anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: FX006: Single 3 mL IA injection
Eligibility criteria:
Main Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female >=40 years of age
Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of restricted medications

Main Exclusion Criteria

Ipsilateral hip OA
Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
History of arthritides due to crystals (e.g., gout, pseudogout)
History of infection in the index joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee
Presence of surgical hardware or other foreign body in the index knee
Unstable joint (such as a torn anterior cruciate ligament)
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening
Prior arthroscopic or open surgery of the index knee within 12 months of Screening
Planned/anticipated surgery of the index knee during the study period
Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
Insulin-dependent diabetes
Active psychiatric disorder including psychosis and major depressive disorder
History of or active Cushing's syndrome
Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
Skin breakdown at the knee where the injection would take place
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: FX006: Single 3 mL IA injection
Eligibility criteria:
Main Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female >=40 years of age
Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of restricted medications

Main Exclusion Criteria

Ipsilateral hip OA
Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
History of arthritides due to crystals (e.g., gout, pseudogout)
History of infection in the index joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee
Presence of surgical hardware or other foreign body in the index knee
Unstable joint (such as a torn anterior cruciate ligament)
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening
Prior arthroscopic or open surgery of the index knee within 12 months of Screening
Planned/anticipated surgery of the index knee during the study period
Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
Insulin-dependent diabetes
Active psychiatric disorder including psychosis and major depressive disorder
History of or active Cushing's syndrome
Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
Skin breakdown at the knee where the injection would take place
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: MYCOPHENOLATE MOFETIL
Trial phase: Phase 2
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Pharmacokinetics-based targeting of mycophenolate mofetil

Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure
Eligibility criteria:
Inclusion Criteria:

Patients must be between 6 months and 21 years of age.
Recipients of an allogeneic blood and marrow transplant (BMT).
Stem cell sources should be bone marrow or umbilical cord blood.
Bone marrow or cord blood unit: Sibling should be HLA matched at A, B and DRB1 loci. Unrelated cord blood unit should be at a minimum 4/6 matched at allele level on HLA A, B and DRB1 loci. Unrelated donor should be HLA allele level matched at A, B, C and DRB1 loci.
Minimum prefreezing nucleated cell dose for cord blood units: 3x10^7/kg for malignant diseases and 5x10^7/kg for nonmalignant diseases.
Conditioning regimen must be myeloablative in intensity. Examples include but are not limited to Cy/TBI, BuCy 200, etc.
Patients ≥ 16 years old must have a Karnofsky score ≥ 70%, and patients < 16 years old must have a Lansky score ≥ 70%.
Renal: Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2.
Hepatic: Total bilirubin ≤ 2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert's syndrome; and SGOT (AST), SGPT (ALT), and Alkaline Phosphatase < 5 x upper limit of normal (ULN) for age.
Cardiac: Left ventricular ejection fraction at rest > 40%, or shortening fraction > 26%, by echocardiogram or radionuclide scan.
Pulmonary: FEV1, FVC, and DLCO (diffusion capacity) > 50% of predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation > 92% of room air.

Exclusion Criteria:

Patients with a known hypersensitivity to MMF.
Prior autologous or allogeneic BMT < 12 months prior to enrollment.
Mismatched related donor.
Mismatched unrelated marrow donor.
Peripheral blood stem cell source.
Reduced intensity conditioning.
Uncontrolled bacterial, viral, fungal or other infection.
Evidence of HIV infection or HIV positive serology.
Requirement of supplemental oxygen.
Patients who are pregnant (B-hCG positive) or breastfeeding. All females of 11 years of age or older and/or who have begun menstruating will be screened for hCG by either urinalysis or a blood sample in order to screen for pregnancy status, as per institutional BMT policy.
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 59
Group description: Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD

Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
Eligibility criteria:
Inclusion Criteria:

Patient´s over 18 years old that received standard indication for sedated esophagogastroduodenoscopy (American Society of Gastrointestinal Endoscopy Guidelines) in our centre between the period of study.

Exclusion Criteria:

Patients under 18 years old
Unable to obtain inform´s consent
Emergency endoscopy
Pregnant women
Encephalopathy
Well known allergic reaction to propofol, amide-anaesthesics, soy or eggs
Methaemoglobinemia induced factor risks
No previous or unknown fasting
Intervention: Gadobutrol
Trial phase: Phase 2
ATC code: V08CA09
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(C(CO)C(O)CO)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Eligibility criteria:
Inclusion Criteria:

Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only

Exclusion Criteria:

Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
Non-sinus rhythm
Sinus node disease or symptomatic bradycardia
Second or third degree atrial ventricular (AV) block
Complete left bundle branch block (LBBB)
Known congenital long QT syndrome or a family history of congenital long QT syndrome
Known previous arrhythmias on drugs that prolong cardiac repolarization
Uncorrected hypokalemia
Uncontrolled hypertension (e.g. systolic blood pressure >185 mm Hg, diastolic blood pressure >110 mm Hg)
Baseline hypotension (e.g. mean arterial pressure <60 mm Hg)
Ejection fraction below 35%
Cardiomyopathy, congenital heart defect or higher degree valvular pathology
Coronary artery stent placement within 4 weeks prior to the MRI procedure
Previous heart transplantation
Intervention: Gadobutrol
Trial phase: Phase 2
ATC code: V08CA09
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(C(CO)C(O)CO)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Eligibility criteria:
Inclusion Criteria:

Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only

Exclusion Criteria:

Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
Non-sinus rhythm
Sinus node disease or symptomatic bradycardia
Second or third degree atrial ventricular (AV) block
Complete left bundle branch block (LBBB)
Known congenital long QT syndrome or a family history of congenital long QT syndrome
Known previous arrhythmias on drugs that prolong cardiac repolarization
Uncorrected hypokalemia
Uncontrolled hypertension (e.g. systolic blood pressure >185 mm Hg, diastolic blood pressure >110 mm Hg)
Baseline hypotension (e.g. mean arterial pressure <60 mm Hg)
Ejection fraction below 35%
Cardiomyopathy, congenital heart defect or higher degree valvular pathology
Coronary artery stent placement within 4 weeks prior to the MRI procedure
Previous heart transplantation
Intervention: Gadobutrol
Trial phase: Phase 2
ATC code: V08CA09
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(C(CO)C(O)CO)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Eligibility criteria:
Inclusion Criteria:

Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only

Exclusion Criteria:

Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
Non-sinus rhythm
Sinus node disease or symptomatic bradycardia
Second or third degree atrial ventricular (AV) block
Complete left bundle branch block (LBBB)
Known congenital long QT syndrome or a family history of congenital long QT syndrome
Known previous arrhythmias on drugs that prolong cardiac repolarization
Uncorrected hypokalemia
Uncontrolled hypertension (e.g. systolic blood pressure >185 mm Hg, diastolic blood pressure >110 mm Hg)
Baseline hypotension (e.g. mean arterial pressure <60 mm Hg)
Ejection fraction below 35%
Cardiomyopathy, congenital heart defect or higher degree valvular pathology
Coronary artery stent placement within 4 weeks prior to the MRI procedure
Previous heart transplantation
Intervention: Gadobutrol
Trial phase: Phase 2
ATC code: V08CA09
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(C(CO)C(O)CO)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Eligibility criteria:
Inclusion Criteria:

Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only

Exclusion Criteria:

Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
Non-sinus rhythm
Sinus node disease or symptomatic bradycardia
Second or third degree atrial ventricular (AV) block
Complete left bundle branch block (LBBB)
Known congenital long QT syndrome or a family history of congenital long QT syndrome
Known previous arrhythmias on drugs that prolong cardiac repolarization
Uncorrected hypokalemia
Uncontrolled hypertension (e.g. systolic blood pressure >185 mm Hg, diastolic blood pressure >110 mm Hg)
Baseline hypotension (e.g. mean arterial pressure <60 mm Hg)
Ejection fraction below 35%
Cardiomyopathy, congenital heart defect or higher degree valvular pathology
Coronary artery stent placement within 4 weeks prior to the MRI procedure
Previous heart transplantation
Intervention: SALICYLIC ACID
Trial phase: Phase 1
ATC code: D01AE12 | N02BA04 | N02BA12 | S01BC08
SMILES: O=C(O)c1ccccc1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study.
Eligibility criteria:
Inclusion Criteria: Healthy adults

Male or female
Non-smoker
18-55 years old
BMI > 18.5 and < 30.0
With medically acceptable form of contraception (female only).

Exclusion Criteria:

Any clinically significant abnormality or vital sign abnormalities
Any abnormal laboratory test
History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
Positive pregnancy test, breastfeeding or lactating
Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
Participation in an investigational study within 30 days prior to dosing
Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of > 499 mL (within 56 days) prior to dosing.
Intervention: SALICYLIC ACID
Trial phase: Phase 1
ATC code: D01AE12 | N02BA04 | N02BA12 | S01BC08
SMILES: O=C(O)c1ccccc1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study.
Eligibility criteria:
Inclusion Criteria: Healthy adults

Male or female
Non-smoker
18-55 years old
BMI > 18.5 and < 30.0
With medically acceptable form of contraception (female only).

Exclusion Criteria:

Any clinically significant abnormality or vital sign abnormalities
Any abnormal laboratory test
History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
Positive pregnancy test, breastfeeding or lactating
Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
Participation in an investigational study within 30 days prior to dosing
Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of > 499 mL (within 56 days) prior to dosing.
Intervention: ACARBOSE
Trial phase: Phase 4
ATC code: A10BD17 | A10BF01
SMILES: [H]C(=O)[C@H](O)[C@@H](O)[C@]([H])(O[C@@]1([H])O[C@H](CO)[C@@]([H])(O[C@H]2O[C@H](C)[C@@H](N[C@@]3([H])C=C(CO)[C@@H](O)[C@H](O)[C@H]3O)[C@H](O)[C@H]2O)[C@H](O)[C@H]1O)[C@H](O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)

Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
Eligibility criteria:
Inclusion Criteria:

Subjects with type-II diabetes mellitus;
Subjects aged between 20 and 80;
Subjects whose HbA1c ratio is between 7.0% and 10.0%;
Subjects who took Metformin and Sitagliptin for at least 12 weeks;
Subjects who were given the explanation about this clinical study and signed the consent form.

Exclusion Criteria:

Subjects who have taken drugs that are likely to affect blood glucose or who need to take such drugs, e.g., glucocorticoid;
Subjects with severe renal diseases (men: Scr>1.5 / women: Scr>1.4);
Subjects with severe liver diseases or whose AST and ALT are at least 2.5 times higher than the upper limits of normal (ULN);
Subjects having the case history of lactic acidosis;
Subjects who have the case history of myocardial infarction or unstable angina or who underwent the coronary artery bypass graft 6 months before the screening test or who have arrhythmia to be treated;
Subjects with congestive heart failures to be treated;
Subjects who fall into New York Heart Association (NYHA) class III or IV;
Subjects having the case history of acute or chronic metabolic acidosis including ketoacidosis;
Subjects who have been pregnant or who are in the period of lactation;
Subjects diagnosed with malignant tumors within 5 years;
Subjects who are hypersensitive to Metformin, Sitagliptin and Acarbose or their ingredients;
Subjects with inflammatory bowel diseases or intestinal ulcers or enterostenosis (includes Subjects who are vulnerable to enterostenosis) or chronic enteric diseases related to digestion and absorption or whose symptoms are likely to worsen due to intestinal gas;
Subjects who participated in other clinical studies as Subjects within 60 days before this study (or before taking the investigational drugs);
Subjects judged unfit for this study by investigators.
Intervention: Ketorolac Tromethamine
Trial phase: Phase 4
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.

Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Eligibility criteria:
Inclusion Criteria:

Key Inclusion Criteria

Male or female between 18 and 64 years of age.
Must sign informed consent prior to initiation of any study procedures. The subject must be able to understand and agree to cooperate with study requirements.
BMI between 19 and 29 kg/m2.
Must require the surgical placement of 1 - 3 dental implants that are being placed in a one or two stage non-immediately loaded surgical procedure employing 2% lidocaine and/or 4% articaine with epinephrine and/or 3% mepivacaine plain for local anesthesia.
Females of child-bearing potential must have a negative urine pregnancy test at screening and immediately prior to the initiation of dental implant surgery and must have been using adequate means of birth control (abstinence, oral contraceptive steroids, intrauterine device (IUD), etc.) for at least one month prior to study entry and during the study.

In the opinion of the investigators the subject can safely tolerate ketorolac and acetaminophen.

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Exclusion Criteria:

Key Exclusion Criteria

Require the placement of more than 3 implants or require extensive bone grafting in addition to implant placement.
Need to administer anxiolytic/sedation drugs during surgery other than nitrous oxide/oxygen.
Need to administer the long acting local anesthetic bupivacaine with 1:200,000 epinephrine.
Implant(s) that are going to be immediately loaded on the day of surgery
Females that are pregnant or breast feeding
Allergies or hypersensitivity (aspirin sensitive asthma) to ketorolac, aspirin, ibuprofen, other NSAIDs, or acetaminophen.
History of gastrointestinal ulcers and/or bleeding.
On warfarin, dicumarol, clopidogrel or any other anticoagulant or antiplatelet therapy other than low dose (81 mg - 325 mg) aspirin.
Clinically significant kidney or liver disease where the intake of NSAIDs or acetaminophen would put the subject at undo risk.
Blood pressure greater than 160/95 at the time of screening or immediately before surgery.
Inflammation of the nasal mucosa or upper respiratory tract infection

Have ingested any analgesic agent within 48 hours of surgery.

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