anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: LY3295668
Trial phase: Phase 1 | Phase 2
SMILES: Cc1cc(Nc2ccc(F)c(C[C@@]3(C(=O)O)CCN(Cc4cccc(Cl)c4F)[C@H](C)C3)n2)n[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 50 mg LY3295668 BID administered orally in 21-day cycles.
Eligibility criteria:
Inclusion Criteria:

Have received at least 1 but no more than 4 prior systemic therapies
Have adequate organ function
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have estimated life expectancy greater than or equal to (≥)12 weeks
Have fully recovered from radiation therapy or surgery, and are recovering from any acute adverse effects of other cancer therapies
Have discontinued all chemotherapy, investigational therapy, molecularly-targeted therapy, and cancer-related hormonal therapy at least 14 days prior, biologic or immunotherapeutic therapy at least 21 days prior, or mitomycin-C or nitrosoureas at least 6 weeks prior
Female participants with reproductive potential agree to use 2 forms of highly effective contraception during the study and for the following 3 months
Male participants must use a barrier method of contraception during the study and for the following 3 months

Phase 1

Have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)

Phase 2

Have disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

Have evidence of a solid tumor that is locally advanced and/or metastatic, and in:

Small Cell Lung Cancer (SCLC), must have failed platinum-containing therapy
Breast Cancer, be Estrogen Receptor positive and/or Progesterone Receptor positive, but Human Epidermal Growth Factor Receptor 2 (HER2) negative, and must have failed a hormone therapy and a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor
Triple negative breast cancer (TNBC) and failed standard therapy
Squamous cell cancers of the head neck associated with the human papilloma virus (HPV), and have failed standard therapy
Other solid tumor type that has been approved by the sponsor

Exclusion Criteria:

Have symptomatic central nervous system (CNS) metastasis (unless asymptomatic and not current receiving corticosteroids) or a primary tumor of the CNS
Have a medical condition that precludes participation (swallowing disorder, organ transplant, pregnant or nursing, HIV, active Hepatitis B or C, cardiac disease, history of major surgery in upper gastrointestinal (GI) tract or GI disease, hypokalemia, hypomagnesaemia or hypocalcaemia that cannot be controlled)
Intervention: DIROXIMEL FUMARATE
Trial phase: Phase 3
ATC code: L04AX09
SMILES: COC(=O)/C=C/C(=O)OCCN1C(=O)CCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 253
Group description: Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Eligibility criteria:
Key Inclusion Criteria:

Capable of understanding and complying with the protocol
Has a confirmed diagnosis of RRMS
Neurologically stable with no evidence of relapse within 30 days prior to randomization
Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal

Key Exclusion Criteria:

Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening
Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening
History of a myocardial infarction, including a silent myocardial infarction or unstable angina
History of clinically significant drug or alcohol abuse within the past year prior to screening
Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
Prior use of Dimethyl Fumarate (DMF)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Valemetostat
Trial phase: Phase 1
SMILES: [H][C@]1([C@@]2(C)Oc3c(Cl)cc(C(=O)NCc4c(C)cc(C)[nH]c4=O)c(C)c3O2)CC[C@H](N(C)C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
Eligibility criteria:
Inclusion Criteria:

Has AML or ALL and failed any prior induction therapy regimen or have relapsed after prior therapy
Has Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Has adequate renal and hepatic function
Had at least 14 days for prior treatment to clear the body before initiation of DS-3201b administration (except for hydroxyurea that needs only 2 days for clearance)
Able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy.
Agrees to use an adequate method of contraception during the study and until 3 months after the last treatment.
Is willing to provide bone marrow biopsies and comply with protocol-defined evaluations
Has a life expectancy of at least 3 months

Exclusion Criteria:

Has presence of central nervous system (CNS) involvement of leukemia or a history of CNS leukemia
Has a second concurrent active primary malignancy such as solid tumor or lymphoma under active treatment
Has refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, graft versus- host disease (GVHD) significantly affecting gut motility or absorption, or any other condition that would preclude adequate absorption of DS- 3201b in the opinion of the treating physician and/or principal investigator (PI)
Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or tested positive for active hepatitis B or C infection
Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor
Has unresolved toxicities from previous anticancer therapy
Has received hematopoietic stem cell transplantation (HSCT) within 60 days of the first dose of DS-3201b
Has received concomitant treatment with a strong inhibitor or inducer of cytochrome P450 (CYP)3A4/5 within 7 days of first receipt of DS-3201b
Has consumed herbs/fruits that may have an influence on pharmacokinetics (PK) of DS-3201b from 3 days (14 days for St. John's wort) prior to the start of the study and throughout the entire study
Had major surgery within 4 weeks before study drug treatment
Has prolonged corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 milliseconds (ms) based on triplicate electrocardiograms (ECGs)
Is pregnant or breastfeeding
Has substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study results
Has received prior treatment with enhancer of zeste homolog (EZH) inhibitor
Intervention: Naropin
Trial phase: Phase 4
SMILES: CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 160
Group description: Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
Eligibility criteria:
Inclusion Criteria:

Patients who have or are:

Orthopedics service patients having shoulder surgery
ASA(American Society of Anesthesiologists) class I, II, or III.
Patients at least 18 years old but less than 71 years old.
Patients giving informed consent.

Non-Emergency Surgery

Exclusion Criteria:

Patients who have or are:

An inability to cooperate during the block placement.
Neuropathy of the planned extremity to block
Diabetes
Documented Kidney Disease
Documented Liver Disease
A lack of or inability to give informed consent.
Currently incarcerated.
Pregnant
Intervention: Metformin
Trial phase: Early Phase 1
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Drug intervention: Metformin 500 mg tablet twice orally for 3 months

Metformin: Metformin (1000 mg)
Eligibility criteria:
Inclusion Criteria:

Clinically diagnosed patients of PCOS.
Must Swallow the tablet(s).
Must give informed consent.

Exclusion Criteria:

Women with cushing syndrome, hyperprolactinemia.
Late onset congenital adrenal hyperplasia, androgen-producing tumors, pregnancy.
Insulin dependent diabetes.
Thyroid disease.
Medications that alters the biochemical or hormonal profile.
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.

Acetaminophen: Acetaminophen 1000mg
Eligibility criteria:
Inclusion Criteria:

Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma)

Exclusion Criteria:

history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen
Intervention: Methadone
Trial phase: Phase 2
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: NAS infants treated for withdrawal symptoms with methadone

Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Eligibility criteria:
Methadone Treatment Group:

Inclusion criteria:

Baby is diagnosed with neonatal abstinence syndrome;
Mother under the care of Operation PAR;
Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;
Mother has been deemed by PAR officials as being compliant with the detoxification program;
Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;
Mother has been prescreened and deemed adequate candidate by the demonstration project team members;
No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;
Newborns ≥ 37 0/7 weeks gestation;
Newborns transferred to JHACH within 72 hours from birth;
Newborns ≥ 2.5 kg weight at birth;
Informed parental consent.

Exclusion Criteria:

Major congenital anomalies;
Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
Infants who are being placed for adoption;
Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
Infants whose maternal UDS at the time of delivery is positive for any other drug of abuse beside opiates.
Mother with hearing or language impairment

Comparison Group:

Inclusion Criteria:

Baby is diagnosed with neonatal abstinence syndrome;
Newborns ≥ 37 0/7 weeks gestation;
Newborns transferred to JHACH within 72 hours from birth;
Newborns ≥ 2.5 kg weight at birth;
Informed parental consent.

Exclusion Criteria:

Infant not requiring pharmacologic treatment for NAS;
Major congenital anomalies;
Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
Infants who are being placed for adoption;
Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
Mother with hearing or language impairment;
Infants known upon admission who will be placed into state custody or sheltered.
Intervention: Ivabradine
Trial phase: Phase 2
ATC code: C01EB17 | C07FX05 | C07FX06
SMILES: COc1cc2c(cc1OC)CC(=O)N(CCCN(C)C[C@H]1Cc3cc(OC)c(OC)cc31)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Ivabradine will be administered for a total of 6 weeks
Ivabradine is taken orally twice daily
Dosage will be adjusted according to physician determination

Ivabradine: lower heart rate in heart failure patients.
Eligibility criteria:
Inclusion Criteria:

Survivors of mediastinal lymphoma (either Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma) with no active malignancy
Prior mediastinal or mantle radiation ≥ 5 years prior to enrollment in the study
Age 18-80 years.

Participants must have normal organ function as defined below:

AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
creatinine clearance ≥ 15 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
Normal sinus rhythm with resting heart rate ≥ 80 bpm on screening EKG
Based on findings in animals, ivabradine may cause fetal harm when administered to a pregnant woman. For this reason, women of child-bearing potential must agree to use adequate contraception.
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Participants who are receiving any other investigational agents.
History of allergic reaction to ivabradine.
Participants receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 are ineligible.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, acute coronary syndrome, symptomatic known coronary artery disease, severe valvular heart disease, active malignancy, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because ivabradine is an agent with the potential for teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ivabradine, breastfeeding should be discontinued if the mother is treated with ivabradine.
HIV-positive participants on combination antiretroviral therapy.
Patients with systolic blood pressure < 90 mm Hg.
Patients with sick-sinus syndrome, sino-atrial block, third degree heart block, atrial fibrillation, and those with permanent pacemakers.
Patients with other established indications for ivabradine: stable, symptomatic chronic HF with a left ventricular ejection fraction ≤ 35% and in sinus rhythm with a resting HR ≥ 70 bpm, who are taking maximally tolerated doses of beta-blockers or have contraindications to beta-blocker use.
Patients with severe hepatic dysfunction (Child Pugh Class C).
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Intervention: Oxycodone
Trial phase: Phase 4
ATC code: N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19
SMILES: COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 86
Group description: Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion

Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to oxycodone 10mg oral
Eligibility criteria:
Inclusion Criteria:

Aged 18 years or older
Seeking elective medical abortion
In good health
Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
Able and willing to receive text messages via phone
Literate in English
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:

Lack of access to cell phone and texting capabilities
Early pregnancy failure
Contraindications to the study medications: Oxycodone, Ibuprofen
Contraindications to medical abortion with Mifepristone or Misoprostol
History of methadone or heroin use
Used alcohol in the past 24 hours
Used marijuana >4 times per week
Any opioid in the past 30 days
Using additional pain medications
Intervention: Acetaminophen
Trial phase: Phase 2
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 600
Group description: 5 mg hydrocodone + 300 mg acetaminophen

hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
Eligibility criteria:
Inclusion Criteria:

Patients ages 21 through 64 years of age
Complaint of acute musculoskeletal pain in one or more extremity, defined as distal to and including the shoulder or hip joints.
Pain of less than seven days duration
Patient speaks Spanish or English
The clinician plans to treat the patient in the ED with oral analgesics and is willing to treat the patient with opioid analgesics or up to 800 mg ibuprofen and 1000 mg acetaminophen
Patient is going to receive imaging of the painful extremity
Clinician judges patient to have capacity to provide informed consent

Exclusion Criteria:

Patient does not have cell phone or cannot receive a verification phone call on their cell phone while in the ED
Any use of methadone currently or previously
Chronic condition requiring frequent pain management such as arthritis, sickle cell disease, fibromyalgia, or any neuropathy
History of an adverse reaction to any of the study medications
Opioids taken in the past 24 hours
Ibuprofen or acetaminophen taken in past 24 hours
Any other prescribed or over the counter topical or oral analgesics taken in past 24 hrs
Pregnancy by either urine or serum human chorionic gonadotropin testing
Breastfeeding per patient report
History of peptic ulcer disease
Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's, or Cushing's disease
Lacerations,
Multiple injuries
Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritonavir, terbinafine, or St John's Wort
Intervention: Topiramate
Trial phase: Phase 2 | Phase 3
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: psychotherapy plus active medication

topiramate: active medication

prolonged exposure: psychotherapy
Eligibility criteria:
Inclusion Criteria:

Veterans of the U.S. military and/or Reserve/National Guard members,
at least 18 years of age,
survivors of a psychological trauma meeting DSM-5 criterion A, and are at least one month post-trauma,
have current DSM-5 diagnoses of AUD and PTSD based on semi-structured diagnostic interviews,
have at least 20 days of heavy drinking (>= 5 drinks/day for men and >= 4/drinks per day for women) in the last 90 days spent in a non-restricted environment and meet criteria for heavy drinking at least 4 days in the last 30 days prior to screening,
are not currently receiving trauma-focused psychotherapy,
are literate in English and intend to stay in the San Diego area during the study,
are willing to attend psychotherapy, medication, and assessment sessions,
trying or planning to try to cut down on or abstain from alcohol,
for females of childbearing potential, agree to use an approved form of contraception for the duration of the study, including hormonal contraceptives (e.g., oral contraceptives or implantable devices), intrauterine device (IUD), or double barrier methods (e.g., diaphragm with spermicidal condom); barrier method is preferred as topiramate may make birth control less effective,
Individuals with clinically significant renal disease and/or impaired renal function, as defined by clinically significant elevation of blood urea nitrogen (BUN) or creatinine or an estimated creatinine clearance of < 60 mL/min, can be included with physician approval, however the dosing schedule and maximum dose will be adjusted in accordance with FDA prescribing guidelines,
if individual is on another addiction medication, they should be on a stable approved addiction medication dose (at least two weeks before starting study drug) throughout the study,
are capable of giving informed consent.

Exclusion Criteria:

Subjects known to have clinically significant unstable medical or psychiatric conditions, where participation is deemed by investigators and study physicians to be risky, including but not limited to:

AST and/or ALT >5 times the upper limit of the normal range and/or an increased serum bilirubin >2 times the upper limit of normal.
Seizure disorders
have been treated with Topiramate for any reason in the past and discontinued the drug due to hypersensitivity reaction
in the opinion of the investigator, should not be enrolled because of the precautions, warnings, or contraindications listed on the Topiramate package insert, (e.g., certain types of glaucoma),
are pregnant, lactating, or plan to become pregnant during the period of participation in the study
in the judgment of the investigator, represent a significant risk of suicidal or homicidal behavior