bioihbjkbjnl/mcl2 huggingface dataset:
Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
Condition: Richter Syndrome
MeSH terms: Syndrome
Intervention: Obinutuzumab; Ibrutinib; CHOP
Intervention description: 100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6; 560mg po daily; cyclophosphamide, doxorubicin, vincristine, and prednisone
Intervention MeSH terms: Obinutuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment based on fitness of participants
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: leukemia; richter

Summary:

      This research study studies the combination of ibrutinib and obinutuzumab with or without the
      standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients
      with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine
      Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal
      needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by
      targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may
      be a better treatment for patients with Richter's Transformation. Depending on fitness, the
      patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP
      (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also
      called vincristine, and P= prednisolone or prednisone (corticosteroids).
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmed Richter's transformation in treatment naïve and previously treated chronic
             lymphocytic leukemia/small lymphocytic lymphoma patients

          -  may have had prior exposure to ibrutinib and other B-cell signaling receptor agents

          -  Adequate hematologic function

          -  Adequate liver and kidney function

          -  Willing and able to participate in all required evaluations and procedures in this
             study protocol

          -  Female subjects of childbearing potential must not be pregnant upon study entry

          -  Male and female subjects who agree to use highly effective methods of birth control

        Exclusion Criteria:

          -  known allergy to any of medications

          -  chemotherapy taken within 21 days of study treatment

          -  targeted therapy within 10 days of study treatment

          -  BCR inhibitors within 24 hours of study treatment

          -  major surgery within 4 weeks of first dose of study treatment

          -  women who are pregnant

          -  known infection with HIV or Hepatitis C

          -  Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BCT197; Placebo
Intervention description: Capsules will be taken orally with fluids over a 5 day period after randomization; Capsules will be taken orally with fluids over a 5 day period after randomization
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 282.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of BCT197 when added on to
      standard of care in adult subjects with acute respiratory exacerbations of chronic
      obstructive pulmonary disease requiring hospitalization. Additionally, the study will
      characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the
      study will be 26 weeks. Subjects will receive study treatment administration over a period of
      5 days after randomization. It is expected that approximately 255 subjects will complete the
      study and follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults

          -  Presence of an active exacerbation of the ongoing COPD requiring hospitalization for
             treatment

          -  Subjects with a documented diagnosis of COPD C or D

          -  Current smokers or ex-smokers

          -  A documented history of at least one moderate or severe COPD exacerbation in the 12
             months preceding the Screening Visit that required antibiotics and/or systemic
             corticosteroid.

          -  Current regular treatment for COPD (for at least 2 months prior to the Screening
             Visit.

        Exclusion Criteria:

          -  Age less than 40 years old

          -  Current diagnosis of asthma

          -  Subjects who have already completed treatment for the current exacerbation of COPD

          -  Subjects currently requiring intensive care unit (ICU) and/or mechanical ventilation

          -  Received a course of PDE4, p38 or PDE3/4 inhibitors within their respective defined
             washout periods.
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA
Condition: Obstructive Sleep Apnea; Excessive Sleepiness
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Sleepiness
Intervention: JZP-110; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Driving

Summary:

      This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the
      effect of JZP-110 on driving performance in subjects with excessive sleepiness due to
      obstructive sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age 21 to 65 years inclusive

          2. Diagnosis of obstructive sleep apnea (OSA) per International Classification of Sleep
             Disorders (ICSD-3)

          3. BMI 18 to <40 kg/m2

          4. Willing and able to provide written informed consent

        Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             OSA that is associated with excessive sleepiness

          3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to Diagnostic
             and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria

          4. History or presence of any unstable medical condition, behavioral or psychiatric
             disorder (including active suicidal ideation), or surgical history that could affect
             the safety of the subject or interfere with study efficacy and/or safety assessments
             per the judgment of the investigator

          5. History of bariatric surgery within the past year or a history of any gastric bypass
             procedure

          6. Presence or history of significant cardiovascular disease

          7. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription
             medications that could affect sleep-wake function
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: diazepam nasal spray
Intervention MeSH terms: Diazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cluster Seizures; Seizures; Clusters; Acute repetitive seizures

Summary:

      This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray
      in adolescents and adults with cluster seizures, with a focus on potential local effects
      (changes in nasal mucosa, olfaction, and taste).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of drug-resistant epilepsy

          -  Patients who experience multiple episodes of acute repetitive seizures requiring at
             least one concomitant antiepileptic drug (AED)

          -  Occurrence of at least 3 seizure clusters within the past 12 months, including at
             least one cluster in the 4 months prior to the Screening Visit

          -  A caregiver must consent to participate together with the subject for purposes of
             observation and data collection

          -  The caregiver must be present when the investigational product is administered

          -  Screening body weight between 26 to 111 kg, inclusive

        Exclusion Criteria:

          -  Female subject who is pregnant, breastfeeding, or planning to become pregnant

          -  Presence or history of any abnormality or illness that may affect the absorption,
             distribution, metabolism or elimination of diazepam

          -  Known allergy or hypersensitivity to diazepam, related drugs, or any of the
             formulation components

          -  Positive screening test for ethanol or other drugs of abuse

          -  Unable to receive medications intranasally
Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Intervention: Splanchnic nerve block
Intervention description: Percutaneous splanchnic nerve block
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: heart failure, exercise, splanchnic nerve block

Summary:

      Splanchnic vasoconstriction may contribute to decompensation of chronic heart failure (HF)
      via volume redistribution from the splanchnic vascular bed to the central compartment. This
      is a sympathetically mediated reflex and can be interrupted through a splanchnic nerve block
      (SNB). We hypothesize that interruption of the efferent/afferent innervation of the
      splanchnic vasculature will decrease cardiac congestion in patients presenting with HF. Based
      on preliminary safety and efficacy data in acute and chronic heart failure patients with
      temporary (<24 h) SNB. Now we will apply a prolonged SNB in chronic heart failure patients
      using a long acting agent. We will test the effects of SNB on long term exercise capacitance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Followed at DUMC for known or suspected diagnosis of HF (NYHA stage 2-4, Class C-D),
             including patients on inotropic medication

          -  Systolic blood pressure (SBP) > 100 mmHg

          -  History of HF hospitalization or ER visit or iv diuretic use in last 12 months.

          -  Patients will be included regardless of left ventricular ejection fraction.

        Exclusion Criteria:

          -  Anticoagulation at the time the procedure or in case of recent warfarin use an INR
             >1.4. Anticoagulation includes: warfarin, or novel oral anticoagulants like
             dabigatran, rivaroxaban, apixaban, endoxaban or full dose intravenous heparin products
             or bivalirudin and fondaparinux). Antiplatelet agents besides aspirin such as
             ticagrelor, prasugrel, Plavix are also considered to be a contraindication if used at
             time point of procedure.

          -  Immunosuppressive medications for solid organ transplant

          -  Acute MI (STEMI or Type I NSTEMI) within 7 days?

          -  Evidence of progressive cardiogenic shock within 48 hours

          -  Restrictive cardiomyopathy

          -  Constrictive pericarditis

          -  Pericardial effusion with evidence of tamponade

          -  Severe valvular stenosis requiring intervention

          -  Known history of an increased bleeding risk

          -  Thrombocytopenia (< 50,000)

          -  End-stage renal disease CKD stage 5 due to primary renal pathology
Topical Aprepitant in Prurigo Patients
Condition: Pruritus
MeSH terms: Pruritus; Prurigo
Intervention: Aprepitant; Placebo
Intervention description: Aprepitant gel (10 mg/g); gel without active component
Intervention MeSH terms: Aprepitant; Fosaprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pruritus

Summary:

      Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically
      Applied Aprepitant in Patients With Prurigo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with Prurigo suffering from chronic pruritus

          -  Disease duration > six month

          -  Therapy refractory to at least two previous antipruritic treatments with topical,
             intralesional or systemic corticosteroids, or other immunosuppressants,
             antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation

          -  Adult male or female patients, aged 18 to 80 years

        Exclusion Criteria:

          -  Concomitant medications that are primarily metabolized through Cytochrome P450 3A4

          -  Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin
             less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial

          -  UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)

          -  Prescribed systemic medications are limited

          -  Clinically significant abnormalities in Blood analyses

          -  Anamnestic excessive use of alcohol or tobacco or drugs

          -  Presence of active tumor disease or history of malignancies within five years prior to
             Visit 1 (Screening)

          -  Known or suspected hypersensitivity to component(s) of investigational products

          -  Within the last 30 days or current participation in any other interventional clinical
             trial

          -  Subjects who have received treatment with any non-marketed drug substance (i.e., an
             agent which has not yet been made available for clinical use following registration)
             within the last 6 month

          -  Previously enrolled/randomised in this clinical trial

          -  In the opinion of the investigator, the subject is unlikely to comply with the
             Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)

          -  Females who are pregnant, of child-bearing potential and wishing to become pregnant
             during the trial or are breast feeding

          -  Females of child-bearing potential with positive pregnancy test

          -  Subjects (or their partner) not using an adequate method of contraception (according
             to national requirements, as applicable)
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Paclitaxel
Intervention description: Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to provide access to paclitaxel therapy to subjects with
      advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388)
      and should have continued therapy with paclitaxel as the discretion of the investigator, and
      to evaluate the frequency and the severity of observed adverse reactions in treated subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with advanced head and neck cancer who have completed the previous late phase
             2 study (CA139-388) and should have continued therapy with paclitaxel as the
             discretion of the investigator
Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer
Condition: Hot Flashes; Hot Flushes; Vasomotor Symptoms
MeSH terms: Hot Flashes
Intervention: Stellate Ganglion Block injection with bupivicaine; Saline
Intervention description: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.; sham injection with saline
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 2.0
Sex: Female
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Vasomotor symptoms (hot flashes, night sweats, VMS) affect up to 65% of breast cancer
      survivors and negatively impact their quality of life. VMS in Hispanic women are
      significantly more severe as compared to non-Hispanic Caucasian women. Few effective
      treatments for VMS are available, especially in the underserved Hispanic and Spanish-speaking
      populations which is problematic, as Hispanics will comprise 20% of the U.S. population by
      2025. Stellate ganglion nerve block (SGB) with local anesthetic, previously performed for
      chronic pain indications, has shown promise as a potential treatment for menopausal women
      with VMS in previous clinical trials, but has not been investigated in Hispanic or
      Spanish-Speaking women with breast cancer in a controlled study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Hispanic or Spanish speaking women aged 30 to 70 years

          2. 28 or more reported moderate-to-very severe hot flashes per week

          3. a minimum of two weeks of VMS diary recording prior to SGB

          4. current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer
             indication for at last six months

          5. willingness to undergo fluoroscopy-guided SGB or sham treatment.

          6. if participant is on an SSRI,SNRI or membrane stabilizer (pregabalin, gabapentin, for
             example), it must be a stable, unchanged dose for previous 3 months

        Exclusion Criteria:

        1. conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the
        anterior neck or cervical spine; goiter, cardiac/pulmonary compromise; acute
        illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications
        to a local anesthetic or contrast dye); pregnancy 2. use of treatments in the past 2 months
        that can affect VMS (e.g., use of oral or transdermal HT or contraceptives,

        -
Safety and Dose Finding Study of Xigris in Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: Drotrecogin alfa activated (Xigris)
Intervention description: We will test different dose regimens of Drotrecogin alfa activated (Xigris) to determine the optimal dose to achieve PTT between 65 and 100 secs. The initial patients will receive Xigris dosed at an infusion rate of 12 mcg/kg/h via pre-filter arterial drip chamber via a standard IV pump. The PTT will be assessed at baseline,15,30,60,120 and 180 mins. Xigris dose will be adjusted in the following patients if the afferent PTT rises above 100 secs (normal range 25-40 secs) or if PTT remains <65 secs. If PTT remains less than 65 secs, the dose will be increased to the second dose regiment of 18 mcg/kg/hr. The dose escalation will continue in increments of 6 mcg/kg/h to a maximum dose of 36 mcg/kg/h. Each patient will receive Xigris only once.
Intervention MeSH terms: Drotrecogin alfa activated; Protein C
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemodialysis; Anticoagulation; Xigris; PTT

Summary:

      The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an
      anticoagulant at different dose levels during dialysis treatment in patients with End Stage
      Renal Disease (ESRD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. >18

          2. Usually used heparin with HD

        Exclusion Criteria:

          1. Plt <100

          2. Pregnancy

          3. H/o bleeding diathesis

          4. H/o CVA

          5. Pt on Ticlid/plavix/warfarin

          6. SBP >200

          7. BASELINE PTT>50

          8. INR>1.6