bioihbjkbjnl/mcl2 huggingface dataset:
A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Bevacizumab
Intervention description: Bevacizumab was supplied as a sterile liquid in single-use vials.
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study evaluated the bone marrow response, safety, and tolerability of 6
      months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic
      leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with
      6 months of follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, ≥ 18 years of age.

          -  B-chronic lymphocytic leukemia not yet requiring treatment.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  No previous treatment of chronic lymphocytic leukemia (CLL) by chemotherapy,
             radiotherapy, or immunotherapy.

          -  Life expectancy > 6 months.

        Exclusion Criteria:

          -  Central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord
             compression.

          -  Computed tomography (CT) scan based evidence of tumor invading major blood vessels.

          -  Gastrointestinal (GI) tract involvement by CLL.

          -  Active viral, bacterial, or fungal infection.

          -  Uncontrolled hypertension, cerebrovascular accident/stroke (≤ 6 months prior to
             randomization), myocardial infarction (≤ 6 months prior to randomization), unstable
             angina (≥ New York Heart Association (NYHA) Grade IV), thrombosis within 6 months
             before enrollment, NYHA Grade II congestive heart failure, or serious cardiac
             arrhythmia requiring ongoing medication.
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: lenalidomide (Revlimid®); Cyclophosphamide; Prednisone
Intervention description: 25 mg p.o. daily on days 1-21 of each 28 day cycle; 50 mg p.o. BID daily on days 1-21 of each 28 day cycle; 50 mg p.o. Q.O.D.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Revlimid

Summary:

      The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and
      prednisone (RCP) in patients with newly diagnosed multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with newly diagnosed, symptomatic multiple myeloma based on the following
        criteria:

          -  Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone
             marrow and/or a documented clonal plasmacytoma

        PLUS one or more of the following:

          -  Calcium elevation (11.5 mg/dl) [42.65 mmol/l]

          -  Renal insufficiency (1.5 x the ULN of serum creatinine)

          -  Anemia (hemoglobin <=10 g/dl or 2 g/dl <= normal)

          -  Bone disease (lytic lesions or osteopenia)

        Measurable disease is defined at least one of the following three measurements:

          -  Serum M-protein >=1 g/dl ( or 10 g/l)

          -  Urine M-protein >=200 mg/24 h

          -  Serum FLC assay: Involved FLC level >=10 mg/dl (>=100 mg/l) provided serum FLC ratio
             is abnormal

          -  Measurable plasmacytoma

          -  NOTE: If a patient meets the criteria for symptomatic multiple myeloma but does not
             meet serum M-protein, urine M-protein or serum FLC levels stated above, percent plasma
             cells in bone marrow will be used to follow response.

        Laboratory test results within these ranges:

          -  Absolute neutrophil count >= 1.0 x 109/L

          -  Platelet count >= 50 x 10(9)/L

          -  Hemoglobin >= 9 gm/dl

          -  Serum creatinine <= 2.5mg/dL.

          -  Total bilirubin <=1.5 x upper limit of normal

          -  AST (SGOT) and ALT (SGPT) <= 3 x ULN

        Exclusion Criteria:

          -  Known hypersensitivity to thalidomide

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Patients with a solitary plasmacytoma

          -  Patients with uncontrolled diabetes

          -  Patients with ≥ Grade 3 sensory neuropathy

          -  History of cardiac disease, with NYHA Class II or greater
Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Fostamatinib
Intervention description: Phase II Trial to evaluate the efficacy of 200mg fostamatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lymphoma; DLBCL; fostamatinib; Diffuse Large B-Cell Lymphoma (DLBCL)

Summary:

      This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients
      with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large
      B-Cell Lymphoma (abbreviated as DLBCL)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged at least 18 years of age.

          -  Patients with relapsed or refractory diffuse large B-cell lymphoma who have previously
             received R-CHOP (or equivalent) chemo-immunotherapy and high dose chemotherapy with
             stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue.

          -  Measurable disease as defined by Cheson et al 2007 criteria.

          -  One fresh pre-treatment excisional or core needle biopsy from suitable and accessible
             site.

          -  World Health Organization (WHO) performance status 0 to 1.

        Exclusion Criteria:

          -  Treatment with nitrosurea, mitomycin C, investigational agents or study drugs w/in28
             days of first dose of study treatment, any other chemotherapy, immunotherapy or
             anticancer agents w/in 3 weeks of first dose of study treatment, previous
             fostamatinib.

          -  With the exception of alopecia, any unresolved toxicities from prior therapy or
             surgery greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.

          -  Uncontrolled hypertension (defined as >140mmHg systolic and/or > 90 mmHG diastolic at
             baseline with or without antihypertensive therapy.

          -  Evidence of tuberculosis (TB).

          -  Inadequate boen marrow reserve.
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Infections; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: BMS-663068 400 mg; BMS-663068 800 mg; BMS-663068 600 mg; BMS-663068 1200 mg; Raltegravir 400 mg; Tenofovir 300 mg; Ritonavir 100 mg; Atazanavir 300 mg
Intervention description: Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 100 mg, Once daily, 96 weeks; Capsules, Oral, 300 mg, Once daily, 96 weeks
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Raltegravir Potassium; Fostemsavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, efficacy, tolerability and
      pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil
      Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well
      tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1
      infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening

          -  Treatment experience with antiretroviral therapies (excluding integrase inhibitors)

          -  Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 < 0.1
             μM

          -  Cluster of differentiation (CD)4+ T-cell count > 50 cells/mm3

        Exclusion Criteria:

          -  History (or evidence at Screening) of genotypic resistance to any component of the
             study regimen [ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir
             (RAL)]

          -  Certain laboratory and electrocardiogram (ECG) values
(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Intervention: Placebo; HBB 20 mg
Intervention description: 1-5 tablets per episode; Active drug, one to five tablets per episode
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB)
      20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment
      of intensity of abdominal pain associated with cramping (APC) in the treatment of two
      episodes.
    

Eligibility criteria:

        Inclusion Criteria:

        History of recurrent abdominal pain with cramping (APC) for at least three months.

        Recorded at least two episodes of APC of at least "moderate" intensity (i.e., 5 or above on
        a 0-10 point scale) lasting one hour in the eDiary during the run-in period.

        Exclusion Criteria:

        Experiencing daily episode of APC during Run-in period Active gastrointestinal disease
        during the past 12 months including malignancy, inflammatory bowel disease, celiac disease
        or complete or partial bowel obstruction and who have undergone major gastrointestinal
        surgery with the past 12 months (patients with history of appendectomy, cholecystectomy,
        bilateral tubal ligation and c-section within past 12 months are allowed in the study).
Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients With Chronic Heart Failure
Condition: Chronic Heart Failure; Patients That Have Received a Left Ventricular Assist Device
MeSH terms: Heart Failure
Intervention: AAV1/SERCA2a; Placebo
Intervention description: AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10^13 DRP (DNase resistant particles); Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic Heart Failure

Summary:

      The aim of the study is to determine the safety and feasibility of giving an adeno-associated
      viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the
      CMV promoter (AAV1-CMV-SERCA2a), to heart failure patients that have received a left
      ventricular assist device (LVAD) for an accepted clinical indication.
    

Eligibility criteria:

        Inclusion criteria

          -  Patients that have had a left ventricular assist device (LVAD) implanted for chronic
             heart failure, where chronic heart failure is defined as at least 6 months

          -  Patients are clinically stable in the opinion of the clinical team looking after the
             patient

          -  Written informed consent

        Exclusion criteria

          -  <18 or >70 years of age at the time of consent

          -  Pregnancy or within 6 months of giving birth

          -  Women of child-bearing potential not using an effective method of contraception

          -  Men not using an effective method of contraception

          -  Suspected or active viral, fungal or parasitic infection within 48 hours prior to
             administration of IMP, in the opinion of the investigator*.

          -  Patients at a high risk of thrombosis in the opinion of the investigator

          -  Patients with a previous episode of LVAD thrombosis

          -  Patients with persistently raised lactate dehydrogenase (LDH >2.5 ULN)

          -  Patients requiring triple anticoagulation i.e. warfarin and dual anti-platelet

          -  Patients participating in another clinical trial

          -  Patients unable to comply with the protocol mandated procedures for social or other
             reasons, in the opinion of the investigator and primary care physician

               -  Eligible, enrolled and randomised patients who develop an infection will have
                  study treatment delayed until 7 or more days after the time point when infection
                  is no longer clinically evident.
An Open Label Extension Study in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399
Intervention description: 60 milligrams [(mg) with potential for dose escalation to 120 mg] subcutaneously every 4 weeks for 48 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arthritis

Summary:

      To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections
      for 48 weeks in participants with Rheumatoid Arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have given written informed consent

          -  Women must not be pregnant, breastfeeding or be at risk to become pregnant during
             study participation

          -  Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH
             (NCT00785928)

        Exclusion Criteria:

          -  Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928),
             any safety event, [including having a recent, ongoing, or serious infection, a serious
             drug reaction, or any adverse event (AE) that caused discontinuation from treatment]
             that in the opinion of the investigator poses an unacceptable risk to participation in
             the study.

          -  Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH
             (NCT00785928), any drug not allowed by the study protocol including unapproved drugs,
             biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.

          -  Enrollment in any other clinical trial involving off-label use of an investigational
             drug or device, or enrollment in any other type of medical research.
An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Intervention: UTTR1147A
Intervention description: UTTR1147A will be administered based on disease status, as described in the protocol.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of UTTR1147A in participants
      with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320
      participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study
      GA39925 (NCT03558152).
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria for Study Entry:

          -  Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry
             criteria

        Inclusion Criteria for Study Entry and Study Re-Entry:

          -  Ability to comply with requirements of the study, in the investigator's judgment

          -  For women and men: use of highly effective contraception as defined by the protocol.

        Exclusion Criteria:

        Exclusion Criteria for Study Entry:

          -  Withdrawal of consent from parent study

          -  Discontinuation of study drug as required by the parent study protocol

          -  Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 or
             from Study GA39925 prior to Week 8

          -  Noncompliance in the parent study, specifically defined as missing scheduled visits or
             non-adherence with background medications and concomitant medications

        Exclusion Criteria for Study Entry and Study Re-Entry:

          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within
             8 weeks after the final dose of study drug or within 18 weeks after the final dose of
             study drug from GA39925, whichever is longer

          -  Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary,
             renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms of
             infection judged by the investigator to be clinically significant since enrolling in
             the parent study

          -  Use of prohibited therapies as defined in the parent study

          -  Abnormal laboratory values, as defined in the protocol, recorded at the last visit in
             the parent study

        Exclusion Criterion for Study Re-Entry:

          -  Use of prohibited concomitant therapy since enrolling in the extension study
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
Condition: Ileus
MeSH terms: Ileus
Intervention: Alvimopan; Placebo
Intervention description: alvimopan pill; placebo pill
Intervention MeSH terms: Alvimopan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIPEC; peritoneal carcinomatosis

Summary:

      The purpose of this study is to investigate the ability of alvimopan to reduce the time to
      return of bowel function in patients undergoing cytoreductive surgery and hyperthermic
      intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half
      will receive placebo immediately before and for up to seven days after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand and the willingness to sign a written informed consent.

          -  Scheduled to undergo open (non-minimally invasive) CRS/HIPEC.

          -  Scheduled to receive postoperative pain management with intravenous opioids.

          -  Age > 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

          -  Women of child-bearing potential with negative pregnancy test prior to initiating
             study drug dosing.

        Exclusion Criteria:

          -  Greater than 7 days of consecutive opioid use immediately prior to scheduled surgery.

          -  Child-Pugh Class C hepatic impairment.

          -  End-stage renal disease (GFR < 15 mL/min/1.73 m2 and/or on peritoneal dialysis or
             hemodialysis).

          -  Complete mechanical bowel obstruction.

          -  Contraindication or inability to tolerate oral medication postoperatively.

          -  Presence of gastrointestinal ostomy after CRS/HIPEC.

          -  Pancreatic or gastric anastomosis performed during CRS/HIPEC.

          -  History of allergic reactions or hypersensitivity attributed to compounds of similar
             chemical or biologic composition as alvimopan at the treating investigators
             discretion.

          -  Severe or uncontrolled medical disorder that would, in the investigator's opinion,
             impair ability to receive study treatment (i.e. uncontrolled diabetes, chronic renal
             disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric
             illness/social situations that would limit compliance with study requirements).

          -  History of myocardial infarction in the 12 months prior to scheduled surgery.

          -  Pregnant or nursing.