bioihbjkbjnl/mcl2 huggingface dataset:
Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Condition: Postoperative Urinary Tract Infection; Pelvic Organ Prolapse; Stress Urinary Incontinence
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Urinary Incontinence; Urinary Incontinence, Stress; Prolapse; Pelvic Organ Prolapse
Intervention: gentamicin sulfate; Catheter clamping only
Intervention description: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.; Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.
Intervention MeSH terms: Gentamicins
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: The subject will be masked as to whether she has been assigned to the gentamicin arm or the control arm. The subject will be unmasked at the completion of the 6 week follow up period.
Enrollment: 370.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gentamicin sulfate; pelvic organ prolapse surgery; midurethral sling; bladder instillation

Summary:

      Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and
      stress urinary incontinence. This prospective, randomized, single-masked (subject),
      two-parallel armed study aims to determine the effect of a single postoperative intravesical
      instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the
      proportion of women treated for UTI within 6 weeks following surgery for pelvic organ
      prolapse (POP) or stress urinary incontinence (SUI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult women undergoing pelvic organ prolapse surgery and/or stress urinary
             incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the
             operating room with a standard-of-care transurethral catheter.

          -  Negative urine culture within 4 weeks or completion of UTI treatment ≥48 hours prior
             to surgery

        Exclusion Criteria:

          -  History of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium
             metabisulfite (one of the preservatives in the gentamicin sulfate product)

          -  Abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula)

          -  Intraoperative urinary tract injury

          -  Suppressive recurrent UTI treatment

          -  Chronic indwelling catheter/self-catheterization

          -  Unable to provide informed consent

          -  Severe renal impairment - glomerular filtration rate of less than 30 mL / minute

          -  Current pregnancy

          -  Currently incarcerated
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: botulinum toxin Type A; normal saline
Intervention description: Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.; Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 380.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to determine the safety and effectiveness of different doses of
      botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic
      hyperplasia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lower urinary tract symptoms due to benign prostatic hyperplasia

          -  Enlarged prostate volume by rectal ultrasound

        Exclusion Criteria:

          -  Previous prostate surgery

          -  Previous or current diagnosis of prostate cancer

          -  Use of other medications for the treatment of prostatic hyperplasia

          -  Urinary tract infection
A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer
Condition: Squamous Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Necitumumab; Paclitaxel; Carboplatin
Intervention description: Administered IV; Administered IV; Administered IV
Intervention MeSH terms: Paclitaxel; Carboplatin; Necitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC

Summary:

      The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy
      of paclitaxel and carboplatin is more effective to treat cancer than the standard
      chemotherapy of paclitaxel and carboplatin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed squamous NSCLC

          -  Stage IV disease at time of study entry based on American Joint Committee on Cancer
             (AJCC) 7th edition

          -  Measurable disease at time of study entry as defined by Response Evaluation Criteria
             in Solid Tumors, (RECIST) Version 1.1

          -  Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a
             paraffin-embedded tissue block) available for analysis of epidermal growth factor
             receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker
             assessments

        Exclusion Criteria:

          -  Nonsquamous NSCLC

          -  Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors,
             or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or
             VEGF receptor

          -  Previous chemotherapy for NSCLC

          -  Major surgery or received any investigational therapy in the 4 weeks prior to
             randomization

          -  Chest irradiation within 12 weeks prior to randomization (except palliative
             irradiation of bone lesions, which is allowed)

          -  Brain metastases that are symptomatic or require ongoing treatment with steroids or
             anticonvulsants (Participants who have undergone previous radiotherapy for brain
             metastases, who are now nonsymptomatic and no longer require treatment with steroids
             or anticonvulsants, are eligible)
Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
Condition: Multiple Myeloma; Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin
Intervention: XM02 Filgrastim; Filgrastim; Apheresis; Plerixafor; Stem Cell Transplant
Intervention MeSH terms: Plerixafor; Lenograstim
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:

      This study will compare the results of stem cell mobilization using drugs called filgrastim
      (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02
      filgrastim (Granix) and plerixafor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Diagnosis of multiple myeloma or non-Hodgkin lymphoma

          -  Eligible for autologous transplantation

          -  Adequate bone marrow function as defined as:

               -  White Blood Cell Count ≥ 3.0x109/L

               -  Absolute Neutrophil Count ≥ 1.5x109/L

               -  Platelet Count ≥ 100x109/L

          -  Able to understand and willing to sign an IRB-approved informed consent document

          -  Surgically or biologically sterile or willing to practice acceptable birth control, as
             follows:

               -  Women of childbearing potential must have a negative serum or urine pregnancy
                  test within 7 days of Day 1 of study treatment. Women of childbearing potential
                  must agree to abstain from sexual activity or use a medically approved
                  contraceptive measure/regimen during and for 3 months after the treatment period.
                  Acceptable methods of birth control include: barriers (condoms), oral
                  contraceptive, intrauterine device (IUD), transdermal/implanted or injected
                  contraceptives, and abstinence

               -  Males must agree to abstain from sexual activity or agree to utilize a medically
                  approved contraception method during and for 3 months after the treatment period.
                  Acceptable methods of birth control include: barriers (condoms), oral
                  contraceptive, intrauterine device (IUD), transdermal/implanted or injected
                  contraceptives, and abstinence

        Exclusion Criteria:

          -  Previous autologous stem cell collection

          -  Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products

          -  Pregnant or breastfeeding
Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: ONO-4641; ONO-4641; ONO-4641; ONO-4641; ONO-4641; ONO-4641
Intervention description: Subjects will be administered with ONO-4641 at a dose of 0.15 milligram (mg) in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.; Subjects will be administered with ONO-4641 at a dose of 0.10 mg in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.; Subjects will be administered with ONO-4641 at a dose of 0.05 mg in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.; Subjects will receive placebo in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.; Subjects will receive placebo in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.; Subjects will receive placebo in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
Intervention MeSH terms: Ceralifimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 340.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; ONO-4641; MSC2430913A; Efficacy

Summary:

      The objective of this active-drug Extension Study is to evaluate the continuing safety and
      efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis
      (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 [NCT01081782]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed 26 weeks of double-blind phase of Study ONO-4641POU006

        Exclusion Criteria:

          -  Presence of any dermatological abnormalities during Study ONO-4641POU006 that could
             increase the risk of the patient developing a skin cancer
Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection
Condition: Sars-CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19
Intervention: Peginterferon lambda alfa-1a subcutaneous injection; Saline
Intervention description: Peginterferon lambda-1a 180 micrograms by subcutaneous injection; Saline subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, single-blind, controlled trial
Masking: Single (Participant)
Masking description: Single-blinded study
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; COVID-19; Lambda interferon

Summary:

      This is a phase 2b prospective, randomized, single-blind, controlled trial of a single
      subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2
      infection in non-hospitalized participants at high risk for infection due to household
      exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate
      the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All
      participants will be followed for up to 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening

          -  Age ≥18 years

        Exclusion Criteria:

          -  Hospitalized or impending hospitalization at the time of screening

          -  Symptoms of cough, fever or shortness of breath within 72 hours

          -  Prior or current treatment with other experimental or approved agents targeting
             SARS-CoV-2 or SARS-CoV-1

          -  Positive pregnancy test

          -  Active autoimmune disease or sarcoidosis (with the exception of controlled thyroid
             disease)

          -  Active decompensated liver disease (ascites, encephalopathy)

          -  Active congestive heart failure
LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
Intervention description: LSA4 intervention includes three phases: induction, consolidation and maintenance
Intervention MeSH terms: Cyclophosphamide; Methotrexate; Asparaginase; Daunorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may
      return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6
      months. To aggressively treat this cancer this study uses effective drugs in three parts:

        -  Induction ends on day 19

        -  Consolidation ends on day 38 or 42

        -  Maintenance may include up to 6 cycles
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-Hodgkin's Lymphoma stages III, IV, IVA with

               1. T cell lymphomas, any primary site irrespective of LDH level

               2. large cell lymphomas, any primary site irrespective of LDH level

               3. B cell lymphomas, any primary site with initial LDH of less than 500

        Exclusion Criteria:

          -  B cell lymphomas, any primary site with initial LDH of less than 500 and initial CNS
             or bone involvement
A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations
Condition: Triple Negative Breast Neoplasms
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: PF-03084014; PF-03084014; PF-03084014
Intervention description: Tablet, 10 mg, twice a day.; Tablet, 50 mg, twice a day; Tablet, 100 mg, twice a day
Intervention MeSH terms: Nirogacestat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PF-03084014; Notch Alterations

Summary:

      This study is designed to evaluate the preliminary anti-tumor activity and tolerability of
      PF-03084014 when administered as a single agent in the treatment of patients with advanced
      triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch
      receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for
      genomic alterations in Notch receptors (NA-)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of triple negative breast cancer (TNBC) with
             evidence of a) metastatic or b) locally recurrent advanced disease that is not
             amenable to resection or radiotherapy with curative intent.

          -  Availability of an original diagnostic tumor tissue or the most recent metastatic
             tumor biopsies (archival biopsy or de novo biopsy) and a peripheral blood sample for
             Notch receptors genomic profiling

        Exclusion Criteria:

          -  Known brain metastases.

          -  Prior treatment with gamma secretase inhibitor or other Notch signaling inhibitor.
CoQ10 and D-ribose in Patients With Diastolic Heart Failure
Condition: Heart Failure, Diastolic
MeSH terms: Heart Failure; Heart Failure, Diastolic
Intervention: CoQ10; D-Ribose Oral Powder; Placebo pills; Placebo powder
Intervention description: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.; Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.; Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.; Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Intervention MeSH terms: Coenzyme Q10
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 216.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: heart failure with preserved ejection fraction

Summary:

      The purpose of this study is to compare the clinical benefits of CoQ10 and D-ribose taken by
      patients who have diastolic heart failure, or heart failure with preserved ejection fraction
      (HFpEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with HFpEF within a 6-month period

          -  New York Heart Association (NYHA) Classification II-III HF

          -  Have left ventricular ejection fraction (EF) ≥ 50% documented by an echocardiogram

          -  Have a telephone or reliable phone contact

          -  Have their own means of transportation to the study site

        Exclusion Criteria:

          -  Acute coronary syndrome in the past 12 weeks

          -  Significant valvular heart disease

          -  Severe cardiac fibrosis (galectin-3 level > 26 ng/ml)

          -  Constrictive pericardium

          -  Pulmonary fibrosis

          -  Congenital heart disease

          -  Hypertrophic or infiltrative cardiomyopathy

          -  Heart transplant

          -  Left ventricular assist device

          -  Heart failure (HF) associated hospital admission or emergency room visit within past
             30 days

          -  Recent percutaneous coronary intervention

          -  Significant renal and/or hepatic dysfunction

          -  Severe cognitive impairment

          -  Consumption of any CoQ10 (ubiquinol) or D-ribose supplements
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: PF-04236921 SC injection; PF-04236921 SC injection; PF-04236921 SC injection
Intervention description: Placebo delivered SC, 2 doses separated by 4 weeks; Drug dose level 1 delivered SC, 2 doses separated by 4 weeks; Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease; safety; efficacy; pharmacokinetics; pharmacodynamics; Crohn's Disease Activity Index (CDAI)

Summary:

      This is a proof of concept study to determine the efficacy and safety of a monoclonal
      antibody with three doses versus placebo. Subjects will be randomized to a treatment and the
      dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate
      to severe refractory Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have failed or are intolerant to anti TNFs

          -  hsCRP greater or equal to 5.0 mg/L

          -  Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
             within 8 weeks of study entry (screening) and able to retrospectively complete the
             SES-CD or colonoscopy performed during screening

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  Crohn's Disease with active fistulae or abscess

          -  History of diverticulitis or symptomatic diverticulosis

          -  Abnormality in hematology or chemistry profiles at screening