bioihbjkbjnl/mcl2 huggingface dataset:
Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases
Condition: Metastatic Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: paricalcitol; immunoenzyme technique; laboratory biomarker analysis; dual x-ray absorptometry; quality-of-life assessment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer; bone metastases

Summary:

      RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to
      grow and spread more slowly. It may also stop the growth of tumor cells in bone.

      PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients
      with advanced prostate cancer and bone metastases.
    

Eligibility criteria:

        Inclusion:

          -  Histologically or cytologically confirmed advanced adenocarcinoma of the prostate

             - Radiographically proven bone metastasis from prostate cancer

          -  Androgen refractory disease (including anti-androgen withdrawal)

          -  Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values > 70
             pg/mL, 14 days apart

          -  ECOG performance status 0-2

          -  Leukocytes ≥ 3,000/μL

          -  Absolute neutrophil count ≥ 1,500/μL

          -  Platelets ≥ 100,000/μL

          -  Total bilirubin normal

          -  AST/ALT ≤ 2.5 times upper limit of normal

          -  Creatinine clearance ≥ 60 mL/min

          -  Calcium normal

          -  25-hydroxyvitamin D (25-OHD) ≥ 20 ng/mL

          -  1,25(OH)_2D normal

          -  Patients with serum 25-OHD indicative of vitamin D insufficiency are eligible provided
             they are treated with ergocalciferol to raise 25-OHD levels to 20 ng/mL prior to
             paricalcitol therapy

          -  More than 8 weeks since prior bisphosphonates

          -  More than 2 weeks since prior palliative radiotherapy

          -  More than 4 weeks since other prior therapy

          -  No more than one prior taxane-containing chemotherapy regimen for metastatic disease

          -  Multiple lines of prior therapy with hormonal agents allowed

          -  Concurrent corticosteroids allowed provided the dose remains stable during the study
             period

        Exclusion:

          -  Underlying metabolic bone disease or vitamin D deficiency

          -  History of hypercalcemia

          -  Concurrent uncontrolled illness or co-morbid condition (including psychiatric illness)
             that would interfere with study compliance

          -  Concurrent ergocalciferol supplementation

          -  Concurrent chemotherapy or hormonal therapy

          -  Concurrent investigational or commercial agents for the malignancy
Esmolol to Treat the Hemodynamic Effects of Septic Shock
Condition: Septic Shock; Hypotension; Tachycardia
MeSH terms: Shock, Septic; Hypotension; Tachycardia; Shock
Intervention: Esmolol; Saline
Intervention MeSH terms: Esmolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esmolol; Septic Shock; Hypotension; Tachycardia

Summary:

      The main purpose of this study is to determine the effects of controlling the heart rate of
      patients with septic shock using an intravenous medication called esmolol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years)

          -  Sepsis defined as suspected or confirmed infection with at least two systemic
             inflammatory response syndrome (SIRS) criteria

          -  Norepinephrine (minimum 0.1 mcg/kg/min) support to maintain a mean arterial pressure ≥
             65 mmHg despite appropriate volume resuscitation (as defined by the clinical team,
             however at least 30mL/kg intravenous fluid

          -  Heart rate ≥ 95 per minute for at least 2 hours prior to enrollment

          -  6-24 hours since ICU admission

        Exclusion Criteria:

          -  Intravenous β-blocker therapy prior to randomization

          -  Pronounced cardiac dysfunction (i.e. cardiac index [CI] ≤ 2.2 L/min/m2)

          -  Known significant valvular heart disease

          -  Research-protected populations (pregnant women, prisoners, intellectually disabled)

          -  Known "Do-not-resuscitate" or "do-not-intubate" order at the time of enrollment

          -  Infusion of epinephrine, dopamine, dobutamine or milrinone at time of enrollment

          -  Known allergy/sensitivity to esmolol or history of asthma/COPD
Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: AZD2281; Liposomal Doxorubicin; AZD2281
Intervention description: 400mg Oral twice daily; 50mg/m2 Monthly Intravenous; 200mg oral twice daily
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Advanced ovarian cancer; BRCA1 protein; BRCA2 protein; Poly(ADP ribose) polymerases

Summary:

      The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281
      against liposomal doxorubicin to see which is effective and well tolerated in treating
      patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed
      previous platinum therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced ovarian cancer with positive BRCA1 or BRCA2 status

          -  Progressive or recurrent disease after platinum-based chemotherapy

          -  Measurable disease by RECIST

        Exclusion Criteria:

          -  Previous anthracycline treatment

          -  Brain metastases

          -  Less than 28 days since last treatment used to treat the disease

          -  Considered a poor medical risk due to a serious uncontrolled disorder
Inhaled Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Hereditary Pulmonary Alveolar Proteinosis (PAP)
Condition: Hereditary Pulmonary Alveolar Proteinosis
MeSH terms: Pulmonary Alveolar Proteinosis
Intervention: Leukine
Intervention description: Participants will receive inhaled rhGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg one time per week for 12 weeks. Following an interim safety evaluation, participants may be entered into a second 12 week treatment period where participants will receive either 250 mcg or 500 mcg once weekly. At the end of any treatment period, participants will be followed for 12 additional weeks in the absence of inhaled rhGM-CSF to evaluate safety and efficacy.
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: PAP

Summary:

      The purpose of this study is to evaluate the therapeutic efficacy of inhaled recombinant
      human GM-CSF in individuals with hereditary Pulmonary Alveolar Proteinosis (PAP) due to
      partial dysfunction of the GM-CSF receptor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of PAP caused by bi-allelic mutations in CSF2RA or CSF2RB associated with
             impaired GM-CSF-R-alpha or GM-CSF-R-beta function, respectively, resulting in reduced
             but non-zero GM-CSF signaling

          -  Able and willing to give written informed consent / assent as necessary

          -  Clinically stable

        Exclusion Criteria:

          -  Confirmed diagnosis of a disorder of surfactant production caused by bi-allelic
             mutations in ABCA3, SFTPB, or SFTPC

          -  Confirmed diagnosis of autoimmune PAP caused by a high level of GM-CSF autoantibody

          -  Confirmed diagnosis of secondary PAP caused by an underlying clinical disorder known
             to be associated with the development of PAP, e.g., inhalation of silica or titanium;
             myelodysplasia and others

          -  Treatment with any investigational agent in the 3 months prior to enrollment

          -  History of severe allergic or anaphylactic reactions to GM-CSF or other yeast-derived
             products

          -  History of asthma or other reactive airways disease

          -  Known active, viral, fungal, mycobacterial, or other infection

          -  A serious medical condition which, in the opinion of the investigator or data and
             safety monitoring committee, would make the patient unsuitable for the study
Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: QGE031; Placebo
Intervention description: QGE031 120 mg per 1 mL liquid in vial; Placebo to QGE031 0 mg per 1 mL liquid in vial
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      This study planned to assess the effect on the reduction in rate of severe asthma
      exacerbations of different dose levels of QGE031 in asthma patients that are inadequately
      controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid.
      However, this study was terminated due to the efficacy results from an interim analysis (at
      the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data
      analyses were not performed for this study due to the early termination and the very limited
      dataset (only 10 participants received study medication of the 440 participants planned).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A diagnosis of allergic asthma, uncontrolled on current medication.

          -  History of at least 2 asthma exacerbations during the last 1 year

          -  Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted
             normal value; reversibility following administration of bronchodilator.

        Key Exclusion Criteria:

          -  Use of tobacco products within the previous 6 months (Social occasional smokers may be
             included).

          -  Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: 50 mg P005672-HCl; Placebo; 100 mg P005672-HCl
Intervention description: P005672-HCl administered as an oral capsule(s) once daily; Dose-matched Placebo capsule administered as an oral capsule(s) once daily; P005672-HCl administered as an oral capsule(s) once daily
Intervention MeSH terms: Sarecycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 285.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: acne

Summary:

      To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo
      for the treatment of moderate to severe facial acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  if women of child-bearing potential, have a negative urine pregnancy test

          -  Willing to use only a non-medicated cleanser and to refrain from use of any other acne
             medication, medicated cleanser, excessive sun exposure, and tanning booths for the
             duration of the study

          -  Male or female, 12-45 years of age with body weight between 52 and 88 kg

          -  Diagnosis of acne vulgaris with:

             20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100
             noninflammatory lesions (open and closed comedones)

          -  No more than 2 nodules on the face

          -  Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)

        Exclusion Criteria:

          -  Dermatological condition of face or facial hair that could interfere with clinical
             evaluations subjects who have used the following medications (topical refers only to
             the facial area) will not be eligible:

        Within 1 week prior to randomization:

          -  Medicated facial cleansers

          -  Topical acne treatments (other than those listed below)

        Within 4 weeks prior to randomization:

          -  Topical retinoids

          -  Topical anti-inflammatories and corticosteroids

          -  Systemic antibiotics

          -  Systemic acne treatments

        Within 12 weeks prior to randomization:

          -  Systemic retinoids

          -  Systemic corticosteroids

          -  Pseudomembranous colitis or antibiotic-associated colitis

          -  Hepatitis, liver damage or renal impairment
The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Condition: Chronic Rhinitis
MeSH terms: Rhinitis
Intervention: Placebo; Guaifenesin
Intervention description: Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID.; Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of
      oral guaifenesin for the therapy of Chronic Rhinitis (CRS) in 36 children between the ages of
      7 and 18 years. The study investigates the effectiveness of guaifenesin in the relief of
      nasal symptoms in children with CRS using the sinonasal 5 survey (SN-5) in comparison to
      nasal airway volume, and biophysical properties of nasal secretion. The investigators
      hypothesize that Guaifenesin use over a period of 14 days improves subjective nasal
      complaints in pediatric patients with chronic rhinitis and nasal congestion, as measured by
      the SN-5 survey compared to use of placebo. There will be an observed improvement in nasal
      volume and cross-sectional area following use of guaifenesin, and nasal secretions will have
      more favorable mucociliary and sneeze clearability compared to use of placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal
             stuffiness for at least 3 month duration.

        Exclusion Criteria:

          -  Children with immunodeficiency, cystic fibrosis, acute or subacute symptoms, signs of
             bacterial infection, and/or those who are unable to cooperate with testing will be
             excluded. Children with documented use of the study medication in the month before
             evaluation and during period of symptoms will also be excluded.
A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ABT-494; Placebo
Intervention description: ABT-494 capsule administered orally twice daily (BID).; Placebo for ABT-494 capsule administered orally twice daily (BID).
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anti-inflammatory agents; Joint Diseases; Arthritis; Musculoskeletal Disease; antirheumatic agents

Summary:

      The primary objective is to compare the safety and efficacy of multiple doses of ABT-494
      versus placebo in moderately to severely active RA subjects on stable background MTX therapy
      with inadequate response or intolerance to anti-TNF biologic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American
             College of Rheumatology (ACR) classification criteria or the 2010 American College of
             Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.

          -  Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3
             months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to
             initiating the study drug. Subjects should also be on a stable dose of folic acid (or
             equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should
             continue with their stable doses of MTX and folic acid throughout the study

          -  Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics
             (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to
             discontinue due to intolerability or toxicity. In addition, subjects with prior
             exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab,
             anakinra, or tocilizumab) are allowed.

          -  Have active RA as defined by the following minimum disease activity criteria: ≥ 6
             swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints
             (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive
             protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor
             and anti-cyclic citrullinated peptide (anti-CCP) antibody.

        Exclusion Criteria:

          -  Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib,
             baricitinib)

          -  Pregnant or breastfeeding female

          -  Ongoing or active infection.
Pharmacokinetic Study of 4 mg Nicotine Lozenge.
Condition: Smoking Cessation
Intervention: nicotine
Intervention description: 4 mg nicotine lozenge experimental
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, single center, open label, single dose, four way crossover study in
      fasted healthy male subjects to compare the pharmacokinetics of nicotine following
      administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg
      nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12
      hours post dose in each treatment session and plasma samples analyzed for nicotine levels.
    

Eligibility criteria:

        Inclusion Criteria:

        - smoked commercially-manufactured cigarettes daily for the preceding 12 months and
        routinely smokes first cigarette within 30mins of awakening.

        Exclusion Criteria:

          -  inability to refrain from smoking during confinement period, smoking tobacco in any
             other form other than commercially manufactured cigarettes, subject has used chewing
             tobacco or other tobacco products other than commercially manufactured cigarettes
             within 7 days of dosing
Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine 3 mg; Cariprazine 6 mg; Cariprazine 12.5 mg
Intervention MeSH terms: Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; antipsychotics; dopamine D3/D2 antagonist

Summary:

      The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed
      doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets
      will be administered to patients starting at an initial dose, followed by up-titration to a
      fixed dose (low, medium or high) for 14 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients meeting DSM-IV-TR criteria for schizophrenia

          -  PANSS total score <= 120 during the observation period

          -  Patients who have been treated with oral antipsychotics within 4 weeks before informed
             consent

          -  Patients whose consent is obtained from themselves in written form

        Exclusion Criteria:

          -  Patients who have defined as any mental disorder other than "Schizophrenia" based on
             the criteria of DSM-IV-TR

          -  History of drug or alcohol abuse

          -  Concurrent Parkinson's disease

          -  History of, or concurrent spastic disorders like epilepsy, cerebrovascular disease,
             anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic
             disorder

          -  Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs,
             ECG, or clinical laboratory values

          -  Current cataract during the observation period

          -  History of shock or anaphylactoid symptoms to drugs

        The information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.