one month of screening
using benzodiazepines on more than on an occasional basis (except when used chronically as AED)
previous use of ESL or participation in a clinical study with ESL
known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances
history of abuse of alcohol, drugs or medications within the last 2 years
uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder
second or third-degree atrioventricular blockade not corrected with a pacemaker
relevant clinical laboratory abnormalities
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 98
Group description: eslicarbazepine acetate : once-daily oral tablet
Eligibility criteria:
Inclusion Criteria:

written informed consent signed by patient
aged 18 years or more
documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening
at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified)
excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests
post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method)

Exclusion Criteria:

only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures) that are not video-EEG documented
primarily generalised epilepsy
known rapid progressive neurological disorder; history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening
seizures of psychogenic origin within the last 2 years
history of schizophrenia or suicide attempt
currently on or with exposure to felbamate or oxcarbazepine more within one month of screening
using benzodiazepines on more than on an occasional basis (except when used chronically as AED)
previous use of ESL or participation in a clinical study with ESL
known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances
history of abuse of alcohol, drugs or medications within the last 2 years
uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder
second or third-degree atrioventricular blockade not corrected with a pacemaker
relevant clinical laboratory abnormalities
Intervention: Sonidegib
Trial phase: Phase 2
ATC code: L01XJ02
SMILES: [H][C@]1(C)CN(c2ccc(NC(=O)c3cccc(-c4ccc(OC(F)(F)F)cc4)c3C)cn2)C[C@@]([H])(C)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

- Patients with multiple basal cell carcinomas and Gorlin syndrome, or patients with multiple basal cell carcinomas and a mutation in the PTCH1 gene at chromosome 9q22.3

Exclusion Criteria:

Previous treatment of the BCC's that are selected for treatment.
Any systemic treatment which is known to affect BCCs esp. cytostatic treatments, retinoids and photodynamic treatments.

Other protocol defined Incl./Excl. criteria may apply.
Intervention: Dantrolene
Trial phase: Phase 1 | Phase 2
ATC code: M03CA01
SMILES: O=C1CN(N=Cc2ccc(-c3ccc([N+](=O)[O-])cc3)o2)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
Eligibility criteria:
Inclusion Criteria:

Participants with aneurysmal SAH admitted to the Massachusetts General Hospital NeuroICU (Blake 12) and undergoing standard-of-care daily transcranial doppler (TCD).
Participants with unilateral or bilateral anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA), or basilar artery vasospasm as defined by the following TCD criteria
a >50% mean velocity increase from the baseline mean TCD velocity (baseline is the first TCD measurement, usually within 24hrs of admission), or
peak systolic TCD velocities of 200 cm/s or higher in the MCA or ACA (for MCA with a concurrent ipsilateral LR of 3.0 or higher), or peak systolic TCD velocities of 120 cm/s or higher in the PCA or basilar artery, or
any daily 100 cm/s peak systolic TCD velocity increase from the previous day, or
any longitudinal mean TCD velocity increase of 80 cm/s or more

Exclusion Criteria:

Inability to obtain consent from patient or health care proxy
Age < 18 years
Pregnancy
Traumatic SAH
Known allergy to dantrolene
Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT >165 Units/L, AST >120 Units/L, alkaline phosphatase >345 Units/L (three times upper limit of normal)
Participants on verapamil
Intervention: Dantrolene
Trial phase: Phase 1 | Phase 2
ATC code: M03CA01
SMILES: O=C1CN(N=Cc2ccc(-c3ccc([N+](=O)[O-])cc3)o2)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Eligibility criteria:
Inclusion Criteria:

Participants with aneurysmal SAH admitted to the Massachusetts General Hospital NeuroICU (Blake 12) and undergoing standard-of-care daily transcranial doppler (TCD).
Participants with unilateral or bilateral anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA), or basilar artery vasospasm as defined by the following TCD criteria
a >50% mean velocity increase from the baseline mean TCD velocity (baseline is the first TCD measurement, usually within 24hrs of admission), or
peak systolic TCD velocities of 200 cm/s or higher in the MCA or ACA (for MCA with a concurrent ipsilateral LR of 3.0 or higher), or peak systolic TCD velocities of 120 cm/s or higher in the PCA or basilar artery, or
any daily 100 cm/s peak systolic TCD velocity increase from the previous day, or
any longitudinal mean TCD velocity increase of 80 cm/s or more

Exclusion Criteria:

Inability to obtain consent from patient or health care proxy
Age < 18 years
Pregnancy
Traumatic SAH
Known allergy to dantrolene
Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT >165 Units/L, AST >120 Units/L, alkaline phosphatase >345 Units/L (three times upper limit of normal)
Participants on verapamil
Intervention: Losmapimod
Trial phase: Phase 2
SMILES: Cc1c(F)cc(C(=O)NC2CC2)cc1-c1ccc(C(=O)NCC(C)(C)C)cn1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Adult subjects with primary diagnosis of moderate to severe MDD without psychotic features, for at least 4 weeks and one previous MDD episode
Males or Females who agree to use protocol specified contraception if of child bearing potential
BMI 18.5-35.0 kg/m2
Normal liver function tests

Key Exclusion Criteria:

History of liver disease or positive hepatitis B surface antigen or hepatitis C antibody in the last 3 months
Elevated liver function tests on >2 ocassions in the last 7 months
Significant medical illness, autoimmune disease or infectious disease
Pregnant or nursing females
Excessive and regular alcohol consumption
History of substance abuse or dependence in past 6 months or positive urine drug screen
Significant suicidal or homicidal risk
Currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid
Psychoactive drugs within 1 week or 5 half lives of randomization visit
Treatment resistant subjects
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Eslicarbazepine acetate 1200 mg once daily

Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Eligibility criteria:
Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
Participation in a clinical study within 3 months prior to screening
Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: Eslicarbazepine 600 mg twice daily

Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Eligibility criteria:
Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
Participation in a clinical study within 3 months prior to screening
Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial