bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
Condition: CKD Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Roxadustat; Placebo
Intervention description: Oral tablets; Oral tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 922.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease (CKD); non-dialysis; Hemoglobin (Hb); End-Stage Renal Disease; erythropoeitin; ASP1517; erythropoeisis stimulating-agent; AZD9941

Summary:

      The purpose of this study is to determine whether roxadustat is safe and effective in the
      treatment of anemia in participants with chronic kidney disease and not on dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis

          -  Anemia qualified by measurements of hemoglobin values during screening

          -  Additional blood work must be in a safe range for study entry

          -  Body weight 45 to 160 kilograms (kg)

          -  Willingness to use contraception if of child-bearing potential

        Exclusion Criteria:

          -  Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to
             study participation

          -  More than 1 dose of intravenous iron within 12 weeks prior to study participation

          -  Blood transfusion within 8 weeks prior to study participation

          -  Active infection

          -  Chronic liver disease

          -  Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot

          -  Uncontrolled blood pressure within 2 weeks prior to study participation

          -  Renal cell carcinoma

          -  History of malignancy, including multiple myeloma or other myelodysplastic syndrome

          -  Chronic inflammatory disease that could impact red blood cell production

          -  Any prior organ transplant or a scheduled organ transplantation

          -  Anticipated elective surgery that is expected to lead to significant blood loss or
             anticipated elective heart procedure

          -  Gastrointestinal bleeding

          -  Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase
             inhibitor (HIF-PHI)

          -  Recent use of an investigational drug or treatment, or participation in an
             investigational study
The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Intervention: 2.5 mg Chlorhexidine gluconate chip
Intervention description: Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 290.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peri-Implantitis; Periodontal Diseases; Chlorhexidine gluconate; PerioChip; Anti-Infective Agents; Mouth Diseases; Antiseptics

Summary:

      The objective of the study is to assess the efficacy and safety of PerioChip® (Chlorhexidine
      gluconate chip) in the treatment of patients with Peri-implantitis.

      The hypothesis of the study is that PerioChip® in adjunct to mechanical subgingival
      debridement is more effective in the treatment of peri-implantitis when compared to the
      common method of mechanical subgingival debridement alone. The primary efficacy measure will
      be the reduction in probing pocket depth at 6 months as measured at sites of qualifying
      target implant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Good general health

          -  At least one implant in the oral cavity with clinical and radiographical signs of
             peri-implantitis. Including bone loss in combination with bleeding and/or suppuration
             on probing and a peri-implant Probing Depth (PD) of 5-8 mm.

          -  The implants have been in function for more than 2 years.

          -  Fixed prosthetic restoration of the implant.

        Exclusion Criteria:

          -  Pregnancy.

          -  Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.

          -  Allergic reaction to Chlorhexidine.

          -  Active Periodontitis which required definitive treatment.

          -  Presence of orthodontic appliances, or any removable appliances, that impinges on the
             tissues being assessed.

          -  Use of systemic antibiotic therapy and/or chronically use of non-steroidal
             anti-inflammatory drugs (NSAIDs).

          -  Uncontrolled diabetes, of any type.
Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Intervention: Taliglucerase alfa
Intervention description: Intravenous infusion every 2 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gaucher Disease; Enzyme replacement therapy

Summary:

      Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the
      human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme
      glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in
      the cells of the monocyte-macrophage system.

      This is an extension trial to Study NCT00376168 and NCT00712348.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of Protocol PB-06-001

          -  The patient signs informed consent

        Exclusion Criteria:

          -  Currently taking another experimental drug for any condition

          -  Presence of severe neurological signs and symptoms, defined as complete ocular
             paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic
             Gaucher disease

          -  Pregnant or nursing

          -  Presence of any medical, emotional, behavioral or psychological condition that in the
             judgment of the Investigator would interfere with the patient's compliance with the
             requirements of the study
Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
Condition: Helicobacter Pylori Infection
Intervention: Dual Mode BreathID Hp System
Intervention description: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode
      BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis
      and post treatment monitoring of H.pylori infection in adult patients and its results will be
      compared to biopsy results.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age.

          -  Have the ability and willingness to sign the Informed Consent Form.

          -  Present with clinical indication of H. pylori and a candidate for upper endoscopy

        For Initial Diagnosis arm:

        • Symptomatic patients naïve to H.pylori treatment in the past 18 months

        For Post-Therapy arm:

          -  Documented biopsy with positive outcome prior to eradication therapy (including method
             of determination)

          -  Documented eradication therapy within the past 6 months and completed at least 6 weeks
             prior to UBT

        Exclusion Criteria:

          -  Participation in other interventional trials.

               -  Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath
                  test.

               -  PPI or H2 blockers within two (2) weeks prior to breath test.

               -  Pregnant or breastfeeding women.

               -  Allergy to test substrates.

               -  Patient did not fast for the hour prior to the UBT
Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)
Condition: Asthma, Exercise-Induced
MeSH terms: Asthma, Exercise-Induced
Intervention: Comparator: Montelukast; Comparator: Salmeterol; Comparator: Placebo (montelukast); Comparator: Placebo (salmeterol)
Intervention description: 1 dose montelukast 10 mg tablet given orally in one of three treatment periods; 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods; 1 dose matching-image placebo to montelukast tablet in two of three treatment periods; 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
Intervention MeSH terms: Salmeterol Xinafoate; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      To determine the effect of an approved medication being studied in support of a new approach
      in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also
      known as exercise-induced bronchospasm), in patients who have a history of worsening asthma
      after exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician-diagnosed exercise-induced bronchospasm

        Exclusion Criteria:

          -  Patient is, other than asthma, not in good, stable health. The Primary Investigator
             will evaluate whether there are other reasons why the patient may not participate.
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: dimethyl fumarate; Placebo
Intervention description: BG00012 capsules; Capsules taken to maintain the blind in the 240 mg BID treatment group.
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1736.0
Sex: All
Minimum age: 19 Years
Maximum age: 58 Years
Healthy volunteers: No
Keywords: relapsing; multiple sclerosis; remitting; oral

Summary:

      The primary objective of this study is to evaluate the long-term safety profile of BG00012
      (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term
      efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further
      the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic
      resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301
      (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on
      health economics assessments and the visual function test.
    

Eligibility criteria:

        Key Inclusion Criteria:

        -Subjects who participated in and completed as per protocol previous BG00012 clinical
        studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

        Key Exclusion Criteria:

          -  Any significant change in medical history from 109MS301 or 109MS302 that would have
             excluded subject's participation from their previous study.

          -  Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE
             or due to reasons other than protocol-defined relapse/disability progression.

          -  Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability
             progression or relapses and did not follow the modified visit schedule up to Week 96.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
Condition: Keratosis, Actinic
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Tirbanibulin ointment 1%
Intervention description: Applied topically for 5 days over a field of approximately 100 cm^2 on the face or balding scalp with AK.
Intervention MeSH terms: Tirbanibulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety, tolerability and treatment effect of
      tirbanibulin ointment 1% when applied to a field of approximately 100 cm^2 on the face or
      balding scalp.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Having a treatment field (TF) on the face or balding scalp (excluding lips, eyelids,
             and inside nostrils and ears) that measures approximately 100 cm^2 (eg, mid face) and
             contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (AK)
             lesions within the TF

          -  Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the
             use of tanning beds, to the face or scalp during the study

          -  Ability to understand the purpose and risks of the trial, willingness and ability to
             comply with the protocol, and provided written informed consent in accordance with
             institutional and regulatory guidelines

        Exclusion Criteria:

          -  Presence in the TF of

               1. Clinically atypical and/or rapidly changing AK lesions in the TF

               2. Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on
                  2 previous occasions) and/or cutaneous horn

               3. Confluent AK lesions (ie, non-discrete lesions defined as per inclusion criteria)

               4. History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell
                  carcinoma (BCC), or other malignant tumors in the TF

               5. Any other dermatological disease that causes difficulty with examination

          -  Previous treatment with tirbanibulin ointment 1%.

          -  Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day
             57

          -  Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic
             therapy, or other treatments for AK within the TF or within 2 cm of the TF, within 8
             weeks prior to the Screening visit

          -  Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months
             prior to the Screening visit
Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: adalimumab (D2E7); placebo
Intervention description: Adalimumab 40 mg every other week (eow); Placebo every other week (eow)
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ankylosing spondylitis; adalimumab

Summary:

      The purpose of the study is to assess the safety and clinical efficacy of adalimumab in
      subjects with active ankylosing spondylitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was age 18 or older and in relatively good health (Investigator discretion)
             with a recent stable medical history.

          -  Subject met the definition of AS based on the Modified New York Criteria.

          -  Subject had an inadequate response to or intolerance to one or more NSAIDs as defined
             by the Investigator

        Exclusion Criteria:

          -  Subject had previously received anti-TNF therapy.

          -  Subject considered by the investigator, for any reason, to be an unsuitable candidate
             for the study

          -  Female subject who is pregnant or breast-feeding or considering becoming pregnant
Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: TAS-102; Placebo
Intervention description: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.; Placebo orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer
      refractory or intolerable to standard chemotherapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has provided written informed consent

          -  Has adenocarcinoma of the colon or rectum

          -  Has failed at least 2 prior regimens of standard chemotherapies for metastatic
             colorectal cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Is able to take medication orally

          -  Has adequate organ function (bone marrow, kidney and liver)

          -  Women of childbearing potential must have a negative pregnancy test and must agree to
             adequate birth control if conception is possible. Males must agree to adequate birth
             control.
A Study For Pregabalin In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: pregabalin; placebo
Intervention description: Pregabalin capsule, 300-450mg/day, twice daily; Placebo, twice daily
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregabalin; fibromyalgia

Summary:

      The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared
      with placebo for management of fibromyalgia in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, at least 18 years of age

          -  Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie,
             widespread pain present for at least 3 months, and pain in at least 11 of 18 specific
             tender point sites)

          -  At screening (V1) and randomization (V2), patients must have a score of no less than
             40 mm on the Pain Visual Analog Scale (VAS)

          -  At randomization (V2), at least 4 pain diaries must be completed satisfactorily within
             the last 7 days and the average pain score must be no less than 4

        Exclusion Criteria:

          -  Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at
             randomization (V2) as compared to screening (V1)

          -  Patients with other severe pain due to other conditions (eg, DPN or PHN) that may
             confound assessment or self-evaluation of the pain associated with fibromyalgia

          -  Patients with any widespread inflammatory musculoskeletal disorders, widespread
             rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine
             disorders

          -  CLcr less than 60 mL/min (estimated from serum creatinine)
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
Condition: Novel 2009 Influenza H1N1
MeSH terms: Influenza, Human
Intervention: MF59-eH1N1_f; eH1N1_f
Intervention description: MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal; Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 784.0
Sex: All
Minimum age: 3 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Swine Flu; Flu; Vaccine; Adjuvant

Summary:

      This study will evaluate the safety and immunogenicity of different combinations of A/H1N1
      S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children, adolescents, and adults 3 to 64 years of age in good health as determined by
             medical history, physical assessment and clinical judgement of the investigator and
             without influenza within the past 6 months.

        Exclusion Criteria:

          -  History of serious disease.

          -  History of serious reaction following administration of vaccine or hypersensitivity to
             vaccine components.

          -  Known or suspected impairment/alteration of immune function.

          -  Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week
             before or after each study vaccination.

        For additional entry criteria, please refer to protocol.