bioihbjkbjnl/mcl2 huggingface dataset:
Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer
Condition: Esophageal Carcinoma
MeSH terms: Esophageal Neoplasms
Intervention: Botulinum Toxin Type A; Esophagectomy; Quality-of-Life Assessment
Intervention description: Given IM; Undergo esophagectomy; Ancillary studies
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well botulinum toxin type A works in preventing
      complication after surgery in patients with esophageal cancer. Botulinum toxin type A may
      cause less complications of nausea and vomiting after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic
             anastomosis

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

          -  Participant must understand the investigational nature of this study and sign an
             Independent Ethics Committee/Institutional Review Board approved written informed
             consent form prior to receiving any study related procedure

        Exclusion Criteria:

          -  Patients who have a history of gastrointestinal dysmotility or functional
             gastroparesis, including diabetic gastroparesis, central and peripheral nervous system
             disorders, renal failure, medication side effects, including chronic dependence of
             promotility agents, anticholinergic antispasmodic agents, or chronic narcotic use over
             2 years due to non-cancer causes

          -  Patients who have a history of previous gastric or duodenal surgery

          -  Patients who have a history of duodenal ulcer or duodenal fibrosis

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Allergy to botulinum toxin and/or egg

          -  Pregnant or nursing female participants

          -  Unwilling or unable to follow protocol requirements

          -  Any condition which in the investigator's opinion deems the participant an unsuitable
             candidate for study participation
Biology and Experience of Eating in Women With Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: Naloxone; Placebo
Intervention description: 4 mg / 0.1 ml; 0.1 ml
Intervention MeSH terms: Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Binge eating

Summary:

      The purpose of this study is to understand how the opioid system is involved in eating
      behavior.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese, as defined by BMI greater than or equal to 30

          -  Self-reported binge eating as defined in the Diagnostic and Statistical Manual of
             Mental Disorders (DSM-5), in the last 4 weeks

          -  If sexually active with men, must agree to use birth control until the final study
             visit is complete (e.g., barrier methods, oral contraceptive)

          -  Subject must be able to complete written informed consent procedures and be able to
             comply with the requirements of the study.

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Severe hypotension (< 90/60 mmHg)

          -  Recent or current use of vasoconstrictor or vasodilator medication

          -  Current or history of diabetes

          -  Allergies to any ingredients in naloxone hydrochloride

          -  History of or current alcoholism or drug dependence

          -  Bulimia Nervosa as defined in DSM 5

          -  Current or past use of opiate-containing medications in the last 30 days

          -  Plan to use opiate-containing medications during study participation period

          -  Medical conditions that are contraindicated with intranasal procedures: Nasal septal
             abnormalities, nasal trauma, epistaxis, excessive nasal mucus, and intranasal damage
             caused by the use of substances (e.g., cocaine)

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the subject or the quality of the data
A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: PF-05280586; MabThera; Rituxan
Intervention description: 1000 mg, IV on days 1 and 15; 1000 mg, IV on days 1 and 15; 1000 mg, IV on days 1 and 15
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis; rituximab; methotrexate; anti-TNF

Summary:

      In this study, patients with moderate to severe rheumatoid arthritis who are being treated
      with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan
      (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs
      will be assessed by sampling the levels of drug in the blood, blood cell counts, and by
      comparing these levels among the different treatments. Safety, tolerability and immunologic
      response also will be evaluated throughout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of rheumatoid arthritis

          -  Meets Class I, II or III of the ACR 1991 Revised Criteria

          -  RA seropositivity

          -  Stable dose of methotrexate

          -  Inadequate response to TNF inhibitors

        Exclusion Criteria:

          -  Any prior treatment with lymphocyte depleting therapies

          -  History of active TB infection

          -  Known or screen test positive for specific viruses or indicators of viral infection
AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
Condition: Ovarian Neoplasms; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: AZD0530; Carboplatin; Paclitaxel
Intervention description: oral once daily dose; intravenous injection; intravenous infusion
Intervention MeSH terms: Paclitaxel; Carboplatin; Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 211.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Tumour; Ovarian Neoplasms; Ovarian Cancer

Summary:

      The main purpose of this study is to determine if AZD0530 can improve the efficacy of
      standard chemotherapy for the treatment of ovarian cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of advanced ovarian cancer

          -  Have evidence of recurrence or disease progression at least 6 months following
             treatment cessation of 1st or 2nd line platinum containing therapy

          -  Estimated life expectancy of more than 12 weeks

        Exclusion Criteria:

          -  Central Nervous System (CNS) metastases

          -  Received more than 2 prior chemotherapy regimens for ovarian cancer treatment

          -  Inadequate bone marrow reserve

          -  Inadequate liver function, renal function or low haemoglobin

          -  Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable
             method of contraception
Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma
Condition: Non-Hodgkins Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: Cyclophosphamide; Mitoxantrone; Vincristine; Prednisone; Rituximab
Intervention description: Cyclophosphamide; Mitoxantrone; Vincristine; Prednisone; Rituximab
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Vincristine; Mitoxantrone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purposes of this trial are to decrease toxicity and improve treatment effectiveness
      elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone,
      vincristine, and prednisone with concurrent administration of rituximab it is likely to be as
      effective as longer programs, and will certainly be better tolerated by this patient group.
      The addition of maintenance therapy may result in substantial prolongation of remission
      duration.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma

          -  No previous treatment

          -  Clinical stage II, III, or IV by the Ann Arbor Staging Criteria

          -  Age > 70 years

          -  ECOG performance status 0, 1, or 2

          -  Adequate bone marrow, liver and kidney function

          -  Must give written informed consent prior to entering this trial

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Age < 18 years

          -  Central nervous system involvement with lymphoma

          -  Coexistent active malignancies treated within five years

          -  Active infection precluding the use of combination chemotherapy

          -  HIV infection

          -  Pregnant or lactating

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.
Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: ACE-031 0.5 mg/kg q4wk; ACE-031 1.0 mg/kg q2wk; Placebo
Intervention description: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.; ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.; Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: Male
Minimum age: 4 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if ACE-031 is safe and well-tolerated in boys with
      Duchenne Muscular Dystrophy (DMD) and to select the optimal doses of ACE-031 in terms of
      safety and pharmacodynamic (PD) activity for designing future studies. [Note: This study was
      terminated based on safety data]
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of DMD confirmed

          -  Ambulant

          -  Corticosteroid therapy for at least one year prior to study day 1 and on a stable dose
             and schedule for at least 6 months prior to study day 1

          -  Evidence of muscle weakness by clinical assessment

        Exclusion Criteria:

          -  Any previous treatment with another investigational product within 6 months prior to
             study day 1

          -  Any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic,
             metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or
             other major disease that is not related to DMD

          -  Inability to perform a whole body dual x-ray absorptiometry (DXA) scan
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Secukinmab; Placebo
Intervention description: Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.; Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis, RA, ACR, inflammatory joints

Summary:

      This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in
      patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48
      with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457
      treatment in combination with MTX in RA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should
             have been on MTX for at least 3 months and must currently be treated with a stable
             dose of MTX (> or =7.5 mg/week - < or = 25 mg/week) for at least 4 weeks

          -  At Baseline: Disease activity criteria defined by > or = 6 out of 28 tender joints and
             > or = 6 out of 28 swollen joints WITH either Screening value of hsCRP > or = 10 mg/L
             OR ESR > or = 28 mm/1st hr

        Exclusion Criteria:

          -  RA patients functional status class IV classified according to the ACR 1991 revised
             criteria

          -  Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or
             morphine)

          -  Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment
             of acute RA flare within 4 weeks before randomization

        Other protocol-defined inclusion/exclusion criteria may apply
Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)
Condition: MPN (Myeloproliferative Neoplasms)
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Myeloproliferative Disorders; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: Ruxolitinib
Intervention description: Ruxolitinib (INCB018424), 5 mg bid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PMF; PPV-MF; PET-MF

Summary:

      To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms
      and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet
      counts of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose
      optimization from the starting ruxolitinib level of 5 mg bid will be associated with
      reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy

          -  Discontinuation of all drugs used to treat underlying MF disease at least 14 days
             prior to baseline visit

          -  INR <= 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry

          -  Hemoglobin level at least 6.5 g/dL at Screening visit

          -  Willingness to be transfused to treat low hemoglobin levels

        Exclusion Criteria:

          -  Females who are pregnant, unable to comply with birth control use to avoid becoming
             pregnant or breastfeeding

          -  Males who cannot comply with birth control use to avoid fathering a child

          -  Platelet count < 50 x10^9/L or absolute neutrophil count (ANC) < 1 x10^9/L at the
             Screening visit

          -  Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over
             the previous 2 years - international normalized ratio (INR) laboratory values cannot
             be > 1.5 x upper limit of normal at study entry.
Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
Condition: Smoking Cessation; Social Stress
Intervention: Social Support; NRT Sampling
Intervention description: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.; A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and
      acceptability of a new approach to smoking cessation induction treatment in cancer survivors
      with low social resources, and 2) To assess the effectiveness of said treatment for key
      events in the process of smoking cessation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cervical or head/neck cancer diagnosis in the past 5 years

          -  Resident of rural and/or Appalachian Kentucky county at cancer diagnosis

          -  Current smoker of ≥ 10 cigarettes per day, on average

          -  Age 18-75 years old

          -  Able to read, write, and understand English

        Exclusion Criteria:

          -  Unreliable phone access

          -  Smoking cessation treatment use in past 30 days

          -  Non-cigarette tobacco use in the past 30 days

          -  Any FDA contraindication for NRT use, including: allergy to nicotine patches and/or
             nicotine lozenges; severe kidney or liver disease; unstable angina or serious
             arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months

          -  Cognitive or psychiatric disorder that would interfere with ability to provide
             informed consent or answer survey questions reliably *

             * Any of these Diagnostic and Statistical Manual-5 (DSM-5) cognitive and psychiatric
             disorders would make someone ineligible: bipolar; delusional; dissociative;
             intellectual developmental; neurocognitive; psychotic; schizophreniform,
             schizophrenia, and schizoaffective.

          -  For women: breastfeeding, pregnancy, or plan to become pregnant within 6 months

          -  For women of childbearing potential: unwillingness to use an effective method of birth
             control (e.g., abstinence, oral contraceptive) while in this study
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
Condition: Leukemia; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: ibrutinib; venetoclax; Placebo
Intervention description: ibrutinib administered orally once daily (three 140 mg capsules); venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.; placebo capsules to match ibrutinib administered orally once daily
Intervention MeSH terms: Venetoclax
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Participants with confirmed undetectable minimal residual disease (uMRD) in the MRD cohort are triple masked.
Allocation was not randomized for the Fixed Duration (FD) cohort.
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease
      (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib +
      venetoclax in subjects with treatment-naïve CLL or SLL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic
             Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at
             least 1 IWCLL criteria for requiring treatment.

          -  Measurable nodal disease by computed tomography (CT)

          -  Adequate hepatic, and renal function

          -  Adequate hematologic function

          -  absolute neutrophil count >750/µL

          -  platelet count >30,000 /μL

          -  hemoglobin >8.0 g/dL

        Exclusion Criteria:

          -  Any prior therapy used for treatment of CLL/SLL

          -  Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk
             for tumor lysis syndrome (TLS)