anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Paricalcitol
Trial phase: Phase 4
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
Eligibility criteria:
Inclusion Criteria:

CKD stages 3 or 4 (estimated glomerular filtration rate (eGFR) between 15 and 59)

Diagnosis of secondary hyperparathyroidism, which is defined as:

Elevated intact PTH (iPTH) as per KDIGO guidelines:

CKD stage 3 (eGFR 30-59) or CKD stage 4 (eGFR 15-29) with iPTH > Upper Limit of Normal for lab (6.8 pmol/L)
Presence of Coronary Artery Calcium (CAC > 0)
Subject will be able to complete the study, to the best of his/her knowledge

Exclusion Criteria:

iPTH >1500 pg/ml
Current or previous use of bisphosphonates
History of parathyroidectomy or anticipated parathyroidectomy
History of cinacalcet use
History of a solid organ transplant or scheduled date for transplant surgery
History of coronary revascularization (coronary artery bypass surgery or percutaneous intervention)
History of coronary artifact (e.g. pacemaker, intracardiac defibrillator, artificial valve or biventricular leads)
Active atrial fibrillation
Weight greater than 300 pounds (due to limitations of equipment)
HIV positive
Current pregnancy (although pregnancy is very rare in the CKD population)
Life expectancy less than two years as judged by primary physician
Institutionalized patients (nursing home or prisoners)
Language barrier or mental incapacity to consent
Inability to swallow tablets or current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications.
Intervention: Meropenem
Trial phase: Phase 2
ATC code: J01DH02 | J01DH52
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](C(=O)N(C)C)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy.
Eligibility criteria:
Inclusion Criteria:

complicated intra-abdominal infections

Exclusion Criteria:

infections limited to hollow viscus
ischemic bowel disease without perforation
acute suppurative cholangitis
acute necrotizing pancreatitis
pts to undergo stated abdominal repair, open abdomen technique or marsupialization
Apache II >25
Intervention: Ramelteon
Trial phase: Not Applicable
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
Eligibility criteria:
Inclusion Criteria:

Subject will be between ages 18 to 65 years.
Subject has not been on ramelteon for at least one month.
Subject agrees to make no change in his/her current pain medications during the entire study period (5 weeks). This requirement will ensure that valid comparisons of primary and secondary measures can be made before and after the study.
Subject has a VAS pain score of 5 or above at the beginning of the study.
Subject has had a neuropathic pain condition as listed above for at least three months. This requirement is to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation.
Female subjects of childbearing potential must have a negative urine pregnancy test at the initial visit.

Exclusion Criteria:

Subject has moderate to severe liver impairment.
Subject has Liver Function Tests (LFT's) >1.5X normal.
Subject has a history of renal impairment.
Subject has moderate or severe cardiac or pulmonary disease including a base line oxygen saturation of less than 95% on room air or any requirement for supplemental oxygen.
Subject has a history of glaucoma.
Subject has obstructive sleep apnea.
Subject is taking medications for sleep disorders including insomnia.
Subject has a major psychiatric disorder (major depression requiring a recent hospitalization within three months prior to the study; bipolar disorder; schizophrenia; psychotic disorders; substance abuse).
Subject has a history of dementia or delirium.
Subject has a history of falls.
Subject is pregnant or lactating.
Subject is using an illicit drug detected by a screening test.
Subject is currently taking Fluvoxamine.
Subject has been taking Ketoconazole in the past two weeks.
Subject has known hypersensitivity to ramelteon.
Subject has pending litigation related to his/her neuropathic pain condition.
Subject has Concurrent participation in other research drug trials or other study participation within 30 days of enrollment in this study.
Intervention: ASPIRIN
Trial phase: Early Phase 1
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Patients with coronary artery disease received chewable aspirin 81 mg qd for 2 weeks
Eligibility criteria:
Inclusion Criteria:

On aspirin 81-325mg daily at time of enrollment
Documented stable coronary artery disease or > 6 months after coronary artery bypass grafting or interventional cardiac procedure
Written informed consent

Exclusion Criteria:

Pre-menopausal female
Renal disease (creatinine >= 2 mg/dl)
Anemia (Hematocrit < 30%)
Thrombocytopenia (platelet count < 135,000/ul)
Use of NSAIDs or coxibs within the previous 2 weeks
Concurrent use of other anti-platelet agents
Uncontrolled hypertension (systolic BP > 180 mmHg)
Decompensated congestive heart failure
Recent coronary syndrome (< 6 months)
History of significant GI bleeding
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: escitalopram 10mg - 30mg daily
Eligibility criteria:
Inclusion Criteria:

meet diagnostic criteria for chronic sinusitis
meet diagnostic criteria for facial pain disorder
meet criteria for major depressive disorder on the PHQ-9
18 years of age or older
established primary care provider
able to read and speak English

Exclusion Criteria:

unable to give informed consent of unable to complete self-administered questionnaires due to cognitive impairment, language barriers or severe medical condition
terminal illness or significantly immunocompromized
complications from chronic rhinosinusitis
presence of sinus tumor
isolated sphenoid disease
immotile cilia syndrome
currently on anti-depressant or mood stabilizer med.
diagnosis of bipolar disorder, schizophrenic disorders, paranoid disorders, or psychotic disorders NOS
significant suicide risk
history of hospitalization for mental disorders including psychosis or depression
history of drug abuse within prev. 6 months or dependency on any drug, including alcohol
pregnant or breast feeding
women of child-bearing potential not currently using an approved method of birth control
Intervention: Citalopram
Trial phase: Not Applicable
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 71
Group description: 12 week open label with 2 week placebo period (14 weeks total)

Escitalopram: 20 mg by mouth daily
Eligibility criteria:
Inclusion Criteria:

Diagnosis: Major depression, unipolar without psychotic features (by DSM-IV criteria) -Severity of depression: A 24-Item HDRS above 19 at screening and at baseline -
Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores - one half of the sample < 26, one of half ≥ 26.
Capacity to provide informed consent.

Exclusion Criteria:

High suicide risk, i.e. intent or plan to attempt suicide in near future
Presence of any current Axis I psychiatric disorder (other than unipolar major depression or specific phobias) including substance abuse (those with a history of substance abuse must be abstinent for at least 3 months prior to entry)
Axis II diagnosis of antisocial personality disorder, mental retardation and pervasive developmental disorder (DSM-IV)
History of psychiatric disorders such as psychotic depression, primary psychotic disorder, or bipolar spectrum disorder (bipolar disorder and hypomania are exclusions)
Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV
Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal
Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases i.e. MS
History of failure to respond to escitalopram (Lexapro) (20mg/day for 6 weeks or longer) during the current or previous depressive episodes
History of intolerance to escitalopram (Lexapro) or use of concomitant drugs that may provide reason to believe that escitalopram is contraindicated. Active treatment with fluoxetine at the time of screening
Patients' unwillingness or inability to gradually withdraw all other psychotropic medications (except for the following: Low and stable doses of opiates and non-benzodiazepine hypnotics (e.g. zolpidem (5 or 10 mg), zaleplon (5 or 10 mg), or eszopiclone (1 or 2 mg).Low and stable doses of diazepam and other anxiolytics should be tapered at screening; inability to tolerate taper is not an exclusion criteria.
Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion
Inability to speak English
Aphasia
Intervention: Cyclosporine
Trial phase: Phase 3
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.

cyclosporine ophthalmic emulsion: Given as eye drops
Eligibility criteria:
Inclusion criteria:

Age greater than or equal to 18 years at time of enrollment
Day 80-120 after first allogeneic stem cell transplant for hematologic malignancies or -marrow failure disorder at time of study enrollment
Signed informed consent
Willing to adhere to protocol requirements

Exclusion criteria:

history of non-compliance
diagnosis of ocular GVHD at time of study enrollment
documented dry eye prior to onset of stem cell transplant
significant non- GVHD ocular problems that precludes participation in study
life expectancy of lesser than 6 months at time of enrollment (viz. grade 4 acute GVHD, florid progression or relapse of underlying disease)
history of documented ocular infections prior to stem cell transplant or during transplant (i.e. history of herpetic keratitis)
females who are pregnant or breastfeeding
Intervention: Testosterone
Trial phase: Phase 2
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: testosterone ophthalmic solution 0.03%

Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days.
Eligibility criteria:
Inclusion Criteria (subjects must):

Be ≥ 60 years of age
Have a corrected visual acuity of LogMAR +0.5 (ETDRS)
Have a documented history of Meibomian Gland Dysfunction
Have a TFBUT ≤ 5 seconds
Have an ocular discomfort score ≥ 1
Have an IOP ≤ 25 mmHg at Visit 1 in both eyes
Report use of and/or desire to use an artificial tears

Exclusion Criteria (subjects may not):

Have contraindications to the use of the study medications
Have a known allergy or sensitivity to the study medications
Have any ocular infections, or active ocular inflammation
Have used ocular medications within 24 hours prior to Visit 1
Be a current contact lens wearer
Require the use of any other ophthalmic medication, other than tear substitutes and study medication provided, for the duration of the trial
Have used systemic or topical antihistamines or steroids 48 hours prior to Visit 1 or require the use of systemic or topical antihistamines or steroids during the course of the study
Have a history of prostate cancer
Intervention: ULIPRISTAL ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 95
Group description: PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Eligibility criteria:
Inclusion Criteria:

Be a pre-menopausal woman between 18 and 50 years inclusive.
Have excessive uterine bleeding due to myoma.
Have a myoma-related anaemia.
Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

Has a history of or current uterine, cervical, ovarian or breast cancer.
Has a history of or current endometrium atypical hyperplasia.
Has a known severe coagulation disorder.
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
Has abnormal hepatic function at study entry.
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Has a current (within twelve months) problem with alcohol or drug abuse.
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Intervention: ULIPRISTAL ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 98
Group description: PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Eligibility criteria:
Inclusion Criteria:

Be a pre-menopausal woman between 18 and 50 years inclusive.
Have excessive uterine bleeding due to myoma.
Have a myoma-related anaemia.
Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

Has a history of or current uterine, cervical, ovarian or breast cancer.
Has a history of or current endometrium atypical hyperplasia.
Has a known severe coagulation disorder.
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
Has abnormal hepatic function at study entry.
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Has a current (within twelve months) problem with alcohol or drug abuse.
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Intervention: Temozolomide
Trial phase: Not Applicable
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Newly diagnosed anaplastic glioma (WHO grade III) or glioblastoma multiforme (WHO grade IV)

Measurable disease

Residual tumor size after surgery ≥ 1 cm in one dimension
Planning to undergo standard chemoradiotherapy with temozolomide

PATIENT CHARACTERISTICS:

Glomerular filtration rate ≥ 60 mL/min
Mini Mental Status Exam score > 15
Sufficiently competent to give informed consent
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment

No contraindication to MRI or to use of the contrast agent gadolinium, including any of the following:

Claustrophobia
Metallic objects or implanted medical devices (e.g., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
Sickle cell disease
Renal failure
High risk for kidney disease (e.g., age > 60 years, diabetes, or history of systemic lupus erythematosus or multiple myeloma)
No known history of chronic obstructive pulmonary disease or emphysema
No other co-existing condition that, in the judgement of the investigator, may increase risk to the patient

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Non-VEGF investigational agent allowed
No concurrent chemotherapy (other than temozolomide)
No concurrent electron, proton, particle, or implant radiotherapy
No concurrent stereotactic radiosurgery
No concurrent anti-VEGF anti-tumor agents
Intervention: Metoprolol
Trial phase: Not Applicable
ATC code: C07AB02 | C07BB02 | C07BB52 | C07CB02 | C07FB02 | C07FB13 | C07FX03 | C07FX05
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.

Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
Eligibility criteria:
Inclusion Criteria:

Being older than 18 but, not older than 75
Scheduled for surgery under general anesthesia
Duration of surgery scheduled as 2 hours or longer

Exclusion Criteria:

Intracranial or intrathoracic surgery (due to difficulty using a BIS monitor or frequent need for beta-receptor antagonism)
Indication for perioperative beta-receptor antagonism
Current use of calcium-channel antagonists
History of coronary artery disease
History of reactive airway disease
History of diabetes or other disorders of glucose metabolism
Reported allergy to any of the study drugs
Reported substance abuse (except nicotine and caffeine)
Use of monoamine oxidase (MAO) inhibitor drugs
Hypersensitivity to metoprolol, esmolol and related derivatives, or to any of the excipients of either.
Hypersensitivity to other beta-blockers (cross-sensitivity between beta-blockers can occur).
Sick-sinus Syndrome.
Heart block greater than first degree, cardiogenic shock, and overt cardiac failure.
Significant first-degree heart block (P-R interval greater than or equal to 0.24 sec; systolic pressure < 100mmHg; or moderate- to-severe cardiac failure).
Severe peripheral arterial circulatory disorders.
Pheochromocytoma.
Baseline heart rate of < 60
Systolic pressure less than 100 mm Hg
Pregnant women
Prisoners
Intervention: Esmolol
Trial phase: Not Applicable
ATC code: C07AB09
SMILES: COC(=O)CCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.

Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
Eligibility criteria:
Inclusion Criteria:

Being older than 18 but, not older than 75
Scheduled for surgery under general anesthesia
Duration of surgery scheduled as 2 hours or longer

Exclusion Criteria:

Intracranial or intrathoracic surgery (due to difficulty using a BIS monitor or frequent need for beta-receptor antagonism)
Indication for perioperative beta-receptor antagonism
Current use of calcium-channel antagonists
History of coronary artery disease
History of reactive airway disease
History of diabetes or other disorders of glucose metabolism
Reported allergy to any of the study drugs
Reported substance abuse (except nicotine and caffeine)
Use of monoamine oxidase (MAO) inhibitor drugs
Hypersensitivity to metoprolol, esmolol and related derivatives, or to any of the excipients of either.
Hypersensitivity to other beta-blockers (cross-sensitivity between beta-blockers can occur).
Sick-sinus Syndrome.
Heart block greater than first degree, cardiogenic shock, and overt cardiac failure.
Significant first-degree heart block (P-R interval greater than or equal to 0.24 sec; systolic pressure < 100mmHg; or moderate- to-severe cardiac failure).
Severe peripheral arterial circulatory disorders.
Pheochromocytoma.
Baseline heart rate of < 60
Systolic pressure less than 100 mm Hg
Pregnant women
Prisoners
Intervention: Saxagliptin
Trial phase: Phase 3
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: 304
Group description: Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes mellitus
Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening
If taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening
Insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component).
Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive)
Body mass index of 45 kg/m² or lower
Fasting C-peptide level of 0.8 ng/mL or higher

Exclusion Criteria:

Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms
History of diabetic ketoacidosis or hyperosmolar nonketotic coma
Women of childbearing potential unable or unwilling to use acceptable birth control
Women who are pregnant or breastfeeding
Active liver disease
Anemia
Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled)
Use of short- or rapid-acting insulin
Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident
Congestive heart failure
Unstable or rapidly progressing renal disease
History of alcohol or drug abuse within the previous year
History of hemoglobinopathies
Unstable major psychiatric disorders
Immunocompromised status