anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Gacyclidine
Trial phase: Phase 2
SMILES: CC1CCCCC1(c1cccs1)N1CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 77
Group description: Subjects randomized to OTO-313 and received a dose of OTO-313.
Eligibility criteria:
Inclusion Criteria:

Subject has early-onset subjective unilateral tinnitus that is persistent (consistently aware of their tinnitus throughout much of the waking day).
Subject is able to use the diary to complete their daily tinnitus ratings.
Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age related hearing loss; resolved otitis media; ototoxic drug exposure.
Subject is willing to comply with the protocol and attend all study visits.

Exclusion Criteria:

Subject has pulsatile tinnitus, temporomandibular joint disease (TMJ) associated with tinnitus perception, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
Subject is pregnant, lactating, or undergoing fertility treatment.
Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.
Intervention: Atogepant
Trial phase: Phase 3
ATC code: N02CD07
SMILES: C[C@@H]1[C@H](c2c(F)ccc(F)c2F)C[C@H](NC(=O)c2cnc3c(c2)C[C@@]2(C3)C(=O)Nc3ncccc32)C(=O)N1CC(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants will receive fixed dose of Atogepant once daily for 12 weeks.

Atogepant: Oral Tablet
Eligibility criteria:
Inclusion Criteria:

Eligible participants completed the double-blind treatment period, and the safety follow-up period, if applicable, depending on the timing of study initiation, of Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

Exclusion Criteria:

Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments, that cannot be discontinued or switched to an allowable alternative. Concomitant medications with demonstrated efficacy for the prevention of migraine is exclusionary, except that participants from lead-in study 3101-303-002 taking 1 medication with demonstrated efficacy for the prevention of migraine may participate in the current study provided that the dose was stable prior to the lead-in study and the participant is willing to continue taking that medication.
Participants with an electrocardiogram (ECG) indicating clinically significant abnormalities at Visit 1.
Participants with hypertension (sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg) at Visit 1.
Participants with a significant risk of self-harm Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others (investigator opinion); participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Intervention: Brexpiprazole
Trial phase: Phase 4
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, PO, QD, and continued on the stable dose of ADT up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.
Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.

Exclusion Criteria:

Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.

Participants with a concurrent DSM-5 diagnosis of the following will be excluded:

Schizophrenia or schizoaffective disorder
Bipolar I or bipolar II disorder
Post-traumatic stress disorder
Dementia
Eating disorder
Borderline personality disorder
Antisocial personality disorder
Participants with a suicidality score of 3 based on Inventory of Depressive Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.
Intervention: Oxymetazoline Hydrochloride
Trial phase: Phase 4
SMILES: Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 57
Group description: Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group)

Oxymetazoline hydrochloride 0.1% ophthalmic solution: One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.
Eligibility criteria:
Inclusion Criteria:

Adults age 18 and above able to provide informed consent to participate
Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention

Exclusion Criteria:

Adults unable to consent
Individuals less than 18 years of age
Prisoners
Pregnant women.
Known contradictions or sensitivities to study medication (oxymetazoline)
Ocular surgery within the past 3 months or refractive surgery within the past six months
Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
Presence of an active ocular infection
Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
Inability to sit comfortably for 15 - 30 minutes
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Ketamine: Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0.
Eligibility criteria:
Inclusion Criteria:

Adult women, aged 18 to 80 years old, who will undergo mastectomy.
Willing to comply with all study procedures and be available for the duration of the study.
Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction
No distant metastases.
Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
Subject is medically stable.

Exclusion Criteria:

Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.
Past ketamine or phencyclidine misuse or abuse.
Schizophrenia or history of psychosis.
Known sensitivity or allergy to ketamine.
Liver or renal insufficiency.
History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated
Pregnancy or nursing women
BMI>35.
Currently participating in another pain interventional trial.
Unwillingness to give informed consent.
Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages
Intervention: Humulin N
Trial phase: Phase 4
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm

Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
Eligibility criteria:
Inclusion Criteria:

• Patients admitted to adult neurology ward with acute stroke with

Patients having hyperglycemia (capillary blood glucose ≥10 mmol/L in 2 or more occasions or having history of treatment for DM)
Patients with age of 18-80 years of both sexes
Patients or their attendants giving consent to take part in the study

Exclusion Criteria:

Patients with hyperglycemic emergencies (hyperglycemic hyperosmolar state or diabetic ketoacidosis)

Pregnant patients
Those not giving consent to participate in the study
Intervention: Naltrexone
Trial phase: Phase 1 | Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Participants who received Naltrexone capsules for 5 days (25mg for days 1 and 2, then 50mg for days 3, 4, and 5) before either the first or second scanning session.
Eligibility criteria:
Inclusion Criteria:

Between 18 and 35 years of age,
Is a moderate drinker (i.e. consumes 1-14 drinks/week for males, or 1-7 drinks/week for females).

Exclusion Criteria:

Non-drinker
Positive result on urine drug screen or breathalyzer at the start of any study visit
Inability to complete MRI (e.g. presence of ferromagnetic objects in body)
Current use of medications that alter the hemodynamic response such as insulin
History of trauma resulting in loss of consciousness longer than 15 minutes
Currently taking opioid medications
Pregnancy
Intervention: Tamsulosin
Trial phase: Phase 2
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay
Eligibility criteria:
Inclusion Criteria:

Women 18-80 undergoing outpatient minimally invasive hysterectomy

Exclusion Criteria:

Inability to provide informed consent
Bladder malignancy
Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization
Plan for sling or anterior repair
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.

Dexamethasone: Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years
Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days
Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min)
Respiratory symptom onset no more than 7 days prior to hospital arrival
Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available

Exclusion Criteria:

Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital
Systemic corticosteroid, baricitinib or tofacitinib (or other JAK-STAT signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days
Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients
Currently receiving IFN-beta-1a therapy
Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only for sleep-disordered breathing
Participation in another concurrent interventional pharmacotherapy trial during the study period
Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only)
Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test)
Subject is not expected to survive for 24 hours
Subject has liver failure (Child-Pugh grade C)
Any clinical condition that in the opinion of the attending clinician or Investigator would present a risk for the subject to participate in the study
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Drug: Proprietary oral formulation of 0.5mg/kg of ketamine

Oral Ketamine: Proprietary oral formulation of 0.5mg/kg of ketamine
Eligibility criteria:
Inclusion Criteria:

Patients age 18 and older
acute musculoskeletal pain
initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
awake, alert, and oriented to person, place, and time

Exclusion Criteria:

altered mental status,
allergy to aspirin and ketamine,
pregnant
unstable vital signs (systolic blood pressure <90 or>180 mm Hg, pulse rate <50 or >150 beats/ min, and respiration rate <10 or >30 breaths/min)
inability to provide consent
consumption of Aspirin or NSAID's within 6 hours of arrival to the ED
active PUD
history of GI Hemorrhage
history of renal and hepatic insufficiency
past medical history of alcohol or drug abuse
schizophrenia
Intervention: Tenofovir
Trial phase: Early Phase 1
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: TDF/FTC (300/2200 mg), 3 pills/week. Total of 6 pills

Tenofovir Disoproxil Fumarate: Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
Eligibility criteria:
Inclusion Criteria:

Age 18 to 50 years, inclusive
General good health (by volunteer history and per investigator judgment) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes) and with an intact gastrointestinal tract, uterus and cervix.
Estimated calculated creatinine clearance (eCcr) of at least 80 mL/min
Body Mass Index (BMI) of ≥18 and <35kg/m2; and a total body weight >45 kg (99.2 lbs)
Willing to give voluntary consent and sign an informed consent form
Willing and able to comply with protocol requirements, including swallowing tablets

Must be protected from pregnancy by:

Condoms
Hormonal contraceptives
Copper or Levonorgestrel intrauterine device (IUD)
Sterilization of either partner
Heterosexual abstinence
Same sex relationship
If in a relationship, must be in a mutually monogamous relationship with a partner who is not known to be HIV positive and has no known risk of STIs

Exclusion Criteria:

Currently pregnant
Currently breastfeeding or planning to breastfeed during the course of the study
In the last three months, diagnosed with or treated for any STI
Positive test for HIV, or Hepatitis B surface antigen (HBsAg)
Systemic use in the last two weeks or anticipated use during the study of any of the following: antiretrovirals (e.g. Viread®, Atripla®, Emtriva®, or Complera®), or drugs that may interact with TFV (e.g., protease inhibitors, anticonvulsants, antimycobacterials, St. John's Wort).
Participation in any other investigational trial with use of a drug/device within the last 30 days or planned participation in any other investigational trial with use of a drug/device during the study
Grade 2 or higher laboratory abnormality, per the 2014 update of the Division of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the Severity of Adverse Events, or clinically significant laboratory abnormality as determined by the clinician
Abnormal finding on laboratory or physical examination or a social or medical condition in the volunteer which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 110
Group description: Participant will receive 2mg IV midazolam and 0.2-0.5mg/kg IV ketamine over 2 minutes, which can be repeated q5 minutes until appropriate analgesia is achieved.

Ketamine: IV ketamine
Eligibility criteria:
Inclusion Criteria:

Aged 14 years or older
Voluntarily requesting surgical pregnancy termination
Intrauterine pregnancy up to 13 weeks 6 days by transabdominal or transvaginal ultrasound performed on day of procedure
Eligible for suction curettage
English or Spanish speaking
Able and willing to give informed consent and agree to terms of the study

Exclusion Criteria:

Age less than 14 years
Reaspiration procedure or failed medication abortion
Early pregnancy loss
Alcohol use disorder or acute alcohol intoxication
Currently incarcerated
Gestational age 14 weeks or more
Requesting a specific pain regimen
Premedication with misoprostol
Contraindications or allergies to ketamine or fentanyl
Intervention: Lasmiditan
Trial phase: Phase 1
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 47
Group description: Participants received 100 mg lasmiditan as IR tablet formulation administered orally.
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy as determined by medical evaluation.
Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).

Exclusion Criteria:

Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy.
Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.
Have clinically significant abnormalities on ECG, as determined by investigator.
Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data.
Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).
Intervention: Lasmiditan
Trial phase: Phase 1
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 47
Group description: Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy as determined by medical evaluation.
Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).

Exclusion Criteria:

Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy.
Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.
Have clinically significant abnormalities on ECG, as determined by investigator.
Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data.
Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).