anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Delafloxacin
Trial phase: Phase 3
ATC code: J01MA23
SMILES: Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 417
Group description: 300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
Eligibility criteria:
Inclusion Criteria:

Adult (≥ 18 years of age) men or women with a diagnosis of ABSSSI (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm^2 and at least two signs of systemic infection
In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy, and the subject must be able and willing to comply with protocol requirements

Exclusion Criteria:

A medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator.
Women who are pregnant or lactating.
Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response, including infection involving a prosthetic joint, human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, sustained shock, gangrene or gas gangrene; burns covering ≥10% of body surface area; severely compromised immune system, severely impaired arterial blood supply to an extremity with an ABSSSI, deep vein thrombosis or superficial thrombophlebitis, and requiring either an amputation or multiple debridement procedures.

Receipt of systemic antibiotic therapy in the 14 days before enrollment unless 1 of the following was documented:

Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).
Recently (within 14 days) completed a treatment course with an antibacterial drug for an infection other than ABSSSI and the drug does not have activity against bacterial pathogens that cause ABSSSI.
Received only 1 dose of either a single, potentially effective, short-acting antimicrobial drug or drug regimen for ABSSSI.
Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study including severe cardiac disease, known history of liver disease, end-stage renal disease, malignancy, psychiatric disorder, ongoing treatment for seizures or untreated history of seizures, or life expectancy of < 3 months.
Intervention: Hiltonol
Trial phase: Phase 2
SMILES: NCCCCNC(=O)O.Nc1ccn(C2OC(COP(=O)(O)O)C(O)C2O)c(=O)n1.O=C(O)CO.O=c1[nH]cnc2c1ncn2C1OC(COP(=O)(O)O)C(O)C1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.

Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.

Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.

Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.

Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.

Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.

Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed diagnosis of melanoma, squamous head and neck cancer, sarcoma, squamous cell carcinoma of the skin, basal cell skin cancer, or breast cancer
Sarcoma Patients must be @ least14 yrs of age; all others 18 yrs of age or older.
Un-resectable disease. Patients with resectable disease may be enrolled after having refused surgery and documented consultation with a surgeon.
Disease progressed through @ least 1 systemic therapy or through local irradiation within the preceding 6 mos.
Radiologically or visually measurable recurrent or metastatic disease and @ least 10mm in longest dimension.
At least 1 accessible primary or metastatic tumor site that can be readily injected IT with poly-ICLC with or without ultrasound guidance. Lesion can be superficial cutaneous, subcutaneous or within a readily accessible lymph node & must measure @ least 10mm in longest dimension.
Tumor site injection cannot have been irradiated within 8 wks of C1D1
ECOG performance status ≤ 2.
Normal hematologic, renal & liver function. INR<2 if off of anticoagulation. Patients on anticoagulation therapy with an INR>2 may be enrolled at the discretion of the investigator.
Patients able to provide informed consent.
Must agree to follow acceptable birth control methods and continue for @ least 2 mos. after last poly-ICLC dose. Women of childbearing potential must have a (-) pregnancy test.

Exclusion Criteria:

Serious concurrent infection or medical illness.
Bulky intracranial metastatic disease with shift of midline structures or progressive brain metastasis. Administration of immunotherapy or conventional chemotherapy treatments for metastatic cancer within 4 wks of C1D1
Radiation treatments within 4 wks of C1D1
AIDS defined as a CD4 count < then 200 in the context of HIV sero-positivity or chronically is taking immunosuppressive medication such as steroids or transplant related medications.
Life expectancy of < than 6 mos.
Intervention: Efavirenz
Trial phase: Phase 4
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Raltegravir 400mg oral twice daily

Efavirenz: Efavirenz 600mg oral at bedtime
Eligibility criteria:
Inclusion Criteria:

Patients who are infected with HIV-1
Patients have not yet received any treatment for HIV
Patients with HIV viral RNA exceeds 5000 copies per ml
Ages at least 20 years

Exclusion Criteria:

Patients with acute or decompensated chronic hepatitis
Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range
Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
Patients with any medical disorder that the use of study medications is contraindicated
Pregnant or breastfeeding women
Patients who are lack of expectation to maintain assigned study medication during study period
Patients who have received therapy with investigational drugs in the previous 3 months
Intervention: Epirubicin
Trial phase: Phase 2
ATC code: L01DB01 | L01DB03
SMILES: COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: The enrolled patients will be treated with pegylated liposomal doxorubicin at 30mg/m2 every 21 days.

Pegylated liposomal doxorubicin: Doxil will be administered intravenously at 30mg/m2 on days 1 of a 21 day cycle.
Eligibility criteria:
Inclusion Criteria:

Metastatic breast cancer and have formalin-fixed, paraffin embedded primary tumor available for testing BRCA1 protein expression
Adults over 18 years of age
Have resolution of all acute toxic effects of any prior chemotherapy or radiotherapy to NCI CTC grade ≤ 1 prior to study registration.
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory and oncological tests and other study procedures
Have a ECOG performance status of 0 - 2
Measurable disease by CT by RECIST 1.1 to evaluate response
Adequate bone marrow function defined as platelets 100 X 109 cells/L, neutrophils 1.5 x 109 cells/L, white blood cells (WBC) 3.0 x 109 cells/L and a hemoglobin 90 gm/L
Creatinine < 1.5 mg/dl or creatinine clearance > 40 ml/min
Liver function tests (AST and or ALT) should be 2 x upper limit of normal (ULN, defined as per laboratory where blood testing is done), total bilirubin 1.5 x ULN (except for patients with liver metastases, ALT and/or ALT 5 times the upper limit of normal is accepted)

Exclusion Criteria:

Myocardial infarction within 6 months of registration
Brain metastases unless documented to be controlled post completion of local therapy (surgery and/or radiation therapy) for at least four weeks prior to registration
Pregnant or breast feeding women. Women with child bearing potential must use effective measures to prevent pregnancy while receiving pegylated liposomal doxorubicin
Have a concurrent active non-breast malignancy except for non-melanoma skin cancer
Her2 positive tumors as defined by FDA guidelines(3+ immunohistochemical staining, defined as uniform, intense membrane staining of more than 10% of invasive tumor cells, and for cases with 2+ staining showing gene amplification by FISH, expressed as a ratio of more than 2 when comparing HER-2 gene and chromosome 17 fluorescent signals)
Intervention: Dasatinib
Trial phase: Phase 1
ATC code: L01EA02 | L01XE06
SMILES: Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: dasatinib 100 mg QD(CP) or 140 mg QD (AP)
Eligibility criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase :

With historically documented Ph+ cells
≥2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML
Currently progressing, resistance to or with a suboptimal response to their most recent therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1

Exclusion Criteria:

Blast phase CML
Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
Intervention: Metformin
Trial phase: Phase 4
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl

Metformin
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes, as defined by ADA criteria
HbA1c < 8% measured at least 1 month prior to this study
BMI ≥27 kg/m2
Pre-treatment with Metformin
Age > 18 and < 65 years old

Exclusion Criteria:

• Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®

Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
Insulin dependent or treated type 2 diabetes
Current use of other injectable incretins
History of diabetes ketoacidosis
Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2
Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
Clinical or laboratory evidences of chronic active liver diseases
Acute or chronic infective diseases
Cancer or chemotherapy
Current use of systemic corticosteroids or in the 3 months prior this study
Known or suspected allergy to Liraglutide, excipients, or related products
Pregnant, breast-feeding or the intention of becoming pregnant
Females of childbearing potential who are not using adequate contraceptive methods
Intervention: SGS-742
Trial phase: Phase 2
SMILES: CCCCP(=O)(O)CCCN
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Participants with SSADH Deficiency receiving SGS-742 while on study drug for six months

SGS-742
Eligibility criteria:
INCLUSION CRITERIA
Aged 4 years or older
4-hydroxybutyric aciduria (gamma-hydroxybutyric aciduria) on two separate tests
Documented succinic semialdehyde dehydrogenase enzyme deficiency
Patients must have clinical features consistent with SSADH deficiency including developmental delay especially deficit in expressive language, hypotonia, ataxia, seizures, and other neuropsychiatric symptoms including sleep disturbances , attention deficit, anxiety, obsessivecompulsive disorder, and autistic traits
During the study, women of child-bearing potential must use a reliable method of birth control until one month after the final drug taper is complete.

EXCLUSION CRITERIA

Current alcohol use (>14 drinks/wk in men and >7 drinks/wk in women or or recreational drug use
Contraindications to MRI: metal in the body including pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have
Claustrophobia
Cannot lie comfortably flat on the back for up to 2h in the MRI scanner
Patients with a history of other major medical disorders with clinical fluctuations, or requiring therapy that might affect study participation or drug response such as severe depression or psychoses, renal or hepatic disease.
Patients requiring treatment with drugs known to affect the GABAergic system, including vigabatrin and benzodiazepines.
Pregnant and lactating women
Intervention: RIFAMPIN
Trial phase: Early Phase 1
ATC code: J04AB02 | J04AM02 | J04AM05 | J04AM06 | J04AM07 | J04BA50 | J04BA51
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c(C=NN5CCN(C)CC5)c(O)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Rifampin 600 mg once a day for 14 days

Rifampin: P450 inducer
Eligibility criteria:
Inclusion Criteria:

Subjects with no history of significant medical conditions including cardiac, pulmonary, gastrointestinal, or renal disease, HIV, diabetes mellitus or Hepatitis B or C
Subjects will be males or females 18-60 years of age
Subjects must read and understand English
Subjects must be able to provide informed consent
Subjects must be willing to avoid prescription medications, OTC drugs, dietary supplements and foods that are known to modulate CYP3A4 expression or activity
Subjects must be willing to maintain a consistent consumption of calcium and Vitamin D during the study and maintain a daily logbook of their dietary consumption
Women not currently pregnant or lactating. In addition, women participants of childbearing age must be willing to utilize a barrier method of birth control (sterilization will be acceptable)
Subjects will have no known allergies to the study drugs to be used
Subject's corrected QTc interval obtained by electrocardiogram will be ≤ 430 ms in men or ≤ 450 ms in women

Exclusion Criteria:

Subjects with any significant chronic medical condition, including cardiac, pulmonary, gastrointestinal, or renal disease, HIV, diabetes mellitus or Hepatitis B or C
Subjects less than 18 or greater than 60 years of age
Subjects unable to read and understand English
Subjects unable to provide informed consent
Subjects unable to avoid prescription medications, OTC drugs, dietary supplements and foods that are known to modulate CYP3A4 expression or activity
Subjects not willing to maintain a consistent consumption of calcium and Vitamin D during the study and maintain a daily logbook of their dietary consumption
Women who are pregnant or lactating and women participants of childbearing age not willing to utilize a barrier method of birth control (sterilization will be acceptable)
Subjects with allergies to rifampin, clarithromycin or grapefruit juice
Potential participants will be excluded if they are concurrently participating in another research study
Subjects with corrected QTc interval > 430 ms in men or > 450 ms in women on electrocardiogram
Intervention: Perflutren
Trial phase: Phase 2
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 66
Group description: Contrast ultrasound

contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.

Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
21 years of age or older
ability to give informed consent.

Exclusion Criteria:

Inability to provide an informed consent
Known allergy to Definity
Unstable cardiopulmonary conditions
pregnancy
Intervention: Perflutren
Trial phase: Phase 2
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 66
Group description: contrast enhanced ultrasound

contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.

Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
21 years of age or older
ability to give informed consent.

Exclusion Criteria:

Inability to provide an informed consent
Known allergy to Definity
Unstable cardiopulmonary conditions
pregnancy
Intervention: Rocuronium
Trial phase: Not Applicable
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 37
Group description: Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).

Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB).
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
Elective patients scheduled to undergo laparoscopic surgery with expected duration > 2h
Physical status ASA I - III

Exclusion Criteria:

Pregnancy
Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia)
Previous lung surgery
History of severe chronic obstructive pulmonary disease
Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery including bypass/banding, history of esophageal varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
Mechanical ventilation within the last 30 days
Neuromuscular disease
Consented for another interventional study or refusal to participate in the present study
Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents
Intervention: Rocuronium
Trial phase: Not Applicable
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 37
Group description: Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).

Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB).
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
Elective patients scheduled to undergo laparoscopic surgery with expected duration > 2h
Physical status ASA I - III

Exclusion Criteria:

Pregnancy
Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia)
Previous lung surgery
History of severe chronic obstructive pulmonary disease
Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery including bypass/banding, history of esophageal varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
Mechanical ventilation within the last 30 days
Neuromuscular disease
Consented for another interventional study or refusal to participate in the present study
Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents
Intervention: Acetaminophen
Trial phase: Phase 4
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: 119
Group description: Infusion of Intravenous acetaminophen (Ofirmev)

Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.
Eligibility criteria:
Inclusion Criteria:

Is scheduled for knee arthroscopy with or without chondroplasty.
Scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures.
Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the initiation of surgery.
Is willing and able to sign an informed consent.

Exclusion Criteria:

Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures
Has self-reported and/or documented previous hypersensitivity to acetaminophen.
Has self-reported and/or documented history of hepatic disease or impairment.
Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.
Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day.
Has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment of the physician PI/Sub-I.