bioihbjkbjnl/mcl2 huggingface dataset:
Are You Sitting Down: Cognitive Exectutive Function Task Comparison Between Seated and Standing Positions
Condition: (Focus) Posture Effect on Cognitive Performance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this trial has been to explore the effects of self-positioning on cognitive
      performance in the work environment using a standardized cognitive test battery to evaluate
      executive function under two conditions: sitting and standing.
    

Detailed description: 
      The aim of this trial has been to explore the effects of self-positioning on cognitive
      performance in the work environment using a standardized cognitive test battery to evaluate
      executive function under two conditions: sitting and standing.

      Methods: This counterbalanced controlled trial involved 17 men (mean age +/-SD: 29.8 +/- 5.5)
      all with a science background and graduate degrees. The participants were accustomed to
      working in an open environment and none of whom currently using standing desks. We used a
      modified version of the CNS Vital Signs (CNSVS) test battery to assess cognitive executive
      function (CEF) in two typical work positions - standing and seated. Participants were
      randomly assigned to a standing or seated position to begin the testing procedure. Upon
      completion of the first test round they were instructed to rest for 10 min. in a dark room
      with no distractions before commencing the second round of testing positioned in the
      alternate fashion. The main outcome measure was a CNSVS score in each of the six CEF domains
      in the two different work positions
    

Intervention name(s): posture: sitting or standing
Intervention type(s): Behavioral
Intervention description(s): Intervention: postural position - whether seated or standing. The person carries out a battery of cognitive executive functioning assessments delivered via a laptop and carried out with the laptop keyboard while either seated or standing.
Other intervention name(s): (no other names)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cognitive executive function; posture; cognitive performance; heart rate; eeg
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ZYIL1 Following Oral Administration in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      ZYIL1 is a novel oral selective NLRP3 inflammasome inhibitor which prevents NLRP3-induced ASC
      oligomerization, thus inhibiting NLRP3 inflammasome pathway. ZYIL1 is expected to show
      benefit in patients demonstrating cytokine, like IL1β flare, including those exhibiting
      cytokine storm related to COVID-19 and other viral inflammatory diseases.
    

Detailed description: 
      It is an open label, study designed to evaluate safety, tolerability, pharmacokinetics (PK)
      and pharmacodynamics (PD) following a multiple-oral dose administration of ZYIL1 to healthy
      subjects aged between 18-55 years old (Both Inclusive).

      It will be conducted in up to 3 cohorts of 6 subjects each. Each cohort will be enrolled
      within a 28 day screening period to ensure subjects meet all the inclusion criteria and none
      of the exclusion criteria. Subjects will be administered multiple oral dose of ZYIL1 from day
      1 to till day 14.
    

Intervention name(s): ZYIL1 Capsule
Intervention type(s): Drug
Intervention description(s): NLRP3 inflammasome inhibitor
Intervention model: Single Group Assignment
Intervention model description: A Phase I, Prospective, Open Label, Multiple Dose study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NLRP3; NLPR3 Inflammasone inhibitor
Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate
      the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as
      a single subcutaneous injection in healthy adult subjects.
    


Intervention name(s): RGB-02 or Neulasta® (pegfilgrastim)
Intervention type(s): Drug
Intervention description(s): Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Therapeutic Trial Using Hydroxyurea in Type II and Type III Spinal Muscular Atrophy Patients
Condition: Muscular Atrophy, Spinal
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Spinal Muscular Atrophies of Childhood; Atrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in
      children with Types II and III Spinal Muscular Atrophy; to identify reliable outcome measures
      for HU treatment in Types II and III SMA; and to detect the clinical efficacy of HU treatment
      in children with Types II and III SMA.
    

Detailed description: 
      SMA is a neuromuscular disorder characterized by degeneration of spinal cord motor neurons
      and muscular atrophy. SMA is classified into three clinical subtypes according to the
      severity and age of onset (Types I, II and III). Type II (intermediate) SMA has its onset in
      early childhood (prior to 18 months) and is characterized by the failure to stand or walk
      unassisted. Individuals with Type III SMA (mild SMA or Kugelberg-Welander disease) typically
      develop symptoms after 18 months of age and display a wide range of clinical heterogeneity.
      The clinical spectrum ranges from rapid progressive weakness resulting in wheelchair
      dependence in late childhood to patients being able to walk in adult years and living
      productive and independent lifestyles for the majority of their lives.

      In our laboratory, our preliminary results indicate that HU treatment significantly increases
      both SMN mRNA expression and intact SMN protein levels in vitro. These data confirm previous
      observations that in vitro treatments of SMA lymphocytes with hydroxyurea resulted in
      augmentation of the SMN2 gene expression in a dose and time related manner. Based on these
      exciting pre-clinical data, coupled with the well-documented side-effect profile of HU in
      children, we are conducting a pilot clinical trial using HU in children with Types II and III
      SMA. This clinical trial study is intended to establish the safety profile in children with
      Types II and III SMA; to identify reliable outcome measures; and to detect the possible
      clinical efficacy of HU treatment in children with Types II and III SMA.
    

Intervention name(s): Hydroxyurea; Placebo to match hydroxyurea
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydroxyurea
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Vitamin D and Type 2 Diabetes - a Cross Sectional Study
Condition: Hypovitaminosis D; Type 2 Diabetes Mellitus
MeSH terms: Rickets; Diabetes Mellitus; Diabetes Mellitus, Type 2; Avitaminosis; Vitamin D Deficiency
Study type: Observational

Summary: 
      The purpose of the study is to describe vitamin D status among patients with type 2 diabetes
      and to determine the association between serum 25-hydroxyvitamin D and glycemic control,
      markers of inflammation and blood pressure
    

Detailed description: 
      It has been estimated that 1 billion people worldwide have vitamin D deficiency or
      insufficiency. It is well known that vitamin D deficiency causes osteoporosis, increases the
      risk of fracture and causes muscle weakness. But there is now evidence that calcium
      malnutrition and hypovitaminosis D are predisposing conditions for various common chronic
      diseases such as malignancies (particularly colon, breast and prostate) chronic inflammatory
      and autoimmune disease (inflammatory bowel disease, multiple sclerosis) as well as metabolic
      disorders (metabolic syndrome, hypertension).

      It has also been reported that vitamin D deficiency may predispose to glucose intolerance,
      altered insulin secretion and type 2 diabetes mellitus.

      The purpose of this study is to determine vitamin D status among type 2 diabetics in our
      outpatient clinic and examine the relationship between vitamin D status , calcium and
      phosphorous metabolism, inflammatory markers, glycemic control, blood pressure and lipid
      profile.

      Moreover the patients are asked to answer a questionnaire regarding lifestyle, exercise, sun
      exposure and food intake.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of Danish type 2 diabetics from the outpatient clinic at
        Silkeborg Hospital.
      
Biospecimen description: 
      Blood samples, urine.
    
Keywords: Hypovitaminosis D; Type 2 diabetes; Glycemic control; Inflammation; Blood pressure
Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%
Condition: Patients Undergoing Lower Limb Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric,
      phase IV comparison of the effects of two local anesthetics intrathecally: 0.5%
      levobupivacaine and ropivacaine 0.5%.
    

Detailed description: 
      Progress in the practice of anesthesia led to a safety requirement of growing in daily
      practice. Spinal anesthesia commonly used technique for surgery of the lower limbs, provides
      a triple neurological lock (sensory, motor and autonomic) of roots of the spinal cord by
      intrathecal injection of a local anesthetic agent, following the rules of and strict aseptic
      conditions.

      Levobupivacaine and ropivacaine local anesthetic agents are considered less toxic and tend to
      replace the use of bupivacaine, reference molecule, but the plasma transition is extremely
      toxic to patients. However, there is currently no study comparing the benefits of
      levobupivacaine and ropivacaine in isobaric form injected intrathecally for trauma surgery of
      the lower limbs. We propose to conduct a prospective, randomized double-blind comparison of
      the use of these two molecules in spinal isobaric form by evaluating the time and duration of
      action (sensory and motor block), hemodynamic and ventilatory changes (sympathetic block),
      and the occurrence of any adverse events.
    

Intervention name(s): ropivacaïne; lévobupivacaïne
Intervention type(s): Drug; Drug
Intervention description(s): spinal anesthesia.
Intervention MeSH terms: Ropivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anesthesia; Randomized study; Lower limbs surgery
Probiotics for Reduction Of Markers In Subjects With Allergy
Condition: Hay Fever; Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional

Summary: 
      In vitro studies reveal immunomodulatory effects of probiotic bacteria that are
      strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated
      directly to in vivo efficacy. Thus, in vitro screening should be followed by comparative
      analysis of the selected immunomodulatory probiotic strains in an in vivo setting. Birch
      pollen allergy is one of the most common forms of respiratory allergy in European countries,
      and recognized by a Th2-skewed immune system. Five Lactobacillus strains will be evaluated
      for their immunomodulatory properties in birch pollen sensitive subjects outside the hay
      fever season. A double-blind placebo-controlled parallel study will be performed in which
      subjects with a proven birch pollen allergy will consume one of 5 different probiotic
      yoghurts containing 4 L. plantarum strains and 1 L. casei strain or a placebo yoghurt. Blood
      samples are collected at the start and after 4 weeks. Immune parameters are determined in
      serum and peripheral blood mononuclear cell cultures (hPBMC) derived from these subjects.
    


Intervention name(s): Yoghurt with L. plantarum strain; Yoghurt with L.casei; Yoghurt with L. plantarum strain; Yoghurt with L. plantarum strain; Yoghurt with L. plantarum strain; Yoghurt
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Intake of yoghurt during 4 weeks; Intake of yoghurt during 4 weeks; Intake of yoghurt during 4 weeks; Yoghurt with L. plantarum strain; Intake of yoghurt during 4 weeks; Intake of yoghurt during 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Caduet and TLC Intervention in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC)
      intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC
      intervention study with or without Caduet therapy for 12 months. The participants underwent
      monthly visits with investigators to obtain vital signs, and to undergo TLC counseling.
      Metabolic parameters were measured before and after intervention.
    

Detailed description: 
      Single center, investigator driven, double blinded, randomized with Caduet 5/10mg vs placebo.
      The participants visited with investigators on a monthly bases to evaluate the BP, weight,
      and obtain the waist measurements, and counseling. OGTT was performed at the beginning and
      the end of the study. Lipid and glucose parameters were measured 5 times in duration of the
      study period.

      Exercise physiologists and dietitians completed the baseline evaluations and provided
      recommendations throughout the study period in person, via phone or e-mail: per subject
      preference. VO2 max was measured at the beginning and end of the study. Pedometers dispensed
      to encourage physical activity.
    

Intervention name(s): Therapeutic Lifestyle Change; Caduet Pill; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Monthly consult with a dietitian and fitness instructor.; Take once daily.; Take once daily.
Other intervention name(s): TLC; 5Mg-10Mg Tablet; Oral Tablet
Intervention MeSH terms: Amlodipine, atorvastatin drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid
Condition: Dental Implants
Study type: Interventional

Summary: 
      Numerous materials are nowadays used in the fabrication of healing abutments to be used for
      dental implants. soft tissue response to different healing abutment materials is still to be
      unraveled. the Aim of this study is to compare the soft tissue response to titanium stock
      healing abutments to customized composite healing abutments through assessing the level of
      matrix metalloproteinase-8 in the peri-implant crevicular fluid
    


Intervention name(s): Stock healing abutments; Compoiste healing abutments
Intervention type(s): Other; Other
Intervention description(s): 2ND stage surgery will be performed and stock healing abutment were placed; 2ND stage surgery will be performed and composite healing abutment were placed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pneumococcal Adult-dose Ranging Immunization Study
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to give seniors different doses of a new pneumococcal vaccine
      called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out
      which amount gives the best immune response. The PCV7 vaccine is currently licensed by the
      FDA for use in infants and toddlers only.
    

Detailed description: 
      The purpose of this prospective randomized study is to assess the safety, post-vaccination
      antibody response, and memory response to a subsequent polysaccharide challenge of varying
      doses of PCV7 compared with the standard dose of PPV23 in immunocompetent adults 70-79 years
      of age who were previously vaccinated with PPV23 at age 65 years or above and at least 5
      years previously. The study will be conducted among a total of 220 persons recruited from GHC
      and the Seattle VAMC. Participants will be randomized into one of 5 study groups with 44
      participants per group. The antigen content of PCV7 will be varied by administration of
      different volumes of the licensed pediatric formulation of that vaccine. Four groups will
      receive one of four volumes (0.1 mL, 0.5 mL, 1.0 mL, 2.0 mL) of the licensed pediatric
      formulation of PCV7 followed 12 months later by administration of a challenge 0.1 mL dose of
      PPV23 to assess the induction of immunologic memory. The comparison group will receive the
      standard 0.5 mL dose of PPV23 following 12 months later by administration of a 0.1 mL dose of
      PPV23.
    

Intervention name(s): PCV7, Prevnar®; Pneumovax 23
Intervention type(s): Biological; Biological
Intervention description(s): Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.; Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Pneumococcal disease; Vaccination; Immunization; PPV23; PCV7
A Study of HNC042 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this First-in-Human study is to evaluate the safety , tolerability and
      pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to
      placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042
      given to healthy subjects daily for 7 days compared to placebo , will be evaluated.
    


Intervention name(s): HNC042 single dose; Placebo single dose; HNC042 multiple ascending doses; Placebo multiple ascending doses
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg; Placebo single ascending doses , Intravenous route Single dose, matching placebo; HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg; Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)
Condition: Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of
      a 12-week treatment with Posaconazole Oral Suspension in participants with IFI
    


Intervention name(s): Posaconazole
Intervention type(s): Drug
Intervention description(s): 400mg BID oral suspension for 12 weeks
Other intervention name(s): Noxafil
Intervention MeSH terms: Posaconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory or first line medication intolerable invasive fungal infection
The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite
Condition: Allergens, House Dust Mites
Study type: Interventional
Phase: Phase 1

Summary: 
      House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the
      eyes, and running nose. The investigators test a possibility to immunize subjects sensitized
      against house dust mite with extracts from their own gut bacteria "auto-vaccination".
    

Detailed description: 
      see above
    

Intervention name(s): Injection of autovaccine (Autovaccine Symbiopharm)
Intervention type(s): Biological
Intervention description(s): increasing dosage schedule, six different concentrations, application over six weeks, 2 weeks break, another six weeks, 2 weeks break, than challenge with inhalative house dust mite extract
Other intervention name(s): Autovaccine Symbiopharm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: house dust mite; asthma; autovaccine; allergy
Dietary Effects on Circulating Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity and Enzyme Activity in Peripheral Blood Mononuclear Cells (PBMCs) in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes
Condition: Impaired Fasting Glucose; Newly Diagnosed Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
Study type: Interventional

Summary: 
      We determined the effects of dietary intervention (replacement of refined rice with whole
      grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and
      enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired
      fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.
    

Detailed description: 
      Ninety-nine patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or
      newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet
      with refined rice) or the whole grain group.
    

Intervention name(s): Dietary intervention-whole grains and legumes; Dietary intervention-Refined rice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects in the whole-grain group consumed replacing of refined rice intake with 1/3 of legumes, 1/3 of barley, and 1/3 of wild rice three times per day as a carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.; Subjects in the control group maintained their usual diet of refined rice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science