bioihbjkbjnl/mcl2 huggingface dataset:
BRAVE Study With Uncontrolled Essential Hypertension (BRAVE Study)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, placebo run-in study to investigate the genetic and biomedical
      predictors of blood pressure response to bisoprolol. After informed consent is obtained,
      subjects will be withdrawn from previous antihypertensive therapy and given placebo for at
      least 2 weeks. Compliance will be assessed using pill counting, and any subject will a
      compliance less than 80% during the placebo run-in period will be excluded from the study.
      Bisoprolol 2.5 mg will be given once daily for 6 weeks. At baseline and after 6 weeks on
      bisoprolol 2.5 mg the clinic sitting blood pressure, 24-hour ambulatory blood pressure (if
      the patient is willing to do this), clinical characteristics and biochemical profile will be
      measured. Central aortic blood pressure will be measured with the A-PULSE device at baseline
      and after 6 weeks treatment.

      After completing 6 weeks treatment with bisoprolol 2.5 mg daily, the patient will continue
      treatment with bisoprolol for a total of 24 weeks unless there is any adverse event that
      requires discontinuation of bisoprolol.
    

Detailed description: 
      Patients with uncontrolled essential hypertension aged 18-79 years on no antihypertensive
      treatment with sitting clinic systolic blood pressure of 140-169 mmHg and/or a sitting clinic
      diastolic blood pressure of 90-109 mmHg, or for patients with diabetes mellitus or with
      chronic kidney disease with sitting clinic systolic blood pressure of 130-169 mmHg and / or a
      sitting clinic diastolic blood pressure of 80-109 mmHg and heart rate > 70 at baseline
      (before starting bisoprolol treatment) will be enrolled. Patients on other antihypertensive
      treatments who are experiencing side effects or whose blood pressure may not be well
      controlled can also enter if they can continue on a stable dose of a calcium channel blocker,
      either amlodipine or nifedipine retard throughout the study.

      Patients will be treated with bisoprolol 2.5mg daily for a total of 26 weeks. The primary
      endpoint will be the influence of common genetic polymorphisms on clinic sitting blood
      pressure or ambulatory blood pressure (ABP) response to bisoprolol 2.5 mg after 6 weeks
      treatment.
    

Intervention name(s): Bisoprolol 2.5 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bisoprolol 2.5 mg will be given once daily; Placebo tablets will be given once daily for 2 weeks during the run-in period.
Other intervention name(s): Concor; Run-in
Intervention MeSH terms: Bisoprolol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influences of Long Term Hormone Therapy on Physical Fitness and Vascular Function in Transgender Women
Condition: Transgender Women
Study type: Interventional

Summary: 
      Transgender women who transitioned from male to female by hormone therapy demonstrate similar
      physical fitness and vascular function to males or females.
    

Detailed description: 
      This cross-sectional study was to compare physical fitness and vascular function between
      cisgender men, cisgender women, and transgender women.
    

Intervention name(s): Estradiol; Estradiol and Anti-Androgen; No intervention
Intervention type(s): Other; Other; Other
Intervention description(s): Estradiol; Estradiol and Anti-Androgen; No intervention
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Androgens; Androgen Antagonists
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Transgender women; Physical fitness; Vascular function; Hormone therapy
Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients
Condition: Intestinal Failure
MeSH terms: Intestinal Failure
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine if patients on long-term olive oil-based parenteral
      nutrition have an adequate essential fatty acid status and immune status, compared to age-
      and sex-matched healthy controls.
    

Detailed description: 
      Patients, who suffer from severe chronic intestinal failure and whose nutritional intake
      cannot be met by oral food intake, have as their final option total parenteral nutrition,
      which contains all necessary macro- and micronutrients. Lipid emulsions are essential for
      these patients as they are a source of non glucose fuel calories, and they contain
      (essential) fatty acids which are important as structural component for many cells in the
      human body. Home parenteral nutrition patients are at risk for essential fatty acid
      deficiency. Data are lacking that indicate the optimal amount of essential fatty acids
      required for these patients. The latter seems especially relevant for patients receiving
      lipid prescriptions which are low in essential fatty acids, like ClinOleic®. Long-term
      parenteral nutrition dependent patients successfully use ClinOleic®. It is however unknown
      whether these patient remain to have an adequate essential fatty acid status in the long run.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Long-term parenteral nutrition dependent patients:Patients who visit the outpatient clinic
        of the Department of Gastroenterology and Hepatology at the Radboud University Medical
        Nijmegen Center.

        Healthy controls: volunteers who are residents in the Netherlands.
      
Keywords: Fatty acid, essential; Immune system; Home parenteral nutrition
The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis
Condition: Choledocholithiasis
MeSH terms: Cholangitis; Choledocholithiasis
Study type: Observational

Summary: 
      Laboratory change induced by common bile duct (CBD) stone is in general observed as the
      higher elevation of alkaline phosphatase (ALP) and gamma-glutamyl transpeptideas (ɤ-GT), in
      comparison to those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
      However, some patients with CBD stone show the marked increased level of aminotransferase,
      which sometimes leads to misdiagnose those as liver disease caused by viral hepatitis,
      ischemia, and drug toxicity. The aim of this study is to investigate the clinicopathologic
      features of patients with CBD stones with the high level of aminotransferase in serum.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        "Patients have been diagnosed as CBD stone under endoscopic retrograde
        cholangiopancreatography (ERCP). Among patients, patients who displayed above 400 IU/L of
        aminotransferase without cholangitis (gallstone hepatitis group) and patients who showed
        the normal value of aminotransferase (control group) were enrolled in this study. We
        estimated two groups by comparing clinical features, lab finding, radiologic images, and
        findings under ERCP such as CBD diameter, CBD stone diameter, CBD stone number,
        periampullary diverticulum.
Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy (CP) Forms
Condition: Hemiplegia; Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy; Hemiplegia
Study type: Observational

Summary: 
      In recent years Ferrari et al. proposed a new classification of manipulation in children with
      spastic hemiplegia which describes five different classes by analyzing and integrating the
      kinematic patterns of the hand and its functional use.

      The investigators believe that this classification provides the clinician with clinically
      meaningful information, by identifying the useful strategies spontaneously adopted by the
      children during manipulation tasks.

      The aim of this study is to determine the criterion validity of the new classification of the
      pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation
      classes with both the scores of the Assisting Hand Assessment and the scores of the Melbourne
      Assessment of Unilateral Upper Limb Function.
    


Intervention name(s): classification of hand manipulation function
Intervention type(s): Other
Intervention description(s): To determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We retrospectively studied children with hemiplegia and CP who are followed by the Unit for
        Severe Disability in the Developmental Age at the Hospital of Reggio Emilia (Italy).
      
Keywords: cerebral palsy; hemiplegia; upper limb; assessment; classification system
Inferior Vena Cava Assessment in Term Pregnancy Using Ultrasound: a Feasibility Study of Subxiphoid and RUQ Views
Condition: Hypotension; Hypovolemic Shock
MeSH terms: Hypotension; Hypovolemia; Shock
Study type: Observational

Summary: 
      This study is to assess the feasibility of 2 different ultrasound views of the inferior vena
      cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy
      and, is regularly used to evaluate the fetus. It is hoped that imaging of the IVC will then
      allow us to determine the fluid status of the parturient which could be helpful in treating
      hemodynamic instability. This study will not involve any change in management of the
      participating patients.
    

Detailed description: 
      Anesthesiology consultants and trainees with US experience will first perform scans from the
      RUQ view starting on the mid-axillary line at the T4 intercostal space, looking to obtain a
      view of the IVC as it enters the right atrium (RA). Following successful acquisition, the
      examiner will perform scan from the subxiphoid position, looking to obtain the same view of
      the IVC transitioning into the RA. Primary endpoint will be time to obtaining quality of
      images. The investigator will use a stopwatch to time acquisition of images. If the duration
      of scanning exceeds ten minutes, the scan will be discontinued and labeled as failed. Each
      image will be separately reviewed by 2 different US specialists with extensive US experience.
      Images will be assessed according to a Likert scale from 1 to 5. (Very poor (1), poor (2),
      acceptable (3), good (4), very good (5)) Secondary endpoints will be assessed as follows: 1.
      Acceptability: all patients participating in the study will complete a questionnaire to
      assess acceptability. 2. Comfort: During the exam the patient will have the option to suspend
      the scan by stating they are uncomfortable and wish to stop. Each request will be noted and
      taken into the account at data analysis. Furthermore, patients will be given a questionnaire
      at the end of the scan and asked to rate their comfort level during procedure according to
      Likert scale. (Very comfortable (5), comfortable (4), equivocal (3), uncomfortable (2), very
      uncomfortable (1)) 3. Ease of exam: Examiner will rate the ease of image acquirement
      according to Likert scale. (impossible (1), difficult (2), equivocal (3), easy (4), very easy
      (5))
    

Intervention name(s): Ultrasound
Intervention type(s): Radiation
Intervention description(s): Evaluating the feasibility and efficacy of IVC ultrasound imaging through the RUQ and subxiphoid view in term parturients.
Patient Acceptability of procedure
Patient Comfort:
Ease of exam for the examiner
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Full term pregnant patient coming for elective cesarean section
Positional Therapy Versus CPAP for Positional OSA
Condition: Sleep Apnea Syndromes
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      This is a crossover randomized controlled trial comparing a convenient positional therapy
      (PT) device to continuous positive airway pressure (CPAP) in the treatment of positional
      obstructive sleep apnea (OSA).
    

Detailed description: 
      This study aims to compare a convenient positional therapy (PT) device used for 8 weeks to
      continuous positive airway pressure (CPAP) used for 8 weeks in patients with positional
      obstructive sleep apnea (OSA) in a crossover randomized controlled trial.
    

Intervention name(s): Night Shift positional device; continuous positive airway pressure
Intervention type(s): Device; Device
Intervention description(s): Night Shift is a small, positional therapy device that is worn at the back of the neck using a latex free silicone rubber strap. The strap is adjustable and is secured with a magnetic clasp. When a supine position is detected, the device vibrates with increasing intensity till the subject changes to a non-supine position.; Automated adjusting continuous positive airway pressure
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 8-week randomized crossover trial with a 1 week washout period.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Apnea Syndromes; Positional sleep apnea; CPAP; Night Shift
Evaluate Tolerability of a Recombinant DNA HIV-1 Vaccine in Healthy Adults
Condition: Human Immunodeficiency Virus; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy
      adults. DNA-based vaccines are being studied for the prevention of human immunodeficiency
      virus (HIV), malaria and hepatitis. DNA vaccines have been well tolerated in human studies to
      date. The vaccine that will be tested in this study was made from the information that the
      virus uses to make a small part of the HIV. This small part is called the envelope or coating
      around the virus. We hope the body will make an immune response against the HIV envelope
      coat. Our potential HIV DNA envelope vaccine is called EnvDNA.
    

Detailed description: 
      This is a research (investigational) study to find out about the safety of a new potential
      vaccine for HIV. This potential vaccine may eventually become a part of a sequence of three
      experimental vaccines that will be studied to see if they can help to protect people from
      HIV. HIV infection is the cause of AIDS (Acquired Immune Deficiency Syndrome). AIDS is one of
      the most serious viral infections we know. This study is being done to help us find an HIV
      vaccine that works.

      The vaccine that will be tested in this study was made from the information that the virus
      uses to make a small part of the HIV. This small part is called the envelope or coating
      around the virus. Because only the information for this one part of the virus is used in the
      vaccine, the vaccine cannot cause HIV infection. We make the vaccine in a test tube. The
      vaccine is made up of DNA. DNA is like an instruction manual that cells use to make basic
      building blocks called proteins. This DNA has the information that cells will use to make the
      envelope coat of HIV. Once the DNA is injected intramuscularly, it should tell cells to make
      the envelope protein. We hope the body will make an immune response against the HIV envelope
      coat. Our potential HIV DNA envelope vaccine is called EnvDNA.
    

Intervention name(s): EnvDNA
Intervention type(s): Biological
Intervention description(s): administered as 100 mcg of DNA in 1.5mL PBS every 28 days for 3 injections
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Prevention; HIV; AIDS
The Effect and Safety of Different Intensity Anticoagulation Therapy in Elderly Patients With Non-valvular Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      Current guidelines recommend standard warfarin anticoagulation international normalized ratio
      (INR) goal of 2.0-3.0 in adults with non valvular atrial fibrillation (NVAF). The
      investigators hypothesized that low-intensity warfarin (INR 1.5-2.0) has the same
      effectiveness and better security in elderly patients (>75) with NVAF.
    

Detailed description: 
      Atrial fibrillation is the commonest chronic arrhythmia in clinical practice, especially in
      octogenarians. Nonvalvular atrial ﬁbrillation increases the risk of ischemic stroke by
      approximately 5-fold and these strokes result in higher mortality and disability. Warfarin is
      recommended as ﬁrst line anticoagulation treatment in patients with NVAF who are at moderate
      or high risk of stroke,while antiplatelet agents, such as aspirin, give a more convenient but
      less effective alternative in the prevention of ischemic stroke and are recommended in low
      risk patients.Current guideline about warfarin anticoagulation therapy recommend that target
      INR value must be maintained between 2.0 and 3.0,which not only reduces the frequency of
      ischaemic stroke but also its low incidence of major bleeding. However, the current status of
      anticoagulation therapy for elderly Chinese AF patients, particularly in aged over 80 years,
      is not clear. The purpose of the present study was to test the hypothesis that an INR target
      of 1.5-2.0 can provide the same efficacy and better safety as compare with a standard target
      of 2.0-3.0 in patients over 75 with NVAF.
    

Intervention name(s): Warfarin; aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Patients randomised to receive warfarin were initiated on treatment at the baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range.; 100mg aspirin was administrated every day
Intervention MeSH terms: Aspirin; Warfarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: atrial ﬁbrillation; stroke; warfarin; aspirin
Supraglottic Airway Devices in Pediatric Difficult Airway Situations
Condition: Airway Morbidity; Emergencies
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The purpose of the study is to compare three supraglottic airway devices (Combitube,
      Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway
      scenario in a pediatric manikin.
    

Detailed description: 
      Supraglottic airway devices (SAD) have been designed for the "cannot intubate, cannot
      ventilate" scenario in prehospital as well as intrahospital settings and are utilized in
      medical emergency services and emergency departments all over the world, not only for
      anticipated and unanticipated difficult airway situations but also as an airway device used
      by non-anesthesiologists or in situations where only limited practice is possible. Securing
      an airway in a pediatric emergency situation is crucial. Unfortunately, pediatricians usually
      lack the required skills and regular practice to perform endotracheal intubation (ETI, which
      is the gold standard for securing an airway) quickly and safely. SADs would pose a safe and
      feasible alternative to ETI. However, no studies on this topic are available. The
      investigators therefore wanted to evaluate three different SADs (Combitube, Easytube,
      laryngeal mask airway) in simulated difficult airway situations in a pediatric manikin in
      comparison to ETI.
    

Intervention name(s): Combitube, Easytube, Laryngeal masks
Intervention type(s): Device
Intervention description(s): Supraglottic airway device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Supplementation of of DHA, Vitamin D3 and Uridine in Children
Condition: Children
Study type: Interventional

Summary: 
      The feasibility of combining a motor and cognitive exercise program with dietary
      supplementation (DDU: Vitamin D, DHA and Uridine or Placebo) is tested in a smaller group of
      prepubescent children.
    


Intervention name(s): DDU-supplement; Placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): DDU: Vitamin D, DHA, Uridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire
Condition: Sleep Apnea Syndromes; Insomnia; Insufficient Sleep Syndrome; Circadian Rhythm Disorders
MeSH terms: Sleep Apnea Syndromes; Sleep Wake Disorders; Parasomnias; Chronobiology Disorders; Sleep Deprivation; Syndrome
Study type: Observational

Summary: 
      The study aims to develop and test a user-friendly, accessible approach to sleep assessment
      which can function as an initial "triage" of targeted sleep conditions, such as insomnia,
      insufficient sleep syndrome, sleep apnea syndromes/snoring, and circadian sleep/wake
      disorders, within the clinical and community population. Specifically, this study will test
      the validity and reliability of a self-rated, digitized, and cost-effective diagnostic
      measure with sufficient sensitivity to accurately assess/diagnose common sleep conditions
      and/or risk for these conditions. Such an approach, would allow for faster assessment of
      common sleep conditions and disorders, and provide clinical knowledge to the individual, the
      physician, and if required insurance companies, as to those persons who need more immediate
      attention or treatment for their sleep condition.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A general community population and clinical population physician-referred for diagnosis and
        assessment of sleep disorders at a sleep clinic within a large medical center.
      
Keywords: sleep disorders; assessment; diagnosis