bioihbjkbjnl/mcl2 huggingface dataset:
Lower Limb Tissue Oxygenation Using Near-infrared Spectroscopy During Hallux Valgus Operation
Condition: Lower Limb Ischemia
MeSH terms: Hallux Valgus; Ischemia
Study type: Observational

Summary: 
      In acute lower limb ischemia the main goal of the treatment is to restore the blood before
      irreversible damage to the soft tissues of the limb. Delays in identifying acute lower limb
      ischemia may lead to limb loss or lead to the loss of the patient. Situations in which the
      patient is unable to express symptoms of the acute lower limb ischemia, such as during
      general anesthesia, in intensive care, or immediately after vascular surgery, are challenging
      for medical staff to identify. A reliable, easy-to-use and non-invasive monitoring method is
      not yet in every day use. The aim of this study is to demonstrate that Near InfraRed
      Spectroscopy (NIRS) monitoring is such a monitoring method.

      Tourniquet induced ischemia is often used in hallux valgus surgery because it offers a
      bloodless view of the anatomical structures. In our study we will measure the soft tissue
      perfusion (rSO2) of the lower limbs during the whole operation. The sensors based on
      near-infrared spectroscopy will be located to the tibial surface and will record the normal
      state before the start of the tourniquet, during the tourniquet and also in the recovery
      phase.

      The hypothesis is that rSO2 decreases linearly as a function of time from the beginning of
      the tourniquet induced ischemia and the recovery time depends on the duration of the
      tourniquet. In our study the patients will be operated under a spinal anesthesia. We also
      hypothesise that rSO2 increases due to the induction of the spinal anesthesia. Our goal is to
      define the percentual decline of rSO2 that is significant for lower limb ischemia and also
      its time response to induction of ischemia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Operative hallux valgus patients in Kuopio University Hospital.
      
Keywords: NIRS Spectroscopy; Lower Limb; Ischemia; Adults
The Effect of Transcranial Direct Stimulation on Cognitive Functions of Healthy Adults
Condition: Cognitive Symptom; Healthy
MeSH terms: Neurobehavioral Manifestations
Study type: Interventional

Summary: 
      Background: Transcranial direct current stimulation(tDCS) has been used to improve cognitive
      functions in healthy young adults.

      Purpose: To investigate the effect of TDCS application on different cortex regions on
      cognitive function.

      Methods: Sixty individuals aged 18-30 were included in the study. The participants were
      randomly divided into the left dorsolateral prefrontal cortex (Left DLPFC Group)(n=20), the
      right posterior parietal cortex (Right PPC Group)(n=20), and the sham group (Sham
      Group)(n=20). tDCS was applied for 20 minutes on weekdays for 2 weeks. The participants were
      evaluated in terms of cognitive functions with Neuropsychometric Test Battery before and
      after treatment.
    


Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Other
Intervention description(s): The intervention protocols were applied using tDCS (Teknofil TESsaNova). All individuals received 2 mA of anodal tDCS for 2 weeks on weekdays. All applications were done in the form of 20-minute sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: tDCS; Dorsolateral Prefrontal Cortex; Posterior Parietal Cortex; Cognitive Function
Clavipectoral Fascial Plane Block Versus Superficial Cervical Block in Fracture Clavicle
Condition: Fracture Clavicle
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Ultrasound-guided Clavipectoral fascial plane block versus ultrasound-guided superficial
      Cervical plexus block in patients undergoing fracture clavicle operation
    

Detailed description: 
      The clavipectoral fascial plane block (CPB) is a novel regional anesthesia technique that has
      been utilized for clavicular fracture surgery. It has been hypothesized that the CPB is an
      effective regional anesthesia technique for peri-operative analgesia since the terminal
      branches of many of the sensory nerves like suprascapular, subclavian, lateral pectoral, and
      long thoracic nerves pass through the plane between the clavipectoral fascia and the clavicle
      itself.

      The ultrasound-guided superficial cervical plexus (SCP) block may be useful for providers in
      emergency care settings who care for patients with ear, neck, and clavicular region injuries,
      including clavicle fractures and acromioclavicular dislocations. The SCP originates from the
      anterior rami of the C1-C4 spinal nerves and gives rise to 4 terminal branches (greater
      auricular, lesser occipital, transverse cervical, and suprascapular nerves) that provide
      sensory innervation to the skin and superficial structures of the anterolateral neck and
      sections of the ear and shoulder.
    

Intervention name(s): pain assessment after clavicular fracture repair
Intervention type(s): Diagnostic Test
Intervention description(s): This group includes (40) patients will have medial and lateral clavipectoral (CPB) block ultrasound guided using 20 ml Bupivacaine 0.5% for medial and lateral block equally after induction of general anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: fracture clavicle; clavipectoral block; superficial cervical block
Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline
Condition: Acne
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate the skin and plasma concentrations of
      minocycline in subjects undergoing treatment of acne vulgaris with oral extended release
      minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.
    

Detailed description: 
      This will be an open label, non randomized, interventional pilot study evaluating the plasma
      and skin levels of minocycline in 10 subjects with moderate to severe acne vulgaris. Subjects
      with non inflammatory acne of nodular acne will not be enrolled. Subjects will be on an oral
      extended release minocycline regimen of up to 2mg/kg once a day for 4 weeks.

      Steady state levels of minocycline in plasma and skin will be determined.
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): Oral extended release minocycline
Other intervention name(s): MCN
Intervention MeSH terms: Minocycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single Ascending Dose Study of CD101 IV in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of
      CD101 IV
    

Detailed description: 
      This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending
      single doses of CD101 Injection administered IV to healthy adult subjects. In this study,
      subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of
      CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending
      single-dose regimen.
    

Intervention name(s): CD101 IV; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): antifungal; normal saline
Intervention MeSH terms: Rezafungin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subjects
Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver
Condition: Liver Tumor; Evidence of Liver Transplantation
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK)
      immunotherapy to tumors in transplanted liver.
    

Detailed description: 
      By enrolling patients with tumors in transplanted liver adapted to enrolled criteria, this
      study will document for the first time the safety and the short and long term efficacy of the
      combined therapy using cryosurgery and NK cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance); Natural killer cell(each treatment: about 10 billion cells transfusion in 3 times, i.v.)
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver tumor; cryosurgery; NK immunotherapy
Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study in healthy male subjects to investigate the
      absorption, metabolism, and excretion (AME) of KW-6356.
    

Detailed description: 
      Subjects will be screened to assess their eligibility to enter the study within approximately
      4 weeks prior to dose administration. Subjects will be confined to the Clinical Research Unit
      (CRU) for their entire participation in this study. Eight subjects will be enrolled to allow
      6 subjects to complete the study. Each subject will report to the CRU and be confined from
      Day -1 (the day before dosing) through at least Day 8 (168 hours postdose). A single dose of
      study drug will be administered on Day 1 (0 hour). On Day 8, subjects can be asked to remain
      as a resident within the CRU for an additional period to allow for ongoing 24-hour urine,
      fecal, and blood sample collections. These collections can continue up to a maximum of 336
      hours postdose (Day 15). Subjects can be discharged prior to Day 15 if the following
      individual subject discharge criteria have been satisfied: ≥ 90% of the 14C dose recovered in
      combined urine and feces, and ≤ 1% of the total radioactive dose is recovered in combined
      excreta (urine and feces) in 3 consecutive 24-hour periods in which a fecal sample is
      provided.
    

Intervention name(s): KW-6356
Intervention type(s): Drug
Intervention description(s): Single oral dose of KW-6356
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Male Subjects
Normobaric Hypoxic Training and Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      To study the effects of normobaric hypoxic training on cardiorespiratory fitness, resting,
      postprandial and exercise activity energy expenditure, immunoregulatory functions and serum
      erythropoietin levels in relapsing-remitting multiple sclerosis patients.
    


Intervention name(s): Hypoxic training; Normoxic training
Intervention type(s): Other; Other
Intervention description(s): Hypoxic training 3 times per week four four weeks; Normoxic training 3 times per week four four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Hypoxia training; Activity energy expenditure; Immunoregulation; Energy Metabolism; Exercise
Measurement of Handgrip Strength and Pinch of Children and Adolescents Using an Electronic Dynamometer
Condition: Hand Strength
Study type: Interventional

Summary: 
      This study has quantified the hand strength in movements of handgrip and pinch with
      electronic dynamometer.
    

Detailed description: 
      The hand is considered the most improved tool and differentiated of the human, with great
      importance in the accomplishment of numerous actions due to an essential function: The
      handgrip strength. The handgrip and pinch movements are very important for an accomplishment
      of daily activities. For an evaluation of the movements, the dynamometry has been used in
      many fields of health and frequently in the area of rehabilitation. However, if the type of
      dynamometer used is not suitable for children, a measurement of the handgrip may be
      compromised. Therefore, the present study verified the effectiveness of an electronic
      dynamometer to evaluate the handgrip strength and pinch in children and adolescents.
    

Intervention name(s): Electronic Dynamometer; Hydraulic dynamometer
Intervention type(s): Device; Device
Intervention description(s): Mensuration of the handgrip strength of each volunteer using an electronic dynamometer.; Mensuration of the handgrip strength of each volunteer using a hydraulic dynamometer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Dynamometer; Handgrip; children
REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19: REHSCU Study
Condition: Acute Respiratory Failure; COVID-19; Trauma; Stroke; Sepsis; Shock
MeSH terms: COVID-19; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients
      hospitalized in intensive care units for an acute respiratory failure in all countries. This
      situation has quickly led to massive shortage in masks, mechanical ventilation machines and
      common medications such as hypnotics. All countries over the world are currently experiencing
      a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as
      well as in the operating theatre. The Principal Investigator proposes to perform a pilot
      study assessing the benefit-risk ratio of Remimazolam (a novel benzodiazepine with a short
      half-life) in the critical care units of Nantes University Hospital during the COVID-19
      pandemic.
    

Detailed description: 
      The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients
      hospitalized in intensive care units for an acute respiratory failure in all countries. This
      situation has quickly led to massive shortage in masks, mechanical ventilation machines and
      common medications such as hypnotics. The reasons for such shortage are multiple: dramatic
      increase of the demand, production discontinuation because of shutdowns in multiple
      countries, and withholding of products by producing countries. All countries over the world
      are currently experiencing a major shortage in basic hypnotic medications (propofol,
      midazolam) in the intensive care as well as in the operating theatre. Remimazolam is a novel
      benzodiazepine with a short half-life that has been administered in patients undergoing major
      surgery, as well as in the intensive care unit. The Principal Investigator proposes to
      perform a pilot study assessing the benefit-risk ratio of Remimazolam in the critical care
      units of Nantes University Hospital during the COVID-19 pandemic.
    

Intervention name(s): Remimazolam
Intervention type(s): Drug
Intervention description(s): Patients will receive an infusion of Remimazolam for a maximum duration of 48 hours. The dose of Remimazolam will be adapted according to the ICU units protocol of analgesia-sedation management, based on validated scale (Richmond Assessment Sedation Scale). Owing to previous data gathered through a previous study in Japan, the initial dose of infusion will be within a 0.2-0.5 mg/min range. The dose of Remimazolam can be increased or decreased by 0.1mg/min when needed. The maximum dose of Remimazolam will be set at 1 mg/min.
Other intervention name(s): Remimazolam (CNS 7056)
Intervention model: Single Group Assignment
Intervention model description: Non-controlled
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Remimazolam; Sedation; Shortage; Critical care; COVID-19
Association of Snowfall and Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Changes in the ambient temperature (esp. warm to cold) as well as exercise are triggers for
      vasospasms and plaque rupture. Weather data (temperature, precipitation in general as well as
      snowfall and changes in atmospheric pressure) will be correlated with the incidence of
      myocardial infarctions.
    

Detailed description: 
      Besides classical cardiovascular risk factors such as smoking, obesity, elevated cholesterol
      levels and diabetes there are also acute factors potentially triggering acute coronary
      events. The impact of air temperature (changes) or humidity are of potential relevance. In
      addition, exercise and the associated increase in oxygen demand of the myocardium and blood
      pressure is another trigger for plaque rupture and the acute onset of myocardial infarction.
      Male patients as well as patients with previous coronary heart disease or little regular
      exercise are at increased risk.

      Possible additional mechanisms of exercise induced myocardial infarction are vasospasm and
      changes in blood clotting.

      Changes in the ambient temperature (warm to cold) can also induce vasospasm which might
      result in reduced perfusion and plaque rupture. It seems that male patients are more involved
      than female patients.

      Taking the exercise and the ambient temperature changes into consideration, heavy snowfall
      with consecutive snow shoveling is an augmented risk for acute myocardial infarction.

      The rationale of the study is to test if the above mentioned constellation of environmental
      factors as well as potential increased exercise have a significant and independent impact on
      the incidence of myocardial infarctions
    

Intervention name(s): snowfall > 5cm/day
Intervention type(s): Other
Intervention description(s): the number of myocardial infarctions of every day analysed in this study will be correlated with the respective values of snowfall
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with myocardial infarction being transfered to a cath lab either at the
        medical university of Graz or the department of cardiology at the state hospital Graz West
Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between
      parents and their children's' primary care providers about asthma. The overarching goal of
      this study is to reduce disparities among a population with high rates of pediatric asthma
      morbidity. The investigators are testing the efficacy of a short message service
      (SMS)-enhanced health communication (HC) intervention ("Text2Breathe") designed to equip
      urban, low-income parents with tools for communicating effectively with their children's
      primary care provider (PCP).
    

Detailed description: 
      Potentially eligible participants are approached and screened in person during an admission
      of their child to the emergency department for asthma care. Those participants randomized to
      the intervention will receive additional education on effective communication with their
      child's primary care provider (PCP). These participants will also receive educational text
      messages for three months after their initial visit. Text messages will include education on
      effectively communicating with their child's provider and general asthma information. Both
      the control group and intervention group will receive text message reminders to schedule
      regular follow up visits with their PCP and get an annual flu shot. Both groups will be
      contacted for follow up phone interviews at 3, 6, 12, 18 and 24 months.
    

Intervention name(s): Text2Breathe Study Group
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
Condition: Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma
MeSH terms: Glioma; Brain Neoplasms; Diffuse Intrinsic Pontine Glioma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Although DIPG is not curable, re-irradiation with a modest total dose and short treatment
      time provides good palliation of symptoms, improves quality of life, delays disease
      progression and has minimal and manageable toxicity.

      Treatment plan:

      At progression, full radiological and clinical documentation necessary including a
      neurological exam by a neurologist will be done. Progressive patients will be referred to
      radiotherapy.

      Radiation guidelines:

      30.6 Gray (Gy) will be applied in 1.8 to 2Gy fractions in conformal radiation to tumor bed.
      Radiation will be done in standard accelerators and according to standard guidelines used in
      treatment for all brain tumor patients.
    


Intervention name(s): Palliative re-irradiation for progressive DIPG in children
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this trial is to investigate the effect of 6 weeks treatment with
      tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and
      exercise tolerance in patients with COPD.
    


Intervention name(s): Placebo; Tiotropium + Olodaterol; tiotropium + Olodaterol; Tiotropium; Olodaterol; Respimat
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Device
Intervention description(s): placebo matching tiotropium + olodaterol; Tiotropium 2.5 mcg + olodaterol 5 mcg once daily; tiotropium 5 mcg + olodaterol 5 mcg once daily; tiotropium; Olodaterol 5 mcg once daily; Respimat inhaler
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment