bioihbjkbjnl/mcl2 huggingface dataset:
Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects
Condition: Leukemia
MeSH terms: Leukemia
Intervention: Dasatinib
Intervention description: Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Phase, Advanced Phase chronic myeloid leukemia; Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Summary:

      The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate
      to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR)
      rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib,
      or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP
      CML and Ph+ALL).
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Signed Written Informed Consent

          -  Men and women, ages 18 years of age or older

          -  Subjects with Chronic Phase (CP) or Advanced Disease (AD) chronic myeloid leukemia
             (CML)/Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)

          -  Subjects resistant/intolerant to imatinib

          -  Subjects presenting:

               1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2

               2. Adequate hepatic function

               3. Adequate renal function

               4. Sodium, Potassium, Magnesium, Phosphorus, Calcium higher or equal than the lower
                  limit of normal range

        Exclusion Criteria:

          -  Women of child bearing potential who are not using adequate birth control

          -  Women who are pregnant or breastfeeding

          -  Subjects eligible for stem cell transplantation

          -  Serious uncontrolled medical disorder or active infection

          -  Uncontrolled or significant cardiovascular disease

          -  Concurrent incurable malignancy other than CML

          -  Subjects who received imatinib, interferon, cytarabine within 7 days or other
             antineoplastic agents other than hydroxyurea within 14 days before dasatinib,
             Dasatinib in the past

          -  History of significant bleeding unrelated to CML
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
Condition: Parkinson's Disease; Dysphagia; Dystussia
MeSH terms: Deglutition Disorders; Parkinson Disease
Intervention: EMST; smTAP
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 45 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Rehabilitation; Parkinson's disease; Swallowing; Cough; Dysphagia; Dystussia

Summary:

      Currently, there are no efficacious behavioral treatment approaches to address uncompensated
      aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD).
      This is of particular public health concern given that aspiration pneumonia is the leading
      cause of death in persons with PD. The overarching aim of the proposed study is to determine
      the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength
      training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway
      protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate
      the results will lead to reductions in the risks associated with airway protective deficits.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with PD (Hoehn and Yahr Stages II-IV)

          2. Difficulty swallowing

          3. Not actively receiving swallowing therapy.

        Exclusion Criteria:

          1. Other neurological disorders (e.g., multiple sclerosis, stroke, etc.)

          2. History of head and neck cancer

          3. History of breathing disorders or diseases (e.g., COPD)

          4. History of smoking in the last five years

          5. Uncontrolled hypertension

          6. Difficulty complying due to neuropsychological dysfunction
Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BCT197; Prednisone placebo; BCT197 placebo; Prednisone
Intervention description: capsules; capsules; capsules
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 183.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; Exacerbation; Pulmonary Inflammation

Summary:

      This study will assess preliminary parameters of safety and efficacy of a single dose of
      BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with COPD (Stage II to IV) with a COPD exacerbation.

          -  Smoking history of 10 pack years.

          -  Females must not be of child-bearing potential.

        Exclusion Criteria:

          -  Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

        Other protocol-defined inclusion/exclusion criteria may apply
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
Condition: Kidney Transplantation
Intervention: Cyclosporine; CP-690,550; CP-690,550
Intervention description: Standard of care; CP-690,550 tablets dosed BID Months 12-72; CP-690,550 tablets dosed BID Months 12-72
Intervention MeSH terms: Cyclosporine; Cyclosporins; Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Immunosuppression; JAK inhibitor; kidney transplantation

Summary:

      This is a study that will follow transplant patients from Study A3921030 to monitor for long
      term safety, tolerability and efficacy for 5 additional years, except in Portugal where the
      study will follow transplant patients through Month 36 posttransplant. Patients will continue
      their study medications that were previously assigned.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who successfully completed Study A3921030

        Exclusion Criteria:

          -  Subjects who are on the waiting list for a second kidney transplant or any non-renal
             organ transplants
Natalizumab High Titer Immunogenicity and Safety
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: BG00002-E (natalizumab high titer)
Intervention MeSH terms: Natalizumab
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: natalizumab; Tysabri; Multiple Sclerosis; Relapsing Forms of Multiple Sclerosis

Summary:

      The primary objective of the study was to evaluate the immunogenicity of natalizumab
      (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E)
      administered intravenously (IV) to participants with relapsing forms of multiple sclerosis
      (MS). The secondary objective of this study was to evaluate the safety of natalizumab high
      titer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a relapsing form of MS

          -  Must fall within the therapeutic indications stated in the locally approved label for
             natalizumab

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Prior treatment with natalizumab

          -  Considered by investigator to be immunocompromised

          -  Other protocol-defined exclusion criteria may apply
A New Oral Treatment For Type II Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; DEN 2.5 mg; DEN 7.5 mg; DEN 15 mg; DEN 30 mg; DEN 45 mg
Intervention description: Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: NIDDM

Summary:

      This is a 24-week study investigating the safety and efficacy of several dosages of a
      potential new oral medicine for Type II diabetes mellitus.
    

Eligibility criteria:

        Inclusion criteria:

          -  Women must not be pregnant and must not be breastfeeding.

          -  Have Type II diabetes.

          -  Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

        Exclusion criteria:

          -  Have any underlying or significant active disease that would prevent the subject from
             safely participating in the trial by the judgement of the study doctor.
Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: SU011248
Intervention description: 37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant
      gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically proven diagnosis of malignant GIST that was not amenable to
             standard therapy.

          -  Failed prior treatment with imatinib mesylate, defined either by progression of
             disease (according to Response Evaluation Criterion in Solid Tumors (RECIST) or World
             Health Organization (WHO) criteria), or by significant toxicity during treatment with
             imatinib mesylate that precluded further treatment. Intolerance to prior imatinib
             mesylate therapy was defined as follows:

          -  Life-threatening adverse events (ie, Grade 4) at any dose (attempt to dose reduce or
             rechallenge not required) or Unacceptable toxicity induced by a moderate dose (eg, 400
             mg/day), specifically, Grade 2 toxicity that was unacceptable to the patient (such as
             nausea) that persisted despite standard countermeasures

          -  Evidence of unidimensionally measurable disease.

        Exclusion Criteria:

          -  Previous treatment on a SU011248 clinical trial.

          -  Diagnosis of any second malignancy within the last 3 years, except basal cell
             carcinoma, squamous cell skin cancer, or in situ carcinoma, that had been adequately
             treated with no evidence of recurrent disease for 12 months.

          -  History of or known brain metastases, spinal cord compression, or carcinomatous
             meningitis, or new evidence of brain or leptomeningeal disease.

          -  Any of the following within the 12 months prior to starting the study treatment:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, congestive heart failure, cerebrovascular accident or transient ischemic
             attack, or pulmonary embolism.

          -  Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc
             interval >450 msec for males or >470 msec for females.

          -  Hypertension that could not be controlled by medications (>150/100 mm/Hg despite
             optimal medical therapy).
A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone; Placebo
Intervention description: 80 mg AM dosing once daily; Matching Placebo to 40mg lurasidone tablets
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Schizophrenia; Latuda; Lurasidone

Summary:

      A 6-week in-patient and out-patient study to test the effectiveness and safety of a new
      medication in the treatment of schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV

          -  The patient must agree to a voluntary hospitalization duration of 31 days minimum at
             the start of the treatment

          -  If female, must not be pregnant, or must be incapable of conceiving or be taking steps
             to prevent conception

        Exclusion Criteria:

          -  The patient has used an investigational drug within the past 30 days

          -  The patient has participated in a previous study of this compound
BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Condition: Colonoscopy
Intervention: BLI4700
Intervention description: BLI4700 Bowel Preparation (Investigational Regimen)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel
      preparation prior to colonoscopy in adult patients.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted
             indication.

          2. At least 18 years of age

          3. If female, and of child-bearing potential, is using an acceptable form of birth
             control.

          4. Negative urine pregnancy test at screening, if applicable

          5. In the Investigator's judgment, subject is mentally competent to provide informed
             consent to participate in the study

        Primary Exclusion Criteria:

          1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
             obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

          2. Subjects who had previous significant gastrointestinal surgeries.

          3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with
             clinically significant electrolyte abnormalities based on Visit 1 laboratory results.

          4. Subjects with a prior history of renal, liver or cardiac insufficiency

          5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

          6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.

          7. Subjects who are pregnant or lactating, or intending to become pregnant during the
             study.

          8. Subjects of childbearing potential who refuse a pregnancy test.

          9. Subjects allergic to any preparation components.

         10. Subjects who, in the opinion of the Investigator, should not be included in the study
             for any reason, including inability to follow study procedures.

         11. Subjects who have participated in an investigational surgical, drug, or device study
             within the past 30 days.
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
Condition: Central Neuropathic Pain; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Neuralgia; Sclerosis
Intervention: AVP-923-45; AVP-923-30; AVP-923-20; Placebo
Intervention description: AVP-923-45 (dextromethorphan 45 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.; AVP-923-30 (dextromethorphan 30 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.; AVP-923-20 (dextromethorphan 20 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.; Matching placebo capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses
      of AVP-923 capsules in the treatment of central neuropathic pain in participants with
      multiple sclerosis.
    

Eligibility criteria:

        Main Inclusion Criteria:

        Multiple Sclerosis (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive
        multiple sclerosis [SPMS]), Clinical history and symptoms of central neuropathic pain
        (dysesthetic pain) for at least 3 months prior to screening, pain rating scale (PRS)
        baseline score = or > 4, No MS relapse within previous 30 days.

        Main Exclusion Criteria:

        Personal history of complete heart block, QT interval corrected for heart rate (QTc)
        prolongation, or torsades de pointes, family history of congenital QT interval prolongation
        syndrome, Myasthenia Gravis, Beck Depression Inventory Second Edition (BDI-II) score > 19
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: BMS-986166; Branebrutinib; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Branebrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; BMS-986166; BMS-986195; Branebrutinib

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166
      and of branebrutinib, each versus placebo, for the treatment of participants with moderate to
      severe atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of
             Hanifin's and Rajka's (E-HR) criteria at Screening

          -  Disease duration of at least 24 months since diagnosis by any criteria

          -  Documented history of inadequate control of AD by a stable regimen (≥ 4 weeks) of
             topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of
             randomization, or inappropriateness of therapy due to side effects or safety risks
             leading to prior discontinuation

          -  Application of fixed doses of an additive-free, basic bland emollient twice-daily for
             ≥ 7 days before baseline visit and for the duration of the study

        Exclusion Criteria:

          -  Any major illness/condition or evidence of an unstable clinical condition or local
             active infection/infectious illness that, in the investigator's judgment, will
             substantially increase the risk to the participant if he or she participates in the
             study or interfere with the interpretation of study results

          -  Clinically relevant cardiovascular conditions or pulmonary conditions

          -  High likelihood - based on participant history, and investigator judgement - of
             requiring rescue therapy in < 4 weeks prior to randomization

          -  Evidence of acute flare between the Screening and Baseline/ Randomization

          -  Skin lesion(s) and/or pruritus due to conditions other than AD that would interfere
             with the study specified assessments

        Other protocol-defined inclusion/exclusion criteria apply