anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Evixapodlin
Trial phase: Phase 1
SMILES: COc1nc(-c2cccc(-c3cccc(-c4cnc(CNCC5CCC(=O)N5)c(OC)n4)c3Cl)c2Cl)cnc1CNCC1CCC(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).
Eligibility criteria:
Key Inclusion Criteria:

Dose Escalation Cohorts: Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
Dose Expansion and 1000 mg twice a day (BID) Dose Escalation Cohorts: Individuals must have available sufficient and adequate formalin fixed tumor sample preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of advanced disease has been made and from a site not previously irradiated. Alternatively, individuals must agree to have a biopsy taken prior to entering the study to provide adequate tissue. For the 1000 mg BID dose escalation cohort, individuals with melanoma, Merkel cell, microsatellite instability-high (MSI-H) cancers, and classical Hodgkin lymphoma (cHL) are not required to have archival or fresh biopsy tissue.
Dose Escalation Biopsy Substudy and 1000 mg BID Dose Escalation Cohorts: Documented ligand 1 of programmed cell death protein 1 (PD-L1) expression in the tumor (tumor proportion score (TPS) ≥ 10% or combined positive score (CPS) ≥ 10). In the 1000 mg BID Cohort, PD-L1 expression will not be required for Merkel cell, melanoma, MSI-H cancers, and cHL.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
Adequate organ function.

Key Exclusion Criteria:

History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completion.
Dose Escalation Cohorts: History of ≥ Grade 3 Adverse Events (AEs) during prior treatment with an immune checkpoint inhibitor, or history of discontinuation of treatment with an immune checkpoint inhibitor due to AEs.
Dose Escalation 1000 mg BID and Dose Expansion Cohort: Prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti- ligand 2 of programmed cell death protein 1 (PD-L2) antibodies).
History of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Evixapodlin
Trial phase: Phase 1
SMILES: COc1nc(-c2cccc(-c3cccc(-c4cnc(CNCC5CCC(=O)N5)c(OC)n4)c3Cl)c2Cl)cnc1CNCC1CCC(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).
Eligibility criteria:
Key Inclusion Criteria:

Dose Escalation Cohorts: Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
Dose Expansion and 1000 mg twice a day (BID) Dose Escalation Cohorts: Individuals must have available sufficient and adequate formalin fixed tumor sample preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of advanced disease has been made and from a site not previously irradiated. Alternatively, individuals must agree to have a biopsy taken prior to entering the study to provide adequate tissue. For the 1000 mg BID dose escalation cohort, individuals with melanoma, Merkel cell, microsatellite instability-high (MSI-H) cancers, and classical Hodgkin lymphoma (cHL) are not required to have archival or fresh biopsy tissue.
Dose Escalation Biopsy Substudy and 1000 mg BID Dose Escalation Cohorts: Documented ligand 1 of programmed cell death protein 1 (PD-L1) expression in the tumor (tumor proportion score (TPS) ≥ 10% or combined positive score (CPS) ≥ 10). In the 1000 mg BID Cohort, PD-L1 expression will not be required for Merkel cell, melanoma, MSI-H cancers, and cHL.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
Adequate organ function.

Key Exclusion Criteria:

History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completion.
Dose Escalation Cohorts: History of ≥ Grade 3 Adverse Events (AEs) during prior treatment with an immune checkpoint inhibitor, or history of discontinuation of treatment with an immune checkpoint inhibitor due to AEs.
Dose Escalation 1000 mg BID and Dose Expansion Cohort: Prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti- ligand 2 of programmed cell death protein 1 (PD-L2) antibodies).
History of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Evixapodlin
Trial phase: Phase 1
SMILES: COc1nc(-c2cccc(-c3cccc(-c4cnc(CNCC5CCC(=O)N5)c(OC)n4)c3Cl)c2Cl)cnc1CNCC1CCC(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
Eligibility criteria:
Key Inclusion Criteria:

Dose Escalation Cohorts: Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
Dose Expansion and 1000 mg twice a day (BID) Dose Escalation Cohorts: Individuals must have available sufficient and adequate formalin fixed tumor sample preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of advanced disease has been made and from a site not previously irradiated. Alternatively, individuals must agree to have a biopsy taken prior to entering the study to provide adequate tissue. For the 1000 mg BID dose escalation cohort, individuals with melanoma, Merkel cell, microsatellite instability-high (MSI-H) cancers, and classical Hodgkin lymphoma (cHL) are not required to have archival or fresh biopsy tissue.
Dose Escalation Biopsy Substudy and 1000 mg BID Dose Escalation Cohorts: Documented ligand 1 of programmed cell death protein 1 (PD-L1) expression in the tumor (tumor proportion score (TPS) ≥ 10% or combined positive score (CPS) ≥ 10). In the 1000 mg BID Cohort, PD-L1 expression will not be required for Merkel cell, melanoma, MSI-H cancers, and cHL.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
Adequate organ function.

Key Exclusion Criteria:

History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completion.
Dose Escalation Cohorts: History of ≥ Grade 3 Adverse Events (AEs) during prior treatment with an immune checkpoint inhibitor, or history of discontinuation of treatment with an immune checkpoint inhibitor due to AEs.
Dose Escalation 1000 mg BID and Dose Expansion Cohort: Prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti- ligand 2 of programmed cell death protein 1 (PD-L2) antibodies).
History of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: CID 163285897
Trial phase: Phase 1
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.
Eligibility criteria:
Inclusion Criteria:

Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening
Are agreeable to receiving study treatment by injections under the skin

Exclusion Criteria:

Have known allergies to tirzepatide or related compounds
Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
Have a prior history of malignant disease(s) in the past 5 years prior to screening
Smoke more than the equivalent of 10 cigarettes per day
Is a known user of drugs of abuse
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: OTX-DP
Eligibility criteria:
Inclusion Criteria:

Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

History of refractive surgery (including LASIK procedures) within the past 2 years
History of retinal detachment, diabetic retinopathy, or active retinal disease
Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
History of IOP increase as a result of steroid treatment
A female who is currently pregnant, planning a pregnancy, or lactating
Intervention: Netarsudil
Trial phase: Phase 2 | Phase 3
ATC code: S01EE51 | S01EX05
SMILES: Cc1ccc(C(=O)OCc2ccc([C@@H](CN)C(=O)Nc3ccc4cnccc4c3)cc2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.

Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography.
Patient is able and willing to administer eye drops.
Patient is able to comprehend and has signed the Informed Consent form.

Exclusion Criteria:

Active intraocular inflammation, corneal ulceration, keratitis, or conjunctivitis.
Known sensitivity to any of the ingredients in the study medications.
Abnormal eyelid function.
History of herpetic keratitis.
History of non-compliance with using prescribed medication.
Current or planned pregnancy within the study duration.
Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study.
Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
Intervention: Gabapentin
Trial phase: Phase 2
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).

Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Eligibility criteria:
Inclusion Criteria:

18 years or older
HIV-positive
Chronic pain (present ≥3 mo) of moderate to severe intensity
Heavy drinking past year (Based on NIAAA criteria: > 14 standard drinks per week/ > 4 drinks in a day for men; > 7 drinks in the past week/ > 3 drinks in a day for women)
If female, negative pregnancy test and willing to use adequate birth control
Provision of contact information for 2 contacts to assist with follow-up
Stable address within 100 kilometers of St. Petersburg
Possession of a telephone (home or cell)
Able and willing to comply with all study protocols and procedures

Exclusion Criteria:

Not fluent in Russian
Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment
Known active TB or current febrile illness
Breastfeeding
Known uncontrolled psychiatric illness (such as active psychosis)
Current suicidal ideation
History of hypersensitivity to naltrexone, gabapentin, or naloxone
Current use (past week) of illicit or prescribed opiates as documented by either self-report or positive urine drug test
Unwilling to abstain from opiates during the treatment period
Current use of neuroleptics
History of seizure disorder
Known liver failure
AST/ALT levels >5x normal
CrCl< 60mL/min
History of Reynaud's disease
Planned surgeries in the next 3 months
Enrolled in another HIV and/or substance use medication intervention study
Taking naltrexone in the past 30 days
Taking gabapentin in the past 30 days
Taking pregabalin in the past 30 days
Diagnosis of chronic obstructive pulmonary disease (COPD)
Intervention: DEOXYCHOLIC ACID
Trial phase: Early Phase 1
ATC code: D11AX24
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(C[C@H](O)[C@]4(C)[C@@H]([C@H](C)CCC(=O)O)CC[C@]43[H])[C@@]1(C)CC[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.)

Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous
Eligibility criteria:
Inclusion Criteria:

Adults aged 18 to 65
Discrete area of mild-to-moderate excess upper inner thigh fat, amenable to treatment at the discretion of the investigator
Subjects who score 0 (extremely dissatisfied) to 2 (slightly dissatisfied) on a Subject Self-Rating Scale, pertaining to upper inner thigh fat, with the scale ranging from 0 (extremely dissatisfied) to 6 (extremely satisfied)
Body mass index (BMI) less than 30 kg/m2
Stable body weight for previous 6 months (weight within 10 pounds of baseline)
Subjects must be in stable health, as confirmed by medical history, per investigator judgment
Subjects must be able to read, sign, and understand the informed consent
Subjects must we willing to avoid any other treatments to the inner thigh, including cryolipolysis and liposuction, during the study period.
Subjects must be willing to avoid changes in diet or exercise, any weight loss program, and any weight loss supplements, during the study period.
Subjects must be able and willing to avoid anticoagulation (aspirin, warfarin, heparin, rivaroxaban) for 1 week prior to each study treatment

Exclusion Criteria:

History of treatment for inner thigh fat, including cryolipolysis, noninvasive body contouring or liposuction in the last year
Previous trauma or surgery to pelvis or thighs
Subjects with an unstable medical condition, as deemed by the investigator
Women who are pregnant or lactating or plan to become pregnant during the study period
Lymphedema or edema of thigh
Excessive skin laxity in the treatment area, as judged by the investigator
Severe thigh cellulite
Subjects with any disease in the treatment area, such as dermatologic disease, that may be exacerbated by the study treatment
Subjects with any condition that may impair the evaluation of inner thigh fat
Subjects with known bleeding diathesis
Subjects with any known hypersensitivity to Kybella (deoxycholic acid) or any of the inactive ingredients: benzyl alcohol, dibasic sodium phosphate, sodium chloride, sodium hydroxide, hydrochloric acid
Intervention: Prednisone
Trial phase: Phase 2
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM

Prednisone: Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM
Eligibility criteria:
Inclusion Criteria:

Patients with Becker muscular dystrophy or LGMD2A (CAPN3), LGMD 2B (DYSF), LGMD 2C (SGCG), LGMD2E (SGCB), LGMD2F (SGCD), LGMD 2I (FKRP), LGMD (ANO5). Genetic mutation or muscle biopsy staining required to confirm genetic subtype
Ages 18-65 years
EKG without evidence of prior infarct or atrial fibrillation done within 2 months of study initiation.
Echocardiogram with LVEF >25% done within 6 months of study initiation.
Stable medications (same medication and dose) for the previous 3 months
Stable pulmonary status for the previous 6 months (No change in FVC by more than 20% in the past 6-months)

Exclusion Criteria:

Diabetes
BMI>35 kg/m2
Cardiac transplantation
Myocardia Infarct in the past 2-years from screening
Any history of tuberculosis
Untreated or uncontrolled (medication and/or dose change in previous month from screening) hypertension
A diagnosis of congestive heart failure
A diagnosis of chronic kidney disease
A diagnosis of untreated hypothyroidism
The patient is believed to be at high risk of osteoporosis by the primary investigator
Inability to provide consent
Full time ventilator dependency
Heart failure symptoms or LVEF <25%
Orthopedic surgery within the prior year or upcoming elective orthopedic surgery within the 6-months from Day 0.
Inability to complete MRI (claustrophobia, metal implants)
Pregnant women at screening, women seeking to become pregnant, or men seeking to father a child within 6-months from Day 0 should not participate in this study.
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 64
Group description: Subjects will receive an injection of non-buffered 2% lidocaine with 1:100,000 epinephrine on one occasion; they will be randomized to this group. After a minimum of one week, subjects will receive the alternate solution.

Buffered Lidocaine: Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion. 8.4% Sodium Bicarbonate will be used.
Eligibility criteria:
Inclusion Criteria:

Patients requiring restorative or surgical dental treatment on two occasions on opposite sides of the mouth; either both maxillary or both mandibular quadrant/sextant involving comparable teeth/areas
Patients able to undergo dental treatment in the dental clinic without general anesthesia, sedation, or anxiolysis
Patients 4-17 years of age
Patients classified as ASA I or ASA II
Patients of parents who can read, write and give consent in English

Exclusion Criteria:

Patients with allergy to local anesthetic
Patients who are pregnant or nursing
Patients with cardiac concerns or contraindications to epinephrine
Patients unable to undergo dental treatment in the clinic for behavior or medical reasons
Patients requiring anxiolysis, sedation, or general anesthesia
Patients unable to keep dental appointments or return for dental appointments
Patients who do not meet inclusion criteria
Patients who experience a missed block (IANB) during injection