anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Prednisolone Sodium Phosphate
Trial phase: Phase 4
SMILES: CC12C=CC(=O)C=C1CCC1C2C(O)CC2(C)C1CCC2(O)C(=O)COP(=O)([O-])[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age & either sex, any race
Willing and able to follow all instructions
Positive history of ocular allergies
Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

Have planned surgery during trial period
Female currently pregnant, planning a pregnancy or lactating
Use of disallowed medications
Have ocular infections, or ocular conditions that could affect study parameters
Have moderate to severe dry eye
Have used an investigational drug or device within 30 days of start of study
Female that is currently pregnant, planning a pregnancy or lactating
Intervention: Ticagrelor
Trial phase: Not Applicable
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: 60
Group description: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).

Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
Eligibility criteria:
Inclusion Criteria:

Patients with a clinical indication to be on ticagrelor therapy (90mg/bid)
On treatment with ticagrelor 90mg twice daily for at least 14 days
Age between 18 to 80 years
On aspirin <100mg/day

Exclusion Criteria:

History of intracranial bleeding
Severe hepatic impairment (ALT >2.5 times the upper limit of normal)
Active bleeding or propensity to bleed
Recent antiplatelet treatment (< 14 days) with a glycoprotein IIb/IIIa antagonist

6. Platelet count <80x106/mL 7. Hemodynamic instability 8. Serum creatinine <30 mL/min 9. On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban) 10. Patients with sick sinus syndrome or II or III degree AV block without pacemaker protection 12. Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin 13. Hemoglobin < 10g/dL 14. Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study].
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: 41
Group description: bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml

bupivacaine
Eligibility criteria:
Inclusion Criteria:

Subjects who have benign or malignant colonic or rectal disease that are being scheduled for laparoscopic colorectal resection.
Subjects who are 18 years of age and older
Subjects of either sex
Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.

Exclusion Criteria:

Subjects who undergo conversion to the open approach will be excluded from the analysis, as the block will be given at the end of the procedure and is being evaluated for laparoscopic cases.
Subjects who are pregnant.
Subjects with a medical condition that may interfere with the use of the study medication Bupivicaine.
Subjects who have another condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
Intervention: Sapropterin Dihydrochloride
Trial phase: Phase 3
SMILES: CC(O)C(O)C1CNc2nc(N)[nH]c(=O)c2N1.Cl.Cl
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Willing and able to provide written informed consent (for children under 18 years old the parent[s]/guardians give informed consent, subjects 14-17 years old give additionally their own written informed consent)
Age of 4 - 18 years, inclusive
Confirmed clinical and biochemical hyperphenylalaninemia due to phenylketonuria documented by past medical history with at least 2 blood phenylalanine level greater than or equal to 400 micromole per liter obtained in 2 separate occasions
Blood phenylalanine level at screening greater than or equal to 450 micromole per liter (mean of two measurements)
For women of childbearing potential, a negative urine pregnancy test is required at screening and willingness to use a highly effective method of contraception is required while participating in the study
Subject and/or the parent/guardian willing and able to comply with study procedures
Subject and/or the parent/guardian willing to continue current diet unchanged during the 8 days response test and to adapt the diet according to phenylalanine therapeutic target range during the 6 week treatment period

Exclusion Criteria:

Subject already assessed for responsiveness to sapropterin dihydrochloride or other tetrahydrobiopterin (BH4)
Used any investigational agent other than Kuvan® (sapropterin dihydrochloride) within 30 days of screening, or required any investigational agent or vaccine prior to completion of all scheduled study assessments
Pregnant or breastfeeding, or considering pregnancy
Concurrent disease or conditions that would interfere with study participation or safety (for example, seizure disorder, asthma or other condition requiring oral or parenteral corticosteroid administration, insulin-dependent diabetes, or organ transplantation recipient)
Concurrent use of required concomitant treatment with any drug known to inhibit folate synthesis (for example, methotrexate), levodopa, phosphodiesterase type-5 (PDE-5) inhibitors (such as, sildenafil, vardenafil or tadalafil), medications that are known to affect nitric oxide synthesis metabolism or action
Any conditions, that, in the view of the Principal Investigator renders the subject at high risk for failure to comply with treatment or to complete the study
Clinical diagnosis of primary BH4 deficiency
Known hypersensitivity to Kuvan® (sapropterin dihydrochloride) or its excipients or to other approved or non-approved formulation of tetrabiopterin
Intervention: Alcaftadine
Trial phase: Phase 4
ATC code: S01GX11
SMILES: CN1CCC(=C2c3ccccc3CCn3c(C=O)cnc32)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 157
Group description: One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
Eligibility criteria:
Inclusion Criteria:

History of ocular allergies within the past 24 months.
Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.

Exclusion Criteria:

Any presence of active ocular infection or history of an ocular herpetic infection.
Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
Have any planned surgery during the study or 30 days after the study.
Intervention: Olopatadine
Trial phase: Phase 4
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 157
Group description: One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
Eligibility criteria:
Inclusion Criteria:

History of ocular allergies within the past 24 months.
Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.

Exclusion Criteria:

Any presence of active ocular infection or history of an ocular herpetic infection.
Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
Have any planned surgery during the study or 30 days after the study.
Intervention: Lidocaine
Trial phase: Phase 2 | Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 239
Group description: 2 gm powder of ginger filled in a capsule
Eligibility criteria:
Inclusion Criteria:

Healthy (i.e., ASA I, or II) patients presenting for planned c-section at New York Methodist Hospital
Signed informed consent

Exclusion Criteria:

They are unable or unwilling to take part in the study
They have a history of an allergy to any medications used including ginger
They have had any gastrointestinal surgery on the stomach, small intestine, or gall bladder.
They have any history of bleeding disorder, (i.e., Hemophilia A/B, ITP, etc.)
They have a contraindication to intrathecal or epidural anesthesia. ( i.e., Arnold- Chiari malformation, etc.)
They are unable to understand instructions or questions related to study
ASA III or IV patients
Intervention: FOLIC ACID
Trial phase: Phase 4
ATC code: B03AD01 | B03AD02 | B03AD03 | B03AD04 | B03AD05 | B03AE01 | B03AE02 | B03BB01 | B03BB51 | V04CX02
SMILES: Nc1nc(=O)c2nc(CNc3ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc3)cnc2[nH]1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 123
Group description: women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.

Placebo
Eligibility criteria:
Inclusion Criteria:

Women who underwent delivery either by elective or emergent cesarean section at 24 week gestation or later with preoperative levels of hemoglobin and hematocrit determined up to 72 hours prior to delivery. The patients must have at least one of the risk factors for uterine atony listed below:

Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).
Polyhydramnios (defined as Phelan´s amniotic fluid index > 24 cm)
Twin or Multiple pregnancy.
Prolonged labour (prolonged active phase > 12 hours) or precipitate labour(cervical dilatation ≥ 10 cm/hour).
Magnesium sulphate or any other tocolytic agent therapy for ≥ 8 hours before cesarean section.
Intravenous oxytocin therapy for at least 4 hours before cesarean section.
Multiparous women (≥ 3 prior abdominal or vaginal deliveries )
Clinical chorioamnionitis was defined as maternal temperature of ≥ 38°C in addition to more than one of the following criteria: fetal tachycardia (> 160 beats per minute), maternal tachycardia (>100 beats per minute, maternal leukocytosis (15,000 cells/mm3), uterine tenderness or foul smelling amniotic fluid.
Known myomatosis, uterine Müllerian malformations or those diagnosed by ultrasound.

Exclusion Criteria:

Misoprostol incorrect administration
Severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other absolute contraindication to misoprostol use.
Any bleeding occurred before delivery (abruptio placentae, placenta praevia) or bleeding due to other causes different than uterine atony.
Intervention: Serine
Trial phase: Phase 1 | Phase 2
SMILES: NC(CO)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: amino acid supplementation with L-serine

L-serine: 400mg/kg/d L-serine or placebo divided TID for year 1, then crossover of placebo arm so that all patients on 400mg/kg/d L-serine divided TID for year 2.
Eligibility criteria:
Inclusion Criteria:

HSAN1 patients with prominent sensory loss with foot ulcers or shooting pains and con-firmed mutations in SPTLC1.
Males and females of 18 years or older
All patients will be able to provide informed consent and comply with oral dietary supple-mentation and study activities. Compliance with supplementation will be monitored through measurement of DSB levels.
Subjects must not have taken L-serine for at least 30 days prior to randomization (L-serine-naïve subjects are permitted in the study).
Women must not become pregnant for the duration of the study and must be willing to use two contraceptive therapies and have a negative pregnancy test throughout the course of the study.

Exclusion Criteria:

Any cause of neuropathy other than HSAN1 (such as diabetes or drug-induced neuropathy), medical history of kidney stones, or history of poliomyelitis or radiotherapy.
Pregnant women, breastfeeding, or not using adequate contraception; for women included, an accepted method of contraception will be used throughout the study.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Patients on blood-thinners such as warfarin (Coumadin) or heparin will not be biopsied until they have held the medication for 5 days. Following the biopsy they will resume the maintenance dose of their medication.
Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 10 days prior to study entry.
The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, according to PI judgment, or a history of active substance abuse within the prior year.
Subjects who are non-ambulatory.
Subjects with uncontrolled diabetes.
Patients who are unable or unwilling to give consent will not be enrolled in the study.
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 27
Group description: 6-Months Atorvastatin Therapy; 40mg oral, once daily

Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.
Eligibility criteria:
Inclusion Criteria:

Survivor of childhood acute lymphoblastic leukemia (ALL) or non-Hodgkins's lymphoma (NHL) (treated for ALL or NHL before the age of 21 years old and ≥5 years post-treatment)
18-39 years old

Exclusion Criteria:

Type 1 or 2 diabetes mellitus
Prior treatment with hematopoietic stem cell transplant
Low-density lipoprotein (LDL) -cholesterol ≥130 mg/dL (individuals with elevated LDL-cholesterol will be referred for clinical management of dyslipidemia)
Alanine transaminase (ALT), Aspartate transaminase (AST), or Creatine kinase (CK) greater than 2 times the upper limit of normal
Current or recent (within 6-months) use of lipid-lowering medication
Recent initiation (within 6-months) of anti-hypertensive medication (individuals on stable therapy may be enrolled)
Current or recent (within 6-months) use of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine or strong CYP3A4 inhibitors (i.e. clarithromycin, HIV protease inhibitors, and itraconazole)
Pregnant, lactating or planning to become pregnant
Liver/renal dysfunction
Intervention: Anidulafungin
Trial phase: Phase 4
ATC code: J02AX06
SMILES: [H][C@@]1([C@@H](C)O)NC(=O)[C@H]([C@H](O)[C@@H](O)c2ccc(O)cc2)NC(=O)[C@@H]2C[C@@H](O)CN2C(=O)[C@H]([C@@H](C)O)NC(=O)[C@@H](NC(=O)c2ccc(-c3ccc(-c4ccc(OCCCCC)cc4)cc3)cc2)C[C@@H](O)[C@@H](O)NC(=O)[C@@H]2[C@@H](O)[C@@H](C)CN2C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Patients at risk will receive therapy with anidulafungin

Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
Eligibility criteria:
Inclusion Criteria:

In the ICU for >2 days AND

Systemic antibiotics on days 1-3 of ICU OR
Central venous catheter on days 1-3 of ICU

AND at least 2 of:

Total parenteral nutrition on days 1-3 of ICU
Any dialysis on days 1-3 of ICU
Major surgery in the 7 days before admission in the ICU
Pancreatitis in the 7 days before admission in the ICU
Use of corticosteroids for at least 3 days in the 7 days before admission
Use of other immunosuppressive agents in the 7 days before admission in the ICU

In addition, the patient must have at least one of the following:

Fever (axillary temperature >37.5 oC)
Hypothermia (axillary temperature <35 oC)
Hypotension
Unexplained acidosis
Unexplained elevation in C-reactive protein

Exclusion Criteria:

Antifungal for >3 days
Allergy to an echinocandin
Intervention: Morphine
Trial phase: Phase 4
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: Child
Healthy volunteers: No
Participants at risk: 31
Group description: Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.

Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.

Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue.
Eligibility criteria:
Inclusion Criteria:

Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) >or= 35 wks
Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen)
Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for treatment

Exclusion Criteria:

Seizures
Major congenital malformations
Unlikely to survive
Parents not able to understand English
Intervention: Clonidine
Trial phase: Phase 4
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 31
Group description: Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.

Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.
Eligibility criteria:
Inclusion Criteria:

Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) >or= 35 wks
Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen)
Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for treatment

Exclusion Criteria:

Seizures
Major congenital malformations
Unlikely to survive
Parents not able to understand English
Intervention: Vancomycin
Trial phase: Phase 4
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;

Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;
Eligibility criteria:
Inclusion Criteria:

Aged 18 years or older
Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia, osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and skin structure infections
Expected to receive vancomycin for at least 72 hours and are within the first 72 hours of therapy
Have at least two or more of the following risk factors for drug-induced nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e. aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5 mg/dL).

Exclusion Criteria:

Pregnancy
End-stage renal disease
Receipt of more than 4 grams of vancomycin prior to enrollment on current admission
Absolute neutrophil count < 1000/mm3
Intervention: Nitisinone
Trial phase: Phase 1
ATC code: A16AX04
SMILES: O=C1CCCC(=O)C1C(=O)c1ccc(C(F)(F)F)cc1[N+](=O)[O-]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
Eligibility criteria:
Inclusion Criteria:

Patients with HT-1 currently managed on Orfadin (nitisinone) capsules.
Age from 1 month to less than 18 years.
Signed informed consent.

Exclusion Criteria:

Any medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
Enrollment in another concurrent clinical study, or intake of an investigational medicinal product (IMP), within one month prior to inclusion in this study.
Foreseeable inability to cooperate with given instructions or study procedures.
Intervention: Capsaicin
Trial phase: Phase 3
ATC code: M02AB01 | M02AB02 | N01BX04
SMILES: COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 58
Group description: omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
Eligibility criteria:
Inclusion Criteria:

healthy smokers; age between 20 and 60 years; score in Fagerström Test for Nicotine Dependence (FTND) up to 5 points (FTND > 5); high motivation to stop smoking (accessed by Richmond Test)

Exclusion Criteria:

psychiatric disorders; taking psychoactive medications; history of alcohol and/or other drugs abuse or dependence;