bioihbjkbjnl/mcl2 huggingface dataset:
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
RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder
Condition: Acute Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: RP5063; placebo; RP5063; RP5063; aripiprazole
Intervention description: daily; daily; daily; daily; daily
Intervention MeSH terms: Aripiprazole; RP5063
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the efficacy and safety of RP5063 relative to
      placebo for the treatment of schizophrenia or schizoaffective disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients providing informed consent prior to any study specific procedures

          -  Patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type,
             disorganized type, catatonic type or undifferentiated type), or schizoaffective
             disorder

          -  Patients with normal physical examination, laboratory, vital signs,and
             electrocardiogram (ECG)

        Exclusion Criteria:

          -  Patients with other primary psychiatric disorders as delirium, or bipolar I or II
             disorder
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hypersensitivity
Intervention: AZD2281; matching placebo
Intervention description: Tablets Oral BID; matching placebo bid
Intervention MeSH terms: Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 265.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Serous,; Ovarian cancer,; PARP,; BRCA1,; BRCA2,; Poly(ADP ribose) polymerases,; Platinum sensitive,; Homologous Recombination Deficiency (HRD)

Summary:

      The primary purpose of this study to determine if AZD2281 is effective and well tolerated in
      maintaining the improvement in your cancer after previous platinum-based chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients with histologically diagnosed serous ovarian cancer or recurrent
             serous ovarian cancer.

          -  Patients must have completed at least 2 previous courses of platinum containing
             therapy; the patient must have been platinum sensitive to the penultimate chemo
             regimen.

          -  For the last chemotherapy course prior to enrolment on the study, patients must have
             demonstrated an objective stable maintained response (partial or complete response)
             and this response needs to be maintained until completion of chemotherapy.

          -  Patients must be treated on the study within 8 wks of completion of their final dose
             of the platinum containing regimen.

        Exclusion Criteria:

          -  Previous treatment with PARP inhibitors including AZD2281

          -  Patients with low grade ovarian carcinoma.

          -  Patients who have had drainage of their ascites during the final 2 cycles of their
             last chemotherapy regimen prior to enrolment on the study

          -  Patients receiving any chemotherapy, radiotherapy (except for palliative reasons),
             within 2 weeks from the last dose prior to study entry (or a longer period depending
             on the defined characteristics of the agents used).
Comparing Smoking Treatment Programs for Lighter Smokers - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: nicotine transdermal system; bupropion; Medication Management; Mayo Counseling; placebo patch; placebo bupropion
Intervention description: starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.; 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks; Brief manual based therapy; four 15 minute session over 10 weeks.; Manual based therapy; Weekly 30 minute sessions for 10 weeks; placebo patch containing no nicotine; placebo pills
Intervention MeSH terms: Bupropion; Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: light smokers, smoking cessation treatment programs

Summary:

      The purpose of this study was to compare two different types of Food and Drug Administration
      (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in
      conjunction with two levels of counseling. It was hypothesized that the higher level of
      counseling would have the highest rates of treatment completion and highest rates of
      abstinence.
    

Eligibility criteria:

        Light smokers (6-15 cigarettes per day

        Inclusion Criteria:

        Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)

        Exclusion Criteria:

        Please contact site for more information
Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Pirfenidone
Intervention description: up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study
Intervention MeSH terms: Pirfenidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: pulmonary fibrosis; respiratory diseases

Summary:

      To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with
      pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).
    

Eligibility criteria:

        General Inclusion Criteria:

          -  Able to understand and sign an informed consent form

          -  Understand the importance of adherence to study treatment and the study protocol,
             including concomitant medication restrictions, throughout the study period

          -  Patients must be willing to travel to an approved regional center for all
             study-related visits

        Roll-Over Criteria:

          -  Entry into study through rollover has been completed

        Criteria for Early Access Program patients:

          -  Clinical symptoms consistent with IPF ≥3 months duration

          -  Age 40 - 85, inclusive

          -  At the time of registration with National Organization for Rare Disorders (NORD),
             patients with IPF must have a percent predicted forced vital capacity (FVC) of ≥50%,
             and percent predicted carbon monoxide diffusing capacity (DLCO) of ≥35%

          -  At the time of enrollment in PIPF-002, (screening/baseline visit) percent predicted
             FVC must be ≥45%, and percent predicted DLCO must be ≥30%

          -  High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients
             with surgical lung biopsy showing definite or probable usual interstitial pneumonia
             (UIP), the HRCT criterion of probable IPF is sufficient

          -  For patients aged <50 years: open or video-assisted thoracoscopic (VATS) lung biopsy
             showing definite or probable UIP. In addition, no features supporting an alternative
             diagnosis on transbronchial biopsy or bronchoalveolar lavage if performed

          -  For patients aged ≥50 years: at least one of the following diagnostic findings as well
             as the absence of any features on specimens resulting from any of these procedures
             that support an alternative diagnosis: 1) Open or VATS lung biopsy showing definite or
             probable UIP; 2) Transbronchial biopsy showing no features to support an alternative
             diagnosis; 3) Bronchoalveolar lavage (BAL) showing no features to support an
             alternative diagnosis
PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
Condition: Solid Tumor; Unresectable or Metastatic Melanoma
MeSH terms: Neoplasms; Melanoma
Intervention: CX-072; Ipilimumab
Intervention description: CX-072 in combination with ipilimumab; CX-072 in combination with ipilimumab
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Combination; ipilimumab; Cancer; checkpoint inhibitor; PD-L1; CTLA-4; PROCLAIM; PROCLAIM-CX-072; Relapsed; Refractory

Summary:

      To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in
      adult patients with solid tumor based upon overall response rate by Response Evaluation
      Criteria in Solid Tumors (RECIST)
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age

          2. Measurable disease as defined by RECIST v1.1

          3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

          4. Agree to provide tumor tissue and blood samples for biomarker assessment

        Exclusion Criteria:

          1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or
             any investigational agent within 28 days prior to the first dose of study treatment.

          2. Prior therapy with a chimeric antigen receptor T cell-containing regimen

          3. History of active autoimmune disease(s) including but not limited to inflammatory
             bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis,
             systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune
             neuropathies, type 1 insulin-dependent diabetes mellitus

          4. History of myocarditis regardless of the cause

          5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to
             discontinue treatment due to an irAE

          6. History of any syndrome or medical condition that required treatment with systemic
             steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.

          7. History of severe allergic or anaphylactic reactions to human mAb therapy or known
             hypersensitivity to any Probody therapeutic
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Condition: Fetal Alcohol Spectrum Disorders
MeSH terms: Fetal Alcohol Spectrum Disorders
Intervention: Choline bitartrate; Placebo
Intervention MeSH terms: Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled trial of choline supplementation in
      children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are
      cognitive measures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 2 years to 5 years of age

          2. Available parent or legal guardian capable of giving informed consent for
             participation.

          3. Documented prenatal alcohol exposure (self-report, social service records, or adoption
             records).

          4. Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS),
             Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder
             (ARND) (Hoyme, May, et al., 2005).

        Exclusion Criteria:

          1. Known history of a neurological condition (ex. epilepsy, traumatic brain injury)

          2. Known history of a medical condition known to affect brain function.

          3. Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)

          4. Known history of very low birthweight (<1500 grams)
5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia; Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: 5-Azacytidine
Intervention description: Starting dose level: 75mg/m^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 5-Aza; Azacytidine; Vidaza; CLL; Chronic Lymphocytic Leukemia; Richter's transformation; Leukemia

Summary:

      The objective of this study is to determine the safety and efficacy of Azacytidine in
      fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and
      T-cell prolymphocytic leukemia (T-PLL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, Richter's
             transformation or T-PLL who have previously been treated with fludarabine or another
             regime are eligible.

          2. Patients with histologically or cytologically confirmed Richter's transformation.

          3. Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase
             (SGPT) less than x 2 normal levels.

          4. Women of childbearing potential who have a negative pregnancy test prior to
             azacytidine treatment.

          5. Women of childbearing potential who agreed not to become pregnant and men agreed not
             to father a child while on azacytidine treatment.

          6. Performance 0-2 (ECOG). Adequate liver function (bilirubin of less than2mg/dl) and
             renal function (creatinine less than 2mg/dl). Adequate cardiac functions (NYHA cardiac
             III-IV excluded).

          7. Signed informed consent.

        Exclusion Criteria:

          1. Breast feeding or pregnant females. Patients of (male and female) childbearing
             potential should practice effective methods of contraception; otherwise, they will be
             excluded. Should a woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her treating physician immediately.

          2. Known or suspected hypersensitivity to azacytidine or Mannitol.

          3. Active and uncontrolled infections.

          4. Patients with advanced malignant hepatic tumors.

          5. Uncontrolled intercurrent illness including, but not limited to, symptomatic
             congestive heart failure, unstable angina pectoris, or psychiatric illness/social
             situations that would limit compliance with study requirements.
Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: AZD8848; Placebo; AZD8848 and placebo
Intervention description: Nasal spray solution, intranasal, three times weekly for one month; Nasal spray solution, intranasal, three times weekly for one month; Nasal spray solution, intranasal, three times weekly for one month
Intervention MeSH terms: Adenosine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: AZD8848; allergic rhinitis; efficacy; tolerability; safety; nasal symptoms

Summary:

      The primary purpose of this study is to investigate effect, tolerability and safety of
      different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis
      patients out of season in an allergen challenge model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seasonal allergic rhinitis patients out of pollen season

          -  Have a history and presence of birch and/or timothy grass pollen induced seasonal
             allergic rhinitis for at least the previous 2 years (verified by a positive skin prick
             test)

          -  Patients with need of treatment for their nasal symptoms during the pollen season

        Exclusion Criteria:

          -  Symptomatic perennial allergic or non-allergic rhinitis

          -  Family history of autoimmune disease A history of asthma
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
Condition: Chronic Traumatic Encephalopathy
MeSH terms: Brain Diseases; Brain Injuries, Traumatic; Chronic Traumatic Encephalopathy
Intervention: florbetapir F 18; Flortaucipir F18
Intervention description: 370 megabecquerel (MBq) IV single-dose; 370 megabecquerel (MBq) IV single-dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Male
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will explore the use of flortaucipir as a biomarker for chronic traumatic
      encephalopathy (CTE) and examine the relationship between clinical presentation and tau
      deposition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects consented and currently enrolled in the Diagnosing and Evaluating
             Traumatic Encephalopathy Using Clinical Tests (DETECT) or the Long-Term Consequences
             of Repetitive Brain Injury in Athletes study protocols

          -  Can tolerate up to two PET imaging sessions

          -  Have the ability to provide informed consent for study procedures

        Exclusion Criteria:

          -  Claustrophobia

          -  Current clinically significant cardiovascular disease or clinically significant
             abnormalities on screening ECG

          -  History of risk factors for Torsades de Pointes or are taking drugs known to cause
             QT-prolongation

          -  Current clinically significant infectious disease, endocrine or metabolic disease,
             pulmonary, renal or hepatic impairment, or cancer that the investigator believes would
             affect study participation or scan results

          -  Have had a non-study related radiopharmaceutical imaging or treatment within 7 days
             prior to study PET imaging sessions
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung
Intervention: Pembrolizumab; Acalabrutinib
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small
      cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age

          -  ECOG performance status of 0 or 1

          -  Histologically confirmed recurrent or metastatic NSCLC (adenocarcinoma, large cell,
             squamous cell, or not otherwise specified) that has either progressed during or after
             platinum-based chemotherapy

          -  Received at least 1 platinum-based chemotherapy regimen. Note: Subjects with EGFR
             mutations or ALK translocations are required to have received prior therapy with
             appropriate TKI; prior platinum-based chemotherapy is not required for this specific
             patient population

        Exclusion Criteria:

          -  Prior malignancy (other than lung cancer), except for adequately treated basal cell or
             squamous cell skin cancer, in situ cervical cancer, or other cancer from which the
             subject has been disease free for ≥ 2 years or which will not limit survival to < 2
             years

          -  Known central nervous system metastases and/or carcinomatous meningitis

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
             partial or complete bowel obstruction, or gastric restrictions and bariatric surgery,
             such as gastric bypass

          -  Breastfeeding or pregnant