anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lidocaine
Trial phase: Early Phase 1
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days.

Ginger Extract: 2gm Capsule of Ginger extract
Eligibility criteria:
Inclusion Criteria:

Men or women age 18 or older;
Treatment with inhaled corticosteroids (ICS) +/- long acting β-agonists/long acting muscarinics and montelukast;
Physician diagnosed asthma;
Forced expiratory volume (FEV1) ≥60% of predicted
Methacholine PC(20) < 16 mg/ml if taking ICS and < 8mg/ml if not taking ICS at Visit 2.
Non-smoker (e.g., tobacco, e-cigarette, marijuana) for ≥1 yr.;
≤10 pack-year smoking history;
Suboptimal control of asthma as determined by a score < 19 or less on the Asthma Control Test (ACT) at Screening Visit (Visit 1) and Randomization Visit (Visit 3).

Exclusion Criteria:

Other major chronic illnesses: Conditions which in the judgment of the study physician would interfere with participation in the study, e.g., non-skin cancer, uncontrolled diabetes mellitus, coronary artery disease, congestive heart failure, stroke, severe hypertension, renal failure, liver disorders, malabsorption disorders, immunodeficiency states, major neuropsychiatric disorder;
Cardiovascular problems: Myocardial infarction or stroke in last 3 months Uncontrolled hypertension Known aortic aneurysm
History of physician diagnosis of chronic bronchitis, emphysema or chronic obstructive pulmonary disease (COPD)
Medication use: Current consumption of ginger supplements, oral corticosteroid use within the past 6 weeks, use of an investigational treatment in the previous 30 days, known adverse reaction to ginger or ginger products;
Females of childbearing potential: Pregnant or lactating; participants of appropriate age who might be pregnant at the time of enrollment will be screened with urine pregnancy tests at each visit and cannot participate if pregnant. Participants must agree to use effective contraception during the trial.
Inability to perform acceptable and repeatable spirometry maneuvers throughout the test procedure.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: The study participants will be given a standard 266 mg single dose injection of liposomal bupivacaine by the surgeon at the start of the surgery.

Liposomal Bupivacaine: intercostal block
Eligibility criteria:
Inclusion Criteria:

over 18 years of age
Undergoing thoracotomy

Exclusion Criteria:

Non-English speaking
Pregnant women (self reported)
Prisoners
Weighing <50 kg
Allergy to local anesthetics
Unable to consent for themselves
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: 5
Group description: 4000 IU Vitamin D taken daily for six months

Vitamin D: Vitamin D taken in two different dosages daily for six months.
Eligibility criteria:
Inclusion Criteria:

must be likely to be able to complete the study
must be able to walk without a walking aid
must be able to complete questionnaires interactively research staff
must have been on dialysis for greater than 3 months
all patients must be receiving standard of care per their nephrologist

Exclusion Criteria:

peritoneal dialysis
an allergy to vitamin D
liver disease
intestinal disorders that would interfere with vitamin D absorption
taking vitamin D supplements >800 IU per day, glucocorticoids, anticonvulsants, or other drug therapies for osteoporosis
are pregnant
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: 5
Group description: 800 IU Vitamin D taken daily for six months

Vitamin D: Vitamin D taken in two different dosages daily for six months.
Eligibility criteria:
Inclusion Criteria:

must be likely to be able to complete the study
must be able to walk without a walking aid
must be able to complete questionnaires interactively research staff
must have been on dialysis for greater than 3 months
all patients must be receiving standard of care per their nephrologist

Exclusion Criteria:

peritoneal dialysis
an allergy to vitamin D
liver disease
intestinal disorders that would interfere with vitamin D absorption
taking vitamin D supplements >800 IU per day, glucocorticoids, anticonvulsants, or other drug therapies for osteoporosis
are pregnant
Intervention: Serine
Trial phase: Phase 1 | Phase 2
SMILES: NC(CO)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
Eligibility criteria:
Inclusion Criteria:

Age between 18 and 50
DSM-V diagnosis of schizophrenia or schizoaffective disorder
Willing to provide informed consent

Auditory Cognitive impairment demonstrated by:

a .MCCB composite domain score less than or equal to 0.5 standard deviation below normal (T score less than or equal to 45) b. And at least one of the following:

MCCB verbal memory domain score less than or equal to 0.5 standard deviation below normal (T score less than or equal to 45)
Tone matching score of less than or equal to 77.7%
Clinically stable for 2 months (CGI less than or equal to 4)
Moderate or lower cognitive disorganization (PANSS P2 less than or equal to 4)
Medically stable for study participation
Willing to use qualified methods of contraception for the study duration and up to 2 months after its end
Fluent English speaker
Normal hearing
Visual acuity corrected to 20/30
An estimated Glomerular Filtration Rate (GFR) greater than or equal to 60
Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
Judged clinically not to be at significant suicide or violence risk

Exclusion Criteria:

ECG abnormality that is clinically significant in the context of study participation in the opinion of the study cardiologist
Current clozapine use
Presence of positive history of unstable significant medical or neurological illness
Positive toxicology screen for any substances of abuse
Substance use disorder (excluding nicotine) within last 60 days
Pregnant women or women of child-bearing potential, who are either not surgically-sterile or for outpatients, using appropriate methods of birth control. Women of childbearing potential must have a negative serum -hCG pregnancy test at every visit.
Participation in study of investigational medication/device within 4 weeks
Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator Section
Intervention: Rifaximin
Trial phase: Phase 2
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
Eligibility criteria:
Key Inclusion Criteria:

A potential participant may only be included if (at screening), he/she:

Understands the study and has signed informed consent
Is an adult, not pregnant or lactating
Has cirrhosis of the liver
Has had 1 instance of HE within 12 months
Has hyperammonaemia defined as ≥37 μmol/L at screening

Key Exclusion Criteria:

A potential participant will be excluded if (at screening), he/she:

Has contraindicated allergies
Expects liver transplant within 1 month
Has had a liver shunt within the last 3 months
Has inadequate kidney, gastrointestinal, or cardiac function

Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:

the safety and well-being of the participant or potential offspring
the safety of study staff
the analysis of results
Intervention: Flunarizine
Trial phase: Not Applicable
ATC code: N07CA03
SMILES: Fc1ccc(C(c2ccc(F)cc2)N2CCN(C/C=C/c3ccccc3)CC2)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Flunarizine is introduced with a single dose of 10 mg/day.

Flunarizine: A calcium overload blocker agent used for migraine prophylaxis.
Eligibility criteria:
Inclusion Criteria:

Migraine diagnosis according to ICHD-2
Ages between 15 -45 Volunteering
Monthly attack number between 5-14
BMI between 18-30
w/o history of nephrolithiasis
w/o history of DM, peripheral vascular disease
w/o history of chronic systemic diseases (lung, heart,liver, kidney)
w/o any detected CNS disease (including MS, movement disorders, CVD, primary or secondary tumors)
w/o history of acute or chronic psychiatric disease
w/o history of antiplatelet and anticoagulant medication
w/o any combination of medication overuse headache or other primary headaches
w/o previous medication of flunarizine and topiramate
w/o previous application of GONB

Exclusion Criteria:

Pregnancy

Lost to follow up

exited with his/her own will
detected primary headache during follow up
cessation due to adverse effects of topiramate
cessation due to adverse effects of flunarizine
Intervention: Mifepristone
Trial phase: Phase 2
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement

Mifepristone 200 MG: Ingestion of study medication
Eligibility criteria:
Inclusion Criteria:

A. Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing to sign informed consent and follow study protocol

Exclusion Criteria:

A. Allergy or known intolerance to mifepristone

B. Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation:

Chronic adrenal failure or insufficiency
Concurrent use of long-term corticosteroid therapy
Inherited porphyrias

C. Any condition that in the opinion of the investigator could impede study participation or collection of study data
Intervention: Firibastat
Trial phase: Phase 2
SMILES: NC(CCS(=O)(=O)O)CSSCC(N)CCS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 98
Group description: Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.

Firibastat: 1 or 2 capsules administered orally, twice daily
Eligibility criteria:
Inclusion Criteria:

Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as chest pain >30 minutes and ST elevation ≥0.2 mV in at least 2 consecutive electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1 V6).
Primary PCI of the index-MI-related artery within 24 hours after the MI.

Exclusion Criteria:

Body mass index >45 kg/m².
Subject is hemodynamically unstable or has cardiogenic shock.
Subjects with clinical signs of HF (Kilipp III and IV).
Systolic blood pressure <100 mmHg at inclusion visit
Early primary PCI of the index-MI-related artery performed within 3 hours after MI.
Subjects treated with angiotensin-converting-enzyme inhibitor (ACE I), angiotensin receptor blocker (ARB) or sacubitril/valsartan prior to the index magnetic resonance imaging. Note: if treatment was for HTN, ACE I/ARB should be stopped, and, if necessary, another therapeutic class can be prescribed for HTN. If the ACE I/ARB was prescribed for congestive HF, the subject is not considered eligible; if the ACE I/ARB prescribed for another reason cannot be stopped, the subject is not eligible for study inclusion.
Subjects scheduled for implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy, or pacemaker within the next 3 months. If an ICD is indicated for ventricular arrhythmia during the course of the study, a life vest, when possible, should be prescribed and the ICD scheduled after study completion.
Intervention: Linezolid
Trial phase: Phase 2
ATC code: J01XX08
SMILES: CC(=O)NC[C@H]1CN(c2ccc(N3CCOCC3)c(F)c2)C(=O)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 108
Group description: Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
Eligibility criteria:
Inclusion Criteria:

Patients, ages 18 years to 80 years
Has an acute complicated skin and skin structure infection
Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

Has received an investigational drug within past 1 month
Has been previously enrolled in this protocol
Has received >48 hr of a potentially effective systemic antibiotic immediately prior to study drug
Is nursing
Intervention: Nitroglycerin
Trial phase: Phase 2 | Phase 3
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Breast skin after mastectomy will be clinically examined by the surgeon, and nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This cream does not have systemic effects but may improve blood flow to the remnant breast skin after mastectomy.

Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.
Eligibility criteria:
Inclusion Criteria:

Patients must be female.
Patients must be between the ages of 18 and 99 years.
Patients must undergo mastectomy with our attending breast oncology surgeons followed by possible implant-based immediate breast reconstruction (IBR) performed by our attending plastic surgeons at WFBMC.
Patients must have the ability to understand and the willingness to sign an IRB-approved informed consent document.

Exclusion Criteria:

Patients who are under the age of 18 or over the age of 99.
Patients who are undergoing mastectomy without immediate breast reconstruction including immediate breast reconstruction with autologous tissue (or combination of autologous tissue with tissue expanders or implants), or patients with a history of mastectomy presenting for delayed breast reconstruction.
Patients with pre-existing conditions in which use of indocyanine-green is contraindicated or must be used with caution, including those with a history of allergy to iodides or iodinated dye, those with chronic kidney disease, those with hepatic failure or cirrhosis of the liver, and females who are nursing, pregnant, or may become pregnant.
Pregnant women are excluded from this study because pregnancy precludes immediate breast reconstruction in our patient population.
Patients with pre-existing conditions in which use of nitroglycerin paste is contraindicated, including those with a history of cardiac insufficiency, hypotension, sensitivity to nitrites, severe liver impairment, glaucoma, hyperthyroidism, recent head trauma, severe anemia, or taking certain medication (i.e. alteplase, aspirin, beta-blocker, calcium channel blocker, diuretics or thiazides).
Patients with pre-existing conditions in whom use of incisional negative pressure wound therapy is contraindicated including those with evidence of surgical site infection ( i.e. erythema, purulent drainage), clinical signs of hematoma (i.e. wound swelling, fluctuance, blood drainage), history of persistent cancer, exposed blood vessel on site of proposed therapeutic use, or sensitivity to acrylics and adhesives.
Intervention: Carbetocin
Trial phase: Phase 4
ATC code: H01BB03
SMILES: [H][C@@]1([C@@H](C)CC)NC(=O)[C@H](Cc2ccc(OC)cc2)NC(=O)CCCSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Participant receives 50 mcg of carbetocin post-delivery.

Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
Eligibility criteria:
Inclusion Criteria:

Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia
American Society of Anesthesiologists (ASA) class 2
Patients ≥ 19 years of age

Exclusion Criteria:

Long QT syndrome
Cardiac disease or rhythm abnormalities
Family history of long QT syndrome or abnormal cardiac conduction
Currently taking medication that is known to prolong the QT interval
Women who are high risk for uterine atony as outlined in SOGC
Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin homologue
Patients who are unable to give informed consent because of a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.
Intervention: Carbetocin
Trial phase: Phase 4
ATC code: H01BB03
SMILES: [H][C@@]1([C@@H](C)CC)NC(=O)[C@H](Cc2ccc(OC)cc2)NC(=O)CCCSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Participant receives 100 mcg of carbetocin post-delivery.

Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
Eligibility criteria:
Inclusion Criteria:

Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia
American Society of Anesthesiologists (ASA) class 2
Patients ≥ 19 years of age

Exclusion Criteria:

Long QT syndrome
Cardiac disease or rhythm abnormalities
Family history of long QT syndrome or abnormal cardiac conduction
Currently taking medication that is known to prolong the QT interval
Women who are high risk for uterine atony as outlined in SOGC
Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin homologue
Patients who are unable to give informed consent because of a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.
Intervention: CLINDAMYCIN PHOSPHATE
Trial phase: Phase 3
SMILES: CCC[C@@H]1C[C@@H](C(=O)N[C@@H]([C@H]2O[C@H](SC)[C@H](OP(=O)(O)O)[C@@H](O)[C@H]2O)[C@H](C)Cl)N(C)C1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1236
Group description: Clindamycin Phosphate Lotion, 1% applied topically as directed.

Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline.
Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period.
Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).
In good general health and free of any other clinically significant disease state or physical condition.
Subject has provided written informed consent / assent.

Exclusion Criteria:

Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study.
Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator.
Subject is planning surgery during the study.
Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles.

Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.
Intervention: Rivaroxaban
Trial phase: Phase 4
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: The cohort of patients on aspirin was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
Eligibility criteria:
Inclusion criteria:

Known CAD (defined as angiographic evidence of >50% coronary artery stenosis or prior coronary revascularization) or PAD (defined as a positive ankle brachial index (ABI) or prior revascularization)
on treatment with either aspirin (81mg/qd), aspirin (81mg/qd) plus clopidogrel (75mg/qd), or aspirin (81mg/qd) plus ticagrelor (90mg/bid) for at least 3 months per standard of care OR
Atrial fibrillation (paroxysmal, persistent or permanent) on treatment with rivaroxaban 20 mg qd (if creatinine clearance [CrCl] >50 mL/min) or 15 mg qd (if CrCl 15 - 50 mL/min) per standard of care. Patients with concomitant CAD or PAD who are also taking antiplatelet medications are not eligible. However, if these are only on oral anticoagulation with rivaroxaban (and no antiplatelet therapy) the person will be eligible.

Exclusion criteria:

Active pathological bleeding, history of clinically significant bleeding events, or deemed at increased risk of bleeding.
CrCL <20 mL/min
Any clinical indication to be on triple antithrombotic therapy (DAPT plus an oral anticoagulant)
An acute coronary event in the past 90 days
Prior hemorrhagic stroke or intracranial hemorrhage
Ischemic stroke/transient ischemic attack in the past 6 months
Chronic use of nonsteroidal anti-inflammatory drugs
On treatment with combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir, and conivaptan) or inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort).
Known moderate or severe hepatic impairment (Child-Pugh B and C)
Prior hypersensitivity reaction to rivaroxaban
On treatment with prasugrel in the past 10 days.
Platelet count <80x106/mL
Hemoglobin <10g/dL
Hemodynamic instability
Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study].