bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Deep Cervical Flexor Muscles Training on Neck Pain, Functional Disability and Muscle Endurance in School Teachers
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Neck pain (NP) is a common work related disorder. Teaching is one profession in which its
      prevalence is high. The Daily job of a school teacher involves head down posture while
      reading, writing, etc., exposing them to risk of developing NP. Deep cervical flexor (DCF)
      muscles have been shown to have lower endurance in patients with cervical impairment which
      has been associated with disability. There is limited evidence that reports efficacy of DCF
      muscles training in occupational NP. This study was done to see the effect of DCF muscles
      training using pressure biofeedback on pain, muscle endurance and functional disability in
      school teachers with NP.
    

Detailed description: 
      Neck pain (NP) is a common work related disorder. Teaching is one profession in which its
      prevalence is high. The Daily job of a school teacher involves head down posture while
      reading, writing, etc., exposing them to risk of developing NP. Deep cervical flexor (DCF)
      muscles have been shown to have lower endurance in patients with cervical impairment which
      has been associated with disability. There is limited evidence that reports efficacy of DCF
      muscles training in occupational NP. This study was done to see the effect of DCF muscles
      training using pressure biofeedback on pain, muscle endurance and functional disability in
      school teachers with NP. 65 teachers, aged between 25 to 45 years with experience of more
      than 5 years were agreed to participate in this study. Subjects were randomly divided into
      two groups, experimental (EG) and control group (CG). In EG, subjects received DCF muscles
      training using pressure biofeedback in addition to conventional exercises for neck pain while
      in CG subjects received only conventional exercises. Pain, muscle endurance and disability
      measured at day 0 (before treatment), day 14 and day 42 after treatment. Endurance of DCF
      muscles was measured by CCF test using pressure biofeedback instrument, Pain intensity was
      measured using NPRS and Functional disability was assessed using NDI questionnaire.
    

Intervention name(s): DCF muscles training using pressure biofeedback in addition to conventional exercises; conventional exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): DCF muscles training using pressure biofeedback in addition to conventional exercises; conventional exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens
Condition: Diabetes Mellitus; Hyperglycemia
MeSH terms: Diabetes Mellitus; Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare the therapeutic efficacy of three regimens of
      insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.
    

Detailed description: 
      Patients will be randomly assigned to one of the three treatment regimens. Also, the use of
      oral antidiabetic drugs would be suspended during their stay at the hospital.
    

Intervention name(s): Once-daily Insulin; Twice-daily Insulin; Triple-daily Insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive NPH insulin in a once-daily regimen. The starting dose is calculate according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the once-daily regimen will be administered subcutaneously before breakfast. Regular insulin subcutaneously wil be given in three equally divided doses before each meal.; Patients receive NPH insulin in twice-daily regimen. The starting dose is calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will de fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the twice-daily regimen will be administered subcutaneously before breakfast and before dinner. Regular insulin will be given in three equally divided doses before each meal.; Patients receive NPH insulin in a triple-daily regimen. The starting dose was calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the triple daily regimen will be administered subcutaneously before each meal. Regular insulin will be given in three equally divided doses before each meal.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Hospital Hyperglycemia
Safety and Tolerability Study With Single Ascending Doses of ODM-102
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of escalating single
      doses of ODM-102 in healthy volunteers
    


Intervention name(s): ODM-102; Placebo for ODM-102
Intervention type(s): Drug; Drug
Intervention description(s): Single dose escalation; Single dose escalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers
Pollutant Altered Allergic Responses
Condition: Allergic Rhinitis; Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      This study is designed to investigate whether exposure to particulate air pollution increases
      the allergic response to allergens. Research studies suggest that symptoms in individuals
      with allergies may be aggravated by exposure to particulate air pollution. We sought to
      experimental determine this by exposing human volunteers to combustion particles, a component
      of air pollution, and then challenge them with an allergen such as ragweed or oak tree
      pollen. Using biological tests we can measure whether the allergen response is magnified by
      prior particulate exposure.
    

Detailed description: 
      To study whether particulates enhance the allergic response, we chose the upper airway as a
      model of allergic inflammation and nasal lavage as a non-invasive method for obtaining
      samples. The nasal cavity is both an excellent model of allergic inflammation and provides an
      easily accessible site for study. We measured inflammatory cells and cytokines in the nasal
      lavage fluid. Our specific hypothesis was that particulate exposure prior to allergen
      challenge would enhance inflammatory cell recruitment and expression of inflammatory
      cytokines.
    

Observational model: Natural History
Time perspective: Prospective
Keywords: Allergy; Air pollution; Lung function; Inflammation
Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons
Condition: Obesity, Morbid
MeSH terms: Callosities; Obesity, Morbid
Study type: Interventional

Summary: 
      Studies have confirmed the association between plantar callosities and severely obese
      individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for
      estimating body composition because it is easy to use, noninvasive, relatively inexpensive,
      and can be performed across a wide range of subjects.

      Our hypotheses for this study are: (1)plantar callosities influence the body composition
      measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates the
      percentage of body fat compared with air-displacement plethysmography (BodPod).
    

Detailed description: 
      As the prevalence of obesity continues to increase, many parts of the world are progressively
      facing a rise in the number of people who fall under WHO obesity class 2 and 3. Since severe
      obesity is characterized by large alterations in body compartments when compared to
      overweight or non-obese individuals, there is a need for the evaluation of the body
      composition of severely obese persons. There is very few published research available on what
      methods of body composition measurements can be used on this population.

      Other studies have also shown the tendency of bioelectrical impedance analysis (BIA)
      instruments to underestimate percentage of fat mass and overestimate the percentage of fat
      free nass, compared with gold-standard techniques. We think that plantar callosities might
      have contributed to the lack of accurate measurements. Thus, the primary aim of this study is
      to determine whether plantar callosities influence the validity of body composition
      measurements obtained by BIA, using the InBody 720. The secondary aim is to assess the
      validity of the body composition measurements obtained by BIA (InBody 720) in severely obese
      individuals, using air-displacement plethysmography (BodPod) as the gold standard.
      Additionally, we will explore various sources of error using test-retest reliabilities by
      measuring body composition with different arm postures. We will examine this further to rule
      out the possibility of "positions of measurement" as a potential confounder of this study.
    

Intervention name(s): Bioelectric impedance; Air displacement plethysmography
Intervention type(s): Device; Device
Intervention description(s): removal of calluses and corns by pedicure
Other intervention name(s): BIA; ADP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Body constitution; Anthropometry; Electric impedance
Amino Acid and Acylcarnitine Profiles in Premature Neonates
Condition: Prematurity; Neonatal Screening; Parenteral Nutrition
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Primary Hypotheses of the study include:

        -  Metabolic profiles are influenced by gestational age, chronological age, type and degree
           of nutritional support and illness

        -  Metabolic profiles differ between neonates who receive commercial formula and neonates
           who receive primarily human breast milk

        -  Neonates who develop parenteral associated cholestasis have metabolic markers that
           identify at risk patients (high serum urea nitrogen, citrulline, histidine, methionine,
           and succinyl carnitine and low thyroxine, serine and glutamate)

        -  Neonates that have hypothyroidism have abnormal metabolic profiles (low tyrosine levels)
    

Detailed description: 
      Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate
      that prematurely born neonates commonly develop a severe nutritional deficit during the first
      weeks after birth, referred to as extrauterine growth restriction. Despite an increase in
      growth during the second month of hospitalization, many neonates are ultimately discharged
      home having grown inadequately. The early nutritional deficit affects weight gain as well as
      growth in length and head circumference. Aggressive administration of parenteral amino acids
      to improve protein accretion rates in very preterm neonates has been supported in the
      literature. Although tolerance of high dose amino acids has been described, researchers
      acknowledge that sensitive tests to monitor amino acid toxicity are not readily available in
      the clinical setting.

      The goals of this study are:

        -  To better define normal amino acid and acylcarnitine values and how they change in
           premature neonates

        -  To measure the effect nutritional support has (human breastmilk vs. formula) on amino
           acid and acylcarnitines profiles

        -  To measure the effect of illness (parenteral nutrition associated cholestasis) on amino
           acid and acylcarnitine profiles

        -  To better define abnormal metabolic profiles (low tyrosine levels) in neonates that have
           hypothyroidism.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hospital
      
Keywords: Prematurity; Neonatal screening; Parenteral nutrition; Amino acids; Acylcarnitine
A Study to Evaluate the Absolute Bioavailability of Intranasal and Oral Esketamine and the Effects of Clarithromycin on the Pharmacokinetics of Intranasal Esketamine in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      esketamine administered by the intranasal (administered through the nose) and oral routes and
      to evaluate the effects of clarithromycin on the pharmacokinetics of intranasally
      administered esketamine.
    

Detailed description: 
      This is a single-center, 4-period, fixed-sequence, open-label study. The study consists of
      Screening Period (Days -21 to -2), Open-label Treatment Period 1, 2, 3, 4 and End of Study (9
      to 13 days after final dose or at Early Withdrawal). The total duration of study will be up
      to 98 days. For all 4 periods, the participants will be admitted into the study center on Day
      -1 of each treatment period and receive a 28 milligram (mg) (intravenous) or 84 mg (oral and
      intranasal) esketamine dose regimen on Day 1 of each period in a fixed sequence. Participants
      will also receive 500 mg of clarithromycin in period 4. Blood samples will be collected to
      evaluate the pharmacokinetic parameters. Participants' safety will be monitored throughout
      the study.
    

Intervention name(s): Esketamine; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): 28 mg of esketamine as a single, 40-minute, intravenous infusion on Day 1 of Period 1, 84 mg of esketamine solution as a single, oral dose on Day 1 of Period 2, 84 mg of intranasal esketamine on Day 1 of Period 3 and on Day 1 of Period 4.; 500 mg of clarithromycin twice daily on Days -3, -2, -1, 1, and 2 of Period 4.
Intervention MeSH terms: Clarithromycin; Esketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Pharmacokinetics; Esketamine; JNJ-54135419
Use of the Leva Incontinence System in Treating Bladder Incontinence.
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This open-label proof-of-concept study is designed to evaluate the impact of the leva digital
      incontinence system on the treatment of stress and mixed urinary incontinence in women over a
      six week period. Subjects will participate in a 2.5 minute exercise program twice daily
      (performed at a clinic with therapist assistance 5x weekly, and at home once daily on
      weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used
      to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed
      weekly to evaluate progress in muscle strengthening.
    


Intervention name(s): Leva Incontinence System For Pelvic Floor Muscle strengthening
Intervention type(s): Device
Intervention description(s): The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Female
Salvage Peanut Oral Immunotherapy Study
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this trial is to study the safety of rescue peanut oral immunotherapy followed
      by the introduction of dietary peanut for patients with peanut allergy who have lost
      desensitization during a peanut immunotherapy trial.
    

Detailed description: 
      Salvage Peanut Oral Immunotherapy Study is a single-arm, open label trial of peanut flour
      oral immunotherapy (OIT) administered for 6 months followed by introduction of dietary peanut
      for an additional 6 months.

      The peanut OIT phase will involve approximately 3 months of dose escalation up to a
      maintenance dose of 300 mg peanut protein. This is followed by 3 months of daily maintenance
      dosing with 300 mg of peanut protein. Patients are then transitioned to the dietary peanut
      phase ingesting common foods containing approximately 300 mg of peanut protein daily.

      Safety will be assessed during both peanut OIT and dietary peanut phases with adverse events
      recorded including gastrointestinal side effects. They will also be monitored for any
      anaphylaxis or injectable epinephrine administration. Data regarding compliance with peanut
      OIT will be collected as well.
    

Intervention name(s): Peanut OIT
Intervention type(s): Drug
Intervention description(s): Participants will be given increasing doses of the peanut flour as peanut oral immunotherapy (OIT) with increasing doses every 2 weeks over a period of 3 months up to a 300 mg target dose. This 300 mg peanut OIT maintenance dose is then continued daily for 3 months. Participants will then introduce dietary peanut of approximately 300 mg of peanut protein and continue daily ingestion for an additional 6 months.
Other intervention name(s): Peanut flour
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peanut
Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients
Condition: Gonarthrosis
MeSH terms: Osteoarthritis, Knee; Osteoarthritis
Study type: Interventional

Summary: 
      The management of knee osteoarthritis via a physical activity protocol for rehabilitation has
      convincing results. However, the effectiveness of these protocols could be improved with a
      connected instrumented knee brace with an exercise protocol adapted for the patient which is
      supervise by an online physiotherapist to check the progression during home-based
      rehabilitation.
    

Detailed description: 
      The management of knee osteoarthritis via physical activity protocol for rehabilitation has
      convincing results. The aim of this study is to determine the improvement of the
      effectiveness of a home-based rehabilitation with and without instrumented knee brace for
      moderated gonarthrosis patients.

      The study will focus during one years on 80 moderated gonarthrosis patients with a Kellgren
      and Lawrence (K&L) score between 2 and 3, aged between 50 and 80. Each patient will practice
      an 8 weeks progressive home exercise program with 3 session per weeks. The effectiveness of
      this protocol will be quantified with a gait analysis with kinematics, kinetics and
      electromyography, before and after the progressive home exercise protocol. The statistical
      analysis will focus on ANOVA and correlation between control group and instrumented knee
      brace group.
    

Intervention name(s): traditional rehabilitation protocol; with instrumented Orthosis
Intervention type(s): Device; Device
Intervention description(s): muscular strengthening protocol with traditional rehabilitation protocol without orthosis; 8 weeks of muscular strengthening with the orthosis connected to the phone app associated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effects of Quetiapine on Ultrastructural Hippocampal and Neurochemical Changes in Patients With Bipolar Disorder: Searching for Antidepressant and Mood Stabilising Neurophysiology
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The aim of the study was to determine the pharmacological induced equivalents of neurogenesis
      and synaptic sprouting in the hippocampus, localized volume changes, changes in water content
      and neurochemical changes in the medial temporal regions.
    

Detailed description: 
      Quetiapine is an antipsychotic that has mood stabilizing and antidepressant effects (Vieta,
      2005). Animal studies showed that the expression of neurotrophins and the subsequent
      modulation of the neuroplastic processes, including neurogenesis in the hippocampus, play a
      key role in the mechanism of mood stabilizing (Kim et al., 2004) and antidepressant
      (Santarelli et al., 2003). Since atypical antipsychotics also have antidepressant and mood
      stabilizing effect, it is hypothesized that the common mechanism of action in all three
      pharmacological classes is neurogenesis and synaptic sprouting in the hippocampal region.
      Thus, the aim of this study was to test this hypothesis.

      Quetiapine was associated with antidepressant and mood stabilizing effects in patients with
      bipolar disorder (Vieta, 2005). The evidence based on animal studies shows that
      administration of quetiapine attenuates the decrease in levels of brain-derived neurotrophic
      factor in the hippocampi. This may explain the improved cognitive symptoms in patients with
      schizophrenia and depression (Luo et al., 2005, Park et al, 2006).

      The aim of the study was to determine the pharmacological induced equivalents of neurogenesis
      and synaptic sprouting in the hippocampus, localized volume changes, changes in water content
      and neurochemical changes in the medial temporal regions.
    

Intervention name(s): Seroquel
Intervention type(s): Drug
Intervention description(s): for 4 weeks, 300 - 800 mg per day in 2 doses
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diffusion Tensor Imaging,; quetiapine; Bipolar Disorder; hippocampus; Volume Brain Morphometry; Magnetic Resonance Spectroscopy; effect of quetiapine on hippocampal neurogenesis