bioihbjkbjnl/mcl2 huggingface dataset:
Effects of cKit Inhibition by Imatinib in Patients With Severe Refractory Asthma (KIA)
Condition: Asthma
MeSH terms: Asthma
Intervention: Imatinib mesylate; Placebo
Intervention description: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.; Placebo
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: cKIT inhibition in Asthma; Efficacy of Imatinib in severe resistent asthma.

Summary:

      The purpose of this study is to see whether a new investigational drug (Imatinib) may help
      improve asthma in people whose symptoms are not well controlled with high dose inhaled
      corticosteroid treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients 18-65 years of age, diagnosed with asthma for at least 1 year;

          2. Refractory asthma, defined as reporting that their asthma has not been completely
             controlled in the past 3 months despite continuous treatment with high-dose inhaled
             corticosteroids (ICS) and an additional controller medication, with or without
             continuous oral corticosteroids (OCS)

        Exclusion Criteria:

          1. Current smoking or smoking history of greater than 10 pack-years

          2. Any other significant respiratory or cardiac disease, or the presence of clinically
             important comorbidities, including uncontrolled diabetes, uncontrolled coronary artery
             disease

          3. If subject cannot undergo bronchoscopy procedure due to safety reasons

          4. Previous treatment with Imatinib

          5. A history of acute heart failure or chronic left sided heart failure

          6. Uncontrolled systemic arterial hypertension

          7. History of major bleeding or intracranial hemorrhage

          8. History of immunodeficiency diseases, including HIV

          9. Use of other investigational drugs at the time of enrollment, or within 30 days or 5
             half-lives of enrollment, whichever is longer

         10. History of malignancy of any organ system (other than localized basal cell carcinoma
             of the skin), treated or untreated, within the past 5 years, regardless of whether
             there is evidence of local recurrence or metastases.

         11. Diagnosis of Hepatitis B or C.

         12. History of alcohol abuse within 6 months of screening.

         13. History of illicit drug abuse within 6 months of screening.

         14. Regular use of anticoagulants (eg: Warfarin Sodium, Coumadin), amiodarone,
             carbamazepine, Cyclosporine, Rifampicin, or reverse transcriptase inhibitors
Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
Condition: Cystic Fibrosis; Exocrine Pancreatic Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: rhBSSL
Intervention description: oral suspension, 170 mg BSSL, 3 times daily for 5-6 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cystic fibrosis; pancreatic insufficiency; bucelipase alfa; bile salt stimulating lipase; BSSL; coefficient of fat absorption

Summary:

      The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and
      pancreatic insufficiency following treatment with BSSL
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with cystic fibrosis and pancreatic insufficiency who are able to refrain
             from their ongoing pancreatic enzyme treatment for a period of 7 days and are able to
             produce stools >= 5 times per week
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Condition: Pseudomonas Aeruginosa Pneumonia
MeSH terms: Pneumonia; Pseudomonas Infections
Intervention: AR-105; Placebo
Intervention description: monoclonal antibody; matching placebo (+ SOC antibiotics)
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pseudomonas aeruginosa; pneumonia

Summary:

      Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic
      of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia
      caused by P. aeruginosa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent

          -  ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only)

          -  pneumonia due to P. aeruginosa

          -  mechanically-ventilated

          -  intubated

          -  APACHE II score between 10 and 35

        Exclusion Criteria (main criteria):

          -  being moribund

          -  effective antibiotic therapy ≥48 hours

          -  immunocompromised

          -  underlying pulmonary disease that may preclude the assessment of a therapeutic
             response
Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer
Condition: Locally Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: SABR Boost Therapy
Intervention description: Initial Pelvic (+/- Para-aortic) fractionated external beam Radiation with 45 Gy to combined PTV with a boost to 55Gy for PET positive/CT enlarged nodes;
Image Guided Hypofractionated Radiation Treatment boost to Cervix High risk CTV/PTV 28GY/4 fx.
Patients will receive 4 fractions of 7 Gy each via stereotactic body radiation as boost therapy to a volume that encompasses the cervical tumor. A minimum of 40 hours should separate each treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether SABR boost therapy is effective in women
      with locally advanced cervical cancer without increased risk of acute gastrointestinal (GI)
      or genitourinary (GU) toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

        1 Locally Advanced stage Cervical Cancer 2. Zubrod performance status 0-2 3. Negative urine
        or serum pregnancy test for women of child-bearing potential 4. Agree to use adequate
        contraception (hormonal or barrier method of birth control; abstinence) prior to study
        entry and for the duration of study treatment 5. Not a candidate for intracavitary
        brachytherapy

        Exclusion Criteria:

          1. Pregnancy

          2. Concurrent untreated cancer excluding non-Melanoma skin cancer

          3. Previous pelvic radiation

          4. Active Inflammatory Bowel disease, Collagen vascular disease - systemic lupus
             erythematosus (SLE), scleroderma

          5. Age <18

          6. Unable to consent for study

          7. Severely immunocompromised patients ( such as Transplant , on immunosuppressive drugs)
BKM120 for Patients With PI3K-activated Tumors
Condition: PI3K Pathway Activated Tumors
MeSH terms: Neoplasms
Intervention: BKM120
Intervention description: BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Solid tumor; malignancy; hematologic malignancy; PI3K pathway activation; P13K activated tumors; BKM120; signature; AML; acute myelogenous leukemia; cervical; ovarian; hepatobiliary; buparlisib

Summary:

      The purpose of this signal seeking study was is to determine whether treatment with BKM120
      demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic
      malignancies to warrant further study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient had a confirmed diagnosis of a solid tumor or hematological malignancy with
             the exception of endometrial cancer, glioblastoma, nonsmall cell lung cancer, prostate
             cancer or breast cancer.

          -  Patient's tumor was evaluated and pre-identified to have activation of the PI3K
             pathway, at a CLIA certified laboratory

          -  Patient must have received at least one prior treatment for recurrent metastatic and
             /or locally advanced disease and for whom no standard therapy options was anticipated
             to result in a durable remission.

          -  Patient must have had progressive and measurable disease as per RECIST 1.1. or other
             appropriate hematological guidelines

          -  Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

        Exclusion Criteria:

        Patient had received previous treatment with BKM120 Patient had symptomatic CNS metastases
        Patient had mood disorder as outlined in Section 5 Patient had received chemotherapy or
        other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C)
        prior to starting study drug.
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
Condition: Schizophrenia and Predominant Negative Symptoms
MeSH terms: Schizophrenia
Intervention: SPD489 (lisdexamfetamine dimesylate); Placebo matching SPD489 (lisdexamfetamine dimesylate)
Intervention description: oral, 20, 30, 40, 50, 60, or 70 mg once daily; oral, once daily
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical
      antipsychotic medication, on negative symptoms in adult subjects with clinically stable
      schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment
      of Negative Symptoms (SANS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 18-55

          -  Clinically stable Schizophrenia and predominant negative symptoms

          -  Taking a stable dose of antipsychotic medication

        Exclusion Criteria:

          -  Clinically notable positive symptoms defined by PANSS
Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
Condition: Endometrial Atypical Hyperplasia; Endometrial Adenocarcinoma
MeSH terms: Adenocarcinoma; Uterine Neoplasms; Hyperplasia
Intervention: Megestrol acetate and metformin; Megestrol acetate
Intervention description: Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.; Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.
Intervention MeSH terms: Metformin; Megestrol; Megestrol Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Endometrial Atypical Hyperplasia; Endometrial Adenocarcinoma; Conservative Medication

Summary:

      The purpose of this study is to see if megestrol acetate plus metformin will be more
      effective in returning the endometrial tissue to a normal state than megestrol acetate alone
      in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be between the ages of 18-45 years old

          -  Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon
             D&C or hysteroscopy

               -  OR primarily have a confirmed diagnosis of endometrial adenocarcinoma(G1, low
                  tumor grade), based upon D&C or hysteroscopy, and three MRI parameters shows
                  there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes

          -  Have a desire for remaining reproductive function or uterus

          -  Need to be able to undergo correlative treatment and follow-up

        Exclusion Criteria:

          -  Have a history of serious liver or renal dysfunction

          -  Have a confirmed diagnosis of malignant tumor in genital system

          -  Have taken oral contraceptive or other medicine for the treatment of endometrial
             hyperplasia in the past 6 months

          -  Ask for removal of the uterus or other conservative treatment

          -  serum CA-125 > 35 Um/L
ELND005 in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo Control; ELND005; ELND005; ELND005
Intervention description: ELND005 matched placebo capsules for oral administration, bid for 78 weeks; ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks; ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks; ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks
Intervention MeSH terms: Inositol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 353.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the dose-related safety and efficacy of multiple
      oral dosages of ELND005 as treatment for Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable AD

          -  Age 50 to 85 years, inclusive

          -  Mini-Mental Status Exam (MMSE) score of 16-26, inclusive

          -  Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD

          -  Fluency in English, French, or Spanish

          -  Stable doses of medications (cholinesterase inhibitors and memantine allowed)

          -  Caregiver is able to attend all study visits

        Exclusion Criteria:

          -  Significant neurological disease other than AD

          -  Major psychiatric disorder

          -  Significant medical illness

          -  History of stroke or seizure

          -  History of a heart attack within the last 2 years

          -  Prior treatment with certain experimental medicines

          -  Presence of pacemakers or foreign metal objects in the eyes, skin, or body that would
             prevent patient from having MRI scan
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally once daily; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 3 (GT-3); HCV; Sustained Virologic Response; Direct Acting Antiviral; GS-7977; GS-5885; Ribavirin; Sofosbuvir; Ledipasvir; Hepatitis C; Hepatitis C, Chronic

Summary:

      This study will evaluate the antiviral efficacy, safety, and tolerability of
      ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in
      treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic genotype 3 HCV infection

          -  HCV treatment-naive

          -  HCV RNA > 10,000 IU/mL at screening

          -  Absence of cirrhosis or compensated cirrhosis

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Coinfection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with the individual's treatment, assessment, or compliance with the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study
Condition: Non Small Cell Lung Cancer; Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: ZD4054; Pemetrexed; Placebo
Intervention description: 10mg oral tablet, once daily; 500mg2/m IV infusion; 10mg oral tablet, once daily
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; Phase II; ZD4054; Pemetrexed; Lung Cancer

Summary:

      The aim of this study is to collect initial efficacy and safety data on the use of a new
      treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard
      chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment
      with pemetrexed alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed locally advanced or metastatic NSCLC on
             entry into study suitable for pemetrexed therapy

          -  Patients that meet one of the following criteria: - progressed following one prior
             platinum-based chemotherapy regimen for locally advanced or metastatic disease;
             -progressed within 6 months of adjuvant platinum-based chemotherapy

          -  Life expectancy of > 12 weeks

        Exclusion Criteria:

          -  Prior treatment with pemetrexed in the last 12 months.

          -  Prior therapy with an ET receptor antagonist

          -  Any recent surgery, unhealed surgical incision, severe concomitant medical condition
             (eg, unstable cardiac, hepatic or renal disease) or significant laboratory finding
             which makes it undesirable for the patient to participate
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD
Condition: Chronic Graft Versus Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Ponesimod
Intervention description: Oral film-coated tablets at the doses of 2, 3, 4, 5, 6, 7, 8, 9, 10, and 20 mg. One tablet of ponesimod at any dose will be taken orally once daily.
Intervention MeSH terms: Ponesimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GVHD; ponesimod

Summary:

      Chronic graft versus host diseasre (GVHD) is a serious reaction that might occur in a person
      (the host) who has received cells or organs (graft) from another person because the graft
      attacks the host's cells. Currently there are no approved therapies for chronic GVHD in the
      USA, and patients with chroninc GVHD are treated with immunosuppressant drugs. T-lymphocytes
      (a type of white blood cells) are likely to play a role in the development of chronic GVHD.
      Due to the capacity of ponesimod to block the traffic of T-lymphocytes, ponesimod may be a
      new therapeutic approach to treat chroninc GVHD.

      The main objective of this study is to assess the effectiveness and safety of several doses
      of ponesimod in subjects with chronic GVHD who did not respond to standard available
      treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Symptomatic moderate or severe chronic GVHD patients in need of a change of systemic
             immunosuppressant (IS) therapy

          -  Women of child bearing potential must have a negative pregnancy test and use reliable
             methods of contraception

        Exclusion Criteria:

          -  Clinically significant medical conditions including active or uncontrolled infections,
             new or recurrent malignancy, serious cardiac, pulmonary, or renal disease, and
             uncontrolled diabetes.

          -  Karnofsky Performance Score < 60.

          -  Immunosuppressant therapies other than allowed background therapy

          -  Anti-arrhythmic and heart rate lowering drugs.

          -  Any other circumstances or conditions, which, in the opinion of the investigator, may
             affect full participation in the study or compliance with the protocol