anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 3
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 103
Group description: 100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
Eligibility criteria:
Inclusion Criteria:

Male or female equal or greater than 18 years of age at Screening
Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.
Scheduled to undergo 2-or3-column excisional hemorrhoidectomy
American Society of Anesthesiology (ASA) Physical Class 1-4
Able and willing to complete with all study visits and procedures
Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments
Willing and capable of provide written informed consent.

Exclusion Criteria:

Pregnant, nursing or planning to become pregnant during the study period
Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.
Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.
Single-column hemorrhoidectomy
Body weight less than 50 kg (110 pounds)
History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine)
contraindication to epinephrine
contraindication to any of the pain-control agents planned for postoperative use
Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration
History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years.
Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance.
Significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial.
Any clinically significant event or condition uncovered during surgery
A cumulative incision length less than 3 cm
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
Eligibility criteria:
Inclusion Criteria:

Male or female equal or greater than 18 years of age at Screening
Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.
Scheduled to undergo 2-or3-column excisional hemorrhoidectomy
American Society of Anesthesiology (ASA) Physical Class 1-4
Able and willing to complete with all study visits and procedures
Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments
Willing and capable of provide written informed consent.

Exclusion Criteria:

Pregnant, nursing or planning to become pregnant during the study period
Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.
Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.
Single-column hemorrhoidectomy
Body weight less than 50 kg (110 pounds)
History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine)
contraindication to epinephrine
contraindication to any of the pain-control agents planned for postoperative use
Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration
History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years.
Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance.
Significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial.
Any clinically significant event or condition uncovered during surgery
A cumulative incision length less than 3 cm
Intervention: Glyburide
Trial phase: Phase 4
ATC code: A10BB01
SMILES: COc1ccc(Cl)cc1C(=O)NCCc1ccc(S(=O)(=O)NC(=O)NC2CCCCC2)cc1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 189
Group description: Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.

Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Eligibility criteria:
Inclusion Criteria:

A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information
An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl
Gestational age of less than or equal to 28 weeks and 0 days at the time of consent/randomization
Singleton gestation

Exclusion Criteria:

Established pregestational diabetes
Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation. Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still be considered for this study if they present again for glucose tolerance testing between 24 and 27 weeks.
Multiple gestations
Known major fetal anomaly or fetal demise
Any renal disease with serum creatinine of >1.0
Known liver disease such as hepatitis
Maternal or fetal conditions likely to require imminent or very preterm delivery such as preeclampsia, preterm premature rupture of the membranes, preterm labor, and intrauterine fetal growth restriction
Known hypersensitivity or allergic reaction to Glyburide
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Males or females, age 55-85
Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
Mini-mental status exam score of 14-26 inclusive
Rosen-Modified Hachinski Ischemia Score of < or = 4

Exclusion Criteria:

Diagnosis or history of other dementia or neurodegenerative disorders
Diagnosis or history of clinically significant cerebrovascular or cardiovascular disease
Subjects with pulmonary disease or evidence of clinically significant pulmonary symptoms
Intervention: Ramelteon
Trial phase: Not Applicable
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Ramelteon (TAK-375) 8mg tablets
Eligibility criteria:
Inclusion Criteria:

Diagnosis of parkinsonism (idiopathic PD, multiple systems atrophy, Lewy body dementia)
RBD frequency of at least once per week based on the RBD screening clinical questionnaire
PSG evidence of RBD
Presence of bed partner/caregiver who sleeps in the same room as PD patient

Exclusion Criteria:

Known hypersensitivity to ramelteon or related compounds, including melatonin and melatonin-related compounds.
Use of hypnotics or other sedatives within a month prior to the study initiation
Presence of active psychosis
Use of neuroleptics, except for the atypical neuroleptics - specifically quetiapine (the dose should not exceed 50mg/day)
Use of antidepressants unless the patient has been on a stable dose for at least three months
Use of Venlafaxine (Effexor®)
Presence of cognitive impairment, defined as the Mini Mental Status Examination (MMSE) score <24
Presence of depression defined as the Beck Depression Inventory (BDI) score >14
Significant sleep disordered breathing (defined as an apnea-hypopnea index>15 events/hr of sleep on screening PSG), significant periodic limb movement disorder (defined as a PLM index>10 events/hr of sleep with awakening on screening PSG)
Travel through two time zones within a month prior to the study initiation
Intervention: Neostigmine
Trial phase: Phase 4
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: (SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (with NG)

Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
Eligibility criteria:
Inclusion Criteria:

1. SCI and able-bodied patients with clinical indication for a colonoscopic examination

Exclusion Criteria:

Able-bodied patients with a GFR 50ml/min.
SCI and able-bodied patients who are not candidates for elective colonoscopy (i.e., those with recent myocardial infarction, terminal illness, etc.)
SCI and able-bodied patients who have a contraindication to PEG and/or ascorbic acid administration (i.e., those with colonic obstruction, etc.)
SCI and able-bodied patients who have a contraindication for magnesium citrate (i.e., those with poor renal function, class 2 or greater symptomatic heart failure, ascites)
SCI and able-bodied patients with a history of bradyarrhythmia, active coronary artery disease or asthma will also be excluded from receiving neostigmine/glycopyrrolate
Known hypersensitivity to neostigmine or glycopyrrolate
Potential for pregnancy. Women who are sexually active and of childbearing potential (i.e. not surgically sterile or at least 2 years postmenopausal) must have negative serum pregnancy test.)
Lactating/nursing females
SCI patients with known adverse reactions to per-rectal colonic lavage.
SCI patients with a serum sodium <130 mM.
Intervention: Neostigmine
Trial phase: Phase 4
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: (SCI, GFR>=50ml/min) PIEE (with NG)

Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
Eligibility criteria:
Inclusion Criteria:

1. SCI and able-bodied patients with clinical indication for a colonoscopic examination

Exclusion Criteria:

Able-bodied patients with a GFR 50ml/min.
SCI and able-bodied patients who are not candidates for elective colonoscopy (i.e., those with recent myocardial infarction, terminal illness, etc.)
SCI and able-bodied patients who have a contraindication to PEG and/or ascorbic acid administration (i.e., those with colonic obstruction, etc.)
SCI and able-bodied patients who have a contraindication for magnesium citrate (i.e., those with poor renal function, class 2 or greater symptomatic heart failure, ascites)
SCI and able-bodied patients with a history of bradyarrhythmia, active coronary artery disease or asthma will also be excluded from receiving neostigmine/glycopyrrolate
Known hypersensitivity to neostigmine or glycopyrrolate
Potential for pregnancy. Women who are sexually active and of childbearing potential (i.e. not surgically sterile or at least 2 years postmenopausal) must have negative serum pregnancy test.)
Lactating/nursing females
SCI patients with known adverse reactions to per-rectal colonic lavage.
SCI patients with a serum sodium <130 mM.
Intervention: Raltegravir
Trial phase: Not Applicable
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Raltegravir 400 mg tablets twice daily
Eligibility criteria:
Inclusion Criteria:

Documentation of blood seropositive for HIV based on self report and confirmed by ELISA and Western blot or detectable HIV RNA

Stable anti-retroviral regimen for at least 3 weeks prior to enrollment
Capable of giving informed consent
Age 18 years and older

Exclusion Criteria:

Neoplasms
Women who are pregnant or nursing
History or current evidence of any significant acute or chronic medical illness that in the opinion of the investigator would preclude the subject from safely participating in the study
Current use of phenobarbital, phenytoin, or rifampin
Any major surgery within 4 weeks of enrollment
Blood transfusion within 4 weeks of enrollment
Inability to tolerate oral medication
Inability to tolerate venipuncture, venous access, or genital tract sampling
History of recent (within 6 months) drug or alcohol abuse
Evidence of organ dysfunction or any clinically significant deviation from normal in the medical history, physical examination, vital signs, and or clinical laboratory determinations that in the opinion of the investigator would preclude the subject from safely participating in the study
Any other sound medical, psychiatric and or social reason for exclusion as determined by the investigator
History of allergy to study medication or related compounds
Intervention: Omeprazole
Trial phase: Not Applicable
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: This arm includes all patients in the study, but focuses on the time period when they were on Esomeprazole only.
Eligibility criteria:
Inclusion Criteria:

age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English

Exclusion Criteria:

pregnancy or breast-feeding, evidence of positive skin tests to a common aeroallergen, treatment with a proton pump inhibitor within the month prior to enrollment, treatment with any other anti-reflux therapy within the last month on a daily basis or within the last two weeks on an as needed basis, and other gastrointestinal disorders leading to reflux symptoms
Intervention: Lubiprostone
Trial phase: Phase 4
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: lubiprostone 24mcg single dose po prior to capsule endoscopy
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea
Intervention: Prednisone
Trial phase: Phase 1
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=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: 8
Group description: Prednisone 15 mg tablets once daily for 15 days
Eligibility criteria:
Inclusion Criteria:

Patient is willing to limit alcohol intake to 3 or less beverages per day
Patient agrees to use only acetaminophen/paracetamol for breakthrough pain

Exclusion Criteria:

Patient has other inflammatory arthritis (e.g. lupus). Patient has had major surgery or donated or lost 1 unit of blood in the last 4 weeks
Patient has a history of drug or alcohol abuse in the last 2 years
Patient has had a vaccine (with a live or attenuated virus) in the last two weeks
Intervention: Prednisone
Trial phase: Phase 1
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=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: 18
Group description: Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days

As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
Eligibility criteria:
Inclusion Criteria:

Patient is willing to limit alcohol intake to 3 or less beverages per day
Patient agrees to use only acetaminophen/paracetamol for breakthrough pain

Exclusion Criteria:

Patient has other inflammatory arthritis (e.g. lupus). Patient has had major surgery or donated or lost 1 unit of blood in the last 4 weeks
Patient has a history of drug or alcohol abuse in the last 2 years
Patient has had a vaccine (with a live or attenuated virus) in the last two weeks
Intervention: Sucroferric oxyhydroxide
Trial phase: Phase 4
ATC code: V03AE05
SMILES: O.O.O.OCC1OC(OC2(CO)OC(CO)C(O)C2O)C(O)C(O)C1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.

If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.

Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial.
Eligibility criteria:
Inclusion Criteria:

Age 18-45 years old
Singleton pregnancy at 32 weeks gestation
Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of < 11 g/dL or hematocrit of < 33%
Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc.
Having no history of allergy to iron containing medication
Having no history or other allergic conditions or asthma
Having no thalassemia disease, for examples: B thalassemia major, hemoglobin E/ B thalassemia, homozygous hemoglobin E, Hemoglobin H, AE Bart disease, and EF Bart disease. Pregnant women who have iron deficiency anemia and are thalassemia carriers such as A-thalassemia 1, B-thalassemia, or less severe Hb E/ B thalassemia are able to enter the study.
Having no history of bleeding tendency
Having no history of blood transfusion within the prior 120 days
Having no history of delivery before 36 weeks gestation
Giving consent and having signed the consent form for this study

Exclusion Criteria:

Stool exam revealed parasitic infestation
C-reactive protein > 3 mg/L
Serum ferritin > 15 mcg/L
Intervention: Simvastatin
Trial phase: Not Applicable
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Escalating dose of simvastatin

Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.
Eligibility criteria:
Inclusion Criteria:

At least three years from completion of treatment for Hodgkin's Disease
Age 18- 35
Ability to complete self report questionnaires in either English or Spanish
Willingness of patient, or parent/guardian if patient less than 18 years of age to sign consent to participate in study
Willingness of patient to sign assent if greater than 7 years of age and less than 18 years

Exclusion Criteria:

Pregnant or breast feeding
Tanner Stage 1
Currently taking cyclosporine, niacin, antiretrovirals, macrolide antibiotic, azole antifungal
Liver enzymes greater than 1.5 times the upper level of normal
Creatine Kinase greater than 2 times the upper level of normal
Use of estrogen containing contraceptive
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
Eligibility criteria:
Inclusion Criteria:

Any female patient, age 18 or older, who elects to have a mid-urethral sling with or without an anterior or posterior repair at the University of North Carolina Hospitals by a member of the Division of Urogynecology.

Exclusion Criteria:

Any patient with a chronic pain syndrome, a contraindication to nonsteroidal anti-inflammatory drugs (NSAIDs) such as liver disease, abnormal coagulation, esophageal disorders or peptic ulcers or where pain evaluation is unreliable because of neurological disease and those on treatment with steroids/NSAIDs/opioids prior to surgery.
Also excluded will be any patient who is having any other reconstructive pelvic surgery concomitantly or would require the placement of a suprapubic catheter.
Patients electing to have their surgery with regional anesthesia, such as an epidural or spinal will be excluded.
All minors, decisional impaired people, nursing mothers and non-English speaking people will be excluded.
Intervention: Kenalog
Trial phase: Not Applicable
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: 40 mg of intraarticular triamcinolone acetonide
Eligibility criteria:
Inclusion Criteria:

knee pain
diagnosis of osteoarthritis in affected knee

Exclusion Criteria:

intraarticular corticosteroids in affected knee within past three months
primary inflammatory connective tissue disease (ie rheumatoid arthritis)
currently taking oral corticosteroids
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Intraarticular injection of 0.9% saline
Eligibility criteria:
Inclusion Criteria:

knee pain
diagnosis of osteoarthritis in affected knee

Exclusion Criteria:

intraarticular corticosteroids in affected knee within past three months
primary inflammatory connective tissue disease (ie rheumatoid arthritis)
currently taking oral corticosteroids