bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: 1.5 mg or 2.0 mg CJC-1134-PC; Placebo
Intervention description: twice-a-week; twice-a-week
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: GLP-1, incretin, type 2 diabetes

Summary:

      This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The
      objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with
      CJC-1134-PC in patients who are currently on metformin monotherapy.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  BMI: 27 to 45 kg/m2

          -  Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator

          -  Stable life-style, i.e. diet & physical activity, as determined by the Investigator

          -  Stable metformin daily dose ≥1000 mg for at least 3 months

          -  Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%
Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: HMPL-004 low dose; Placebo; HMPL-004 high dose
Intervention description: HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).; Matching dose of Placebo; HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with
      active mild to moderate ulcerative colitis (UC), compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have active confirmed mild to moderate ulcerative colitis

        Exclusion Criteria:

          -  Diagnosed with Crohn's Disease or
Safety Tolerability and Efficacy Study of Cabaletta to Treat Oculopharyngeal Muscular Dystrophy (OPMD) Patients
Condition: Oculopharyngeal Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Oculopharyngeal
Intervention: Cabaletta
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Case control, safety, tolerability, efficacy.

Summary:

      The Purpose of this study is to assess the Safety, Tolerability and Efficacy of Intravenous
      Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females

          -  18 - 80 years (inclusive) of age

          -  Clinically and genetically diagnosed as OPMD

          -  Moderate dysphagia (abnormal drinking test at screening and on the first dosing day,
             before drug administration)

          -  Patients who provide written informed consent to participate in the study

          -  Body Mass Index (BMI) <30 kg/m2

        Exclusion Criteria:

          -  Diabetes mellitus type 1 or 2

          -  Other major diseases, e.g.: renal failure (creatinine clearance <60ml/min), liver
             failure and chronic liver diseases (e.g. hepatitis B or C) , HIV carriers,
             tuberculosis, SLE, rheumatoid polyarthritis, sarcoidosis, collagenosis

          -  Uncontrolled heart disease , CHF,

          -  Other neuromuscular diseases

          -  Other disorders associated with esophageal dysphagia: e.g. severe gastroesophageal
             reflux (GERD), esophageal stricture due to mechanical or chemical trauma, infection
             (e.g. esophageal moniliasis), drug-induced dysphagia (e.g. bisphosphonates),
             esophageal rings and webs, spastic motility disorders of the esophagus.

          -  History of malignancy (except non-invasive skin malignancy)

          -  History of neck irradiation

          -  Pregnant or currently lactating women

          -  Obesity (BMI≥ 30) and associated morbidity

          -  Prior pharyngeal myotomy

          -  Weight loss of more than 10% in the last 12 months.

          -  Known hypersensitivity to any ingredients in the injection

          -  Patient receiving anticoagulant treatment (e.g. warfarin)
Safety Study of Eteplirsen to Treat Advanced Stage Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Eteplirsen
Intervention description: Eteplirsen solution for IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 7 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: DMD; exon 51; dystrophin; dystrophy; eteplirsen; Duchenne

Summary:

      The primary objective of this study is to explore safety and tolerability of eteplirsen in
      participants with advanced stage Duchenne muscular dystrophy (DMD) who are amenable to exon
      51 skipping.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male 7 - 21 years of age

          -  Diagnosis of DMD with a mutation that is amenable to exon 51 skipping, confirmed by a
             genetic report

          -  Stable dose of oral corticosteroids for at least 24 weeks or has not received
             corticosteroids for at least 24 weeks

          -  Non-ambulatory, or incapable of walking ≥300 meters on the 6-Minute Walk Test (6MWT).

          -  Score of ≤4 on the Brooke Score for Arms and Shoulders.

          -  Stable cardiac and pulmonary function

          -  Use of contraceptives for sexually active males throughout the study

          -  Willing to provide consent and comply with the study

        Exclusion Criteria:

          -  Use of any pharmacologic treatment (other than corticosteroids) within 12 weeks that
             may have an effect on muscle strength or function (e.g., growth hormone, anabolic
             steroids).

          -  Previous treatment with SMT C1100/BMN 195 at any time.

          -  Previous treatment with drisapersen (PRO051) within the last 6 months.

          -  Participation in any other DMD interventional clinical study within 12 weeks

          -  Major change in physiotherapy regimen within the past 3 months

          -  Major surgery within 3 months

          -  Presence of other clinically significant illness

          -  Use of an aminoglycoside antibiotic within 12 weeks or the need for this antibiotic or
             statin during study

          -  Forced vital capacity % predicted [FVC % predicted] <40%, or requiring daytime
             ventilation.

          -  Require antiarrhythmic and/or antidiuretic therapy for heart failure.

          -  Have a left ventricular ejection fraction (LVEF) of <40%.

          -  Prior or ongoing medical condition that could adversely affect the safety of the
             patient, make it unlikely that the course of treatment would be completed, or impair
             the assessment of study results.
Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone; Elotuzumab (BMS-901608)
Intervention MeSH terms: Dexamethasone; Lenalidomide; Elotuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone +
      Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM)
      in Japan.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Newly diagnosed with symptomatic Multiple Myeloma (MM)

          -  Have not received any prior systemic anti-myeloma therapy

          -  Have measurable disease

          -  Are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because
             of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy
             with SCT is NOT sufficient for entry onto CA204-116 for a subject < 65 years old.
             There must be a comorbidity that prevents SCT for a subject < 65 years old

        Exclusion Criteria:

          -  Non-secretory myeloma

          -  Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

          -  Monoclonal Gammopathy of Undetermined Significance (MGUS)

          -  Active plasma cell leukemia

          -  Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma (MCL)
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: ACP-196 (acalabrutinib)
Intervention MeSH terms: Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Bruton tyrosine kinase inhibitor; Btk; Mantle Cell Lymphoma; MCL; ACP-196; Acalabrutinib; ACE-LY-004; Calquence

Summary:

      The purpose of this study is to characterize the safety and efficacy profile of ACP-196
      (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).
    

Eligibility criteria:

        Inclusion criteria:

          -  Men and women ≥ 18 years of age.

          -  Pathologically confirmed MCL, with documentation of monoclonal B cells that have a
             chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

          -  Agreement to use contraception during the study and for 30 days after the last dose of
             study drugs if sexually active and able to bear or beget children.

        Exclusion criteria:

          -  A life-threatening illness, medical condition or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of ACP-196 (acalabrutinib), or put the study outcomes at
             undue risk

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening, or
             any Class 3 or 4 cardiac disease as defined by the New York Heart Association
             Functional Classification, or corrected QT interval (QTc) > 480 msec.

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel or ulcerative colitis, symptomatic
             inflammatory bowel disease, or partial or complete bowel obstruction.

          -  Breast feeding or pregnant
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis
Condition: Primary Biliary Cholangitis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Intervention: APD334
Intervention description: APD334 active treatment for 24 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this open-label, pilot, proof of concept study is to evaluate the safety,
      tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary
      cholangitis (PBC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or females aged 18 to 80 years (inclusive) at the time of screening, with
             confirmed Primary Biliary Cholangitis (PBC) diagnosis based upon at least 2 of 3
             criteria:

               -  Anti-mitochondrial antibodies (AMA) titer >1:40 on immunofluorescence or M2
                  positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific
                  antinuclear antibodies (anti-GP210 and/or anti-SP100)

               -  Alkaline phosphatase (ALP) >1.5 x upper limit of normal (ULN) for at least 6
                  months

               -  Liver biopsy findings consistent with PBC

          -  Use of ursodeoxycholic acid (UDCA) for at least 6 months prior to screening (stable
             dose for at least 3 months immediately prior to screening)

          -  Participants must have ALP >1.5 x ULN but <10 x ULN, alanine aminotransferase (ALT)
             and aspartate aminotransferase (AST) <5 x ULN, and total bilirubin <ULN, at all
             screening visits

          -  AST, ALT, ALP, and total bilirubin must have 2 values at least 4 weeks apart that are
             within 20% of each other

        Key Exclusion Criteria:

          -  Chronic liver disease of a non-PBC etiology. However, PBC participants accompanied
             with primary Sjögren's syndrome (pSS) are eligible to be enrolled.

          -  History or evidence of clinically significant hepatic decompensation

          -  Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)

          -  Clinically significant infections within 6 weeks prior to treatment start, or
             infection with hepatitis C virus anytime in the past

          -  Immunosuppressive, immunomodulating, or investigational agents within 30 days prior to
             treatment start

          -  Treatment with obeticholic acid (OCA) within 30 days prior to Day 1

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
Effects of Aripiprazole on Cocaine Craving and Self-Administration
Condition: Cocaine Abuse
MeSH terms: Cocaine-Related Disorders
Intervention: Aripiprazole + Cocaine; Placebo + Cocaine
Intervention description: Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).; Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
Intervention MeSH terms: Cocaine; Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In order to achieve steady-state concentrations, participants (n=8 men) were administered placebo and aripiprazole (15 mg/day) capsules in counter-balanced order for 21 days. A smoked cocaine dose-response curve (0, 12, 25, 50 mg) was determined twice under placebo and aripiprazole maintenance.
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Aripiprazole; Cocaine abuse

Summary:

      The purpose of this study is to investigate whether aripiprazole will decrease cocaine
      self-administration, subjective effects and cravings compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for current cocaine abuse

          -  Average use of smoked cocaine is at least 2x/week for past 6 mos); currently spends at
             least $70 per week on cocaine

          -  Has patterns of smoked cocaine use in terms of frequency and amounts which parallel or
             exceed those administered in the study

          -  Age 21-45

          -  Able to give informed consent, and comply with study procedures

        Exclusion Criteria:

          -  Current seizure disorder, heart disease or psychiatric disorders (other than cocaine
             dependence)

          -  Dependence on substances other than cocaine or nicotine

          -  Request for drug treatment

          -  Judged to be noncompliant with study protocol

          -  Current use of any medication that has the potential to interact with aripiprazole
             (i.e., seizure medications, anti-fungal medications, cardiac medications, or
             medication that produces drowsiness)

          -  Clinical laboratory tests outside normal limits that are clinically unacceptable to
             the study physician (BP > 140/90; BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for
             women, < 36 for men; pseudocholinesterase deficiency)

          -  Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other
             than transient psychosis due to drug abuse

          -  Current parole or probation

          -  History of significant violent or suicidal behavior
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: PF-06651600 or Placebo; PF-06700841 or Placebo; PF-06700841; PF-06651600
Intervention description: Delivered orally for 8 weeks.; Delivered orally for 8 weeks.; Delivered orally for 24 weeks.; Delivered orally for 24 weeks.
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 319.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Mayo score

Summary:

      The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective
      in treatment of moderate to severe ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ulcerative colitis for greater than/equal to 3 months.

          -  Moderate to severe active ulcerative colitis

          -  Inadequate response to, loss of response to, or intolerance to at least one
             conventional therapy for UC.

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Clinical findings suggestive of Crohn's Disease

          -  History of bowel surgery within 6 months
Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating Mutations
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-561; Placebo; IVA
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of CTP-656 in patients with cystic fibrosis
      (CF) who have a cystic fibrosis transmembrane conductance regulator (CFTR) gating mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating
             mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.

          -  Has been stable on Kalydeco therapy for at least 3 months prior to screening

          -  Has FEV1 ≥ 60% of predicted normal for age, sex, and height at screening and baseline
             (Day 1) assessments

          -  Weighs at least 40 kg at screening

          -  Patients of either gender and women of childbearing potential must be willing to use a
             medically highly effective form of birth control during the treatment period and 30
             days after the last dose of study treatment.

        Exclusion Criteria:

          -  Acute upper respiratory infection or lower respiratory infection, pulmonary
             exacerbation, or changes in therapy within 4 weeks of study treatment

          -  Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes

          -  History of hepatitis C or chronic active hepatitis B infection

          -  History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or
             allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2
             years prior to screening

          -  Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within
             2 years prior to Screening

          -  Abnormal liver function

          -  History of abnormal renal function

          -  History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females

          -  History of solid organ or hematological transplantation

          -  Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30
             days of screening

          -  Women who are pregnant or lactating, or have plans to become pregnant during the study
             or within 1 month following the last dose