anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tranexamic acid
Trial phase: Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: 1 g of IV TXA at the end of surgery
Eligibility criteria:
Inclusion Criteria:

Male or female, ≥18 years of age at screening.
Scheduled to undergo elective unilateral open TKA under general, spinal, or regional anesthesia.
American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
Female subject must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, or transdermal, contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
Planned concurrent surgical procedure (e.g., bilateral TKA).
Prior open knee surgery on ipsilateral knee. Prior arthroscopy is permitted.
Subjects taking a medication with a known procoagulant effect (e.g., combination hormonal contraceptives, Factor IX complex concentrates or anti-inhibitor coagulant concentrates, or all-trans retinoic acid).
Contraindication or hypersensitivity to TXA.
History of thrombosis or prior Venous thromboembolism (VTE).
Known coagulopathy or active intravascular clotting.
Prior myocardial infarction.
Prior cardiovascular accident (stroke) or subarachnoid hemorrhage.
History of epilepsy.
Presence of an intravascular stent.
History of impaired kidney function, chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in extremities.
Renal insufficiency (serum creatinine level >2 mg/dL).
Anemia (Hb level <10 g/dL).
Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.
Acquired defective color vision.
Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
Suspected or known history of drug or alcohol abuse within the previous year.
Body weight <50 kg (110 pounds) or a body mass index >44 kg/m2.
Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Patients will receive a placebo dose of all three study medications

Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.
Eligibility criteria:
Inclusion Criteria:

Women who are 18 - 45 years of age at the time of cesarean delivery with the ability to give informed consent
Elective cesarean delivery
Gestational age ≥ 34 weeks
Fluent in either English or Spanish
Spinal anesthesia

Exclusion Criteria:

Urgent or emergent CD
Epidural or combined spinal epidural regional anesthesia
General anesthesia
Patients with a contraindication for regional anesthesia
Acute or chronic hepatic disease
Acute or chronic renal disease
Active asthma
Gastrointestinal ulceration
Inflammatory bowel disease
Allergy to ketorolac, acetaminophen, hydrocodone, codeine, ibuprofen or bupivacaine
Opioid dependence
Non reassuring fetal or maternal status requiring immediate delivery
Placenta previa or accreta
Acute or chronic pain disorder
Maternal weight <50 kilograms
Uncontrolled hypertension
Ischemic cardiac disease
Congestive heart failure
Thrombocytopenia, platelet count <150,000/microliter
Preeclampsia including Hemolysis Elevated Liver enzymes Low Platelets syndrome
Disseminated intravascular coagulation (DIC) or active hemorrhage before randomization
Estimated blood loss > 2000 mL
Intervention: Isoflurane
Trial phase: Phase 4
ATC code: N01AB06
SMILES: FC(F)OC(Cl)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.

Isoflurane
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for spine surgery.
Age between 18-65 years
American Society of Anaesthesiologists (ASA) Grade I and II patients
Patients with Glasgow Coma Scale (GCS) of 15
Postoperative Aldrette score > 9

Exclusion Criteria:

Cardiorespiratory disorders
Associated cerebral disease
Psychiatric illness
Electrolyte and hormonal imbalance
History of drug abuse
Postoperative meningitis
Administration of high dose steroids
Intervention: Desflurane
Trial phase: Phase 4
ATC code: N01AB07
SMILES: FC(F)OC(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.

Desflurane
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for spine surgery.
Age between 18-65 years
American Society of Anaesthesiologists (ASA) Grade I and II patients
Patients with Glasgow Coma Scale (GCS) of 15
Postoperative Aldrette score > 9

Exclusion Criteria:

Cardiorespiratory disorders
Associated cerebral disease
Psychiatric illness
Electrolyte and hormonal imbalance
History of drug abuse
Postoperative meningitis
Administration of high dose steroids
Intervention: Dihomo-gamma-linolenic acid
Trial phase: Phase 2
SMILES: CCCCC/C=C\C/C=C\C/C=C\CCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks

DS107
Eligibility criteria:
Inclusion Criteria:

Patients with a clinically confirmed diagnosis of active Atopic Dermatitis according to Hanifin and Rajka criteria
Patients with mild to moderate Atopic Dermatitis at baseline as defined by an Investigator's Global Assessment (IGA) score of 3 or 2 at baseline visit
Patients with Atopic Dermatitis covering a minimum 5% of the body surface area at baseline
Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF)

Exclusion Criteria:

Patients with other skin conditions that might interfere with Atopic Dermatitis diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal topical skin infections) as assessed by the Investigator
Patients who have used systemic treatments (other than biologics) that could affect Atopic Dermatitis less that 4 weeks prior to baseline visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids. Intranasal corticosteroids for stable medical conditions are allowed
Patients who have used any topical medicated treatment for Atopic Dermatitis two weeks prior to the start of treatment/baseline (Day 0) including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials, and bleach baths
Patients who use topical products containing urea, ceramides or hyaluronic acid two weeks prior to Day 0
Patients who have a history of hypersensitivity to any substance in DS107 cream or vehicle cream
Patients who have any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with the interpretation of study results
Patients with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and floride arthritis or any other illness that, in the opinion of the Investigator, is likely to interfere with completion of the study
Patients with chronic infectious diseases (e.g. hepatitis B, hepatitis C, or infection with human immunodeficiency virus)
Intervention: Ticagrelor
Trial phase: Phase 2
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: crushed ticagrelor (180 mg); (n=50 patients)

Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.
Eligibility criteria:
Inclusion Criteria:

Patients with unstable angina/troponin negative ACS.

Exclusion Criteria:

need for oral anticoagulation therapy (Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban)
increased risk of bradycardia, and the associated therapy with a strong cytochrome P-450 inhibitors (anti-retroviral agents, antifungal agents and some antibiotics eg. Indinavir, Nelfinavir, Lopinavir, Ritonavir, Itraconazole, Ketoconazole, Voriconazole, Clarithromycin, Telithormycin)
surgery<4 weeks
use of any thienopyridines (Clopidogrel, Prasugrel) 7 days prior to randomization
administration of GP IIb/IIIa inhibitors
bleeding diathesis or major bleeding episode within 2 weeks
thrombocytopenia (Platelet count < 100000)
incessant chest pain
hemodynamic instability (Mean arterial pressure < 65 mm Hg; need for vasopressor or inotropic agents; need for mechanical circulatory support for coronary intervention), NSTEMI as evidenced by elevation of troponin levels (Troponin > 0.034 ng/ml); renal failure with a serum creatinine >2.0 mg/dL
anemia with HCT<30%.
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Gabapentin liquid by mouth or per Tube 300mg twice a day
Eligibility criteria:
Inclusion Criteria:

Subjects undergoing definitive mucosal head and neck resection including oral cavity, oropharynx, larynx, and hypopharynx
At least one night of planned inpatient stay

Exclusion Criteria:

Incapable of giving informed consent
Age less than 18
Glomerular Filtration Rate (GFR) less than 30
Allergy to gabapentin
Baseline gabapentin or lyrica use
Chronic opioid use for over six months
Intervention: Fenfluramine
Trial phase: Phase 3
ATC code: A08AA02 | A08AA04 | N03AX26
SMILES: CCNC(C)Cc1cccc(C(F)(F)F)c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 43
Group description: ZX008 0.5 mg/kg/day (maximum 20 mg/day) dose administered twice a day (BID) in equally divided doses.
Eligibility criteria:
Key Inclusion Criteria:

Subject must be male or non-pregnant, non-lactating female, aged 2 to 18 years (inclusive).
Subject must have documented medical history to support a clinical diagnosis of Dravet syndrome, where convulsive seizures are not completely controlled by current antiepileptic drugs.
Subject must be receiving a therapeutically relevant and stable dose of stiripentol (STP) plus clobazam (CLB) and/or valproate (VPA), and for at least 4 weeks prior to screening and be expected to remain stable throughout the study (Cohort 2 only).
Subject must be receiving a stable dose of CLB and VPA, administered twice daily (BID), to be eligible for Dose Regimen 1 and 2, or subject must be receiving a stable dose of CLB, VPA, and STP, administered BID, to be eligible for Dose Regimen 3 (Cohort 1 only).

Key Exclusion Criteria:

Subject has a known hypersensitivity to fenfluramine or any of the excipients in the study medication.
Subject has pulmonary arterial hypertension.
Subject has a current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, or stroke.
Subject has a current or recent history of anorexia nervosa, bulimia, or depression within the prior year that required medical treatment or psychological treatment for a duration greater than 1 month.
Subject has a current or past history of glaucoma.
Subject is receiving concomitant therapy with: centrally acting anorectic agents; monoamine-oxidase inhibitors; any centrally acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; triptans, atomoxetine, or other centrally acting noradrenergic agonists; cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates.
Subject is currently taking carbamazepine ,oxcarbazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days, as maintenance therapy.
Subject has a positive result on urine tetrahydrocannabinol (THC) panel or whole blood cannabidiol (CBD) at the Screening Visit.
Subject has a clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
Intervention: 7,8-Dihydro-2,3-bis(4-methylphenyl)pyrido[2,3-b]pyrazine-5(6H)-heptanoic acid
Trial phase: Phase 2
SMILES: Cc1ccc(-c2nc3c(nc2-c2ccc(C)cc2)N(CCCCCCC(=O)O)CCC3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Adult patients with pulmonary arterial hypertension (PAH) on QCC374. All patients were initiated at 0.03 mg BID (Day 1-3), and were up-titrated to next higher dose 0.06 mg BID (Day 4) and increased to 0.12 mg BID (Day 7-14).
Eligibility criteria:
Inclusion Criteria:

Male and female patients 18 years of age or older with symptomatic PAH.
Subjects with PAH belonging to one of the following subgroups of the Updated Clinical Classification Group 1 (Nice, 2013):
Idiopathic PAH
familial PAH
PAH associated with connective tissue disease, congenital heart disease (surgically repaired at least 12 months prior to screening) or drug or toxin induced (for example, anorexigen use).
Subjects must have persistent symptoms due to PAH despite therapy with at least one of the following PAH medications: an endothelin receptor antagonist, asoluble guanylate cyclase stimulator or a phosphodiesterase inhibitor. The subjects' PAH medication regimen, with typical medications including calcium channel blockers, endothelin receptor antagonists, soluble guanylate cyclase stimulators and/or phosphodiesterase inhibitors, must have been used at a stable dose and frequency for at least 12 weeks before the screening visit and during the screening period.
Diagnosis of PAH established according to the standard criteria before the screening visit:
Resting mean pulmonary arterial pressure > 25 mmHg.
PVR > 240 dynes s/cm5.
Pulmonary capillary wedge pressure or left ventricular end diastolic pressure < 15 mmHg
PVR > 400 dynes s/cm5 at the time of the baseline right heart catheterization (RHC) (if a RHC was completed within one month of the screening visit, that result may be used for inclusion).
6-minute walk distance greater than 150 meters at Screening. This distance must be confirmed by a second 6MWT prior to randomization. The value of the second 6MWD should be within ± 15% of the value obtained at Screening.

Exclusion Criteria:

Subjects with clinically unstable right heart failure within the last three months (New York Heart Association (NYHA) Class IV).
Subjects with PAH associated with portal hypertension, Human Immunodeficiency Virus (HIV) infection or unrepaired congenital systemic to pulmonary shunts
Subjects who have received or have been scheduled to receive long-term treatment with epoprostenol or any prostacyclin within the three months prior to the screening visit or during the screening period.
Hypotensive subjects (systemic systolic blood pressure < 85 mmHg)
Subjects with a history of left sided heart disease, chronic left sided heart failure, congenital or acquired valvular disease and/or pulmonary venous hypertension.
Subjects with significant obstructive (forced expiratory volume in one second [FEV1]/forced vital capacity [FVC] < 70% predicted) or restrictive (total lung capacity < 70% predicted) lung disease at screening.
Intervention: Augmentin
Trial phase: Not Applicable
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.

Augmentin: Antibiotic augmentin for 3 weeks
Eligibility criteria:
Inclusion Criteria:

They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the taskforce on rhinosinusitis.
They have a CT-scan in the clinic or have a viewable recent (< 3 weeks prior to clinic visit) CT-scan with a Lund Mackay score of 6 or greater. A Lund Mackay score of 6 or greater is felt to be indicative of at least moderate CRS.
They do not have nasal polyps on initial clinic nasal endoscopy
They are willing to participate in a clinical study
They are between the ages of 18 to 80.

Exclusion Criteria:

They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded.
They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded.
They have been treated with a > 3 week course of antibiotics and/or systemic steroids will also be excluded.
They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.
They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants.
They have nasal polyps on physical exam.
They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging.
They have a Lund-Mackay score on CT scan of < 6
They are < 18 or > 80 years old
Intervention: Ibuprofen
Trial phase: Phase 3
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Group A: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days.

.

Ibuprofen: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days
Eligibility criteria:
PATIENTS MUST HAVE MILITARY INSURANCE TO PARTICIPATE

Inclusion/exclusion criteria:

Inclusion:

Active Duty members and DoD beneficiary patient 18 years or older
Elective, open unilateral inguinal herniorrhaphy using Lichtenstein (tension free with mesh) hernia repair technique Agree to take only the prescribed oral analgesic medication (oxycodone/acetaminophen), plus or minus ibuprofen, for the initial fourteen-day post-operative period, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued.Agree to honestly complete a depression screening questionnaire, illicit drug use personal history and questionnaire, and physical activity assessment questionnaire, with the knowledge that if the patient is an active duty member, this information could result in a referral to medical or command authorities for potential Uniform Code of Military Justice (UCMJ) violations or concerns for subject health and fitness for duty.

Exclusion:

Subjects who are pregnant or nursing.
Patients who refuse to complete the illicit drug use, physical activity, and depression questionnaires.
Strangulated, incarcerated, or otherwise emergent, urgent, and non-elective inguinal herniorrhaphy.
Those patients who are allergic to, refuse to take, or are otherwise unable to take oxycodone, ibuprofen, or acetaminophen medication orally for post-operative pain management.
Patients on pain contracts, or under the care of a pain medicine specialist for management of chronic pain at the time of surgery.
Subjects with serum creatinine level > 1.3 mg/dL as measured at the baseline study visit.
Subjects with serum aspartate transaminase (AST) greater than 3 times the upper limit of normal (level >102 U/L)
Subjects with serum alanine transaminase (ALT) greater than 3 times the upper limit of normal (level > 165 U/L)
Subjects who do not speak, read, and write fluently in English.
Subjects with a history of cirrhosis.
Subjects enrolled in another clinical trial during the same period as their involvement as this study.
Subjects, who in the investigator's opinion, will be unable to complete a pain diary or follow-up visits, or otherwise not comply with the study protocol.
Intervention: MECLOFENAMIC ACID
Trial phase: Phase 2
ATC code: M01AG04 | M02AA18
SMILES: Cc1ccc(Cl)c(Nc2ccccc2C(=O)O)c1Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 150mg meclofenamic acid daily for 8 weeks

Meclofenamic acid
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorders, unspecified schizophrenia spectrum and other psychotic disorders
Negative pregnancy test in females of childbearing age

Exclusion Criteria:

Urine drug screen positive for psychostimulants such as cocaine, amphetamines and ecstasy
Any infection, neoplasm, autoimmune disease or other primary inflammatory condition (3) Previous diagnosis of intellectual disability or dementia
Current treatment with heparin
Use of or allergy to non-steroidal anti-inflammatory agent or pentosan polysulfate sodium
Current or anticipated corticosteroid use
History of peptic ulcer disease, gastro esophageal reflux disease, or gastrointestinal bleeding
Those on warfarin or any anticoagulant
Current treatment with lithium or asthma medication
Individuals with pre-existing liver, cardiac, or kidney disease