anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Itacitinib
Trial phase: Phase 2
ATC code: L04AA46 | L04AF05
SMILES: N#CCC1(n2cc(-c3ncnc4[nH]ccc34)cn2)CN(C2CCN(C(=O)c3ccnc(C(F)(F)F)c3F)CC2)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Itacitinib 200 mg administered orally daily for 28 days, with a second 28 day cycle allowed for responding patients.
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed GVHD that meets criteria for Minnesota standard risk
Ann Arbor 1 GVHD by biomarkers
GVHD not previously treated systemically (topical therapies and non-absorbed steroids are allowed)
Any donor type, HLA-match, conditioning regimen is acceptable
Age 12 - 75 years (children <18 years must also weigh 50 kg or more)
Patients must be engrafted post-transplant (ANC >500/μL and platelet count >20,000). Use of growth factor supplementation to maintain neutrophil count is allowed.
Direct bilirubin must be <2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
ALT/SGPT and AST/SGOT must be <5x the upper limit of the normal range within 3 days prior to enrollment.
Signed and dated written informed consent obtained from patient or legal representative.

Exclusion Criteria:

Patients currently being treated with any JAK inhibitor including ruxolitinib
Relapsed, progressing, or persistent malignancy requiring withdrawal of systemic immune suppression
Patients with uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
Severe organ dysfunction including requirement for dialysis, mechanical ventilation or oxygen supplementation exceeding 40% FiO2 within 7 days of enrollment.
Creatinine clearance or estimated glomerular filtration rate <30 ml/min as calculated by institutional practice (e.g., Cockcroft-Gault equation, CKD-EPI equation, etc)
A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
Patients receiving corticosteroids >10 mg/day prednisone (or other steroid equivalent) for any indication within 7 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions/IV meds
Patients who are pregnant
Patients receiving investigational agents within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of itacitinib
History of allergic reaction to itacitinib or any JAK inhibitor
Intervention: PENICILLIN V
Trial phase: Phase 1
ATC code: J01CE02
SMILES: CC1(C)S[C@@H]2[C@H](NC(=O)COc3ccccc3)C(=O)N2[C@H]1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Phenoxymethyl Penicillin: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study

Microneedle array: The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
Eligibility criteria:
Inclusion Criteria:

Adult >18 years old
Healthy with no evidence of active infection
Previously received penicillin with no adverse effects

Exclusion Criteria:

High risk of skin soft tissue infection or local skin and soft tissue infection near sensor site
Previous history of allergies to adhesive strips or active dermatitis
Penicillin allergy or previous adverse event whilst receiving penicillin
Anaemia on screening bloods (defined as haemoglobin <13 g/dL in males and <12 g/dL in females)
Intervention: PROPYLENE GLYCOL
Trial phase: Phase 4
SMILES: CC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: Subjects in this group will use Systane Complete before, during, and after contact lens use.

Systane Complete: Systane Complete is an artificial tear.
Eligibility criteria:
Inclusion Criteria:

Daily disposable contact lens wearers
20/30 visual acuity or better
Self-report contact lens discomfort
Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12

Exclusion Criteria:

Other contact lens modalities/wear schedules (e.g., two week and monthly replacement CLs, gas permeable CLs)
Non-compliant daily disposable contact lens wearers
Systemic health conditions that alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)
History of ocular surgery within the past 12 months
History of severe ocular trauma
History of active ocular infection or inflammation
Isotretinoin-derivatives use
Ocular medication use
Pregnant or breast feeding
Intervention: Dolutegravir
Trial phase: Phase 2
ATC code: J05AJ03 | J05AR13 | J05AR21 | J05AR25 | J05AR27
SMILES: [H][C@]12Cn3cc(C(=O)NCc4ccc(F)cc4F)c(=O)c(O)c3C(=O)N1[C@H](C)CCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Dolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily with an additional dolutegravir 50 mg dose taken 12 hours later.

Dolutegravir 50 mg: Dolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily is given with a supplementary dose of dolutegravir 50 mg.
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection as documented by screening plasma HIV-1 RNA >1000 c/mL
ART-naïve (short-term antiretroviral use for prevention of mother-to-child transmission will be allowed) or
ART treatment interrupters on ART <6 months prior to interruption or virologically suppressed (<50 copies/mL or LDL) <6 months prior to interruption
On rifampicin-based therapy for tuberculosis for <3 months
CD4 counts >100 cells/µL
Women of child-bearing potential willing to use adequate contraception (defined as either an intrauterine contraceptive device or hormonal contraception as per national guidelines)

Exclusion Criteria:

Pregnant/breastfeeding
Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (calculated by the Modification of Diet in Renal Disease (MDRD) study)
Alanine aminotransferase >3 times upper limit of normal (ULN)
Allergy or intolerance to one of the drugs in regimen
Concomitant medication known to significantly reduce or increase dolutegravir exposure (except rifampicin)
Active psychiatric disease or substance abuse
On treatment for active AIDS-defining condition other than tuberculosis (participants on maintenance therapy may be enrolled)
Malignancy
Any other clinical condition that in the opinion of an investigator puts the patient at increased risk of participating in the study.
Intervention: Methylnaltrexone
Trial phase: Phase 2
ATC code: A06AH01
SMILES: C[N@+]1(CC2CC2)CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).

Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
Eligibility criteria:
Inclusion Criteria:

Subject is scheduled to undergo a 1 - 3 level lumbar spinal fusion for degenerative spinal conditions including neurogenic claudication and/or lumbar radiculopathy with stenosis and/or spondylolisthesis.
Subject must be over the age of 18 years old.
Subject has been unresponsive to conservative care for a minimum of 6 months.
The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol and have the ability to understand and give written informed consent.

Exclusion Criteria:

Previous Treatment with MNTX
History of mechanical gastrointestinal obstruction
History of OIC refractory to outpatient medical management
Presence of a peritoneal catheter for intraperitoneal chemotherapy or dialysis
Clinically relevant active diverticular disease
Recent history of bowel surgery within previous 12 months
Use of vinca alkaloids within previous four months
Renal failure defined as Estimated Glomerular Filtration Rate (eGFR) <30 ml/min per 1.73 m^2 or requires dialysis
Known or suspected allergy to MNTX or similar compounds (e.g. naltrexone or naloxone)
Participation in a study with investigational products within 30 days before first dose of MNTX
Pregnant or nursing
Clinically important abnormalities that may interfere with participation or compliance to the study, as determined by investigator.
Intervention: Methylprednisolone
Trial phase: Phase 2
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP < 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level > 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone).

Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Eligibility criteria:
For the Pneumonia arm of the study:

Inclusion Criteria:

Patients admitted to hospital with community acquired pneumonia.
Acute respiratory failure SpO2/FiO2 < 315 (SpO2<90% on room air or <97% on 2L NC).

Exclusion Criteria:

Contraindications or unwilling to use steroids by patient or provider
Refractory septic shock defined as a requirement of norepinephrine dose or equivalent above >0.1 microgram/kilogram/minute or 2 or more vasopressors
Pre-admission chronic use of steroids or other immunosuppressive medications
Adrenal insufficiency
Comfort care
Leukopenia <1000/mm or neutropenia <500/mm (except if attributable to pneumonia) and HIV positive with a CD4 count <100
Recent or past history of bone marrow or solid organ transplantation
Hospital admission in the previous 30 days
Suspected flare of Interstitial lung disease (infectious and non-infectious)
Positive influenza testing or high suspicion for influenza

For the COVID-19 arm of the study:

Inclusion Criteria:

Patients admitted to hospital with COVID-19 pneumonia (high suspicion or confirmed by positive SARS CoV-2 testing).
Acute respiratory failure SpO2/FiO2 < 315 (SpO2<90% on room air or <97% on 2L NC).

Exclusion Criteria:

Contraindications or unwilling to use steroids by patient or provider
Refractory septic shock defined as a requirement of norepinephrine dose or equivalent above >0.1 microgram/kilogram/minute or 2 or more vasopressors
Pre-admission chronic use of steroids or other immunosuppressive medications
Adrenal insufficiency
Comfort care
Leukopenia <1000/mm or neutropenia <500/mm (except if attributable to pneumonia) and HIV positive with a CD4 count <100
Recent or past history of bone marrow or solid organ transplantation
Suspected flare of Interstitial lung disease (infectious and non-infectious)
Positive influenza testing or high suspicion for influenza
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 3
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Eligibility criteria:
Inclusion Criteria:

Nonpregnant women of childbearing potential must be using a medically acceptable form of birth control for at least 3 months prior to Screening, and must continue its use for the duration of the study. Women not of childbearing potential must be surgically sterilized or at least one year post menopausal, or be otherwise incapable of bearing children
2-year history of seasonal allergic rhinitis
Positive skin test response to a local seasonal allergen within last 2 years
Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria:

Women who are pregnant or breastfeeding
Women of childbearing potential who are not using an acceptable form of birth control
Pre-menarchal females
Asthma requiring therapy with inhaled or systemic corticosteroids
Significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, may interfere with the study, or require treatment which might interfere with the study
On immunotherapy (unless maintenance therapy)
Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks
Use of any investigational drug within the previous 90 days unless the investigational drug is a nasal corticosteroid or has a short (12 hours or less) duration of action, in which case the washout period will be 30 days
Large nasal polyps, marked septal deviations or any other nasal structural abnormality that significantly interferes with nasal air flow
Allergy to corticosteroids, or a history of multiple drug allergies
History of posterior subcapsular cataracts
Dependence upon nasal, oral or ocular decongestants or who are diagnosed with rhinitis medicamentosa
Chronic use of any medication which could affect the course of seasonal allergic rhinitis
Clinically significant abnormal electrocardiogram (ECG)
Intervention: Tranexamic acid
Trial phase: Phase 2 | Phase 3
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 110
Group description: Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
Eligibility criteria:
Inclusion Criteria:

Intrauterine pregnancy
Age ≥ 18
Gestation age ≥ 37 weeks 0 days
Scheduled cesarean delivery
Second or third cesarean delivery
Singleton pregnancy

Exclusion Criteria:

First cesarean delivery
Four or more cesarean deliveries
Intrauterine fetal death
Fetal anomalies
Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))
Thrombocytopenia (Platelet count < 100k)
Internal bleeding, external bleeding, easy bruising
History of thrombotic event
Hypertension
Diagnosis of renal insufficiency (Creatinine> 1 mg/dL)
Insulin-treated diabetes
Suspected morbidly adherent placenta
Placenta previa
Multiple Gestations
BMI ≥ 50
Hematocrit ≤ 25
Blood transfusion within 24 hours prior to cesarean delivery
History of abnormal bleeding or blood disorder
Planned general anesthesia
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.

Saline: 40 mL sterile normal saline
Eligibility criteria:
Inclusion Criteria:

Adults 18-80 years old
Candidate for general anesthesia
Undergoing laparoscopic sleeve gastrectomy
Patients of participating surgeons

Exclusion Criteria:

Prior bariatric surgery of any kind
Previous abdominoplasty
Allergy or intolerance to one of the study medications
ASA > 4
Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of >5mg/day for one month)
History of alcohol/drug abuse
History of hepatic or renal insufficiency
Patient refusal
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: 43
Group description: Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.

Bupivacaine: 40 mL 0.25% bupivacaine
Eligibility criteria:
Inclusion Criteria:

Adults 18-80 years old
Candidate for general anesthesia
Undergoing laparoscopic sleeve gastrectomy
Patients of participating surgeons

Exclusion Criteria:

Prior bariatric surgery of any kind
Previous abdominoplasty
Allergy or intolerance to one of the study medications
ASA > 4
Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of >5mg/day for one month)
History of alcohol/drug abuse
History of hepatic or renal insufficiency
Patient refusal
Intervention: Pilocarpine Hydrochloride
Trial phase: Phase 3
SMILES: CCC1C(=O)OCC1Cc1cncn1C.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 212
Group description: Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Eligibility criteria:
Inclusion Criteria

Subjective complaints of poor near vision that impact activities of daily living

Exclusion Criteria

Uncontrolled systemic disease

Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of AGN-190584. History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. However, participants with history of photorefractive keratectomy (PRK) or laser-assisted in situ keratomileusis (LASIK) with corrected distance visual acuity (CDVA) meeting inclusion criteria will be allowed to enroll.

Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications

Concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study

Concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes

Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study

Participation in a blood or plasma donation program within 30 days prior to study intervention administration

Severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point Oxford scale and an ocular surface disease index (OSDI) score of > 33) at the screening visit

Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity

Narrow iridocorneal angles (Shaffer grade ≤ 2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy

History of iris trauma, Adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria > 1 mm between pupils under mesopic conditions at the screening visit

Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy

Diagnosis of any type of glaucoma or ocular hypertension

Bifocal or multifocal spectacles or contact lenses for habitual correction. Participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled

Abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history

Females who are pregnant, nursing, or planning a pregnancy during the study
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
Healthy volunteers: No
Participants at risk: 86
Group description: Participants received Crinone 8% (90 milligrams [mg] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.
Eligibility criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

Participants who will receive artificial frozen-thawed embryo transfer (FET) cycle study interventions
Participants who have no more than two Day 5 embryos are planned to be transferred (follow the clinical practice of the study site)
Participants have received estradiol valerate for no more than 20 days
Participants have a transitional-endometrium of greater than or equal to 8 millimeter
Participants have normal uterine cavity
Participants can give signed informed consent
Participants are willing to follow the study protocol and able to complete the study

Exclusion Criteria:

Participants are willing to follow the study protocol and able to complete the study
Participants with greater than or equal to three previously failed cycles of ET
Participants with diseases that cannot tolerate pregnancy
Hydrosalpinx
Severe endometriosis (Endometriosis American Society for Reproductive Medicine (ASRM) criteria from 1996)
Known hypersensitivity to progesterone, the excipients of Crinone and Duphaston Vaginal bleeding of unknown origin
History of recurrent miscarriages
Vaginitis
Thromboembolic diseases (thrombophlebitis, thromboembolic disorder, or cerebral apoplexy) or participants with a history of these conditions
Known or suspected progestogen-dependent neoplasm
Participation in another clinical trial within the past 30 days
Contraindications of both Crinone and Duphaston