bioihbjkbjnl/mcl2 huggingface dataset:
Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The trial is randomized prospective study to examine the effects of subcutaneous
      immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to
      treatment or control group. The effect measures are changes in the basophil activity and
      biology as well as changes in plasma cells during and after treatment. Clinical outcome is
      assessed by QoL questionnaires and clinical testing.

      Hypotheses:

        -  changes in plasma cells correlate to changes in immunoglobulins and effector cell
           responses

        -  the reduction of inflammation due to SCIT has influence on the effector cell responses

        -  changes in paraclinical measurements can be related to clinical findings
    

Detailed description: 
      The investigators are recruiting 30 participants, which are randomized to receive SCIT (24)
      or no treatment (6) The following will be measured

        -  the development of immunoglobulin response

        -  plasma cells under updosing phase

        -  changes in basophil activity under updosing and maintenance treatment

        -  subtyping of allergic sensitization

        -  clinical outcome and quality of life

        -  changes in mast cells in the nasal mucosa

        -  changes in the cell biology of the basophils
    

Intervention name(s): Alutard phleum pratense subcutaneous immunotherapy; Alutard phl prat
Intervention type(s): Biological; Drug
Intervention description(s): standard regimen of SCIT
Other intervention name(s): alutard phleum pratense; subcutaneous immunotherapy; Alutard 225, phleum pratense, ALK-abelló
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: basophil activity; plasma cells; IgE; IgG1; IgG4; mast cells; IgE receptor; allergic rhinoconjunctivitis; grass pollen allergy
Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation
Condition: Hypotension After Reperfusion in Liver Transplantation
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver
      transplantation which is characterized by an acute drop in blood pressure immediately after
      the prefusion is restored to the transplanted liver. We hypothesized that PRS would be
      prevented when phenylephrine or epinephrine is administered immediately prior to reperfusion
      in liver transplantation.
    


Intervention name(s): phenylephrine; epinephrine; placebo control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion; 10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion; 10ml of normal saline is administered at the time of reperfusion
Intervention MeSH terms: Phenylephrine; Epinephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: postreperfusion syndrome; phenylephrine; epinephrine; liver transplantation
Prevalance of Temporomandibular Joint Disease
Condition: Temporomandibular Joint Disorders
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      Temporomandibular joint (TMJ) disorders are common problems in the society and involve the
      masticator muscles, jaw joint and related structures. Since TMJ disorders affect functions
      such as eating and speaking, they can cause important problems in the daily life of the
      patient. Therefore, its diagnosis and treatment are of great importance. In the treatment of
      these patients, methods such as analgesic and anti-inflammatory drugs, splint, exercise,
      physical therapy modalities can be applied.
    

Detailed description: 
      Although the prevalence of TMJ disease detected in the community is between 40-60%, the rate
      of symptoms or clinical findings was reported to be 87% in a study including 1040 people.
      Incomplete clarification of the etiology and pathogenesis, the lack of standard diagnostic
      and treatment approaches cause patients to learn to live with this problem, and severe pain
      and limitation of movement cause a decrease in quality of life and loss of workforce.
      Specific pathologies such as systemic inflammatory diseases, tumor, fracture, developmental
      anomaly cause temporomandibular joint diseases. It also causes a wider group of non-specific
      TMB originating from the musculoskeletal system.When the literature was reviewed, no
      publications on the frequency of TMJ joint disease were found in medical faculty students.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We planned to include 500 volunteer students between the ages of 18-35, studying at Bolu
        Abant Izzet Baysal University Faculty of Medicine, with or without TMJ symptoms and
        agreeing to participate in the study.
      
Keywords: Temporomandibular Joint Disorders
The Impact of Vaping Ethanol in the Evaluation of Impairment
Condition: Electronic Cigarette Use
Study type: Interventional

Summary: 
      The purpose of this research study is to find out about ethanol-containing e-cigarettes
      impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a
      common part of e-cigarette liquids.
    


Intervention name(s): E-cigarette liquid with ethanol, 1 puff; E-cigarette liquid without ethanol, 1 puff; E-cigarette liquid with ethanol, 10 puffs; E-cigarette liquid without ethanol, 10 puffs
Intervention type(s): Other; Other; Other; Other
Intervention description(s): E-cigarette liquid with ethanol, 1 puff; E-cigarette liquid without ethanol, 1 puff; E-cigarette liquid with ethanol, 10 puffs; E-cigarette liquid without ethanol, 10 puffs
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Survival of Different Core Build-up Materials
Condition: Dental Prosthesis Failure
MeSH terms: Prosthesis Failure
Study type: Observational

Summary: 
      The purpose of this study is to compare three different core build-up materials for dental
      use. The study hypothesis is that there is no differences in survival rate of the different
      core build-ups.
    

Detailed description: 
      Core build-ups replace dental structures which are decayed through caries or tooth fractures.
      Often there are necessary before insertion of dental restorations. In clinical practice,
      there are two main material groups: glass ionomer cements and composites. Because of there
      good physical properties the composite materials claimed to fulfill the expected criteria of
      core build-ups. However, some of these composite core build-ups get lost before insertion of
      definite prosthetic restorations. The current prospective, randomized controlled study should
      investigate the survival rate of three different composite materials: "Rebilda DC", "Clearfil
      Core DC / Plus" and "Multicore Flow". The statistical analysis will performed with logistic
      regression performed by the institute of institute of Medical Biometry and Informatics,
      university of heidelberg. The study hypothesis is that there is no differences in the
      survival rate.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients of the department of porsthodontics, university of heidelberg
Comparison of Three Laryngoscopes in Difficult Laryngoscopy
Condition: Intubation; Difficult
Study type: Interventional

Summary: 
      Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three
      axes are not aligned, intubation becomes difficult. In the researchers' study, the
      investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This
      neck collar renders intubation difficult not only by restricting neck movement, but also
      reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and
      Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.
    

Detailed description: 
      Airtraq laryngoscope is an optical laryngoscope which allows visualization of vocal cord as a
      reflected image through multiple lenses and prisms. MacCoy laryngoscope is a modification of
      Macintosh laryngoscope. It has a lever which, when pressed, moves its flexible tip. In the
      investigators' study, the researchers compared the performances of Airtraq laryngoscope with
      MacCoy and Macintosh laryngoscopes in simulated difficult laryngoscopy using a rigid neck
      collar. The researchers recruited 120 patients and randomly divided those patients into three
      equal groups i.e. 30 patients in each group. These three groups are 1-Airtraq, 2-MacCoy and
      3-Macintosh. The researchers compared efficacy and safety in these three laryngoscopes. The
      researchers compared efficacy in terms of time of intubation, ease of intubation, overall
      success, Intubation difficulty score, visualization of vocal cord in terms of POGO
      (percentage of Glottic Opening) score. The researchers compared safety in terms of
      hemodynamic pressor response and airway trauma.
    

Intervention name(s): Intubation- Macintosh laryngoscope; Intubation- MacCoy laryngoscope; Intubation- Airtraq laryngoscope
Intervention type(s): Device; Device; Device
Intervention description(s): Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.; In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.; In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
Condition: Pulmonary Hypertension; Hypersensitivity Pneumonitis
MeSH terms: Pneumonia; Hypertension, Pulmonary; Alveolitis, Extrinsic Allergic; Hypertension; Hypersensitivity
Study type: Interventional

Summary: 
      Hypersensitivity pneumonitis (HP) is a complex immune mediated disorders caused by repeated
      inhalation of and sensitization to wide range of antigens including organic particles and
      chemical compounds, leading to exaggerated immuneresponse. Hypersenstivity pneumonitis is a
      common form of diffuse parenchymal lung diseases in Egypt .Pulmonary hypertension has been
      found as a complication of a number of diseases affecting the lung interstitium, including
      hypersensitivity pneumonitis, with subsequent affection of the life expectancy Rationale of
      the study: to find predictors for the development of pulmonary hypertension in patients with
      hypersensitivity pneumonitis
    

Detailed description: 
      Cross sectional study included 60 patients with established diagnosis of HP , work up
      includes history of exposure, clinical examination, HRCT chest, ABGs,6MWD, desaturation
      degree , spirometry, echocardiography and right heart catheter in patients with high echo
      probability of PH.
    

Intervention name(s): Right heart catheter
Intervention type(s): Procedure
Intervention description(s): Right heart catheterization was performed for 4 cases with high probability of pulmonary hypertension using multi-lumen swan ganz catheter.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)
Condition: Breast Cancer
MeSH terms: Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Study type: Observational

Summary: 
      In this research study, the investigators are testing a new type of breast camera, called
      Molecular Breast Imaging, to see if it can find tumors in the subject's breast.
    

Detailed description: 
      Patients who are suspected to have DCIS based on mammographic findings will be invited to
      participate in this study. The investigators plan to recruit 200 patients who are scheduled
      to undergo a breast biopsy for a breast lesion considered suggestive or highly suggestive of
      DCIS as determined by a radiologist specializing in breast imaging. Each patient will have a
      suspicious area of calcification on mammography of extent < 3 cm, or a non-focal area of
      abnormality on ultrasound or MRI that is scheduled for evaluation by biopsy. Each patient
      will undergo an MBI study immediately prior to biopsy. The study coordinator will approach
      these patients and inform them of the research project. If they are interested in
      participating, informed consent will be obtained and the patient will be scheduled for the
      MBI study prior to the breast biopsy.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Prospective patients will be identified by the radiologist based on findings in their
        mammographic, ultrasound or MRI studies. Patients who are suspected to have DCIS based on
        mammographic findings will be invited to participate in this study.
      
Keywords: MBI; Molecular Breast Imaging; Breast Cancer; DCIS; Breast; Calcifications; Microcalcifications
A Study to Evaluate the Safety, Tolerability and Immunogenicity of a Universal Influenza A Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and immunogenicity of
      ascending doses of a novel, universal flu vaccine, in healthy volunteers.
    

Detailed description: 
      FP-01.1 is composed of a mixture of synthetic peptides, modified with a fluorocarbon vector,
      which is anticipated to enhance the immune properties of the drug, and allows differentiation
      from recent investigational interventions by avoiding the use of adjuvant. The peptide
      sequences, derived from internal influenza-A proteins, were selected based on the presence of
      CD4+ and CD8+ T cell epitopes and a high degree of conservation across all influenza strains,
      using a proprietary bioinformatics approach, and, it is proposed, will enable FP-01.1 to
      universally treat influenza-A -infected populations.

      This study is the initial exploration of the safety, tolerability and immunogenicity response
      of FP-01.1 in healthy volunteers. Ascending doses of FP-01.1 will be assessed.
    

Intervention name(s): FP-01.1; placebo
Intervention type(s): Biological; Biological
Intervention description(s): Ascending doses of FP-01.1 will be administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of AMG 139 following
      single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and
      subjects with moderate to severe psoriasis (PsO).
    


Intervention name(s): AMG 139
Intervention type(s): Drug
Intervention description(s): Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amgen; AMG 139
PEEZY Midstream Urine Device Compared to Catheterized Urine Sample
Condition: Lower Urinary Tract Symptoms; Lower Urinary Tract Infection
MeSH terms: Urinary Tract Infections; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY
      midstream urine collection, and urethral catheter collection.
    

Detailed description: 
      Female patients presenting to the Baylor Scott & White Health (Temple, TX) Urology clinic for
      complaints of lower urinary tract symptoms will be included. They will be approached by a
      clinical research coordinator and given more information. If they meet eligibility by
      screening, consents will be completed.

      Patients will proceed with their regular clinic visit with their clinician. Just prior to the
      physical exam, patients will use the PEEZY device to give a urine specimen in the privacy of
      the bathroom. The package with PEEZY includes the simple instructions for use. Patients
      return to the clinic room and the physical exam proceeds. An in-and-out catheter is used to
      obtain a post-void residual as well as a control urine specimen. After the remainder of the
      patient routine exam is complete, they will fill out a brief questionnaire.

      The 2 specimens will then be delivered to the lab. The clinical research coordinator will
      store consents and questionnaires that include the subjects study identification number in
      individual opaque envelopes that will be kept in a locked drawer accessible to only the
      investigators.
    

Intervention name(s): Midstream urine collection device; Catheter for urine collection
Intervention type(s): Device; Device
Intervention description(s): Non-invasive midstream urine collection device; In-and-out catheter obtains urine through the urethra.
Other intervention name(s): PEEZY; Straight catheter
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Patient spontaneously voids in the bathroom using PEEZY (research sample). Within 10 minutes, patient is catheterized during physical exam (control sample) for post-void residual.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: urine specimen; contamination
NMES in Critically Ill Patients
Condition: Critically Ill Patients With a Predicted Prolonged ICU Stay
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular
      electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant
      side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients
      will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and
      non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle
      strength if the patients are awake and cooperative (using the medical research council scale
      and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the
      investigators hypothesize that electrical stimulation will preserve muscle mass with respect
      to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that
      electrical stimulation can reduce muscle strength loss and leads to a better protein balance
      and thicker muscle fibers in the stimulated quadriceps.
    


Intervention name(s): electrical stimulation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System (CNS) Involvement and Who Are Currently Receiving Treatment With Elaprase®
Condition: Hunter Syndrome
MeSH terms: Mucopolysaccharidosis II; Syndrome
Study type: Observational

Summary: 
      This study is being conducted to identify pediatric patients with Hunter syndrome who have
      neurodevelopmental disease characteristics, who are currently receiving treatment with
      Elaprase, and who may be suitable to participate in a clinical study with an investigational
      agent.
    


Intervention name(s): Neurobehavioral testing; Visual and auditory assessments
Intervention type(s): Behavioral; Other
Intervention description(s): If the patient is found to be eligible after completion of a telephone interview, he will undergo further testing to assess his neurodevelopmental status using a standardized battery of neurobehavioral testing.; If the patient is found to be eligible after completion of a telephone interview, he will undergo further testing to evaluate his visual and auditory function.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Initial patient eligibility will be based on patient age and gender. Patients must be
        receiving weekly IV Elaprase infusions to be eligible for enrollment.
Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers
Condition: Soft Tissue Injuries
MeSH terms: Soft Tissue Injuries
Study type: Interventional

Summary: 
      Sensory coverage in the finger continues to be a challenging problem. This study reports
      sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps
      and compares the results between the dual- and single-innervated flaps.The main evaluated
      outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the
      flap, fingertip pain and joint motion.
    

Detailed description: 
      Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS
      consists of a 10 cm line that was grouped into mild (0-3 cm), moderate (4-6 cm) and severe
      (7-10 cm). Tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight
      tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand
      because of any stimulation of the neuroma.
    

Intervention name(s): Flap including bilateral nerve branches
Intervention type(s): Procedure
Intervention description(s): Two nerve branches are attached with the flap for sensory coverage
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Soft tissue defect; dorsal branch of the digital nerve; dorsal branch of the digital artery; dorsal digital flap