anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Humulene
Trial phase: Phase 1
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer
Eligibility criteria:
Inclusion Criteria:

Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission
Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
Have a body mass index (BMI) in the range of 19 to 36 kg/m2
Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
Report prior experience inhaling cannabis (either via smoking or vaporization).

Exclusion Criteria:

History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
Use of an Over-the-Counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of hemp seeds or hemp oil in any form in the past 3 months.
Use of dronabinol (Marinol) within the past 6 months.
History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Abnormal EKG result that in the investigator's opinion is clinically significant.
Epilepsy or a history of seizures.
Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing
Intervention: Humulene
Trial phase: Phase 1
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
Eligibility criteria:
Inclusion Criteria:

Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission
Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
Have a body mass index (BMI) in the range of 19 to 36 kg/m2
Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
Report prior experience inhaling cannabis (either via smoking or vaporization).

Exclusion Criteria:

History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
Use of an Over-the-Counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of hemp seeds or hemp oil in any form in the past 3 months.
Use of dronabinol (Marinol) within the past 6 months.
History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Abnormal EKG result that in the investigator's opinion is clinically significant.
Epilepsy or a history of seizures.
Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.

Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
Eligibility criteria:
Inclusion Criteria:

Women age 18+
English-speaking
Planning to undergo a vaginal SSLF

Exclusion Criteria:

Pregnant or planning to become pregnant during study participation
Prior vaginal mesh surgery for pelvic organ prolapse
Planning a concurrent total vaginal hysterectomy, colpocleisis (total vaginectomy or LeFort colpocleisis), mesh excision, anal sphincteroplasty, fistula repair, or urethral diverticulectomy
Cognitive impairment (indicated by a score of 0-2 on Mini-Cog)
Currently taking gabapentin or pregabalin (Lyrica) or previous intolerance to gabapentin or pregabalin
Daily use of narcotics for ≥ 2 months
Acute or chronic renal failure based on past medical history (PMH) or glomerular filtration rate (GFR) < 30ml/min (see meds info below)
Severe uncontrolled depression or bipolar disease based on PMH
Fall risk if history of fall in last year or current use of cane/walker
Intervention: Rifaximin
Trial phase: Phase 3
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: 36
Group description: Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.

Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18 years.
Patients with dyspeptic symptoms, ie pain or discomfort (including abdominal bloating, early satiety and bloating) centered on the upper abdomen, persistent or recurrent, with proven H. pylori infection (through testing breath or gastric biopsy based methods, if it has been done) with a validity period of one year.

Having been previously prescribed by routine clinical practice the standard triple therapy as eradication treatment:

Proton Pump Inhibitor. Omeprazole 40 mg (or equivalent) every 12 hours. Treatment duration: 10 days.
Clarithromycin. Dose: 500 mg every 12 hours. Treatment duration: 10 days.
Amoxicillin. Dose: 1000 mg every 12 hours. Treatment duration: 10 days.
Not having yet begun taking the eradication therapy.
Written informed consent from the patient.
The first five patients included in the study, should had cited from the outpatient and prior to his arrival in consultation, a routine analysis in the month after the completion of the eradication therapy.
If the patient is a woman of childbearing age, she will be asked to commit to not get pregnant or to use an adequate contraception method.

Exclusion Criteria:

Previous eradication treatment for H. pylori (these patients are often carriers of antibiotic resistant strains and have a much lower response than those that had never received treatment).
Allergy to any of the antibiotic in the treatment.
Taking antibiotics or bismuth salts since performing the breath test.
Previous gastric surgery.
Presence of severe pulmonary, hepatic, renal, endocrine, metabolic, hematologic or tumor disease.
Very advanced chronic disease or other conditions that prevent attending to controls and follow ups.
Previous history of alcohol or drugs abuse.
Patients who are pregnant or lactating.
Intervention: Danicopan
Trial phase: Phase 2
ATC code: L04AJ09
SMILES: CC(=O)c1nn(CC(=O)N2C[C@H](F)C[C@H]2C(=O)Nc2cccc(Br)n2)c2ccc(-c3cnc(C)nc3)cc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants received 100 mg of danicopan TID during the Treatment Period.
Eligibility criteria:
Key Inclusion Criteria:

Must have had clinical diagnosis of C3G (C3 glomerulonephritis or dense deposit disease, the 2 types of C3G) or idiopathic IC-MPGN by renal biopsy for at least 3 months prior to dosing, with the pathologic diagnosis verified by a review of the renal biopsy by the study central pathologist
C3 must have been <50% of the lower limit of normal
C4 complement protein (C4) must have been >90% of the lower limit of normal
Must have been willing to comply with study-specific vaccination requirements for Haemophilus influenzae, Streptococcus pneumoniae, and Neisseria meningitidis strains A, C, W, and Y
Negative pregnancy test for females prior to dosing and throughout the study

Key Exclusion Criteria:

History of a major organ transplant (for example, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. Individuals receiving renal replacement therapy were also excluded
Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G or IC-MPGN may have been secondary
Estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) <45 milliliters/minute/1.73 square meters at the time of Screening or at any time over the preceding 4 weeks
Receipt of eculizumab at any dose or interval within the past 75 days prior to dosing
Use of tacrolimus or cyclosporine within 2 weeks of the first dose of danicopan
History of febrile illness, a body temperature >38°Celsius, or other evidence of a clinically significant active infection, within 14 days prior to study drug administration
History of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection
Females who were pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration or participants with a female partner who was pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration
Intervention: Danicopan
Trial phase: Phase 2
ATC code: L04AJ09
SMILES: CC(=O)c1nn(CC(=O)N2C[C@H](F)C[C@H]2C(=O)Nc2cccc(Br)n2)c2ccc(-c3cnc(C)nc3)cc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants received not more than 200 mg of danicopan TID during the Treatment Period.
Eligibility criteria:
Key Inclusion Criteria:

Must have had clinical diagnosis of C3G (C3 glomerulonephritis or dense deposit disease, the 2 types of C3G) or idiopathic IC-MPGN by renal biopsy for at least 3 months prior to dosing, with the pathologic diagnosis verified by a review of the renal biopsy by the study central pathologist
C3 must have been <50% of the lower limit of normal
C4 complement protein (C4) must have been >90% of the lower limit of normal
Must have been willing to comply with study-specific vaccination requirements for Haemophilus influenzae, Streptococcus pneumoniae, and Neisseria meningitidis strains A, C, W, and Y
Negative pregnancy test for females prior to dosing and throughout the study

Key Exclusion Criteria:

History of a major organ transplant (for example, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. Individuals receiving renal replacement therapy were also excluded
Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G or IC-MPGN may have been secondary
Estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) <45 milliliters/minute/1.73 square meters at the time of Screening or at any time over the preceding 4 weeks
Receipt of eculizumab at any dose or interval within the past 75 days prior to dosing
Use of tacrolimus or cyclosporine within 2 weeks of the first dose of danicopan
History of febrile illness, a body temperature >38°Celsius, or other evidence of a clinically significant active infection, within 14 days prior to study drug administration
History of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection
Females who were pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration or participants with a female partner who was pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration
Intervention: Betamethasone
Trial phase: Phase 4
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: 63
Group description: Dexamethasone 8 mg pre-operative

Dexamethasone: pre-operative intravenous administration
Eligibility criteria:
Inclusion Criteria:

planned unilateral mastectomy with or without axillary dissection or sentinel node in the study period
informed signed consent

Exclusion Criteria:

Chronic/ongoing use of glucocorticoids (except inhalation therapy)
ongoing use of immunosuppressive therapy
insulin dependent diabetes
pregnancy/breastfeeding
allergies toward study medication, or medication in a standard treatment
contralateral surgery (lumpectomy/mastectomy) at time of mastectomy
surgery cannot be performed
Intervention: Betamethasone
Trial phase: Phase 4
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: 64
Group description: Dexamethasone 24 mg pre-operative

Dexamethasone: pre-operative intravenous administration
Eligibility criteria:
Inclusion Criteria:

planned unilateral mastectomy with or without axillary dissection or sentinel node in the study period
informed signed consent

Exclusion Criteria:

Chronic/ongoing use of glucocorticoids (except inhalation therapy)
ongoing use of immunosuppressive therapy
insulin dependent diabetes
pregnancy/breastfeeding
allergies toward study medication, or medication in a standard treatment
contralateral surgery (lumpectomy/mastectomy) at time of mastectomy
surgery cannot be performed
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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Each subject was injected intraorally with Buffered 1% Lidocaine (with 1/100,00 epinephrine) to block the Inferior alveolar, Lingual, and Buccal nerves. Mandibular molar and canine tested for pulpal anesthesia.
Eligibility criteria:
Inclusion Criteria:

Age 18-30 years American Society Anesthesiologists I,II

Exclusion Criteria:

Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms in teeth or oral mucosa
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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Each subject was injected intraorally with Non-buffered 1% Lidocaine (with 1/100,00 epinephrine) to block the Inferior alveolar, Lingual and Buccal nerves. Mandibular molar and canine tested for pulpal anesthesia.
Eligibility criteria:
Inclusion Criteria:

Age 18-30 years American Society Anesthesiologists I,II

Exclusion Criteria:

Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms in teeth or oral mucosa
Intervention: Bosutinib
Trial phase: Phase 2
ATC code: L01EA04
SMILES: COc1cc(Nc2c(C#N)cnc3cc(OCCCN4CCN(C)CC4)c(OC)cc23)c(Cl)cc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of CP CML of ≤6 months (from initial diagnosis); Diagnosis of CP CML with molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic assessment for Ph is not required for enrollment; however, patients with known Ph- CML prior to registration are not eligible for this study)
Age ≥20 years
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Adequate Liver and Renal Function

Exclusion Criteria:

Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea treatment, which is permitted for up to 6 months prior to registration
Any past or current CNS involvement, including leptomeningeal leukemia
Extramedullary disease only
Major surgery or radiotherapy within 14 days prior to registration
History of clinically significant or uncontrolled cardiac disease
Patients with active, uncontrolled bacterial, fungal, or viral infection
Recent or ongoing clinically significant GI disorder
History of another malignancy within 5 years prior to registration
Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the QT interval
Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations
Participation in other studies involving investigational drug(s) within 30 days or 5 half-lives of investigational product, whichever is longer, prior to registration and/or during study participation
Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study
Intervention: Nifedipine
Trial phase: Not Applicable
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Participants will be given this medication orally

Nifedipine: Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours.
Eligibility criteria:
Inclusion Criteria:

Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 140 weeks by gestational age (see dating below) is acceptable.
Gestational age at randomization between 240 weeks to 315 weeks by using the dating determinations as below

Preterm labor with intact membranes. Preterm labor is defined as at least 6 regular uterine contractions in 60 minutes either seen on tocodynamometer, palpated by health providers and/or subjectively felt by the patient and at least one of the following:

Associated with cervical change by cervical dilation greater than or equal to 1cm OR effacement greater than or equal to 25 to 50%
Cervix greater than or equal to 2cm dilated on initial digital exam
At least 75% effaced on initial digital exam
Short cervical length (defined by each institution's policy) as obtained by transvaginal cervical sonography [in general, this is defined as a measurement of 2.0 - 2.5 cm or less] and/or a positive fetal fibronectin test (defined as a level greater than 50ng/mL).
Intact membranes
18 years of age or older

Exclusion Criteria:

Fetal demise, or known major fetal anomaly, including cardiac anomaly and hydrops
Maternal contraindication to nifedipine: preload cardiac lesions or maternal hypotension (systolic blood pressure less than 100 or diastolic blood pressure less than 60). A delayed dose can be given if blood pressure improves - it will be documented if dose is delayed, how long from scheduled dose it was delayed and reason for delay.
Maternal contraindication to indomethacin: platelet dysfunction or bleeding disorders, hepatic dysfunction, gastrointestinal ulcerative disease, renal dysfunction and asthma
Obstetrical contraindication to tocolysis not already mentioned: non reassuring fetal status, severe preeclampsia or eclampsia, maternal bleeding with hemodynamic instability, chorioamnionitis, preterm premature rupture of membranes
Participation in another interventional study that influences neonatal morbidity or mortality
Participation in this trial earlier in the pregnancy
Maternal allergy to either indomethacin or nifedipine
Maternal allergy to aspirin and other NSAIDs.
Maternal hypertension requiring treatment.
Maternal kidney disorder that would require adjustment in magnesium dosing.