anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Dexamethasone 16mg, administered intravenously

Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
Eligibility criteria:
Inclusion Criteria:

Moderate or severe migraine

Exclusion Criteria:

Medication contra-indication
Concern for secondary cause of headache
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: No
Participants at risk: 20
Group description: Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control

liposomal bupivicaine: local field infiltration
Eligibility criteria:
Inclusion Criteria:

adult patients (>18 years old)
diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.

Exclusion Criteria:

patients undergoing revision procedures, bilateral procedures,
advanced osteoarthritis (<2mm joint space on plain radiographs)
frank dysplasia (anterior and/or lateral center edge angles <20 degrees and/or Tonnis angle >15 degrees)
diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity).
allergy to liposomal bupivicaine
Intervention: Ecopipam
Trial phase: Phase 2
SMILES: [H][C@@]12c3cc(O)c(Cl)cc3CCN(C)[C@@]1([H])CCc1ccccc12
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Participants received ecopipam HCl tablets at a targeted dose of 2 mg/kg/day, orally, once daily for up to 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up Visit within the last 30 days (or longer with permission of the medical monitor) without a major reportable protocol deviation and must be someone the Investigator feels would benefit from continued participation.

Exclusion Criteria:

Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder).
Unstable medical illness or clinically significant lab abnormalities.
Risk of suicide.
Pregnant or lactating women.
Moderate to severe renal insufficiency.
Positive urine drug screen.
Certain medications that would lead to drug interactions.
Intervention: Pioglitazone
Trial phase: Phase 1 | Phase 2
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset

Pioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset
Eligibility criteria:
Inclusion Criteria:

Stroke Patients ages 21 and over
Blood sugar ≥ 150 mg/dl
Study drug treatment should be initiated within 12 hours after time of symptom onset, if known, or the time last known normal (if time to symptom onset is unknown)
MRI or CT proven ischemic stroke
Initial NIH SS of ≥ 2
Willing and able to provide consent

Exclusion Criteria:

Known hypersensitivity to PGZ.
Infection at the time of presentation as defined by body temperature > 38 degrees C , pneumonia evident on chest X-ray, urinary tract infection (positive tests for nitrites, leukocyte esterase, and bacteria on urine analysis), other acute infection per history or current use of antibiotic or antiviral treatment.
Active malignancy and / or autoimmune disease requiring treatment.
Use of immunomodulatory drugs or chemotherapy.
History of stroke or brain injury within the last 90 days prior to presentation.
Acute illness within the last 30 days which could have affected the white blood cell count.
Known history of clinically significant hypoglycemia.
Patients already taking PGZ.
Active liver disease (ALT and /or AST 2.5 times the upper limit of normal, total bilirubin > 1.2 mg/dl).
Acute decompensated heart failure, and/or admission for an acute coronary syndrome, myocardial infarction (MI), cardiac arrest, coronary artery surgery within the past 3 months and patients with New York Heart association Class III and IV heart failure.
History of bladder cancer
Pregnant and nursing women.
Currently incarcerated patients.
Intervention: Humulene
Trial phase: Phase 1
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Smoked cannabis containing 10mg THC + No nicotine/tobacco

Cannabis: Cannabis will be smoked
Eligibility criteria:
Inclusion Criteria:

Have provided written informed consent
Be between the ages of 18 and 55
Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
Test negative for drugs of abuse aside from cannabis (via urine sample) and alcohol (via breath sample) at the screening visit and upon arrival for each experimental session.
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
Have a body mass index (BMI) in the range of 18 to 36 kg/m2
Blood pressure at screening visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Have not donated blood in the prior 30 days.
Report prior experience inhaling cannabis.
Report using cannabis at least 5 times in the past year.
Smoke ≥5 tobacco cigarettes per day on average in the past month.
Use an e-cigarette at least 15 of the past 30 days.
Have a breath carbon monoxide (CO) of >8ppm or urine cotinine >200ng/mL to confirm current nicotine use status.

Exclusion Criteria:

Non-medical use of psychoactive drugs (aside from cannabis) other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;
History of or current evidence of significant medical or psychiatric illness which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
Epilepsy or a history of seizures.
Individuals who have a recent history of traumatic brain injury diagnosed by CT/MRI and have current sequela from prior brain injury, as determined by the study physician
Individuals with anemia.
Prior history of allergic or serious adverse reaction to either cannabis or tobacco/nicotine.
Average use of cannabis more than 2 times per week in the prior 3 months.
Intervention: Melatonin
Trial phase: Phase 3
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: The group received standard treatment with the oral administration of Melatonin

Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect.
Eligibility criteria:
Inclusion Criteria:

Patients with locally advanced oral squamous cell carcinoma
Patients with locally advanced oral squamous cell carcinoma who are planned with neoadjuvant chemotherapy
Patients with locally advanced oral squamous cell carcinoma who are planned with neoadjuvant chemotherapy who have not received any definitive treatment modalities, including surgical resection and chemoradiation therapy before the study conducted
Patients who are willing to sign the informed consent form to be our subject participants
Karnofky >50

Exclusion Criteria:

Patients who are already treated with definitive therapy for locally advanced oral squamous cell carcinoma
Patients who are not eligible to be treated with chemotherapy
Intervention: Morphine
Trial phase: Phase 1 | Phase 2
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: These numbers are for all participants
Eligibility criteria:
Inclusion Criteria:

Healthy
Non-obese (body mass index less than 30 kg/m2)
Body mass greater than or equal to 65 kg

Exclusion Criteria:

Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
Any known history of renal or hepatic insufficiency/disease
Pregnancy or breast feeding
Current smokers, as well as individuals who regularly smoked within the past 3 years
Positive urine drug screen
Currently taking pain modifying medication(s)
Intervention: Perfluorohexyloctane
Trial phase: Phase 3
SMILES: CCCCCCCCC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 208
Group description: 100% Perfluorohexyloctance solution 4 times daily (QID)

NOV03: 100% Perfluorohexyloctane
Eligibility criteria:
Inclusion Criteria:

Signed ICF (Informed Consent Form)
Subject-reported history of Drye Eye Disease (DED) in both eyes
Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

Women who are pregnant, nursing or planning pregnancy
Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
Clinically significant slit-lamp findings or abnormal lid anatomy at screening
Ocular/peri-ocular malignancy
History of herpetic keratitis
Active ocular allergies or ocular allergies that are expected to be active during the study
Ongoing ocular or systemic infection
Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
Presence of uncontrolled systemic diseases
Presence of known allergy and/or sensitivity to the study drug or saline components
Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
Intervention: BALOXAVIR MARBOXIL
Trial phase: Phase 4
ATC code: J05AX25
SMILES: [H][C@@]12COCCN1C(=O)c1c(OCOC(=O)OC)c(=O)ccn1N2[C@@H]1c2ccccc2SCc2c1ccc(F)c2F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 302
Group description: Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant

Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Eligibility criteria:
Inclusion Criteria:

Household Level:
Group of at least 3 individuals of any ages defined as at least 3 persons residing at the same address for at least 4 days per calendar week
Household group utilizes common household areas
At least 2 household members meeting all individual inclusion/exclusion criteria listed below and willing to participate (e.g. at least two members of the household are 12 years of age or older)
At least one member of the household has a smartphone
Individual Level: Drug Eligible
Resident of a household with 3 or more members (including eligible cases) for 4 or more days a calendar week
Age 12 years or older weighing at least 40 kg (greater than 88 pounds)
Willing and able to take study medication
Willing to comply with all study procedures
English-speaking
Able to provide written, informed consent and/or assent (if applicable)
Permanent mailing address that is available for study staff to mail necessary materials
Individual Level: Drug Ineligible
Resident of a household with 3 or more members (including eligible cases) for 4 or more days a calendar week
Willing to comply with all study procedures
English-speaking
Able to provide written, informed consent and/or assent (if applicable)

Exclusion Criteria:

Household Level:
Previous documentation of an influenza infection prior to or during the annual influenza season in any household member prior to enrollment
Individual Level:
Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration
Individuals with hypersensitivity to baloxavir
Individuals that already have a tele-health account
Any individual that has one or more of the following conditions:
Pregnant
Currently lactating
Immunosuppressed or immunocompromised (by disease or medication)
Cancer
Liver disease
Kidney disease
Intervention: Ibuprofen
Trial phase: Phase 4
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: 51
Group description: Intranasal povidone-iodine (PDI PROFEND) will be applied to the patients' noses before orthopedic trauma surgery and after surgery. This intranasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product.

intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic
Eligibility criteria:
Inclusion Criteria:

Patients undergoing operative fixation of lower extremity fractures at the University of Iowa during the study period.

Exclusion Criteria:

Patients unable to provide informed consent due to head trauma or dementia.
Intervention: X062KF5ZV3
Trial phase: Phase 2
SMILES: CC(C)C(=O)N1CCCC12CN(C(C(N)=O)C(C)O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: NYX-2925 50 mg QD

NYX-2925 50 mg: NYX-2925 administered orally
Eligibility criteria:
Inclusion criteria:

Informed consent
Subject has diabetic peripheral neuropathy of symmetrical nature in lower extremities for ≥4 years and reports at least moderate pain over the last week
Stable diabetic and protocol allowed medication during the study
Agrees to use highly effective birth control during the study
Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study

Exclusion Criteria:

Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
Current or historical serious medical conditions
Prior participation in NYX-2925 clinical trial
Intervention: Lta4H-IN-1
Trial phase: Phase 2
SMILES: NC(CC(=O)O)Cn1nnc(-c2ccc(Oc3ncc(Cl)cc3F)cc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Phenotypic diagnosis of NASH based on the presence of all of the following:

ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
BMI ≥ 27 kg/m2 (race other than Asian) or ≥ 23 kg/m2 (Asian race)
History of type 2 diabetes mellitus with HbA1c ≤ 9%
ELF test score ≥ 8.5 and ≤ 10.5
Liver fat ≥ 8%
Patients must weigh between 40 kg (88 lbs.) and 150 kg (330 lbs.)

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of randomization or within 3 months, whichever is longer
Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1 month of randomization
Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7 days of randomization, whichever is longer
History or presence of other concomitant liver diseases
History or current diagnosis of ECG abnormalities
Patients with contraindications to MRI imaging
Current or history of significant alcohol consumption
Clinical evidence of hepatic decompensation or severe liver impairment
Women of child bearing potential (unless on highly effective methods of contraception)
Presence of liver cirrhosis
Use of OAT3 inhibitors within 5 half-lives or 7 days of randomization, whichever is longer
Intervention: Tropifexor
Trial phase: Phase 2
SMILES: O=C(O)c1cc(F)c2nc(N3[C@@H]4CC[C@H]3C[C@@H](OCc3c(-c5ccccc5OC(F)(F)F)noc3C3CC3)C4)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Phenotypic diagnosis of NASH based on the presence of all of the following:

ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
BMI ≥ 27 kg/m2 (race other than Asian) or ≥ 23 kg/m2 (Asian race)
History of type 2 diabetes mellitus with HbA1c ≤ 9%
ELF test score ≥ 8.5 and ≤ 10.5
Liver fat ≥ 8%
Patients must weigh between 40 kg (88 lbs.) and 150 kg (330 lbs.)

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of randomization or within 3 months, whichever is longer
Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1 month of randomization
Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7 days of randomization, whichever is longer
History or presence of other concomitant liver diseases
History or current diagnosis of ECG abnormalities
Patients with contraindications to MRI imaging
Current or history of significant alcohol consumption
Clinical evidence of hepatic decompensation or severe liver impairment
Women of child bearing potential (unless on highly effective methods of contraception)
Presence of liver cirrhosis
Use of OAT3 inhibitors within 5 half-lives or 7 days of randomization, whichever is longer
Intervention: X062KF5ZV3
Trial phase: Phase 2
SMILES: CC(C)C(=O)N1CCCC12CN(C(C(N)=O)C(C)O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: NYX-2925 50 mg administered orally once daily.
Eligibility criteria:
Inclusion criteria:

Informed consent
Subject has a history of fibromyalgia that was diagnosed >1 year prior to screening and reports at least moderate pain over the last week
Stable protocol allowed medication and other therapies during the study
Agrees to use highly effective birth control during the study
Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study

Exclusion Criteria:

Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
Current or historical serious medical conditions
Prior participation in NYX-2925 clinical trial
Intervention: X062KF5ZV3
Trial phase: Phase 2
SMILES: CC(C)C(=O)N1CCCC12CN(C(C(N)=O)C(C)O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: NYX-2925 100 mg administered orally once daily.
Eligibility criteria:
Inclusion criteria:

Informed consent
Subject has a history of fibromyalgia that was diagnosed >1 year prior to screening and reports at least moderate pain over the last week
Stable protocol allowed medication and other therapies during the study
Agrees to use highly effective birth control during the study
Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study

Exclusion Criteria:

Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
Current or historical serious medical conditions
Prior participation in NYX-2925 clinical trial
Intervention: Fluconazole
Trial phase: Phase 2
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 397
Group description: The placebo will consist of 10 mL of 9 mg/mL sodium chloride (NaCl, "normal saline") administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.

Sodium chloride 0.9%: Placebo
Eligibility criteria:
Inclusion Criteria:

Out-of-hospital cardiac arrest
Age ≥ 18 years
Received at least one dose of adrenaline

Exclusion Criteria:

Traumatic cardiac arrest - including drowning and external asphyxia (e.g., hanging, strangulation, or foreign object airway obstruction)
Known or strongly suspected pregnancy
Prior enrollment in the trial
Received adrenaline during cardiac arrest before arrival of prehospital personnel with the study drug
Clinical indication for calcium administration during the cardiac arrest