anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Alobresib
Trial phase: Phase 1
SMILES: Cc1noc(C)c1-c1cc(C(O)(c2ccccn2)c2ccccn2)c2nc(C3CC3)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
Eligibility criteria:
Key Inclusion Criteria:

Group 1: Histologically or cytologically confirmed advanced malignant solid tumor or lymphoma (any subtype) that is refractory to or intolerant of standard therapy or for which no standard therapy is available
Group 2: Post-menopausal women with advanced stage estrogen receptor positive breast cancer who are candidates for exemestane or fulvestrant
Group 3: Individuals with lymphoma are limited to diffuse large B-cell lymphoma and peripheral T-cell lymphoma that are refractory to or intolerant of standard therapy or for which no standard therapy is available
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Adequate organ function defined as follows:

Hematologic: Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9.0 g/ dL; Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without platelet transfusion or any growth factors within previous 7 days of the hematologic laboratory values obtained at screening visit). Participants in the Group 3 lymphoma expansion may be enrolled with an ANC of ≥ 1.0 x 10^9 /L; Platelets ≥ 75 x 10^9 /L.
Hepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) (if liver metastases are present, ≤ 5 x ULN); Total or conjugated bilirubin ≤ 1.5 x ULN
Renal: Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 ml/min as calculated by the cockcroft-gault method
Coagulation: International Normalized Ratio (INR) ≤ 1.2

Key Exclusion Criteria:

Known brain metastasis or leptomeningeal disease
Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of first dose of study drug
History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 450 ms for males and > 470 ms for females). Individuals who screen-fail due to this criterion are not eligible to be re-screened
Clinically significant bleeding within 28 days of study Day 1
Known human immunodeficiency virus (HIV) infection
Hepatitis B surface antigen positive
Hepatitis C virus (HCV) antibody positive
No active anticoagulation within 7 days of study Day 1; including acetylsalicylic acid, low molecular weight heparin, or warfarin.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Alobresib
Trial phase: Phase 1
SMILES: Cc1noc(C)c1-c1cc(C(O)(c2ccccn2)c2ccccn2)c2nc(C3CC3)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
Eligibility criteria:
Key Inclusion Criteria:

Group 1: Histologically or cytologically confirmed advanced malignant solid tumor or lymphoma (any subtype) that is refractory to or intolerant of standard therapy or for which no standard therapy is available
Group 2: Post-menopausal women with advanced stage estrogen receptor positive breast cancer who are candidates for exemestane or fulvestrant
Group 3: Individuals with lymphoma are limited to diffuse large B-cell lymphoma and peripheral T-cell lymphoma that are refractory to or intolerant of standard therapy or for which no standard therapy is available
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Adequate organ function defined as follows:

Hematologic: Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9.0 g/ dL; Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without platelet transfusion or any growth factors within previous 7 days of the hematologic laboratory values obtained at screening visit). Participants in the Group 3 lymphoma expansion may be enrolled with an ANC of ≥ 1.0 x 10^9 /L; Platelets ≥ 75 x 10^9 /L.
Hepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) (if liver metastases are present, ≤ 5 x ULN); Total or conjugated bilirubin ≤ 1.5 x ULN
Renal: Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 ml/min as calculated by the cockcroft-gault method
Coagulation: International Normalized Ratio (INR) ≤ 1.2

Key Exclusion Criteria:

Known brain metastasis or leptomeningeal disease
Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of first dose of study drug
History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 450 ms for males and > 470 ms for females). Individuals who screen-fail due to this criterion are not eligible to be re-screened
Clinically significant bleeding within 28 days of study Day 1
Known human immunodeficiency virus (HIV) infection
Hepatitis B surface antigen positive
Hepatitis C virus (HCV) antibody positive
No active anticoagulation within 7 days of study Day 1; including acetylsalicylic acid, low molecular weight heparin, or warfarin.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Pemigatinib
Trial phase: Phase 1 | Phase 2
ATC code: L01EN02
SMILES: CCN1C(=O)N(c2c(F)c(OC)cc(OC)c2F)Cc2cnc3[nH]c(CN4CCOCC4)cc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects, age 18 years or older on day of signing consent
Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
Life expectancy > 12 weeks

Eastern Cooperative Oncology Group (ECOG) performance status:

Part 1: 0 or 1
Part 2 and 3: 0, 1, or 2

Exclusion Criteria:

Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
Prior receipt of a selective FGFR inhibitor
History of a calcium/phosphate homeostasis disorder
History and/or current evidence of ectopic mineralization/calcification
Current evidence of corneal disorder/keratopathy
Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
Prior radiotherapy within 2 weeks of study treatment
Intervention: Pemigatinib
Trial phase: Phase 1 | Phase 2
ATC code: L01EN02
SMILES: CCN1C(=O)N(c2c(F)c(OC)cc(OC)c2F)Cc2cnc3[nH]c(CN4CCOCC4)cc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects, age 18 years or older on day of signing consent
Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
Life expectancy > 12 weeks

Eastern Cooperative Oncology Group (ECOG) performance status:

Part 1: 0 or 1
Part 2 and 3: 0, 1, or 2

Exclusion Criteria:

Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
Prior receipt of a selective FGFR inhibitor
History of a calcium/phosphate homeostasis disorder
History and/or current evidence of ectopic mineralization/calcification
Current evidence of corneal disorder/keratopathy
Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
Prior radiotherapy within 2 weeks of study treatment
Intervention: Pemigatinib
Trial phase: Phase 1 | Phase 2
ATC code: L01EN02
SMILES: CCN1C(=O)N(c2c(F)c(OC)cc(OC)c2F)Cc2cnc3[nH]c(CN4CCOCC4)cc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects, age 18 years or older on day of signing consent
Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
Life expectancy > 12 weeks

Eastern Cooperative Oncology Group (ECOG) performance status:

Part 1: 0 or 1
Part 2 and 3: 0, 1, or 2

Exclusion Criteria:

Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
Prior receipt of a selective FGFR inhibitor
History of a calcium/phosphate homeostasis disorder
History and/or current evidence of ectopic mineralization/calcification
Current evidence of corneal disorder/keratopathy
Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
Prior radiotherapy within 2 weeks of study treatment
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: amide local anesthetic

Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus
Eligibility criteria:
Inclusion Criteria:

80 ASA Grade I and II patients of either sex, aged 18-60 years, undergoing various orthopaedic surgeries on the upper limb under supraclavicular brachial plexus block.

Exclusion Criteria:

Patient refusal
Patients with chronic pain (pain lasting more than 12 weeks)
Those using chronic analgesic medications (opioid, non steroidal anti-inflammatory drugs, anticonvulsants, antidepressants)
Coagulopathy
History of brachial plexus injury
Allergy to the study drugs
Patients taking other medications with α-adrenergic blocking effect
Hepatic or renal insufficiency
Systemic infection or infection at the site of injection, and shoulder surgery.
Intervention: Cortrosyn
Trial phase: Phase 4
ATC code: H01AA02
SMILES: CSCCC(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(N)CO)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1c[nH]cn1)C(=O)NC(Cc1ccccc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NCC(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)N1CCCC1C(=O)NC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)N1CCCC1C(=O)O)C(C)C)C(C)C)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Cosyntropin 500 mcg in 1000cc Normal Saline

Cosyntropin: Intravenous Drug Infusion over 1 hour and a half
Eligibility criteria:
Inclusion Criteria:

18 years of age or older,
Diagnosed by Anesthesia provider as having PDPH
Agrees to participation in study

Exclusion Criteria:

In-patient status and/or unstable medical condition
Patient's contraindication to EBP: Local infection at injection site, systemic infection, hemodynamically unstable, severely hypovolemic
Patient's contraindication to EBP: Known or past reaction to natural ACTH or Cosyntropin
Signs or symptoms of ICP such as Mental Status changes, Bradycardia and hypertension
Congestive Heart Failure
Patient refusal to participate
Current Pregnancy
Intervention: Zafirlukast
Trial phase: Not Applicable
ATC code: R03DC01
SMILES: COc1cc(C(=O)NS(=O)(=O)c2ccccc2C)ccc1Cc1cn(C)c2ccc(NC(=O)OC3CCCC3)cc12
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 88
Group description: Each patient received triple antibiotic solution on one breast and the CHG on the other breast.

CHG consisted of commercially prepared 0.05% CHG solution (IrriSept, 0.05% CHG in sterile water, Irrimax Corporation, Lawrenceville, GA.
Eligibility criteria:
Inclusion Criteria:

females between 18 - 81 years of age
and are undergoing bilateral mastectomy
and are candidates for immediate breast reconstruction with tissue expanders.

Exclusion Criteria:

females younger than 18 and older than 81 years of age;
undergoing unilateral mastectomy and reconstruction;
bilateral reconstruction using other techniques,
patients allergic to one or more components of the antibiotic solution;
allergy to CHG
Intervention: Eflornithine
Trial phase: Phase 2
ATC code: D11AX16 | P01CX03
SMILES: NCCCC(N)(C(=O)O)C(F)F
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 140
Group description: All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group.
Eligibility criteria:
Inclusion Criteria:

Age: 0-21 years at the time of diagnosis.
Diagnosis: histologic verification at either the time of original diagnosis or a previous relapse of high risk neuroblastoma.
Disease Status: Neuroblastoma that is in remission
First dose of study medication must be greater than 30 days from completion of cytotoxic and antibody therapy and less than 120 days from previous therapy
A negative serum or urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ≥13 years of age).
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Absolute Neutrophil Count (ANC) > 500/μl and platelet count >50,000/μl

Organ Function Requirements: Subjects must have adequate liver function as defined by:

Aspartate Aminotransferase (AST) and Alanine transaminase (ALT) <10x upper limit of normal
Serum bilirubin must be ≤ 2.0 mg/dl
Serum creatinine based on age/gender
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria:

Lansky score < 60%
Body Surface Area (BSA) (m2) of <0.25
Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the effects of prior chemotherapy (hematological and bone marrow suppression effects).
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
Intervention: Fidaxomicin
Trial phase: Phase 3
ATC code: A07AA12
SMILES: CCc1c(Cl)c(O)c(Cl)c(O)c1C(=O)OC1C(C)OC(OCC2=CC=CCC(O)C(C)=CC(CC)C(OC3OC(C)(C)C(OC(=O)C(C)C)C(O)C3O)C(C)=CC(C)=CCC(C(C)O)OC2=O)C(OC)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: 30-day fidaxomicin
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older.
Able to provide informed consent.
Willing and able to comply with all the required study procedures.
A positive stool test for C. difficile toxin/gene using either PCR or enzyme immunoassay within 3 months of recruitment.
History of at least ≥ 2 recurrent CDI within 6 months where recurrence is deﬁned as return of diarrhea consistent with CDI within 8 weeks following CDI symptom resolution for at least 24 hours after a minimum of 10-day course of standard antibiotic therapy and positive stool test for C. difficile toxin or toxin gene and/or ongoing symptoms consistent with CDI despite at least 5 days of treatment using oral vancomycin.
Has more than three unformed bowel movements or 200 mL of stool for individuals with a stool collection device such as rectal tube or colostomy during a 24-hour period at the time of initiation of fidaxomicin. Participants will be enrolled when they meet inclusion criteria 1 - 5; will be initiated at fidaxomicin when they have CDI symptoms and stool will be tested for C. difficile toxin/gene. Only those with positive stool for C. difficile toxin/gene with current episode of CDI will continue with the study
Females of child bearing potential must be willing to use acceptable birth control as per the Health Canada Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences.

Exclusion Criteria:

Planned or actively taking an investigational product for another study.
Prior fidaxomicin use.
Hypersensitivity to fidaxomicin or to any ingredient in the formulation or component of the container.
Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray or life expectancy of less than 72 hours.
Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
Anticipated requirement for systemic antibiotic therapy for more than 7 days during the study period.
Actively taking Saccharomyces boulardii or other probiotics other than yogurt.
Any condition that, in the opinion of the investigator, that the treatment may pose a health risk to the subject.
Pregnant or lactating.
Intervention: Lovenox
Trial phase: Phase 4
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
Blunt or penetrating trauma
Requires VTE thromboprophylaxis
High-risk for VTE

Exclusion Criteria:

Presence of VTE upon admission
Pregnant or nursing
Inability to give informed consent by patient or healthcare proxy
Contraindication to enoxaparin
Contraindication to aspirin
Epidural or subdural hematoma
Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures
Intervention: AZD8529
Trial phase: Phase 2
SMILES: Cc1cc(-c2nc(CN3CCNCC3)no2)cc2c1C(=O)N(Cc1ccc(OC(F)(F)F)cc1)C2
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 104
Group description: Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
Eligibility criteria:
Inclusion Criteria:

Be a female smoker between the ages of 18 to 75 years.
Want to quit smoking.
Be currently (last 30 days) smoking 10 or more cigarettes per day and report less than 3 months of consecutive smoking abstinence during the past year.
Be able, in the opinion of the site investigator (SI), to understand and follow all protocol-specified instructions and understand and provide written informed consent.
Be willing to provide personal information for entry into a clinical trial registry.
Agree to use and continue using at least one acceptable contraceptive method (oral contraceptives, IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, condoms with spermicide, or abstinence) or, if not of childbearing potential, must fulfill one of the following criteria at screening: post-menopausal defined as amenorrhea for at least 12 months and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range and/or documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation verified by the Site Investigator.
Agree not to use any other smoking behavioral intervention (self-help or formal treatment), acupuncture, or other smoking cessation pharmacotherapy during the study.
Agree to refrain from using dietary/herbal supplements other than vitamins and minerals for 7 days prior to receiving study drug and throughout the 13-week treatment period.
Agree to attend all required clinic appointments (including 3 eye exams) during the course of the 19-week study.

Exclusion Criteria:

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