bioihbjkbjnl/mcl2 huggingface dataset:
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab
Intervention description: Monthly intravenous infusions dosed as 10 mg/kg body weight
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: treatment holiday; PGA; belimumab; Lymphostat-B; rebound; SELENA SLEDAI; Systemic Lupus Erythematosus; immunogenicity

Summary:

      This study will assess the effect of a 24-week withdrawal followed by a 28-week
      reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with
      stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be
      assessed for subjects who have permanently withdrawn from further belimumab treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current
             SLE belimumab continuation study.

          -  Be 18 years of age at the Day 0 visit.

          -  Non-prenant, non-lactating females willing to comply with specific birth control
             requirements as set forth in the protocol.

          -  Able to provide written informed consent to participate.

          -  Subjects who wish to enroll in the control group and the group taking a 6 month
             belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the
             minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels
             at or above the lower limit of the central laboratory reference range, and are on a
             stable SLE treatment regimen during the 30 day screening period prior to Day 0.

          -  Subjects who wish to enroll in the long-term discontinuation group have voluntarily
             withdrawn from their continuation studies.

        Exclusion Criteria:

          -  Subjects who have developed clinical evidence of significant, unstable or
             uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse
             event (AE) in their belimumab continuation study that could, in the opinion of the
             principle investigator, put the subject at undue risk.

          -  Subjects who have developed any other medical diseases, laboratory abnormalities, or
             conditions that, in the opinion of the principle investigator, makes the subject
             unsuitable for the study.
Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Placebo plus standard therapy; Belimumab 10 mg/kg plus standard therapy; Standard therapy
Intervention description: Placebo plus standard therapy; Belimumab 10 mg/kg plus standard therapy; The standard therapies allowed in this study are:
- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy
OR
- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 448.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies; Systemic Lupus Erythematosus; Autoimmune Disease; Glomerulonephritis; Belimumab; Lupus; Nephritis; Kidney Diseases; SLE

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab
      in adult patients with active lupus nephritis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.

          -  Biopsy confirmed active lupus nephritis.

          -  Clinically active lupus renal disease at screening requiring /receiving induction
             therapy with Standard of Care medications.

          -  Autoantibody-positive.

        Key Exclusion Criteria:

          -  Pregnant or nursing.

          -  On dialysis within the past year.

          -  Treatment with belimumab within the past year .

          -  Receipt of induction therapy with cyclophosphamide within 3 months prior to induction
             therapy for the study.

          -  Receipt of any B cell targeted therapy (for example, rituximab), investigational
             biological agent within the past year.

          -  Severe active central nervous system (CNS) lupus.

          -  Required management of acute or chronic infections within the past 60 days.

          -  Current drug or alcohol abuse or dependence.

          -  Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

          -  History of severe allergic reaction to contrast agents or biological medicines.
The Bladder Instillation Comparison Study
Condition: Urinary Bladder Neoplasms
MeSH terms: Urinary Bladder Neoplasms
Intervention: Mitomycin C; Gemcitabine
Intervention description: Cancer chemotherapeutic agent; Cancer chemotherapeutic agent
Intervention MeSH terms: Gemcitabine; Mitomycins; Mitomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bladder tumors; urinary tumors; non-muscle invasive bladder tumors; NMIBC

Summary:

      To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single
      intraoperative instillation in preventing recurrence of bladder cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. sign an informed consent for the study

          2. be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.

        Exclusion Criteria:

          1. patients unable to consent for themselves

          2. individuals under 18 years old

          3. pregnant women

          4. prisoners

          5. patients with known allergy or intolerance to the mitomycin C or Gemcitabine

          6. any other sound medical, psychiatric and/or social reason as determined by the
             investigator.
Ivermectin for Severe COVID-19 Management
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Ivermectin
Intervention description: Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under "Good Manufacturing Practices" (GMP) certification conditions.
Intervention MeSH terms: Azithromycin; Hydroxychloroquine; Ivermectin; Favipiravir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients who were hospitalised with a pre-diagnosis of severe COVID-19 pneumonia and thereafter diagnosis of COVID-19 was also confirmed microbiologically with polymerase chain reaction (PCR) positivity in respiratory tract samples were included into the study. They were randomized to the study and control group, respectively. Single numbered patients were accepted as study group and double numbered patients as control group
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ivermectin; SARS-CoV-2; Treatment

Summary:

      In this multicenter study; it was aimed to investigate the effectiveness and safety of
      ivermectin use in the treatment of patients with severe COVID-19 pneumonia that have no
      mutations which alter ivermectin metabolism and cause side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who were hospitalised with a pre-diagnosis of "severe COVID-19 pneumonia" and
             thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR
             positivity in respiratory tract samples were included into the study. They were
             randomized to the study and control group, respectively.

        Patients with at least one of the criteria below were accepted as patients with severe
        COVID-19 pneumonia;

          1. Presence of tachypnea ≥ 30/minute, SpO2 level < 90% in room air, PaO2/FiO2 <300 in
             oxygen receiving patient

          2. Presence of specific radiological finding for COVID-19 in lung tomography (bilateral
             lobular, peripherally located, diffuse patchy ground glass opacities)

          3. Mechanical ventilation requirement

          4. Acute organ dysfunction findings; patients with SOFA (sepsis-related organ failure
             assessment) score >2

        Exclusion Criteria:

          -  Patients with the following characteristics were excluded from the study.

               1. Pediatric patients; <18 years of old

               2. Patients with chronic liver or kidney disease

               3. Pregnant women

               4. Patients with known ivermectin allergy
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
Condition: Whole Cell Pertussis; Haemophilus Influenzae Type b; Hepatitis B; Diphtheria; Tetanus; Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis; Tetany
Intervention: Tritanrix-HepB/Hib-MenAC; Mencevax ACWY; Tritanrix-HepB/Hiberix; Meningitec
Intervention description: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine; GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine; Wyeth's MenC CRM197 conjugated vaccine, Meningitec
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 617.0
Sex: All
Minimum age: 427 Days
Maximum age: 730 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylaxis diphtheria; Hib & meningococcal serogroup A & C disease

Summary:

      The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a
      booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15
      to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody
      persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity
      of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to
      subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male or female between and including 15 and 24 months of age

          -  Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack
             No. 100480)

        Exclusion criteria:

          -  Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus
             influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not
             foreseen in the protocol, after the date of the study conclusion visit of the primary
             vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).

          -  History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib
             and/or meningococcal serogroup A or C disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures including febrile seizures (at least
             two events) in infancy.
Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: Thymoglobulin; Daclizumab; Plasmapheresis; Mycophenolate mofetil; Tacrolimus; Dexamethasone; Prednisone; Cytogam
Intervention description: Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered; 2 gm/day. Standard of care; To achieve serum level of 8-10 ng/ml.; 100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses; Taper over three months to 5 mg daily; Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
Intervention MeSH terms: Mycophenolic Acid; Dexamethasone; Prednisone; Tacrolimus; Thymoglobulin; Daclizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: kidney; transplantation; positive crossmatch; antibody mediated rejection; rejection; induction; therapy; trial

Summary:

      The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is
      a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney
      transplant recipients who have a positive crossmatch with their live donor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (18 years or older)

          -  End-stage renal disease

          -  Identified to have positive lymphocytotoxic crossmatch or flow cytometric crossmatch
             with live donor

        Exclusion Criteria:

          -  Deceased donor recipients

          -  Pregnancy

          -  Active infection

          -  History of cancer within the past two years (with the exception of non-melanomatous
             skin cancer)

          -  History of heparin induced thrombocytopenia

          -  Medical contraindications to transplant procedure
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo; Idalopirdine
Intervention description: Once daily, matching placebo capsules, orally; Once daily, encapsulated tablets, orally
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 933.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic
      treatment of patients with mild-to-moderate Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a knowledgeable and reliable caregiver.

          -  The patient is an outpatient.

          -  The patient has probable AD.

          -  The patient has mild to moderate AD.

          -  Stable treatment with donepezil.

          -  The patient, if a woman, must have had her last natural menstruation ≥24 months prior
             to baseline, OR be surgically sterile.

          -  The patient, if a man, agrees to protocol-defined use of effective contraception if
             his female partner is of childbearing potential, OR must have been surgically
             sterilised prior to the screening visit.

        Exclusion Criteria:

          -  The patient has evidence of any clinically significant neurodegenerative disease, or
             other serious neurological disorders other than AD.

          -  The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition,
             Text Revision (DSM-IV-TR) Axis I disorder other than AD.

          -  The patient has evidence of clinically significant disease.

          -  The patient's donepezil therapy is likely to be interrupted or discontinued during the
             study.

          -  The patient is currently receiving memantine or has taken memantine within 2 months
             prior to screening.

        Other inclusion and exclusion criteria may apply.
KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
Condition: Mucocutaneous Lymph Node Syndrome
MeSH terms: Mucocutaneous Lymph Node Syndrome
Intervention: IVIG; Infliximab
Intervention description: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours; Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
Intervention MeSH terms: Infliximab; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Kawasaki disease

Summary:

      Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels
      (coronary arteries) of infants and children and is now the most common cause of acquired
      heart disease in children. A mixture of proteins from human blood (Intravenous
      immunoglobulin, IVIG) is a treatment that reduces the rate of the major complication of the
      disease: a bulging of the wall of the coronary arteries called an aneurysm. However, 10-20%
      of children are resistant to this treatment and the fever returns. These children have the
      highest rates of aneurysm formation and thus should be treated aggressively. Unfortunately,
      there are no guidelines for the best secondary treatment for these resistant patients because
      the problem has never been adequately studied. Most physicians choose either a second
      infusion of IVIG or an engineered antibody called infliximab that inactivates a molecule that
      promotes inflammation. This trial will randomize (assign by chance like the flip of a coin)
      IVIG-resistant patients to receive either a second IVIG infusion or infliximab and the
      response to treatment will be compared to learn which treatment stops the fever the fastest.
      In addition, parents and caregivers will provide observations about their child's response to
      the different treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible subjects will be as follows:

               1. 4 weeks to 17 years of age,

               2. fulfill the American Heart Association case definition for complete or incomplete
                  KD,

               3. have had fever (T ≥38°C) for 3 to 10 days prior to initial IVIG treatment,

               4. have fever (T ≥38°C orally or rectally) between 36 hours and 7 days after end of
                  the first IVIG infusion without other likely cause

        Exclusion Criteria:

          1. Patient treated with infliximab or steroids for present illness (pts who received oral
             steroids as outpatients prior to KD diagnosis but who otherwise qualify for the study
             will not be excluded)

          2. Known prior infection with tuberculosis, coccidiomycosis, or histoplasmosis.
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Condition: Asthma
MeSH terms: Asthma
Intervention: QAW039; QAW039; Placebo
Intervention description: QAW039 150 mg once daily; QAW039 450 mg once daily; Placebo once daily
Intervention MeSH terms: Indoleacetic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 894.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; QAW039; allergic asthma; allergy triggered asthma; reactive asthma; asthma attack; difficulty breathing

Summary:

      This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg,
      compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5
      standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

        -  patient with inadequately controlled severe asthma and high eosinophil counts at
           baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)

        -  patients with inadequately controlled severe asthma (overall study population)

      Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and assent (if applicable).

          -  Male and female patients aged ≥12 years (or ≥lower age limit allowed by health
             authority and/or ethics committee/institutional review board approvals).

          -  A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.

          -  Evidence of airway reversibility or airway hyper- reactivity.

          -  FEV1 of ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90%
             for patients aged 12 to <18 years

          -  An ACQ score ≥1.5.

          -  A history of 2 or more asthma exacerbations within the 12 months prior to entering the
             study.

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of study entry, or within 30
             days, whichever is longer.

          -  Subjects who have participated in another trial of QAW039.

          -  A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).

          -  History of malignancy with the exception of local basal cell carcinoma of the skin.

          -  Pregnant or nursing (lactating) women.

          -  Serious co-morbidities.

          -  Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin,
             greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin