anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Buprenorphine
Trial phase: Phase 4
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.

Buprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.
Eligibility criteria:
Inclusion Criteria:

Adults >18yo incarcerated in NYC jails with known release dates.
DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid treatment program.

Exclusion Criteria:

Individual not interested in XRB treatment. Current SLB patients are otherwise by definition appropriate for XRB.
Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine with a sensitivity/specificity of: 25 mIU hCG/ml, >99%. Time to result is four minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant
No severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.
Intervention: Buprenorphine
Trial phase: Phase 4
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.

Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.
Eligibility criteria:
Inclusion Criteria:

Adults >18yo incarcerated in NYC jails with known release dates.
DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid treatment program.

Exclusion Criteria:

Individual not interested in XRB treatment. Current SLB patients are otherwise by definition appropriate for XRB.
Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine with a sensitivity/specificity of: 25 mIU hCG/ml, >99%. Time to result is four minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant
No severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.
Intervention: Dronabinol
Trial phase: Phase 4
ATC code: A04AD10
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)Oc1cc(CCCCC)cc(O)c12
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo

Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
Eligibility criteria:
Inclusion Criteria:

Aged 21 years or older
Consented for elective medical abortion
Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
Able and willing to receive text messages via phone
English speaking
Able and willing to give informed consent and agree to the study terms
Have assistance at home; no motor vehicle use while taking study medications

Exclusion Criteria:

Desires to continue pregnancy or currently breastfeeding
Lack of access to cell phone and texting capabilities
Prior participation in this study
Early pregnancy failure
Contraindications to the study medications: Marinol or marijuana derivatives, sesame oil, Ibuprofen
Contraindications to medical abortion with Mifepristone or Misoprostol
History of methadone, buprenorphine or heroin use within the last year
History of a seizure disorder
Used marijuana 5 or more days in the last week
History of any adverse effects associated with prior use of recreational or medical marijuana products, or sensitivity/allergy to Marinol.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Women in this arm will receive a flush with saline after normal saline Sono HSG.

Saline: Up to 10cc of saline will be infused via intrauterine catheter
Eligibility criteria:
Inclusion Criteria:

Eligible for Sono HSG for fertility testing
In good general health
Willing and capable of complying with the study procedures
At least one patent tube and no endometrial pathology on Sono HSG
Ready to undergo infertility treatment immediately after the test
Not planning on IVF therapy in the next 6 mos

Exclusion Criteria:

Known tubal or endometrial (polyp, submucous fibroid, etc.) pathology
At high risk for tubal disease due to history of Pelvic Inflammatory Disease
Known hypersensitivity to Lipiodol UF®or known allergy to iodine containing contrast media or shellfish
Endometrial pathology on Sono HSG requiring further evaluation (as per the performing physician)
Bilateral tubal occlusion on Sono HSG
Unable to tolerate potential pain associated with the study.
Requiring IVF due to severe male factor, known pelvic adhesions, etc.
Couples with decreased male factor fertility rate (i.e., low sperm count or motility, i.e. less than 5 million/mL concentration on semen analysis
Intervention: Febuxostat
Trial phase: Phase 1 | Phase 2
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)

Febuxostat: Intervention is orally administered to patients in this arm.
Eligibility criteria:
Inclusion Criteria:

male and female children of 6 to less than 12 years of age, adolescents of 12 to less than 18 years of age and adults from 18 years:

scheduled for first cytotoxic chemotherapy cycle because of hematologic malignancies
and at intermediate or high risk of TLS
and with no access to rasburicase

Exclusion Criteria:

patients with contraindications as per febuxostat summary of product characteristics
patients with severe renal insufficiency
patients with severe hepatic insufficiency
patients with diagnosis of Laboratory TLS (LTLS) or Clinical TLS (CTLS)
Intervention: Febuxostat
Trial phase: Phase 1 | Phase 2
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)

Febuxostat: Intervention is orally administered to patients in this arm.
Eligibility criteria:
Inclusion Criteria:

male and female children of 6 to less than 12 years of age, adolescents of 12 to less than 18 years of age and adults from 18 years:

scheduled for first cytotoxic chemotherapy cycle because of hematologic malignancies
and at intermediate or high risk of TLS
and with no access to rasburicase

Exclusion Criteria:

patients with contraindications as per febuxostat summary of product characteristics
patients with severe renal insufficiency
patients with severe hepatic insufficiency
patients with diagnosis of Laboratory TLS (LTLS) or Clinical TLS (CTLS)
Intervention: Diclofenac
Trial phase: Phase 4
ATC code: D11AX18 | M01AB05 | M01AB55 | M02AA15 | S01BC03 | S01CC01
SMILES: O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.

diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
Eligibility criteria:
Inclusion Criteria:

english speaking
candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
scheduled for surgery at Texas Sinus Institute

Exclusion Criteria:

allergy to either NSAIDs or opioids
contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
surgical plan exceeding basic endoscopic sinus surgery
use of anticoagulation
the presence of any pain disorder
the current usage of any analgesic medication
history of opioid addiction
pregnancy
history of chronic pain or fibromyalgia
current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Tranexamic Acid (TXA): One gram of intravenous tranexamic acid (TXA) will be administrated before tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount with minimal side effects
Eligibility criteria:
Inclusion Criteria:

Patients undergoing TTO
Age 18-60
Willing and able to provide consent

Exclusion Criteria:

Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age
Older than 60 years of age
Any patient considered a vulnerable subject
Have bleeding or clotting disorder
Preoperative anticoagulation therapy
Abnormal coagulation profile
Renal disorder or insufficiency
Sickle cell disease
Intervention: Buprenorphine
Trial phase: Phase 1 | Phase 2
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: Buprenorphine 0.075 mg ml sublingual solution

Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose < Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24

Buprenorphine: buprenorphine 0.075 mg/ml solution
Eligibility criteria:
Inclusion Criteria:

≥ 36 weeks gestation
Exposure to opioids in utero
Demonstration of signs and symptoms of neonatal abstinence syndrome requiring pharmacologic treatment

Exclusion Criteria:

Major congenital malformations and/or intrauterine growth retardation, defined as birth weight <2000 gm
Medical illness requiring intensification of medical therapy. This includes but is not limited to suspected sepsis requiring antibiotic therapy.
Hypoglycemia requiring treatment with intravenous dextrose
Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)
Inability of mother to give informed consent due to co-morbid psychiatric diagnosis
Intervention: Fasoracetam
Trial phase: Phase 2
SMILES: O=C1CC[C@H](C(=O)N2CCCCC2)N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 53
Group description: Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d.
Eligibility criteria:
Inclusion Criteria:

Subject and parent/legally authorized representative (LAR) can speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
Subject is 6 to 17 years of age (inclusive) at the time of consent/assent. The date of signature of the informed consent/assent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the Screening Visit (Visit 1).
Subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements prior to administration of investigational product (IP).
Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based upon DSM 5 criteria.
Subject has a minimum score of ≥28 on the ADHD-RS-5 at the Baseline Visit (Visit 2).
Subject has been genotyped previously and has their identity confirmed (if required).

Exclusion Criteria:

Subject or parent/LAR is, in the opinion of the investigator, mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit (Visit 1) which could interfere with the conduct of study evaluations.
Subject has a current, controlled or uncontrolled, co-morbid major psychiatric diagnosis (aside from ADHD), including an anxiety disorder, major depression, bipolar disease, schizophrenia (or any psychotic disorder), and moderate or severe intellectual disability. Mild anxiety and/or depressive symptoms that do not meet diagnostic criteria for an anxiety disorder or major depression and/or do not require treatment are not exclusionary.
Subject has autism spectrum disorder to include a DSM-IV diagnosis of autistic disorder, Asperger's disorder, or pervasive developmental disorder.
Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
Subject has a known history of cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, cardiac conduction problems, exercise-related cardiac events including syncope and pre-syncope, or other serious cardiac problems.
Subject has any clinically significant abnormality on 12-lead ECG performed at the Screening Visit (Visit 1) and/or the Baseline Visit (Visit 2) such as serious arrhythmia, cardiac conduction problems, or other abnormalities deemed to be a potential safety issue.
Intervention: Primaquine
Trial phase: Not Applicable
ATC code: P01BA03
SMILES: COc1cc(NC(C)CCCN)c2ncccc2c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 257
Group description: This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy.

Primaquine: Different total dose and supervision.
Eligibility criteria:
Inclusion Criteria:

1. Age ≥5 years 2. Body weight <120 kg 3. Documented fever (axillary temperature ≥37.5o C) or history of fever during the previous 48 hours in the absence of another obvious cause of fever, such as pneumonia, otitis media, etc 4. Monoinfection with P. vivax with parasitemia between 100 and 200,000 asexual parasites/µl as determined by microscopic examination of thick and thin peripheral blood smears 5. Informed consent from the patient or parent/guardian (for those <18 years), assent from child (ages 7 to 17 years inclusive), patients 5 through 6 years old will not need an assent 6. Willingness on the part of the patient to return to the clinic and/or receive home visits for regular check-ups during the 24-week (168 days) follow-up period 7. Place of residence within 30-45 minutes of study site.

Exclusion Criteria:

1. Presence of malaria danger signs

Unable to drink
Vomiting (more than twice in the previous 24 hours)
Recent history of convulsions (one or more in the previous 24 hours)
Impaired consciousness
Unable to sit or stand 2. Presence of signs of severe malaria (WHO criteria)
Cerebral malaria (unarousable coma)
Severe anemia (hematocrit <15% or clinical signs) hemoglobin <5 mg/ml) (Note: we will use hemoglobin less than 8 mg/ml as exclusion criteria)
Renal failure (serum creatinine >3 mg/dL or clinical signs)
Pulmonary edema
Hypoglycemia (blood glucose <40mg/dL or clinical signs)
Shock (systolic blood pressure <70 mm Hg in adults; 50 mm Hg in children)
Spontaneous bleeding/disseminate intravascular coagulation
Repeated generalized convulsions
Acidemia/acidosis (clinical signs)
Macroscopic hemoglobinuria

Jaundice 3. Self-reported presence of other underlying chronic or severe diseases (e.g., cardiac, renal, hepatic diseases, HIV/AIDS, tuberculosis, malnutrition, psoriasis) 4. History of hypersensitivity reactions to any of the drugs being tested. Mild itching with CQ is not in itself a criterion for exclusion. This occurrence will be evaluated by the study doctor before excluding the patient for this reason alone.

5. Use of drugs with antimalarial activity in the past 30 days. (Annex D) 6. Current pregnancy (either self-reported being pregnant at enrollment or a positive urine or plasma pregnancy test at time of enrollment), previous pregnancy is not an exclusion criteria 7. Hemoglobin <8 mg/mL 8. G6PD deficiency. This will be a late exclusion criteria as soon as the results of G6PD testing becomes available.
Intervention: Primaquine
Trial phase: Not Applicable
ATC code: P01BA03
SMILES: COc1cc(NC(C)CCCN)c2ncccc2c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 257
Group description: This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy.

Primaquine: Different total dose and supervision.
Eligibility criteria:
Inclusion Criteria:

1. Age ≥5 years 2. Body weight <120 kg 3. Documented fever (axillary temperature ≥37.5o C) or history of fever during the previous 48 hours in the absence of another obvious cause of fever, such as pneumonia, otitis media, etc 4. Monoinfection with P. vivax with parasitemia between 100 and 200,000 asexual parasites/µl as determined by microscopic examination of thick and thin peripheral blood smears 5. Informed consent from the patient or parent/guardian (for those <18 years), assent from child (ages 7 to 17 years inclusive), patients 5 through 6 years old will not need an assent 6. Willingness on the part of the patient to return to the clinic and/or receive home visits for regular check-ups during the 24-week (168 days) follow-up period 7. Place of residence within 30-45 minutes of study site.

Exclusion Criteria:

1. Presence of malaria danger signs

Unable to drink
Vomiting (more than twice in the previous 24 hours)
Recent history of convulsions (one or more in the previous 24 hours)
Impaired consciousness
Unable to sit or stand 2. Presence of signs of severe malaria (WHO criteria)
Cerebral malaria (unarousable coma)
Severe anemia (hematocrit <15% or clinical signs) hemoglobin <5 mg/ml) (Note: we will use hemoglobin less than 8 mg/ml as exclusion criteria)
Renal failure (serum creatinine >3 mg/dL or clinical signs)
Pulmonary edema
Hypoglycemia (blood glucose <40mg/dL or clinical signs)
Shock (systolic blood pressure <70 mm Hg in adults; 50 mm Hg in children)
Spontaneous bleeding/disseminate intravascular coagulation
Repeated generalized convulsions
Acidemia/acidosis (clinical signs)
Macroscopic hemoglobinuria

Jaundice 3. Self-reported presence of other underlying chronic or severe diseases (e.g., cardiac, renal, hepatic diseases, HIV/AIDS, tuberculosis, malnutrition, psoriasis) 4. History of hypersensitivity reactions to any of the drugs being tested. Mild itching with CQ is not in itself a criterion for exclusion. This occurrence will be evaluated by the study doctor before excluding the patient for this reason alone.

5. Use of drugs with antimalarial activity in the past 30 days. (Annex D) 6. Current pregnancy (either self-reported being pregnant at enrollment or a positive urine or plasma pregnancy test at time of enrollment), previous pregnancy is not an exclusion criteria 7. Hemoglobin <8 mg/mL 8. G6PD deficiency. This will be a late exclusion criteria as soon as the results of G6PD testing becomes available.
Intervention: Primaquine
Trial phase: Not Applicable
ATC code: P01BA03
SMILES: COc1cc(NC(C)CCCN)c2ncccc2c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 257
Group description: This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy.

Primaquine: Different total dose and supervision.
Eligibility criteria:
Inclusion Criteria:

1. Age ≥5 years 2. Body weight <120 kg 3. Documented fever (axillary temperature ≥37.5o C) or history of fever during the previous 48 hours in the absence of another obvious cause of fever, such as pneumonia, otitis media, etc 4. Monoinfection with P. vivax with parasitemia between 100 and 200,000 asexual parasites/µl as determined by microscopic examination of thick and thin peripheral blood smears 5. Informed consent from the patient or parent/guardian (for those <18 years), assent from child (ages 7 to 17 years inclusive), patients 5 through 6 years old will not need an assent 6. Willingness on the part of the patient to return to the clinic and/or receive home visits for regular check-ups during the 24-week (168 days) follow-up period 7. Place of residence within 30-45 minutes of study site.

Exclusion Criteria:

1. Presence of malaria danger signs

Unable to drink
Vomiting (more than twice in the previous 24 hours)
Recent history of convulsions (one or more in the previous 24 hours)
Impaired consciousness
Unable to sit or stand 2. Presence of signs of severe malaria (WHO criteria)
Cerebral malaria (unarousable coma)
Severe anemia (hematocrit <15% or clinical signs) hemoglobin <5 mg/ml) (Note: we will use hemoglobin less than 8 mg/ml as exclusion criteria)
Renal failure (serum creatinine >3 mg/dL or clinical signs)
Pulmonary edema
Hypoglycemia (blood glucose <40mg/dL or clinical signs)
Shock (systolic blood pressure <70 mm Hg in adults; 50 mm Hg in children)
Spontaneous bleeding/disseminate intravascular coagulation
Repeated generalized convulsions
Acidemia/acidosis (clinical signs)
Macroscopic hemoglobinuria

Jaundice 3. Self-reported presence of other underlying chronic or severe diseases (e.g., cardiac, renal, hepatic diseases, HIV/AIDS, tuberculosis, malnutrition, psoriasis) 4. History of hypersensitivity reactions to any of the drugs being tested. Mild itching with CQ is not in itself a criterion for exclusion. This occurrence will be evaluated by the study doctor before excluding the patient for this reason alone.

5. Use of drugs with antimalarial activity in the past 30 days. (Annex D) 6. Current pregnancy (either self-reported being pregnant at enrollment or a positive urine or plasma pregnancy test at time of enrollment), previous pregnancy is not an exclusion criteria 7. Hemoglobin <8 mg/mL 8. G6PD deficiency. This will be a late exclusion criteria as soon as the results of G6PD testing becomes available.