anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment.

Normal Saline Solution: Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment.
Eligibility criteria:
Inclusion Criteria:

Male or female aged 0 days to 12 years, inclusive:

(0 to 28 days);
(29 days to 23 months);
(2 to 5 years 11 months);
(6 to 12 years).
Subjects undergoing elective cardiac, abdominal, orthopedic, or transplant surgery.
Subjects with a clinical diagnosis of hypovolemia developed within 24 hours from the completion of surgery, as judged by the Investigator.
Admitted to ICU or acute care floor for post-operative recovery and care, in relatively stable condition.
Subject, parent or guardian agrees to comply with the requirements of the protocol.
Subject, parent or guardian has signed an informed consent form (ICF) and a child assent form if appropriate.
Subject, parent or guardian has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

Intra-operative blood loss > 50 mL/kg.
Severe hypoalbuminemia with serum albumin levels < 1g/dL.
Known intolerance or allergy to albumin and/or plasma proteins.
Preterm neonates, defined as neonates with a gestational age of <37 weeks (this criteria would only affect the 0-28 days group).
Burn and trauma patients.
Renal surgery.
Subjects with acute CNS injury or trauma would be excluded from the study.
Chronic renal insufficiency or acute renal failure (creatinine > 1.5 of normal value or based on age-appropriate renal function parameters), or a history of renal transplantation.
Subjects with hypernatremia, defined as a Na level of ≥ 155 mEq/L.
Severe congestive heart failure (CHF) using one of the following classification systems: Ross Heart Failure Classification, modified Ross Heart Failure Classification, or New York University Pediatric Heart Failure Index (NYU PHFI).
Any concurrent medical, surgical or psychiatric condition that may, in the Investigator's opinion, affect the subject's ability to meet the protocol requirements.
Subject has participated in another interventional clinical study within 30 days prior to study enrollment. Subjects who are participating in another observational study are not excluded.
Intervention: Midodrine
Trial phase: Phase 3
ATC code: C01CA17
SMILES: COc1ccc(OC)c(C(O)CNC(=O)CN)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Midodrine: Patients will be randomized to blinded to 20 mg of midodrine
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Admitted to the SICU
Requiring IV vasopressors at a rate of less than 100 mcg/min of phenylephrine, or 8 mcg/min of norepinephrine, or 60 mcg/min of metaraminol; and unable to wean for more than 24 hours while still maintaining desired blood pressure goal

Exclusion Criteria:

Inadequate tissue oxygenation
Liver failure
Renal failure
Hypovolemic shock or hypotension due to adrenal insufficiency
Pregnancy
Severe organic heart disease
Urinary retention
Pheochromocytoma
Thyrotoxicosis
Midodrine as pre-admission medication
Any known allergies to midodrine
Enrollment in another clinical trial
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.

Serum hepcidin was the primary outcome variable and was quantified at all visits.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of stage 2-5 Chronic Kidney Disease (estimated glomerular filtration rate [GFR] between 15 and < 90 ml/min/1.73m2) based on the new bedside Schwartz formula estimation using serum creatinine and height [height in cm x 0.413/serum creatinine]
1-21 years of age
Willingness and ability to provide informed consent and assent

Exclusion Criteria:

Children less than 1 year of age (in whom risk of vitamin D toxicity may be increased) or greater than 21 years at time of study screening
Children with a documented history of hypercalcemia or nephrolithiasis
Children with GI tract discontinuity (ostomy)
Current pregnancy or pregnancy within the last 12 months
Children with known anemia-related disorders including sickle cell anemia, thalassemia
Children with severe 25D deficiency (< 5 ng/mL) likely to be associated with severe morbidity and requiring prompt high dose vitamin D supplementation, or with 25D levels > 60 ng/mL which could be associated with increased risk of vitamin D toxicity
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.

Serum hepcidin was the primary outcome variable and was quantified at all visits.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of stage 2-5 Chronic Kidney Disease (estimated glomerular filtration rate [GFR] between 15 and < 90 ml/min/1.73m2) based on the new bedside Schwartz formula estimation using serum creatinine and height [height in cm x 0.413/serum creatinine]
1-21 years of age
Willingness and ability to provide informed consent and assent

Exclusion Criteria:

Children less than 1 year of age (in whom risk of vitamin D toxicity may be increased) or greater than 21 years at time of study screening
Children with a documented history of hypercalcemia or nephrolithiasis
Children with GI tract discontinuity (ostomy)
Current pregnancy or pregnancy within the last 12 months
Children with known anemia-related disorders including sickle cell anemia, thalassemia
Children with severe 25D deficiency (< 5 ng/mL) likely to be associated with severe morbidity and requiring prompt high dose vitamin D supplementation, or with 25D levels > 60 ng/mL which could be associated with increased risk of vitamin D toxicity
Intervention: Apricoxib
Trial phase: Not Applicable
SMILES: CCOc1ccc(-c2cc(C)cn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
Eligibility criteria:
Inclusion Criteria:

Adults over the age of 18 capable of giving informed consent. Radiographic findings suspicious for primary lung cancer or pathologically confirmed NSCLC which is surgically resectable and radiographically early stage (stage I and II).
ECOG performance status of 0, 1, or 2 (see Appendix A).
Ineligible for or refuse preoperative chemotherapy or chemoradiation therapy
Normal renal function (defined as serum creatinine ≤ 2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73m2).
Normal liver function (defined as total bilirubin ≤ 1.5 x ULN, SGOT & SGPT ≤ 2.5 xULN).
Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment.
Preoperative pulmonary function test (PFT) with FEV1 and D LCO ≥ 60% or predicted postoperative FEV1 and DLCO ≥ 40% based on quantitative lung perfusion scan
Must be able to come off anticoagulants and have normal coagulation studies (PTT < 40 seconds and INR < 1.4) prior to planned surgery.
For subjects on COX-2 inhibitors or other NSAIDS prior to study initiation, cessation of the drug for 1 week prior to Apricoxib administration is required for study enrollment.

Exclusion Criteria:

Radiation therapy, chemotherapy, non-cytotoxic investigational agents, or corticosteroids within 4 weeks of initiating treatment.
Comorbid disease or a medical condition that would impair the ability of the subject to receive or comply with the study protocol.
Hypersensitivity to apricoxib, sulfonamides, aspirin, or other NSAIDS or to any reagents used in the study.
Previous history of gastrointestinal ulceration, bleeding, or perforation.
Required concurrent use of COX-2 inhibitors or other NSAIDS during Apricoxib administration.
Chronic or concurrent use of steroids (topical steroids are acceptable if medically indicated).
Pregnant or nursing women.
Evidence of NYHA class III or greater cardiac disease.
History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months of initiating treatment.
History of heart surgery for coronary artery disease.
Known HIV infection or AIDS.
Intervention: Apricoxib
Trial phase: Not Applicable
SMILES: CCOc1ccc(-c2cc(C)cn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
Eligibility criteria:
Inclusion Criteria:

Adults over the age of 18 capable of giving informed consent. Radiographic findings suspicious for primary lung cancer or pathologically confirmed NSCLC which is surgically resectable and radiographically early stage (stage I and II).
ECOG performance status of 0, 1, or 2 (see Appendix A).
Ineligible for or refuse preoperative chemotherapy or chemoradiation therapy
Normal renal function (defined as serum creatinine ≤ 2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73m2).
Normal liver function (defined as total bilirubin ≤ 1.5 x ULN, SGOT & SGPT ≤ 2.5 xULN).
Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment.
Preoperative pulmonary function test (PFT) with FEV1 and D LCO ≥ 60% or predicted postoperative FEV1 and DLCO ≥ 40% based on quantitative lung perfusion scan
Must be able to come off anticoagulants and have normal coagulation studies (PTT < 40 seconds and INR < 1.4) prior to planned surgery.
For subjects on COX-2 inhibitors or other NSAIDS prior to study initiation, cessation of the drug for 1 week prior to Apricoxib administration is required for study enrollment.

Exclusion Criteria:

Radiation therapy, chemotherapy, non-cytotoxic investigational agents, or corticosteroids within 4 weeks of initiating treatment.
Comorbid disease or a medical condition that would impair the ability of the subject to receive or comply with the study protocol.
Hypersensitivity to apricoxib, sulfonamides, aspirin, or other NSAIDS or to any reagents used in the study.
Previous history of gastrointestinal ulceration, bleeding, or perforation.
Required concurrent use of COX-2 inhibitors or other NSAIDS during Apricoxib administration.
Chronic or concurrent use of steroids (topical steroids are acceptable if medically indicated).
Pregnant or nursing women.
Evidence of NYHA class III or greater cardiac disease.
History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months of initiating treatment.
History of heart surgery for coronary artery disease.
Known HIV infection or AIDS.
Intervention: Solifenacin
Trial phase: Phase 4
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Solifenacin: Solifenacin (5mg, qd, oral)
Eligibility criteria:
Inclusion Criteria:

Female aged 20 ≤ and < 70 years
History of OAB symptoms for ≥ 3 months
International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary

Exclusion Criteria:

Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine
Any condition that would contraindicate their usage of anticholinergics or alpha blockers
History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation)
History of stress urinary incontinence or urinary retention
History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
Pregnant or nursing women
Current urinary tract infection
Neurological bladder dysfunction
Treatment with drugs that may interfere with CYP3A4 metabolic function
Significant hepatic or renal disease
Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Intervention: Tamsulosin HCl
Trial phase: Phase 4
SMILES: CCOc1ccccc1OCCNC(C)Cc1ccc(OC)c(S(N)(=O)=O)c1.Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Eligibility criteria:
Inclusion Criteria:

Female aged 20 ≤ and < 70 years
History of OAB symptoms for ≥ 3 months
International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary

Exclusion Criteria:

Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine
Any condition that would contraindicate their usage of anticholinergics or alpha blockers
History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation)
History of stress urinary incontinence or urinary retention
History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
Pregnant or nursing women
Current urinary tract infection
Neurological bladder dysfunction
Treatment with drugs that may interfere with CYP3A4 metabolic function
Significant hepatic or renal disease
Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Intervention: Gabapentin
Trial phase: Phase 2
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.

Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.
Eligibility criteria:
Inclusion Criteria:

Men 18 years or older with histologically proven adenocarcinoma of the prostate

Prior or current androgen deprivation for at least 6 months prior to study entry with either bilateral orchiectomy or being maintained on a stable dose of LHRH (luteinizing hormone-releasing hormone) agonist or antagonist

Hot flash frequency of an average of 2 or more per day (average of 14 hot flash episodes per week)

Exclusion Criteria:

cannot currently be taking serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors (MAOIs)

cannot have uncontrolled hypertension
cannot have history of past or current of epilepsy, epilepsy syndrome or other seizure disorder
cannot have psychiatric history of mania, hypomania, bipolar disorder or anorexia nervosa
cannot be receiving concurrent treatment with amy medications or herbal products being used with the express purpose of treating hot flashes.
Intervention: Venlafaxine
Trial phase: Phase 2
ATC code: N06AX16
SMILES: COc1ccc(C(CN(C)C)C2(O)CCCCC2)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.

Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Eligibility criteria:
Inclusion Criteria:

Men 18 years or older with histologically proven adenocarcinoma of the prostate

Prior or current androgen deprivation for at least 6 months prior to study entry with either bilateral orchiectomy or being maintained on a stable dose of LHRH (luteinizing hormone-releasing hormone) agonist or antagonist

Hot flash frequency of an average of 2 or more per day (average of 14 hot flash episodes per week)

Exclusion Criteria:

cannot currently be taking serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors (MAOIs)

cannot have uncontrolled hypertension
cannot have history of past or current of epilepsy, epilepsy syndrome or other seizure disorder
cannot have psychiatric history of mania, hypomania, bipolar disorder or anorexia nervosa
cannot be receiving concurrent treatment with amy medications or herbal products being used with the express purpose of treating hot flashes.
Intervention: Enzalutamide
Trial phase: Phase 2
ATC code: L02BB04
SMILES: CNC(=O)c1ccc(N2C(=S)N(c3ccc(C#N)c(C(F)(F)F)c3)C(=O)C2(C)C)cc1F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
Eligibility criteria:
Inclusion Criteria:

Has completed a prior study with MDV3100, can be enrolled in this extension study without any interruption in study drug
No new clinically significant abnormalities based upon physical examination, safety laboratory data, vital signs, ECG, and other clinical assessments noted from the last visit conducted during the subject's active MDV3100 study prior to initiation of this study

Male subjects and their female spouses/partners who are of childbearing potential must be using highly effective contraception1 consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 3 months after final study drug administration. Male subjects must not donate sperm starting at Screening and throughout the study period and for at least 3 months after final study drug administration. 1Highly effective contraception is defined as:

Established use of oral, injected or implanted hormonal methods of contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal form/gel/film/ cream/suppository
Subject agrees not to participate in another interventional study while on treatment

Exclusion Criteria:

Subject will be excluded from participation if any of the following apply:

Subject has a history of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumours, brain metastases, or alcoholism.
Subject has a history of loss of consciousness or transient ischemic attack within 12 months prior to Day 1 of the completed preceding study.

Use of the following prohibited medication/therapies:

Concomitant medication that likely could cause clinically relevant drug-to-drug interactions with MDV3100.
Other (than MDV3100) androgen-receptor (AR) antagonists (bicalutamide, flutamide, nilutamide).
Investigational therapy other than MDV3100 or investigational procedures of any kind.
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: 5
Group description: Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 8 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