anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Calcitriol
Trial phase: Phase 2
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Calcitriol 4mcg PO/NGT/OGT daily x 5 days

Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18
Admitted to the ICU within 48h prior to enrollment
Likely to remain in the ICU (alive) for ≥72h
Naso/orogastric tube or ability to swallow
High risk of severe AKI

Exclusion Criteria:

Serum total calcium > 9.0 mg/dl or phosphate > 6.0 mg/dL within previous 48h
Currently receiving oral calcium supplementation
Ingestion of vitamin D3 >1,000 IU/day or any 25-hydroxyvitamin D or 1,25-dihydroxyvitamin D during the previous 7 days
AKI stage 2 or 3 (based on KDIGO serum creatinine and/or urine output criteria)
History of transplantation or receiving chronic (>7days) of immunosuppressive medications (not including glucocorticoid steroids at a dose less than or equivalent to prednisone 20 mg/day)
Neutropenia in the previous 48h
Active primary parathyroid disease, active granulomatous disease, or symptomatic nephrolithiasis in the previous 3 months
Receiving cytochrome P450 inhibitors
Chronic Kidney Disease stage V or End Stage Renal Disease
Hemoglobin < 7 g/dL
GI malabsorption
Prisoner
Pregnancy or breast feeding
Intervention: Linerixibat
Trial phase: Phase 4
SMILES: CCCC[C@]1(CC)CS(=O)(=O)c2cc(CNC(CC(=O)O)CC(=O)O)c(OC)cc2[C@@H](c2ccccc2)N1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes.

Sphenopalatine ganglion Block
Eligibility criteria:
Inclusion Criteria

Age 18 years or age or greater
Postpartum obstetric parturient who was previously admitted to UCH.

Diagnosis of post-dural puncture headache based on the International Classification of Headache Disorders:

Dural puncture has been performed
Headache has developed within 5 days of the dural puncture
Not better accounted for by another ICHD-3 diagnosis.
Occurring immediately or within seconds of assuming an upright position and resolving quickly (within 1 minute) after lying horizontally.

Exclusion Criteria

Refusal to participate in the study
Placement of an EBP within the past 5 days
Allergy and/or intolerance to any the study materials
Contraindications to an EBP
Plan for therapeutic anticoagulation post-partum
Intervention: Victoza
Trial phase: Phase 3
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Eligibility criteria:
Inclusion Criteria:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
BMI above or equal to 30 kg/m^2
Male or female, age 18 years or older at the time of signing informed consent

Exclusion Criteria:

HbA1c (glycosylated haemoglobin) above or equal to 6.5% (at screening visit), or diagnosis of type 1 or type 2 diabetes mellitus
Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block
Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple Endocrine Neoplasia type 2 (MEN2)
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
History of pancreatitis (acute or chronic)
History of major depressive disorder within the past 2 years
Any lifetime history of a suicide attempt
Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to 110 mmHg)
History of malignancy (except for non-melanoma skin cancer) within the past 5 years
Intervention: Tramal
Trial phase: Phase 4
SMILES: COc1cccc(C2(O)CCCCC2CN(C)C)c1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure
Eligibility criteria:
Inclusion Criteria:

Patients with craniotomy for supratentorial tumors under general anesthesia
American Society of Anaesthesiologists (ASA) 2 and stable ASA 3 patients
Elective surgery
Patients with Glasgow Coma Scale (GCS) 15/15

Exclusion Criteria:

Patients with a history of allergy or hypersensitivity to tramadol.
History of epilepsy or convulsions due to any reason.
Chronic usage of analgesic drugs.
Patients using monoamine oxidase inhibitors.
Patients with clinical signs of raised ICP.
Obesity (women with a body mass index >35 kg/m2 or men with a body mass index >42 kg/m2)
Language barrier.
Patients taking B-blockers or Ca channel blockers.
Patients above 65 years of age ( Physiology difference)
Intervention: Squaric acid dibutyl ester
Trial phase: Phase 1 | Phase 2
SMILES: CCCCOc1c(OCCCC)c(=O)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: 2-dose
Eligibility criteria:
Inclusion Criteria:

Age ≥18
Clinical diagnosis of herpes labialis, which may be made at the screening visit based on the patient's self-reported history of symptoms. An active herpes labialis outbreak at the time of entry into the clinical trial will neither be required nor will be an exclusion criteria.
Self report having four or more episodes of herpes labialis in the past 12 months

Exclusion Criteria:

People that have had treatment with anti viral therapy within 2 weeks before sensitization dose.
Pregnant or lactating females.
Current or recurrent non-herpetic infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection.
Therapy with glucocorticoid or immunosuppressants at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma or topical steroids in sites other than face.
History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers)
History of organ transplantation
HIV-positive status determined by history at screening or known history of any other immunosuppressive disease.
Severe co-morbidities (diabetes mellitus requiring insulin, CHF (EF<50% at baseline will be exclusionary) MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
History of exposure to squaric acid or squaric acid dibutyl ester.
Known hypersensitivity to DMSO
Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
Previous or current participation in a clinical trial of SADBE to treat herpes labialis.
Intervention: Phenylephrine
Trial phase: Not Applicable
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements.

Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop
Eligibility criteria:
Inclusion Criteria:

Any self-declared ethno-racial category.
Medically healthy subjects.
Subjects with two healthy eyes.
Intraocular pressure (IOP) less than 22 mmHg in each eye.
Best-corrected visual acuity (BCVA) in each eye 20/50 or better.
Open angles in both eyes.
Contact lens wear stopped at least 3 days prior to study, and during the study.
Ability to cooperate for examinations required for study.

Exclusion Criteria:

Chronic or acute ophthalmic diseases including glaucoma, wet type macular degeneration, uveitis and clinically significant cataract.
Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis.
Cornea pathologic changes preventing reliable measurement.
Narrow anterior chamber angle.
Previous intraocular surgeries, laser procedures, and intravitreal injections.
Previous corneal refractive surgeries.
Myopia greater than -6.00 D spherical equivalent.
Hyperopia greater than +2.00 D spherical equivalent.
Lack of suitable episcleral vein for measurement.
Ocular trauma within the past 6 months.
Ocular infection or ocular inflammation in the past 3 months.
Ocular medication of any kind within 30 days of study visit.
Known hypersensitivity to Phenylephrine or topical anesthetic medication.
Severe hypertension: Systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 105 mmHg.
A known history of ischemic heart disease (angina or myocardial infarction), cerebrovascular accidents, cardiac arrhythmias, cerebral or aortic aneurysms.
Uncontrolled diabetes mellitus.
Uncontrolled hyperthyroidism.
Use of some systemic medications within 30 days prior to study including: β-adrenergic antagonists, α-adrenergic agonists and antagonists, calcium channel blockers, diuretics, vasodilators, monoamine oxidase inhibitors, and systemic steroids.
Participation in any interventional study within the past 30 days prior to study visit.
Women who are pregnant.
Intervention: ASPIRIN
Trial phase: Phase 4
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 650 mg. Twice a day for 8 weeks

Aspirin
Eligibility criteria:
Inclusion Criteria:

Adults who have Fontan repair of single ventricle

Exclusion Criteria: Persons with the following history, conditions, or behavior will be excluded

Active protein losing enteropathy within the past three years
Congestive heart failure
Active arrhythmias
Taking Coumadin (Warfarin)
Bleeding disorder
Known esophageal varicies
Consuming more than 10 alcoholic drinks per week.
Pregnant
Planning to become pregnant
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily for 8 or 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.
Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at Screening Visit.
Participant must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed greater than or equal to 2 months prior to screening.
Participant must be documented as having no cirrhosis or compensated cirrhosis.

Exclusion Criteria:

Female participant who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
Intervention: Posaconazole
Trial phase: Phase 4
ATC code: J02AC04
SMILES: CC[C@@H]([C@H](C)O)n1ncn(-c2ccc(N3CCN(c4ccc(OC[C@@H]5CO[C@@](Cn6cncn6)(c6ccc(F)cc6F)C5)cc4)CC3)cc2)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU

Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.
Eligibility criteria:
Inclusion Criteria:

Age greater than 18 years
Admission for ICU care
The presence of suspected or confirmed fungal infection requiring systemic antifungal therapy
Presence of central venous access for drug administration

Exclusion Criteria:

Age < 18 years
Pregnancy
Prescription of drugs that are known to interact with posaconazole
Oral posaconazole use within the last two week prior to enrolment
Documented history of drug reaction to the triazole antifungal medications
Intervention: Ritlecitinib
Trial phase: Phase 2
ATC code: L04AF08
SMILES: C=CC(=O)N1C[C@H](Nc2ncnc3[nH]ccc23)CC[C@@H]1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Eligibility criteria:
Inclusion Criteria

Subjects between the ages of 18 and 75 years, inclusive
Must have moderate-to-severe, active Rheumatoid Arthritis
Must have had an inadequate response to Methotrexate
Subjects may have received one approved TNF inhibiting biologic agent that was inadequately effective and/or not tolerated

Exclusion Criteria

Subjects with any acute or chronic infections or infection history
Have acute or active chronic dermatological disorders prior to study start
Any major illness/condition(s) or evidence of an unstable clinical condition that in the judgment of the investigator would make the subject inappropriate for entry into this study
Known immunodeficiency disorder or a first degree relative with hereditary immunodeficiency
Any live (attenuated) vaccines or current routine household contact with anyone who has received live (attenuated) vaccine
Intervention: Amifampridine Phosphate
Trial phase: Phase 3
SMILES: Nc1ccncc1N.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: amifampridine phosphate 10 mg (amifampridine equivalent) by mouth, 30 to 80 mg total daily dose, 3 to 4 times per day for 4 days

Amifampridine Phosphate
Eligibility criteria:
Inclusion Criteria:

Male or female ≥18 years of age and currently receiving amifampridine phosphate for LEMS.
Diagnosis of LEMS by antibody testing or electromyography (EMG).
Completion of anti-cancer treatment at least 3 months (90 days) prior to Screening.
If receiving peripherally acting cholinesterase inhibitors (e.g. pyridostigmine), a stable dose of cholinesterase inhibitors is required for at least 7 days prior to randomization and throughout the study.
If receiving permitted oral immunosuppressants (prednisone or other corticosteroid), a stable dose is required for at least 30 days prior to randomization and throughout the study.
Female patients of childbearing potential must practice an effective, reliable contraceptive regimen during the study.
Able to perform all study procedures and assessments.
Willing and able to travel to study site and attend all clinic study visits.
Willing and able to provide written informed consent.

Exclusion Criteria:

Clinically significant long corrected QT (QTc) interval on ECG in previous 12 months.
Seizure disorder.
Active brain metastases.
Unable to ambulate.
Pregnant or lactating females.
Any other condition which, in the opinion of the Investigator, might interfere with the patient's participation in the study or confound the assessment of the patient.
Intervention: Progesterone
Trial phase: Phase 4
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Daily self-administered vaginal progesterone

Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
viable intrauterine pregnancy confirmed by ultrasound
presentation to antenatal care prior to 24 weeks gestation
antibody-confirmed HIV-1 infection
initiating or continuing ART treatment in pregnancy
ability and willingness to provide written informed consent
willing to adhere to study visit schedule

Exclusion Criteria:

multiple gestation
non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length <20mm on screening ultrasound)
planned or in situ cervical cerclage
evidence of threatened abortion, preterm labor, or ruptured membranes
major fetal anomaly detected on screening ultrasound
known uterine anomaly
known or suspected allergy or contraindication to VP or placebo components
Intervention: ULOTARONT
Trial phase: Phase 2
SMILES: CNC[C@@H]1OCCc2ccsc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 156
Group description: SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
Eligibility criteria:
Inclusion Criteria:

Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator.

Subject has completed Study SEP361 201 through Week 4
Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201.
Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration

Exclusion Criteria:

Subject answers "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of Study SEP361 201.
Subject is pregnant or lactating.
Subject is at high risk of non-compliance in the Investigator's opinion.
Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.
Intervention: Fluconazole
Trial phase: Phase 2
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Fluconazole Diflucan

Fluconazole
Eligibility criteria:
Key Inclusion Criteria:

Informed consent

Clinical diagnosis of moderate to severe VVC

Negative pregnancy test

Vaginal pH less than 4.5

Key Exclusion Criteria:

Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole antifungal drugs

Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy

Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months

Has another cause of vulvovaginitis

Has other urogenital infection(s) that would potentially alter their response to disease

Has another vaginal or vulvar condition that would confound the interpretation of clinical response

Has significant laboratory abnormality at screening

Has any known azole-resistant Candida infection;

Has any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk