anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour

Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Eligibility criteria:
Inclusion Criteria:

Pregnant women
18 to 45 years of age
Admitted to MUSC in labor or for induction of labor resulting in a vaginal delivery epidural analgesia
Postpartum tubal ligation following delivery
American Society of Anesthesiologists (ASA) Physical Class 1, 2, and 3

Exclusion Criteria:

Critically Ill Patients (patients admitted to the ICU)
Cognitively Impaired Persons (patients with a diagnosis of cognitive deficit)
Cesarean delivery
Punctured dura
Patients enrolled in other epidural research studies
Intervention: OXYTOCIN
Trial phase: Early Phase 1
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Subjects will come in for one visit, and will receive only oxytocin

Oxytocin: To test that intranasal oxytocin administration blunts the deleterious hypoxia/hypercapnia induced changes in heart rate that occur during nocturnal apnea in patients with OSA, we will examine the changes in heart rate in a group of patients that have recently been diagnosed with OSA. Ten subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysomnography (per standard of care medical guidelines, and not for research purposes) and have been diagnosed with OSA will be recruited into a study to assess the beneficial effects of oxytocin treatment.
Eligibility criteria:
Inclusion Criteria:

Inclusion Criteria:

Men or women 18 years old or older of any ethnic background
Subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysonmography (per standard of care medical guidelines), or the "at home" diagnostic test for cohort B, and have been diagnosed with OSA will be recruited into a follow-up study to assess the beneficial effects of oxytocin treatment.

Exclusion Criteria:

Pregnant or nursing women or women at any child bearing age who are not willing to undergo . methods to prevent pregnancy

A female subject of childbearing potential is a nonmenopausal female who has not had a . hysterectomy, bilateral oopherectomy, or medically documented ovarian failure. Menopause . can be assumed to have occurred in a woman when there is either:

Appropriate medical documentation of prior complete bilateral oophorectomy OR
Permanent cessation of previously occurring menses as a result of ovarian failure with . documentation of hormonal deficiency. Ovarian hormonal deficiency is documented by . serum follicle stimulating hormone (FSH) level elevated to within the post-menopausal . . range based on the laboratory reference range where the hormonal assay is performed.
Menopause is defined as occurring 12 months after your last menstrual period and marks the . end of menstrual cycles
Subjects who are on medications that affect cardiac autonomic function (eg. Beta blockers)
Smokers
Subjects who are unable to read or answer questions in the English language
Intervention: Iron
Trial phase: Phase 2
ATC code: A11AA01 | B03AE01 | B03AE02 | B03AE03 | B03AE04
SMILES: [Fe]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 4
Group description: Group II (non-treatment group): Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks.

Iron: Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks.
Eligibility criteria:
Inclusion Criteria

Newborns less than 4 weeks old at diagnosis
Gestational age >34 weeks
Birth weight 2.2-4kg
Cyanotic heart disease who have had a surgical shunt or a catheterization intervention that is equivalent to a shunt (patent ductus arteriosus stent, right ventricular outflow tract stent).
Baseline hematocrit to be below <40%.
Completes at least 1 injection in the study by 8 weeks of age.

Exclusion Criteria

Infants diagnosed at greater than 4 weeks of age
Gestation <34 weeks
Birth weight <2.2 kg or >4kg
Hematocrit >40%
Newborns with acyanotic heart disease

Infants with significant co-morbidities:

Renal failure (Creatinine > 2 standard deviations above age adjusted norm)
Hepatic failure (elevated AST/ALT levels > 2 standard deviations above age adjusted norm
Hemolytic disease
Hemoglobinopathies (Sickle-cell disease, Thalassemias)
Intervention: Dapagliflozin
Trial phase: Phase 4
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Dapagliflozin 10mg + Metformin 1000mg
Eligibility criteria:
Inclusion Criteria:

Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)
Patients in insufficient glycemic control (HbA1c > 7.5% and < 9.5% in recent 4 weeks)
Patients with an unchanged dose of metformin (≥ 1,000 mg/day) for > 8 weeks prior to randomization
Written informed consent

WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.

WOCBP must have a negative urine pregnancy test at screening visit WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.

Exclusion Criteria:

Type 1 diabetes or history of diabetic ketoacidosis
Pregnant or breast-feeding patients
eGFR < 60 mL/min/1.73 m2 (MDRD) on visit 1.
Indication of active liver disease (AST/ALT/total bilirubin > 3 X upper limits of normal) on visit 1.
Acute coronary syndrome, stroke or TIA within 3 months prior to randomization
Bariatric surgery within 2 years; treatment of anti-obesity drugs 3 months prior to randomization; any treatment leading to unstable body weight. (Unstable body weight is considered reliable in the judgment of the Investigator.)
History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
History of alcohol or drug abuse judged by physician within 3 months prior to randomization
Concomitant participation in any other clinical study.
Intervention: Glimepiride
Trial phase: Phase 4
ATC code: A10BB12 | A10BD04 | A10BD06
SMILES: CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Glimepiriide 1-2mg + Metformin 1000mg
Eligibility criteria:
Inclusion Criteria:

Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)
Patients in insufficient glycemic control (HbA1c > 7.5% and < 9.5% in recent 4 weeks)
Patients with an unchanged dose of metformin (≥ 1,000 mg/day) for > 8 weeks prior to randomization
Written informed consent

WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.

WOCBP must have a negative urine pregnancy test at screening visit WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.

Exclusion Criteria:

Type 1 diabetes or history of diabetic ketoacidosis
Pregnant or breast-feeding patients
eGFR < 60 mL/min/1.73 m2 (MDRD) on visit 1.
Indication of active liver disease (AST/ALT/total bilirubin > 3 X upper limits of normal) on visit 1.
Acute coronary syndrome, stroke or TIA within 3 months prior to randomization
Bariatric surgery within 2 years; treatment of anti-obesity drugs 3 months prior to randomization; any treatment leading to unstable body weight. (Unstable body weight is considered reliable in the judgment of the Investigator.)
History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
History of alcohol or drug abuse judged by physician within 3 months prior to randomization
Concomitant participation in any other clinical study.
Intervention: Lasmiditan
Trial phase: Phase 3
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 991
Group description: Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Eligibility criteria:
Inclusion Criteria:

Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).
Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)
Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.

Exclusion Criteria:

Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
Pregnant or breast-feeding women.
Women of child-bearing potential not using or not willing to use highly effective contraception.
Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
Intervention: Lasmiditan
Trial phase: Phase 3
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1039
Group description: Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Eligibility criteria:
Inclusion Criteria:

Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).
Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)
Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.

Exclusion Criteria:

Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
Pregnant or breast-feeding women.
Women of child-bearing potential not using or not willing to use highly effective contraception.
Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
Intervention: Razpipadon
Trial phase: Phase 1
SMILES: Cc1cc(Oc2ncccc2OC(F)F)ccc1-c1c(C)c(=O)[nH]c(=O)n1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
Eligibility criteria:
Inclusion Criteria:

Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
Must be Hoehn & Yahr Stage II-III inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia.
Subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of Parkinson's disease medication. Subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome.

Exclusion Criteria:

- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.
Intervention: Tiotropium
Trial phase: Phase 4
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 188
Group description: Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 50% of the predicted normal value and post-bronchodilator FEV1/FVC < 0.7 (COPD Grade 1 or 2 by severity of airflow limitation (GOLD 2015)
Patients with CAT score ≥ 10 at Visit 0 and Visit 1.
Patients who are on and have been on tiotropium monotherapy for the past 3 months.
0 or 1 COPD exacerbation in the previous 12 months (not leading to hospital admission).

Exclusion Criteria:

Treatment with any inhaled corticosteroid (ICS) in the 3 months prior to Visit 1.
COPD exacerbation between Visit 0 and 1.
Patients with concomitant pulmonary disease
Patients with a history of respiratory infection within 4 weeks prior to Visit 0.
Prior or current diagnosis of asthma.
Presence of any contraindication, warning, precaution, hypersensitivity to LABA and LAMA

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Caffeine
Trial phase: Phase 4
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
Eligibility criteria:
Inclusion Criteria:

Age 25-40.
Male.
Normal healthy subject without systematic diseases or conditions.
Metabolic Equivalents of Functional Capacity >= 5.
Low risk for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to > 3 items- high risk of OSA
No History of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases.
BMI < 30 kg/m2.
No history of prior difficulty with anesthesia.
No personal or family history of malignant hyperthermia.
No history of any mental illness.
No history of drugs or alcohol abuse (urine drug screens required).
Subjects capable of giving consent.
Living less than 30 miles away from University of Chicago.
No history of seizure disorders.
No history of head trauma.

Exclusion Criteria:

Age <25 or >40.
Female.
ASA physical status > 1 (normal healthy subject without systematic diseases or conditions)
Metabolic Equivalents of Functional Capacity (METs) < 5.
High risks for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to > 3 items- high risk of OSA
History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
BMI>30 kg/m2.
Prior difficulty with anesthesia.
Personal or family history of malignant hyperthermia.
History of any mental illness.
History of drugs or alcohol abuse (urine drug screens required)
Subjects capable of giving consent
Living more than 30 miles away from University of Chicago.
History of seizure disorders.
History of head trauma.
Intervention: Cyproheptadine
Trial phase: Phase 4
ATC code: R06AX02
SMILES: CN1CCC(=C2c3ccccc3C=Cc3ccccc32)CC1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for a total of two months. Standard dose of 0.25 mg/kg divided BID will be used.

Cyproheptadine
Eligibility criteria:
Inclusion Criteria:

All children aged 1-10 years, presenting to initial intake appointment with the Pediatric Gastroenterology Feeding Team Clinic at the Children's Hospital of Wisconsin (CHW), with BMI Z score of < or equal to 0 (normal WHO BMI defined as Z score of -1 to 1), who have a parent willing to participate, will qualify for inclusion in the study. Children with vomiting due to presumed volume intolerance may be included in the study.

Exclusion Criteria:

Untreated organic disease Anatomical barrier to swallowing or known swallowing disorder Diagnosis of severe developmental delay or mental retardation Significant brain pathology or seizure disorder that may affect oropharyngeal motor skills On medication with known effects on appetite or interactions with cyproheptadine
Intervention: Cyproheptadine
Trial phase: Phase 4
ATC code: R06AX02
SMILES: CN1CCC(=C2c3ccccc3C=Cc3ccccc32)CC1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for two weeks cycled with no cyproheptadine given for two weeks for a total of two months. Patients on cycled dosing will be given cyproheptadine for two weeks, then no medication for two weeks; repeating this cycle for the two month duration of study

Cyproheptadine
Eligibility criteria:
Inclusion Criteria:

All children aged 1-10 years, presenting to initial intake appointment with the Pediatric Gastroenterology Feeding Team Clinic at the Children's Hospital of Wisconsin (CHW), with BMI Z score of < or equal to 0 (normal WHO BMI defined as Z score of -1 to 1), who have a parent willing to participate, will qualify for inclusion in the study. Children with vomiting due to presumed volume intolerance may be included in the study.

Exclusion Criteria:

Untreated organic disease Anatomical barrier to swallowing or known swallowing disorder Diagnosis of severe developmental delay or mental retardation Significant brain pathology or seizure disorder that may affect oropharyngeal motor skills On medication with known effects on appetite or interactions with cyproheptadine
Intervention: DABIGATRAN ETEXILATE
Trial phase: Phase 1
ATC code: B01AE07
SMILES: CCCCCCOC(=O)NC(=N)c1ccc(NCc2nc3cc(C(=O)N(CCC(=O)OCC)c4ccccn4)ccc3n2C)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Single dose of 150mg dabigatran etexilate administered orally.
Eligibility criteria:
Inclusion Criteria:

- Overtly healthy males and females

Exclusion Criteria:

Eye abnormalities or disease
History of vitiligo or any skin color disorder
Have a history psychiatric or brain disease including seizures
Have smoked within the last 3 months
Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for the duration of the study
Have known allergies to dabigatran etexilate and related compounds
Intervention: Tranexamic acid
Trial phase: Not Applicable
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 52
Group description: Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.

Tranexamic Acid
Eligibility criteria:
Inclusion Criteria:

Any patient scheduled for a primary anatomic or reverse TSA

Exclusion Criteria:

Allergy to TXA
Acquired disturbances of color vision
Pre-op use of anticoagulant therapy within five days before surgery
History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA
Pregnancy or breastfeeding
Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement
Renal impairment
Refusal of blood products
Any patient undergoing a revision TSA
Patients who decline to participate
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.

Liposomal bupivacaine: Local infiltration of liposomal bupivacaine
Eligibility criteria:
Inclusion Criteria:

Patients over the age of 18 scheduled for primary shoulder arthroplasty by three fellowship trained surgeons will be eligible for inclusion

Exclusion Criteria:

Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy.