anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lisinopril
Trial phase: Phase 2
ATC code: C09AA03 | C09BA03 | C09BB03 | C10BX07
SMILES: NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Participants received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure

Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure
Eligibility criteria:
Inclusion Criteria:

Patients must be undergoing open bariatric surgery at WVUH-ruby hospital. - They must be ASA class 1, 2 and 3.
Consented individuals.
They must be between the age of 18 to 55.

Exclusion Criteria:

History of bradycardia or tachy-brady syndrome HR<45.
1st degree heart block or higher.
Patient refusal.
On pain medication for any reason for more than 24 hrs within 2 weeks of procedure.
Allergy to medication.
History of alcohol or drug abuse.
History of Cardiac/ liver/ kidney disease
Intervention: Istradefylline
Trial phase: Phase 3
ATC code: N04CX01
SMILES: [H]/C(=C(/[H])c1nc2c(c(=O)n(CC)c(=O)n2CC)n1C)c1ccc(OC)c(OC)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 239
Group description: Treatment for 52 weeks

Istradefylline 20 mg or 40 mg
Eligibility criteria:
Inclusion Criteria:

Written informed consent;
Subjects who completed Study No. 6002-014 inclusive of the 30-day follow-up period;
Currently taking levodopa combination (carbidopa/levodopa or benserazide/levodopa) therapy plus at least one adjunctive PD medication;
Women of child-bearing potential (WOCBP) must use a reliable method of contraception and have a negative serum pregnancy test at Screening;

Exclusion Criteria:

Subjects with less than 70% treatment compliance throughout their enrollment on Study No 6002-014 and or with major protocol deviations in Study No. 6002-014 (subjects who failed to meet any of the inclusion criteria, subjects who met any of the exclusion criteria or subjects who met the criteria for subject withdrawal but who were not withdrawn);
Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion;
Subject who have had neurosurgical operation for PD;
Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers;
Subjects who have had a diagnosis of cancer or evidence of continued malignancy within the past three years (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal prostate-specific antigens post resection).
Intervention: Nifurtimox
Trial phase: Phase 3
ATC code: P01CC01
SMILES: CC1CS(=O)(=O)CCN1/N=C/c1ccc([N+](=O)[O-])o1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 219
Group description: Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment)
Eligibility criteria:
Inclusion Criteria:

Part 1:

Male and female pediatric subjects aged 0 days to younger than 18 years
Chagas' disease diagnosed/ confirmed for a) Subjects < 8 months of age at randomization must demonstrate direct observation of Trypanosoma cruzi by concentration test; b) Subjects ≥ 8 months to < 18 years of age at randomization must demonstrate a positive conventional ELISA result for both recombinant ELISA and total purified antigen ELISA

Part 2:

- Male and female subjects who were randomized and received at least one dose of their assigned 60- or 30-day regimen of nifurtimox treatment

Exclusion Criteria:

Part 1:

Subjects aged 0 to 27 days who, at birth, were pre-term, weighed less than 2500 g, or had a maximum Apgar score < 7 at 5 minutes
Known evidence of Chagas' disease-related cardiomyopathy/ Chagas' heart disease
Known evidence of Chagas' disease-related gastrointestinal dysfunction (e.g. megaoesophagus, megacolon, or both) or Chagas' digestive disease
Serious manifestations of acute Chagas' disease, including myocarditis, meningoencephalitis, or pneumonitis
Known evidence of Chagas' disease-related damage to the peripheral nervous system or peripheral neuropathy
Clinically significant psychiatric disorder (e.g. moderate to severe depression, severe anxiety, or psychosis) or epilepsy
Subjects with contraindications/ warnings to nifurtimox administration, or with conditions that may increase the risk of the undesirable effects of nifurtimox
Subjects who have had previous treatment with trypanocidal agents or an accepted indication for antiparasitic therapy (e.g. reactivation of Chagas' infection due to immunosuppression by several diseases or treatment with steroids)
Subjects living in housing conditions where there is no active or effective vector control to Trypanosoma cruzi reinfection as determined by Ministry of Health guidelines in each country

Part 2:

Subjects with acute or chronic health conditions or congenital disorders which, in the opinion of the investigator, would make them unsuitable for participation in the clinical study
Subjects living in housing conditions where there is no active or effective vector-control to Trypanosoma cruzi reinfection as determined by Ministry of Health guideline of the respective country
Subjects with clinical manifestations of Chagas' disease-related gastrointestinal dysfunction or serious manifestations of acute Chagas' disease
Immuno-compromised subjects (e.g. with human immunodeficiency virus or treated with immunosuppressive drugs)
Intervention: Oxybutynin Chloride
Trial phase: Not Applicable
SMILES: CCN(CC)CC#CCOC(=O)C(O)(c1ccccc1)C1CCCCC1.Cl
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks

Oxybutynin 3% gel
Eligibility criteria:
Inclusion Criteria:

Eligible subjects must be 12-25 years old and meet consensus criteria for primary focal hyperhidrosis: focal, visible, excessive sweating of at least 6 months duration without apparent cause with at least two of the following characteristics: 1) Bilateral and relatively symmetric, 2) Impairs daily activities, 3) Frequency of at least one episode per week, 4) Age of onset less than 25 years, 5) Positive family history, 6) Cessation of focal sweating during sleep.
Eligible subjects must have moderate to severe hyperhidrosis which correlates to a score of 3 or 4 on the HDSS.
Hyperhidrosis must affect the bilateral axilla; however, patients with concurrent focal hyperhidrosis affecting the palms, soles, face, or other area will not be excluded.
Subjects must be willing to comply with the study protocol.

Exclusion Criteria:

Subjects with hyperhidrosis of less than 6 months duration or hyperhidrosis secondary to an underlying infectious, endocrine, or neurologic disorder.
Treatment with botulinum toxin injections to the axillae or other affected areas within the last 12 weeks OR treatment with other agents (oral anticholinergic medications, topical aluminum chloride) in the last 4 weeks.
Subjects with active skin inflammation or infection affecting the axilla
Subjects who report history of closed-angle glaucoma, urinary retention, decreased gastrointestinal motility, hiatal hernia, cardiac arrhythmia, coronary artery disease, congestive health failure, hyperthyroidism, myasthenia gravis, xerostomia, renal insufficiency, or hepatic impairment.
Subjects with hypertension defined as systolic blood pressure > 140 or diastolic blood pressure > 90 on more than 1 occasion separated by 1 week.
Subjects with the following: history of somnolence, confusion, hallucinations OR subjects taking other medications that may cause somnolence, confusion, hallucinations OR subjects with other medical conditions that may predispose them for somnolence, confusion, or hallucinations.
Subjects who have demonstrated hypersensitivity to the drug substance or other components of the product
Subjects taking drugs which inhibit Cytochrome P450 3A4 (CYP3A4)
Pregnant and/or nursing females
Any other disease that would interfere with the study or place them at undue risk or who are in any way unable to comply with study requirements.
Intervention: Natrii lactatis solutio composita
Trial phase: Not Applicable
SMILES: CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 52
Group description: Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement

Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty
Eligibility criteria:
Inclusion Criteria:

All patients >= 18 years of age, undergoing a total primary knee or hip arthroplasty

Exclusion Criteria:

Patients weighing less than 80 kg.
Patients undergoing irrigation and debridement, explantation, or revision will not be eligible.
history of kidney disease, congestive heart failure, pulmonary edema, cirrhosis of the liver, or history of systemic fluid overloard will be excluded from the study.
No one will be excluded based on gender, ethnicity or race.
Intervention: Misoprostol
Trial phase: Phase 4
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 236
Group description: These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.

Vaginal Misoprostol
Eligibility criteria:
Inclusion Criteria

Nulliparous women aged 18 or above
BMI ≥ 30 at the time of labor induction
Singleton gestation
Cephalic presentation (includes successful external cephalic version)
Intact fetal membranes
Unfavorable cervix (Bishop score of ≤ 6)
Gestational age ≥ 32 weeks

Exclusion Criteria

Patient not candidate for IOL with misoprostol as deemed by the treating physician
Multiple gestation
Major fetal anomalies
Fetal demise
Intervention: Natrii lactatis solutio composita
Trial phase: Phase 2
SMILES: CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.

Lactated Ringer's: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.
Eligibility criteria:
Inclusion Criteria:

Non-pregnant female patients
Patients undergoing elective cardiac surgery
Aspirin, heparin, or warfarin preoperatively accepted

Exclusion Criteria:

Previous sternotomy
Emergency surgery
Combined procedures (vascular or thoracic operations)
Congenital heart repair
Hypothermic cardiopulmonary bypass (CPB) < 28 degrees C
Serum creatinine greater than or equal to 1.5 mg/dL
Dialysis dependent renal failure
Neurologic injury or event within 30 days (including transient ischemic attack)
Cerebrovascular accident with significant residual neurologic deficit
Severe chronic obstructive pulmonary disease with Forced Expiratory Volume in 1 Second (FEV1) < 45% of predicted value
Home oxygen use
Previous difficult intubation
Acute normovolemic blood conservation techniques
Liver disease with serum aspartate aminotransferase (AST) > 31 U/L
Circulatory arrest
Thrombolysis
Pre-existing clotting disorder
Platelet receptor glycoprotein IIb/IIIa (GP IIb/IIIa) antagonist medication received within 48 hours
Steroids
Ejection Fraction < 40%
Intra-aortic balloon pumps
Ongoing congestive heart failure
Ventricular assist devices
Total hearts
Pregnant women
Adults lacking capacity to consent
Any patients initially enrolled in the study that end up with an intra-aortic balloon pump, left ventricular assist device, or on extracorporeal membrane oxygenation will be eliminated from the study.
Intervention: Morphine sulphate
Trial phase: Phase 4
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O=S(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection
Eligibility criteria:
Inclusion Criteria:

Adult men and women aged 19 years or more
Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study
Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher)
Subjects who voluntarily signed the Informed Consent Form for the study
Subjects who are capable of understanding details of the study and verbal communication on pain intensity

Exclusion Criteria:

Patients who reached the narcotic analgesic dose corresponding to the followings for cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day, oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour)
Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics
Patients who have contraindications and cautions when study drugs administered.
Intervention: Misoprostol
Trial phase: Phase 2
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 243
Group description: single dose of misoprostol
Eligibility criteria:
Inclusion Criteria:

Any pregnant woman undergoing induction of labor
Live singleton pregnancy ≥ 37 week gestation
Bishop score < 6
Category I fetal heart rate

Exclusion Criteria:

Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.)
Pregnancies complicated by major fetal anomalies
Any contraindication to the use of misoprostol, including
History of previous c-section or major uterine surgery
Prior allergic reaction
Category II or III fetal heart rate
Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30 minutes
Estimated fetal weight < 10 percentile
Premature rupture of membranes
Age < 18 years old
Women who do not have the capacity to consent
Intervention: Misoprostol
Trial phase: Phase 2
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 243
Group description: multiple doses of misoprostol
Eligibility criteria:
Inclusion Criteria:

Any pregnant woman undergoing induction of labor
Live singleton pregnancy ≥ 37 week gestation
Bishop score < 6
Category I fetal heart rate

Exclusion Criteria:

Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.)
Pregnancies complicated by major fetal anomalies
Any contraindication to the use of misoprostol, including
History of previous c-section or major uterine surgery
Prior allergic reaction
Category II or III fetal heart rate
Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30 minutes
Estimated fetal weight < 10 percentile
Premature rupture of membranes
Age < 18 years old
Women who do not have the capacity to consent
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 2
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18 years or older
Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
HbA1c ≤ 12%, as assessed by the central laboratory
Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field stereo colour fundus photograph
Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic macular oedema
No evidence of total PVD in the study eye
Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR
Presence of epiretinal membrane in the study eye
Presence of foveal ischemia in the study eye
Presence of pre-retinal or vitreous haemorrhage in the study eye
Presence of iris or angle neovascularisation in the study eye
Any active ocular / intraocular infection or inflammation in either eye
Aphakic study eye
Uncontrolled hypertension in the opinion of the Investigator
Pseudoexfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens / zonular instability
Intervention: Oxygen
Trial phase: Phase 2
ATC code: V03AN01
SMILES: O=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Eligibility criteria:
Inclusion Criteria:

A diagnosis of osteomyelitis (first episode) defined by:
Pain or point tenderness upon palpation or probing to bone
Plain radiograph or Magnetic resonance imaging (MRI) consistent with osteomyelitis (indistinctly marginated edema-like pattern of bone marrow hypointensity on unenhanced T1-weighted sequences, hyperintensity on fat-saturated T2-weighted and Short tau inversion recovery (STIR) sequences and/or abnormal enhancement on gadolinium-enhanced fat-saturated T2-weighted sequences, with or without visible periostitis or cortical bone destruction) OR Gram-positive cocci documented on a baseline Gram-stain from a bone specimen
Elevated C-reactive protein (CRP) (low sensitivity) above the upper limit of normal (ULN) (reference range for low sensitivity CRP is 3-10 mg/L)
Participants must be willing and able, if discharged from the hospital, to return to the hospital or a designated clinic for scheduled visits, treatment, laboratory tests, and other outpatient procedures as required by the protocol.

Exclusion Criteria:

Treatment with an investigational drug within 30 days preceding the first dose of investigational product.
Receipt of > 24 hours of potentially effective IV antibacterial therapy for osteomyelitis within 96 hours of randomization, unless the pathogen isolated was documented to be Methicillin-resistant Staphylococcus aureus (MRSA) that was resistant to the administered antibiotic.
A prior episode of osteomyelitis, or a failed course of therapy for osteomyelitis.
Infection associated with a burn wound, with a sacral decubitus ulcer, or with multiple sites of osteomyelitis.
Septic arthritis that is non-contiguous to osteomyelitis, as diagnosed by isolation of a pathogen from synovial fluid culture.
Immunosuppression/immune deficiency
Evidence of Gram-negative bacteria by Gram stain in the absence of Gram-positive organisms.
Gram-negative bacteremia
Patients with concomitant endocarditis, necrotizing fasciitis, or prosthetic material at the site of infection at the time of study initiation.
Infection due to an organism known prior to study entry to not be susceptible to dalbavancin (dalbavancin mean inhibitory concentration [MIC] > 0.12 μg/mL) or vancomycin (vancomycin MIC > 2 μg/mL).
Concomitant systemic antibacterial therapy for Gram-positive infections (eg, rifampin, gentamicin).
Known or suspected hypersensitivity to glycopeptide antibiotics.
Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
Pregnant or nursing females; positive urine (or serum) pregnancy test at Screening (pre-menopausal females only) or after admission (prior to dosing)
Sexually active females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least the first dose of study drug until the last pregnancy test.
Intervention: Oxygen
Trial phase: Not Applicable
ATC code: V03AN01
SMILES: O=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.

oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis or Radiological diagnosis of acute appendicitis.
Appendectomy through the Mc Burney incision.

Exclusion Criteria:

Patients with chronic obstructive pulmonary diseases.
Immunodeficiency disease.
Patients requiring midline incision.
Patients requiring general anaesthesia after failure of spinal anaesthesia.
Patients requiring higher oxygen in perioperative period.