anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Healon
Trial phase: Phase 4
SMILES: CC(=O)NC1C(O)OC(CO)C(O)C1OC1OC(C(=O)O)C(OC2OC(CO)C(O)C(OC3OC(C(=O)O)C(O)C(O)C3O)C2NC(C)=O)C(O)C1O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Subjects treated with Euflexxa
Eligibility criteria:
Inclusion Criteria:

Age 18 to 80 years
Symptomatic knee OA as defined by the American College of Rheumatology criteria
Kellgren-Lawrence grade I, II or III on prior x-rays (take within 6 months of screening visit)
knee pain score >40 mm on a 100 mm visual analogue scale for > 15 days in the last month
NSAIDs permitted if the dose has been stable for at least one month prior to baseline and stays stable during the study
Have been recommended for Euflexxa treatment by physician
Knee effusion based on clinical exam or imaging

Exclusion Criteria:

Any contraindication to MRI (pregnancy, metallic fragments in the eyes, vascular clips, Pacemakers etc)
History of knee replacement
Known sensitivity or allergy to any component of Euflexxa
Inflammatory arthritis
Previously received viscosupplementation therapy within 6 months of study enrollment
Intra-articular injection of corticosteroid to study joint within the past 3 months
Arthroscopic or open surgery within the previous 12 months or planned surgery to the study joint
Concomitant medications of oral/parenteral corticosteroids
Morbid obesity defined as body mass index (BMI) >40 kg/m2
Active malignancy; an active systemic infection; recent high impact or high energy trauma (clinically defined) to the study joint
Large knee effusion based on clinical exam or imaging
Intervention: LATANOPROSTENE BUNOD
Trial phase: Phase 3
ATC code: S01EE06
SMILES: O=C(CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O)OCCCCO[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 130
Group description: Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.

Latanoprostene bunod
Eligibility criteria:
Inclusion Criteria:

Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma [NTG],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes.
Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day 0[after washout for the subjects already on treatment]): mean/median IOP ≥15 mmHg and ≤36 mmHg at 10 AM in at least 1 eye; and IOP ≤36 mmHg in both eyes.
Subjects with a corrected Decimal visual acuity (VA) or a Best-Corrected Decimal Visual Acuity (BCVA) of 0.5 or better in both eyes.

Exclusion Criteria:

Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and during study visits.
Subjects who are unable to discontinue other eye drop medications such as artificial tears for 15 minutes prior to and 15 minutes after instillation of study drug.
Subjects with a central corneal thickness greater than 600 μm in either eye.
Subjects with any condition that prevents reliable applanation tonometry in either eye.
Subjects with advanced glaucoma with a mean deviation (MD) < -12 dB, a history of split fixation, or a field loss threatening fixation in either eye.
Subjects with any condition that prevents clear visualization of the fundus.
Subjects who are monocular (fellow eye is absent).
Subjects with aphakia in either eye.
Subjects with an active corneal disease in either eye.
Subjects with severe dry eye in either eye.
Subjects with a history/diagnosis of a clinically significant or progressive retinal disease in either eye.
Subjects with very narrow angles and subjects with angle closure congenital, or secondary glaucoma, and subjects with history of angle closure in either eye.
Subjects with any intraocular infection or inflammation in either eye within 3 months prior to Visit 1 (Screening).
Subjects with a history of ocular laser surgery in either eye within the 3 months (90 days) prior to Visit 1 (Screening).
Subjects with a history of incisional ocular surgery or severe trauma in either eye within 3 months prior to Visit 1 (Screening).
Intervention: Modafinil
Trial phase: Phase 2
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: 150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days

Armodafinil
Eligibility criteria:
Inclusion Criteria:

First clinical stroke, either cerebral infarction or intracerebral hemorrhage
Severe hemiparesis as measured by a Fugl-Meyer motor scale score of 0-25
Screening Motricity Index score of 0-83
Date of stroke onset between 7 to 21 days prior to study inclusion

Exclusion Criteria:

Age less than 18
Previous clinical stroke
Pregnant and/or nursing patients
Major psychiatric history, including psychosis and history of substance abuse
Dementia
Known CNS pathology such as brain tumor
Significant language dysfunction or severe neglect that hinders comprehension, participation, and barrier to testing
Seizures
Left ventricular hypertrophy (LVH)
Mitral valve prolapse (MVP)
Severe chronic renal failure or severe hepatic failure
History or current use of anti-epileptic medications, psychostimulants, or neuroleptics
Current use of diazepam, phenytoin, propranolol, tricyclic antidepressants, steroidal contraceptives, cyclosporine, or theophylline
Intervention: Sertraline
Trial phase: Phase 4
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: 50-200mg daily
Eligibility criteria:
Inclusion Criteria:

Age 60 years or older.
Current diagnosis of major depressive disorder (DSM-IV-TR), single episode, recurrent or chronic, without psychotic features, as detected by MINI and clinical exam.
Minimum MADRS score ≥ 15.
Mini-Mental State Exam ≥ 22.
Ability to read and write English.

Exclusion Criteria:

Current or past diagnoses of other Axis I psychiatric disorders, including panic disorder and substance dependence.
Any use of illicit substances (such as marijuana or cocaine) or abuse of prescription medications (such as benzodiazepines or opiates) within the last three months.
Presence of acute suicidality
Current or past psychosis
Known primary neurological disorder, including dementia, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
Chronic untreated medical disorders (including but not limited to hypertension, hyperlipidemia, fibromyalgia, hypothyroidism, or any other disorder) where treatment is warranted
Need for continuous oxygen use or any medical disorder where the hypercapnia challenge would be contraindicated or put the subject at increased risk. This would include active respiratory disease, chronic angina or other unstable cardiac conditions.
Any physical or intellectual disability affecting completion of assessments
MRI contraindications
Electroconvulsive therapy in last 6 months
Use of fluoxetine in the last 6 weeks. Occasional use of benzodiazepines or non-benzodiazepine sedatives (such as zolpidem, eszopiclone, or zaleplon) during the last month is allowable.
Known allergy or hypersensitivity to sertraline
A failed therapeutic trial of sertraline in the current depressive episode (defined as at least 6 weeks of treatment at a daily dose of 100mg or higher)
Current or planned psychotherapy
Intervention: Digoxin
Trial phase: Phase 1
ATC code: C01AA05
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@@H](C5=CC(=O)OC5)CC[C@@]43O)[C@@]1(C)CC[C@H](O[C@H]1C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O[C@H]4C[C@H](O)[C@H](O)[C@@H](C)O4)[C@@H](C)O3)[C@@H](C)O1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Digoxin: Participants received a single dose of 0.5 mg digoxin administered orally on Day 1. Adverse events (AEs) are reported through predose on Day 6
Eligibility criteria:
Inclusion Criteria:

Overtly healthy males and females (of non-childbearing potential)
Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
Normal renal function

Exclusion Criteria:

Participants who currently smoke or use tobacco or nicotine products
Intervention: Ticagrelor
Trial phase: Phase 2
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen
Eligibility criteria:
Inclusion Criteria:

Patients with ST-elevation myocardial infarction undergoing primary PCI.
Age between 18 and 80 years old.

Exclusion Criteria:

History of prior intracranial bleeding.
On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 30 days.
Known allergies to aspirin or ticagrelor.
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
Treatment with IIb/IIIa glycoprotein inhibitors.
Fibrinolytics within 24 hours
Known blood dyscrasia or bleeding diathesis.
Known platelet count <80x106/mL.
Known hemoglobin <10 g/dL.
Active bleeding.
Hemodynamic instability.
Known creatinine clearance <30 mL/minute.
Known severe hepatic dysfunction.
Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.

Pregnant females*.

Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Intervention: Ticagrelor
Trial phase: Phase 2
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen
Eligibility criteria:
Inclusion Criteria:

Patients with ST-elevation myocardial infarction undergoing primary PCI.
Age between 18 and 80 years old.

Exclusion Criteria:

History of prior intracranial bleeding.
On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 30 days.
Known allergies to aspirin or ticagrelor.
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
Treatment with IIb/IIIa glycoprotein inhibitors.
Fibrinolytics within 24 hours
Known blood dyscrasia or bleeding diathesis.
Known platelet count <80x106/mL.
Known hemoglobin <10 g/dL.
Active bleeding.
Hemodynamic instability.
Known creatinine clearance <30 mL/minute.
Known severe hepatic dysfunction.
Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.

Pregnant females*.

Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Intervention: Livoletide
Trial phase: Phase 2
SMILES: [H][C@@]12CCCN1C(=O)[C@H](CO)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@H](CCC(=O)O)NC2=O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training

Ghrelin: 2:1 ratio placebo to ghrelin

Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Eligibility criteria:
Inclusion Criteria:

Individuals with three, four or five frailty criteria using the Fried frailty criteria

Exclusion Criteria:

Diabetes mellitus or fasting glucose ≥ 126 mg/dL
Hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months.
New York Heart Association Class III or IV congestive heart failure
Therapy for cancer in the past 12 months, except non-melanoma skin cancer
BMI ≥ 30 kg/m2
Current use of corticosteroids other than topical, ophthalmic, and inhaled preparations
Therapy with megestrol acetate or dronabinol within the last 6 weeks
Thyroid stimulating hormone measured as < 0.4 uIU/L or greater than 10uIU/L
Abnormal liver function tests (LFTs > 2x upper limit of normal)
Hemoglobin < 11g/dL
Insulin-like growth factor-I (IGF-I) above the age-specific reference range
History of surgery within the last 30 days
Hip fracture of hip or knee replacement within the previous 6 months or unable to walk
Deemed unsafe to participate by one of the study exercise therapists
Undergoing physical therapy or an exercise program
Unstable medical or psychological conditions or unstable home or food environment
Cognitive deficit as defined by a Folstein Mini Mental State Exam score < 24/30
Depression (defined as a score of > 11 on the Geriatric Depression Questionnaire)
Out of town for > 1 week during the 12 week study
Residing outside of a 15 mile radius of University of Pennsylvania Health System
Intervention: Apadenoson
Trial phase: Phase 3
SMILES: CCNC(=O)[C@H]1O[C@@H](n2cnc3c(N)nc(C#CC[C@H]4CC[C@H](C(=O)OC)CC4)nc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.

ON101 Cream
Eligibility criteria:
Inclusion Criteria

Has signed a written informed consent prior to the first study evaluation;
Male or female is at least 20 and < 80 years of age;
Diabetes mellitus (type 1 or 2) with an HbA1c < 12.0% measured during screening or within three months prior to randomization;
An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization;

The target ulcer must have the following characteristics:

Grade 1 or 2 per Wagner Ulcer Classification System;
No higher than the ankle;
No active infected;
A cross-sectional area of between 1 and 25 cm2 post-debridement;
Present for at least 4 weeks before randomization;
If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit;
Able and willing to attend the scheduled visits and comply with study procedures.

Exclusion Criteria:

Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to randomization;
Poor nutritional status defined as an albumin < 2.5 g/dL;
Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) >3 x the normal upper limit;
Serum Creatinine >2 x the normal upper limit;
Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization;
Use of any investigational drug or therapy within the 4 weeks prior to randomization;
A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance;
Judged by the investigator not to be suitable for the study for any other reason.
Intervention: Desipramine hydrochloride
Trial phase: Not Applicable
SMILES: CNCCCN1c2ccccc2CCc2ccccc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were <10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10^6 cells/kg was reached. If the collected CD34+ cell dose was <0.5x10^6 on two consecutive days, aperheris was stopped and the patient was taken off study.

Despiramine hydrochloride: PO Filgrastim: PO
Eligibility criteria:
Inclusion Criteria:

Patients eligible for autologous stem cell transplant for multiple myeloma; planned use of filgrastim (GCSF) for stem cell mobilization
Ability to give informed consent
Glomerular filtration rate (GFR) > 30 ml/minute
Liver function tests < 2.5 x upper limit of normal (ULN)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or less

Based on prior therapy patients will be classified into two categories:

Initial mobilizers with no exposure to alkylators
Remobilizers or with prior exposure to alkylators or with greater than 5 cycles of lenalidomide therapy prior to mobilization

Exclusion Criteria:

Use of a monoamine oxidase inhibitor (MAO-I) during or within 2 weeks of desipramine therapy
Concomitant therapy with any drugs shown to have major interactions with desipramine
Concurrent use of drugs that are contraindicated with desipramine
Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death; baseline corrected QT (QTc) > 460 msec
Active alcohol abuse
Bipolar disorder
Untreated active major depression
History of seizures in the past 3 years
Pregnancy and lactation; refusal to use adequate contraception
Uncontrolled thyroid disease
GCSF or pegfilgrastim use within 14 days prior to enrollment
Bortezomib, Revlimid or thalidomide use within 7 days of enrollment
Patients with sickle cell disease
Intervention: Bepotastine besilate
Trial phase: Phase 3
SMILES: O=C(O)CCCN1CCC(OC(c2ccc(Cl)cc2)c2ccccn2)CC1.O=S(=O)(O)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 58
Group description: TAU-284 10mg twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Patients aged between 7 and 15 years
Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
Patients with a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 3 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.

Exclusion Criteria:

Patients with vasomotor rhinitis or eosinophilic rhinitis
Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
Patients with a history of any of the nasal surgical procedures
Patients with current or previous history of drug allergy
Patients who concurrently have renal function abnormalities that may cause safety problems etc.
Intervention: Bevenopran
Trial phase: Phase 3
SMILES: COc1cc(CNCCC2CCOCC2)ccc1Oc1cnc(C(N)=O)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: 0.25 mg CB-5945 administered orally BID for a 12-week treatment period
Eligibility criteria:
Key Inclusion Criteria:

Is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily dose (METDD) for chronic non-cancer pain
Has constipation that is caused by the chronic use of opioids
Is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from Screening until the last study assessment

Key Exclusion Criteria:

Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example [e.g.], obstruction) or contribute to bowel dysfunction
Has evidence of intestinal obstruction
Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening
Has an active malignancy of any type (participants with a history of successfully treated malignancy >5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone)
Is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)
Intervention: Bevenopran
Trial phase: Phase 3
SMILES: COc1cc(CNCCC2CCOCC2)ccc1Oc1cnc(C(N)=O)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: 0.25 mg CB-5945 administered orally BID for a 12-week treatment period
Eligibility criteria:
Key Inclusion Criteria:

Is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily dose (METDD) for chronic non-cancer pain
Has constipation that is caused by the chronic use of opioids
Is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from Screening until the last study assessment

Key Exclusion Criteria:

Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example [e.g.], obstruction) or contribute to bowel dysfunction
Has evidence of intestinal obstruction
Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening
Has an active malignancy of any type (participants with a history of successfully treated malignancy >5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone)
Is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)
Intervention: Ibuprofen
Trial phase: Phase 4
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 800mg ibuprofen

IV ibuprofen
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for knee arthroscopy

Exclusion Criteria:

Inadequate IV access.
History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.
Less than 18 years of age.
Use of analgesics less than 8 hours prior to surgery.
Patients with active, clinically significant anemia.
History or evidence of asthma or heart failure.
Pregnant.
Recent history of chronic opioid use.
Concomitant use of probenecid.
Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.
Refusal to provide written authorization for use and disclosure of protected health information.