bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of Delphi Screener for Cervical Cytology
Condition: Cervical Neoplasia
MeSH terms: Neoplasms
Intervention: Delphi Screener
Intervention description: Self-sampling device for cervical vaginal lavage
Phase: Phase 2
Study type: Interventional
Primary purpose: Screening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cervical cytology; Pap smear; self-sampling; abnormal; normal

Summary:

      The aim of this study is to see whether a new self-sampling device, the Delphi Screener
      (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The
      results using the new device will be compared to results using the current gold standard. The
      gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often
      referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of
      using the device and how easy it is to understand the user instructions.

      The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline
      which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is
      that the device may work well for cervical cytology and will be acceptable to the women in
      the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Valid Pap smear in last 1-3 months obtained at participating clinic

          -  18 years or older

          -  Self-report being able to read in English and/or Spanish

          -  Willing to sign informed consent

        Exclusion Criteria:

          -  Used vaginal product (douche, spermicide, antifungal) in last 48 hours

          -  Last menses started ≤ 4 days prior to enrollment visit

          -  No uterus / history of hysterectomy

          -  Self-report currently pregnant

          -  Self-report currently breastfeeding
Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors
Condition: Leukemia; Lymphoma; Myelodysplastic Syndrome
MeSH terms: Myelodysplastic Syndromes
Intervention: Bortezomib; Tacrolimus; Methotrexate
Intervention description: Bortezomib 1.3 mg/m^2 IV; Tacrolimus 0.05 mg/kg PO bid; Methotrexate 15 mg/m^2 IV
Intervention MeSH terms: Methotrexate; Bortezomib; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Stem Cell Transplant; Allogeneic Transplant; Donors

Summary:

      A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a
      complication of transplantation where the donor graft attacks and damages some of your
      tissues. After stem cell transplant, all patients receive prophylactic medications against
      GVHD.

      In this research study, we are studying the safety and effectiveness of a bortezomib based
      GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call
      transplantation from a matched unrelated donor, mismatched related or unrelated donor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced and/or aggressive hematologic
             malignancy (including myelodysplastic syndrome) that is unlikely to be cured by
             alternative therapies

          -  HLA-Matched unrelated donor; or 1-locus HLA-mismatched related or unrelated donor

          -  ECOG performance status 0-2

          -  Adequate organ function

          -  Able to understand and willing to sign a written informed consent document

          -  Agrees to practice adequate contraception per study requirements

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Recipient of prior allogeneic or autologous stem cell transplantation

          -  Prior abdominal radiation therapy

          -  HIV-positive on combination antiretroviral therapy

          -  Seropositive for hepatitis B or C

          -  Allergies to bortezomib, boron, or mannitol

          -  Myocardial infarction within last 6 months, NYHA Class III or IV heart failure,
             uncontrolled angina, severe uncontrolled ventricular arrhythmias

          -  Uncontrolled bacterial, viral or fungal infections

          -  Seizures or history of seizures

          -  History of another non-hematologic malignancy unless disease-free for at least 5 years

          -  Uncontrolled intercurrent illness
A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Respiratory Sounds
Intervention: Lumicitabine; Placebo
Intervention description: Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.; Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 56 Days
Maximum age: 39 Months
Healthy volunteers: No

Summary:

      The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the
      clinical diagnosis of asthma and the frequency of wheezing in infants and children with
      respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo)
      and have completed their last planned study-related visit in a feeding Phase 2 study
      (64041575RSV2004).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants and children who were previously randomized in study
             64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and
             who completed the planned course of the study drug and the last study-related visit of
             study 64041575RSV2004

          -  The participant's legally acceptable representative must sign an informed consent form
             (ICF) indicating that he or she understands the purpose of, and procedures required
             for, the study and is willing for the participant to participate in the study

        Exclusion Criteria:

          -  The participants legally acceptable representative, i.e, parent/legal
             guardian/caregiver, is not able to maintain reliable communication with the
             investigator

          -  Any condition for which, in the opinion of the investigator, participation would not
             be in the best interest of the participant (example, compromise the well-being) or
             that could prevent, limit, or confound the protocol-specified assessments
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Intervention: dexamethasone; lenalidomide; melphalan
Intervention description: 40 mg once weekly; 10 mg/day D1-21; 5 mg/m2 D1-4
Intervention MeSH terms: Dexamethasone; Lenalidomide; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: primary systemic amyloidosis

Summary:

      RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different
      ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping
      them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune
      system in different ways and stop the abnormal plasma cells from growing. Giving melphalan
      together with lenalidomide and dexamethasone may be an effective treatment for primary
      systemic amyloidosis.

      PURPOSE: This phase II trial is studying the side effects and how well giving melphalan
      together with lenalidomide and dexamethasone works in treating patients with primary systemic
      amyloidosis.
    

Eligibility criteria:

        Inclusion Criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of primary systemic amyloidosis

        PATIENT CHARACTERISTICS:

          -  Not pregnant

          -  Negative pregnancy test

          -  Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day,
             therapeutic warfarin, or low molecular weight heparin)

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior therapy

               -  Permanent or stable side effects/changes allowed

          -  Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed

          -  More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or
             radiotherapy

        Exclusion Criteria:

          -  No secondary or familial amyloidosis

          -  No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions)

          -  No prior cumulative doses of oral melphalan > 200 mg

          -  No more than one prior course of high-dose melphalan with stem cell transplant
COVID-19 PrEP HCW HCQ Study
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine (HCQ)
Intervention description: Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Total number of participant: 350 (Group A and B)
Group A: projected 300 (HCW choose to be provided HCQ)
Group B: projected 50 (HCW choose not to be provided HCQ)
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to
      prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 350
      participants will be assigned to the group that takes HCQ or the group that opts to not take
      the study medication. Participants will be NYULH HCW at high risk for occupational exposure
      to SARS-CoV-2. Study timepoints will include screening/enrollment, 30 day, 60 day, and 90 day
      visits. Questionnaires, and DBS will be collected in all timepoints.
    

Eligibility criteria:

        Inclusion Criteria for Group A and B

          -  Men or women ages ≥18 years NYULH health care worker who meets one of the following
             criteria

               1. Involved in an aerosol generating procedure (nasopharyngeal specimen collection,
                  tracheal intubation, nebulizer treatment, open airway suctioning, collection of
                  sputum, tracheostomy, bronchoscopy, CPR) on a confirmed COVID-19 patient while
                  wearing PPE

               2. Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more
                  shifts in a 7 day period

               3. Direct care of PUIs in the ED or other inpatient unit while wearing PPE for 3 or
                  more shifts in a 7 day period

          -  Willing and able to provide informed consent

        Exclusion Criteria for Group A only :

          -  Known hypersensitivity to hydroxychloroquine or chloroquine

          -  Known diagnosis of COVID-19

          -  Concomitant use of

               1. amiodarone

               2. digoxin

               3. flecainide

               4. procainamide

               5. propafenone

          -  History of Torsades de pontes

          -  History of retinal disease

          -  Known chronic kidney disease ≥ stage 4

          -  Congenital prolonged QTc interval syndrome (Jervell and Lange-Nielsen syndrome,
             Romano-Ward syndrome)
Safety and Dose Finding Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: NS-065/NCNP-01; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: Male
Minimum age: 4 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to evaluate the safety of a high (80mg/kg) and low
      (40mg/kg) dose of NS-065/NCNP-01 delivered as an intravenous infusion in patients with
      Duchenne Muscular Dystrophy (DMD) amendable to exon 53 skipping. Additional objectives
      include tolerability, muscle function and strength, pharmacokinetics and pharmacodynamics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male ≥ 4 years and <10 years of age

          -  Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon
             53 to restore the dystrophin mRNA reading frame;

          -  Able to walk independently without assistive devices;

          -  Ability to complete the time to stand, time to run/walk and time to climb assessments;

          -  Stable dose of glucocorticoid for at least 3 months

        Exclusion Criteria:

          -  Acute illness within 4 weeks prior to the first dose of study medication;

          -  Evidence of symptomatic cardiomyopathy. [Note: Asymptomatic cardiac abnormality on
             investigation would not be exclusionary];

          -  Severe allergy or hypersensitivity to medications;

          -  Severe behavioral or cognitive problems that preclude participation in the study, in
             the opinion of the Investigator;

          -  Previous or ongoing medical condition, medical history, physical findings or
             laboratory abnormalities that could affect safety, make it unlikely that treatment and
             follow-up will be correctly completed or impair the assessment of study results, in
             the opinion of the Investigator;

          -  Patient is taking any other investigational drug currently or within 3 months prior to
             the start of study treatment; or

          -  Patient has had surgery within the 3 months prior to the first anticipated
             administration of study medication or surgery is planned for anytime during the
             duration of the study;

          -  Patient has previously participated in this study or any other study during which
             NS-065/NCNP-01 was administered.
Cellular Immune Augmentation in Colon and Rectal Cancer
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Rectal Neoplasms; Colonic Neoplasms
Intervention: GM-CSF
Intervention description: 250ug/m^2 SQ QD with a cap of 500mcg SQ QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic colon cancer; Metastatic rectal cancer

Summary:

      While new treatments for metastatic and recurrent colorectal cancer have become available
      over the past several years, this disease remains incurable with a limited life expectancy
      from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer
      are needed. Under this proposal, patients with advanced colorectal cancer will receive
      Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic
      cells and enhance anti-tumor immune mechanisms. This will be combined with standard
      chemotherapy and patients will be followed for response and overall survival. Detailed
      correlative laboratory analysis will also be performed to define the extent of dendritic cell
      and cellular immune system stimulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have: metastatic, disseminated or recurrent colon or rectal cancer

          -  Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks)
             Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent)
             given once weekly 5FU/leucovorin/irinotecan given once weekly

          -  Patient must be able to be taught to administer GM-CSF subcutaneously

        Exclusion criteria:

          -  Known allergic or other adverse reaction to GM-CSF

          -  Chemotherapy administration more frequently than bi-weekly

          -  Pregnant or lactating women
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Intervention: Acetaminophen ER; Placebo
Intervention description: Single dose (2 tablets) Acetaminophen ER 750 mg; Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
Intervention MeSH terms: Acetaminophen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 403.0
Sex: All
Minimum age: 17 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acetaminophen; Paracetamol Analgesics; Analgesics; Non-Narcotic Pain; Postoperative Pain; Antipyretics Dental Surgery; Third molar extraction

Summary:

      The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg
      (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar
      extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg
      tablets) in a sub-group of subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 17 and less than 46 years of age

          -  Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30

          -  Scheduled to undergo surgical extraction of one impacted third molar from the lower
             jaw. The third molar from the upper jaw from the same side may also be removed.

          -  Experiencing moderate to severe pain after extraction of third molars.

        Exclusion Criteria:

          -  Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory
             drugs (e.g., Motrin, Advil, Aleve, Naproxen).

          -  Cannot be pregnant (or planning to be pregnant) or nursing a baby

          -  Unable to swallow whole large tablets or caplets.

          -  Cannot have any other medical conditions that the investigator feels may compromise
             your safety or the study results.
E3-Hormone Refractory Prostrate Cancer Taxotere Combination
Condition: Prostate Cancer; Metastatic; Hormone Refractory
MeSH terms: Prostatic Neoplasms
Intervention: Zactima (vandetanib); Docetaxel; Prednisolone
Intervention MeSH terms: Prednisolone; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 86.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; zactima; vandetanib; metastatic

Summary:

      The purpose of this study is to determine whether treatment with Zactima (vandetanib) in
      combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and
      Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer
      who have not previously received chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic hormone refractory prostate cancer defined as those patients with evidence
             of progression of disease in spite of castrate levels of testosterone indicated by
             rising levels of PSA

          -  No previous chemotherapy although those patients that have received estramustine can
             enter the study provided the estramustine was stopped 3 weeks before dosing of study
             drug

          -  screening PSA values >20ng/ml. this must be confirmed by two separate measurements at
             least 2 weeks apart

        Exclusion Criteria:

          -  Treatment within 4 weeks before randomization and/or whilst on study, treatment with
             the following: 1)non-approved or experimental drug, 2)treatment with a drug with
             similar mechanism of action to ZD6474

          -  concurrent treatment with other anticancer agents, othr than docetaxel and
             prednisolone as defined in the protocol
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Condition: Bladder Cancer; Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Renal Pelvis Carcinoma; Ureter Carcinoma; Urinary Bladder Carcinoma; Urethra Carcinoma; Muscle Invasive Bladder Cancer
MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
Intervention: Rucaparib
Intervention description: Rucaparib will be administered daily.
Intervention MeSH terms: Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PARP inhibitor; PARPi; HRD; ATLAS; homologous recombination; DNA repair; LOH; DNA defect; DNA anomaly; Rucaparib; MIBC

Summary:

      The purpose of the ATLAS study is to determine how patients with locally advanced
      unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically or cytologically confirmed locally advanced unresectable or
             metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter,
             urinary bladder or urethra)

          -  Received 1 or 2 prior treatment regimens for advanced or metastatic disease

          -  Confirmed radiologic disease progression during or following recent treatment

          -  Mandatory biopsy is required during screening

          -  Measurable disease per RECIST v1.1

          -  Adequate organ function

          -  ECOG 0 or 1

        Exclusion Criteria:

          -  Prior treatment with a PARP inhibitor

          -  Symptomatic and/or untreated CNS metastases

          -  Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption
             of rucaparib