anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hydrocortisone
Trial phase: Not Applicable
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 19
Group description: Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.

Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off.
Eligibility criteria:
Inclusion Criteria:

Neonate (< 28 days old) undergoing correct cardiac surgery, or infants undergoing the following surgery procedures: Norwood, Arterial Switch, Total Anomalous Pulmonary Venous Return Repair, Interrupted Aortic Arch Repair, Truncus Arteriosus Repair
Successfully weaned off cardiopulmonary bypass after cardiac surgery

Exclusion Criteria:

requirement for extracorporeal membrane oxygenation (ECMO) in the operating room
Known immune deficiency
Having previously received systemic steroids (except for two routine preoperative doses)
A current signed Do not resuscitate (DNR) or limitation of care order
Current enrollment in another interventional clinical study
Refusal of parental consent
Previous diagnosis of adrenal insufficiency
> 28 days old at time of surgery whose repair dose not require CPB
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.
Eligibility criteria:
Inclusion Criteria:

Adults
Undergoing Craniotomy for Supratentorial Tumor Resection
Weight between 50 and 120 kilograms
ASA Physical Status I-III
Be able to communicate verbally
Be able to use Visual Analog Score

Exclusion Criteria:

Allergies to acetaminophen, morphine or any of the anesthetic agents required by the protocol.
Use of opioids, tramadol, benzodiazepines, or gabapentin on a daily basis for > 7 days prior to the day of surgery.
Use of acetaminophen, NSAIDs, or any other analgesic medication in the 12 hours immediately prior to study enrollment.
Hepatic insufficiency (elevated transaminases > 1.5 times the upper limit of normal) or renal insufficiency (plasma creatinine > 2mg/dl).
Known or suspected history of alcohol or illicit drug abuse.
Pregnant or breast-feeding.
Surgical plan for infratentorial (suboccipital) craniotomy.
Plan for neurophysiologic monitoring that precludes the use of neuromuscular blockade.
Inability to communicate due to a language barrier, impaired consciousness, cognitive defect or intellectual disability.
Uncontrolled Hypertension
Intervention: GLYCOPYRRONIUM
Trial phase: Phase 3
ATC code: A03AB02 | A03CA05 | D11AA01 | R03AL04 | R03AL07 | R03AL09 | R03AL11 | R03AL12 | R03BB06
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 226
Group description: Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
Eligibility criteria:
Inclusion Criteria:

Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening.
Current or ex-smokers who have a smoking history of at least 10 pack years
Symptomatic patients according to daily diary data.

Exclusion Criteria:

Pregnant or nursing (lactating) women.
Women of child-bearing potential unless using adequate contraception.
Patients with Type I or uncontrolled Type II diabetes.
Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
Patients with paroxysmal (e.g. intermittent) atrial fibrillation
Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Acetaminophen
Trial phase: Phase 2
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 741
Group description: Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.

Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
Eligibility criteria:
Inclusion Criteria:

Patients ages 2-18 undergoing tonsillectomy with or without adenoidectomy by electrocautery alone for sleep disordered breathing or infectious tonsillitis will be included.
Patients with complex medical conditions and craniofacial abnormalities will be included.
Informed consent and child assent will be required for enrollment

Exclusion Criteria:

Patients with a known personal or family history of a bleeding disorder will be excluded.
Patients with a history of asthma, kidney or liver problems will also be excluded.
Patients with tonsillectomy or adenoidectomy performed using a cold knife technique, microdebrider, coblation or plasma knife.
Patients on NSAIDs for other medical conditions, or those who have taken NSAIDs within 1 week of surgery will be excluded.
Patients with allergy to aspirin or other NSAIDs, acetaminophen, Red Dye #40 or Red Dye #33 will also be excluded.
Pregnancy testing using urine β-subunit of hCG gonadotropin (beta-HCG) will be performed on all children > 13 years of age, or those younger than 13 who are menstruating; this is the testing protocol used at the Children's Hospital of Boston. Patients found to be pregnant will be excluded from participation.
Intervention: Mannitol
Trial phase: Phase 3
ATC code: A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04
SMILES: OCC(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.

mannitol: After induction of general anesthesia Normosol or Lactated Ringers , at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The treatment arm will receive a standard dose of 12.5 grams of mannitol (200 cc of a 6.25% mannitol solution) intravenously completely infused through an existing intravenous access catheter within 30 minutes prior to renal artery clamping.
Eligibility criteria:
Inclusion Criteria:

Age > or = to 18 years
Scheduled for partial nephrectomy at MSKCC (open or minimally invasive technique) during which renal ischemia is anticipated
Preoperative eGFR > 45 cc/min/1.73m2 as measured by the CKD-EPI study equation

Exclusion Criteria:

Allergy to mannitol
Severe renal impairment (stage 3B) defined as eGFR < 45 cc/min/1.73m2 as measured by the CKD-EPI calculation.
Combined major surgical cases that include a partial nephrectomy.
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.
Eligibility criteria:
Inclusion criteria:

Patients undergoing surgical management for CRS (with or without polyps)
Operating time must be at least 2 hours in duration.
Number of sinuses involved must be 3 or greater

Exclusion criteria:

History of hypersensitivity to acetaminophen
End stage renal disease
End stage liver disease
History of chronic pain, or use of opioid medication in the previous two weeks
Severe depression or anxiety
Use of gabapentin or any other pain modulator
History of acute sinusitis or mucocele
History of seizures
Known or suspected history of alcohol or drug abuse
Known or suspected history of morphine intolerance
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
Eligibility criteria:
Inclusion Criteria:

Age 18-70 years
Fasting insulin >12 μU/mL and/or serum glucose between 140-200 mg/dl after 75 g 2hr oral glucose tolerance test
Central fat deposition or Peripheral fat atrophy
Fasting glucose ≤126 mg/dL
BMI ≥18 and ≤35 kg/m2
CD4 cell count ≥100 cells/mm3
Stable antiretroviral regimen ≥12 weeks and HIV RNA <1000 copies

Exclusion Criteria:

Diabetes mellitus
Cardiac pacemaker or metal implant
Liver enzymes >2.5x upper normal limit
Alkaline phosphatase or prothrombin time >2x upper normal limit
Serum creatinine >1.4 mg/dL
History of congestive heart failure
Hemoglobin <8 g/dL
Alcohol abuse
Pregnancy
History of lactic acidosis
Use of steroids
Acute infection within last one month
History of bladder cancer
Intervention: Ivacaftor
Trial phase: Phase 3
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female with confirmed diagnosis of CF
Must have at least 1 allele of the R117H CFTR mutation
Percent predicted forced expiratory volume in 1 second (FEV1) 40 percent (%) to 90% (for subjects aged 12 years or older) or 40% to 105% (for subjects aged 6 to 11 years) predicted normal for age, sex, and height
6 years of age or older
Minimum weight of 15 kilogram (kg) at screening
Females of childbearing potential must not be pregnant
Willing to comply with contraception requirements

Exclusion Criteria:

CFTR gene mutation leading to CFTR channel with gating defect (that is, any 1 of the following mutations: G551D, G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D)
History of any illness or condition that might confound the results of the study or pose an additional risk in administering ivacaftor to the subject
An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before the first dose of study drug
Abnormal liver function, at screening, defined as greater than or equal to (>=) 3 time upper limit of normal (ULN), of any 3 or more of the following: serum aspartate transaminase (AST), serum alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT), serum alkaline phosphatase (ALP), total bilirubin
Colonization with organisms associated with a more rapid decline in pulmonary status (for example, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus) at screening
History of solid organ or hematological transplantation
History of alcohol, medication or illicit drug abuse within 1 year before the first dose of study drug
Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days before screening
Any "non-CF-related" illness within 2 weeks before Day 1 (first dose of study drug). "Illness" was defined as an acute (serious or non-serious) condition (for example, gastroenteritis)
Use of any inhibitors or inducers of cytochrome (CYP) P450 3A
Intervention: Ivacaftor
Trial phase: Phase 3
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female with confirmed diagnosis of CF
At least 1 allele of the following CFTR gating mutations: G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349D
Percent predicted forced expiratory volume in 1 second (FEV1) greater than or equal to (>=) 40 percent (%) predicted normal for age, sex, and height
6 years of age or older
Minimum weight of 15 kilogram (kg) at screening
Females of childbearing potential must not be pregnant
Willing to comply with contraception requirements

Exclusion Criteria:

G551D-CFTR mutation on at least 1 allele
History of any illness or condition that might confound the results of the study or pose an additional risk in administering ivacaftor to the subject
An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before the first dose of study drug
History of solid organ or hematological transplantation
History of alcohol, medication or illicit drug abuse within 1 year before the first dose of study drug
Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days before screening
Use of inhaled hypertonic saline treatment
Use of any inhibitors or inducers of cytochrome (CYP) P450 3A
Evidence of cataract or lens opacity at screening
Intervention: Fentanyl
Trial phase: Not Applicable
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
Eligibility criteria:
Inclusion Criteria:

Patients undergoing unilateral primary total knee replacement
ASA class I-III
18 years and older

Exclusion Criteria:

Patient refusal
Pregnancy
Coagulopathy
Adverse/allergic reaction to any opioids or local anesthetics
History of long-term opioid use (greater than 60 days)
Infection
Traumatic lower extremity injury
Intervention: Fentanyl
Trial phase: Not Applicable
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
Eligibility criteria:
Inclusion Criteria:

Patients undergoing unilateral primary total knee replacement
ASA class I-III
18 years and older

Exclusion Criteria:

Patient refusal
Pregnancy
Coagulopathy
Adverse/allergic reaction to any opioids or local anesthetics
History of long-term opioid use (greater than 60 days)
Infection
Traumatic lower extremity injury
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Metformin oral tablets 500 mg were given three times daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Obese infertile polycystic ovarian syndrome (PCOS) women

Exclusion Criteria:

Women 40 years or older
Women using fertility treatments, oral contraceptives or other confounding medications during the last 3 months
Smokers or with history of general diseases like cardiovascular, liver, kidney or respiratory disease, diabetes, uncontrolled hypertension, or malignancy
Intervention: Mannitol
Trial phase: Phase 3
ATC code: A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04
SMILES: OCC(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula

Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)
Eligibility criteria:
Inclusion Criteria:

All patients who are scheduled for elective complex cardiac surgical procedures including

double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR)
Redo-sternotomies
Aortic root repair +/- AVR

Exclusion Criteria:

Any known congenital or pre-existing bleeding disorder
pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)
severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)
inability to provide informed consent
emergency surgery
pregnancy or nursing
age under 18 years
intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)
allergy to concentrated fibrinogen or other components in the product
anemia (Hgb < 110)
diagnosed deep vein thrombosis (DVT)
pulmonary embolism
acute stroke
acute myocardial infarction
Intervention: Mannitol
Trial phase: Phase 3
ATC code: A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04
SMILES: OCC(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula

Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Eligibility criteria:
Inclusion Criteria:

All patients who are scheduled for elective complex cardiac surgical procedures including

double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR)
Redo-sternotomies
Aortic root repair +/- AVR

Exclusion Criteria:

Any known congenital or pre-existing bleeding disorder
pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)
severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)
inability to provide informed consent
emergency surgery
pregnancy or nursing
age under 18 years
intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)
allergy to concentrated fibrinogen or other components in the product
anemia (Hgb < 110)
diagnosed deep vein thrombosis (DVT)
pulmonary embolism
acute stroke
acute myocardial infarction
Intervention: Fingolimod
Trial phase: Phase 3
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Participants received Fingolimod 0.5 mg orally once daily.
Eligibility criteria:
Inclusion Criteria

written informed consent must be obtained before any assessment is performed
The diagnosis of CIDP will use the definition of the EFNS/PNS Task Force First Revision. Patients must either have a clinical diagnosis of CIDP fulfilling the clinical inclusion criteria for typical CIDP or one of the following atypical forms of CIDP: pure motor, or asymmetrical (MADSAM [Lewis-Sumner syndrome]), or IgA or IgG (not IgM) MGUS paraprotein associated.
All patients must also fulfill the clinical exclusion criteria and the definite electrodiagnostic criteria of the EFNS/PNS Task Force First Revision.
disability defined by an INCAT Disability Scale score of 1-9 or, if INCAT score is 0, a documented history of disability sufficient to require treatment within the past 2 years following reduction or interruption of CIDP treatment
receiving IVIg treatment (minimal dose equivalent to 0.4 g/kg every 4 weeks for a minimum of 12 weeks) or corticosteroids (minimal dose equivalent to prednisone 10 mg/day) treatment prior to the screening visit
history of documented clinically meaningful deterioration confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to Screening
stable CIDP symptoms for the 6 weeks before randomization

Exclusion Criteria

other chronic demyelinating neuropathies, including: Distal Acquired Demyelinating Symmetric Neuropathy (DADS) Multifocal Motor Neuropathy (MMN) pure sensory CIDP hematopoietic malignancy except for MGUS
conditions in which the pathogenesis of the neuropathy may be different from CIDP such as: Lyme disease, POEMS syndrome, osteosclerotic myeloma, Castleman's disease
treatment with plasma exchange within 2 months of randomization, immunosuppressive/chemotherapeutic medications: azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate tacrolimus or other immunosuppressive drugs within 6 months of randomization or 5 half-lives (whichever is later), Rituximab in the 2 years prior to randomization (patients that have received rituximab between 1 and 2 years should have B-cell levels within normal range), other cytotoxic immunosuppressive medications with sustained effects (including mitoxantrone, alemtuzumab, cladribine) at any time, hematopoietic stem cell transplantation at any time