bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Debio 025; Peg-IFNα2a; Ribavirin
Intervention description: Debio 025 supplied as a 100 mg/mL oral solution; Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes; Ribavirin supplied as 200 mg tablets
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Hepatitis; Hepatitis C

Summary:

      Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action
      demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and
      patients.

      The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha
      and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated. Only
      40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study
      assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin
      can improve the outcome of treatment in this group of patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients between 18 and 60 years of age.

          -  Hepatitis B negative and human immunodeficiency virus (HIV) negative.

          -  Diagnosed with hepatitis C genotype I and not responsive to treatments such as
             peginterferon alpha-2a or 2b and ribavirin for at least 12 weeks.

          -  Adequate liver function (Child-Pugh-Turcotte score A) and other laboratory parameters
             within acceptable range.

          -  Females may participate only if they cannot become pregnant, i.e., are surgically
             sterile, post-menopausal, or using 2 reliable contraceptive methods.

          -  Male patients must be surgically sterile or utilizing a barrier contraceptive method.

          -  For female patients of child bearing potential, negative pregnancy test within 1 week
             of first investigational product administration.

        Exclusion Criteria:

          -  Treatment with any investigational drug within 6 months prior to the start of the
             study.

          -  Ongoing or recent use of antiviral medication within 1 month before the start of the
             study.

          -  A known bad reaction or intolerance to Debio 025, peginterferon alpha-2a, and/or
             ribavirin.

          -  Presence or history of any severe related disease.
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms
Intervention: Gemcitabine; Epirubicin; Albumin-bound Paclitaxel
Intervention description: Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles; Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles; ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Intervention MeSH terms: Paclitaxel; Gemcitabine; Albumin-Bound Paclitaxel; Epirubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Locally Advanced Breast Cancer; Inflammatory Breast Cancer; Breast Cancer; Abraxane; nab Paclitaxel; Epirubicin; Gemcitabine; Gemzar

Summary:

      In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the
      biweekly pegfilgrastim support, in order to further improve upon the effectiveness and
      favorable toxicity of this triplet.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Locally advanced/inflammatory adenocarcinoma of the breast

          -  18 years of age or older

          -  Normal heart function

          -  Able to perform activities of daily living with minimal assistance

          -  No prior chemotherapy for breast cancer

          -  Adequate bone marrow, liver and kidney function

          -  No evidence or history of significant cardiovascular abnormalities

          -  Sentinel node or axillary dissection

          -  Sign an informed consent form

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Pregnant or breast feeding

          -  History of heart disease with congestive heart failure

          -  Heart attack within the previous 6 months

          -  Prior chemotherapy or hormone therapy for breast cancer

          -  History of active uncontrolled infection

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.
Vortioxetine for Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Intervention: Vortioxetine; Placebo
Intervention description: Medication currently approved for major depression.
Intervention MeSH terms: Vortioxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The aim of the present study is to examine the efficacy and safety of vortioxetine vs placebo
      in adults with moderate to severe Binge eating disorder, as indicated by at least 3 binge
      eating days per week for the 2 weeks before the baseline visit.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women age 18-65;

          2. Primary diagnosis of Binge eating disorder;

          3. At least 3 binge eating days per week for the 2 weeks before the baseline visit;

          4. Ability to understand and sign the consent form.

        Exclusion Criteria:

          1. Unstable medical illness based on history or clinically significant abnormalities on
             baseline physical examination (history of medical illness which is currently stable is
             allowed such as diabetes well controlled, treated hypothyroidism, hypertension, etc)

          2. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity
             rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

          4. Past 12-month DSM-5 major psychiatric disorder (psychotic disorder, bipolar disorder,
             major depressive disorder)

          5. Past 6-month alcohol or substance use disorders

          6. Illegal substance use based on urine toxicology screening

          7. Initiation of psychological or weight-loss interventions within 3 months of screening

          8. Use of any other prescription psychotropic medication (except an as needed hypnotic or
             as needed benzodiazepine)

          9. Previous treatment with Vortioxetine

         10. Currently taking over the counter weight loss medications. If willing to stop these
             medications, the participant will not be excluded based on this criterion.

        10) Cognitive impairment that interferes with the capacity to understand and
        self-administer medication or provide written informed consent
A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Mycophenolate mofetil; Prednisone; Erythropoietin Beta
Intervention description: 1 gm twice daily orally until end of study.; 10 mg/day orally until end of study.; Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon,
      CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes
      (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily)
      plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon
      (30000 IU/week, s.c.) will be added to the treatment regimen. If there is no response to
      NeoRecormon after 6 weeks, the dose will be increased to 60000 IU/week. The anticipated time
      on study treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  diagnosis of MDS, according to International Prognostic Scoring System (IPSS)
             criteria;

          -  low or intermediate risk, who are not candidates for treatment with growth factors, or
             who have not responded to these treatments.

        Exclusion Criteria:

          -  previous treatment with CellCept, or any erythropoietin-stimulating drug;

          -  diagnosis of proliferative chronic myelomonocytic leukemia;

          -  prior or concomitant malignancies other than MDS, with the exception of basocellular,
             spinocellular or adequately treated in situ cervical cancer, in the past 3 years;

          -  biological antitumor and myelosuppressive treatment within 28 days before start of
             study;

          -  bone marrow precursor cell transplantation previous to study.
Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Brodalumab; Placebo; Methotrexate; folic acid
Intervention description: 3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10; 3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10; Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses < 7.5 mg/week necessitated discontinuation from study.; at least 5 mg per week
Intervention MeSH terms: Folic Acid; Methotrexate; Brodalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Autoimmune Diseases; Musculoskeletal Diseases; Joint Diseases; Arthritis; Connective Tissue Diseases; Arthritis, Rheumatoid; Rheumatic Diseases

Summary:

      Study in participants with RA who have an inadequate response to methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active RA for least 6 months

          -  Current RA defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8
             tender/painful joints (out of 68 joints examined) at screening and baseline (swollen
             and tender/painful joint count must not include distal interphalangeal joints) and at
             least 1 of the following at screening: Erythrocyte sedimentation rate ≥ 28 mm or
             C-reactive protein > 15 mg/L

          -  At least 1 of the following at screening: Rheumatoid factor positive or Anti-cyclic
             citrullinated peptide antibody positive

          -  Currently taking methotrexate for ≥ 12 weeks and on a stable dose of methotrexate at
             15 to 25 mg weekly for ≥ 4 weeks at day -1.

        Exclusion Criteria:

          -  Prosthetic joint infection within 5 years of screening or native joint infection
             within 1 year of screening

          -  Class IV RA

          -  Felty's syndrome

          -  Presence of serious infection

          -  Significant concurrent medical conditions

          -  Pregnant or breast feeding

          -  Significant Laboratory abnormalities

          -  Any disease-modifying anti-rheumatic drug (DMARD) other than methotrexate within 28
             days

          -  Leflunomide or live vaccines within 3 months

          -  Previous use of any experimental or commercially available biologic DMARD
AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms; Ascites
Intervention: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Intervention description: 4.0 mg/kg administered intravenously (IV) once every 2 weeks
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian cancer; malignant ascites; angiogenesis; angiogenesis inhibition; VEGF-Trap fusion recombinant protein

Summary:

      The primary objective of this study was to compare the time between paracenteses before and
      after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in
      ovarian cancer participants with symptomatic malignant ascites.

      The secondary objectives were to further assess efficacy and safety of Aflibercept treatment,
      and the exploratory objectives were to assess pharmacokinetics, immunogenicity and
      health-related quality of life.
    

Eligibility criteria:

        Participants that met the following criteria were eligible.

        Inclusion Criteria:

          -  Symptomatic malignant ascites resulting from advanced ovarian epithelial cancer
             (including fallopian tube and primary peritoneal adenocarcinoma) that required at
             least 3 previous therapeutic paracenteses at a frequency of 1 to 4 paracenteses per
             month for management.

          -  Platinum resistant disease defined by relapse or progression of disease during or
             after treatment, or drug intolerance.

          -  Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or
             progression of disease during or after treatment, or drug intolerance.

        Exclusion Criteria:

          -  Peritoneovenous or other type of shunt that was placed for the management of ascites

          -  Prior treatment with a VEGF or VEGF receptor inhibitor

          -  Uncontrolled hypertension

        The above information is not intended to contain all considerations relevant to
        participation in a clinical trial.
A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251
Condition: Chronic Obstructive Pulmonary Disease, COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QBW251; Placebo
Intervention description: QBW251 capsule(s) taken orally twice per day; Matching placebo capsule(s) taken orally twice per day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: COPD,; chronic bronchitis,; inflammation,; airway,; LCI,; pulmonary function test,; lung function,; controlled clinical trial,; randomized,; airflow,; smoker

Summary:

      To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo
      administered orally, on airway function, lung volume, and quality of life in patients with
      chronic obstructive pulmonary disease (COPD)
    

Eligibility criteria:

        Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonary
        disease (COPD); Must have clinical diagnosis of chronic bronchitis; Must be either a
        current smoker (smoked ≤ 1 pack per day on average for the last 3 months with at least a 10
        pack year smoking history) OR an ex-smoker with at least a 10 pack year smoking history;
        Exclusion Criteria: Must not be receiving chronic, daily, systemic steroids; Must not have
        severe emphysema (determined by HRCT); Must not have had a COPD exacerbation or respiratory
        tract infection requiring antibiotics or oral steroids or hospitalization within 6 weeks of
        screening; Must not be pregnant or nursing or a woman of child bearing potential; Other
        protocol-defined inclusion/exclusion criteria may apply
Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Intervention: EpiCeram Skin Barrier Emulsion; Experimental Product 1% Colloidal Oatmeal Balm
Intervention description: EpiCeram Skin Barrier Emulsion; Experimental Product 1% Colloidal Oatmeal Balm
Intervention MeSH terms: Decanoic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Eczema, Itchy Skin

Summary:

      The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC)
      1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to comprehend and follow the requirements of the study (including availability on
             scheduled visit dates)

          2. Male or female of any race or ethnicity, ages 12 and older

          3. Diagnosed as having eczema

          4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire
             duration of the study

        Exclusion Criteria:

          1. Known sensitivity to any investigational product ingredient

          2. Females who are pregnant , breastfeeding , or planning on becoming pregnant during the
             study

          3. Individuals with a history of skin cancer

          4. Use of a therapeutic (over-the-counter or prescription) body wash that contains an
             active ingredient for eczema

          5. Participation in any clinical study within 30 days of Visit 1

          6. Active infection of any type at the start of the study

          7. Diagnosed as having severe eczema

          8. Has a compromised immune system

          9. Individuals with any planned surgeries and/or invasive medical procedures during the
             course of the study

         10. Requires greater than 2.0mg/day inhaled or intranasal corticosteroids
Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects
Condition: Hypertension; Concurrent Obesity
MeSH terms: Hypertension
Intervention: LCZ696; amlodipine; Placebo
Intervention description: LCZ696 was provided as 400 mg tablets.; amlodipine was provided as 5 mg tablets.; Matching placebo to LCZ696 and amlodipine.
Intervention MeSH terms: Amlodipine; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension, obesity, insulin sensitivity, lipolysis, LCZ696

Summary:

      This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and
      oxidative metabolism in obese hypertensive subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any study assessment is performed.

          -  Males and females of non-childbearing potential ≥ 18 years of age.

          -  Subjects with mild to moderate essential hypertension,

               -  Untreated subjects must have a mean seated SBP (msSBP) ≥ 130 mmHg and < 180 mmHg
                  at screening.

               -  Pre-treated subjects must have a msSBP ≤ 160 mmHg at screening and < 180 mmHg at
                  the end of the washout period.

          -  Waist circumference ≥ 102 cm (men) and ≥ 88 cm (women);

        Exclusion criteria:

          -  Use of other investigational drugs at the time of enrollment, or within 30 days or 5
             half-lives of enrollment, whichever is longer; or longer if required by local
             regulations.

          -  History of angioedema, drug-related or otherwise

          -  History of hypersensitivity to LCZ696, amlodipine, or drugs of similar chemical
             classes.

          -  Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180
             mmHg) at screening or at the end of the washout period.

          -  Type 1 or Type 2 diabetes mellitus.

          -  Dyslipidemia requiring pharmacological therapy with a fibrate or nicotinic acid.

          -  Concomitant use of anti-hypertensives, anti-diabetics, or drugs with effects on
             glucose or lipid metabolism for the duration of the study.

        Other protocol defined inclusion/exclusion criteria may apply