bioihbjkbjnl/mcl2 huggingface dataset:
A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to confirm the safety profile of alemtuzumab 30 mg
      (the US/European Union (EU) approved dose) in Japanese patients with relapsed or refractory
      Chronic Lymphocytic Leukemia (CLL).
    

Detailed description: 
      NOTE: This study was previously posted by Bayer. In December 2009, this study was acquired by
      Genzyme Corporation. Genzyme Japan K.K. is the sponsor of the trial.
    

Intervention name(s): alemtuzumab
Intervention type(s): Drug
Other intervention name(s): MabCampath, BAY86-5045, CAMPATH-1H
Intervention MeSH terms: Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed or Refractory Chronic Lymphocytic Leukemia,; CLL
The Drug-drug Interaction of SP2086 and Valsartan
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the potential interaction between SP2086 and
      Valsartan after multiple oral doses treatment in healthy adult volunteers.
    

Detailed description: 
      This is an open-label (volunteers will know the names of treatments they are assigned)
      single-center and cross-over study of SP2086 and Valsartan in healthy adult volunteers. All
      subject were randomized into two groups, and the drugs will be administered according to the
      AB and BA sequences, all subjects must completed the two stages(A and B). The A sequence was
      that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by
      mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on
      Days 8-Day12.There were 6 days washout period between the two stages. The whole study needs
      31 days.
    

Intervention name(s): SP2086; Valsartan
Intervention type(s): Drug; Drug
Intervention description(s): The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12; The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SP2086; Valsartan; Drug-drug Interaction
Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions
Condition: Breast Cancer Screening; Colon Cancer Screening; Prostate Cancer Screening
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      The purpose of this retrospective observational study is to evaluate the performance of the
      Shared Decision Making Process scale in a sample of patients who have received a decision aid
      about the decision to screen or not screen for breast cancer, colon cancer, prostate cancer,
      or lung cancer.
    

Detailed description: 
      This is a retrospective observational study that will examine the performance of the Shared
      Decision Making Process in a sample of patients who made a decision about cancer screening in
      the last 2 years. Patients from 4 hospitals who have received a patient decision aid for
      breast, colon, prostate, or lung cancer screening will be screened for eligibility. A random
      sample of eligible patients will be sent a one-time survey. The survey asks patients about
      their experiences talking with healthcare providers about the specific cancer screening
      decision. The survey includes the Shared Decision Making Process scale, knowledge,
      preferences, decisional conflict and decision regret. The study will obtain 400 completed
      surveys, or 100 for each cancer topic.

      The sample consists of patients who received a decision aid for cancer screening within the
      last two years and meet specific qualifications.

      All analyses will be conducted separately for each group, and results may be pooled. First,
      study staff examine the descriptives for the Shared Decision Making Process items. Study
      staff will also test several hypotheses to examine performance of the scores such as whether
      higher shared decision making process scores are associated with less decisional conflict and
      less regret.
    

Intervention name(s): Decision aid
Intervention type(s): Behavioral
Intervention description(s): Healthwise patient decision aids for breast, prostate, colon and lung cancer screening provide information on the pros and cons of cancer screening and guidance in process of selecting a choice.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults who received a cancer screening decision aid in the last 2 years while receiving
        care at 4 hospitals within a major healthcare network.
      
Keywords: decision making; decision aids; decision quality instruments; shared decision making; cancer screening
Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation
Condition: Healthy; Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel
      motor function in subjects with constipation.
    


Intervention name(s): Orafti® Inulin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary fiber; Maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stool frequency; Bowel motor function; Orafti® Inulin; Dietary Fiber
MIND Diet Intervention and Cognitive Performance
Condition: Obesity
Study type: Interventional

Summary: 
      This single-center, randomized trial examined the effect of MIND diet intervention on
      cognition and brain structure changes of healthy obese women over three months. The
      intervention group was lea to calorie-restricted modified by the MIND diet, and the control
      group received a calorie-restricted standard diet. The primary end-point was an assessment of
      cognitive performances measured with a comprehensive cognitive test battery. Secondary
      end-points were voxel-based morphometry to quantify the differences in brain structures. Our
      results revealed MIND diet could improve working memory, verbal recognition memory, and
      attention, more in comparison with the control group. Results also suggest that an increase
      in inferior frontal gyrus in the MIND diet group. Our study, for the first time, underlined
      that good adherence to the MIND diet as well as calorie restriction could reverse the
      destructive effect of obesity on cognition.
    


Intervention name(s): New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))
Intervention type(s): Other
Intervention description(s): A new brain-protection pattern that has been designed after the Mediterranean and DASH diet to improve some of their dietary factors to have the highest impact on brain health and cognitive performance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID
      compared to placebo in the treatment of subjects with mild to moderate persistent asthma
    

Detailed description: 
      The incidence of respiratory allergy in the US has increased gradually over the past several
      years, and current estimates suggest that allergic rhinitis and bronchial asthma affect
      approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently
      coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis
      have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety
      concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease,
      and poor compliance with asthma medication regimens, point to the need for the development of
      safe and convenient oral therapies for asthma. Histamine is an important chemical mediator of
      inflammation in asthma. The benefits of antihistamine treatment in patients with mild to
      moderate asthma have been well documented, however their clinical use has been previously
      limited due to the high doses required for efficacy and their associated side effects
      including sedation and cognitive impairment.

      Recent evidence indicates that in addition to H1-receptor antagonism, some of the newer
      nonsedating, non-impairing antihistamines appear to possess various anti-inflammatory
      properties at concentrations achieved at therapeutic dosages suggesting an additional benefit
      of these drugs in the management of allergic diseases and asthma. The purpose of this study
      is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in
      the treatment of subjects with mild to moderate persistent asthma.
    

Intervention name(s): Fexofenadine
Intervention type(s): Drug
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Particulate Matter on the Pulmonary Function and Acute Exacerbation of COPD and Asthma
Condition: Pulmonary Function
MeSH terms: Asthma
Study type: Observational [Patient Registry]

Summary: 
      Particulate matter(PM) exposure has been shown to increase the morbidity and mobility of a
      variety of respiratory diseases, including COPD and asthma. This study focus on the effects
      of PM on the pulmonary function and acute exacerbation of COPD and asthma patients in China,
      where PM exposure is much heavier than the United States and European countries.
    

Detailed description: 
      Particulate matter(PM) exposure has been shown to increase the morbidity and mobility of a
      variety of respiratory diseases, including COPD and asthma. This study focus on the effects
      of PM on the pulmonary function and acute exacerbation of COPD and asthma patients in China,
      where PM exposure is much heavier than the United States and European countries. This study
      is an observational study which lasts 3 years. Primary outcome measures:Change in spirometry
      (FEV1) of COPD, asthma patients and healthy volunteers in response to different exposure
      doses of PM.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Clinic-based population
      
Biospecimen description: 
      Biological specimens are preserved in serum, plasma, and leukocytes
    
Keywords: Pulmonary function; Particulate matter; COPD; Asthma
Bevacizumab for Primary Pterygium Treatment
Condition: Pterygium
MeSH terms: Pterygium
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study was to investigate the efficacy and safety of subconjunctival
      bevacizumab application as an adjuvant therapy for primary pterygium.
    


Intervention name(s): Autoconjunctival grafting; Subconjuntival bevacizumab injection
Intervention type(s): Procedure; Drug
Intervention description(s): The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.; The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pterygium; bevacizumab; autoconjunctival graft
Aortopathy in Persons With Bicuspid Aortic Valve, Turner and Marfan Syndrome
Condition: Turner Syndrome; Bicuspid Aortic Valve; Marfan Syndrome
MeSH terms: Marfan Syndrome; Arachnodactyly; Turner Syndrome; Gonadal Dysgenesis; Bicuspid Aortic Valve Disease; Heart Valve Diseases; Syndrome
Study type: Observational

Summary: 
      The study aim is:

        1. To examine aortic tissue by light microscopy

        2. To examine aortic tissue by electron microscopy

        3. To study changes in the epigenome and transcriptome of the X chromosome specific to
           aortic tissue.

        4. To examine aortic tissue using biochemistry including proteomics.

        5. To establish the karyotype of fibroblasts with standard chromosome examination on 10
           meta-phases as well as by fluorescent in situ hybridization (FISH) with probes covering
           the X and Y chromosome. Using the latter 200 meta-phases will be examined.

      30 controls who did not die from aortic dissection or dilation will be recruited from The
      Department of Forensic Medicine at Aarhus University Hospital.

      The investigators will subject samples of aortic tissue from women undergoing prophylactic
      aortic surgery due to either Marfan syndrome or bicuspid aortic valve to the same panel of
      examinations (except karyotyping). Lastly the investigators will compare the results from the
      three groups (Turner syndrome, Marfan syndrome and Bicuspid aortic valve).
    

Detailed description: 
      Turner syndrome is a congenital complete or partial lack of one of the female sex chromosomes
      affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence
      of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and
      autoimmune diseases in general.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals with Turner syndrome will be recruited from out-patient clinics. Individuals
        with Turner syndrome, Marfan syndrome and bicuspid aortic valve will be recruited from
        departments of cardiology or thoracic surgery in Odense, Copenhagen or Aarhus (Denmark).
      
Biospecimen description: 
      Aortic tissue

      Blood Serum
    
Keywords: Sex chromosome; Turner Syndrome; Marfan syndrome; Bicuspid aortic valve; Aortic Aneurysm; Epigenetics; Transcriptome; non-coding RNA; Electron microscopy; Proteomics
Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents
Condition: Insulin Resistance; Depression
MeSH terms: Insulin Resistance; Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for
      quality of life and altered health related issues.
    

Detailed description: 
      Matched historical control study designed to examine outcomes on insulin resistant
      adolescents who were treated in the Insulin Resistance Syndrome Clinic at Children's Mercy
      Hospital in the past year. New patients will be screened at baseline, 4 and 12 months to
      evaluate if there is improvement in the BMI Z-score, HgA1c, lipid profile or waist
      circumference when depression and/or altered health related quality of life are identified
      and treated in this population.
    

Intervention name(s): Health-Related Quality of Life instrument; Depression Scale for Children (CES-DC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Adolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome; questionnaire
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.
      
Keywords: Health-Related Quality of Life
Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics
Condition: Gram-positive Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Gram-Positive Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin
      in patients aged 2-17 years old who have a suspected or proven gram-positive infection for
      which they are receiving standard antibiotic therapy. The tolerability of a single dose of
      daptomycin in these patients will also be assessed.
    


Intervention name(s): daptomycin
Intervention type(s): Drug
Intervention MeSH terms: Daptomycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Gram-Positive Infection
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
Condition: Systemic Infections
MeSH terms: Infections; Communicable Diseases; Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in
      children from 3 months of age to <18 years.
    

Detailed description: 
      This is a phase I, open-label, single-dose study. The study aims to characterize the
      pharmacokinetics of CAZ-AVI and assess its safety and tolerability following a single IV dose
      given to hospitalized pediatric patients receiving systemic antibiotic therapy for suspected
      or confirmed infection. This study will include 4 cohorts, each consisting of at least 8
      evaluable pediatric patients, aged ≥3 months to <18 years, who are hospitalized with
      infections.
    

Intervention name(s): CAZ-AVI
Intervention type(s): Drug
Intervention description(s): Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ceftazidime, Avibactam, Anti-Infectives
Study of Drug Combination on Pharmacokinetics in Healthy Volunteers
Condition: Hepatitis C Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325
      on the pharmacokinetics of selective serotonin reuptake inhibitors.
    


Intervention name(s): Escitalopram; Sertraline; DCV 3DAA FDC; BMS-791325
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 milligrams administered each morning; 50 milligrams administered each morning; Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily; 75 milligrams single-agent film coated oral tablet administered twice daily
Other intervention name(s): Lexapro; Zoloft
Intervention MeSH terms: Sertraline; Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Transcutaneous Electrical Stimulation & Sinoatrial Node Function
Condition: Electricity; Effects; Heart Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      Transcutaneous electrical stimulation (TES) is used in clinical practice to diagnose or treat
      a diverse range of medical conditions for over a century. Although the benefits of TES are
      well known, its potential side effects on the heart have not been convincingly clarified.
      This study will test whether TES has any effect on the sinoatrial node (SAN).
    

Detailed description: 
      It was hypothesized that: 1) TES has effects indirectly via peripheral afferents or directly
      on the SAN, and 2) TES causes a change in the R-R interval (HRV). The aim of this study was
      to test these hypotheses.

      This research protocol will have three phases: first, the effect of a single electrical pulse
      on heart rate variability (HRV) will be examined in Experiment I. The effects of conventional
      TENS and acupuncture-like TENS on HRV will be also investigated in Experiment II. Finally,
      the effect of time and rest on the HRV will be tested in Experiment III. Subjects will be in
      a sitting position with 90-degree flexion at the elbow and supination of the hand during
      electrical stimulation. A pair of square (4 x 4 cm), self-adhesive, pre-gelled skin
      electrodes will be used for stimulation. The electrodes will be placed over the flexor aspect
      of the right forearm. Three-lead electrocardiogram (ECG) recording will be obtained to
      determine the change of HRV during rest and electrical stimulation sessions. The
      participant's ECG data will be continuously captured by noninvasive sensors [self-adhesive
      pre-gelled Ag/AgCl surface electromyography (sEMG) electrodes, Redline® Istanbul, Türkiye]
      transmitted through a data acquisition system.

      The main outcome variable is the heart rhythm. In this context, electrical stimulus-related
      QRS wave and RR interval change (heart rate variability) will be examined. The possible
      direct effect of an electrical stimulus on the appearance of the QRS wave will be
      investigated in the time domain using the Peristimulus time histogram and the Waveform
      average technique. ECG data will be analyzed using a software package (Cambridge Electronic
      Designs, Cambridge, UK).
    

Intervention name(s): Transcutaneous Electrical Stimulation
Intervention type(s): Procedure
Intervention description(s): Electrical Stimulation and a sham will be administered through the skin in random consecutive sessions in a study group. A single monophasic square electrical pulse and transcutaneous electrical nerve stimulation will be applied to the forearm volar aspect.
Intervention model: Single Group Assignment
Intervention model description: This study will be conducted in an experimental study design.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Transcutaneous electrical nerve stimulation; Neuromuscular electrical stimulation; Heart rhythm; heart rate variability