anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Racivir
Trial phase: Phase 3
ATC code: J05AF09 | J05AR03 | J05AR06 | J05AR08 | J05AR09 | J05AR17 | J05AR18 | J05AR19 | J05AR20 | J05AR22
SMILES: Nc1nc(=O)n(C2CSC(CO)O2)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Currently receiving a TDF and FTC or 3TC-containing 'backbone' (maximum 2 NRTIs) regimen plus a third agent for ≥ 6 consecutive months prior to screening visit. For individuals with 3 or more ART regimens, a regimen history must be provided for approval by the Sponsor.

Refer to assigned interventions for allowed third agents of the current regimen.

Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay). In the preceding 6 months prior to screening, one episode of "blip" (HIV-1 RNA > 50 and < 400 copies/mL) is acceptable, only if HIV-1 RNA is < 50 copies/mL immediately before and after the "blip".
Plasma HIV-1 RNA level < 50 copies/mL at screening visit
Adequate renal function
Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula (eGFRCG) and are on ARVs that are appropriately dose adjusted for renal function per package insert
All documented historical plasma genotype(s) must not show resistance to TDF or FTC, including, but not limited to the presence of reverse transcriptase resistance mutations K65R, K70E, M184V/I, or thymidine analog-associated mutations (TAMs) that include M41L, L210W, D67N, K70R, T215Y/F, K219Q/E/N/R. If historical plasma prior to first ART is not available or individual has 3 or more ART regimens, individuals will have proviral genotype analysis prior to Day 1 to confirm absence of archived resistance to TDF or FTC.
Study performed dual energy x-ray absorptiometry (DXA) scan and T-score received prior to Day 1

Key Exclusion Criteria:

Previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time) if the current regimen contains a PI/r
Individuals will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV)
A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4+ cell count and/or percentage criteria)
Hepatitis C virus that would require therapy during the study
Individuals receiving ongoing treatment for bone disease (eg, osteoporosis), including bisphosphonates, denosumab, and strontium ranelate

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Cyclosporine
Trial phase: Phase 2
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Active comparator, open label arm . Cyclosporine A 0.05% ophthalmic emulsion topical ocular eye drops.

1 drop in each eye, twice daily.
Eligibility criteria:
Inclusion Criteria:

Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document
Patient-reported history of dry eye in both eyes
Current use of over-the-counter and/or prescription eye drops for dry eye symptoms
Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

Women who are pregnant, nursing or planning a pregnancy
Unwillingness to submit a blood pregnancy test at screening and at 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
DED secondary to scarring or ocular or periocular malignancy
History of herpetic keratitis
Active ocular allergies or ocular allergies that are expected to be active during the study period
Ongoing ocular or systemic infection at screening or baseline
Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening
Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
Presence of an uncontrolled systemic disease
Presence of a known allergy and/or sensitivity to the study drug or its components
Intervention: Tranexamic acid
Trial phase: Phase 4
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: 32
Group description: Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first.

Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Eligibility criteria:
Inclusion Criteria:

all patients undergoing intervention for chronic subdural hematoma (cSDH) including drainage
cSDH will be defined as hematoma on CT imaging that is predominantly iso- to hypodense to brain
18-85 years of age

Exclusion Criteria:

cSDH not requiring surgical drainage
patients undergoing bedside twist drill craniostomy
medically unstable for surgery
patients requiring long-term anticoagulation (unable to stay off for less than 30 days)
patients not expected to survive to the completion of followup
patients comatose prior to the initiation of treatment
history of thromboembolic problem including stroke, myocardial infarction, deep vein thrombosis and/or pulmonary embolism
pregnant
minor
allergy/sensitivity to tranexamic acid
irreversible coagulopathy
known clotting disorder
bilateral hematomas with both requiring drainage
incarcerated
any patient not judged suitable for the study by the investigators
women who are taking combination hormonal contraception
Intervention: Molindone
Trial phase: Phase 3
ATC code: N05AE02
SMILES: CCc1c(C)[nH]c2c1C(=O)C(CN1CCOCC1)CC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 56
Group description: Subjects were randomized to receive SPN-810 9 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.
Eligibility criteria:
Inclusion Criteria:

Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication.
Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.

Exclusion Criteria:

Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as the primary diagnosis.
Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or substance or alcohol abuse.
Intervention: Molindone
Trial phase: Phase 3
ATC code: N05AE02
SMILES: CCc1c(C)[nH]c2c1C(=O)C(CN1CCOCC1)CC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 142
Group description: Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.
Eligibility criteria:
Inclusion Criteria:

Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication.
Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.

Exclusion Criteria:

Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as the primary diagnosis.
Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or substance or alcohol abuse.
Intervention: Adriforant
Trial phase: Phase 2
SMILES: CN[C@@H]1CCN(c2cc(NCC3CC3)nc(N)n2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally OD for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

A documented history of moderate to severe plaque psoriasis for at least 6 months prior to screening.
Male or female, aged ≥18 years.
Psoriasis Area and Severity Index (PASI) ≥10 at both Screening and Day 0.
An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.
Psoriasis affecting ≥10% body surface area (BSA) at Screening and Day 0.

Exclusion Criteria:

Current diagnosis of Pustular, Guttate, Erythrodermic, exfoliative or only nail psoriasis or a diagnosis of inverse psoriasis without having plaque psoriasis.
Concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.
Active skin infections (e.g. impetigo, abscesses) or any other clinically apparent infections.
Biologic treatments for psoriasis (e.g. Enbrel, Humira, Stelara, Cosentyx) within 3 months of the start of the Run-In.
Phototherapy (e.g. UVA, UVB, PUVA) within 4 weeks of the start of the Run-In.
Oral calcineurin inhibitors and immunosuppressants (e.g. cyclosporine, azathioprine, methotrexate) within 4 weeks of the start of the Run-In.
Systemic corticosteroids within 4 weeks of the start of the Run-In.
Oral antihistamines and leukotriene inhibitors and tricyclic antidepressants within 1 week of the start of the Run-In.
Topical steroids (any potency), topical calcineurin inhibitors (tacrolimus, pimecrolimus), salicylic acid and urea containing treatments and coaltar preparations, topical and oral retinoids and vitamin D derivatives, within 1 week of the start of the Run-In.
Intervention: Ademetionine
Trial phase: Phase 3
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.

DSXS: active treatment

Placebo: placebo treatment
Eligibility criteria:
Inclusion Criteria:

male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of mild to moderate plaque psoriasis

Exclusion Criteria:

patient is< 12 years old.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: 0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300

Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair
Eligibility criteria:
Inclusion Criteria:

children 2-12 years requiring laceration repair using suturing and use of injected lidocaine

Exclusion Criteria:

Administration in ER of analgesia or sedation other than acetaminophen or ibuprofen prior to enrolment
ASA of III or greater
Multi-system trauma
Severe neurologic impairment or non-verbal autism, known allergy/hypersensitivity to lidocaine or midazolam
Parent/guardian does not speak one of French or English
No parent/guardian present during procedure
Intervention: Midazolam
Trial phase: Phase 4
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: 0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300

Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair
Eligibility criteria:
Inclusion Criteria:

children 2-12 years requiring laceration repair using suturing and use of injected lidocaine

Exclusion Criteria:

Administration in ER of analgesia or sedation other than acetaminophen or ibuprofen prior to enrolment
ASA of III or greater
Multi-system trauma
Severe neurologic impairment or non-verbal autism, known allergy/hypersensitivity to lidocaine or midazolam
Parent/guardian does not speak one of French or English
No parent/guardian present during procedure
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.

Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Patients scheduled for total hip or knee replacement

Exclusion Criteria:

Patients taking anticoagulation
Infection at or near the intended needle insertion site
Patients with sacral decubitus ulcer at or near the intended needle insertion site aortic stenosis
Complex spine anatomy
ASA class greater than III
Failed SAB as determined by the staff anesthesiologist
Intervention: Midazolam
Trial phase: Phase 2 | Phase 3
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.

Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
Eligibility criteria:
Inclusion Criteria:

50 pregnant women
ASA-I and II parturients
Weight 50-80 kgs
Pre-eclampsia

Exclusion Criteria:

Thrombocytopenia
HELLP syndrome
Parturients on magnesium therapy
Foetal distress
Parturients on benzodiazepine therapy
Patient refusal
Contraindications to regional anaesthesia
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2 | Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Infants in the Placebo arm will receive 0.9% sodium chloride (0.1 ml/hr). If, after 6 hrs there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion (in this arm the placebo) will be increased to 0.2 ml/kg/hr. This rate will be continued throughout the remainder of the study.

0.9%NS: Randomized to receive Fenoldopam or 0.9%NS
Eligibility criteria:
Inclusion Criteria:

Gestational age at birth 23 0/7 to 27 6/7 weeks by best obstetrical dating
No previous exposure to indomethacin
Clinical determination to use indomethacin to attempt closure of PDA
No known congenital abnormalities involving the kidneys, heart or lungs
No preexisting renal dysfunction, defined as serum creatinine > 1.0 mg/dl, or urine output <1.0 ml/kg/hour over the previous 24 hours.

Exclusion Criteria:

Enrollment in concurrent study in which interventions may contribute confounding variables or have competing outcomes
Infants with antenatally or postnatally diagnosed renal or urinary tract abnormalities
Infants with umbilical cord or infant blood pH below 7.0 at any time before enrollment
Attending physician unwilling to have infant participate in study
Absence of informed consent
Intervention: Fenoldopam
Trial phase: Phase 2 | Phase 3
ATC code: C01CA19
SMILES: Oc1ccc(C2CNCCc3c2cc(O)c(O)c3Cl)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Infants in the experimental arm will receive fenoldopam (60 ug/ml; 0.1 ml/hr to provide 0.1ug/kg/min). If, after 6 hrs there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion will be increased to 0.2 ml/kg/hr (0.2 ug/kg/min for infants receiving fenoldopam). This rate will be continued throughout the remainder of the study.

Fenoldopam: Randomized to receive Fenoldopam or 0.9%NS
Eligibility criteria:
Inclusion Criteria:

Gestational age at birth 23 0/7 to 27 6/7 weeks by best obstetrical dating
No previous exposure to indomethacin
Clinical determination to use indomethacin to attempt closure of PDA
No known congenital abnormalities involving the kidneys, heart or lungs
No preexisting renal dysfunction, defined as serum creatinine > 1.0 mg/dl, or urine output <1.0 ml/kg/hour over the previous 24 hours.

Exclusion Criteria:

Enrollment in concurrent study in which interventions may contribute confounding variables or have competing outcomes
Infants with antenatally or postnatally diagnosed renal or urinary tract abnormalities
Infants with umbilical cord or infant blood pH below 7.0 at any time before enrollment
Attending physician unwilling to have infant participate in study
Absence of informed consent
Intervention: Mifepristone
Trial phase: Phase 4
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery

Mifepristone
Eligibility criteria:
Inclusion Criteria:

Intrauterine fetal death as confirmed by absence of cardiac motion on ultrasound by Attending physician at the time of admission to the hospital.
Estimated gestational age greater than 20 weeks
Hemodynamically stable and appropriate for induction of labor as per primary clinical health team in house
Women with one prior low transverse cesarean delivery

Exclusion Criteria:

History of 2 or more low transverse cesarean deliveries
Prior classical cesarean delivery
History of abdominal myomectomy
Known or suspected allergic reaction to mifepristone
Known or suspected adrenal gland disease
Known or suspected bleeding diatheses or coagulopathies
Known or suspected use of QTc-prolonging medication
Known maternal medical or physical conditions that prohibits vaginal delivery
Intervention: Alectinib
Trial phase: Phase 1
ATC code: L01ED03 | L01XE36
SMILES: CCc1cc2c(cc1N1CCC(N3CCOCC3)CC1)C(C)(C)c1[nH]c3cc(C#N)ccc3c1C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants with moderate hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 milligrams (mg) on Day 1.
Eligibility criteria:
Inclusion Criteria:

All Participants

Body mass index between 18 to 35 kilograms per square meter (kg/m^2) inclusive and weight greater than (>) 50 kilograms (kg)
Female participants must be surgically sterile or post-menopausal
Male participants and their partners of child-bearing potential must be willing to use 2 effective methods of contraception, one of which must be a barrier method

Participants with Hepatic Impairment

- Documented chronic stable liver disease (Child-Pugh Class A, B or C)

Exclusion Criteria:

All Participants

Pregnant or lactating women, males with female partners who are pregnant or lactating, or women of child bearing potential
Positive test for drugs of abuse or alcohol
Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to study drug administration
History of hypersensitivity to any of the additives in the alectinib formulation
Participants under judicial supervision, guardianship, or curatorship
History of severe drug-related allergic reactions or drug-induced hepatotoxicity

Healthy Participants

Use of any medications (prescription or over-the-counter), within 2 weeks or 5 half-lives (whichever longer) prior to study drug administration
Use of any herbal supplements or any metabolic inducers within 4 weeks, or 5 half-lives (whichever is longer) prior to study drug administration

Participants with Hepatic Impairment

Positive screening test for human immunodeficiency virus (HIV)
History of liver transplantation
Hepatocellular carcinoma or acute liver disease
Severe ascites at screening or admission to the clinic
Recent history (past 2 years) or current severe hepatic encephalopathy (Grade 3 or higher)
Any evidence of progressive liver disease within the last 4 weeks
Presence of surgically created or transjugular intrahepatic portal systemic shunts