bioihbjkbjnl/mcl2 huggingface dataset:
Conducting Airways in Lung Fibrosis (VACFI)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to determine whether extension of the conducting airways into
      the distal lung, or bronchiolization, occurs early in the course of Idiopathic Pulmonary
      Fibrosis, a disease wherein normal lung structures are destroyed and replaced by
      non-functional scar tissue.
    

Detailed description: 
      Diffuse Interstitial Pneumonias are a heterogeneous group of chronic respiratory diseases.
      Idiopathic Pulmonary Fibrosis, one of such diseases, is characterized by lesions of the
      conducting airways including extension of bronchioles towards the distal lung, or
      bronchiolization of the distal lung. Such lesions are traditionally referred to as "traction
      bronchiectasis" although no evidence supports a cause-and-effect relationship between
      alveolar fibrosis and airway lesions. Another feature of IPF is chronic, invalidating dry
      cough. Our hypothesis is that IPF is characterized by early increases in the volume of
      conducting airways, that such changes correlate with cough, and that airway changes are in
      direct relation with airway fibrosis. The primary aim of this study is to demonstrate
      increased anatomical dead space (VD), a surrogate for conducting airway volume, in patients
      with moderate (or early) IPF, in comparison with subjects without any respiratory disease
      ("non-DIP controls"). The secondary aims are : To show that VD is increased in patients with
      IPF in comparison with patients with other DIPs ("DIP controls"), to show that in patients
      with IPF increased VD does not correlate with indices of alveolar fibrosis, and to show
      associations between increased VD and cough and other respiratory symptoms in patients with
      IPF.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        IPF will be diagnosed according to ATS/ERS/JRS/ALAT 2012 guidelines, either in the presence
        of a typical Usual Interstitial Pneumonia pattern on CT imaging of the lung or in the
        presence of a probable UIP pattern on a pathological lung specimen, and in the absence of
        any identified cause of secondary interstitial pneumonia.

        Patients with non-IPF interstitial pneumonias will be recruited. Due to the case mix at
        Bichat and Pompidou hospitals, patients with idiopathic Non Specific Interstitial Pneumonia
        and interstitial pneumonia associated with sarcoidosis and auto-immune disease will be
        recruited.

        In some patients, a definitive diagnosis of either IPF or non-IPF interstitial pneumonia
        will not be available at the time of inclusion.
      
Keywords: conducting airway, bronchiolization
Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume
Condition: Peripheral Vascular Response
Study type: Observational

Summary: 
      The purpose of this study is to determine the clinical usefulness of measuring the heart's
      pumping ability by measuring the Peripheral Pulse Volume (PPV).
    

Detailed description: 
      Peripheral Pulse Volume (PPV) is the change in the volume of a limb that occurs when blood
      passes through the limb. The limb also acts as an electrical conductor whose electrical
      impedence changes with limb geometry and volume. Each time the heart beats, the volume of the
      limb segment changes, and therefore its electrical impedence changes. A plethysmograph can be
      used to measure volume changes of a part of the body by producing a plethysmographic
      waveform. Selectively capturing a number of these plethysmographic wave forms with acceptable
      noise levels and averaging them using the EKG as a reference-timing signal generate a highly
      reproducible pulse volume signal. Signal averaged pulse volume measurement will be obtained
      non-invasively from the lower extremities of patient volunteers. A disposal non-occluding
      electrical monitoring strap will be applied to the calf of each patient. Changes in the
      calf's size/volume caused by changes in the patient's cardiac output and calf blood flow will
      result in electrical impedance changes. These changes will be recorded by an analog
      admittance plethysmograph attached to the lower extremity strap. The analog plethysmograph is
      coupled to a digital computer for signal enhancement and measurement.
    

Intervention name(s): Pulse Volume Measurement
Intervention type(s): Device
Intervention description(s): patients will wear a newly designed calf monitor that will be hooked up to a computer that will monitor leg peripheral pulse volumes which will then be correlated to pressures obtained with Swan Ganz monitoring. The calf monitor is gut two bands with sensors that are wrapped around the ankle and below the knww
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient who are having a right heart catherization done for other diagnostic purposes or
        patient in the critical care units who have Swan Ganz catheters in place for other medical
        management
      
Keywords: Peripheral Pulse Volume
Trauma-focused Cognitive-behavioural Therapy(TF-CBT) for Children: A Study of Process and Outcome.
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Trauma focused cognitive behavioral therapy
      (TF-CBT)is more effective in the treatment of traumatized youth than treatment as usual(TAU).
    

Detailed description: 
      Children experiencing traumas, such as sexual abuse, physical abuse, domestic violence,
      serious accidents, or natural disasters, may develop severe health problems.

      This study will examine the short and long-term effects of trauma-focused
      cognitive-behavioural therapy on children exposed to serious trauma, and moderating factors
      of treatment outcome.

      The study will use a random control design, and will be implemented in regular clinical
      practice in Norway.

      More knowledge within this field is important for practitioners as well as policy makers in
      planning interventions and therapy for children and their caregivers.
    

Intervention name(s): TF-CBT; Treatment as Usual (TAU)
Intervention type(s): Other; Other
Intervention description(s): TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.; Participants will receive regular therapy as is usually practiced in clinics
Other intervention name(s): TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TF-CBT; Effectiveness study; Trauma; Therapy
90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      This investigation seeks to understand if and how, the 90 Days film can be used as an
      intervention to address HIV-related stigmas, intimate partner status disclosure and HIV ART
      medical adherence among Black HIV positive women.
    


Intervention name(s): 90 DAYS film; HIV pamphlet on disclosure
Intervention type(s): Behavioral; Behavioral
Intervention description(s): the intervention conditions include exposure to a film, 90 DAYS (approx 20 minutes long), an entertainment film detailing a woman's decision to tell her romantic partner that she is HIV-positive.; A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy
      with radiosurgery for locally advanced pancreas cancer.
    

Detailed description: 
      The purpose of the trial is to test the efficacy of treating locally advanced pancreatic
      cancer with 5FU and concurrent conventional radiotherapy followed by precisely administered
      single fraction of high-energy radiation using a radiosurgical technique.
    

Intervention name(s): Stereotactic Radiosurgery (Cyberknife)
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
Condition: Tobacco Use; Nicotine Dependence, Other Tobacco Product; Tobacco Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery
      Systems (ENDS) in Adult Smokers
    

Detailed description: 
      This will be an open label study to evaluate puff topography in adult smokers using a JUUL 5%
      ENDS. Up to 30 subjects will be enrolled and evaluated on Day 1 and Day 15. The duration of
      the study is 15 days with up to a 28 days screening window.
    

Intervention name(s): JUUL 5%, Virginia Tobacco, ENDS product
Intervention type(s): Other
Intervention description(s): Subjects participate in a 15 day product use period during which subjects will be requested to predominantly use the JUUL 5% product ad libitum as their primary source of nicotine. Subjects will be asked to report their daily use of the JUUL 5% product and CPD throughout the 15 day product use period.
Other intervention name(s): ENDS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System (ENDS); ENDS; Puff Topography
Vitamin D as a Key Player in Rheumatoid Arthritis
Condition: the Immunomodulatory Effect
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to
      autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and
      anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and
      some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

      Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The
      serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α)
      and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent
      assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation
      and group II will receive placebo and follow up for 3 months.
    

Detailed description: 
      Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to
      autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and
      anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and
      some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

      Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The
      serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α)
      and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent
      assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation
      and group II will receive placebo and follow up for 3 months.
    

Intervention name(s): Vitamin D; Steroid Drug
Intervention type(s): Drug; Drug
Intervention description(s): vitamin D supplementation; control
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia.
Condition: Anesthesia, Local
Study type: Interventional

Summary: 
      The aim of this study is to compare the duration of postoperative analgesia, and any side
      effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in
      pediatric patients undergoing thoracic surgeries.
    

Detailed description: 
      The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups:
      Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with
      bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using
      morphine with bupivacaine.

      Randomization will be achieved by using an online random number generator. Patient codes will
      be placed into sequentially numbered sealed opaque envelopes by a research assistant who is
      not involved in the study. An anesthesia resident not involved in patient management will be
      responsible for opening the envelope. The anesthesia resident will prepare the study drug
      according to the instructions contained within each envelope and give it to the
      anesthesiologist.
    

Intervention name(s): Dexmedetomidine; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): Caudal block with Dexametomedine as an adjuvant to bupivacaine.; Addition of morphine as adjuvant to bupivacaine during caudal block.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thoracic surgeries; pediatric caudal; dexmedetomidine
Analysis of Response of Subjects With Atopic Dermatitis or Psoriasis to Oral Vitamin D3
Condition: Atopic Dermatitis; Psoriasis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine whether administration of oral Vitamin D3 given over 21 days will
      change the antimicrobial peptide expression in the skin or saliva of subjects with Atopic
      Dermatitis (AD). This study will help researchers determine if the lack of the expression of
      antimicrobial peptides in individuals with AD plays a role in the susceptibility to eczema
      vaccinatum (EV).
    

Detailed description: 
      Atopic Dermatitis (AD) is a chronic inflammatory skin disorder in which the skin becomes
      extremely itchy and is susceptible to recurrent skin infections. AD is thought to occur from
      a combination of immunological, genetic, and environmental factors. Individuals with AD are
      at risk for developing a severe and widely disseminated infection called eczema vaccinatum
      (EV). EV is caused when the live attenuated vaccinia virus in the vaccine reproduces and
      spreads throughout the body. Individuals with AD lack certain antimicrobial peptides,
      specifically cathelicidins.

      This trial also includes a sub-study with individuals who have psoriasis. Psoriasis is also
      an immune-mediated skin disease, and is characterized by scaling skin and inflammation (pain,
      swelling, heat, and redness). Most psoriasis cause patches of thick, red skin with silvery
      scales. These patches can itch or feel sore. This sub-study will provide additional
      information on psoriatic responses to oral vitamin D. (Originally listed separately as
      ADVN-CATH-03-01).
    

Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of oral vitamin D3 at 4000IU; Administration of oral Vitamin D3 placebo
Other intervention name(s): cholecalciferol; vitamin D3 placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D3; Atopic Dermatitis; Antimicrobial Peptide Expression
Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
Condition: Inflammatory Bowel Disease; Perianal Fistula; Perianal Abscess
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Fistula
Study type: Interventional

Summary: 
      To show that prevalence of inflammation of the small bowel in patients with anorectal disease
      is under-diagnosed based on colonoscopy ileoscopy alone.
    

Detailed description: 
      IBD of the small bowel is associated with perianal disease such as ano-rectal abscesses and
      fistulas. Colonoscopy with ileoscopy and small bowel series are relied upon to document the
      presence of Crohn's disease of the small bowel. We suspect that the prevalence of
      inflammatory small bowel disease is underestimated.

      In my practice I have cases that had negative colonoscopy ileoscopy and positive findings at
      capsule endoscopy. These patients are receiving therapy for Crohn's disease. It is important
      to prove that the prevalence is higher.

      Capsule Endoscopy (CE) is the "first line tool" diagnostic procedure for the examination of
      the small bowel. It is performed today in more than 2,900 GI clinics in hospitals, outpatient
      departments and physicians' offices all over the world using the PillCam® Platform. Over
      500,000 CE procedures with the Given PillCam SB have been completed to date.
    

Intervention name(s): capsule endoscopy
Intervention type(s): Device
Intervention description(s): The disposable, ingestible PillCam® SB2 Capsule acquires the video images during natural propulsion through the digestive system. The Capsule transmits the acquired images via digital radio frequency communication channel to the Given® Data Recorder unit located outside the body.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: inflammation of the small bowel
Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
Condition: Spinal Cord Injuries; Amputation, Traumatic; Pain
MeSH terms: Spinal Cord Injuries; Wounds and Injuries; Amputation, Traumatic
Study type: Interventional

Summary: 
      Pain is a major problem for people after spinal cord injuries and amputations. This is a
      study to test how pain is affected by adding methadone to a six-week program of weekly
      physical therapy, relaxation training and counseling. Individuals who qualify for this study
      will receive a comprehensive medical and physical therapy evaluation.
    

Detailed description: 
      Pain has a major impact on the functioning of individuals with spinal cord injuries and
      individuals with amputations. This double-masked randomized trial to evaluate the utility of
      a combination of psychological intervention and physical therapy in order to improve pain
      reduction, increase physical functioning and quality of life for patients with pain
      associated with spinal cord injuries or amputations will compare the effect of a 6 week
      program of physical therapy and cognitive-behavioral therapy with methadone to one without
      methadone (n = 400). Secondary outcomes are to evaluate the maintenance of effects of the
      combined intervention and to evaluate the usefulness of a course of opioid therapy compared
      to active placebo medication. Based on the sample size, all measures have greater than 0.7
      power to detect major within group differences at posttreatment, 6-month follow-up, and
      12-month follow-up (taking into account a 15% attrition rate, alpha .05). Patients who
      qualify for this study will receive a comprehensive medical and physical therapy evaluation
      at baseline. Outcome will be assessed by the physician, psychiatrist and physical therapist
      who are all masked both to the treatment condition and therapy. Pain is assessed through
      self-report (measures include pain inventories) and clinical interview.
    

Intervention name(s): cognitive therapy; Physical Therapy; Methadone
Intervention type(s): Behavioral; Procedure; Drug
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Spinal cord injury; Amputation; Pain management
Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smokers Versus Non-Smokers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non-randomized, single dose, pharmacokinetic study in 36 healthy adult
      male and female volunteers, including 18 smokers and 18 non-smokers. All subjects will be
      administered a single inhaled dose of Staccato alprazolam 1 mg via hand-held inhaler. Blood
      samples will be drawn for pharmacokinetic analysis. Eligible subjects are admitted to Phase 1
      unit for up to 48 hours. Subjects will receive a post-study safety phone call 14 days(± 2
      days) after dosing.
    


Intervention name(s): Staccato Alprazolam 1 mg
Intervention type(s): Drug
Intervention description(s): alprazolam I mg administered via the Staccato hand-held inhaler device system.
Intervention MeSH terms: Alprazolam
Intervention model: Single Group Assignment
Intervention model description: All subjects receive a single dose of Staccato Alprazolam 1 mg
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia, Europe and North America. The aim of the trial is to
      evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body)
      of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with
      Haemophilia B.
    


Intervention name(s): nonacog beta pegol
Intervention type(s): Drug
Intervention description(s): A single dose of 40 U/kg will be administered intravenously, i.v. (into the vein) once weekly.
Other intervention name(s): NNC-0156-0000-0009
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment