anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bupivacaine
Trial phase: Phase 2
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: Upon completion of the operation for a period of 72 hours will be implemented continuous epidural local anesthetic through the Patient Controlled Analgesia (PCA) pump (Levobupivacaine 0.125%, basal flow of 6 ml / hour, a bolus dose of 2 ml, lockout interval of 20 minutes, hour limit of 3 doses).

levobupivacaine
Eligibility criteria:
Inclusion Criteria:

patients age 65 and over
fracture of the proximal femur
preoperative assessment American Society of Anesthesiologists(ASA) score I - ASA III
a written consent of the patient to participate in research

Exclusion Criteria:

patient non-compliance
ASA status IV and IV above
patients younger than 65 years
dementia, Parkinson's disease, cerebrovascular accident history; simultaneous head injuries,the use of opioids and benzodiazepines longer than a month before the surgery; alcoholism; serious liver disease (class C according to Child-Pugh's classification); severe kidney disease that require dialysis
result of MMSE test (Mini-Mental State Examination) under 17
the existence of any contraindications for the implementation of regional anesthesia and one or other form of post-operative analgesia.
Intervention: Suvorexant
Trial phase: Phase 4
ATC code: N05CJ01 | N05CM19
SMILES: [H][C@@]1(C)CCN(c2nc3cc(Cl)ccc3o2)CCN1C(=O)c1cc(C)ccc1-n1nccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks

suvorexant: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
Eligibility criteria:
Inclusion Criteria:

[At interim registration]

Patients who meet the following criteria are eligible for the study:

Patients who give written consent of agreement to voluntarily participation in the clinical study
Age 20 years or older
Sex: Male or female
Treatment classification: Outpatient

Hypertensive patient who meet at least one of the following:

Under antihypertensive medications
Clinic systolic blood pressure (SBP) less than 160 mmHg

Patients with insomnia who meet at least one of the following:

Patients with any one of the following symptoms twice a week or more and at least 1 month-continuation: difficulty initiating sleep (time to sleep onset 2 hours or more longer than usual), difficulty maintaining sleep (awakening twice or more in the night), early morning awakening (awakening 2 hours or more earlier in the morning than usual), difficulty sleeping deeply (no soundly asleep feeling at the time of awakening in the morning).

b. Patients with interference with social or occupational function due to the above insomnia symptoms

[At official registration]

Patients who meet the following criteria at the end of run-in period are eligible for the study:

Stable unchanged antihypertensive medication for run-in period.
Average morning home SBP more than 135 mmHg during 5 days before the end of run-in period.

Exclusion Criteria:

Patients with serious liver disease.
Patients with serious respiratory disease.
Patients with secondary hypertension
Patients with sleep apnea syndrome
Patients with history of narcolepsy or cataplexy
Patients with history of organic cerebral disorders
Patients with history of hypersensitivity to suvorexant
Patients received CYP3A strongly-inhibitors including itraconazole, clarithromycin and ritonavir, saquinavir, nelfinavir, indinavir, telaprevir and voriconazole at the start of the run-in period
Patients with average clinic SBP of 160 mmHg or more at the start of the run-in period
Patients received suvorexant and other hypnotic at the start of the run-in period on a regular basis
Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
Patients who are considered not to be eligible for this study by their investigator or sub-investigator
Intervention: Suvorexant
Trial phase: Phase 4
ATC code: N05CJ01 | N05CM19
SMILES: [H][C@@]1(C)CCN(c2nc3cc(Cl)ccc3o2)CCN1C(=O)c1cc(C)ccc1-n1nccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: 10 to 20 mg to be administered after an evening written trauma narrative exposure session.

suvorexant: First in class orexin antagonist approved by the FDA for the treatment of insomnia
Eligibility criteria:
Inclusion Criteria:

- Adult men and women (age 18 or older) who meet the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for PTSD.

Exclusion Criteria:

Medical or psychiatric conditions that require consistent use of medication that affects sleep or psychiatric symptoms, except for hormonal contraceptives
Any persistent medical condition that affects sleep
Inability to remember most details of the index event
Diagnosis of a sleep disorder other than insomnia including polysomnography findings of apnea/hypopnea index > 10/hour
Consumption of more caffeine than 5 cups of coffee/day equivalent
Smoking > 20 cigarettes/day
Habitual bedtimes after 3AM, habitual rise times after 10AM, or average napping > 2 hour/day in a given week
Moderate or severe alcohol use disorder within the past 6 months or moderate or severe drug use disorder within the past year
Positive urine toxicology for illicit drugs including cannabis
A history of psychotic disorders or bipolar disorder
Current depression with history of recurrent depression that precedes exposure to a traumatic event
Suicidal ideation with intent to act or with specific plan and intent in the past 6 months [Type 4 - 5 ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)] or history of a suicide attempt
Completion of exposure-based therapy targeting the index trauma
Pregnancy or breast feeding
Known sensitivity or allergy to an orexin receptor antagonist
Limited ability to read or write English.
Intervention: Humulene
Trial phase: Phase 1 | Phase 2
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 65
Group description: Placebo Cannabis (.02% THC)
Eligibility criteria:
Inclusion Criteria:

Be a licensed driver.
Need to have acuity of 20/40 or better, with or without correction on a Snellen Visual Acuity eye chart.

Exclusion Criteria:

At the discretion of the examining physician, individuals with significant cardiovascular, hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (eg, asthma, COPD) will be excluded.
Unwillingness to abstain from cannabis for 2 days prior to screening and experimental visits
Positive pregnancy test
A positive result on toxicity screening for cocaine, amphetamines, opiates, and phencyclidine (PCP) will exclude individuals from participation.
Unwilling to refrain from driving or operating heavy machinery for four hours after consuming study medication.
Intervention: Humulene
Trial phase: Phase 1 | Phase 2
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 70
Group description: Cannabis with 5.9% THC, smoked ad libitum
Eligibility criteria:
Inclusion Criteria:

Be a licensed driver.
Need to have acuity of 20/40 or better, with or without correction on a Snellen Visual Acuity eye chart.

Exclusion Criteria:

At the discretion of the examining physician, individuals with significant cardiovascular, hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (eg, asthma, COPD) will be excluded.
Unwillingness to abstain from cannabis for 2 days prior to screening and experimental visits
Positive pregnancy test
A positive result on toxicity screening for cocaine, amphetamines, opiates, and phencyclidine (PCP) will exclude individuals from participation.
Unwilling to refrain from driving or operating heavy machinery for four hours after consuming study medication.
Intervention: Humulene
Trial phase: Phase 1 | Phase 2
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 64
Group description: Cannabis with 13.4% THC, smoked ad libitum
Eligibility criteria:
Inclusion Criteria:

Be a licensed driver.
Need to have acuity of 20/40 or better, with or without correction on a Snellen Visual Acuity eye chart.

Exclusion Criteria:

At the discretion of the examining physician, individuals with significant cardiovascular, hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (eg, asthma, COPD) will be excluded.
Unwillingness to abstain from cannabis for 2 days prior to screening and experimental visits
Positive pregnancy test
A positive result on toxicity screening for cocaine, amphetamines, opiates, and phencyclidine (PCP) will exclude individuals from participation.
Unwilling to refrain from driving or operating heavy machinery for four hours after consuming study medication.
Intervention: Lidocaine
Trial phase: Not Applicable
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: 17
Group description: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.

At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.

Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.

At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.
Eligibility criteria:
Inclusion Criteria:

ASA I-III subjects
Ages 18-80 years
Weight between 60 and 110 Kg
At least 60in (152cm) tall
Scheduled for elective open colonic surgery at UPMC Presbyterian Shadyside Hospital in Pittsburgh, Pennsylvania

Exclusion Criteria:

Age younger than 18 years or older than 80 years
Any contraindication to the placement of bilateral thoracic paravertebral catheters
American Society of Anesthesiologists physical status IV or greater
Chronic painful conditions
Preoperative opioid use
Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
Allergy to any of the drugs/agents used study protocol
Personal or family history of malignant hyperthermia
Serum creatinine greater than 1.3 g/dl
Pregnancy
Having an altered mental status (not oriented to place, person, or time)
Emergency surgery and those with sepsis, unstable angina, congestive heart disease, valvular heart disease, and severe COPD
Patient's inability to provide adequate informed consent
Non-english speaking
Patient refusal
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.

Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.

Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.
Eligibility criteria:
Inclusion Criteria:

ASA I-III subjects
Ages 18-80 years
Weight between 60 and 110 Kg
At least 60in (152cm) tall
Scheduled for elective open colonic surgery at UPMC Presbyterian Shadyside Hospital in Pittsburgh, Pennsylvania

Exclusion Criteria:

Age younger than 18 years or older than 80 years
Any contraindication to the placement of bilateral thoracic paravertebral catheters
American Society of Anesthesiologists physical status IV or greater
Chronic painful conditions
Preoperative opioid use
Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
Allergy to any of the drugs/agents used study protocol
Personal or family history of malignant hyperthermia
Serum creatinine greater than 1.3 g/dl
Pregnancy
Having an altered mental status (not oriented to place, person, or time)
Emergency surgery and those with sepsis, unstable angina, congestive heart disease, valvular heart disease, and severe COPD
Patient's inability to provide adequate informed consent
Non-english speaking
Patient refusal
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks

Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Eligibility criteria:
Inclusion Criteria:

Age 18 years and older.
Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the last week).

Exclusion Criteria:

Patients already on topical or systemic steroids.
Inability to comply with study instructions.
Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
VAS sensitivity score < 7.
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks

Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Eligibility criteria:
Inclusion Criteria:

Age 18 years and older.
Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the last week).

Exclusion Criteria:

Patients already on topical or systemic steroids.
Inability to comply with study instructions.
Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
VAS sensitivity score < 7.
Intervention: Primaquine
Trial phase: Phase 2
ATC code: P01BA03
SMILES: COc1cc(NC(C)CCCN)c2ncccc2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 50
Group description: Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).

Primaquine: 50 patients will receive primaquine
Eligibility criteria:
Inclusion Criteria:

Weight ≥ 6 kg
Uncomplicated malaria caused by P. falciparum
Asexual parasites ≥ 2 000/µl and ≤ 100 000/µl
Axillary temperature ≥ 37.5°C or a history of fever during the last 24 hours
Burkinabe nationality
Permanent residence in the study area with no intention of leaving during the surveillance period
Written informed consent of parents or care takers

Exclusion Criteria:

Severe malaria
Mixed malaria infection
Vomiting (>2 times within 24 hours before the visit)
Any apparent significant disease, including severe malnutrition
A history of a previous, significant adverse reaction or known allergy to one or more of the study drugs
Anaemia (haemoglobin < 7 g/dl)
Treated in the same trial before
All modern antimalarial treatment prior to inclusion (last seven days)
Therapy with serotonin reuptake inhibitors (e.g. citalopram, escitalopram, fluoxetine, Paroxetine, Sertraline)
Simultaneous participation in another investigational study
Patients with known HIV/AIDS disease
Therapy with drugs known to inhibit the liver enzymes cytochrome 2A6 (e.g. methoxsalen, pilocarpine, tranylcypromine) and/or cytochrome 2C8 (e.g. trimethoprim, ketoconazole, ritonavir, saquinavir, lopinavir, gemfibrozil, montelukast)
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 15
Group description: Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)

Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose

Morphine Maintenance/Escalation

Maintain dose if score 0-8
Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
Increase score by 0.06 if score 17-20

Weaning Instructions:

Maintain on dose 48 hrs before starting weaning
Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12

Re-escalation

If neonate scores 9-12 re-score as described for initiation,
If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc

Morphine: Morphine wean protocol as described in arm description

Adverse events were recorded only for infants of each dyad.
Eligibility criteria:
Inclusion criteria:

Born at University of New Mexico Hospital
Greater than 34 weeks gestation
Primary in-utero drug exposure was opioids other than buprenorphine
Maternal or infant urine drug screen positive for methadone and/or opioids on admission

Exclusion criteria:

Born prior to 34 weeks
Neonatal intensive care unit admission
Serious medical comorbidities
Primary substance exposure in-utero was buprenorphine, or was not opioids
Intervention: Lidocaine
Trial phase: Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 72
Group description: Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure

Lidocaine Gel (2%)
Eligibility criteria:
Inclusion Criteria:

Women 18 and older
Intrauterine pregnancy ≥16 weeks gestation
English speaking competency
Willing and able to sign consent forms
Agree to comply with study procedures

Exclusion Criteria:

Women less than 18 years of age
IV conscious sedation
Known allergy to study medication (lidocaine)
Any women not meeting inclusion criteria above will be excluded from participation
Intervention: Varenicline
Trial phase: Phase 2 | Phase 3
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
Eligibility criteria:
Inclusion Criteria:

enrolled in the Comprehensive Opioid Addiction Treatment (COAT) program
report smoking >10 cigarettes per day for >1 year
provide an expired air carbon monoxide (CO) reading of >10 parts/million (ppm)
report interest in making a quit attempt in the next 1-6 months (Contemplation or Preparation stages via the Stage of Change; Prochaska & Diclemente, 1983)
willing to try varenicline for smoking cessation

Exclusion Criteria:

current engagement in any form of tobacco cessation (e.g., pharmacotherapy)
current use of contraindicated medications (e.g., theophylline, warfarin, insulin)
Stage of Change category as Precontemplation (no plans to quit), Action (actively trying to quit), or Maintenance (have already quit)
self-reported seizures in the past year
untreated cardiovascular disease
self-report breast-feeding
pregnancy (verified by urinalysis)
not within 4 weeks of advancing to the next COAT group
Intervention: Varenicline
Trial phase: Phase 2 | Phase 3
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
Eligibility criteria:
Inclusion Criteria:

enrolled in the Comprehensive Opioid Addiction Treatment (COAT) program
report smoking >10 cigarettes per day for >1 year
provide an expired air carbon monoxide (CO) reading of >10 parts/million (ppm)
report interest in making a quit attempt in the next 1-6 months (Contemplation or Preparation stages via the Stage of Change; Prochaska & Diclemente, 1983)
willing to try varenicline for smoking cessation

Exclusion Criteria:

current engagement in any form of tobacco cessation (e.g., pharmacotherapy)
current use of contraindicated medications (e.g., theophylline, warfarin, insulin)
Stage of Change category as Precontemplation (no plans to quit), Action (actively trying to quit), or Maintenance (have already quit)
self-reported seizures in the past year
untreated cardiovascular disease
self-report breast-feeding
pregnancy (verified by urinalysis)
not within 4 weeks of advancing to the next COAT group