anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Drug: Atorvastatin
Eligibility criteria:
Inclusion Criteria:

Clinically isolated syndrome (CIS) as defined by an acute or subacute well-defined neurological event lasting at least 48 hours and consistent with MS (i.e., optic neuritis, spinal cord syndrome, brainstem/cerebellar syndromes). Other causes for optic neuritis other than CIS must be ruled out by an ophthalmologist. Patients with other "clinically silent" abnormal findings found upon neurological examination that are not attributable to the presenting symptom are not excluded.
Onset of CIS symptoms occurring within 90 days of randomization
Abnormal, unenhanced brain MRI with 2 or more clinically silent T2 lesions greater than or equal to 3 mm in diameter, at least one of which is periventricular in location or ovoid in shape
Willing to use acceptable methods of contraception
Have received 3 to 5 days of corticosteroid therapy within 60 days of CIS onset

Exclusion Criteria:

Definite diagnosis of MS according to McDonald criteria
Previous history of neurological symptoms lasting more than 48 hours. Patients with a history of neurological symptoms lasting less than 48 hours will not be excluded.
Prior use of interferon, glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis anytime prior to study entry
Use of interferon preparations (unless as specified by the protocol), glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis during the study
Use of cyclosporine, fibric acid derivatives, niacin, erythromycin, or azole antifungal during the study
Received more than 5 g of methylprednisolone (or the equivalent of other IV corticosteroid) prior to study screening
Use of a cholesterol-lowering agent during the 3 months prior to study screening or need for such agents during the study
Previous history of severe side effects with statin therapy
Prior exposure to total lymphoid irradiation
History of substance abuse in the 12 months prior to study screening
History of systemic illness or medical condition that would limit the likelihood of completing the MRI procedures or would interfere with the measurement of a therapeutic effect
Implanted pacemakers, cochlear implants, defibrillators, or metallic objects on or inside the body
Uncontrolled hypertension, asthma, known malignancy other than skin cancer, symptomatic cardiac disease, epilepsy, insulin-dependent diabetes, or symptoms that can only be explained by systemic lupus erythematosus (SLE) or other autoimmune diseases
Active liver disease
Major medical illnesses or psychiatric impairment that in the investigator's opinion could interfere with the study
History of severe depression or suicidal ideation within 1 year of study entry
Pregnancy or breastfeeding
Intervention: Curcumin
Trial phase: Phase 2
SMILES: COc1cc(/C=C/C(=O)CC(=O)/C=C/c2ccc(O)c(OC)c2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Oral curcumin daily for eight weeks, starting dose 8 gm per day.
Eligibility criteria:
Inclusion Criteria:

The patient has pathologically confirmed adenocarcinoma of the pancreas that is not amenable to curative surgical resection (includes locally advanced, metastatic, or recurrent disease). Histology must be confirmed by the pathology department of the investigational center.
The patient has a Karnofsky Performance Status of greater than or equal to 60 at study entry.
The patient has given informed consent.
The patient is at least 18 years of age.
The patient has adequate hematologic function as defined by an absolute neutrophil count greater than or equal to 1,500/mm3, platelet count greater than or equal to 100,000/mm3.
The patient has adequate hepatic function as defined by a total bilirubin less than or equal to 2.0 X ULN, alkaline phosphatase, AST and/or ALT less than or equal to 5 X ULN, and creatinine less than or equal to 2.0 mg/dL.
The patient has measurable disease.
The patient agrees to use effective contraception if procreative potential exists.

Exclusion Criteria:

The patient has a history of treated or active brain metastases, carcinomatous meningitis, an uncontrolled seizure disorder, or active neurological disease.
The patient has received prior radiation. Patients with measurable disease outside the radiation port or documented disease progression of previously irradiated measurable disease are eligible. Patient must be greater than or equal to four weeks post-therapy and have recovered from all toxicities.
The patient has an unstable medical condition according to the investigator, including uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals, unstable CHF, uncontrolled arrythmias, or unstable coagulation disorders.
The patient is pregnant (confirmed by serum Beta-HCG) or is breast feeding.
The patient has received an investigational agent(s) within four weeks of study entry.
Intervention: Sitagliptin
Trial phase: Phase 3
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 588
Group description: The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
Eligibility criteria:
Inclusion Criteria:

Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus
Intervention: Nitric Oxide
Trial phase: Phase 2
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Inhaled Nitric Oxide INO
Eligibility criteria:
Inclusion Criteria:

Each subject must meet all of the following inclusion criteria during the screening process in order to participate in the study:

Patient must have a diagnosis of SCD (known SS, S-Beta-thalassemia or other hemoglobinopathies causing sickle cell disease). Patients with disease due to Hgb SC are not permitted.
Must present to the ED/EC or other appropriate unit in VOC.
Greater than or equal to 10 years old.
Written informed consent/assent has been obtained.

Exclusion Criteria:

Subjects meeting any of the following criteria during baseline evaluation will be excluded from entry into the study:

Exposure to therapeutic nitric oxide within the past 12 hours.
Patient has received sildenafil or other phosphodiesterase 5 inhibitors, therapeutic L-arginine, nitroprusside or nitroglycerine within the past 12 hours.
Patient has received previous ED/EC or other appropriate unit treatment for a vaso-occlusive crisis less than 48 hours or hospitalization less than 14 days ago (patients transferred directly from another ED or clinic may be enrolled).
Patient has visited the ED/EC or other appropriate unit greater than 10 times in the past year having a vaso-occlusive crisis.
Patients presenting with clinically diagnosed bacterial infection (e.g., osteomyelitis, pneumonia, sepsis or meningitis).
Patients who are currently enrolled in any other investigational drug study except for hydroxyurea studies.
Pregnant women (urine HCG + )/ nursing mothers.
Patients who have received an exchange transfusion (not simple transfusion) in the last 30 days or are on a chronic simple or exchange transfusion program.
Suspected splenic sequestration.
Acute chest syndrome or pneumonia: Abnormal new pulmonary infiltrate (alveolar infiltration and not atelectasis) and one or more pulmonary signs and/or symptoms (fever, rales, wheezing, cough, shortness of breath, retractions).
Previous participation in this study.
Intervention: Alvocidib
Trial phase: Phase 2
SMILES: CN1CC[C@H](c2c(O)cc(O)c3c(=O)cc(-c4ccccc4Cl)oc23)[C@H](O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed B-cell chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL) arising from CLL

No de novo PLL
Lymphocyte count > 5,000/mm^3 at some point since initial diagnosis of CLL
B-cells co-expressing CD5 AND CD19 or CD20
If no dim serum immunoglobulin or CD23 expression on leukemia cells, must be examined for cyclin D1 overexpression OR t(11;14) to rule out mantle cell lymphoma

Requiring therapy, defined by any of the following:

Massive or progressive splenomegaly and/or lymphadenopathy
Anemia (hemoglobin < 11 g/dL) OR thrombocytopenia (platelet count < 100,000/mm^3)
Weight loss > 10% within the past 6 months
Grade 2 or 3 fatigue
Fevers > 100.5°C or night sweats for > 2 weeks with no evidence of infection
Progressive lymphocytosis with an increase of > 50% over a 2-month period OR an anticipated doubling time < 6 months
Received ≥ 1 prior chemotherapy regimen that included fludarabine or nucleoside equivalent OR alternative therapy if contraindication to fludarabine exists (i.e., autoimmune hemolytic anemia)
Performance status - ECOG 0-2
More than 2 years
See Disease Characteristics
Baseline cytopenias allowed
WBC ≤ 200,000/mm^3
Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease, hemolysis, or disease infiltration of the liver)
AST ≤ 2 times ULN (unless due to hemolysis or disease infiltration of the liver)
Creatinine ≤ 2.0 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy that would limit life expectancy
See Disease Characteristics
No other concurrent chemotherapy
No concurrent chronic corticosteroids or corticosteroids as antiemetics
No concurrent hormonal therapy except steroids for new adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
No concurrent radiotherapy
Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Eligibility criteria:
Criteria:

M-protein >= 30 g/L
No clinical evidence of chronic infectious or inflammatory disease
No present evidence of active malignancy (nonmelanoma skin cancer or cervical intraepithelial neoplasia allowed)
No hypersensitivity (e.g., asthma, urticaria, or acute rhinitis induced by NSAIDs) to aspirin or other NSAIDs
No hypersensitivity to sulfonamides
No uncontrolled diabetes
No history of diabetic retinopathy
No condition that would preclude study participation
No condition that would preclude the use of NSAIDs
New or preexisting diagnosis of 1 of the following for at least 2 months:
Monoclonal gammopathy of undetermined significance as defined by the following criteria:
M-protein =< 30 g/L
Bone marrow clonal plasma cells < 10% and low level of plasma cell infiltration in a trephine biopsy (if done)
Smoldering myeloma as defined by at least 1 of the following criteria:
Bone marrow clonal plasma cells >= 10%
No related organ or tissue impairment (i.e., end organ damage) or symptoms
Asymptomatic patients with =< 3 lytic lesions (without other organ damage) attributable to plasma cell dyscrasia allowed
No condition associated with a secondary monoclonal gammopathy
IgG, IgA, or light chain M-component >= 1.0 g/dL for at least 2 consecutive lab readings taken at least 4 weeks apart
No anemia
No hepatic insufficiency
AST or ALT < 1.5 times upper limit of normal (ULN)
Bilirubin =< 1.5 times ULN
Creatinine =< 1.8 mg/dL
No hypercalcemia
No renal insufficiency
No uncontrolled congestive heart failure
No history of cerebrovascular or cardiovascular accident
No history of gastrointestinal hemorrhage
No active or suspected peptic ulcer disease
Previously treated H. pylori infection allowed
More than 12 months since limited chemotherapy
More than 28 days since prior chronic or frequent use of glucocorticoids (> 5 mg of prednisone or equivalent per day)
More than 28 days since prior chronic or frequent use of non-steroidal anti-inflammatory drugs (NSAIDs) (> 100 mg of aspirin per day)
More than 28 days since prior bisphosphonate therapy
More than 28 days since prior investigational agents
Concurrent low-dose aspirin ( =< 100 mg/day) allowed
No evidence of other B-cell proliferative disorders (e.g., multiple myeloma, Waldenstrom's macroglobulinemia, primary amyloidosis, or lymphoproliferative disease)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
AND/OR
ECOG 0-1 or Zubrod 0-1
Intervention: Risperidone
Trial phase: Phase 2
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 133
Group description: Risperidone : atypical antipsychotic
Eligibility criteria:
Inclusion Criteria:

18 years or older
Military service related chronic PTSD
CAPS score >50
Participant in VA outpatient PTSD clinic
History of non-response to two or more antidepressants

Exclusion Criteria:

Comorbid Axis I diagnosis requiring antipsychotic medication
Substance dependence diagnosis (excluding nicotine)
Hepatic or renal problems
Incompatible medical diagnosis or medication (i.e., coumadin, insulin)
Unstable living arrangements
Assault or suicide gesture within 1 year
Intervention: Ezetimibe
Trial phase: Phase 3
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Participants received 10 mg ezetimibe once daily for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Eligible patients will be otherwise healthy men and women (if not on oral contraceptives or hormone replacement therapy) 18 through 70 years of age with moderately high cholesterol.

Exclusion Criteria:

Individuals on other lipid-lowering therapy (medicines that lower cholesterol) including statins (within 6 weeks) and fibrates (within 8 weeks) prior to administration of the study drug.
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 256
Group description: Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Exclusion Criteria:

Serum creatinine >1.5 mg/dL
Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
Pregnancy or lactation;
Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
A history of xanthinuria, active liver disease, or hepatic dysfunction;
A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 251
Group description: Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Exclusion Criteria:

Serum creatinine >1.5 mg/dL
Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
Pregnancy or lactation;
Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
A history of xanthinuria, active liver disease, or hepatic dysfunction;
A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.
Intervention: Allopurinol
Trial phase: Phase 3
ATC code: M04AA01 | M04AA51
SMILES: Oc1ncnc2[nH]ncc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 253
Group description: Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Exclusion Criteria:

Serum creatinine >1.5 mg/dL
Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
Pregnancy or lactation;
Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
A history of xanthinuria, active liver disease, or hepatic dysfunction;
A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 325
Group description: All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
Eligibility criteria:
Inclusion Criteria:

Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode

Exclusion Criteria:

Patients with a co-morbid serious, uncontrolled systemic illness
Patients with a significant risk of committing suicide
Intervention: Romidepsin
Trial phase: Phase 2
ATC code: L01XH02
SMILES: C/C=C1\NC(=O)[C@H]2CSSCC/C=C/[C@H](CC(=O)N[C@H](C(C)C)C(=O)N2)OC(=O)[C@H](C(C)C)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
Eligibility criteria:
Inclusion Criteria:

Stage III unresectable or American Joint Committee on Cancer (AJCC) stage IV cutaneous, mucosal, ocular, or unknown primary melanoma with measurable disease by physical examination or imaging studies.
Palpable cutaneous or nodal metastases suitable for punch, trucut, or similar biopsy if the patient agrees.
Normal electrocardiogram (EKG)
Left ventricular ejection fraction (LVEF) > 40% by Multi Gated Acquisition Scan (MUGA)
Corrected QT (QTc) < 500 msec
Age greater than or equal to 18
Negative pregnancy test
Fertile patients must use effective contraception
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Normal organ and marrow function
Patients on hydrochorthiazide should be switched to a potassium-sparing diuretic or another antihypertensive
At least 4 weeks since prior radiotherapy
Patients with cardiac hypertrophy may be enrolled but should be carefully monitored.

Exclusion Criteria:

Prior FR901228 (depsipeptide)
Prior chemotherapy
Other concurrent chemotherapy
Active central nervous system (CNS) metastases by brain computed tomography (CT) scan or magnetic resonance imaging (MRI)
History of coronary atherosclerotic heart disease
History of myocardial infarction
History of congestive heart failure
Non-melanoma malignancy within the past 5 years except carcinoma in situ or squamous cell or basal cell skin cancer
Pregnant or nursing women
Conditions that in the opinion of the investigator would interfere with the ability of the patient to complete this protocol
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Depsipeptide
Co-medication with an agent that causes QTc prolongation
Human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
Concurrent radiotherapy
Left ventricular hypertrophy (LVH) on their baseline EKG tracing
Intervention: Triamcinolone
Trial phase: Phase 3
ATC code: A01AC01 | C05AA12 | D07AB09 | D07BB03 | D07CB01 | D07XB02 | H02AB08 | R01AD11 | R03BA06 | S01BA05 | S02CA04
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Eligibility criteria:
Inclusion Criteria:

Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
Individuals, 18 years of age or older, willing to provide consent may be eligible for the SCORE Study.

Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for listing.
Intervention: Triamcinolone
Trial phase: Phase 3
ATC code: A01AC01 | C05AA12 | D07AB09 | D07BB03 | D07CB01 | D07XB02 | H02AB08 | R01AD11 | R03BA06 | S01BA05 | S02CA04
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 91
Group description: Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Eligibility criteria:
Inclusion Criteria:

Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
Individuals, 18 years of age or older, willing to provide consent may be eligible for the SCORE Study.

Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for listing.