anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 2, 2, 2, 2 mg.

Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
Eligibility criteria:
Inclusion Criteria:

Aged 18 - 55
Smoke >9 cigarettes/day for at least the past 12 months
Able to understand and consent to study procedures
Able to read and write in English
Exhaled Carbon Monoxide <12 ppm at in-person screening

Exclusion Criteria:

Unstable or significant medical conditions and conditions such as elevated blood pressure (Systolic >140 mm Hg or diastolic >90mm Hg at baseline), COPD and those that are likely to affect biomarker data such as kidney or liver disease.
Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label.
More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes or inpatient treatment for these in the past 6 months.
Use of non-cigarette nicotine delivery product in the prior week (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco).
Use of an FDA approved cessation medication in past week (any NRT, Chantix, Wellbutrin)
Women who are pregnant (verified by urine pregnancy test at visit), trying to become pregnant (not using a medically acceptable form of birth control for at least one month prior to visit i.e., oral contraceptives, intrauterine device, double barrier), or nursing.
Uncontrolled serious psychiatric illness or inpatient treatment in the past 6 months.
Unwillingness to provide blood samples or history of repeatedly fainting during blood draws
Any previous adverse reaction to NRT.
Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol.
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 4, 4, 0, 4 mg.

Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
Eligibility criteria:
Inclusion Criteria:

Aged 18 - 55
Smoke >9 cigarettes/day for at least the past 12 months
Able to understand and consent to study procedures
Able to read and write in English
Exhaled Carbon Monoxide <12 ppm at in-person screening

Exclusion Criteria:

Unstable or significant medical conditions and conditions such as elevated blood pressure (Systolic >140 mm Hg or diastolic >90mm Hg at baseline), COPD and those that are likely to affect biomarker data such as kidney or liver disease.
Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label.
More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes or inpatient treatment for these in the past 6 months.
Use of non-cigarette nicotine delivery product in the prior week (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco).
Use of an FDA approved cessation medication in past week (any NRT, Chantix, Wellbutrin)
Women who are pregnant (verified by urine pregnancy test at visit), trying to become pregnant (not using a medically acceptable form of birth control for at least one month prior to visit i.e., oral contraceptives, intrauterine device, double barrier), or nursing.
Uncontrolled serious psychiatric illness or inpatient treatment in the past 6 months.
Unwillingness to provide blood samples or history of repeatedly fainting during blood draws
Any previous adverse reaction to NRT.
Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol.
Intervention: Ranolazine
Trial phase: Phase 2 | Phase 3
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: tablet, 1000 mg twice daily for four weeks
Eligibility criteria:
Inclusion Criteria

Males and non-pregnant, non-breastfeeding females with established diagnosis of IBS-D by modified Rome III criteria (Abdominal Pain Intensity: weekly average of worst daily score of >3.0 on a 0 to 10 point scale and Stool Consistency: at least one stool with a consistency of Type 5, 6 or 7 Bristol stool score on at least 2 days per week)
18-70 years old
U.S. resident
English-speaking (to provide consent and complete questionnaires)

Exclusion Criteria

Structural or metabolic diseases/conditions that affect the gastrointestinal system

Unable to withdraw the following medications 48 hours prior to the study:

Drugs that alter GI transit including Lomotil, and bile acid binders such as cholestyramine, prokinetics (e.g. metoclopramide, cisapride and erythromycin), narcotics (e.g. oxycodone, morphine) and anticholinergics (dicyclomine, hyoscyamine).
Analgesic drugs including narcotics, NSAID, cyclooxygenase-2 ( COX2) inhibitors (celecoxib, rofecoxib, and valdecoxib)
GABAergic agents (baclofen)
Benzodiazepines (e.g. lorazepam, alprazolam, and diazepam). Low stable doses of thyroid replacement, estrogen replacement, and low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.

Unable to withdraw the following medications, which are contraindications of ranolazine:

Strong Cytochrome P450, Family 3, Subfamily A (CYP3A) inhibitors (e.g. ketoconazole, clarithromycin, and nelfinavir)
CYP3A inducers (e.g. rifampin, phenobarbital, St. John's wort)
Female subjects who are pregnant or breastfeeding.
Current symptoms of severe depression, as measured by Hospital Anxiety And Depression Scale ( HADS) score greater than 15.
Clinical evidence (including physical exam, ECG, laboratory studies and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
The Corrected QT Interval (QTc) > 490 msec.
Active alcoholics not in remission or known substance abusers.
Liver cirrhosis
Patients with clinically significant hepatic disease.
Major cardiovascular events in the last 6 months.
Participation in another clinical trial (within 30 days).
Incarcerated.
Intervention: Memantine
Trial phase: Not Applicable
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.

Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine.
Eligibility criteria:
Inclusion Criteria:

18-65 years old of age at time of enrollment
Severe traumatic brain injury (TBI)
Feeding access (e.g., orogastric (OG), nasogastric (NG), or percutaneous endoscopic gastrostomy (PEG) tube) permitting delivery of memantine or placebo
Availability of legally-authorized representative (LAR) to provide consent and participate in some study activities (e.g., monitoring for side effects, providing information about the patient)

Exclusion Criteria:

Pre-existing history of serious neurological disorder
Pre-existing history of serious psychiatric disorder (e.g., schizophrenia)
Anticipated poor prognosis, based on the presence of bilaterally fixed and dilated pupils, severe hemodynamic instability, severe elevations in intracranial pressure refractory to interventions, or other factors leading to a determination of a probable non-survivable injury
Primarily penetrating mechanism of injury (e.g., gunshot wound to the head)
Isolated epidural hematoma with anticipated good prognosis
Low probability of participant being compliant or being able to finish study procedures (e.g., present for outcome rating) in the judgment of the investigator
Not English speaking (due to inability to complete outcome measure)
Medical contraindications to memantine: Severe hepatic impairment (defined as albumin > 15gm/dL, Alk Phos > 375 U/L, ALT > 150 U/L, AST > 120 U/L or bilirubin > 3mg/dL). Moderate-to-Severe renal impairment (defined as creatinine clearance < 60)
Pregnancy or breastfeeding
Intervention: Ibuprofen
Trial phase: Phase 2
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).

Ibuprofen
Eligibility criteria:
Inclusion Criteria:

Age<=18 years
Undergoing ERCP (defined as cannulation of the major or minor papilla) for any indication

Exclusion Criteria:

Age>18
Pancreatitis within the 72 hours preceding ERCP
Allergy or hypersensitivity to Aspirin or NSAID medications
Pregnancy or breastfeeding mother
Cr >1.4
Gastrointestinal hemorrhage in preceding 72 hours
Heart disease reliant upon a patient ductus arteriosis
History of sickle cell disease
Intervention: Levodopa
Trial phase: Phase 3
ATC code: N04BA01 | N04BA02 | N04BA03
SMILES: N[C@@H](Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 153
Group description: 60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day for OFF episodes for 12 months duration.
Eligibility criteria:
Inclusion Criteria:

Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
Hoehn and Yahr Stage 1-3 in an "on" state;
Require levodopa-containing medication regimen at least 3 times during the waking day;
Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
Are on stable PD medication regimen;
Total daily levodopa (LD) dose <1600 mg/day;
Able to perform a spirometry maneuver in the ON and OFF states
Normal cognition confirmed by Mini Mental State Examination (MMSE) score ≥25 ;

Exclusion Criteria:

Pregnant or lactating females;
Previous surgery for PD or plan to have stereotactic surgery during the study period. Patients who have had deep brain stimulation [DBS] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment.
History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
Known contraindication to the use of levodopa;
Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
Any any contraindication to performing routine spirometry.
Intervention: Levodopa
Trial phase: Phase 3
ATC code: N04BA01 | N04BA02 | N04BA03
SMILES: N[C@@H](Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 159
Group description: 84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day for OFF episodes for 12 months duration.
Eligibility criteria:
Inclusion Criteria:

Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
Hoehn and Yahr Stage 1-3 in an "on" state;
Require levodopa-containing medication regimen at least 3 times during the waking day;
Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
Are on stable PD medication regimen;
Total daily levodopa (LD) dose <1600 mg/day;
Able to perform a spirometry maneuver in the ON and OFF states
Normal cognition confirmed by Mini Mental State Examination (MMSE) score ≥25 ;

Exclusion Criteria:

Pregnant or lactating females;
Previous surgery for PD or plan to have stereotactic surgery during the study period. Patients who have had deep brain stimulation [DBS] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment.
History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
Known contraindication to the use of levodopa;
Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
Any any contraindication to performing routine spirometry.
Intervention: Methylprednisolone
Trial phase: Not Applicable
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Methylprednisolone, 20 mg, will be injected

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
History and physical examination consistent with shoulder pain and subacromial bursitis
At least 2 weeks of shoulder pain and subacromial bursitis

Exclusion Criteria:

Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone
History or examination suspicious for a humeral head fracture
History or examination consistent with adhesive capsulitis (normal X-Ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side
History or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint
Any shoulder surgery involving the affected arm within the last 6 months
Intervention: Methylprednisolone
Trial phase: Not Applicable
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Methylprednisolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
History and physical examination consistent with shoulder pain and subacromial bursitis
At least 2 weeks of shoulder pain and subacromial bursitis

Exclusion Criteria:

Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone
History or examination suspicious for a humeral head fracture
History or examination consistent with adhesive capsulitis (normal X-Ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side
History or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint
Any shoulder surgery involving the affected arm within the last 6 months
Intervention: Triamcinolone
Trial phase: Not Applicable
ATC code: A01AC01 | C05AA12 | D07AB09 | D07BB03 | D07CB01 | D07XB02 | H02AB08 | R01AD11 | R03BA06 | S01BA05 | S02CA04
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Triamcinolone, 20 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 40 mg: Compared with methylprednisolone
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
History and physical examination consistent with shoulder pain and subacromial bursitis
At least 2 weeks of shoulder pain and subacromial bursitis

Exclusion Criteria:

Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone
History or examination suspicious for a humeral head fracture
History or examination consistent with adhesive capsulitis (normal X-Ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side
History or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint
Any shoulder surgery involving the affected arm within the last 6 months
Intervention: Triamcinolone
Trial phase: Not Applicable
ATC code: A01AC01 | C05AA12 | D07AB09 | D07BB03 | D07CB01 | D07XB02 | H02AB08 | R01AD11 | R03BA06 | S01BA05 | S02CA04
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Triamcinolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
History and physical examination consistent with shoulder pain and subacromial bursitis
At least 2 weeks of shoulder pain and subacromial bursitis

Exclusion Criteria:

Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone
History or examination suspicious for a humeral head fracture
History or examination consistent with adhesive capsulitis (normal X-Ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side
History or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint
Any shoulder surgery involving the affected arm within the last 6 months
Intervention: Saxagliptin
Trial phase: Phase 4
ATC code: A10BD10 | A10BD21 | A10BD25 | A10BH03
SMILES: N#CC1CC2CC2N1C(=O)C(N)C12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 241
Group description: The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with type 2 diabetes mellitus
Men and women (non-pregnant and using a medically approved birth-control method) aged at least 18 years at screening.
T2D patients treated with stable metformin monotherapy for at least 8 weeks prior to screening. Metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated dose), but not more than the maximum dose specified in the label
HbA1c ≥ 7.5% and ≤ 11.0% at screening or within 4 weeks prior to screening (by local laboratory) and HbA1c ≥ 7.0% and ≤ 11.0% at pre-randomization visit (by central laboratory)
FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)
Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

Women who are pregnant, intending to become pregnant during the study period, lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.

Diagnosis or history of:

Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome.
Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past one year.
History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.
Treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 8 weeks prior to screening