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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Saline, Single dose, Intramuscular injection into right EDB

Saline: Single Dose, Intramuscular into right EDB muscle
Eligibility criteria:
Inclusion Criteria:

Normal, healthy, male or female subjects, 18 to 54 years of age.
Written informed consent has been obtained.
Females with child-bearing potential have a negative urine pregnancy test and agree to use a reliable form of contraception during the study.
Ability to follow study instructions and likely to complete all required visits.
Written authorization for Use and Release of Health and Research Study Information has been obtained.

Exclusion Criteria:

Abnormality by focused history and examination including the presence of foot deformity.
Abnormal (as determined by the investigator) screening nerve conduction studies of the lower limbs.
Identification of anomalous innervation of right EDB via screening nerve conduction studies.
The subject having a foot which does not adequately fit in the modified ankle-foot orthosis used with the strain gauge.
The subject having a foot in which anatomic bone landmarks cannot be adequately identified.
Body mass index (BMI) greater than 30.
History of significant (as determined by the investigator) lower limb injury or lower limb surgery
Any uncontrolled clinically significant medical condition.
Known allergy or sensitivity to any of the components in the study medication.
Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
Concurrent participation in another investigational drug or device study or participation within 3 months prior to study.
Treatment with botulinum toxin of any serotype prior to enrollment in study or prior clinical botulism.
Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
Evidence of alcohol abuse, drug abuse, or other relevant neuropsychiatric condition.
Infection or skin disorder at an anticipated injection site.
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results (e.g. variable strength on serial testing during screening examination; or foot, toe, or ankle pain that may limit full participation in muscle strength testing), or interfere significantly with the subject's participation in the study.
Intervention: Zopiclone
Trial phase: Phase 4
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors

Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older.
Eligibility criteria:
Inclusion Criteria:

Patients with recent (less than or equal to 8 weeks) "uncomplicated" acute myocardial infarction, can either be ST elevation MI (STEMI) or non-ST elevation MI (non-STEMI) and subsequent to successful treatment (percutaneous revascularization or medical therapy).

Exclusion Criteria:

Obstructive sleep apnea (OSA, defined as apnea-hypopnea index > 15 per hour) or previous diagnosis of OSA.
Patients with life-threatening arrhythmias (such as atrial fibrillation/flutter with hypotension, ventricular tachycardia, or ventricular fibrillation, or significant heart block that requires pacing [Type III, Type IIb]), cardiogenic shock, severe heart failure requiring high levels of inspired oxygen (FiO2 >40%), persistent chest pain despite medical or other interventions, and patients who are considered too unstable to participate for other medical reasons or complications (such as concomitant strokes, retroperitoneal hematoma, gastro-intestinal bleeding). Also excluded are patients with history of cardiac arrest during the same hospitalization.
Unable to take oral medications
Use of other sedative-hypnotics
Hypersensitivity to Eszopiclone or any component of the formulation
Pregnancy
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: 53
Group description: titrated to achieve 40-60% PTH suppression

Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression
Eligibility criteria:
Inclusion Criteria

Age >18; Able to give informed consent
Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation
intact PTH (iPTH) >120 pg/ml at baseline
albumin corrected calcium > 8.5 mg/dL to < 10.0 mg/dL at baseline
Phosphorus < 4.6 mg/dL at baseline
If on a phosphorus binder; no change in dose within the 4 weeks prior to screening

Exclusion Criteria

Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)
Receiving >50,000 IU per month of ergocalciferol or > 1000 IU of cholecalciferol per day within the previous 30 days.
history of primary HPT
On prednisone > 30 days within the previous 6 months
receiving bisphosphonates or calcitonin within the previous 12 months
Non-elective hospitalization within the previous 30 days.
Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.
History of renal or other organ transplant
History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism
Receiving cinacalcet within 4 weeks prior to screening.
An active drug/alcohol dependence or abuse history
History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator
Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
Intervention: Calcitriol
Trial phase: Phase 4
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: titrated to achieve 40-60% PTH suppression

Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
Eligibility criteria:
Inclusion Criteria

Age >18; Able to give informed consent
Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation
intact PTH (iPTH) >120 pg/ml at baseline
albumin corrected calcium > 8.5 mg/dL to < 10.0 mg/dL at baseline
Phosphorus < 4.6 mg/dL at baseline
If on a phosphorus binder; no change in dose within the 4 weeks prior to screening

Exclusion Criteria

Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)
Receiving >50,000 IU per month of ergocalciferol or > 1000 IU of cholecalciferol per day within the previous 30 days.
history of primary HPT
On prednisone > 30 days within the previous 6 months
receiving bisphosphonates or calcitonin within the previous 12 months
Non-elective hospitalization within the previous 30 days.
Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.
History of renal or other organ transplant
History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism
Receiving cinacalcet within 4 weeks prior to screening.
An active drug/alcohol dependence or abuse history
History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator
Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
Intervention: Ganirelix
Trial phase: Phase 4
ATC code: H01CC01
SMILES: CC/N=C(\NCC)NCCCC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CCCCN/C(=N/CC)NCC)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@@H](Cc1cccnc1)NC(=O)[C@@H](Cc1ccc(Cl)cc1)NC(=O)[C@@H](Cc1ccc2ccccc2c1)NC(C)=O)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 147
Group description: Start 150IU rFSH s.c. cycle day 2
Eligibility criteria:
Inclusion Criteria:

Female age < 36 years
FSH < 12 IU/l
BMI 18-29 kg/m2
Regular cycle (25-35 days)
No major uterine or ovarian abnormalities
No previous IVF cycles
Written informed consent

Exclusion Criteria:

Oocyte donation
Medical contra indication for pregnancy or IVF treatment
Endometriosis ≥ grade 3
Polycystic Ovarium Syndrome (PCOS)
Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Intervention: Ganirelix
Trial phase: Phase 4
ATC code: H01CC01
SMILES: CC/N=C(\NCC)NCCCC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CCCCN/C(=N/CC)NCC)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@@H](Cc1cccnc1)NC(=O)[C@@H](Cc1ccc(Cl)cc1)NC(=O)[C@@H](Cc1ccc2ccccc2c1)NC(C)=O)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 147
Group description: Start 150IU rFSH s.c. cycle day 2=5
Eligibility criteria:
Inclusion Criteria:

Female age < 36 years
FSH < 12 IU/l
BMI 18-29 kg/m2
Regular cycle (25-35 days)
No major uterine or ovarian abnormalities
No previous IVF cycles
Written informed consent

Exclusion Criteria:

Oocyte donation
Medical contra indication for pregnancy or IVF treatment
Endometriosis ≥ grade 3
Polycystic Ovarium Syndrome (PCOS)
Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Intervention: Velac
Trial phase: Phase 2 | Phase 3
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O.CCCC1CC(C(=O)NC(C(C)Cl)C2OC(SC)C(OP(=O)(O)O)C(O)C2O)N(C)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects 18 years of age and older.
Clinical diagnosis of papulopustular facial rosacea.
A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules).
Willing and able to understand and sign informed consent.
Able to complete study and comply with study procedures.

Exclusion Criteria:

Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis, bloody diarrhea) or similar symptoms.
Use of topical rosacea treatments in the past 2 weeks.
Use of systemic antibiotics in the past 4 weeks.
Use of systemic retinoids within the past 3 months.
Use of laser or light based rosacea treatments within the past 2 months.
Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments.
Current drug or alcohol abuse.
Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or acne vulgaris.
Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Subjects who are pregnant or planning a pregnancy.
Use of any investigational therapy within the past 4 weeks.
Known hypersensitivity or previous allergic reaction to clindamycin or retinoids
Intervention: Besifloxacin Hydrochloride
Trial phase: Phase 1
SMILES: Cl.NC1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Besifloxacin ophthalmic suspension
Eligibility criteria:
Inclusion Criteria:

Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.

Exclusion Criteria:

Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
Subjects who had any corneal refractive surgery in the study eye.
Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
Subjects who are monocular.
Intervention: Moxifloxacin Hydrochloride
Trial phase: Phase 1
SMILES: COc1c(N2CC3CCCNC3C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Eligibility criteria:
Inclusion Criteria:

Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.

Exclusion Criteria:

Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
Subjects who had any corneal refractive surgery in the study eye.
Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
Subjects who are monocular.
Intervention: Gatifloxacin
Trial phase: Phase 1
ATC code: J01MA16 | S01AE06
SMILES: COc1c(N2CCNC(C)C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Zymar (gatifloxacin ophthalmic solution, 0.3%)
Eligibility criteria:
Inclusion Criteria:

Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.

Exclusion Criteria:

Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
Subjects who had any corneal refractive surgery in the study eye.
Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
Subjects who are monocular.
Intervention: 2-(Chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride
Trial phase: Phase 2
SMILES: C=CCN.Cl.ClCC1CO1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
Eligibility criteria:
Main Inclusion Criteria:

≥ 18 years of age,
Receiving stable maintenance hemodialysis 3 times a week
On restricted phosphate diet at screening and throughout study
Receiving stable dose of phosphate binder for at least 1 month
Serum phosphate levels >1.78 mmol/L

Main Exclusion Criteria:

Uncontrolled hyperphosphatemia
Hypercalcemia at screening or during washout
Serum calcium < 1.9 mmol/L (<7.6 mg/dL)
Severe hyperparathyroidism (iPTH levels >600 ng/L)
Pregnancy or lactation
Iron deficiency anemia
History of hemochromatosis or ferritin >800 mg/L,
Hepatitis B, hepatitis C or other significant concurrent liver disorders
Known positivity to HIV
Use of oral iron preparations 1 month before screening,
Serious medical condition or uncontrolled systemic disease
Intervention: Gefitinib
Trial phase: Phase 2
ATC code: L01EB01 | L01XE02
SMILES: COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1OCCCN1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Gefitinib retreatment
Eligibility criteria:
Inclusion Criteria:

Recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) stage IV or IIIB patients after chemotherapy following gefitinib failure
Male and female patients aged over 18 years
World Health Organization (WHO) performance status 0-2 (those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
Had at least stable disease with previous Gefitinib treatment
Had at least one anticancer agent therapy after gefitinib failure ;Following treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)- erlotinib or other TKIs should not be included in anticancer agent therapy.
The current approved indication of Gefitinib is 2nd or 3rd line monotherapy for recurrent or metastatic NSCLC. However, in practice with off-label indication, it can also be used as a 1st line treatment at the patient's own expenses. Thus, in this trial gefitinib retreatment will be 3rd line or more.
Measurable lesion according to Response Evaluation Criteria in Solid Tumors(RECIST) with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
Provision of written informed consent
Life expectancy of at least 12 weeks

Exclusion Criteria:

Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
Expected life expectancy less than 2 months
Known severe hypersensitivity to gefitinib or any of the excipients of this product
Any unresolved chronic toxicity greater that Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Serum bilirubin greater than 3 times the upper limit of reference range (ULRR)
Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x Upper Limit Normal (ULN) if no demonstrable liver metastases (or >5 x in presence of liver metastases)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
Newly diagnosed central nervous system (CNS) metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (no steroid therapy or steroid dose being tapered) for at least 2 weeks
Intervention: Bosentan
Trial phase: Phase 2
ATC code: C02KX01 | G01AE10
SMILES: COc1ccccc1Oc1c(NS(=O)(=O)c2ccc(C(C)(C)C)cc2)nc(-c2ncccn2)nc1OCCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.

bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study.
Eligibility criteria:
Inclusion Criteria:

Patients with Pulmonary Arterial Hypertension (PAH) must be stable on therapy for at least 3 months prior to enrollment in the trial. We will include patients with idiopathic PAH and Familial PAH as well as PAH associated with collagen vascular disease or drug or toxin exposure. With the exception of PAH, subjects must be free of major medical illnesses, including diabetes mellitus (must have fasting plasma glucose < 126 mg/dL and taking no anti-hyperglycemic agent), malignancy or significant hepatic or renal disease. Subjects may be hypertensive and on anti-hypertensive medications as long as blood pressure is < 150/100 mm Hg. Subjects may also be dyslipidemic and/or taking drugs to improve abnormalities of lipid metabolism, but they will be excluded if they are taking medications known to alter insulin sensitivity, including glucocorticoids, niacin, anti-retrovirals, thiazolidinediones, or metformin. Use of oral contraceptives or estrogen and/or progesterone replacement therapy is permitted. Weight must be stable and the subjects agree not to change their eating habits or exercise regimen during the study period. There will be no restrictions with regard to race or socioeconomic status, and the racial/ethnic composition of the study population will be reflective of the communities surrounding the Stanford University Medical Center.

Exclusion Criteria:

* Vulnerable subject status.

Concurrent Endothelin-1 antagonist therapy
Concurrent Thiazolidinedione therapy
New York Heart Class III or IV
PAH related to other etiologies.
Diabetes Mellitus with Fasting Glucose Levels > 126 mg/dL
Allergy or hypersensitivity to pioglitazone or bosentan administration.
Current treatment with statin therapy.
Initiation of PAH therapy (prostacyclin analogues, phosphodiesterase-5 inhibitors) within three months of enrollment.
Inability or unwillingness to avoid systemic steroid containing medications for four months. Inhaled steroid use is acceptable.
Current or recent use or planned treatment with: glyburide, cyclosporine, nilotinib, nisoldipine, ranolazine, thioridazine
Hepatic transaminases > 2x the upper limit of normal at the center at screening.
Current or recent (< 6 months) chronic heavy alcohol consumption.
Current use of another investigational drug (non-FDA approved) for PAH.
Lung transplant recipients.
History of myositis.
Renal failure (Cr 2.0).
Hospitalized or acutely ill.
Chronic liver disease (cirrhosis, chronic hepatitis, etc.).
Abnormalities of the arm or hand or radical mastectomy (preventing brachial artery ultrasound).
Pregnant or lactating women.