bioihbjkbjnl/mcl2 huggingface dataset:
Initial Study of Rituximab to Treat Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in
      treating patients with Primary Biliary Cirrhosis (PBC). Rituximab is a laboratory-made
      antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with
      PBC, a disease of the immune system. However, the safety of rituximab in PBC patients must
      first be established.
    

Detailed description: 
      This is a pilot, open-label, study on 10 female patients with AMA-positive PBC to determine
      the effects of two infusions of rituximab on response of memory B cells to bacterial motifs,
      on biochemical function, and histological features. We will enroll 10 consecutive
      AMA-positive patients with the diagnosis of PBC based on internationally accepted criteria
      and histological staging determined at liver biopsy and being currently treated with UDCA.
      Importantly, patients with advanced histological stages, decompensated liver disease, or
      waiting for OLT will not be included in the study (see exclusion criteria).

      Patients eligible and willing to enter the study will be evaluated at baseline by isolation
      and study of frequency and absolute numbers of B cells and their function, biochemical and
      AMA tests. Histology and quality of life will be also evaluated in all patients. The
      methodology to be used for B cell study is already well-established in our laboratory as can
      be seen in the attached paper (Kikuchi et al. 2005b). Patients will be administered 1,000 mg
      rituximab intravenously by slow infusion on Day 1 and Day 15 (+/- 1 day). Rituximab's
      pharmacokinetics indicate that complete B cell depletion is obtained 2-3 days after
      administration and that such effect may be lost after 9 months (Vieira et al. 2004). In
      addition to our B cell work, serum samples will undergo AMA testing, including titers, using
      recombinant mitochondrial antigens (Miyakawa et al. 2001). Patients will also undergo serum
      chemistry panel, which includes liver function tests. Patients will continue on a steady dose
      of UDCA therapy throughout the study.
    

Intervention name(s): rituximab
Intervention type(s): Drug
Intervention description(s): rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours
Other intervention name(s): Rituxan (R)
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Biliary Cirrhosis
Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing
Condition: Asthma; Wheezing
MeSH terms: Respiratory Sounds
Study type: Observational

Summary: 
      The purpose of this study is to evaluate hair trace elements and toxic metals and plasma
      total antioxidant activity in children with recurrent wheezing and to evaluate whether these
      toxic metals and trace elements have any impact on serum cytokine levels.
    

Detailed description: 
      Context:

      In many studies it was demonstrated that children are much more susceptible than adults for
      environmental toxic metal exposure. Hair analysis is a promising tool for routine clinical
      screening and diagnosis of heavy metal exposure and essential trace element states in the
      human body. Additionally it was demonstrated that oxidants and antioxidants play a central
      role in the pathogenesis of many pulmonary diseases including asthma. Furthermore, toxic
      metals, trace elements and oxidative stress have many pivotal role on immune system.

      Objective:

      To evaluate and compare hair toxic metals, hair essential trace elements levels and plasma
      total antioxidant activity between children with recurrent wheezing and age and sex matched
      healthy children.

      Intervention: Hair samples will be collected for the analysis of the toxic metals, trace
      elements. Blood samples will be collected for the analysis of the cytokine levels and plasma
      antioxidant activity.

      Study Measures:

      Differences in hair toxic metals, hair trace elements, plasma cytokine levels and plasma
      total antioxidant activity will be compared between children with recurrent wheezing and
      age-sex matched healthy children
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Group 1: Children with recurrent wheezing Group 2: Age and sex matched healthy children
      
Biospecimen description: 
      Group 1: Children with recurrent wheezing. Plasma and Hair specimen are retined Group 2:
      Healthy children. Plasma and Hair specimen are retined
    
Keywords: Wheezing; Hair trace elements; Hair toxic metals; Oxidative stress
Electrostimulation PROTOCOL Incontinence
Condition: Female Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      To verify the effect of an adapted electrostimulation (EE) protocol for stress and mixed
      urinary incontinence (SUI / M) and its impact on quality of life (QoL)
    

Detailed description: 
      Controlled and randomized clinical trial performed at the Physiotherapy Outpatient Clinic at
      the Magalhães Neto Pavilion of ComHUPES / UFBA. Women aged between 30 and 65 years and
      diagnosis of SUI / IUM. The patients were allocated to two groups (GA) submitted to selective
      electrostimulation for tonic fiber, phasic fibers IIa / IIb and different times of electrical
      stimulation; (GB) used 50hz for all fibers by 20mm, both answered the questionnaire King's
      Health Questionnaire (KHQ).
    

Intervention name(s): Electro-stimulation
Intervention type(s): Other
Intervention description(s): Intracavitary electrostimulation with Quark medical vaginal electrode for perineal muscle strengthening protocol.
Other intervention name(s): electro physical therapy; dualpex 961 quark
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: Methotrexate is the sheet anchor for the treatment of rheumatoid arthritis.
      Folic acid supplementation is usually given at a dose of 5-30 mg per week to ameliorate
      adverse effects. Patients at our center are usually on the higher dose. However, it is
      unclear if higher doses are required, recent international recommendations suggest 5-10 mg
      per week only.

      Objectives: To randomize rheumatoid patients being being started on Methotrexate into 2
      groups- one on 5mg for 6 days a week (30mg per week) of folic acid and the other 5 mg twice a
      week (10 mg per week) for 24weeks. To look at difference in

        1. Adverse effects due to methotrexate

           a. Minor adverse effects: By symptom chart

           a. Major adverse effects: Cytopenia (predefined) and transaminitis.

        2. Disease activity using Disease activity score 28 joints (3 variable) and functional
           status by health assessment questionnaire

        3. RBC folic acid levels Methodology: Randomised controlled trial, double blinded, placebo
           controlled. Sample size 50 in each group. One group of patients will receive folic acid
           5 mg twice a week with placebo for 4 days and the other group will receive folic acid 5
           mg 6 days a week for 24 weeks.

      Patients will be administered adverse effects proforma, assessed for having cytopenias and
      transaminitis (pre defined) and disease activity will be calculated at every visit, ie., in
      the beginning at then at 8,16 and 24 weeks. In addition will look at the functional status
      and RBC folate levels at 0 and 24 weeks. Statistical analysis using chi-square test for
      proportions and t test for continuous variables.
    

Detailed description: 
      THIS TRIAL WILL INCLUDE NEW RHEUMATOID ARTHRITIS PATIENTS These patients will then be
      randomized into two groups - one which continues to take the same folic acid dose and one
      which is shifted to folic acid 10 mg per week.
    

Intervention name(s): Folic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Folic acid tablets 5 mg; Matched placebo to folic acid 5 mg tables, to be given for 4 days a week
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; folic acid; methotrexate
A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled,
      parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to
      adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic
      Fibrosis Transmembrane conductance Regulator (CFTR) mutation.
    


Intervention name(s): GLPG2222 50 mg; GLPG2222 100 mg; Placebo; GLPG2222 200 mg; GLPG2222 400 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral tablet(s) containing GLPG2222; Oral tablet(s) containing GLPG2222; Matching oral tablet(s) containing placebo; Oral tablet(s) containing GLPG2222; Oral tablet(s) containing GLPG2222
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Benefits and Risks of Newborn Screening for Cystic Fibrosis
Condition: Cystic Fibrosis; Lung Disease; Pseudomonas Infections
MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Lung Diseases; Fibrosis
Study type: Interventional

Summary: 
      Although cystic fibrosis (CF) is the most common, life-threatening autosomal recessive
      genetic disorder of the white population, there are often delays in diagnosis and hence start
      of treatment. Advances of the past two decades have made CF screening feasible using
      routinely collected neonatal blood specimens and measuring an enzyme level followed by CF
      mutation DNA analysis. Our overall goal of the study is to see if early diagnosis of CF
      through neonatal screening will be medically beneficial without major risks. ''Medically
      beneficial'' refers to better nutrition and/or pulmonary status, whereas '' risks'' include
      laboratory errors, miscommunication or misunderstanding, and adverse psychosocial
      consequences. Specific aims include assessment of the benefits, risks, costs, quality of
      life, and cognitive function associated with CF neonatal screening and a better understanding
      of the epidemiology of CF.

      A comprehensive, randomized clinical trial emphasizing early diagnosis as the key variable
      has been underway since 1985. Nutritional status has been assessed using height and weight
      measurements and biochemical methods. The results have demonstrated significant benefits in
      the screened (early diagnosis) group. We are now focusing on the effect of early diagnosis of
      CF on pulmonary outcome. Pulmonary status is measured using chest radiographs, chest scans
      using high resolution computerized tomography, and pulmonary function tests. Other factors
      that we are looking at include risk factors for the acquisition of respiratory pathogens such
      as Pseudomonas aeruginosa, quality of life and cognitive function of children with CF who
      underwent early versus delayed diagnosis, as well as the cost effectiveness of screening and
      the costs of diagnosis and treatment of CF throughout childhood.

      If the questions underlying this study are answered favorably, it is likely that neonatal
      screening using a combination of enzyme level (immunoreactive trypsinogen) and DNA test will
      become the routine method for identifying new cases of CF not only in the State of Wisconsin,
      but throughout the country.
    


Intervention name(s): CF newborn screening
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Diagnostic
Keywords: Cystic Fibrosis; Immunoreactive trypsinogen; deltaF508- CFTR gene; newborn screening; Pseudomonas aeruginosa infection; nutrition; pulmonary status; meconium ileus; growth; Genetic counseling; risk communication
Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether oral intake of COMT inhibitors affects the
      smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced
      Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma
      concentrations of levodopa more fluctuating.
    

Detailed description: 
      The aim is to measure variability in plasma levodopa levels during the following three
      treatments:

      Day 1: Duodopa in individually optimised dose Day 2: 80% of optimised Duodopa dose + two
      tablets of entacapone at t=0 hours and at t= 6 hours Day 3: 80% of optimised Duodopa dose +
      two tablets of tolcapone at t=0 hours and at t= 6 hours Plasma samples for determination of
      levodopa concentrations will be taken every 30 minutes during 8 hours. Video recordings will
      be performed every 30 min during 8 hours, for later blinded assessments by 2-3 experts.
      Sequences will be in randomised order. Patient self-scores regarding mobility will be
      recorded, every 30 min during 8 hours.
    

Intervention name(s): levodopa/carbidopa; entacapone; tolcapone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intestinal gel, continuous infusion (daytime or 24-hour); Tablet, 200 mg, given twice during the study at t=0h and t=5hrs; Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.
Other intervention name(s): Duodopa; Comtess, Comtan.; Tasmar
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone; Tolcapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Levodopa/carbidopa infusion; entacapone; tolcapone; efficacy; pharmacokinetic; pharmacodynamics
A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the
      maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral
      vorinostat in patients with malignant lymphoma.
    


Intervention name(s): vorinostat
Intervention type(s): Drug
Intervention MeSH terms: Vorinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug
      being developed for the treatment of patients with severe major depressive disorder) has on
      the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your
      body and acts in the body.)
    


Intervention name(s): AZD6765; midazolam
Intervention type(s): Drug; Drug
Intervention description(s): IV solution
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Midazolam; Pharmacokinetics
HIT in Insulin-resistant and Insulin-sensitive Obese Adolescents
Condition: Obesity; Insulin-resistant; Adolescents
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Evaluate the effects of HIT on the cardiorespiratory performance and substrate oxidation of
      insulin-resistant and insulin-sensitive obese adolescents.
    

Detailed description: 
      Objective: To evaluate the effect of high-intensity interval training (HIT) on the
      cardiorespiratory performance and substrate oxidation pattern in insulin-resistant and
      insulin-sensitive obese adolescents.
    

Intervention name(s): Group Insulin-Resistant; Group Insulin-Sensitive
Intervention type(s): Other; Other
Intervention description(s): High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.; High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
Other intervention name(s): Insulin-resistant obese adolescents; Insulin-sensitive obese adolescents
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Insulin-resistant; Adolescents; High-intensity interval training
Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human
      papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects
      will receive the HPV vaccine and the other group will receive an active control (GSK
      Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with
      those from the HPV group included in the NCT00779766 study (aged 18-25 years).
    

Detailed description: 
      This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading
      to:

        -  The removal of 3 outcome measures

        -  The update of 1 outcome measure
    

Intervention name(s): GSK580299 (CervarixTM); Engerix-BTM
Intervention type(s): Biological; Biological
Intervention description(s): 3-dose schedule intramuscularly vaccination (Months 0, 1 and 6); 3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; HPV vaccine; Immune response; Human papillomavirus; China
Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the
      Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study
      objectives are to confirm the treatment effect of pirfenidone compared with placebo on change
      in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary
      fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo
      in patients with IPF.
    


Intervention name(s): Pirfenidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.; Placebo equivalent given as 3 divided doses 3 times per day.
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pirfenidone; ASCEND; IPF; FVC
Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether transdermal fentanyl patch
    

Detailed description: 
      Total knee arthroplasty (TKA) has severe postoperative pain that prevents mobilization of
      patient. The best standard analgesia regimen is patient-control analgesia (PCA) which
      requires a PCA pump that is expensive.

      Transdermal fentanyl patch (TFP)(50 mcg/hr) can release fentanyl into blood circulation at
      rate 50 mcg/hr for three days. It has slow onset of about 12-14 hours, so it's used to treat
      chronic pain, not popular for a cure of pain. If the investigators apply TFP at appropriate
      times, i.e. 12-14 hours before surgery, it may be used to treat acute postoperative pain.

      If it can give good analgesia for TKA, it can replace PCA. The benefit is that it is much
      cheaper and more convenient.
    

Intervention name(s): transdermal fentanyl patch; placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): TFP = transdermal fentanyl patch (50 microgram/hour); group 2 = placebo patch
Other intervention name(s): Duragesic; Duragesic
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative; pain score; morphine consumption
Measure of Engagement of Epilepsy Patients in Messaging Groups
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      This study will measure the engagement of people with epilepsy in a mobile phone based
      messaging platform as well as understand if there is an impact on their self-management
    

Detailed description: 
      The primary purpose of this study is to assess a person with epilepsy's level of usage of a
      mobile messaging application for peer support. The secondary purpose is to understand what
      characteristics of their group drive different levels of usage and improvements in
      self-management.

      Participants can participate as much or little as they want for a minimum of six weeks.
      Participants will complete an initial and a final questionnaire.
    

Intervention name(s): Facilitator support and education
Intervention type(s): Behavioral
Intervention description(s): Group engaged with facilitator support and education
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care