anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: IVERMECTIN
Trial phase: Phase 1 | Phase 2
ATC code: D11AX22 | P02CF01
SMILES: [H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: All subjects will be treated with topical ivermectin daily for up to 12 weeks.

Ivermectin
Eligibility criteria:
Inclusion Criteria:

Subject is male or non-pregnant female, 18 - 70 years of age.
Subjects willing and able to give informed consent.
Subjects willing and able to comply with the requirements of the study.
Subject has the clinical diagnosis of rosacea with at least one inflammatory papule and at least mild erythema.
Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
Subject is in general good health in the opinion of the investigator.
Subject has normal baseline labs or in the opinion of the investigator are values are not clinically significant and would not inhibit the ability to monitor the patient for both safety and efficacy throughout the study.

Exclusion Criteria:

Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans).
Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days
Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
Subject has had laser or light-based treatment for rosacea within the prior 3 months.
Subject has had systemic retinoids and retinoid derivatives over the past 6 months
Subject has a known hypersensitivity or allergy to topical ivermectin or components of the vehicle.
Subject is pregnant or lactating or planning a pregnancy during the duration of the study
Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation
Intervention: Dexmedetomidine
Trial phase: Phase 1 | Phase 2
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Oral Dexmedetomidine

Dexmedetomidine: Oral form
Eligibility criteria:
Inclusion Criteria:

Age between 18-50
Native English speaking
ASA physical status classification P1 and P2 (stable chronic condition)
Normal body habitus.

Exclusion Criteria:

Abnormal sleep habits
Sleeping less than 5 hours each night
Going to sleep before 9:00 PM or after 2:00 AM on a regular basis
Waking up before 5:00 AM or after 10:00 AM on a regular basis.
Takes medication that alters sleep, cognitive function, or both. -Has a history of a known neurological or psychiatric problem.
Younger than 18 or older than 50 years of age.
Known or suspected sleep disorder(s).
Intervention: FLUCICLOVINE
Trial phase: Phase 2
SMILES: N[C@]1(C(=O)O)C[C@@H](F)C1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-[18F]FACBC radiotracer intravenously prior to PET scan.
Eligibility criteria:
Inclusion Criteria:

Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)
Ability to lie still for PET scanning
Ability to provide written informed consent

Exclusion Criteria:

Age less than 18 years
Inability to lie still for PET scanning
Inability provide written informed consent
Currently undergoing chemotherapy for organ confined or systemic disease. This does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.
Intervention: Tirbanibulin
Trial phase: Phase 2
ATC code: D06BX03
SMILES: O=C(Cc1ccc(-c2ccc(OCCN3CCOCC3)cc2)cn1)NCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Males and females ≥18 years old
Clinical diagnosis of stable, clinically typical actinic keratosis
A define treatment area on the face or scalp
Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment
Males who have not had a vasectomy must agree to use barrier contraception
Participants who in the judgment of the Investigator, are in good general health
Willing to avoid excessive sun exposure
Able to comprehend and are willing to sign an informed consent form (ICF)

Exclusion Criteria:

Clinically atypical and/or rapidly changing AK lesions on the treatment area
Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence
Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1
Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
A history of sensitivity and/or allergy to any of the ingredients in the study medication
A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation
Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation
Females who are pregnant or nursing
Participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
Intervention: Methylene Blue
Trial phase: Phase 2
ATC code: V03AB17 | V04CG05
SMILES: CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 50
Group description: Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.

Methylene Blue: 50 patients will receive methylene blue
Eligibility criteria:
Inclusion Criteria:

Weight ≥ 6 kg
Uncomplicated malaria caused by P. falciparum
Asexual parasites ≥ 2 000/µl and ≤ 100 000/µl
Axillary temperature ≥ 37.5°C or a history of fever during the last 24 hours
Burkinabe nationality
Permanent residence in the study area with no intention of leaving during the surveillance period
Written informed consent of parents or care takers

Exclusion Criteria:

Severe malaria
Mixed malaria infection
Vomiting (>2 times within 24 hours before the visit)
Any apparent significant disease, including severe malnutrition
A history of a previous, significant adverse reaction or known allergy to one or more of the study drugs
Anaemia (haemoglobin < 7 g/dl)
Treated in the same trial before
All modern antimalarial treatment prior to inclusion (last seven days)
Therapy with serotonin reuptake inhibitors (e.g. citalopram, escitalopram, fluoxetine, Paroxetine, Sertraline)
Simultaneous participation in another investigational study
Patients with known HIV/AIDS disease
Therapy with drugs known to inhibit the liver enzymes cytochrome 2A6 (e.g. methoxsalen, pilocarpine, tranylcypromine) and/or cytochrome 2C8 (e.g. trimethoprim, ketoconazole, ritonavir, saquinavir, lopinavir, gemfibrozil, montelukast)
Intervention: Dexmedetomidine
Trial phase: Phase 2 | Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 469
Group description: Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.

Dexmedetomidine: Dexmedetomidine
Eligibility criteria:
Inclusion Criteria:

Age ≥ 60
Scheduled for a cardiac surgical procedure with planned post-operative admission to the CSICU for ≥ 24 hours
Scheduled same day surgical admission

Exclusion Criteria:

Blind, deafness or the inability to speak English
Greater than 2 days of ICU admission in the month preceding the current surgical procedure
Renal and liver failure requiring dialysis or Child-Pugh score > 5
Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)
Previous cardiac surgery within 1 year of surgical procedure
Allergy to dexmedetomidine
Chronic therapy with benzodiazepines and/or antipsychotics
Severe deficit due to structural or anoxic brain damage
Surgical procedure requiring total circulatory arrest

Objective Drop Criteria

Scheduled for a second surgical procedure during hospital stay
Post-operative intubation > 12 hours
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery

Dexmedetomidine
Eligibility criteria:
Inclusion Criteria:

BMI ≥ 95th percentile.
Hospitalized overnight after surgery

Exclusion Criteria:

History or a family (parent or sibling) history of malignant hyperthermia
Renal or hepatic disorders
Allergy to opioid analgesics
An allergy to α2-adrenergic agonists or sulfa drugs
Uncontrolled hypertension
Clinically significant neurologic diseases
Pregnancy or lactating female
Intervention: Guanfacine
Trial phase: Not Applicable
ATC code: C02AC02
SMILES: N=C(N)NC(=O)Cc1c(Cl)cccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Guanfacine 1 mg capsule by mouth, one time prior to surgery.

Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
Eligibility criteria:
Inclusion Criteria:

VUMC patients undergoing sinus surgery in MCE OR

Exclusion Criteria:

Inability to read and freely consent
Patients who take alpha-2 agonists routinely (guanfacine, clonidine, tizanidine)
Patients undergoing sinus surgery planned for greater than 3 hours
Patients with significant pre-existing pain, on chronic pain (opioid, methadone) therapy, severe fibromyalgia or other pre-existing pain condition in any body part
Patients with preoperative nausea/vomiting at baseline.
Pregnant or lactating women
Intervention: Sildenafil
Trial phase: Phase 2
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants who received Sildenafil 50 mg once daily in either the first or last 3 months of the study
Eligibility criteria:
Inclusion Criteria:

Meets 2010 American College of Rheumatology (ACR) classification criteria for diagnosis of RA
Aged 18 years or older
No known history of CVD (see Exclusion Criteria)
At least one traditional CV risk factor (i.e., older age [men ≥45 years, women ≥55 years], obesity [defined as body mass index (BMI) >30 kg/m2], smoking, hypertension, hyperlipidemia, diabetes mellitus, family history of premature [defined as diagnosed at <65 years old] CVD in first-degree relative)
On stable baseline doses of RA medications, defined as no change in dose within past 4 weeks and no anticipated changes over the next 6 months
On no higher than 10 mg per day of prednisone or prednisone-equivalent within past 4 weeks
RA disease duration (from symptom onset) of more than 6 months
Having clinical disease activity index (CDAI) of >2.8 but ≤22 (i.e., either low or moderate disease activity), within 30 days of study enrollment

Exclusion Criteria:

Aged <18 years
Pregnant women
Known personal history of CVD (clinical diagnoses of stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, peripheral arterial disease, percutaneous coronary intervention or coronary bypass graft surgery)
Use of high-dose statins (e.g., atorvastatin 40-80 mg/day or rosuvastatin 20-40 mg/day) currently or within past 3 months, or any dose changes of statins or of blood pressure medications that may affect endothelial function (i.e., angiotensin-converting-enzyme [ACE] inhibitors or angiotensin receptor blockers [ARBs]) within past 3 months. If on statin or an ACE-I or ARB, there should be no anticipated dose changes over the next 6 months.
Persons with intra-cardiac and intra-pulmonary shunts, unstable cardiopulmonary conditions, or anyone on chronic oxygen therapy
Persons taking nitric oxide donors, organic nitrites and nitrates, such as glyceryl trinitrate (nitroglycerin), sodium nitroprusside, amyl nitrite ("poppers")
Severe hepatic impairment (liver function tests >1.5 times upper limit of normal) within past 4 weeks
Severe impairment in renal function (serum creatinine ≥1.5 mg/dL) within past 4 weeks
Hypotension (defined as blood pressure [BP] <90/60)
Hereditary degenerative retinal disorders (including genetic disorders of retinal phosphodiesterases)
Persons already taking (or taken within 3 months) sildenafil or other PDE inhibitors (i.e., tadalafil, vardenafil)
Persons unable to provide voluntary written informed consent
Severe hypertension (BP >170/110)
Persons with HIV/AIDS
Intervention: Nabilone
Trial phase: Phase 1 | Phase 2
ATC code: A04AD11
SMILES: CCCCCCC(C)(C)c1cc(O)c2c(c1)OC(C)(C)C1CCC(=O)CC21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Will receive nabilone at 1 mg daily (BID) over 4 weeks.

Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD.
Eligibility criteria:
Inclusion Criteria:

Age 18-60
Physically healthy, not pregnant
Primary Obsessive-Compulsive Disorder (OCD)
Patient off all psychotropic (except selective serotonin reuptake inhibitors [SSRIs]) and other types of drugs likely to interact with nabilone
Ability to provide informed consent
Ability to tolerate a treatment free-period

Exclusion Criteria:

History of any significant medical condition that may increase the risk of participation
Females who are pregnant or nursing
Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation (e.g. lifetime psychosis or bipolar disorder)
Current substance use disorder or positive urine toxicology at screening, or any adverse reaction to a cannabinoid
Patients already receiving EX/RP
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 4
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: Eslicarbazepine Acetate (800mg once daily).
Eligibility criteria:
Inclusion Criteria:

Healthy adults between the ages of 18 and 55 years old.
Male or female

Exclusion Criteria:

Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease or pregnancy.
Presence or history of drug or alcohol abuse.
The use of concomitant medications, which are known to affect ESL or Carbamazepine or the use of any concomitant medications that may alter cognitive function (see Section VII.E for a partial list).
Use of oral contraceptive hormones or other medications that could be affected by ESL or Carbamazepine.
Prior adverse reaction to or prior hypersensitivity to either study medication or to related compounds.
Prior participation in studies involving anticonvulsant medications.
Subjects who have received any investigational drug within the previous thirty days.
Subjects with IQ < 70 as determined by the Peabody Picture Vocabulary Test.
Presence of HLA B*1502 in subjects of Asian descent; this will be obtained at screening in subjects of Asian descent.
Intervention: Travoprost
Trial phase: Phase 3
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 348
Group description: Three hundred forty eight (348) subjects were randomized to OTX-TP
Eligibility criteria:
Inclusion Criteria:

Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession
IOP is currently controlled as assessed by the Investigator

Exclusion Criteria:

Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge
A history of an inadequate response or no response to topical prostaglandin
Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products
Intervention: ICOSAPENT ETHYL
Trial phase: Phase 4
SMILES: CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Vascepa (4 gm/day), oral dose

Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
Eligibility criteria:
Inclusion Criteria:

Elevated triglycerides (fasting value between 200-499 mg/dl) at qualifying or baseline visit.
LDL-C ≤115 mg/dL on appropriate statin therapy
LDL-C >40 mg/dL
Stable diet and exercise, as defined as the same pattern for the previous 4 weeks
Stable treatment with a statin+/- ezetimibe for at least 4 weeks
Patients with at least 1 angiographic stenosis with at least 20% narrowing by coronary computed tomography angiography (CTA).
Willingness to be on birth control for women of childbearing age or established post-menopausal

Exclusion Criteria:

A contraindication to fish or fish oils including: known hypersensitivity to drug or fish.
Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
Non-study lipid altering medications or supplements (ie - Niacin, PCSK9, fibrates, bile acid Sequestrants, dietary fish oil supplement capsules, orlistat [OTC (Alli®) as well as Rx (Xenical®)] or other drugs used for weight loss).
Stable (same daily dose for the last 4 weeks) on medications that can affect lipids (retinoids, hormones, steroids, HIV medications, chemotherapy, thyroid medications).
BMI > 40
Bleeding disorder
Uncontrolled hypertension (SBP≥ 180 mmHg or DBP≥100 mmHg)
History of known myocardial infarction, stroke or life-threatening arrhythmia within the prior six months.
NYHA Class III- IV heart failure
History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy.
Serum creatinine > 1.4 mg/dl
Drug or alcohol abuse, or current intake of more than 14 ounces of alcohol per week for men and 10 ounces for women
Concurrent enrollment in another placebo-controlled trial or within 30 days of finishing another trial
Partial ileal bypass or known gastrointestinal disease limiting drug absorption
History of hypertensive encephalopathy or cerebrovascular accident
Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
Pregnancy
Genetic mutations/polymorphisms having an effect on blood lipids
History of coronary artery bypass surgery
Allergy to contrast material
Allergy to beta-blocker in subjects with resting heart rate >70 bpm
Intervention: Diphenhydramine
Trial phase: Phase 3
ATC code: D04AA32 | D04AA33 | R06AA02 | R06AA52
SMILES: CN(C)CCOC(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 135
Group description: Diphenhydramine Injection, 50 mg/mL, 1 mL

Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL
Eligibility criteria:
Inclusion Criteria:

Male or female patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their symptoms;
18 years of age or older;
Be willing and able to give informed consent;
Patients with a Patient rated Pruritus Severity Score ≥ 1

Exclusion Criteria:

Receipt of an investigational drug or device, within the past 30 days;
Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy);
Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg;
Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
Receipt of an H2 antagonist within the past 2 hours;
Receipt of doxepin within the past 2 hours; doxepin is an antidepressant, but it also has antihistamine properties;
Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 4 hours to manage an acute allergic reaction;
Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes;
Anaphylaxis prior to the acute anaphylactic symptoms having been treated.
Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
Pregnancy or breastfeeding;
Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication;
Patients who, based on their medical history or in the opinion of the investigator, have chronic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response;
Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;
History of HIV or other known immunodeficiency;
Major medical or psychiatric illness, other than acute urticaria, at the time of presentation;
Inability to provide informed consent.
Patients on concomitant p-glycoprotein inhibitors