anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: VALPROIC ACID
Trial phase: Phase 2
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Patients receive valproic acid daily for 16 weeks.
Eligibility criteria:
INCLUSION CRITERIA:

DISEASE CHARACTERISTICS

Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin that is radioiodine-unresponsive
Cumulative dose of radioiodine < 800 mCi
No radioiodine uptake on whole body scan within 18 months of enrollment
Inoperable extensive locoregional tumor mass and/or metastatic spread
Failed conventional therapy that included total thyroidectomy AND radioactive iodine I 131 ablation
Elevated thyroglobulin level (>2ng/ml on thyroid hormone, >10ng/ml off thyroid hormone)or Tg-antibody positive

PATIENT CHARACTERISTICS

-18 years or older

Entry lab results:

Hemoglobin > 8.0 gm/dl
Absolute Neutrophil Count > 750 cells/mm3
Platelet count > 75000/mm3
BUN < 1.5 times upper limit of normal (ULN)
Creatinine < 1.5 times ULN
Total protein > 6.4
Total bilirubin should be < 1.5 times ULN.
AST (SGOT), ALT (SGPT), ALKP and amylase < 1.5 times ULN
Amylase < 1.5 times ULN
Albumin > 2.5
Ammonia < 1.5 times ULN

EXCLUSION CRITERIA:

Not pregnant
No nursing within the past 3 months
No allergy to valproic acid
No coexisting malignancy other than basal cell carcinoma
No hepatic disease or significant dysfunction
Karnofsky score > 80
No pancreatitis
No kidney dysfunction
Fertile patients must use effective contraception
Intervention: Sorafenib
Trial phase: Phase 2
ATC code: L01EX02 | L01XE05
SMILES: CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Sorafenib & Endocrine Therapy

sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Eligibility criteria:
Inclusion Criteria:

All subjects must be female.
Age ≥ 18 years old.
Histologically proven carcinoma of the breast.
Estrogen receptor and/or Progesterone positive disease.
Metastatic or locally advanced disease.
Patients on a preexisting endocrine agent for at least 3 months before enrollment.

Have residual measurable disease after

maximal response to endocrine therapy or
no response to endocrine therapy or
progressive non-visceral disease on endocrine therapy.
Must be able to provide a tumor block from either the primary or metastatic site, if available.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
Adequate organ function.

Exclusion Criteria:

Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
Prior use of anti-angiogenic agents.
As judged by the investigator, uncontrolled intercurrent illness.
Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
Known or suspected allergy to sorafenib or any agent given in the course of this trial.
A serious non-healing wound or ulcer.
Evidence or history of bleeding diathesis or coagulopathy.
Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug.
Pulmonary hemorrhage/bleeding event ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within the 4 weeks prior to the first dose of study drug.
Pregnancy
Any condition that impairs patient's ability to swallow whole pills.
Documented malabsorption problem.
Intervention: Dimethylcurcumin
Trial phase: Phase 2
SMILES: COc1ccc(/C=C/C(=O)/C=C(O)/C=C/c2ccc(OC)c(OC)c2)cc1OC
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

At least 12 years of age.

Facial acne, with:

20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

Exclusion Criteria:

Women who are pregnant or breastfeeding
Skin diseases other than acne vulgaris
Use of oral retinoids within 6 months of Baseline Visit
Unwilling to discontinue all other treatments for facial acne
Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
Intervention: Dimethylcurcumin
Trial phase: Phase 2
SMILES: COc1ccc(/C=C/C(=O)/C=C(O)/C=C/c2ccc(OC)c(OC)c2)cc1OC
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

At least 12 years of age.

Facial acne, with:

20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

Exclusion Criteria:

Women who are pregnant or breastfeeding
Skin diseases other than acne vulgaris
Use of oral retinoids within 6 months of Baseline Visit
Unwilling to discontinue all other treatments for facial acne
Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
Intervention: Dimethylcurcumin
Trial phase: Phase 2
SMILES: COc1ccc(/C=C/C(=O)/C=C(O)/C=C/c2ccc(OC)c(OC)c2)cc1OC
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

At least 12 years of age.

Facial acne, with:

20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

Exclusion Criteria:

Women who are pregnant or breastfeeding
Skin diseases other than acne vulgaris
Use of oral retinoids within 6 months of Baseline Visit
Unwilling to discontinue all other treatments for facial acne
Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
Intervention: Eovist
Trial phase: Phase 3
SMILES: CCOc1ccc(CC(CN(CCN(CC(=O)[O-])CC(=O)[O-])CC(=O)[O-])N(CC(=O)[O-])CC(=O)[O-])cc1.[Gd+3].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 234
Group description: Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
Eligibility criteria:
Inclusion Criteria:

Patients between 18 and 75 years of age inclusive.
Patients (men or women) with at least one focal liver lesion, either identified or suspected by ultrasound (US), Computed Tomography (CT)/spiral-CT, conventional angiography, CT-angiography (CTA), CT-arterioportography (CTAP) or unenhanced / contrast-enhanced MRI* within 2 months before entering the study

For reference, the following pathologies will meet the definition of 'focal liver lesions':

Hepatocellular carcinoma
Cholangiole carcinoma
Metastasis
Focal lymphoma
Adenoma
Focal nodular hyperplasia
Hemangioma
Abscess
Focal liver fibrosis
Regenerative nodules
Focal fatty infiltration
Hydatid cyst
Liver cyst
Focal sparing in fatty liver
Others
Patients willing to undergo study procedures including safety follow-up
Patients who have undergone or who are scheduled to undergo the defined procedure for SOR within one month before or after the study MRI
Women of child-bearing potential with negative urine pregnancy test result within 24 hours before contrast medium (CM) injection
Patients who are fully informed about the study and have signed the informed consent form

Exclusion Criteria:

Patients who have previously entered this study
Patients who have received any contrast material within 24 hours before injection with study drug, or who are scheduled to receive any contrast material within 24 hours after injection
Patients who are, or suspected to be, nursing
Patients who require emergency treatment
Patients with severely impaired hepatic or renal functions (e.g. serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of reference range, acute renal failure)
Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery, acute myocardial infarction)
Patients with any physical or mental status that interferes with the signing of informed consent
Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs
Patients with a contraindication for MRI
Patients who are scheduled for liver biopsy/surgery or other surgeries within 24 hours after injection with contrast media, or who would have a biopsy within 24 hours before planned injection with contrast media
Patients who are likely to have any therapy or change in therapy between the study MRI and the procedures for the SOR
Intervention: Itraconazole
Trial phase: Phase 4
ATC code: J02AC02
SMILES: CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Itraconazole 5mg/kg/day

Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
Eligibility criteria:
Inclusion Criteria

Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
Patient must be known to be chronically colonized with Aspergillus fumigatus.
Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization.
6 years of age and older
Patients must weigh at least 20 kg
Post-menarche females must be using an effective form of contraception.

Exclusion Criteria

Inability to give informed consent.
Respiratory culture positive for B.cepacia complex
Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization
Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization
Neutropenia, absolute neutrophil count&lt; or = 1000 within a 3-day period prior to randomization
History of biliary cirrhosis documented by liver biopsy or imaging.
History of portal hypertension.
Investigational drug use within 30 days of randomization date.
History of alcohol, illicit drug or medication abuse within 1 year of randomization.
Women who are pregnant, breastfeeding or trying to conceive
Intervention: Itraconazole
Trial phase: Phase 4
ATC code: J02AC02
SMILES: CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
Eligibility criteria:
Inclusion Criteria

Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
Patient must be known to be chronically colonized with Aspergillus fumigatus.
Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization.
6 years of age and older
Patients must weigh at least 20 kg
Post-menarche females must be using an effective form of contraception.

Exclusion Criteria

Inability to give informed consent.
Respiratory culture positive for B.cepacia complex
Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization
Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization
Neutropenia, absolute neutrophil count&lt; or = 1000 within a 3-day period prior to randomization
History of biliary cirrhosis documented by liver biopsy or imaging.
History of portal hypertension.
Investigational drug use within 30 days of randomization date.
History of alcohol, illicit drug or medication abuse within 1 year of randomization.
Women who are pregnant, breastfeeding or trying to conceive
Intervention: Simvastatin
Trial phase: Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Simvastatin 80 mg once daily PO (or via NG or G-tube)

Simvastatin: 80 mg once daily PO/NG x 4 days
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Initial presentation to the Emergency Department or University of Chicago MD office/Dialysis Center for current hospital admission

Sepsis (ACCP/SCCM criteria)

Clinically suspected infection as per the treating physician or confirmed infection
2 or more of the following: Temperature 38ºC (100.4ºF)or 36ºC (96.8ºF), Heart rate (HR) > 90/min, Respiratory rate (RR) > 20/min or PaCO2 < 32 mmHg, White blood cell count > 12,000/mm3 or < 4000/m3 or > 10%immature neutrophils
Initiation of antibiotics by treating physician for sepsis
Hospitalized from the Emergency Department or University of Chicago MD office/Dialysis Center to an inpatient medical service (intensive care unit (ICU)or non-ICU service) OR admission to the medical ICU (MICU) from a non-ICU inpatient medical floor.
Assent of the primary treating physician at the time of enrollment.
The meeting of SIRS criteria is due to an infection as per the treating physician.

Exclusion Criteria:

Pregnancy
ALT >3 times above the upper limit of normal
Elevated creatine phosphokinase (CPK) (>3 times the upper limit of normal)
Concurrent treatment with any of the following drugs: daptomycin, fenofibrate, ketoconazole,triaconazole, amiodarone, clarithromycin, cyclosporine, erythromycin,nefazodone, niacin, protease inhibitors, telithromycin, verapamil,danazol, gemfibrozil
History of allergy or intolerance to statins
Greater than 16 hours after meeting inclusion criteria
Use of 1 more doses of statins in the previous 4 weeks
Clinical indication for treatment with statin during hospital admission (per treating physician)
Sufficiently poor prognosis prior to enrollment that treating physicians have elected to employ comfort care or plan to discharge to hospice
Transfer from surgical service to medical service
Needing transfusion for either active bleeding or severe hemolysis.
Intervention: 2-(1-Hexyloxyethyl)-2-devinyl pyropheophorbide-a
Trial phase: Phase 2
SMILES: CCCCCCOC(C)C1=C(C)C2=NC1=CC1=NC(=CC3=C(C)C4=C(O)CC(=C5NC(=C2)C(C)C5CCC(=O)O)C4=N3)C(CC)=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.

HPPH: 4 mg/m2 IV

endoscopic procedure: Treatment with 150 joules from laser
Eligibility criteria:
DISEASE CHARACTERISTICS:

Biopsy confirmed advanced obstructing endobronchial non-small cell lung cancer

May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology
Ineligible for or refused surgical resection
Local endobronchial recurrence after prior surgical resection, radiotherapy, or chemotherapy allowed
No evidence of tumor encasement of major pulmonary vessels on CT scan of the chest

PATIENT CHARACTERISTICS:

Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
WBC ≥ 4,000/mm³
Platelet count ≥ 100,000/mm³
Prothrombin time < 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 2.0 mg/dL
Creatinine ≤ 2.0 mg/dL
Alkaline phosphatase (hepatic) ≤ 3 times ULN
SGOT ≤ 3 times ULN
No contraindications for bronchoscopy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after the completion of study treatment
Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous/debris formation at the site of treatment
Patients who cannot breathe due to complete upper airway obstruction and who need emergency treatment to open the airway are not eligible
No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
No severe chronic obstructive pulmonary disease that, in the opinion of the investigator, would preclude multiple bronchoscopies
No partial central airway obstruction from mucous/debris formation
No high-grade upper airway obstruction of the trachea

PRIOR CONCURRENT THERAPY:

Any type of prior therapy (e.g., chemotherapy or radiotherapy) for lung cancer allowed
At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Intervention: Doxercalciferol
Trial phase: Phase 4
ATC code: H05BX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive

doxercalciferol 2 mcg or 4 mcg three times per week for 1 month
Eligibility criteria:
Inclusion Criteria:

Stage 5 Chronic Kidney Disease
Hyperparathyroidism (PTH>300) requiring vitamin D therapy
Age 18-80 years old
Ability to provide informed consent

Exclusion Criteria:

Subjects with neovascularization present, such as neoplasm, active wounds or significant retinopathy
Subjects with contraindications or allergy to vitamin D
Subjects currently on vitamin D therapy or a history of vitamin D therapy in the previous 60 days
Serum phosphorus > 6
Serum calcium > 10.5
contraindications to nitroglycerin (such as being on sildenafil)
Intervention: Methylnaltrexone
Trial phase: Phase 3
ATC code: A06AH01
SMILES: C[N@+]1(CC2CC2)CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: Participants received MOA-728 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
Eligibility criteria:
Inclusion Criteria:

Males and females, ages 18 and older.
Scheduled for ventral wall hernia repair with general anesthesia.
Meets the American Society of Anesthesiologists physical status I, II, or III.

Exclusion Criteria:

Received investigational drug or procedure within 30 days of randomization.
Women who are pregnant or lactating.
Calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate [GFR] formula) less than or equal to (</=) 50 milliliters/minute (mL/min).
Intervention: Methylnaltrexone
Trial phase: Phase 3
ATC code: A06AH01
SMILES: C[N@+]1(CC2CC2)CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: Participants received MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
Eligibility criteria:
Inclusion Criteria:

Males and females, ages 18 and older.
Scheduled for ventral wall hernia repair with general anesthesia.
Meets the American Society of Anesthesiologists physical status I, II, or III.

Exclusion Criteria:

Received investigational drug or procedure within 30 days of randomization.
Women who are pregnant or lactating.
Calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate [GFR] formula) less than or equal to (</=) 50 milliliters/minute (mL/min).
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: Child | Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Two out of every 3 patients will receive atorvastatin.
Eligibility criteria:
Inclusion Criteria:

Individuals 10-19 years of age (Tanner Stage II or greater),
The presence of one or more serum antibodies to islet cell proteins (anti- glutamic acid decarboxylase [GAD], islet antigen 2 or insulin autoantibodies) as assessed in standard practice,
Diagnosis of T1DM within the 8 weeks prior to study entry
Peak stimulated C-peptide level >0.2pmol/mL following mixed meal tolerance test (MMTT) performed at least 3 weeks after diagnosis,
Females of reproductive potential must not plan on conceiving a child during the treatment program, and agree to use a medically accepted form of contraception

Exclusion Criteria:

Subjects currently receiving cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, clarythromycin, nefazodone, itraconazole, ketoconazole or protease inhibitors,
Pregnancy or breast-feeding,
Clinical AIDS, AIDS related syndrome (ARS) or known positive HIV serology,
Subjects treated with immunosuppressive therapy in the past 12 months,
Subjects receiving glucocorticoid therapy or therapy other than insulin that is likely to affect glucose homeostasis (such as sulfonylureas, thiazolidinediones, metformin or amylin),
Subjects with other autoimmune diseases, except autoimmune thyroid disease,
Subjects with any illness that might complicate diabetes management or preclude treatment with atorvastatin,
Transplant recipients,
Evidence of liver dysfunction or myopathy