bioihbjkbjnl/mcl2 huggingface dataset:
Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic
      effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of
      sildenafil 20 mg.
    


Intervention name(s): Riociguat (Adempas, BAY63-2521)
Intervention type(s): Drug
Intervention description(s): The investigational drug will be given twice per subject, as single dose administration of BAY 63-2521 (0.5 mg and 1.0 mg) during the hemodynamic investigation.
Intervention MeSH terms: Riociguat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary hypertension
Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort
Condition: Vitamin-D Insufficiency
Study type: Observational

Summary: 
      The purpose of this study was to study seasonal inter-individual and intra-individual
      variations in S-25(OH)D and to explore parameters associated with S-25-OHD in healthy Swedish
      adults.
    

Detailed description: 
      Serum was collected during 12 months and analysed for 25(OH)D in 540 healthy blood donors.
      The blood donors answered questionnaires concerning vitamin D supplements, smoking, physical
      activity, sunbed use and holidays in sunny locations. Repeated serum samples were also
      collected from thrombocyte donors to study the intra-individual variations in S-25(OH)D.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Blood donors
      
Biospecimen description: 
      Serum
    
Keywords: Vitamin D; vitamin D deficiency; parathyroid hormone
Monitoring Hypertensive Patients's Cerebral Oxygen Saturation
Condition: Surgical Complications From General Anesthesia; Hypertension; Cerebral Ischemia; Cerebral Anoxia
MeSH terms: Brain Ischemia; Cerebral Infarction; Hypoxia, Brain; Hypertension; Ischemia
Study type: Observational

Summary: 
      The purpose of this study is to determine whether there is a significant decrease in cerebral
      oxygen saturation in hypertensive patients undergoing major abdominal surgery and their
      correlation with standard monitoring parameters.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients scheduled for major abdominal surgery such as gastrectomy, colon resection ,liver
        resection and duodenocephalo-pancreasectomy
      
Keywords: hypertension; cerebral oxygen saturation; near-infrared spectroscopy; cognitive function
The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man
Condition: Cardiovascular Diseases; Nephropathy
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      It has been documented that statin reduce mortality and morbidity in patients with
      cardiovascular disease. This effect can partly be related to a reduction in cholesterol
      levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as
      nephropathy, diabetes and hypertension. The purpose of this study is to investigate the
      effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular
      variables in healthy man.
    

Detailed description: 
      Subjects will be examined on two examination days. 4 days prior to each examination day
      subjects are treated with either atorvastatin or placebo. During treatment periods subject
      are given a standardized diet.

      On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO
      inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal
      function, central hemodynamic and vasoactive hormones are evaluated prior, during and after
      L-NMMA infusion.

      Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and
      albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl
      cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel
      (ENaC)will be measured to evaluate channel activity in the nephron.

      Central blood pressure, pulse wave analysis, and augmentation index are measured using
      SphygmoCor® from Atcor.

      The vasoactive hormones aldosterone, renin, angiotensin II, atrial natriuretic peptide (ANP),
      brain natriuretic (BNP) and endothelin is measured in plasma
    

Intervention name(s): Placebo; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet Unikalk 1 time pr day for 5 days; Zarator, 80 mg pr day for 5 days
Other intervention name(s): Unikalk; Zarator
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Statin; L-NMMA; Healthy subjects; Nephrology
Simulation Training of Closed-Loop Communication (CLC)
Condition: Pediatric Intensive Care Unit; Closed Loop Communication; In-situ Simulation; Behavioral Changes
Study type: Interventional

Summary: 
      Open interventional before and after study on the effect of on-site full-scale simulation
      with a subsequent course follow-up and a three month follow-up observation pertaining to
      behavioural changes in communication of the paediatric intensive care unit staff that is
      participating in the on-site simulation training.
    

Detailed description: 
      Closed-Loop Communication (CLC) is a proposed, taught and practiced Crisis Resource
      Management (CRM) strategy thought to be effective for enhancing patient safety by enforcing
      reiteration and clarity, thus reducing ambiguity during verbal communication among health
      care providers. The transfer of this CRM strategy into clinical practice seems to require
      recurring exposure. Teaching and training is needed to help health care providers develop
      routine in communicating. This training is most effective if practiced in the clinical
      setting that is familiar to the health care provider (in situ simulation). As trainees become
      more proficient, the ultimate goal is to integrate Closed-Loop Communication into daily
      habits of verbal interaction in every health care setting. One way to practice the
      utilization of Closed-Loop Communication is simulation. The investigators seek to investigate
      if simulation participants can incorporate CRM strategies such as Closed-Loop Communication
      into their communication repertoire. This shall serve as an example of attitude transfer
      following a simulation based learning experience.The primary study objective is to measure
      the success of simulation training for increasing Closed-Loop Communication as a behavioural
      change in the clinical setting.
    

Intervention name(s): Simulation
Intervention type(s): Other
Intervention description(s): Intervention phase: Study participants will be subjected to on-site simulation training focusing on communication, including CRM and non-technical skills in the PICU setting.
Intervention model: Single Group Assignment
Intervention model description: Open interventional before and after study on the effect of on-site full-scale simulation with a subsequent course follow-up and a three month follow-up observation pertaining to behavioural changes in communication of the paediatric intensive care unit staff that is participating in the on-site simulation training
Masking: None (Open Label)
Primary purpose: Treatment
Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
Condition: Emotions; Mood; Cognitive Function 1, Social; Empathy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the project is to assess brain network dynamics, self-referential information
      processing and prosociality and learning following the modulation of the serotonin-system by
      serotonergic-psychoactive compounds.
    


Intervention name(s): DMT; Harmine; Placebo (Harmine); Placebo (DMT)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): DMT; Harmine; Placebo for Harmine; Placebo for DMT
Intervention MeSH terms: Harmine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the
      spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality
      of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals
      who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters
      2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3.
      Individuals who are fit with an AFO will demonstrate improvements in muscle firing
      profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements
      in quality of life.
    

Detailed description: 
      This is a non-randomized, single group (N=15), repeated measures study. The outcome measure
      for the study include: 1. GAITRite System for step length, 2. EMG of the anterior tibialis,
      gastrocnemius, soleus, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance)
      4. 12-Item MS Walking Scale (Quality of Life assessment). This study will be 24 weeks long.
      Over the 24-week period, the subject will participate in 14 gait training sessions which will
      be at weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 17, 20 and 23. The treatments will be 45-60
      minutes in duration. Outcome measures (all or part) will be assessed at the following times:
      initial (T1), week 5 (T2), week 13 (T3), and week 24 (T4). Subjects will be closely monitored
      throughout the 24 week study and will be un-enrolled by self-request or the following medical
      reasons: 1. Acute exacerbation of MS symptoms, 2. New diagnosis with direct consequences
      affecting gait training, 3. Inability to tolerate the AFO.
    

Intervention name(s): Ankle foot orthosis
Intervention type(s): Device
Intervention description(s): The ankle foot orthoses (AFOs) that will be used are designed to provide assistance with anterior tibial advancement during stance and dorsi flexion assistance during swing. The device(s) are polypropylene and are custom-fabricated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; gait; ankle foot orthosis (AFO)
Vestibular Rehabilitation Strategies in PTSD Effectiveness of Carrick Brain Centers Strategies Vestibular Rehabilitation Treatment in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries
Condition: Post Traumatic Stress Disorder PTSD
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The specific aim of this proposed study is to compare the effectiveness of Vestibular
      Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain
      injuries in a randomized controlled trial in terms of PTSD symptom reduction.
    

Detailed description: 
      The study has been approved by our Institutional IRB and conducted in accordance with the
      principles of the Declaration of Helsinki. The trial will be registered at
      Clinicaltrials.gov, a service of the U.S. National Institutes of Health. There is equipoise.
      This randomized controlled trial will compare the effectiveness of VR in in patients with
      PTSD who have suffered combat related traumatic brain injuries. A blinded investigator that
      will not be involved in the study will perform the randomization and allocation procedure.

      We will accomplish the specific aim of our study by analyzing the difference in the Clinician
      Administered DSM-IV PTSD Scale (CAPS) scores between the two groups in our study as outcomes
      to compare the effectiveness of VR. The CAPS is considered to be the gold standard for
      diagnosing PTSD and assessing symptom severity. We expect differences in the outcomes between
      both treatments to be immediate and at follow-up over time, i.e. immediately after 3 months,
      6 months and 12 months after cessation of a 2 week treatment period. The study design will
      include one pre-treatment assessment and our post-treatment assessments (at 3 months, 6
      months and 12 months). Investigators who will be blinded for the allocated treatment will
      perform all assessments. The study will be performed at the department of Neurology of our
      Institutional Brain Center in Dallas, Texas. Patient recruitment will begin starting in
      September 2014.
    

Intervention name(s): Vestibular Rehabilitation
Intervention type(s): Procedure
Intervention description(s): Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vestibular Rehabilitation; PTSD; DSM-IV
BAX 826 Dose-Escalation Safety Study
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To assess tolerability and safety of BAX 826 after a single infusion in previously
           treated patients (PTPs) with severe hemophilia A

        2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE

        3. To evaluate immunogenicity of polysialic acid linked to Factor VIII (FVIII)
    


Intervention name(s): BAX 826; Octocog alfa
Intervention type(s): Biological; Biological
Other intervention name(s): BAX826; ADVATE (Antihemophilic Factor [Recombinant]); ADVATE
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Transbronchial, Cryoprobe, and VATS Biopsy for the Diagnosis of Interstitial Lung Disease
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      The objective of this study is to compare the sample size, architectural preservation and
      diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) in
      comparison to bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted
      Thoracoscopic Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease
      (ILD).
    

Detailed description: 
      This is a prospective cohort study in which 20 subjects that have suspected ILD who are
      undergoing non-emergent surgical biopsy will be enrolled.

      Patients who have been referred to the thoracic surgery service for VATS biopsy to diagnose
      suspected ILD and meet basic inclusion/exclusion criteria will be approached by the study
      investigators and informed of the study. An informed consent will be obtained during the
      clinic visit with the thoracic surgeon.

      At the beginning of the surgical procedure, under general anesthesia in the operating room,
      patients will undergo flexible bronchoscopy through the endotracheal tube and obtain 10
      standard transbronchial biopsies (S-TBBx) and 5 Cryoprobe biopsies (C-TBBx) with fluoroscopic
      guidance. S-TBBx will be performed using standard biopsy forceps (Boston Scientific, Natick,
      MA) - 2.0mm diameter. C-TBBx will be performed using the cryoprobe (ERBE, Tubingen, Germany)
      -1.9 mm diameter, 78cm in length. This cryoprobe is routinely used in the bronchoscopy suite
      for other applications such as foreign body removal and local treatment of carcinoma;
      therefore it is a technique already employed by the interventional pulmonologists who are
      familiar with its use. Once the biopsies are obtained by the interventional pulmonologist,
      the thoracic surgeon will perform video-assisted thoracoscopic biopsy (VATS) biopsy.
      Following their procedure, subjects will be monitored in the post-anesthesia care unit as per
      standard of care. As part of their ongoing follow-up care, all subjects will be monitored for
      any adverse events that may have resulted from either the surgical or bronchoscopic
      procedure, specifically bleeding or pneumothorax.

      All biopsy samples will be analyzed by a specialist in pulmonary pathology.

      The number and size of all biopsies, architectural preservation of the airways/alveoli, and
      pathological diagnosis will be reported by the pathologist. Diagnostic yield will be
      calculated for each biopsy technique and compared
    

Intervention name(s): Transbronchial biopsy; Cryoprobe biopsy; VATS biopsy
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      The investigators performed a 4-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia.
      The investigators measured Improvement of Anemia parameters , including hemoglobin,
      transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.
    


Intervention name(s): Heme-Iron Polypeptide; Placebo; Heme-Iron; Organic Iron
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Heme-Iron Polypeptide (1g/day); Placebo (1g/day); Heme-Iron (1g/day); Organic Iron (1g/day)
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Hybrid Ablation of Persistent and Long-standing Persistent Stand-alone Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      This study evaluates in detail efficacy and safety (including neurological safety) of hybrid
      ablation of stand-alone, persistent and long-standing persistent atrial fibrillation (AF). An
      implantable ECG monitor will be implanted to all patients for rhythm monitoring. Neurological
      safety will be assessed by cerebral magnetic resonance, neuropsychological examination and
      periprocedural transcranial Doppler measurement.
    

Detailed description: 
      Hybrid ablation (i.e. surgical thoracoscopic ablation, followed by catheter endocardial
      ablation) represent a new treatment option for patients with atrial fibrillation.

      60 patients will undergo a two-stage, hybrid ablation, all of them will have an ECG
      monitoring device implanted and will be followed for up to three years. Neurological safety
      of both surgical and catheter procedures will be assessed by three examinations. Magnetic
      resonance will be performed before surgery, 5 days after surgery and at the 180 days visit to
      search for (subclinical) cerebral ischemia. Complex neuropsychological examination will be
      performed before surgery, afer 1 month after surgery and at 180 days visit to search for
      changes in cognitive functions, behavioral functions etc. Transcranial Doppler will be
      performed during surgical and catheter ablation to detect microembolic signals.
    

Intervention name(s): hybrid ablation
Intervention type(s): Procedure
Intervention description(s): Surgical thoracoscopic epicardial ablation (box-lesion) and left atrial appendage occlusion , followed (after 2-3months) by electrophysiological examination, and catheter ablation (completion of the box-lesion, cavotricuspid isthmus ablation and other ablation if indicated)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with symptomatic, drug-resistant, stand-alone, persistent or long-standing
        persistent atrial fibrillation
      
Keywords: Atrial fibrillation; Hybrid ablation
Stellate Gnaglion Block in Refractory Bell's Palsy
Condition: Facial Palsy; Neuropathy
MeSH terms: Bell Palsy; Facial Paralysis
Study type: Interventional

Summary: 
      Idiopathic facial nerve palsy (Bell's palsy) is caused by damage to the facial nerve at any
      site of the peripheral branches after the facial nucleus.Stellate ganglion block is inteneded
      to increase blood flow and promotes nerve regeneration.
    

Detailed description: 
      the conventional systemic corticosteroid treatment for acute peripheral facial nerve palsy in
      patients can induce hyperglycemia, and an alternative local therapy may be necessary and some
      time may ve ineffective.

      Our purpose in this study is to evaluate therapeutic effects of stellate ganglion block (SGB)
      on idiopathic persistant facial nerve palsy.
    

Intervention name(s): Stellate Ganglion Block Group
Intervention type(s): Procedure
Intervention description(s): Patients underwent a stellate-ganglion block at the anterolateral aspect of the C6 vertebra. After local analgesia (lidocaine 2%), a 22-gauge Quincke needle was placed in the anterolateral aspect of the C6 vertebral body. When the needle contacted the bone, it was drawn back 1 mm. 5 mL of 0·5% ropivacaine was subsequently injected next to the stellate ganglion to produce a sympathetic block.The effect of the stellate-ganglion block on the sympathetic nervous system was confirmed by the presence of Horner's syndrome (ie, facial anhydrosis, enophthalmos, ptosis, swelling of the lower eyelid, miosis, and blood-shot conjunctiva), and an increase in the temperature of the right hand of at least 2°F from baseline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuropathy