anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Sublingual film containing 120 Micrograms Dexmedetomidine

Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
Eligibility criteria:
Inclusion Criteria:

Male and female patients between the ages of 18 to 75 years, inclusive.
Patients who have met DSM-5 criteria for bipolar I or II disorder.
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Patients who read, understand and provide written informed consent.
Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
Patients who are judged to be at significant risk of suicide.
Female patients who have a positive pregnancy test at screening or are breastfeeding.
Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.
Intervention: Levetiracetam
Trial phase: Phase 2
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.

Levetiracetam 500 mg: Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus.
Eligibility criteria:
Inclusion criteria for psychosis subjects:

Men and women age 18 - 65.
Communicative in English.
Provide voluntary, written informed consent.
Physically healthy by medical history.
BMI > 17.5 and < 45.
Diagnosis of a psychotic disorder confirmed by Structured Clinical Interview for DSM-V (SCID) or diagnostic interview with a trained clinician.
Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study; and,
For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.
Not breastfeeding/nursing at time of screening or at any time during the study.

Inclusion criteria for healthy controls All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.

Exclusion criteria for psychosis subjects

Age less than 18 or greater than 65.
Not communicative in English.
Unable to provide written informed consent.
Current medical or neurological illness.
History of severe head trauma.
BMI < 17.5 or > 45.
Meets criteria for diagnosis of substance or alcohol use disorder within the past month.
Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study.
Breastfeeding/nursing at time of screening or at any time during the study.
Conditions that preclude MR scanning
Conditions that preclude study drug administration

Exclusion criteria for healthy controls

All of the above and in addition:

Current use of psychotropic or potentially psychoactive prescription medication.
Major psychiatric disorder as determined by DSM-V (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)
Intervention: Hexose
Trial phase: Early Phase 1
ATC code: V04CE01 | V06DC01
SMILES: OCC1OC(O)C(O)C(O)C1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Dextrose: Administering dextrose to health volunteers for our placebo group
Eligibility criteria:
Inclusion Criteria:

18-20 years old OR 30-40 years old
Body Mass Index 19-26
High school education, fluent in English
Occasional cannabis users ( 0 times in past 30 days AND used cannabis no more than 20 times in lifetime)

Exclusion Criteria:

History of daily cannabis use
Past or present severe substance use disorder
Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia
Cardiovascular illness, high blood pressure, abnormal electrocardiogram
Current medications
Pregnant or planning to become pregnant
Intervention: Hydroxychloroquine
Trial phase: Phase 3
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 494
Group description: 400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks

Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
Eligibility criteria:
Inclusion Criteria:

- A healthcare worker at high risk for COVID-19 exposure (defined below):

Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel)
Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists)
Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs)
First responders (i.e. EMTs, paramedics)

Exclusion Criteria:

Active COVID-19 disease
Prior COVID-19 disease
Current fever, cough, shortness of breath
Allergy to chloroquine or hydroxychloroquine
Prior retinal eye disease
Known Chronic Kidney disease, Stage 4 or 5 or dialysis
Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
Weight <40 kg
Prolonged QT syndrome
Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone
Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.
Intervention: Hydroxychloroquine
Trial phase: Phase 3
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 495
Group description: 400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks

Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
Eligibility criteria:
Inclusion Criteria:

- A healthcare worker at high risk for COVID-19 exposure (defined below):

Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel)
Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists)
Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs)
First responders (i.e. EMTs, paramedics)

Exclusion Criteria:

Active COVID-19 disease
Prior COVID-19 disease
Current fever, cough, shortness of breath
Allergy to chloroquine or hydroxychloroquine
Prior retinal eye disease
Known Chronic Kidney disease, Stage 4 or 5 or dialysis
Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
Weight <40 kg
Prolonged QT syndrome
Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone
Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.
Intervention: Dexmedetomidine
Trial phase: Phase 4
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: 9
Group description: Dexmedetomidine: Administration of a 0.5 mcg/kg bolus followed by an infusion of 0.5-0.7 mcg/kg/hr, titrated up by 0.1 mcg every 1 minute until the subject spontaneously closes his or her eyes. When the subject spontaneously closes his or her eyes the infusion continues for 90 minutes from that point.

Dexmedetomidine: All subjects will receive Dexmedetomidine to induce sedation between their pre-sedation and post-sedation perceptual learning tests.
Eligibility criteria:
Primary Inclusion Criteria for "Healthy" volunteers

Age between 18-35
Native English speaking
No hearing or speech difficulties
No psychiatric, neurologic, or sleep disorders
No chronic medical conditions, as reflected below under Primary Exclusion Criteria and above in 'Medical History'
Non-smokers (within 3 months)
Non-users of recreational or illicit drugs (including marijuana)
Must be willing and able to pass the drug tests (no psychoactive substances), no ingestion of alcohol or sleep-altering drugs for the 48 hours prior to the study session.
Normal weight

Primary Exclusion Criteria for "Healthy" volunteers

Speech difficulties/disorders
Hearing difficulties (including occluded or infected ear canals)
Current hairstyles that do not allow the high-density EEG cap to make contact with the scalp (e.g., individuals with hair extensions, braids, dreadlocks or hairstyles that restrict the ability of electrodes to touch the scalp)
Metal on/in/near their heads (including jewelry) that cannot be removed for the duration of the study
Metal implants
Serious abusers of alcohol or caffeine.
Existing or suspected psychological or neurological disorders
Pregnancy or suspected pregnancy (urine pregnancy test at visit 2)
Chronic or transient (e.g., jet lag) problems with sleep; suspected sleep disorder

Abnormal sleep habits, such as:

Sleeping less than 5 hours each night
Going to sleep before 8:00 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.
Currently taking medications that regulate blood pressure; a history of high blood pressure, diabetes or stroke
Chronic smokers
Current use of aspirin, or other medications which increase bleeding, prior to the study session.
Known drug allergies to anesthetics or a history of an adverse reaction to anesthesia.
Known allergy to adhesives or electrode gel
Medication that alters sleep, cognitive function, or both
Intervention: Hydroxychloroquine
Trial phase: Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
Eligibility criteria:
Inclusion Criteria:

Adult (age ≥ 18 years)

Confirmed OR suspected COVID-19,

Confirmed: Positive assay for COVID-19 within the last 10 days
Suspected: Pending assay for COVID-19 WITH high clinical suspicion
Scheduled for admission or already admitted to an inpatient bed

Exclusion Criteria:

Allergy to hydroxychloroquine or azithromycin
History of bone marrow transplant
Known G6PD deficiency
Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min
Psoriasis
Porphyria
Concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone, cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol
Known history of long QT syndrome
Current known QTc>500 msec
Pregnant or nursing
Prisoner
Weight < 35kg
Seizure disorder
Severe liver disease
Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed COVID-19
Patient has recovered from COVID-19 and/or is being discharged from the hospital on day of enrollment.
Treating physician refuses to allow patient participation in the study
Unable to obtain informed consent
Prior enrollment in this study
Intervention: Hydroxychloroquine
Trial phase: Phase 3
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 242
Group description: Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.

Hydroxychloroquine: Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.

For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years
Currently hospitalized or in an emergency department with anticipated hospitalization.

Symptoms of acute respiratory infection, defined as one or more of the following:

cough
fever (> 37.5° C / 99.5° F)
shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy).
sore throat
Laboratory-confirmed SARS-CoV-2 infection within the past 10 days prior to randomization.

Exclusion Criteria:

Prisoner
Pregnancy
Breast feeding
Symptoms of acute respiratory infection for >10 days before randomization
>48 hours between meeting inclusion criteria and randomization
Seizure disorder
Porphyria cutanea tarda
Diagnosis of Long QT syndrome
QTc >500 ms on electrocardiogram within 72 hours prior to enrollment
Known allergy to hydroxychloroquine, chloroquine, or amodiaquine
Receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol
Receipt of >1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment
Inability to receive enteral medications
Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to day 15
Previous enrollment in this trial
The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient
Intervention: Hydroxychloroquine
Trial phase: Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 101
Group description: Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks
Eligibility criteria:
Inclusion Criteria:

Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent

Healthcare workers with

• One day or more of exposure to suspect and/or positive COVID-19 patients, including but not limited to those working in the Emergency Department or Intensive Care Unit.

OR

• Unprotected exposure to a known positive COVID-19 patient within 72 hours of screening.

Afebrile with no constitutional symptoms
Willing and able to comply with scheduled visits, treatment plan, and other study procedures
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures

Exclusion Criteria:

Participation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days
Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested Note: the following criteria follow standard clinical practice for FDA approved indications of this medication
Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia
Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
Having dermatitis, psoriasis or porphyria
Taking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs, antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas, amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine, praziquantel, Pyridostigmine, tamoxifen citrate
Allergies: 4-Aminoquinolines
Pre-existing retinopathy of the eye
Has a chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis
Untreated or uncontrolled active bacterial, fungal infection
Known or suspected active drug or alcohol abuse, per investigator judgment
Women who are pregnant or breastfeeding
Known hypersensitivity to any component of the study drug
A known history of prolonged QT syndrome or history of additional risk factors for torsades de pointe (e.g., heart failure, requires a lab test , family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval
Intervention: Hydroxychloroquine
Trial phase: Phase 3
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 683
Group description: Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Hydroxychloroquine: oral self administered tablet
Eligibility criteria:
Inclusion:

Completed Informed Consent
Age ≥ 18 years old
Currently working in any environment in which there is a risk of exposure to patients with COVID-19 infections ("healthcare worker")

Exclusion Criteria:

Prior diagnosis of COVID-19 infection
Participation in another COVID-19 prophylaxis trial within 30 days of consent
Respiratory illness with new-onset fever (Temperature > 100°F) or ongoing cough or dyspnea within 14 days
Known allergy to HCQ or chloroquine
Congenital prolonged QT syndrome
Current or planned use of QT prolonging drugs (e.g. procainamide, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol, cimetidine, dronedarone, dofetilide, levofloxacin, ciprofloxacin, moxifloxacin) and other contraindicated medications
End stage renal disease
Pre-existing retinopathy
Current or planned use of Hydroxychloroquine (study drug) for any indication

Current or planned use of the following for treatment or prevention of COVID-19 infection:

Chloroquine

Azithromycin

Known cirrhosis or severe liver disease
History of severe skin reactions such as Steven-Johnson syndrome, toxic epidermal necrolysis
History of psoriasis or porphyria
Ventricular arrhythmias requiring medical treatment
Severe coronary artery disease or heart failure/cardiomyopathy with ongoing symptoms
Current or planned use of use of anti-seizure drugs
History of Glucose-6-phosphate dehydrogenase deficiency
Intervention: Hydroxychloroquine
Trial phase: Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: Participants randomized to the HCQ arm will receive HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days. The drug dose (2.4 gm over 5 days) falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of >20.

Hydroxychloroquine: HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days
Eligibility criteria:
Inclusion Criteria:

Patient age ≥18 years, competent to provide consent
Within 48 hours of positive nucleic acid test for SARS-CoV-2

Exclusion Criteria:

Patient already prescribed chloroquine or hydroxychloroquine
Allergy to hydroxychloroquine
History of bone marrow or solid organ transplant
Known G6PD deficiency
Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate < 20ml/min/1.73m2
Known liver disease (e.g. Child Pugh score ≥ B or AST>2 times upper limit)
Psoriasis
Porphyria
Known cardiac conduction delay (QTc > 500mSec) or taking any prescription medications known to prolong QT interval
Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
Seizure disorder
Prisoner
Weight < 35kg
Inability to follow-up - no cell phone or no address or not Spanish or English speaking
Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation
Patient or another member of patient's household has been already enrolled in this study.
Intervention: Povidone iodine
Trial phase: Phase 1 | Phase 2
SMILES: C=CN1CCCC1=O.II
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of COVID-19 by lab test within 5 days of study participation

Exclusion Criteria:

Allergy to "iodine," shellfish, or food dye
Receiving intranasal steroids
Sinus surgery within 30 days of beginning the study
Intubated at the time of enrollment
Pregnancy
Participation in other COVID-19 studies - to be determined on a case by case basis
Intervention: Povidone iodine
Trial phase: Phase 1 | Phase 2
SMILES: C=CN1CCCC1=O.II
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of COVID-19 by lab test within 5 days of study participation

Exclusion Criteria:

Allergy to "iodine," shellfish, or food dye
Receiving intranasal steroids
Sinus surgery within 30 days of beginning the study
Intubated at the time of enrollment
Pregnancy
Participation in other COVID-19 studies - to be determined on a case by case basis