bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Salmeterol on Walking Capacity in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to test the following hypothesis:

      The acute changes in exercise tolerance during the endurance shuttle walk will be greater
      with salmeterol compared to placebo in patients with chronic obstructive pulmonary disease.
    

Detailed description: 
      Background: Little is known about the responsiveness of the endurance shuttle walking test
      (ESWT) to pharmacotherapy in patients with chronic obstructive pulmonary disease (COPD). This
      exercise testing modality needs to be further investigated because of its relevance for
      activity of daily living.

      Objective: To evaluate, in patients with COPD, the responsiveness of the ESWT to detect
      improvement in walking performance after single dose of salmeterol.

      Methods: In a randomised, double-blind, placebo-controlled, crossover study, 20 patients with
      COPD will perform, on two separate days, an ESWT at 80% of peak capacity, 2 hours after
      inhaling either a placebo or 50µg of salmeterol. Cardiorespiratory parameters will be
      monitored breath-by-breath during each walking test with a portable telemetric gas analyzer
      (Oxycom Mobile, Jaeger, Germany). Inspiratory capacities and Borg ratings for dyspnea were
      obtained every other minute throughout the tests.

      Planned analysis. The main outcome will be endurance time. This variable will be compared
      between the two treatment arms using a paired t test. The time course of the
      cardiorespiratory parameters and dyspnea over time will be compared between the two exercise
      modalities. Comparisons will be done using a repeated measure design (ANOVA). Significance
      level will be set at a p value of 0.05.
    

Intervention name(s): Placebo; Salmeterol diskus inhalation powder
Intervention type(s): Drug; Drug
Intervention description(s): Placebo diskus inhalation powder; 50 micrograms twice a day
Other intervention name(s): Serevent
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease (COPD); Exercise; Endurance shuttle walking test; Bronchodilation; Salmeterol
Evaluation of Adjunctive Injectable PRF Therapy Used in Conjunction With Scaling and Root Planning
Condition: Periodontal Pockets
MeSH terms: Periodontal Pocket
Study type: Interventional

Summary: 
      Clinical evaluation of local administration of injectable PRF (injectable platelet-rich
      fibrin) in periodontal pockets as adjunctive therapy to scaling and root planing. 15
      periodontal patients will receive a through traditional mechanical treatment (scaling and
      root planing). Each patient will receive subgingival i-PRF injected in half mouth and the
      opposite side will be injected with saline, immediately after the deep scaling session.
    

Detailed description: 
      The aim of the study is to evaluate the efficacy of i-PRF subgingival injection right after
      scaling and root planing as adjunctive therapy to traditional mechanical therapy. 15
      periodontal patients will receive traditional mechanical supra and subgingival scaling and
      root planing. I-PRF will be applied subgingivally in the deep pockets in a half mouth design.
      The injected half mouth (study group) for each patient will be allocated randomly. The
      opposite side will be injected with saline (control group). Clinical parameters will be
      evaluated: plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical
      attachment level (CAL). Clinical measurements will be performed at baseline and at 8 weeks.
    

Intervention name(s): : i-PRF; saline
Intervention type(s): Procedure; Procedure
Intervention description(s): The description of this intervention has been already given before; The description of this intervention has been already given before
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: periodontal pockets; injectable platelet-rich fibrin; saline
Multimodal Investigation of Post COVID-19 in Females
Condition: Post COVID-19; Cognitive Dysfunction
MeSH terms: COVID-19; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of transcutaneous vagus nerve
      stimulation (t-VNS) on Long Covid symptoms in females and to identify factors influencing
      susceptibility and recovery-particularly in the cognitive domain, as over 80% of long-haulers
      experience "brain fog".
    

Detailed description: 
      Long COVID is a post-viral illness estimated to affect 10-30% of COVID-19 patients.
      Post-COVID symptoms can last for months and affect multiple organs. Major risk factors of
      long COVID include the female sex and pre-existing anxiety/depression. Because women already
      have higher rates of anxiety/depression, the combined risks could exacerbate their
      susceptibility.

      Based on the rationale that long COVID symptoms significantly overlap with functions of the
      vagus nerve, which serves as a conduit between the brain and body, the investigators propose
      to use non-invasive transcutaneous vagus nerve stimulation (t-VNS) as a novel treatment for
      long COVID in 20 female participants.

      This pilot study will utilize a holistic approach by integrating neuromodulation,
      neuroimaging, genetics, blood biomarkers, behavioral assessments, and wearable technology to
      examine the effects of VNS therapy on post COVID-19 symptoms and to identify factors that
      influence susceptibility and recovery, particularly in the cognitive domain, as over 80% of
      long-haulers report experiencing "brain fog" (i.e., cognitive disruptions).
    

Intervention name(s): Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)
Intervention type(s): Device
Intervention description(s): Electrode clip will be placed on the left ear.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Long COVID; Post COVID-19 Syndrome; COVID long-haulers; Brain fog; Anosmia/Hyposmia; Neurological symptoms; EEG; MRI; Genetics; Inflammation; Transcutaneous vagus nerve stimulation; Fatigue; Anxiety; Depression; Cognitive impairment
Motor Response to Sildenafil in PD
Condition: Parkinsons Disease; Erectile Dysfunction
MeSH terms: Parkinson Disease; Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Sildenafil (Viagra(R))is widely used by men with Parkinsons Disease (PD) and erectile
      dysfunction. A number of patients have reported that when they take Sildenafil, their need of
      anti-PD medication is reduced.

      We hypotheses that sildenafil increases brain blood flow and hence improves the function of
      specific brain regions, improving motor function.

      Motor function and cerebral blood flow of 8 patients will be tested before and after
      Sildenafil intake and before and after anti-PD medication.
    

Detailed description: 
      Erectile dysfunction can be experienced by up tp 40% of men with Parkinsons Disease (PD).
      Sildenafil (Viagra(R))is widely used by men with PD and erectile dysfunction. A number of
      patients have reported that when they take Sildenafil, their need of anti-PD medication is
      reduced.

      We hypotheses that sildenafil increases cerebral blood flow in basal ganglia and hence
      improves the function, improving motor function.

      Motor function and cerebral blood flow (rCBF) of 8 patients will be tested before and after
      Sildenafil intake and before and after anti-PD medication.

      rCBF will be measured by the Xe133 inhalation method and a fast-rotating, brain-dedicated,
      single photon emission computerized tomograph (SPECT, Tomomatic, 232, Medimatic, Inc.,
      Denmark). Two scans will be perfomed, when patients are i)in normal medicated state and ii)
      in normal medicated state 1 hour after intake of 100 mg sildenafil.

      Motor function will be measured i 4 conditions: i)in normal medicated state and ii) in normal
      medicated state 1 hour after intake of 100 mg sildenafil, iii) after 12 hours of
      discontiation of anti-PD mediciation and iiii) after 14 hours of discontiation of anti-PD
      mediciation and 1 hour after intake of 100 mg sildenafil.
    

Intervention name(s): Sildenafil
Intervention type(s): Drug
Other intervention name(s): Sildenafil (Viagra (R)) 100 mg
Intervention MeSH terms: Sildenafil Citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to
      odontological usage.
    


Intervention name(s): Cetylpyridinium chloride
Intervention type(s): Drug
Intervention description(s): Cetylpyridinium chloride during 21 consecutive days.
Intervention MeSH terms: Cetylpyridinium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 diabetes is characterized by increased insulin resistance and impaired insulin
      secretion. In addition, type 2 diabetes is associated with low grade inflammation indicated
      by increased levels of proinflammatory cytokines such as TNF-α. TNF-α has previously been
      shown to impair peripheral insulin signaling in vitro and in vivo. However, it is unclear
      whether TNF-α may also affect endogenous glucose production (EGP) during fasting and glucose
      stimulated insulin secretion (GSIS) in vivo.

      We hypothesized that low dose TNF-α would increase EGP and attenuate GSIS. Recombinant human
      TNF-α or placebo was infused in healthy, non-obese and non-diabetic young men (n=10) during a
      4-hour basal period followed by an intravenous glucose tolerance test (IVGTT).
    


Intervention name(s): Low-dose TNF-alpha
Intervention type(s): Other
Primary purpose: Basic Science
Needle Aspiration for Large Cephalohematoma
Condition: Cephalohematoma
Study type: Observational

Summary: 
      The cephalohematoma is a common pathology of newborns. Observation is the primary treatment
      for the most of small uncomplicated cephalohematoma. However large cephalohematoma can lead
      to calcification with anesthetic local deformation or deformational plagiocephaly. The
      objective of the study was to evaluate the iatrogenic risk associated with early puncture on
      local anesthesia.
    

Detailed description: 
      This is a retrospective study of 67 newborns followed at the University Hospital of
      Montpellier between 2010 and 2017. Treatment was puncture under local anesthesia between 2
      and 4 weeks of life.

      Any potential complication events were searched retrospectively during the month after the
      puncture. Analyze of the electronic medical record was made as followed: read of
      peri-operative and post-operative reports, looking for readmission in Pediatric Emergency
      department and finally read of the report of the clinical control 1 month after the procedure
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients presenting cephalohematoma
      
Keywords: Cephalohematoma; Infant, Newborn; Perinatal Care; Plagiocephaly; Nonsynostotic; Skull/pathology
Mindfulness Meditation in Older Adults
Condition: Aging
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to test if an 8-week mindfulness meditation training (vs a
      wait-list control condition) program reduces neurobehavioral reactivity and improves affect
      regulation in a sample of older adults, as measured by functional magnetic resonance imaging.
      Additionally, we will examine if mindfulness meditation training reduces loneliness and
      markers of chronic inflammation.
    

Detailed description: 
      It is well established that mindfulness meditation interventions improve a wide-range of
      mental and physical health outcomes in stressed patient populations, although the underlying
      mechanisms are currently unknown. It has been suggested that mindfulness training may reduce
      reactivity to stimuli and improve regulation, although these mechanisms have not been
      examined (using functional neuroimaging). Additionally, it is well-established that
      loneliness and inflammation are major risk factors for morbidity and mortality in older
      adults, although it is currently unknown whether mindfulness meditation training may reduce
      these risk factors. The purpose of the proposed study is to test if mindfulness meditation
      training (vs a wait-list control condition) reduces neurobehavioral reactivity and improves
      affect regulation in a sample of healthy older adults, as measured by functional magnetic
      resonance imaging. Additionally, we will examine whether mindfulness meditation training
      reduces loneliness and markers of inflammation.

      Participants will be recruited in the Los Angeles area and randomly assigned to the 8-week
      Mindfulness-Based Stress Reduction (MBSR) intervention or to a wait-list. All participants
      will provide a blood sample and complete a psychosocial survey before and after the
      intervention, and complete a 60-minute neuroimaging assessment before and after the MBSR
      program. All participants who are randomly assigned to the wait-list will be offered the MBSR
      intervention after the 8-week intervention period and then complete an additional post-test
      assessment after completing the MBSR program (which will include a blood sample, psychosocial
      survey, and a neuroimaging assessment). Participants will complete neuroimaging tasks (where
      they will be presented with words, pictures, and sounds) before and after receiving the MBSR
      intervention, which will assess neural activity and regulation responses before and after
      mindfulness meditation training.
    

Intervention name(s): Mindfulness-Based Stress Reduction
Intervention type(s): Behavioral
Intervention description(s): 8-week standardized mindfulness meditation training program
Other intervention name(s): MBSR
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of AAT Training in Smokers
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate the effect of a brief computer task
      (Approach Avoidance Task) on smoking cessation. The investigators will use a novel training
      protocol that works to target automatic thoughts and tendencies that occur outside of
      conscious control. Previous research suggests that these automatic tendencies may have a
      direct effect on certain health behaviors- like continuing to smoke despite having previous
      quit attempts.

      The investigators hypothesize that individuals in the AAT training condition will evidence a
      greater decrease in reaction times to avoid smoking-related stimuli & approach positive
      stimuli relative to those in the control condition. The investigators also expect that
      individuals in the AAT condition will exhibit superior outcomes on several quit-related
      variables as evidenced by an increase in motivation to quit smoking, an increase in number of
      days abstinent following a self-guided quit attempt, an increase in self-efficacy, and a
      decrease in urge to smoke compared to those in the SHAM training condition.
    


Intervention name(s): Approach Avoidance Training; SHAM Training
Intervention type(s): Other; Other
Intervention description(s): The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Tobacco Use; Nicotine Dependence
BAX 326 Surgery Study in Hemophilia B Patients
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in
      subjects with severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B
      undergoing major or minor elective or emergency surgical, dental or other invasive
      procedures.
    


Intervention name(s): Recombinant factor IX
Intervention type(s): Biological
Intervention description(s): Following a loading dose with BAX326, participants will receive BAX326 as a bolus infusion. The treatment regimen will be determined by the intensity and duration of the hemostatic challenge and the institution´s standard of care. The dose will be tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries.
Other intervention name(s): BAX326; RIXUBIS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Feasibility Study of a Low Tidal Volume Ventilation Strategy in One Lung Ventilation
Condition: Low Tidal Volume Ventilation
Study type: Interventional

Summary: 
      A study of two ventilatory strategies for low tidal volume ventilation compared to a control
      group to elucidate if low tidal volumes of 3ml/kg or 4ml/kg were feasible for one lung
      ventilation.
    

Detailed description: 
      This study investigated the feasibility of low tidal volume ventilation for one lung
      ventilation.

      45 patients were recruited - 15 patients in each of three groups, 3ml/kg, 4ml/kg or usual
      care.

      Outcomes studied were length of stay, 30 day mortality, unplanned ICU admission, evidence of
      respiratory failure or requirement for non-invasive ventilation, chest x-ray infiltrates and
      requirement for antibiotics.
    

Intervention name(s): tidal volume ventilation
Intervention type(s): Procedure
Intervention description(s): low tidal volume ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment
Masking: None (Open Label)
Primary purpose: Prevention
Folate Absorption Across the Large Intestine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine whether the intact human colon with an unaltered
      microflora distribution absorbs folate and to what extent it is absorbed into the systemic
      circulation using a dual/oral intravenous route. This will elicit an understanding of colonic
      folate absorption and metabolism.
    

Detailed description: 
      This study supplements two earlier in print exploratory studies investigating the absorption
      of folate across the colon after an infusion during colonoscopy and a pre-trial with the
      purpose of determining dissolution characteristics of two placebo caplet formulations. Using
      a dual route oral/intravenous, folate (pharmaceutical name Calcium Leucovorin), labeled with
      a stable isotope will be used to quantitatively measure total folate levels, as well as the
      uptake of (13C) labeled folate. A pH dependent caplet targeted to the colon and fluoroscopy
      will determine dissolution characteristics. Labeled and unlabelled folate in blood and urine
      samples will be used to quantitatively measure the uptake of folate. This will further our
      understanding of the kinetics (caplet transit times), colonic folate absorption (metabolism)
      and impact on folate status (bioavailability) in healthy adults.
    

Intervention name(s): 13C5-Calcium-L-Leucovorin
Intervention type(s): Drug
Intervention description(s): This drug will be used in a clinical trial the objective of which is to determine whether, and to what extent, a physiological concentration of natural folate is absorbed across the large intestine with an intact microflora.
Other intervention name(s): 13C5 Folate
Intervention MeSH terms: Leucovorin; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: (13C5) Calcium Leucovorin; Folate absorption across the large intestine; Folate Bioavailability
Effect of Hepatic Impairment on LDK378 Pharmacokinetics
Condition: Normal Hepatic Function; Impaired Hepatic Function
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired
      hepatic function and healthy subjects with normal hepatic function.
    


Intervention name(s): LDK378
Intervention type(s): Drug
Intervention description(s): Oral LDK378 750 mg once
Intervention MeSH terms: Ceritinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LDK378; pharmacokinetics; hepatic impairment