bioihbjkbjnl/mcl2 huggingface dataset:
Central Sleep Apnea Treated by CO2 Supplied by a Novel Device
Condition: Central Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Central
Study type: Interventional

Summary: 
      In general, central sleep apnea is not as common as obstructive sleep apnea but it is common
      in patients with heart failure. It has been repeatedly shown that central sleep apnea worsens
      the prognosis of heart failure. The current concept in the development of CSA is hypocapnia
      which causes temporary cessation of respiratory neural output. Different methods for
      supplement of CO2 have been used to eliminate CSA. However, variation of CO2 concentration
      during overnight treatment and tight-fitting mask made the treatment uncomfortable. It is
      important to develop a device with a comfortable mask to supply constant low dose CO2 without
      breathing difficulty. We recently developed a device for treatment of CSA.
    

Detailed description: 
      Objective: To determine whether the device could improve sleep quality while eliminating CSA
      during the overnight study. Methods: Patients with central sleep apnea diagnosed by diaphragm
      EMG will be recruited in this study. CO2 concentration for treatment would be manually
      titrated during overnight PSG. Patients were then treated with an effective lowest
      concentration of CO2 derived from titration under PSG on the third night. The sleep apnea
      hypopnea index (AHI), central sleep apnea index (CHI), arousal index (ArI), Oxygen
      desaturation index (ODI), sleep structure, blood pressure, heart rate, diaphragm EMG,
      treatment side effects and treatment preference were to be observed.
    

Intervention name(s): novel device with a comfortable mask
Intervention type(s): Device
Intervention description(s): Using a device with a comfortable mask to supply constant low dose CO2 to treat patients.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CSA
Laparoscopic Sleeve Gastrectomy: a Cohort Study
Condition: Laparoscopic Sleeve Gastrectomy
Study type: Observational

Summary: 
      This is a prospective cohort study, which subjects were obese patients requiring LSG surgery.
      LSG with different gastric resection starting points (2-4cm/4-6 cm from pylorus) as
      intervention method. The main observation is the incidence and extent of upper
      gastrointestinal symptoms (such as nausea, vomiting, retching, reflux, difficulty swallowing,
      etc.).In addition, secondary observations include the excess weight loss (%EWL) and
      postoperative complications. Aim to investigate the effects of LSG surgery in different
      starting points of gastric resection on postoperative upper gastrointestinal symptoms.
    


Intervention name(s): 4-6cm from starting point of gastrectomy to pylorus; 2-4cm from starting point of gastrectomy to pylorus
Intervention type(s): Procedure; Procedure
Intervention description(s): The starting point of gastrectomy of the distance from the pylorus is 4-6cm during operative.; The starting point of gastrectomy of the distance from the pylorus is 2-4cm during operative.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will comprise male and non-pregnant female patients, aged 16-65years
        both inclusive, with morbid obesity.
      
Keywords: metabolic surgery; laparoscopic sleeve gastrectomy
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this protocol is to improve the current FDA-approved continuous positive
      pressure auto-titration algorithm, including treatment precision, residual disease detection
      characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.
    


Intervention name(s): DeVilbiss AutoAdjust CPAP with revised algorithm
Intervention type(s): Device
Intervention description(s): Subjects attended a one-night polysomnogram (PSG) titration study. DeVilbiss AutoAdjust CPAP with a revised algorithm was compared to hand-scored PSG to determine whether the machine results were equivalent to hand scores. Each subject acted as their own control for assessing accuracy of sleep event analysis and prescribed CPAP pressure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Dietary Manipulation on Metabolism in Healthy Adults
Condition: Metabolic Regulation; Fasting; Ketogenic Diet
Study type: Interventional

Summary: 
      This study will examine the potential changes in the blood levels of a recently discovered
      metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that
      in healthy adults key regulatory factors involved in lipid oxidation will respond to changes
      in diet, particularly fasting and diet-induced ketosis.
    

Detailed description: 
      There is scant data regarding the metabolic events that occur in humans during ketosis which
      may be brought about by fasting or ingestion of diets low in carbohydrate.

      We aim to employ both fasting and dietary manipulation in order to bring about a ketotic
      state in healthy human adults. During the study blood levels of key metabolic regulators will
      be monitored 1) during a 16 hour fast followed by re-feeding and 2) during dietary induction
      of ketosis followed by re-feeding with a standard meal.
    

Intervention name(s): Dietary manipulation ketogenic diet; Dietary Manipulation - 12 day ketogenic diet; 16 Hour Fast
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects will consume a ketogenic diet for 3 days.; Subjects will consume a ketogenic diet for 12 days.; Subjects will fast for 16 hours.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This trial is conducted in Europe. The aim of this observational study is to evaluate the
      blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes
      under normal clinical practice conditions in Romania.
    


Intervention name(s): biphasic insulin aspart 30
Intervention type(s): Drug
Intervention description(s): Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
Other intervention name(s): NovoMix® 30
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 and type 2 diabetes patients inadequately controlled on human premixes
Normative Values Laser Nociceptive Evoked Potentials Depending on the Age
Condition: Healthy
Study type: Interventional

Summary: 
      Different neurological damage may alter the pain conduction systems centrally (spinothalamic
      pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal
      stimulation selectively stimulates the pain pathways and generates nociceptive signals
      conveyed to the cortex. Registering these cortical responses constitute the technical laser
      nociceptive evoked potentials. If these tests are routinely used, their interpretation must
      remain cautious especially in the elderly.
    

Detailed description: 
      Different neurological damage may alter the pain conduction systems centrally (spinothalamic
      pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal
      stimulation selectively stimulates the pain pathways and generates nociceptive signals
      conveyed to the cortex. Registering these cortical responses constitute the technical laser
      nociceptive evoked potentials. If these tests are routinely used, their interpretation must
      remain cautious especially in the elderly. Normal values that are available have been
      obtained in young subjects. However, various studies have shown that the integration of
      nociceptive messages depended on age. The aim of this study was to establish normal values of
      nociceptive evoked potentials for each age group of 18 to 75 years.
    

Intervention name(s): laser stimulations on lower limbs; laser stimulations cervical; 20 laser stimulations for each site on the upper limbs; laser stimulations on face and neck
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 20 laser stimulations for each site : back foot, outer face of the legs, and anterior thigh; 15 laser stimulations cervical areas below the ears.; 20 laser stimulations for each site : back of the hands and arms front face; 15 lasers stimulations for each site : mandibular areas and areas below the ears.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: healthy volunteers
How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance
Condition: Healthy
Study type: Interventional

Summary: 
      Investigate how manipulating the time between caffeine ingestion and exercise may alter
      exercise performance and cognition
    


Intervention name(s): Caffeine powder -60; Caffeine powder -30; Caffeine powder 0; Placebo powder -60; Placebo powder -30; Placebo powder 0
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Motor and Visual Development in 2 Year Olds
Condition: Development, Child; Motor Skills Disorders; Visual Disorder
MeSH terms: Vision Disorders; Motor Skills Disorders
Study type: Observational

Summary: 
      It is a study where investigators are going to measure variables related to motor development
      and vision through objective tests in children with typical development of two years of age.
    


Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): To Observe and describe motor and visual development
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        two-year-old children with typical development
      
Keywords: developmet; motor; visual; infant
Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      In nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that
      does not meet international recommendations and is insufficient to allow reliable and
      reproducible biological analyzes in the sweat collected. In children between 3 and 12 months,
      this rate is about 10% when it should not exceed 5%. Insufficient amount of sweat prevents
      confirmation or reversal of the early diagnosis of cystic fibrosis and early treatment before
      irreversible complications of the disease.

      In this trial, a new support of sweat collection (Macroduct® Advanced Model 3710 Sweat
      Collection System, Wescor) will be tested with the goal to increase the amount of sweat
      collected during the sweat test, in comparison with the clinical routine method.
    


Intervention name(s): Macroduct® Advanced Model 3710 SYS, Wescor
Intervention type(s): Device
Intervention description(s): for each subject, both methods will be tested in order to compare the efficacy of the new sweat collection method (Macroduct® Advanced Model 3710 SYS, Wescor) to the method currently used in clinical routine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cystic Fibrosis Children
Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
Condition: Pediatric Patients Undergoing Hypospadias Surgery
MeSH terms: Hypospadias
Study type: Interventional

Summary: 
      Hypospadias is a congenital malformation that occurs in an embryological process, and occurs
      with an incidence of about 1/300 in male children. The caudal block was the most commonly
      performed method for pain control after hypospadias surgery, and showed very good analgesic
      effect in the immediate postoperative stage. However, the caudal block is a neuraxial block
      that has a limitation in its duration with single shot and shows complications and adverse
      effects. In recent studies, the pudendal nerve block has been suggested as an alternative
      method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer
      duration compared to the caudal block, decreased the use of analgesics within 24 hours after
      surgery, and showed higher parental satisfaction. On the other hand, there have been many
      studies to prolong the duration of the relatively short duration of caudal block. Among them,
      dexamethasone administered intravenously is known to improve the duration of various regional
      blocks and reduce the administration of additional analgesics. The aim of this study is to
      verify whether a single administration of dexamethasone can enhance the effect of the
      pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.
    


Intervention name(s): normal saline; dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): 2cc of normal saline is administered to patient instead of dexamethasone.; dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Exercise Training in Hypertrophic Cardiomyopathy: (SAFE-HCM)
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional

Summary: 
      To explore the feasibility, safety, health and psychological benefits of a 12-week high
      intensity exercise programme in a young group of individuals with hypertrophic cardiomyopathy
      (HCM). This will pave the way for a large-scale randomised study of safety of exercise in
      HCM, the results of which will strengthen the evidence base for exercise recommendations.
    

Detailed description: 
      A greater understanding of the pathogenic mechanisms underpinning HCM has translated to
      improved medical care and better survival of affected individuals. Historically these
      patients were considered to be at high risk of sudden cardiac death during exercise,
      therefore exercise recommendations were highly conservative and promoted a sedentary life
      style. There is emerging evidence which suggests that exercise in HCM has a favourable effect
      on cardiovascular remodelling and moderate exercise programmes have not raised any safety
      concerns. Furthermore, individuals with HCM have a similar burden of atherosclerotic risk
      factors as the general population in whom exercise has been associated with a reduction in
      myocardial infarction, stroke and heart failure, especially among those with a high-risk
      burden.

      Small studies have revealed that athletes who choose to continue with regular competition do
      not demonstrate adverse outcomes when compared to those who discontinue sport, and active
      individuals implanted with an implantable cardioverter defibrillator (ICD) do not have an
      increased risk of appropriate shocks or other adverse events. The recently published exercise
      recommendations from the European Society of Cardiology account for more contemporary
      evidence and adopt a more liberal stance regarding competitive and high intensity sport in
      individuals with low-risk HCM.

      However, further work is required into exercise prescription in younger non competitive
      individuals participating in higher intensity exercise. Moreover low/moderate intensity
      exercise may be appropriate for older HCM patients, it is unlikely to attract younger, often
      asymptomatic patients, who wish to engage in higher intensity regimes.Therefore this study
      aims to assess the feasibility, safety and outcomes of an individually tailored, high
      intensity exercise programme in young patients with HCM.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): 12 weeks high intensity exercise programme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Hypertrophic cardiomyopathy; Cardiac rehabilitation; Exercise; High intensity
Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
Condition: Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Progressive Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal
      stem cell transplantation, involving approximately 24 ambulatory participants with relapsing
      forms of MS (approximately equal numbers with relapsing-remitting and secondary progressive/
      progressive relapsing MS) and evidence of involvement of the anterior afferent visual system.
    


Intervention name(s): Autologous mesenchymal stem cell transplantation
Intervention type(s): Biological
Intervention description(s): A single IV infusion of up to 2 million cells per kg based on the MSC numbers achieved after culture expansion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal Stem Cell; MSC; Autologous; Multiple Sclerosis
V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
Condition: Staphylococcal Infection
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.
    


Intervention name(s): V710; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1; Saline placebo (0.5 ml) single injection on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women
Condition: Postmenopausal Symptoms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the effect of two different dose levels of estrogen
      or placebo in healthy postmenopausal women by measuring the changes in hormone levels and
      examining the changes in the uterine lining (endometrium).
    


Intervention name(s): Comparator: Estrace 0.5 mg; Comparator: Estrace 2 mg; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 mg tablet taken once daily for 28 days; 2 mg tablets taken once daily for 28 days.; Placebo 0 mg capsule taken once daily for 28 days
Other intervention name(s): Estrace; Estrace
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants
Condition: Growth and Development
Study type: Interventional

Summary: 
      The study is designed to show equivalence of an infant formula containing L-5-
      Methyltetrahydrofolate (MTHF) compared to a standard infant formula containing folic acid in
      respect to weight gain of healthy term infants receiving these infant formulae exclusively
      during the first 4 months of life. Healthy non breast fed infants will be randomized to
      receive either a standard infant formula with folic acid or a corresponding formula with MTHF
      instead of folic acid. Besides weight and length further anthropometric measures will be
      taken monthly from the age of 4 weeks to the age of 16 weeks and at the age 4 and 16 weeks
      blood samples will be taken for the determination of folate status and genotyping. As a
      reference the same measures will be taken in a group of breast fed infants, whose mothers'
      folate status will be determined as well.
    


Intervention name(s): infant formula containing folic acid; infant formula containing MTHF
Intervention type(s): Other; Other
Other intervention name(s): folic acid; L-5-Methyltetrahydrofolate
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study
Condition: Atherosclerosis
MeSH terms: Carotid Artery Diseases; Atherosclerosis
Study type: Observational

Summary: 
      The purposes of this study are to determine:

        1. Inter-site variability in CIMT image measurement using SonoCalcTM.

        2. If non-sonographer health care professionals working in an office practice setting can
           be trained to follow a carotid scanning protocol that permits (a) accurate measurement
           of CIMT and (b) determination of plaque presence.

        3. If (a) CIMT measurements and (b) determination of plaque presence by non-sonographer
           health care professionals are bioequivalent to those made by a core laboratory.

        4. If CIMT measurements and plaque assessment performed in office practices lead to
           meaningful changes in patient and physician behavior related to cardiovascular disease
           prevention.
    

Detailed description: 
      Phase

      IV

      Type (observational vs. interventional)

      Observational

      Currently recruiting or not?

      NO

      Randomized? (or not)

      No Blinded? (single, double, or open)

      Primary outcome(s)

      Bioequivalency of carotid IMT measurements.

      Secondary outcome(s)

      Variability in carotid IMT measurements Intention to behavior change in patients Effects of
      carotid IMT on physician management

      Type of Intervention (e.g., drug; device; behavioral)

      Device

      Name of Intervention

      Handheld ultrasound measurement of carotid IMT
    

Intervention name(s): Carotid Ultrasound performed in office practice
Intervention type(s): Procedure
Time perspective: Prospective
Keywords: Hand held Ultrasound; Office practice; Atherosclerosis prevention; Ultrasound training