anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Midazolam
Trial phase: Phase 3
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Eligibility criteria:
Inclusion Criteria:

Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes

Has an established diagnosis of partial or generalized epilepsy that includes all the following:

A documented history of seizure clusters lasting a minimum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
A second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition
A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures
A seizure cluster pattern established >3 months before Visit 1
A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1
At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1
Currently on a stable regimen of AED(s) that includes a benzodiazepine
Weight is 40 kg to 125 kg, inclusive

Exclusion Criteria:

Has a neurological disorder that is likely to progress in the next year
Has a severe chronic cardio-respiratory disease
Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1
Has a history of acute narrow-angle glaucoma
Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years
Intervention: Ropivacaine
Trial phase: Phase 3
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg).

Ropivacaine: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block
Eligibility criteria:
Inclusion Criteria:

Be Female aged 18-100 years.
Choose mastectomy followed by bilateral immediate tissue expander breast reconstruction.
Have no inflammatory breast cancers.
Be aware of the nature of her malignancy.
Understand the study purpose, requirements, and risks.
Be able and willing to give informed consent.

Exclusion Criteria:

Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible).
Liver dysfunction and/ or cirrhosis.
Renal insufficiency, with creatinine greater than 1.5 mg/mL.
Patients weighing less than 50 Kg.
Concurrent use of the SSRI antidepressant fluvoxamine (Luvox).
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner.

Saline: Up to 0.8 mL/kg of normal saline administered
Eligibility criteria:
Inclusion Criteria:

Be Female aged 18-100 years.
Choose mastectomy followed by bilateral immediate tissue expander breast reconstruction.
Have no inflammatory breast cancers.
Be aware of the nature of her malignancy.
Understand the study purpose, requirements, and risks.
Be able and willing to give informed consent.

Exclusion Criteria:

Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible).
Liver dysfunction and/ or cirrhosis.
Renal insufficiency, with creatinine greater than 1.5 mg/mL.
Patients weighing less than 50 Kg.
Concurrent use of the SSRI antidepressant fluvoxamine (Luvox).
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 99
Group description: 1% lidocaine intradermal injection

1% lidocaine
Eligibility criteria:
Inclusion Criteria:

adult patients (aged 18 or older)
admitted to a general medical or surgical unit at Durham Regional Hospital (DRH)
have a physician's order for an IV
are able to speak, read and understand English
referred to the Vascular Access Specialty Team (VAST) at DRH for IV catheterization

Exclusion Criteria:

admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit, an intensive care unit, a pre- or postnatal care unit, or labor and delivery units;
history of a psychological disorder, as determined from the patient's chart;
history of peripheral neuropathy, as determined by patient's chart;
history of IV drug abuse, as determined from the patient's chart;
decreased sensation in the arm or hands, as reported in the chart or by the patient;
patient disorientation or confusion (i.e., unable to state person, place, time or unable to comprehend instructions for completing Visual Analog Scale);
a known allergy to lidocaine or benzyl alcohol as determined from the patient's chart;
veins that cannot be palpated and are difficult to visualize by VAST nurses;
pregnancy;
an order for the emergency insertion of an IV by the patient's doctor or assigned nurse;
an IV insertion that requires the use of a catheter gauged 18 or larger
severe vision impairment, as determined by the patient's inability to read the Visual Analogue Scale
Intervention: Prednisolone
Trial phase: Not Applicable
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: Male
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 28
Group description: Systemic high-dose steroids (30 mg/kg methylprednisolone) have been shown in a randomized, double-blind, placebo-controlled trial in humans not to negatively impact wound infection or dehiscence rates, instead benefitting patients in the postoperative period in ways such as decreasing pain. An acute course of oral systemic steroids has been routinely used in patients under the age of 12 with asthma exacerbations (liquid prednisolone at 1-2 mg/kg/day in 1-2 divided doses for up to 10 days, although usually given for 5 days, which is at least 19 times less than the dose proven to be safe in the randomized controlled trial mentioned above) and proven to be safe without adverse effects. Effect of prednisolone on the systemic response and wound healing after colonic surgery.

Prednisolone: In order to analyze the data, we will establish a chart which will show the degree of cosmetic appearance, incidences and degree of complications. This we be assessed on a mild to severe scale.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing proximal hypospadias repair

Exclusion Criteria:

All patients currently taking steroids at the time of surgery or during the six-week recovery period as well as patients with betamethasone hypersensitivity will be excluded from the study. Selection will be based on parent willingness to allow the child to participate in the study.
Intervention: Gabapentin
Trial phase: Phase 2
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 1800-2400mg/day divided tid or qid, orally.

Gabapentin
Eligibility criteria:
Inclusion Criteria:

Have received at least 2 administrations of intravenous (iv) hydration separated by at least 1 week or daily emesis for at least the last 14 days and 1 administration of iv hydration.
Have at least one of the following: 2-4+ ketonuria, serum potassium < 3.4mmol, or >5% weight loss from weight upon entry to prenatal care.
Have failed therapy with at least one antiemetic.
Have fetal ultrasound within 6 weeks prior to enrollment confirming a normal-appearing, intrauterine, singleton pregnancy of gestational age < 16 weeks at time of enrollment.
Felt by the patient's obstetrician or emergency room attending physician not to have other medical problems such as bowel obstruction, pancreatitis, biliary colic, or peptic ulcer disease that could be contributing to the patient's symptoms.
Be >18 years old and not decided to terminate the pregnancy.
Have not received or planning to receive a peripherally inserted central catheter (PIC line).
Have a Motherisk-PUQE score of ≥12 for the 24-hour Baseline period.
Felt not to have any other significant medical, psychiatric or substance abuse problem that would preclude participation in the study.
Denies drinking any alcohol after learning about current pregnancy.
Agrees to discontinue any current anti-emetic treatments (including antihistamines, ginger, > 10mg/day vitamin B6, serotonin or dopamine antagonists, anticholinergics, acupuncture, hypnosis, or wrist bands) for the next 4 weeks.
Pregnancy not conceived through in-vitro fertilization.
Able to understand and comply with the study procedures and give informed consent.

Exclusion Criteria:

None not mentioned under Inclusion Criteria.
Intervention: Metoclopramide
Trial phase: Phase 2
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: 45-60mg/day divided tid or qid, orally

Metoclopramide
Eligibility criteria:
Inclusion Criteria:

Have received at least 2 administrations of intravenous (iv) hydration separated by at least 1 week or daily emesis for at least the last 14 days and 1 administration of iv hydration.
Have at least one of the following: 2-4+ ketonuria, serum potassium < 3.4mmol, or >5% weight loss from weight upon entry to prenatal care.
Have failed therapy with at least one antiemetic.
Have fetal ultrasound within 6 weeks prior to enrollment confirming a normal-appearing, intrauterine, singleton pregnancy of gestational age < 16 weeks at time of enrollment.
Felt by the patient's obstetrician or emergency room attending physician not to have other medical problems such as bowel obstruction, pancreatitis, biliary colic, or peptic ulcer disease that could be contributing to the patient's symptoms.
Be >18 years old and not decided to terminate the pregnancy.
Have not received or planning to receive a peripherally inserted central catheter (PIC line).
Have a Motherisk-PUQE score of ≥12 for the 24-hour Baseline period.
Felt not to have any other significant medical, psychiatric or substance abuse problem that would preclude participation in the study.
Denies drinking any alcohol after learning about current pregnancy.
Agrees to discontinue any current anti-emetic treatments (including antihistamines, ginger, > 10mg/day vitamin B6, serotonin or dopamine antagonists, anticholinergics, acupuncture, hypnosis, or wrist bands) for the next 4 weeks.
Pregnancy not conceived through in-vitro fertilization.
Able to understand and comply with the study procedures and give informed consent.

Exclusion Criteria:

None not mentioned under Inclusion Criteria.
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 3
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.

KPI-121 0.25%: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
Eligibility criteria:
FURTHER STUDY DETAILS PROVIDED BY KALA PHARMACEUTICALS, INC.

Inclusion Criteria:

Candidates for routine, uncomplicated cataract surgery
In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.

Exclusion Criteria:

Known hypersensitivity/contraindication to study product(s) or components.
History of glaucoma, IOP >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 19 days following surgery.
In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 3
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.

KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
Eligibility criteria:
FURTHER STUDY DETAILS PROVIDED BY KALA PHARMACEUTICALS, INC.

Inclusion Criteria:

Candidates for routine, uncomplicated cataract surgery
In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.

Exclusion Criteria:

Known hypersensitivity/contraindication to study product(s) or components.
History of glaucoma, IOP >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 19 days following surgery.
In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
Intervention: Rifaximin
Trial phase: Not Applicable
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: rifaximine
Eligibility criteria:
Inclusion Criteria:

>18y hepatic encephalopathy: positive Conn score

Exclusion Criteria:

<18y pregnancy inability to fulfil questionnaires acute infection unstable clinical condition bone or articular disease resulting in significant disability
Intervention: DEOXYCHOLIC ACID
Trial phase: Phase 3
ATC code: D11AX24
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(C[C@H](O)[C@]4(C)[C@@H]([C@H](C)CCC(=O)O)CC[C@]43[H])[C@@]1(C)CC[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 113
Group description: This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
Eligibility criteria:
Inclusion Criteria:

Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies
Willingness to comply with the schedule and procedures of this study.
Signed informed consent form (ICF).

Exclusion Criteria:

1. Participants who have had any treatment or condition (e.g., pregnancy or metabolic disease, which may lead to unstable weight) that may affect assessment of safety or efficacy since enrollment in the predecessor study.
Intervention: 9-(4-Phenoxyphenyl)-3,4-dihydropyrido(2,1-c)(1,2,4)thiadiazine 2,2-dioxide
Trial phase: Phase 1
SMILES: O=S1(=O)CCN2C=CC=C(c3ccc(Oc4ccccc4)cc3)C2=N1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
Eligibility criteria:
Inclusion Criteria:

Is a male or female adult who is 18 to 55 years of age, inclusive.
Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
Has a documented diagnosis of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 1 year.
Is willing to discontinue all medications to treat adult ADHD (eg, stimulants, antidepressants) and all other medications and dietary products as specified in the protocol, from Day -7 until Follow-up phone call (Day 14).

Exclusion Criteria:

Has received any investigational compound within 30 days prior to the first dose of study medication.
Has uncontrolled, clinically significant neurologic (including mildly abnormal or significantly abnormal EEG at screening), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder (other than ADHD), or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
Has a positive urine drug result for drugs of abuse other than amphetamines or other medications to treat ADHD or positive result for alcohol at Screening or Check-in (Day -1).
Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products.
Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1).
Intervention: 9-(4-Phenoxyphenyl)-3,4-dihydropyrido(2,1-c)(1,2,4)thiadiazine 2,2-dioxide
Trial phase: Phase 1
SMILES: O=S1(=O)CCN2C=CC=C(c3ccc(Oc4ccccc4)cc3)C2=N1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
Eligibility criteria:
Inclusion Criteria:

Is a male or female adult who is 18 to 55 years of age, inclusive.
Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
Has a documented diagnosis of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 1 year.
Is willing to discontinue all medications to treat adult ADHD (eg, stimulants, antidepressants) and all other medications and dietary products as specified in the protocol, from Day -7 until Follow-up phone call (Day 14).

Exclusion Criteria:

Has received any investigational compound within 30 days prior to the first dose of study medication.
Has uncontrolled, clinically significant neurologic (including mildly abnormal or significantly abnormal EEG at screening), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder (other than ADHD), or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
Has a positive urine drug result for drugs of abuse other than amphetamines or other medications to treat ADHD or positive result for alcohol at Screening or Check-in (Day -1).
Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products.
Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1).
Intervention: 9-(4-Phenoxyphenyl)-3,4-dihydropyrido(2,1-c)(1,2,4)thiadiazine 2,2-dioxide
Trial phase: Phase 1
SMILES: O=S1(=O)CCN2C=CC=C(c3ccc(Oc4ccccc4)cc3)C2=N1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
Eligibility criteria:
Inclusion Criteria:

Is a male or female adult who is 18 to 55 years of age, inclusive.
Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
Has a documented diagnosis of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 1 year.
Is willing to discontinue all medications to treat adult ADHD (eg, stimulants, antidepressants) and all other medications and dietary products as specified in the protocol, from Day -7 until Follow-up phone call (Day 14).

Exclusion Criteria:

Has received any investigational compound within 30 days prior to the first dose of study medication.
Has uncontrolled, clinically significant neurologic (including mildly abnormal or significantly abnormal EEG at screening), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder (other than ADHD), or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
Has a positive urine drug result for drugs of abuse other than amphetamines or other medications to treat ADHD or positive result for alcohol at Screening or Check-in (Day -1).
Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products.
Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1).