bioihbjkbjnl/mcl2 huggingface dataset:
Azithromycin Treatment for the Airway Microbiome in Asthma
Condition: Asthma Chronic
MeSH terms: Asthma
Intervention: Azithromycin; Placebo
Intervention description: 8 weeks of Azithromycin (250 mg) once daily by mouth; Placebo
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; Azithromycin; Microbiome; Sputum

Summary:

      The purpose of this study to determine whether the bacteria inside the lungs of people with
      asthma can be modified (changed) if they are given an antibiotic and if this change is
      associated with an improvement in asthma symptoms.
    

Eligibility criteria:

        Inclusion criteria (All participants):

          1. Age 18 - 55 years

          2. Able to provide informed consent

          3. Smoking history < 10 pack-years

        Inclusion Criteria for subjects with poorly controlled asthma

          1. Methacholine PC20 < 16 mg/ml or PD 20 < 400 mcg/ml or albuterol response > 12% on FEV1
             after 4 puffs of albuterol

          2. Currently prescribed ICS + LABA

          3. Meet definition for Th2-low asthma: peripheral blood eosinophil count < 300 and
             exhaled nitric oxide level < 30 ppb.

        Exclusion Criteria (All participants)

          1. History of allergy or intolerance to any medications used in this study

          2. Medication exclusions:

               1. Current use of medications that prolong QTc interval

               2. Current use of omalizumab or other ant-IgE therapies

               3. Current use of anti-IL 5 therapies

               4. Current use of anticoagulants

          3. Prednsione or other oral steroids within past 3 months

          4. Pregnancy or lactation, or plans to become pregnant

          5. Other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema)

          6. Pre-existing liver disease by history

          7. Smoking within the last 6 months

          8. Exacerbation of asthma in past 3 months

          9. Affected by a hearing disorder

         10. Clinically significant medical condition (e.g., heart failure, seizure disorder) which
             may in-crease risk as determined by study investigator

         11. Corrected QT interval > 450 msec. Patients with known cardiac history or prolonged QT
             interval on a screening EKG are excluded given the small but real potential for
             macrolide-related side effects
Effect of Glycine in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Glycine; Placebo
Intervention description: Daily oral supplement of glycine at a dose of 0.5 g/kg divided in three doses during 8 weeks; Daily oral administration of placebo (sugar glass) at a dose of 0.5 g/kg divided in three doses during 8 weeks
Intervention MeSH terms: Glycine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 5 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: cystic fibrosis; glycine; airway inflammation

Summary:

      The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5
      g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic fibrosis,
      as compared with placebo. During all of the study children will receive their usual treatment
      for cystic fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children of either sex

          -  Between 5 and 15 years of age

          -  With CF diagnosed according to established criteria

          -  Without changes in the CF treatment in the last 30 days

          -  Without CF exacerbation in the last 30 days

          -  Without acute respiratory infection (e.g., common cold) in the last 15 days

          -  Informed consent letter signed by their parents or legal guardians

        Exclusion Criteria:

          -  Children with CF that had participated in a research protocol in the last 3 months

          -  Presence of serious adverse effects attributable to glycine, in which case the result
             will be considered as therapeutic failure in the statistical analysis

          -  Development of a CF exacerbation, in which case the available data so far collected
             will be included in the statistical analysis
A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: PRA023 IV; Companion diagnostic (CDx)
Intervention description: PRA023 administered at timepoints as directed by the protocol; CDx+ or CDx-
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: APOLLO-CD; APOLLO; Crohn's Disease

Summary:

      The purpose of this study is to assess the safety and efficacy of PRA023 in participants with
      moderately to severely active Crohn's Disease.

      After the completion of the 12-week induction period, all participants have the option to
      continue in the open-label extension for another 38 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Crohn's disease

          -  Moderately to severely active CD as defined by Crohn's disease activity index (CDAI)
             score and centrally read endoscopy

          -  Must have corticosteroid dependence or have had no response, insufficient response,
             loss of response and/or intolerance to at least one of the following therapies:
             corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF),
             anti-integrin, or anti-interleukin (IL)12/23

          -  Able to provide written informed consent and understand and comply with the
             requirements of the study

        Exclusion Criteria:

          -  Women of child bearing potential (WOCBP) and men with female partner of childbearing
             potential who are unwilling to use two highly effective methods of contraception to
             avoid pregnancy for the entire study period and up to 12 weeks after the last dose of
             study drug

          -  Diagnosis of ulcerative colitis (UC) or indeterminate colitis

          -  CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic
             and/or illeal involvement

          -  Suspected or diagnosed intra-abdominal or perianal abscess at screening

          -  Current stoma or need for colostomy or ileostomy

          -  Previous small bowel resection with a combined resected length of >100 cm or previous
             colonic resection of > 2 segments

          -  Surgical bowel resection within 3 months before screening

          -  Past or current evidence of definite low-grade or high-grade colonic dysplasia not
             completely removed

          -  Subjects in the opinion of the investigator are at an unacceptable risk for
             participation in the study

          -  Subjects who meet the protocol criteria for important laboratory exclusion criteria
Phase II Study, Evaluation of Safety and Efficacy of IdeS in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: IdeS
Intervention description: Doses are administered in ascending doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: transplantation; sensitised patients; HLA-antibodies

Summary:

      IdeS is an immunoglobulin g (IgG) cleaving enzyme. It will given to patients with donor
      specific antibodies to reduce the antibody load and thus enable kidney transplantation. IdeS
      antibody reducing efficacy and its safety will be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with chronic kidney disease and in dialysis with identified antibodies
             against at least two HLA antigens of which at least one is 3000 MFI or more as
             measured by SAB assay on at least two occasions.

        Exclusion Criteria:

          -  Prior malignancy within 2 years excluding adequately treated basal cell or squamous
             cell skin cancer, cervical carcinoma in situ and prostate cancer Gleason <6 and
             prostate-specific antigen (PSA) <10 ng/mL.

          -  Any positive result on screening for serum hepatitis B surface antigen, hepatitis C
             antibody and human immunodeficiency virus (HIV

          -  Clinical signs of ongoing infectious disease.

          -  Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure
             > New York Heart Association (NYHA) grade 3, unstable coronary disease or oxygen
             dependent chronic obstructive pulmonary disease (COPD)

          -  History of any other clinically significant disease or disorder which, in the opinion
             of the investigator, may either put the patient at increased risk because of
             participation in the study, or influence the results or the patient's ability to
             participate in the study

          -  Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L

          -  History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as
             judged by the investigator or history of hypersensitivity to drugs with a similar
             chemical structure or class to IdeS (e. g streptokinase and/or staphylokinase)

          -  Has received another new chemical entity (defined as a compound which has not been
             approved for marketing) or has participated in any other clinical study that included
             drug treatment within 4 months of the first administration of investigational product
             in this study. Patients consented and screened but not dosed in previous studies are
             not excluded
BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: Placebo; Placebo; BI 409306; Donepezil
Intervention description: for blinding purposes
Intervention MeSH terms: Donepezil; BI 409306
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 329.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The study is designed to compare the effects of BI 409306 compared to placebo in patients
      with cognitive impairment due to Alzheimer's Disease
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with early signs of dementia of Alzheimer Type

          -  Male and female patients with an age of at least 55 years

          -  Previous use of Alzheimer's Disease (AD) medications (AChEIs, memantine) is allowed up
             3 month prior to screening. Patients who are currently taking AChEIs are eligible as
             long as they have been using a stable dose for at least 3 months prior to screening
             and no change is foreseen for the duration of the study. This dose must be consistent
             with the product label in the concerned country. Patients currently taking memantine
             are excluded.

          -  Patients must have at least 6 years of formal education and fluency in the test
             language as verbally confirmed by the patient and documented by the study
             investigator.

          -  Patients must have a reliable study partner (per investigator judgement, for instance
             a family member, partner etc., guardian or, if applicable, a legal representative)

        Exclusion criteria:

          -  Cognitive impairment or dementia with any etiology other than Alzheimer's Disease (AD)

          -  Substantial concomitant cerebrovascular disease (defined by a history of a stroke /
             intracranial haemorrhagia) temporally related to the onset of worsening of cognitive
             impairment per investigator judgement

          -  Medical history or diagnosis of any of symptomatic and unstable/uncontrolled
             conditions per investigator judgement

          -  Any other psychiatric disorders such as schizophrenia, or mental retardation

          -  Previous participation in investigational drug studies of mild cognitive
             impairment/Dementia of Alzheimer Type (DAT) within three months prior to screening.
             Having received active treatment in any other study targeting disease modification of
             AD like Aß immunization and tau therapies. Previous participation in studies with
             non-prescription medications, vitamins or other nutritional formulations is allowed.

          -  Clinically significant uncompensated hearing loss in the judgment of the investigator.
             Use of hearing aids is allowed.
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms
Intervention: Gemcitabine; Epirubicin; Docetaxel
Intervention description: Gemcitabine; Epirubicin; Docetaxel
Intervention MeSH terms: Gemcitabine; Docetaxel; Epirubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Treatment strategies that include induction chemotherapy have several potential advantages:
      early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging
      of both the primary tumor and regional lymphatic metastases, making breast conservation an
      option for many. The aim of the present study is to determine the efficacy and toxicity of
      induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel,
      in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the
      upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new
      agents and combination of agents are likely to have the greatest potential impact.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Adenocarcinoma of the breast confirmed by biopsy

          -  Female Patients >18 years of age

          -  Normal cardiac function

          -  Ability to perform activities of daily living with minimal assistance

          -  Chemotherapy naïve or have received prior chemotherapy > 5 years ago

          -  Adequate bone marrow, liver and kidney function

          -  Be informed of the investigational nature of this study

          -  Sign an informed consent form

          -  Sentinel lymph node and/or axillary dissection prior to enrollment

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Life expectancy of < than 6 months

          -  History of significant heart disease

          -  Prior chemotherapy or hormonal therapy

          -  Concurrent Trastuzumab therapy

          -  History of significant psychiatric disorders

          -  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.
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Diabetes Mellitus; Nutrition Disorders
Intervention: semaglutide; liraglutide; placebo
Intervention description: Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.; Once-daily subcutaneous (s.c., under the skin) administration.
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 957.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to investigate safety and efficacy
      of once-daily semaglutide in obese subjects without diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial-related activities.
        Trial-related activities are any procedures that are carried out as part of the trial,
        including activities to determine suitability for the trial - Male or female, age 18 years
        or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0
        kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per
        investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or
        above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment
        with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal
        to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or
        multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) -
        Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any
        medication within 90 days before screening that based on investigator's judgement may cause
        significant weight change - Previous surgical treatment for obesity (liposuction and/or
        abdominoplasty performed 1 year before screening is allowed) - History of major depressive
        disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt -
        Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
        potential and not using an adequate contraceptive method (adequate contraceptive measures
        as required by local regulation or practice)
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: lovastatin
Intervention description: The HMG-coA reductase inhibitor used in this study will be lovastatin. Dosage: 20 mg/d PO with evening meal. Patients on a higher dose of lovastatin at the time of study entry may continue at that dose level; for patients switching to lovastatin, the dose will be at the discretion of the prescribing physician, but must be at least 20 mg/day.Schedule: begin on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months. Patients or their third party payers will be expected to cover the cost of the drug.
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; radiation therapy; lovastatin; rectal injury

Summary:

      Lovastatin may protect against late effects of radiation therapy in patients with prostate
      cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate

          -  Planned treatment with radiation therapy to include external beam and/or brachytherapy
             with curative intent (total dose ≥60 Gy). A portion of the rectum must receive at
             least 60 Gy.

          -  Age at least 18 years

          -  Karnofsky Performance Status (KPS) ≥ 70

          -  No history of prior radiotherapy to the prostate or rectum

          -  History of prior malignancy, if likely to live at least 4 years, is acceptable.

          -  No evidence of distant metastases

          -  Patients may be taking an HMG-coA-reductase inhibitor, but to be eligible, they must
             be able to be changed to lovastatin 20 mg/day, with the permission of their
             prescribing physician.

          -  Creatine kinase < 5 times upper normal limit

          -  Sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min

          -  transaminases < 3 times upper normal limit

        Exclusion Criteria:

          -  Planned abdomino-perineal resection after radiotherapy

          -  Contraindication to an HMG-coA-reductase inhibitor

          -  Major medical or psychiatric illness, which in the investigator's opinion, would
             prevent completion of treatment and would interfere with follow-up.

          -  Currently taking an inhibitor of cytochrome P450 3A4

          -  Active liver or muscle disease
Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Canakinumab
Intervention description: Canakinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Anti-interleukin-1 beta; ACZ885

Summary:

      This study will assess the long-term safety and tolerability of ACZ885 in patients with
      rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or
      improvement of joint structure and bone mineral density, and long term maintenance of
      health-related quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients (male and non-pregnant, non-lactating females) who completed the core
             CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe
             drug-related adverse effects may enter the extension study upon signing informed
             consent

        Exclusion Criteria:

          -  Patients for whom continued treatment in the extension is not considered appropriate
             by the treating physician.

          -  Patients who were non-compliant or who demonstrated a major protocol violation in the
             core study.

          -  Patients who did not complete / discontinued from the core study.

          -  Patients with drug related serious adverse events or severe adverse events.

        Other protocol-defined inclusion/exclusion criteria may apply.