anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 80
Group description: Mometasone furoate nasal spray (MFNS) 50 mcg device.

Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.

Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
Male or female outpatients aged 3 to 15 years at the time of providing informed consent.

Exclusion Criteria:

Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration
Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
Subjects with repeated epistaxis
Subjects with coexisting fungal infection in nasal/sinus cavity
Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
Intervention: Decitabine
Trial phase: Phase 1 | Phase 2
ATC code: L01BC08
SMILES: Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Eligibility criteria:
Inclusion

MDS classified by hematopathology review as WHO categories refractory anemia (RA) or refractory cytopenia with multi-lineage dysplasia (RCMD) or refractory anemia with ring sideroblasts (RARS) or refractory anemia with excess blasts (RAEB1 or RAEB2) or chronic myelo-monocytic leukemia (CMML1 or CMML2)
Symptomatic anemia OR thrombocytopenia with a platelet count of < 100 x 10^9/L OR transfusion dependence for red-cells OR transfusion dependence for platelets OR absolute neutrophil count < 1 x 10^9/L

Exclusion

MDS of the WHO sub-types RA or RCMD with sole 5q- abnormality on cytogenetics unless failed lenalidomide (Revlimid) therapy
Previous treatment with decitabine
Untreated erythropoietin deficiency defined as an erythropoietin level of < 200 IU/L and erythropoietin replacement therapy for < 8 weeks (erythropoietin deficiency until corrected)
Uncontrolled infection
Severe sepsis or septic shock
Current pregnancy or breast feeding
The patient is of childbearing age, and is unwilling to use contraception and has not had a tubal ligation, hysterectomy, or vasectomy , or their partner is also unwilling to use an acceptable method of contraception as determined by the investigator
Not able to give informed consent
Altered mental status or seizure disorder
ALT > 300 IU; or albumin < 2.0 mg/dL
Creatinine > 2.5 mg/dl and creatinine clearance < 60ml/min
B12, folate, or iron deficient, until corrected
NYHA class III/IV status
ECOG performance status > 2
HIV positive or history of seropositivity for HIV
Transformation to acute leukemia ( >= 20% myelo-blasts in marrow aspirate)
Any experimental agents other than the study drug decitabine
Intervention: Chlordiazepoxide
Trial phase: Phase 4
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Control - BSS

Control: intrableb BSS injection - 29 patients
Eligibility criteria:
Inclusion Criteria:

Age more than 18 years old
Patients with glaucoma that is inadequately controlled on maximal tolerated medical therapy and scheduled for trabeculectomy surgery (with/without combined cataract extraction)
Decision makers fluent in English
Decision makers able to understand and read consent form

Exclusion Criteria:

Patients with active intraocular inflammation/uveitis or neovascular glaucoma
History of previous trabeculectomy surgery or prior retinal detachment with scleral buckle placement in the surgical eye
Aphakia in surgical eye
Pregnant and nursing women
Unable to fulfill inclusion criteria
Refusal of consent
Intervention: Iron sucrose
Trial phase: Not Applicable
ATC code: B03AB02 | V03AE05
SMILES: O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: 100 mg IV TIW

Iron sucrose: 100 mg IV TIW
Eligibility criteria:
Inclusion Criteria:

ICU admission for trauma
Adults (age ≥ 18 years)
Anemia (hemoglobin < 12 g/dL)
≤ 72 hours from ICU admission
Expected ICU length of stay ≥ 7 days

Exclusion Criteria:

Active hemorrhage requiring RBC transfusion
Iron overload (serum ferritin concentration ≥ 1,000 ng/mL) or any condition associated with iron overload (e.g., hemochromatosis, aceruloplasminemia
Chronic inflammatory conditions (e.g., systemic lupus erythematosis, rheumatoid arthritis, ankylosing spondilitis)
Pre-existing hematologic disorders (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, myeloproliferative disease)
Macrocytic anemia (mean corpuscular volume ≥ 100 fL)
Current use of immunosuppressive agents including corticosteroids (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, exclusive of inhaled corticosteroids), calcinurin inhibitors (e.g., cyclosporine, tacrolimus), antimetabolites (e.g., azathioprine), or biologics (e.g., OKT3, thymoglobulin)
Use of recombinant human erythropoietin formulation within the prev 30 days
Pregnancy or lactation
Prohibition of RBC transfusion
Stay of ≥ 48 hours duration in the ICU of a transferring hospital
History of intolerance or hypersensitivity to either enteral or intravenous iron
Moribund state in which death is imminent
Enrollment in any other clinical trial
Intervention: INSULIN DETEMIR
Trial phase: Not Applicable
ATC code: A10AE05
SMILES: CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Eligibility criteria:
Inclusion Criteria:

Diabetic ketoacidosis (DKA) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip.
Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
Patient with both types of diabetes will be among those treated with insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition
Patients will be of age 19 to 80.

Exclusion Criteria:

Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drop 2 weeks and longer, pregnancy, Levemir allergy, and concurrent sulfonamide treatment
Intervention: Dexmedetomidine
Trial phase: Phase 2 | Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Dexmedetomidine given intranasally in OR without any pre-medication.
Eligibility criteria:
Inclusion Criteria:

functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)
patients scheduled for placement of bilateral myringotomy tubes

Exclusion Criteria:

history of allergy to either dexmedetomidine or fentanyl
concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 98
Group description: Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Each participant must have schizophrenia, diagnosed and confirmed by board-eligible or board certified psychiatrists with at least two years of specialization in pediatric/adolescent psychiatric medicine.
Each participant must be ≥12 years of age and <18 years of age.
Each participant must have a minimum PANSS total score of 80 at Screening and Baseline.
Each participant must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/ persecution) at Screening and Baseline.
Each participant must have a CGI-S scale score of ≥4 at Screening and Baseline.
Each participant must taper off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers) prior to Baseline.
Each participant must agree not to begin formal, structured psychotherapy during the trial.

Exclusion Criteria:

A participant must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with "continuous," "single episode in partial remission," or "single episode in full remission" course specifiers.
A participant must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment.
A participant must not have a known or suspected diagnosis of mental retardation or organic brain disorder.
A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR^TM) criteria for substance abuse or dependence (excluding nicotine).
A participant must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse.
A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).
Intervention: Bisoprolol
Trial phase: Phase 4
ATC code: C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05
SMILES: CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Adult subjects with hypertension, either newly diagnosed or treated but currently uncontrolled as defined by Joint National Committee (JNC) 7 for subjects with Type 2 diabetes mellitus (T2DM) (that is, greater than or equal to [>=] 130/80 mmHg)
Aged at least 18 years old
Diagnosed with T2DM and already on anti-diabetic therapy, and with glycosylated hemoglobin of less than 7 percent

Exclusion Criteria:

Subjects who were already on beta-blocker therapy at the time of recruitment
Subjects with heart rate of at most 60 beats per minute (bpm) at rest
Subjects with secondary hypertension, congenital heart disease, coronary artery disease, peripheral arterial disease or congestive heart failure in any stage
Subjects with coronary conduction disorders (bundle branch block)
Subjects with signs of definitive target organ damage consistent with World Health Organization (WHO) Stage III or with severe renal or hepatic disease
Subjects who are pregnant or expect to be pregnant within the 24-week study period
Subjects on oral contraceptives
Subjects with asthma or a history of asthma
Subjects with documented severe renal disease
Subjects on anti-neoplastic drugs
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.

Dexmedetomidine: 1 mcg/kg/hour
Eligibility criteria:
Inclusion Criteria:

Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
2. Gender of Patients: Male & female,Age of Patients: 18 and older

Exclusion Criteria:

Conduction disturbance (second degree AV block or greater), or previous reaction to medications used in this study. Patients receiving spinal anesthesia will not be included.
Intervention: Ringer's lactate
Trial phase: Not Applicable
SMILES: CC(O)C(=O)O.[Ca+2].[Cl-].[Cl-].[Cl-].[Cl-].[K+].[Na+].[Na]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 534
Group description: Lactated Ringers solution will be used for fluid replacement.

Crystalloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes.
Eligibility criteria:
Inclusion Criteria:

ASA Physical Status 1-3
Body Mass Index < 35
Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia.

Exclusion Criteria:

cardiac insufficiency (EF<35%)
coronary disease with angina (NYHA IV)
severe chronic obstructive pulmonary disease
coagulopathies
symptoms of infection or sepsis
renal insufficiency (creatinine clearance <30ml/min or renal replacement therapy)
ASA Physical Status > 3.
Intervention: Zoledronic acid
Trial phase: Phase 3
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Eligibility criteria:
Key Inclusion criteria:

Written informed consent before any study-related procedure.

Group 1:

Children and adolescents, male or female, 6-19 years old, who met the inclusion criteria for entry into the Core study and who took at least one dose of study drug and have completed Visit 8 of the CZOL446H2337 Core study.
Patient must be enrolled into the extension at Visit 9 up to 10 months after Visit 5 (month 6) of the Core study.
Patients who followed the regimen of calcium and vitamin D intake as required in the Core study through diet or supplementation.

Group 2:

Children and adolescents, male or female, 5 - 17 years old who met the inclusion criteria for entry into the Core study but were not enrolled because of clinically significant back pain from vertebral fracture and the preexisting clinical care at the Investigator site is to treat this type of patient with a bisphosphonate.
Confirmed diagnosis of non-malignant conditions (including but not limited to rheumatic conditions, inflammatory bowel disease, Duchenne muscular dystrophy, nephrotic syndrome), treated with systemic glucocorticoids (i.v. or oral) within the 12 months preceding enrollment in the study (any duration)
LS-BMD Z-score of -0.5 or worse confirmed by the central imaging vendor
Evidence of at least 1 vertebral compression fracture (at least Genant Grade 1 vertebral compression or radiographic signs of vertebral compression) confirmed by central reading OR At least one lower OR 2 upper extremity long-bone, low-trauma, fracture which occurred sometime within the 2 years or preceding enrollment in the study, confirmed by radiological report. (*Low trauma fracture is defined as falling from standing height or less).

Key Exclusion criteria:

Major protocol violation in the Core Study (Group 1 only).
Prior use of bisphosphonates (Group 2 only) or sodium fluoride (doses for osteoporosis not for dental hygiene).
Hypocalcemia and hypophosphatemia: any value (age-matched) below the normal range at Visit 8 or 8A.
Vitamin D deficiency (serum 25-hydroxy vitamin D concentrations of < 20 ng/mL or < 50 nmol/L) at Visit 8 (Group 1) or Visit 8A (Group 2).
Renal impairment defined as an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 at screening based on the Schwartz formula at Visit 8 or 8 A; a serum creatinine above the normal range at Visit 9 (Group 1) or an increase between Visit 8A and Visit 9 greater than 0.5 mg/dL (44.2 μmol/L) for Group 2.
Female patients of child bearing potential are eligible only if they are not pregnant/non-lactating. Females of child bearing potential must be practicing a medically acceptable form of birth control for greater than 2 months prior to screening visit and consent to pregnancy tests during the study.
Intervention: Dexmedetomidine
Trial phase: Not Applicable
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Subjects will be sedated with dexmedetomidine.

dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Eligibility criteria:
Inclusion Criteria:

ASA I-III.
Scheduled for DBS.

Exclusion Criteria:

History of dystonia.
Severe heart failure with ejection fraction less than 30%.
History of obstructive sleep apnea.
History of renal failure with creatinine level > 2 mg/dl.
Allergies to α-2 agonists and propofol.
Current use of α-2 agonist medications such as clonidine.
Intervention: Vismodegib
Trial phase: Phase 2
ATC code: L01XJ01 | L01XX43
SMILES: CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participants received vismodegib 150 mg orally daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Confirmed new (not recurrent or previously treated) nodular basal cell carcinoma (BCC) at 1 of the listed anatomical sites, which must be biopsy confirmed at the study site.
Willingness to consent to biopsy of the lesion.
Willingness to delay excision of the target tumor site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability.
Adequate hematopoietic capacity.
Adequate hepatic function.
For women of childbearing potential, agreement to use 2 acceptable forms of birth control (including one barrier method) during the study and for 7 months after discontinuation of study drug.
For men with female partners of childbearing potential, agreement to use a male condom (with spermicide) and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug.
Agreement not to donate blood/blood products during the study and for 7 months after discontinuing study drug.
Agreement not to donate sperm or semen during treatment and for 2 months after the last dose of vismodegib.

Exclusion Criteria:

Prior treatment with vismodegib or any Hedgehog pathway inhibitor.
Inability or unwillingness to swallow capsules.
Pregnancy or lactation.
BCC with any clinical and histological pattern other than nodular BCC.
Patients with known Gorlin's syndrome (basal cell nevus syndrome) or clinical suspicion of Gorlin's syndrome.
Recent (ie, within the past 28 days), current, or planned participation in another experimental drug study.
Use of any excluded medication or therapy within 21 days of study entry.
History of other malignancies within 3 years of the first day of treatment (Day 1), except for tumors with a negligible risk of metastasis, such as other non-melanoma skin cancer (BCC, squamous cell cancer), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
Uncontrolled medical illness.
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
Any medical or psychological illness or condition preventing adequate consent.