anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Donepezil
Trial phase: Phase 2
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 54
Group description: Participants who received donepezil in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Down syndrome (established during study E2020-A001-220).
Completion of study E2020-A001-219 (NCT00570128 [also known as A2501059]) with no ongoing seroius adverse events and no severe drug reactions.

Exclusion Criteria:

Weight less than 20 kg.
Clinically significant conditions affecting absorption, distribution or metabolism of the study medication.
No reliable parent or caregiver, or unwillingness or inability of parent or caregiver to fulfill the requirements of the study.
Females of childbearing potential who are not practicing an effective means of birth control.
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 180
Group description: Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.

0.5mg/kg of midazolam taken orally.
Eligibility criteria:
Inclusion Criteria:

Laceration in need of repair with sutures, with no other major injuries
Age >=6 months and < 7 years
No meal within the last 2 hours

Exclusion Criteria:

Closed head injury associated with loss of consciousness
Abnormal neurologic exam, relative to baseline status
Significant developmental delay or baseline neurologic deficit
Severe trauma with suspected internal injuries
Acute or chronic respiratory condition
Acute or chronic renal, cardiac or hepatic abnormalities
Allergy to benzodiazepines or previous reaction to benzodiazepines
Taking erythromycin containing antibiotics
Nasal and intraoral lacerations
Intervention: Cephalexin
Trial phase: Not Applicable
ATC code: J01DB01
SMILES: [H][C@]12SCC(C)=C(C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: Cephalexin plus placebo
Eligibility criteria:
Inclusion Criteria

Must have cellulitis as defined here:

Definition A (preferred definition):

Recent onset of soft tissue erythema, considered by the treating clinician to be bacterial in origin, and associated with signs of infection that include at least two of the following: pain, swelling, warmth, fever, lymphangitis, induration, or ulceration.

Definition B (ONLY for darkly-pigmented subjects who cannot use Definition A):

Recent onset of soft tissue color change, pain, or swelling, considered by the treating clinician to be bacterial in origin, and at least one of the following: warmth, fever, induration, or ulceration

Clinical (non-research) attending physician agrees with treatment with cephalexin until 3 days after all symptoms gone, using our weight-based dosing
Responsible clinical attending physician comfortable with adding trimethoprim-sulfamethoxazole vs. placebo to the above
Subject understands the study and signs written informed consent.
Subject agrees to drink at least 1 liter of fluid per day.
Subject will commit to all follow-up appointments

Exclusion Criteria:

Age < 12 months or weight <15 kg
Current skin infection has already been treated
Allergy to sulfa drugs
History of severe allergic reaction to penicillin (defined as anaphylactoid reaction, angioedema, bronchospasm)
Current use of any antibiotic (other than topicals)
Diabetes mellitus
Cellulitis complicated by underlying peripheral vascular disease
Renal insufficiency, defined as patient report, clinical suspicion, or creatinine>1.3 or EGFR<60 on the last-available set of chemistry results in our computer system
Hospital admission required
Presence of > 1 cc of purulent discharge at any time
Cellulitis involving an indwelling vascular, enteric, or urinary catheter
Immunocompromise of any etiology
Pregnancy
Breast feeding
Facial cellulitis (infection is above the clavicles)
Cellulitis associated with marine or freshwater injury, or animal or human bite. (Insect bites not excluded.)
History of glucose-6-phosphate dehydrogenase deficiency
Taking coumadin (warfarin), methotrexate, cisapride, phenytoin (dilantin), digoxin, or dofetilide
Known megaloblastic anemia due to folate deficiency.
Intervention: Testosterone
Trial phase: Not Applicable
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Testosterone Patch 300mcg replaced every 3-4 days
Eligibility criteria:
Inclusion Criteria:

Female, age 18-75
Written informed consent
Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (by Structured Clinical Interview for DSM-IV (SCID)) for Major Depressive Disorder
Meet DSM-IV criteria for a current major depressive episode, as assessed by SCID
Montgomery-Asberg Depression Rating Scale (MADRS) greater than or equal to 16 at baseline visit
Currently treated with SSRI or SNRI, with or without adjunctive therapy, at an adequate dose (see adequate dose table below) for at least six weeks

Exclusion Criteria:

Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
Serious suicide or homicide risk, as assessed by evaluating clinician
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic (including uncontrolled seizure disorder)
Substance use disorder active within last six months
Psychotic features (current episode or lifetime), as assessed by SCID
Laboratory evidence of untreated hypothyroidism
If treated hypothyroidism, significant change in levo-thyroxine dose within the prior three months
If receiving oral estrogen therapy, including oral contraceptives or transdermal estrogen therapy, significant change in dose in the prior three months
Use of androgens or androgen precursors, including testosterone, Dehydroepiandrosterone (DHEA) and methyltestosterone, within the prior three months
Any investigational psychotropic drug within the last two weeks
In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period (three or more episodes of self-harm in the past year, documented history of poor treatment adherence, or frequent missed appointments (greater than 50%) in the past year)
Alanine aminotransferase (ALT) greater than 1.5 times the upper limit of normal.
Creatinine greater than 1.5 times upper limit of normal
History of a hormone-responsive cancer
History of congestive heart failure
MADRS greater than 31
Intervention: Simvastatin
Trial phase: Phase 2 | Phase 3
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Simvastatin: Simvastatin 40mg PO or NGT
Eligibility criteria:
Inclusion Criteria:

Greater than 18 years old
Hypotensive requiring vasopressors
Suspected Infection

Exclusion Criteria:

Pregnant
Liver Failure (ALT or AST > 120)
Rhabomyolysis (CPK > 3x normal)
Comfort care measures status
Chronic Liver Disease (Cirrhosis)
Use of Cyclosporin, Digoxin, Statins
Patients who are unable to take medications by mouth or NGT
Intervention: Imatinib Mesylate
Trial phase: Phase 2
SMILES: CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Biopsy-proven NSF
Ability to give consent

Exclusion Criteria:

Known sensitivity to imatinib mesylate or to any of its components
Pregnant or lactating woman
Bullous dermatologic disease
Aspartate aminotransferase / alanine aminotransferase (AST/ALT) >3 x upper limit of normal
Severe congestive heart failure [New York Heart Association (NYHA) Class III or IV]
Patients who have received Gleevec in the past 12 months
Intervention: Ofloxacin
Trial phase: Phase 2
ATC code: A02BD10 | J01MA01 | J01MA12 | J01RA05 | J01RA09 | S01AE01 | S01AE05 | S02AA16
SMILES: CC1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: MP-376 120 mg Once Daily (QD) Group
Eligibility criteria:
Inclusion Criteria (selected):

> 16 years of age
Confirmed Diagnosis of Cystic Fibrosis
Positive sputum culture for P. aeruginosa within the past 18 months
Patients are able to elicit a forced expiratory volume in 1 second (FEV1) >/= 25% but </= 85% of predicted value at screening
Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
Clinically stable with no changes in health status within the last 30 days
Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

Use of any nebulized or systemic antibiotics within 30 days prior to baseline
History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
Creatine clearance < 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin >/= 3 x upper limit of normal (ULN) at Screening
Intervention: Cholecalciferol
Trial phase: Not Applicable
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Vitamin D
Eligibility criteria:
Inclusion Criteria:

End-stage renal disease undergoing maintenance hemodialysis at KUMC outpatient hemodialysis unit
Dialysis vintage of at least 6 months duration
Nutritional vitamin D deficiency, defined as 25(OH)D <25 ng/ml
Age 21 to 88 years

Exclusion Criteria:

Active infection
Recent hospitalization for acute illness (within last 1 month)
Refusal to study participation
Poorly controlled secondary hyperparathyroidism (iPTH>500)
History of chronic inflammatory disease process, such as inflammatory bowel, rheumatoid arthritis, lupus, etc.
Cinacalcet therapy
Previous allergy to ergocalciferol
History of parathyroidectomy
Current treatment with immunosuppressant medications
Noncompliance with prescribed hemodialysis regimen (i.e. skipping treatments, ending sessions early)
Functional renal transplant within the last five years
Intervention: Indacaterol
Trial phase: Phase 3
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 144
Group description: Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Eligibility criteria:
Inclusion Criteria:

Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).

In addition the following inclusion/exclusion criteria specified below must be met.

Patients must complete Stage 2 of the core study B2335S (NCT00463567).
Written informed consent to participate in the extension must be obtained.
Patients must be able to comply with all study requirements.

Exclusion Criteria:

Patients who were randomized to open-label tiotropium in Study B2335S.
Patients who participated in Stage 1 of the core study (B2335S).
Patients discontinued irrespective of the reason from Stage 2 of the core study.
Patients who fail to comply with the core protocol requirements and procedures.
Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
Patients who in the Investigator's opinion should not participate in the extension study.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Indacaterol
Trial phase: Phase 3
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 146
Group description: Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Eligibility criteria:
Inclusion Criteria:

Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).

In addition the following inclusion/exclusion criteria specified below must be met.

Patients must complete Stage 2 of the core study B2335S (NCT00463567).
Written informed consent to participate in the extension must be obtained.
Patients must be able to comply with all study requirements.

Exclusion Criteria:

Patients who were randomized to open-label tiotropium in Study B2335S.
Patients who participated in Stage 1 of the core study (B2335S).
Patients discontinued irrespective of the reason from Stage 2 of the core study.
Patients who fail to comply with the core protocol requirements and procedures.
Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
Patients who in the Investigator's opinion should not participate in the extension study.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Nitrofurantoin
Trial phase: Not Applicable
ATC code: J01XE01 | J01XE51
SMILES: O=C1CN(/N=C/c2ccc([N+](=O)[O-])o2)C(=O)N1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC

Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC
Eligibility criteria:
Inclusion Criteria:

Women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (CISC) prior to discharge from the hospital

Exclusion Criteria:

Known drug allergy to nitrofurantoin
A history of renal insufficiency
Renal transplant
Renal nephropathy
A recent history of more than 3 Urinary Tract Infections (UTIs) per year
Known immunocompromised condition (organ transplant, chemotherapy for cancer or arthritis, autoimmune diseases (lupus etc)).
Intervention: Humulin N
Trial phase: Not Applicable
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: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Insulin

Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Eligibility criteria:
Inclusion Criteria:

The onset of T2DM for less than 10 years prior to the onset of pregnancy by patient history
Treatment with diet or oral hypoglycemic agents prior to pregnancy.
Pregnancies less than 20 weeks of pregnancy. This gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin A1C (primary outcome) with medical therapy prior to delivery.
Newly diagnosed diabetes in the first 20 weeks of pregnancy. These women likely have had diabetes prior to the onset of pregnancy. They do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. Diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dL, a 50 gram glucola result greater than 200 mg/dL or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. An abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values.
Hemoglobin A1C <9%

Exclusion Criteria:

Gestational age greater than 20 weeks
Multiple gestations (twins or more gestations)
Type 1 diabetes by patient history
Known fetal chromosomal or structural defects
Contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis.
Those with a hemoglobin A1C greater than 9%.
On insulin at the start of pregnancy
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Normal Saline

normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.

A - normal saline
Eligibility criteria:
Inclusion Criteria:

Age 3 - 17 years old
BMI < 35
Negative pregnancy test in female patients age 10 and older
Diagnosed with adenotonsillar hypertrophy, recurrent adenotonsillitis or upper airway obstruction and will be undergoing tonsillectomy alone or adenotonsillectomy

Exclusion Criteria:

Diagnosis of obstructive sleep apnea
Patient with peritonsillar abscess
Allergy to study medication
Any major systemic illness, genetic disorder or diagnosed syndrome
Bleeding disorder
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: armodafinil
Eligibility criteria:
Inclusion Criteria:

If possible, 60 subjects will be included in this study.
All males/females of any race are eligible if aged between 18 and 65 and
Subjects must speak English and have capacity to receive and utilize informed consent
Agree to use barrier method contraception or are infertile x2 years due to medical condition or surgery
Have been formally diagnosed by a Board Certified Rheumatologist using the ACR 1990 research criteria for fibromylagia
Report that fatigue, in addition to FM pain is a key distressing symptom of their FM
Have a score of >4 on the Brief Fatigue Inventory (BFI)
Women of child bearing potential must agree to use barrier contraception as armodafinil may decrease the effectiveness of oral contraceptives

Exclusion Criteria:

Exclusion: Subjects cannot
Be pregnant or be attempting to conceive at present (urine bHCG must be negative)
Have an active substance abuse problem with last use within the past 180 days (outside of nicotine)
Use other stimulating medication ie stimulants, caffeine products (this refers to OTC stimulants OR patients clinically tolerant to and withdrawing from caffeinated beverages, bupropion, desipramine, etc UNLESS said drug has been in steady dosing for >4 weeks
Have a known medical condition outside of FM that causes fatigue (i.e. obstructive apnea, hypothyroidism, depression, etc)
Have a known medical condition or other medication use that relatively contraindicates armodafinil use (ie substance abuse, sensitivity to armodafinil, known cardiac abnormalities of left ventricular hypertrophy, recent MI, mitral valve prolapse dependent on stimulant use, history of psychosis
Has a prior history of modafinil use and failure
Be receiving daytime sedating medication with clear chronological impact on fatigue UNLESS fatigue predates sedating medication or said medication has been steadily dosed > 4 weeks
Medications that induce/inhibit p450 3A4 as they may alter armodafinil plasma levels, and vica versa
Intervention: Cannabidiol
Trial phase: Phase 3
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Eligibility criteria:
Inclusion Criteria:

Willing and able to give informed consent.
Male or female, aged 18 years or over.
Diagnosed with MS and with detrusor overactivity not wholly relieved by current therapy.
At least three incontinence episodes within five consecutive days during the baseline period
Stable dose of anticholinergic medication for at least 14 days leading to study entry.
Agreement, if female and of child bearing potential or if male with a partner of child bearing potential, to ensure that effective contraception is used during the study and for three months thereafter.
Has not used cannabinoids (including cannabis, Marinol® or nabilone) for at least seven days before Visit 1 and willing to abstain from any use of cannabinoids during the study.
Agreement for the UK Home Office, their general practitioner, and their consultant if appropriate, to be notified of their participation in the study.

Exclusion Criteria:

A symptomatic UTI or any cause of detrusor overactivity other than neurogenic causes due to MS.
Using ISC.
A history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
A history of alcohol or substance abuse.
A severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
A history of epilepsy.
If female, are pregnant of lactating, or are planning a pregnancy to occur during the course of the study.
Significant renal or hepatic impairment.
Elective surgery or other procedures requiring general anesthesia scheduled to occur during the study.
Terminal illness or any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the result of the study, or the subjects ability to participate in the study.
Regular levodopa (Sinement®, Sinement Plus®, Levodopa, L-dopa, Madopar®, Benserazide) within the seven days leading up to study entry.
Receiving and unwilling to stop fentanyl for the duration of the study.
Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
Intention to travel internationally or to donate blood during the study.
Participation in another research study in the 12 weeks leading up to study entry.
Previous randomization in to this study