anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lenalidomide
Trial phase: Phase 3
ATC code: L04AX04
SMILES: Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: Initial autologous transplant followed by lenalidomide maintenance

Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
Eligibility criteria:
Inclusion Criteria:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:

Enrolled and randomized on the BMT CTN 0702 protocol.
Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
Signed Informed Consent Form.
Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data AND receive long-term lenalidomide maintenance therapy as part of this study:

Enrolled and randomized to BMT CTN 0702.
Completion of 3 years of maintenance therapy on BMT CTN 0702.
Registered in the mandatory Revlimid REMS® program (formerly the RevAssist® for Study Participants (RASP) program), and be willing and able to comply with the requirements of the Revlimid REMS® program, including counseling, pregnancy testing, and phone surveys.
Signed informed consent form.
Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Exclusion Criteria:

Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:

Patients who have evidence of disease progression prior to enrollment.
Patients who were discontinued from BMT CTN 0702 lenalidomide maintenance therapy, for any reason, prior to the completion of the 3 years of 0702 maintenance.
Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.
Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.
Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.
Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.
Intervention: Abemaciclib
Trial phase: Phase 1
ATC code: L01EF03
SMILES: CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: 200 mg LY2835219 administered orally on day 1.
Eligibility criteria:
Inclusion Criteria:

Overtly healthy sterile males or surgically sterile females or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

Have participated in a clinical trial involving investigational product within the last 90 days
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have an abnormal blood pressure
Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Have donated blood of more than 500 milliliters (mL) within the last month
Have consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A inducer, herbal supplements, grapefruits or grapefruit containing products, Seville oranges or Seville orange containing products, star fruits or star fruit containing products within 2 weeks prior to dosing or intend to consume during the study
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Intervention: Methadone
Trial phase: Not Applicable
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants will begin methadone during detention.

Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.
Eligibility criteria:
Inclusion Criteria:

1) Meets Diagnostic and Statistical Manual -5 (DSM-5) criteria for opioid use disorder; (2) detained for at least 48 hours; (3) receiving opioid withdrawal treatment (as-usual) through the Detention Center's medical providers; (4) able and willing to provide informed consent in English; (5) detained for a charge that, if found guilty, will result in a sentence of less than 1 year; (6) plan to reside in Baltimore upon release; (7) 18 years of age and older.

Exclusion Criteria:

(1) enrolled in methadone or buprenorphine treatment in the community at the time of arrest; (2) having a medical (liver failure, congestive heart failure) or psychiatric condition (e.g., suicidal ideation, psychosis) that would make participation unsafe in the judgment of the medical staff or the PI; (3) pregnancy; (4) allergy to methadone; and, (5) requiring treatment for alcohol or sedative hypnotic withdrawal.
Intervention: Methotrexate
Trial phase: Phase 3
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 227
Group description: Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks

Methotrexate
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma
Documented progressive disease after chemotherapy for locoregionally advanced or recurrent/metastatic SCCHN which included a platinum derivative
Measurable or non measurable disease
adequate haematological, hepatic and renal functions
WHO performance status < 1

Exclusion Criteria:

Nasopharyngeal carcinoma
History of brain or leptomeningeal involvement
Albumin level < 35 g/L
Patients with weight loss ≥ 5% within the last 3 months
Grade > 2 peripheral neuropathy at study entry
"Third space" fluids (pleural effusion, ascites, massive edema)
Prior treatment with vinca-alkaloids and methotrexate
Intervention: Morphine sulfate pentahydrate
Trial phase: Phase 4
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.

Intrathecal morphine injection: 0.2 mg
Eligibility criteria:
Inclusion Criteria:

Females ≥18 years of age at screening.
Scheduled to undergo elective C-section (single or multiple births).
American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.
Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.
Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.
Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study or cause inability to comply with the study requirements.
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years.
Received an investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure while participating in this study.

Previous participating in an EXPAREL study.

The subject will be withdrawn from the study if she meets the following criteria:

Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
Her baby's 5-minute Apgar score is ≤7.
Intervention: Amlodipine Besylate
Trial phase: Phase 4
SMILES: CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl.O=S(=O)(O)c1ccccc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.
Eligibility criteria:
Inclusion Criteria:

18 years or older;
Pregnant female
Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy;
Hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery
Breastfeeding or breast and bottle-feeding their infant

Exclusion Criteria:

Known kidney disease
Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage
Administration of greater than 5 mg of amlodipine in 24 hour period
Intervention: Spironolactone
Trial phase: Phase 3
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Spironolactone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Aldactone. Spironolactone is a potassium-sparing diuretic.

Spironolactone: 26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months.
Eligibility criteria:
Inclusion Criteria:

Boys age ≥7 years with DMD confirmed clinically and by mutation analysis able to undergo cardiac magnetic resonance (CMR) without sedation
LV EF ≥45% (+/-5%) by clinically-acquired echocardiography, nuclear scan or cardiac MRI done within 2 weeks of enrollment

Exclusion Criteria:

Non-MR compatible implants
Severe claustrophobia
Gadolinium contrast allergy
Kidney disease
Prior use of or allergy to aldosterone antagonist
Use of other investigational therapy.
Intervention: Fluoxetine
Trial phase: Phase 4
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Active control arm
Eligibility criteria:
Inclusion Criteria:

consent obtained from patients and their parents (assent for patients under 18);
age 12-25 years (inclusive);
English-speaking;
at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe or severe.

Exclusion Criteria:

lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features;
current psychosis (any positive symptom SOPS score of 6, i.e., extreme);
current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features;
current stimulant treatment;
history of neurological, neuroendocrine or other medical condition known to affect the brain;
any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine;
past or current substance dependence; sunstance abuse within the last 4 weeks;
IQ < 70.
Intervention: Tetracycline
Trial phase: Not Applicable
ATC code: A01AB13 | A02BD02 | A02BD08 | D06AA04 | J01AA07 | J01AA20 | J01RA08 | S01AA09 | S02AA08 | S03AA02
SMILES: [H][C@]12C[C@@]3([H])[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C(=O)c1c(O)cccc1[C@@]2(C)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 27
Group description: 200mg minocycline

Minocycline: Minocycline will be compared with placebo
Eligibility criteria:
Inclusion Criteria:

Males and females, between the ages of 18 and 55
Diagnosed with opioid dependence and currently enrolled in methadone maintenance treatment
Compliant in methadone maintenance treatment and on a stable dose for two weeks or greater
No current dependence or abuse of any other drugs (other than tobacco or marijuana)
No current medical problems

For women:

not pregnant as determined by pregnancy screening;
not breast feeding; u
using acceptable birth control methods;
not experiencing moderate to severe premenstrual symptoms (may interfere with pain assessment);
regular menstrual cycles

Exclusion Criteria:

Current major psychiatric illnesses including mood, psychotic, or anxiety disorders
History of major medical illnesses, including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for inclusion in the study
Current use of over-the-counter or prescription psychoactive drugs (including regular use of NSAIDS, antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, Percocet, and other opiate drugs
Liver function tests (ALT or AST) greater than 3x normal
Allergy to minocycline or other tetracyclines
Intervention: Canagliflozin
Trial phase: Phase 4
ATC code: A10BD16 | A10BK02
SMILES: [H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.

Canagliflozin: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes
BMI 25-45 kg/m2
Hemoglobin A1C > 6.5% but < 9%
Normal renal function (GFR > 60)
Age 18-75

Exclusion Criteria:

Type 1 diabetes
History of recurrent UTI or mycotic genital infections
Treatment with insulin or a GLP1 agent
Pregnant or breastfeeding
Intervention: Sodium fluoride and triclosan
Trial phase: Phase 4
SMILES: Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 129
Group description: Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).
Eligibility criteria:
Inclusion Criteria:

Subjects, ages 18-70, inclusive.
Availability for the six-week duration of the clinical research study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form

Exclusion Criteria:

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Antibiotic use any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Dental prophylaxis during the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Pregnant or lactating subjects.
Intervention: Bictegravir
Trial phase: Not Applicable
ATC code: J05AR20
SMILES: O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Invasive bladder cancer treated with 3-6 weeks of intravesical BCG

BCG strain of Mycobacterium bovis: Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
Eligibility criteria:
Inclusion Criteria:

Have suspected or known invasive (≥T1) bladder cancer
Be able to give informed consent
Be age 18 or older
Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)

Exclusion Criteria:

Have non-invasive (<T1) bladder cancer
Unable to give informed consent
< 18 or older
Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
Intervention: Sodium fluoride and triclosan
Trial phase: Phase 4
SMILES: Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 179
Group description: Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Eligibility criteria:
Inclusion Criteria:

Male and female subjects, ages 18-70, inclusive.
Availability for the six-month duration of the study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Exclusion Criteria:

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Use of antibiotics any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Pregnant women or women who are breast feeding.
Dental prophylaxis received in the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 86
Group description: Patient receives 1g intravenous acetaminophen after the incision

Acetaminophen (Ofirmev)
Eligibility criteria:
Inclusion Criteria:

Patients undergoing robotic-assisted laparoscopic prostatectomy
≥18 years old males
American Society of Anesthesiologists class 1-4

Exclusion Criteria:

Chronic opiate use
Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)
Allergy/hypersensitivity to acetaminophen
Patients with baseline dementia
Chronic diathesis
Chronic kidney disease