bioihbjkbjnl/mcl2 huggingface dataset:
18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma
Condition: Recurrent Adult Soft Tissue Sarcoma; Stage I Adult Soft Tissue Sarcoma; Stage II Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: fludeoxyglucose F 18; 18F-fluoromisonidazole; positron emission tomography; computed tomography; laboratory biomarker analysis
Intervention description: Undergo 18F FDG and 18F FMISO PET/CT scans; Undergo 18F FDG and 18F FMISO PET/CT scans; Undergo 18F FDG and 18F FMISO PET/CT scans; Undergo 18F FDG and 18F FMISO PET/CT scans; Correlative studies
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans
      to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue
      sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic
      procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to
      find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors
      predict how well a patient will respond to treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed intermediate- or high-grade soft tissue sarcoma

               -  Biopsy proven or highly suspicious primary or recurrent disease

               -  Tumor size ≥ 2 cm

          -  Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy

          -  Life expectancy ≥ 12 months

          -  Negative pregnancy test

          -  Willing to undergo PET scanning

          -  Willing to undergo possible urinary bladder catheterization (for patients with pelvic
             or proximal thigh tumors)

          -  Able to lie on the imaging table for up to 1.5 hours

          -  Weight ≤ 400 lbs

          -  Not pregnant
A Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor in Paediatric Patients With Sickle Cell Disease
Condition: Investigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Ticagrelor Dose 1a + Dose 2a; Ticagrelor Dose 1b + Dose 2b
Intervention description: Ticagrelor Dose 1a and ticagrelor Dose 2a single doses + 1 week ticagrelor repeated dosing followed by 4 weeks repeated dosing ticagrelor or placebo.; Ticagrelor Dose 1b and ticagrelor Dose 2b single doses + 1 week ticagrelor repeted dosing followed by 4 weeks repeated dosing ticagrelor or placebo.
Intervention MeSH terms: Ticagrelor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: sickle cell anemia; paediatric

Summary:

      The purpose of this Phase II dose-ranging study is to investigate pharmacokinetic (PK) and
      pharmacodynamic (PD) properties of various doses of ticagrelor followed by 4 weeks of
      twice-daily treatment in paediatric patients with sickle cell disease
    

Eligibility criteria:

        Inclusion criteria

          -  Children aged ≥2 to <18 years of age

          -  Diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0)

        Exclusion criteria

          -  At risk for haemorrhagic or bradycardic events

          -  Significant hepatic impairment

          -  Renal failure requiring dialysis

          -  Concomitant oral or intravenous therapy with strong CYP3A4 (cytochrome) inhibitors,
             CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers.

          -  Surgical procedure planned to occur during the study.

          -  Patients who are currently pregnant or breastfeeding or planning to become pregnant
             during the study.

          -  Patients who have known hypersensitivity or contraindication to ticagrelor.
Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL
Intervention description: 400/100 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C
      virus (HCV)-infected adults who are undergoing liver transplantation.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HCV-infected, male and non-pregnant/non-lactating females, who are undergoing liver
             transplantation

        Key Exclusion Criteria:

          -  Receiving an HCV-infected liver

          -  HIV or hepatitis B virus (HBV) co-infected

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Multi-Center, Open Label, Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
Condition: Exudative Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: RBM-007
Intervention description: Intravitreal injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, non-comparative
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This is a multi-center, open label, extension study of NCT04200248 assessing the efficacy and
      safety of additional intravitreal injections of RBM-007 in subjects with wet age-related
      macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide signed written informed consent on the Institutional Review Board (IRB)/Ethics
             Committee (EC) approved Informed Consent Form (ICF) and provide authorization as
             appropriate for local privacy regulations.

          2. Male or female 55 years of age or older on the date of signing the ICF and able and
             willing to comply with all treatment and study procedures.

          3. Subjects must have completed all scheduled visits of previous study. Subjects can only
             enter this study after exiting previous study

          4. Subjects for which previous previous masked treatment arms with intravitreal
             anti-vascular endothelial growth factor (anti-VEGF) agents Eylea® and/or RBM-007 has
             not demonstrated improvement in vision; subjects with less than 15 letter Best
             Corrected Visual Acuity (BCVA) improvement in TOFU study at exit visit over its
             baseline.

          5. Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as
             assessed by spectral domain optical coherence tomography (SD-OCT).

          6. Absence of central atrophy or retinal epithelial tear in the fovea or any condition
             preventing VA improvement in the study eye.

          7. BCVA of 24 ETDRS letters (20/320) or better in the fellow eye.

          8. Reasonably clear media and some fixation in the study eye to allow for good quality
             SD-OCT and fundus photography.

        Exclusion Criteria:

          -  1. Subjects whose vision have improved >15 BCVA letters at exit visit of previous
             study over its baseline 2. Subjects who experienced any drug related serious adverse
             event during previous study
A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction
Condition: Acute Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Intervention: APD418; APD418; Placebo
Intervention description: Participants will receive a single dose of APD418 as an intravenous (IV) infusion.; Participants will receive a single dose of APD418 as an IV infusion.; Participants will receive a single dose of APD418 matching placebo as an IV infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Heart failure with reduced ejection fraction; HFrEF; APD418; Acute Heart Failure (AHF)

Summary:

      The purpose of this study is to evaluate the safety, pharmacokinetics, and effect on cardiac
      function of intravenous APD418 in adult participants with heart failure with reduced ejection
      fraction (HFrEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced chronic Heart Failure with Reduced Ejection Fraction (HFrEF), defined as left
             ventricular ejection fraction (LVEF) less than or equal to (≤) 35% at Screening,
             including documented history of HFrEF (LVEF ≤ 35%) for at least 4 months prior to
             Screening

          -  New York Heart Association Class II-IV

          -  Cardiac index ≤ 2.5 liters per minute per square meter (L/min/m^2) and pulmonary
             capillary wedge pressure ≥ 15 millimeters of mercury (mm Hg) at Day 1

          -  Body mass index 18.0 to 37.0 kilograms per square meter (kg/m^2), inclusive, and body
             weight < 150 kg at Screening and Day 1

        Exclusion Criteria:

          -  Hemodynamically unstable at Day 1 or in the opinion of the Investigator likely to
             progress to becoming hemodynamically unstable during the course of the study

          -  Treated with carvedilol or at a dose higher than a total of 25 milligrams per day any
             time within 72 hours of Day 1 through the end of the in-clinic observation Post-dose
             Period.

          -  Receiving any mechanical (respiratory or circulatory) or renal support therapy at
             Screening or Day 1

          -  Systolic Blood Pressure ≤ 90 millimeter of mercury (mm Hg) or ≥ 160 mm Hg, or Heart
             Rate < 50 beats per minute (bpm) or > 110 bpm, at Screening or Day 1

          -  Recently treated with inotropic, intravenous (IV) vasoactive or IV diuretic therapy,
             or expected to require such therapy with these drugs any time from Day 1 through the
             end of study conduct.
An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type II; Diabetes Mellitus, Non Insulin Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin (JNJ-28431754); Sitagliptin; Placebo
Intervention description: One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.; One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.; One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.
Intervention MeSH terms: Sitagliptin Phosphate; Canagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; Metformin; Hemoglobin A1c

Summary:

      The purpose of this study is to evaluate the effectiveness, safety, and tolerability of
      JNJ-28431754 compared with placebo in patients with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of type 2 diabetes mellitus

          -  Hemoglobin A1c levels >=7% and <=10.5%

          -  taking a stable daily dose of metformin

          -  Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI
             of 24 to 45 kg/m2

          -  Stable body weight

          -  Serum creatinine <=1.5 mg/dL (132.6 umol/L) for men and <=1.4 mg/dL (123.76 umol/L)
             for women

        Exclusion Criteria:

          -  Patients must not have prior exposure or known contraindication or suspected
             hypersensitivity to canagliflozin (JNJ-28431754)

          -  Known contraindication or suspected hypersensitivity to sitagliptin or metformin

          -  A history of diabetic ketoacidosis or type 1 diabetes mellitus

          -  History of pancreas or beta-cell transplantation

          -  History of active proliferative diabetic retinopathy

          -  History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Dasatinib; Fulvestrant
Intervention description: Tablets, Oral, 100 mg, once daily (QD), upto 2 years; Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years
Intervention MeSH terms: Dasatinib; Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out what effect the combination of fulvestrant
      (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant
      alone.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation,
        please visit www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Histologically confirmed hormone receptor positive (HR+) [(estrogen receptor (ER+)
             and/or progesterone receptors(PgR+)] breast cancer according to immunohistochemistry
             (IHC)

          -  Measureable or evaluable-only disease

          -  human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer

          -  Males and females ≥18 years of age

          -  Females are post menopausal or surgically sterile

          -  Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that
             has progressed: (a) during or within 12 months after completion of adjuvant Aromatase
             Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic
             therapy)

        Exclusion Criteria:

          -  Pregnant or breast feeding

          -  >1 chemotherapy regimen for advanced disease

          -  Pleural or pericardial effusion

          -  Serious cardiac condition
Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor
Condition: Cesarean Section; Surgical Site Infection; Nosocomial Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Cross Infection
Intervention: 2% chlorhexidine gluconate cloth; 4% Chlorhexidine gluconate vaginal scrub
Intervention description: applied to their abdomen; applied as a vaginal cleanse in the operating room prior to cesarean section
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 319.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cesarean section; Labor; Surgical Site Infections; Chlorhexidine gluconate

Summary:

      Surgical site infections (SSI) are the second most common cause of nosocomial infections
      accounting for 15% of all nosocomial infections among hospitalized patients and 38% of
      nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e.
      SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal
      deliveries. Additionally, infectious morbidity is thought to be highest in those patients who
      have cesarean sections after undergoing labor.

      Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria,
      reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI.

      Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant
      surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is
      limited. This study intends to evaluate the effectiveness of use of both chlorhexidine
      gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean
      section that have previously been laboring. Patients will be randomized to one of two groups:
      wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal
      scrub in addition to standard preoperative scrub as compared to standard preoperative scrub
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women at > 24 weeks gestation who are admitted in labor or admitted for induction of
             labor at Mount Sinai Hospital

        Exclusion Criteria:

          -  Allergy to chlorhexidine

          -  Unplanned or emergency cesarean section

          -  Women at <24 weeks gestation

          -  Estimated fetal weight <500 grams

          -  Fetal face presentation regardless of gestational age.
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
Condition: Neoplasm Metastasis; Palliative Care
MeSH terms: Neoplasm Metastasis
Intervention: Tanezumab 10 mg IV; IV Placebo for tanezumab
Intervention description: Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.; Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and efficacy of tanezumab in
      combination with opioids in treating pain due to cancer that has spread to bone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has
             spread to bone, causing moderate to severe bone pain.

          -  Requires daily opioid medication

        Exclusion Criteria:

          -  Patients who do not have bone pain caused by cancer are not eligible for the study.

          -  Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy
             less than 4 weeks ago, are not eligible.

          -  Known history or evidence of osteoarthritis. History of significant trauma to a major
             joint within 1 year prior to Screening.

          -  Known history of rheumatoid arthritis.
PF-06741086 Multiple Dose Study in Severe Hemophilia
Condition: Hemophilia A or B
MeSH terms: Hemophilia A
Intervention: PF-06741086; PF-06741086; PF-06741086; PF-06741086
Intervention description: PF-06741086 subcutaneous (SC) injection; PF-06741086 SC injection; PF-06741086 SC injection; PF-06741086 SC injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: hemophilia

Summary:

      This study is designed to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of
      PF-06741086 in subjects with severe hemophilia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%), including patients
             with inhibitors to Factor VIII or Factor IX

          -  Episodic (on-demand) treatment regimen prior to screening

          -  At least 6 acute bleeding episodes during the 6-month period prior to screening

        Exclusion Criteria:

          -  Known coronary artery, thrombotic, or ischemic disease

          -  Currently receiving treatment for acute bleeding episodes with APCC and cannot
             substitute treatment with rFVIIa