anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block

Normal Saline
Eligibility criteria:
Inclusion Criteria:

Elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression)
ASA I-III
Age 18-80 years old

Exclusion Criteria:

Any contraindication to interscalene brachial plexus block anesthesia
Interscalene brachial plexus block failure
Known local anesthetics allergy
Dexamethasone allergy or intolerance
Any contraindication to acetaminophen
Any contraindication to morphine or hydromorphone
Brachial plexus neuropathies
Chronic pain syndrome other than shoulder pain
Routine use of opioid medication
Routine use of systemic corticosteroid
Pregnancy
Weight below 50 kilograms
Incapability to understand a numeric verbal pain scale
Incapability to consent
Patient refusal
Intervention: Sodium Nitrite
Trial phase: Phase 2
ATC code: V03AB08
SMILES: O=N[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Treatment twice daily with 40 mg sustained release sodium nitrite
Eligibility criteria:
Inclusion Criteria:

Female subjects must be post-menopausal, sterilized or using suitable birth control
Diagnosis of diabetes (HbA1c > 6.0)
Diagnosis of diabetic peripheral neuropathy pain in feet
Presence of ongoing diabetic neuropathic for at least 3 months
A pain score of greater than or equal to 4 on the Numerical Pain Rating Scale at screening
Ability to provide written informed consent

Exclusion Criteria:

Patients with fibromyalgia or regional pain caused by lumbar or cervical compression
History or diagnosis of significant neurological disease
History and diagnosis of clinically significant psychiatric diseases
Serious liver disease
Poorly controlled diabetes
Hypersensitivity to sodium nitrite or related compounds
Life expectancy < 6 months
A chronic illness that may increase the risks associated with this study
Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation
Pregnant or nursing women
Current diagnosis of alcohol or other substance abuse
Current use of sildenafil or other phosphodiesterase Type 5 Inhibitors
History of methemoglobinemia, (met-Hb ≥ 15%)
Subject is involved in litigation or receives worker's compensation
Inability to speak English
Intervention: Sodium Nitrite
Trial phase: Phase 2
ATC code: V03AB08
SMILES: O=N[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
Eligibility criteria:
Inclusion Criteria:

Female subjects must be post-menopausal, sterilized or using suitable birth control
Diagnosis of diabetes (HbA1c > 6.0)
Diagnosis of diabetic peripheral neuropathy pain in feet
Presence of ongoing diabetic neuropathic for at least 3 months
A pain score of greater than or equal to 4 on the Numerical Pain Rating Scale at screening
Ability to provide written informed consent

Exclusion Criteria:

Patients with fibromyalgia or regional pain caused by lumbar or cervical compression
History or diagnosis of significant neurological disease
History and diagnosis of clinically significant psychiatric diseases
Serious liver disease
Poorly controlled diabetes
Hypersensitivity to sodium nitrite or related compounds
Life expectancy < 6 months
A chronic illness that may increase the risks associated with this study
Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation
Pregnant or nursing women
Current diagnosis of alcohol or other substance abuse
Current use of sildenafil or other phosphodiesterase Type 5 Inhibitors
History of methemoglobinemia, (met-Hb ≥ 15%)
Subject is involved in litigation or receives worker's compensation
Inability to speak English
Intervention: Celecoxib
Trial phase: Not Applicable
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.
Eligibility criteria:
Inclusion Criteria:

Age between 18 - 50
Volunteers must be in good health as based on medical history
All volunteers must be non-smoking and non-pregnant

Exclusion Criteria:

Subjects with any medical condition, which according to the investigator, may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject (cancer or history of significant cardiovascular disease (including stroke or TIA), renal, hepatic, gastrointestinal, respiratory, endocrine, metabolic, hematopoietic, or neurological disorders).
Subjects who have received an experimental drug within 30 days prior to the study
Subjects who have taken medications at least two weeks prior to the study. Subjects using hormonal birth control, however, will not be an exclusionary criterion.
Subjects who have taken aspirin or aspirin containing products for at least two weeks prior to the study.
Subjects who are sensitive or allergic to celecoxib (Celebrex) or its components
Subjects who have taken any formulation of celecoxib including but not limited to Celebrex, Celebra, Onsenal for at least two weeks prior to the start of the study and throughout the study
Subjects who have taken acetaminophen, NSAIDs, COX-2 inhibitors (OTC or prescription) for at least two weeks prior to the study.
Subjects who are consuming any type of tobacco product(s).
Subjects who consume high doses of antioxidant vitamins daily (vitamin C> 1000mg, Vitamin E> 400IU, Beta Carotene> 1000IU, Vitamin A> 5000IU, Selenium> 200mcg, Folic Acid> 1mg) for the two weeks prior to the start of the study and throughout the study.
Subjects who consume alcohol, caffeine or high fat food 24 hours prior to the study.
Intervention: Sarecycline
Trial phase: Phase 3
ATC code: J01AA14 | J01AA20
SMILES: [H][C@@]12Cc3c(CN(C)OC)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 236
Group description: Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
Eligibility criteria:
Inclusion Criteria:

Successfully completed participation in Phase 3 study of sarecycline (SC1401 or SC1402)
Signed informed consent or assent form
Body weight between 33 kg and 136 kg, inclusive
Negative urine pregnancy test for females of childbearing potential
Agrees to use effective method of contraception throughout study, if applicable.
Able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information)

Exclusion Criteria:

Currently participating in another clinical study, unless it is a pharmacokinetic sarecycline study and participation approved by medical monitor; has received investigational medication (except sarecycline) within 30 days of enrollment.
Discontinued participation in a Phase 3 study with sarecycline for any reason
Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with sarecycline
Is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone)
Is pregnant, lactating or planning a pregnancy during the study period
Has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
Is judged by the Investigator to be unsuitable for any reason
Intervention: Sarecycline
Trial phase: Phase 3
ATC code: J01AA14 | J01AA20
SMILES: [H][C@@]12Cc3c(CN(C)OC)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 247
Group description: Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
Eligibility criteria:
Inclusion Criteria:

Successfully completed participation in Phase 3 study of sarecycline (SC1401 or SC1402)
Signed informed consent or assent form
Body weight between 33 kg and 136 kg, inclusive
Negative urine pregnancy test for females of childbearing potential
Agrees to use effective method of contraception throughout study, if applicable.
Able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information)

Exclusion Criteria:

Currently participating in another clinical study, unless it is a pharmacokinetic sarecycline study and participation approved by medical monitor; has received investigational medication (except sarecycline) within 30 days of enrollment.
Discontinued participation in a Phase 3 study with sarecycline for any reason
Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with sarecycline
Is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone)
Is pregnant, lactating or planning a pregnancy during the study period
Has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
Is judged by the Investigator to be unsuitable for any reason
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 160
Group description: 10 mg Tablets, Oral, Once daily, 24 weeks
Eligibility criteria:
Inclusion Criteria:

Female or male aged ≥18 years and <75 years.
History of T2DM for more than 12 months.
Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%
Stable anti-diabetic treatment regimen
Renal impairment: CKD 3A

Exclusion Criteria:

Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg
Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:

Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.

History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening.
Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.
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: No
Participants at risk: 4
Group description: Transforaminal Epidural Steroid Injections

TESI: Transforaminal epidural steroid injections given in the lumbar spine.
Eligibility criteria:
Inclusion Criteria:

Single level subligamentous lumbar disc herniation with a size of up to 1/3 of the spinal canal sagittal diameter, with unilateral radicular pain attributed to nerve root impingement from lumbar disc material correlated with MRI or CT findings
Axial MRI demonstrating unilateral focal contained disc herniation with single nerve contact
Patient failed at least 3 weeks of conservative management within a 6 month period including anti-inflammatory medication and physical therapy
Patient has not had previous epidural steroid injections at the affected lumbar level within 3 months of presenting for the study
Patient is a candidate for transforaminal epidural steroid injections
Positive Straight Leg Raising (SLR) test
Patient has a leg pain > back pain
The subject is physically and mentally able to participate in the study
Patient is willing and able to provide informed consent
Patient is willing and able to comply with the study protocol

Exclusion Criteria:

Patient has had surgery at the affected level
Extruded or sequestered disc herniation
Free fragment herniation
Discogenic pain without nerve root compression
Previous surgery at the involved lumbar level
Segmental instability (motion on flexion/extension films)
Spondylolisthesis > Grade 2
Severe central canal stenosis or bony impingement at the index level
Significant loss of disc height (> 60%) compared with the adjacent higher level or disc height < 6mm at affected level
Motor deficit (strength rating less than 4/5 in the lower extremity test)
Positive Waddell test (> 3 of 5 tests)
Active local or systemic infection
Actively in litigation for pain symptoms
Currently on Workman's Compensation
Women who are pregnant
Intervention: Ketamine
Trial phase: Early Phase 1
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate >110/minute or systolic/diastolic blood pressure (BP) >180/100 or >20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.

Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
Eligibility criteria:
Inclusion Criteria:

Patients ≥18 years with unipolar major depressive disorder (DSM-IV)
24-item Hamilton Rating Scale for Depression (HRSD-24) score of ≥21
Referred for ECT

For the randomised Phase 2, patients must have

received a substantial course of ECT in Phase 1 (i.e. at least five sessions)
achieved at least response criteria (i.e. ≥60% decrease from baseline HRSD-24 score and score ≤16 on two consecutive weekly ratings)
have a nominated adult who can stay with them for 24-hours on out-patient treatment days
Mini-Mental State Examination (MMSE) score of ≥24
able to provide informed consent

Exclusion Criteria:

Any condition rendering patient medically unfit for ECT; general anaesthesia, ketamine or midazolam - assessed by physical examination, routine haematology and biochemistry investigations prior to enrolment in Phase I (routine care)
Active suicidal intention
Dementia, intellectual disability, or MMSE <24
Lifetime history of bipolar affective disorder
Current history of post-traumatic stress disorder
Other Axis I diagnosis (DSM-IV)
ECT in the six months prior to recruitment
Alcohol dependence or substance misuse in the six months prior to recruitment
Pregnancy or breast-feeding
Residing in a nursing home
Prisoner
Diagnosis of terminal illness
Inability or refusal to provide valid informed consent
Intervention: Midazolam
Trial phase: Early Phase 1
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.

Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
Eligibility criteria:
Inclusion Criteria:

Patients ≥18 years with unipolar major depressive disorder (DSM-IV)
24-item Hamilton Rating Scale for Depression (HRSD-24) score of ≥21
Referred for ECT

For the randomised Phase 2, patients must have

received a substantial course of ECT in Phase 1 (i.e. at least five sessions)
achieved at least response criteria (i.e. ≥60% decrease from baseline HRSD-24 score and score ≤16 on two consecutive weekly ratings)
have a nominated adult who can stay with them for 24-hours on out-patient treatment days
Mini-Mental State Examination (MMSE) score of ≥24
able to provide informed consent

Exclusion Criteria:

Any condition rendering patient medically unfit for ECT; general anaesthesia, ketamine or midazolam - assessed by physical examination, routine haematology and biochemistry investigations prior to enrolment in Phase I (routine care)
Active suicidal intention
Dementia, intellectual disability, or MMSE <24
Lifetime history of bipolar affective disorder
Current history of post-traumatic stress disorder
Other Axis I diagnosis (DSM-IV)
ECT in the six months prior to recruitment
Alcohol dependence or substance misuse in the six months prior to recruitment
Pregnancy or breast-feeding
Residing in a nursing home
Prisoner
Diagnosis of terminal illness
Inability or refusal to provide valid informed consent
Intervention: Humulin N
Trial phase: Phase 2
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 51
Group description: 40 IU of regular human insulin once daily over 24 weeks

Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
Eligibility criteria:
Inclusion Criteria:

Men and women aged 50-85 years old
Able to walk for 6 minutes
Diabetes type 2 (DM) group: diagnosis and treatment for type 2 DM with non-insulin oral or injectable agents
Non-DM group with similar age range as the DM group, non-diabetic fasting plasma glucose (<126 mg/dL) and hemoglobin A1c (HbA1c) (<6.5%)
Participants capable of providing informed consent

Exclusion Criteria:

Type 2 DM treated with insulin (since 9/25/2017)
Type 1 DM
Intolerance to insulin
History of severe hypoglycemia
Participants who have >1 asymptomatic and/or symptomatic episode of hypoglycemia (glucose < 54 mg/dL) during finger stick or plasma glucose (cut off value since 6/11/2018)
Acute medical condition that required either hospitalization or surgery within the past 6 months (e.g., severe hypoglycemia, malignancies, myocardial infarction,stroke)
Liver or renal failure or transplant
Dementia (Mini Mental State Examination [MMSE] scores ≤20)
Current recreational drug or alcohol abuse
Serious systemic disease that would interfere with conduction of clinical trial (mild forms of neurological conditions e.g. Parkinson's Disease, autonomic neuropathy etc. would be allowed)
Magnetic Resonance Imaging (MRI) substudy in 40 DM patients only: claustrophobia and implants incompatible with 3-Tesla MRI
Safety substudy in 20 IDDM patients only: Insulin-treated type 2 diabetics with a C-peptide of <0.8 ng/mLd and fasting blood glucose >150 mg/dL will be excluded even without history of hypoglycemia during finger stick measurements.
Intervention: Diethylstilbestrol
Trial phase: Not Applicable
ATC code: G03CB02 | G03CC05 | L02AA01 | L02AA04
SMILES: CC/C(=C(/CC)c1ccc(O)cc1)c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported.
Eligibility criteria:
Inclusion Criteria:

Elective anterior approach to subaxial cervical spine (C3 - T1);
ages 18-80

Exclusion Criteria:

Traumatic or tumor etiologies
undergoing anterior-posterior operations
neoplastic, or infectious conditions requiring surgery
a history of previous anterior cervical spine surgery
any patient requiring a halo vest
patients on chronic steroids
patients remaining intubated post-operatively (please see more under risks below)
less than 18 years of age
pregnant women
no phone