bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain
Condition: Constipation
MeSH terms: Constipation
Intervention: N-methylnaltrexone bromide (MOA-728); placebo
Intervention description: Oral; placebo
Intervention MeSH terms: Bromides; Methylnaltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the safety and dose-response relationship of
      N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects
      with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel
      dysfunction (OIBD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not
             due to malignant cancer.

          -  Taking oral, transdermal, intravenous, or subcutaneous opioids.

          -  Willingness to discontinue all pre-study laxative therapy and use only study permitted
             rescue laxatives.

        Exclusion Criteria:

          -  History of chronic constipation before the initiation of opioid therapy.

          -  Other GI disorders known to affect bowel transit.

          -  Women who are pregnant, breast-feeding, or plan to become pregnant.
Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty
Condition: Abdominoplasty
MeSH terms: Musculoskeletal Pain
Intervention: Botulinum Neurotoxin Serotype E; Placebo
Intervention description: Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.; Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
Intervention MeSH terms: Botulinum Toxins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 23 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: pain, neurotoxin

Summary:

      To determine the safety and efficacy of single intra-operative treatment of Botulinum
      Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA)
      in participants undergoing abdominoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women 23 to 55 years of age, inclusive

          2. Scheduled to undergo elective abdominoplasty surgery with full length plication from
             xyphoid to pubis, and removal of skin/fat flap under general anesthesia (endotracheal
             or otherwise) without liposuction

          3. American Society of Anesthesiologist (ASA) Physical Class 1-2.

        Exclusion Criteria:

          1. History of prior major abdominal surgery as judged by the investigator

          2. Pre-existing lung disease that could impact participant safety in the opinion of the
             investigator

          3. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton-
             Lambert syndrome, or amyotrophic lateral Sclerosis)

          4. At high risk of deep vein thrombosis as judged by the investigators determined by a
             Caprini score of 3 or higher

          5. Slow vital capacity that is below 80% of normal value for respective race, age,
             height, and gender or below 2.5 Liters (L) of absolute volume

          6. Pulse oximetry below 95%

          7. Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32

          8. Reported use of any botulinum toxin within 3 months prior to the date of surgery

          9. Use of long acting opioids within 3 days or any opioid medication within 24 hours
             prior to surgery

         10. Aminoglycoside intake within 48 hours prior to or during surgery

         11. Participants on anti-depressant or anti-psychotic medications

         12. Reported pain score of 2 or more at screening on the 11-point scale numerical pain
             rating scale-administered after an activity (NPRS-A) following an activity after and
             walking approximately 10 feet.
A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Fovista®; bevacizumab; ranibizumab; aflibercept
Intervention MeSH terms: Bevacizumab; Ranibizumab; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; subfoveal choroidal neovascularization; Fovista®; Avastin®; Lucentis®; Eylea®

Summary:

      To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with
      anti-VEGF therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years.

          -  Active subfoveal choroidal neovascularization (CNV) due to AMD.

        Exclusion Criteria:

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication.

          -  Subjects with subfoveal scar or subfoveal atrophy

          -  Any ocular or periocular infection in the past twelve (12) weeks.

          -  History of any of the following conditions or procedures in the study eye:
             Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.
             trabeculectomy), glaucoma drainage device, corneal transplant.
Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
Condition: Lymphoma, Mantle-Cell
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: CpG-MCL vaccine; PF-3512676; Vaccine-primed T-cells; Autologous hematopoietic stem cell transplant (HSCT); Rituximab; Standard induction chemotherapy; Cyclophosphamide; Filgrastim
Intervention description: CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection.; PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. PF-03512676 acts as an agonist of human Toll-like receptor 9, leading to activation of antigen-presenting cells and a cascade of antitumor immune reactions.; Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells.; Regular medical procedure; 375 mg/m² by infusion; Patient-specific, regular medical care treatment as determined by treating oncologist; Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC); Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
Intervention MeSH terms: Cyclophosphamide; Rituximab; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Mantle cell lymphoma (MCL) is a sub-type of non-Hodgkin's lymphoma (NHL) which is generally
      considered incurable with current therapy. Participants will receive an autologous vaccine
      against their individual lymphoma after undergoing stem cell transplantation. This
      vaccination may prolong the time which patients will stay in remission from their disease.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Newly-diagnosed with mantle cell lymphoma (MCL) with accessible disease site for
             excisional biopsy, OR have sufficient peripheral blood tumor to leukapherese ≥ 1.5 x
             10e9 lymphoma cells in a single session

          -  Medically appropriate by standard clinical criteria to receive rituximab and standard
             induction chemotherapy and high-dose chemotherapy with autologous hematopoietic cell
             transplant (AHCT)

          -  HIV-negative

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status, OR Karnofsky performance
             scale 50 to 100%

          -  Capable of providing informed consent

        EXCLUSION CRITERIA

          -  Currently receiving immunosuppressive medications

          -  Severe psychological or medical illness

          -  Pregnant or lactating

          -  Unable to safely complete the study, at the discretion of the principal investigator
Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: GZ/SAR402671
Intervention description: Pharmaceutical form:capsule
Route of administration: oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To assess the long-term safety of GZ/SAR402671 in adult male participants with Fabry disease
      who previously completed study ACT13739 (NCT02489344).

      Secondary Objective:

      To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy
      endpoints in adult male participants with Fabry disease who previously completed study
      ACT13739.
    

Eligibility criteria:

        Inclusion criteria :

          -  Male participant with Fabry disease who previously completed study ACT13739.

          -  Participants, willing and able to provide signed informed consent.

          -  Sexually active participants, willing to practice true abstinence in line with their
             preferred and usual lifestyle or using two acceptable effective methods of
             contraception.

        Exclusion criteria :

        -Participants, in the opinion of the Investigator, unable to adhere to the requirements of
        the study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: EFX; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind,
      placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4
      NASH.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive,
             based on the date of the screening visit.

          -  Main Study only: Body mass index (BMI) > 25 kg/m^2 (unless the patient has
             biopsy-proven NASH documented within the last 2 years).

          -  Main Study only: Must have confirmation of ≥ 10% liver fat content on magnetic
             resonance imaging- proton density fat fraction (MRI-PDFF) at screening.

          -  Main Study only: Biopsy-proven NASH. Must have had a liver biopsy within 180 days of
             randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease
             (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the
             following NAS components:

               -  Steatosis (scored 0 to 3),

               -  Ballooning degeneration (scored 0 to 2), and

               -  Lobular inflammation (scored 0 to 3)

          -  Cohort C only: FibroScan® measurement > 13.1 kPa.

          -  Cohort C only: Cirrhosis due to NASH. Liver biopsy consistent with F4 fibrosis
             according to the NAS system, confirmed by the central or local reader.

        Exclusion Criteria:

          -  Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6
             months prior to screening.

          -  Type 1 and insulin-dependent Type 2 diabetes.

          -  Poorly controlled hypertension (blood pressure > 160/100).
A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)
Condition: Hematologic Malignancy
MeSH terms: Neoplasms; Hematologic Neoplasms
Intervention: Duvelisib
Intervention description: Administered as oral capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a long-term, continued treatment study that evaluated the long-term safety, clinical
      activity, and overall survival (OS) of duvelisib in individuals with hematologic malignancies
      that were previously treated with duvelisib in a previous sponsor-approved study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have participated in a previous study of duvelisib, and:

               -  Be actively receiving duvelisib monotherapy on the previous study (within 14 days
                  of study entry) and demonstrating clinical benefit (complete response [CR]/
                  partial response [PR]/ stable disease [SD]) of continued use, or

               -  Be in the survival follow-up phase of a previous duvelisib study

          -  Have completed the required components of the previous study and be appropriate for
             enrollment into this long-term continued treatment and follow-up study, as determined
             by the Sponsor

        Exclusion Criteria:

          -  Had any ongoing ≥ Grade 3 adverse event (AE) considered related to duvelisib treatment
             at screening

          -  Was pregnant or nursing
A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome
Condition: Hemophagocytic Syndrome (HPS)
MeSH terms: Lymphohistiocytosis, Hemophagocytic; Syndrome
Intervention: Ruxolitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study to determine the efficacy of Ruxolitinib in secondary hemophagocytic
      syndrome. The primary objective is to assess the efficacy of ruxolitinib 15 mg PO twice daily
      in patients with HPS. The primary endpoint is overall survival at two months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, or their legally authorized representative, must voluntarily provide written
             IRB-approved informed consent.

          -  Males and females, 18 years of age or older at the time of enrollment.

          -  Patients must meet the diagnostic criteria for HPS (at least 5 of the following):
             fever, splenomegaly, cytopenia involving ≥2 cell lines (Hemoglobin <9 g/dL; platelets
             <100,000/μL; absolute neutrophil count <1000/μL), hypertriglyceridemia or
             hypofibrinogenemia, tissue demonstration of hemophagocytosis, low or absent NK
             (Natural Killer) cell activity, serum ferritin ≥3000 ug/L, soluble IL-2 receptor
             (CD25) >2400 U/mL.

          -  In the investigator's opinion, the patient has the ability to participate fully in the
             study, and comply with all its requirements.

        Exclusion Criteria:

          -  CNS (Central Nervous System) involvement

          -  Malabsorption

          -  Known secondary HPS (Hemophagocytic Syndrome) that is otherwise treatable (e.g.
             non-Hodgkin's lymphoma).

          -  Pregnant or lactating female: all females of child-bearing potential must have a
             negative serum pregnancy test within 7 days of treatment; lactating females must
             discontinue breast feeding.

          -  Estimated creatinine clearance <15mL/min

          -  Has received any prior systemic therapy, excluding corticosteroids, within 7 days (or
             5 half-lives) of treatment.

          -  No active malignancy at the time of enrollment, except nonmelanoma skin cancers or
             carcinoma in situ. Patients with a prior history of malignancy are eligible if their
             malignancy has been definitely treated or is in remission and does not require ongoing
             adjuvant or cancer-directed therapies.

          -  Active hepatitis B or hepatitis C or known HIV infection

          -  Known (and biopsy-confirmed) liver cirrhosis; or, a reported history of liver
             cirrhosis with a Model for End-stage Liver Disease (MELD) score >20.
SBRT Plus Pembrolizumab and Trametinib for Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Cyberknife plus Pembrolizumab and Trametinib; Cyberknife plus Gemcitabine
Intervention description: Radiation therapy plus drug; Radiation therapy plus drug
Intervention MeSH terms: Gemcitabine; Pembrolizumab; Trametinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stereotactic body radiation therapy; CyberKnife; Initial treatment

Summary:

      Hypothesis: Survival benefits could be found in SBRT Plus Pembrolizumab and Trametinib
      compared with SBRT plus gemcitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed pancreatic ductal adenocarcinoma with unequivocal first
             progression after surgery followed by chemotherapy

          2. Without any immunotherapy or targeted therapy

          3. A life expectancy of >3months

          4. ECOG of 0 to1

          5. Age of 18 years or older

          6. Analysis of surgical specimens showed KRAS mutations and positive immunohistochemical
             staining of PD-L1

          7. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×109 cells/L,
             leukocyte count≥ 3.5 ×109 cells/L, platelets ≥ 70×109 cells/L, hemoglobin ≥ 8.0 g/dl

          8. Liver and kidney function tests: Albumin > 2.5 g/dL, total bilirubin < 3 mg/dL,
             creatinine < 2.0 mg/dL, AST<2.5 × ULN(Upper Limit of Normal)(0-64U/L), ALT<2.5 ×
             ULN(0-64U/L)

          9. INR < 2 (0.9-1.1)

         10. Ability of the research subject or authorized legal representative to understand and
             the willingness to sign a written informed consent document.

        Exclusion Criteria:

          1. Prior immunotherapy or targeted therapy

          2. Evidences of metastatic disease confirmed by chest CT or FDG PET-CT

          3. Contraindication to receiving immunotherapy, targeted therapy or SBRT

          4. ECOG ≥2

          5. Age <18 years

          6. Analysis of surgical specimens showed KRAS wild type or negative immunohistochemical
             staining of PD-L1

          7. Secondary malignancy

          8. Abnormal results of blood routine examinations and liver and kidney and coagulation
             tests

          9. Patients with active inflammatory bowel diseases or peptic ulcer

         10. Gastrointestinal bleeding or perforation within 6 months

         11. Heart failure: NYHA III-IV

         12. Respiratory insufficiency

         13. Women who are pregnant

         14. Participation in another clinical treatment trial while on study

         15. Patients in whom fiducial implantation was not possible

         16. Inability of the research subject or authorized legal representative to understand and
             the willingness to sign a written informed consent document.
A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough
Condition: Chronic Refractory Cough
MeSH terms: Cough
Intervention: Orvepitant Maleate; Placebo
Intervention description: Tablet, once daily, oral; Tablet, once daily, oral
Intervention MeSH terms: Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness of three doses of orvepitant,
      taken once a day, in the treatment of chronic refractory cough.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male and female subjects ≥18 years of age.

          -  Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines
             attached).

          -  An awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during
             the screening period.

        Key Exclusion Criteria:

          -  Subjects with respiratory tract infection (<4 weeks prior to study start)

          -  Current smokers or ex-smokers with <6 months' abstinence or cumulative history of >10
             pack years

          -  Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of
             screening

          -  FEV1 <80% predicted, measured at screening using spirometry

          -  History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant
             bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease
             (COPD)

          -  Any clinically significant abnormal laboratory test result(s)

          -  Inability to comply with the use of prohibited and allowed medications as described in
             the protocol.