bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)
Condition: Complication, Postoperative; Regeneration Liver
MeSH terms: Postoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, we aim to analyse the effect of phosphate supplementation on donors undergoing
      partial hepatectomy for LDLT. In Group A, we are going to supplement phosphate in donors
      postoperatively from day 1 to day 5. We will analyse the trend of serum phosphate levels in
      donors postoperatively, its correlation with occurrence of postoperative complications and
      status of liver regeneration by CT volumetry on Day 7. Group B will constitute the controls
      for the study and hence attempt to find out the effect of phosphate supplementation in all
      donors postoperatively. We will analyse the data and elucidate the value of phosphate
      supplementation in reducing the occurrence of complications and effect on liver regeneration
      in donors in LDLT.
    


Intervention name(s): Potassium Phosphate Injection
Intervention type(s): Drug
Intervention description(s): One ml of the preparation contains 3 mmol of phosphorous which when equated with RDA 10ml ie 30 mmol of preparation will be supplemented. The preparation is given slowly, intravenously over 4 hours diluted in 500 ml normal saline
Intervention MeSH terms: Potassium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis
Condition: Alveolar Osteitis
MeSH terms: Osteitis; Dry Socket
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficacy of CGF and Ozone in the treatment of
      alveolitis and to develop a new treatment protocol that can enable a quick and effective
      solution of this clinical problem, which significantly affects patients' comfort of life.
    

Detailed description: 
      In the present study, 60 healthy patients > 18 years old and have alveolitis, will included.
      60 patient will divided randomly into three groups as Control, Ozone and Ozone+CGF. After
      irrigation of the sockets alvogyl, ozone and ozone+CGF will applied to the sockets
      respectively. Post operative pain, will measured at 1st to 7th days. Post operative
      infection, and granulation tissue will measured at 1st, 3rd and 7th days. Oral hygiene will
      evaluated at first visit. Quality of life will evaluated at 7th day.
    

Intervention name(s): Ozone; CGF; Traditional treatment
Intervention type(s): Device; Other; Other
Intervention description(s): topical gaseous ozone application; concentrated growth factor (CGF) application; Alvogyl application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alveolitis; Dry socket; Ozone; CGF
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
Condition: Urinary Incontinence; Overactive Bladder With Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in
      participants with overactive bladder and urinary incontinence.
    


Intervention name(s): OnabotulinumtoxinA and Hydrogel admixture; Placebo and Hydrogel admixture
Intervention type(s): Drug; Drug
Intervention description(s): BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation; Placebo and Hydrogel admixture administered as a single intravesical instillation
Other intervention name(s): BOTOX®; Botulinum Toxin Type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of the Consumption of a Supplement Rich in Docosahexaenoic Acid (DHA) From Algae
Condition: Vegetarian Diet
Study type: Interventional

Summary: 
      Vegetarian diets are increasing worldwide. To prevent nutritional deficiencies,
      supplementation with nutrients that are only present in animal food can be needed. In
      relation to fatty acids, vegetarian diets involve low intake of omega-3 polyunsaturated fatty
      acids (n-3 PUFA) and low blood levels of the long-chain n-3 derivatives, whose main dietary
      sources are fish and shellfish, particularly the levels of docosahexaenoic acid (DHA), which
      has important health benefits, are low.

      In this regard, validation of supplements rich in the n-3 fatty acid DHA that are not
      obtained from fish is needed, thus the study will test the bioavailability and metabolic
      effects of a DHA supplement form algae.

      The study will be conducted on the effects of the DHA supplement versus placebo in vegetarian
      and non-vegetarian healthy adults.
    


Intervention name(s): Dietary supplement, DHA or Placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Consumption of 2 capsules per day of the dietary supplement, DHA or Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Vegetarian diets; Plant-based diets; Vegetarians; Vegans; docosahexaenoic acid; DHA; omega-3 fatty acids; algae; supplementation
Peripheral Vascular Function in Obstructive Sleep Apnoea
Condition: Obstructive Sleep Apnoea; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Peripheral vascular function is impaired in people with obstructive sleep apnoea who are
      untreated compared with age-, weight- and sex-matched healthy controls.
    

Detailed description: 
      Obstructive sleep apnoea (OSA) is a chronic respiratory disorder associated with endothelial
      dysfunction, increased sympathetic activation and increased cardiovascular risk. The standard
      treatment paradigm is continuous positive airway pressure (CPAP), however, patient adherence
      to CPAP is variable. It is unclear to what extent that poor adherence to CPAP therapy
      augments vascular endothelial function and reduces cardiovascular risk compared to excellent
      adherence. The main aim of this research is to investigate vascular endothelial function in
      OSA patients who are poorly-adherent to CPAP therapy. Nitric oxide (NO)-mediated,
      endothelium-dependent macrovascular and microvascular function (by brachial artery
      flow-mediated dilatation and forearm cutaneous thermal hyperaemia, respectively) and
      generalised microvascular function (by post-occlusion reactive hyperaemia) will be assessed
      in three obese OSA patient populations (high-adherence (n=20); low adherence (n=20); and,
      untreated (n=20)) and age-/BMI-matched OSA-free controls. We will also assess body
      composition, cardiovascular risk, lipid status and functional capacity. This research will
      evaluate treatment efficacy in patients who are poorly-adherent to CPAP treatment and could
      identify whether an alternative approach to their care should be explored.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients and controls living in and around Sheffield, UK
Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women
Condition: Insomniac Postmenopausal Women
Study type: Interventional
Phase: Phase 3

Summary: 
      1. Sex hormone including estrogen have synergistic effect to serotonin activity and
           decrease activity of monoamine oxidase activity so the norepinephrine is not be
           metabolized, these substance are important to regulate hemostasis and circadian process
           of sleep

        2. Estrogen also regulate gamma-aminobutyric acid (GABA) secretion

             -  GABA substance is in order to initiate sleep and continue sleep

        3. According to epidemiologic data, problem of sleep was increasing in postmenopause group
           compare to premenopause group (aged-match)

        4. This research perform to find out the actual effect of estrogen in improving sleep
           quality.
    

Detailed description: 
      1. 40-60 year-old postmenopausal women with insomnia and mild-moderate vasomotor symptom
           were screened and included in project

        2. Block of four randomization was use to categorize participants into 2 groups

             -  Study group (estrogen patch)

             -  Control group (placebo patch)

        3. Sleep quality was measured before intervention by subjective and objective sleep quality

             -  Subjective sleep quality (self sleep questionnaire)

             -  Objective sleep quality (wrist actigraphy and sleep diary):

           wrist actigraph sleep test at home for 1 week

        4. Intervention phase : continuous use of weekly patch for 8 weeks

             -  Estrogen patch in study group

             -  Placebo patch in control group

        5. Follow up phase

             -  At 4 weeks of use, investigator will telephone call for follow up the participant's
                compliance and the side effects during patch use.

             -  After completed use of 7th patch, sleep quality was measured again, self sleep
                quality questionnaire and 1 week-wrist actigraphy and sleep diary test

        6. Then the data will be analysed and open label, in nonhysterectomized postmenopausal
           women in study group will take the medroxyprogesterone acetate for washing out the
           endometrium for 2 weeks

        7. The participants will be counseled, further investigate and proper treatment.
    

Intervention name(s): Estrogen patch; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 microgram estrogen patch weekly; Placebo patch for 8 weeks
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: postmenopause; sleep quality; estrogen; objective sleep quality; actigraph
A Double-Blind, Randomized, Placebo Controlled, Clinical Trial of an Antiplaque Chewing Gum (30 mg) - Phase 2 Proof of Concept in a Generally Healthy Patient Population
Condition: Plaque Regrowth
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase 2 two-armed placebo-controlled, double-blind, randomized (1:1),
      multiple dose, single center study to evaluate the safety and proof of concept in a chewing
      gum formulation 3 times per day over 4 treatment days.
    


Intervention name(s): KSL-W; Chewing Gum Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Plaque reducing gum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      Hydrolysis of dietary protein may impact their gastrointestinal kinetics and further
      metabolism. The primary goal of this work was to measure the metabolic fate of intact or
      hydrolyzed protein using a protein of good nutritional quality, i.e., casein. A second aim of
      this study was to assess the true ileal digestibility of dietary protein using different
      methods including the hydrolyzed casein method and to measure its possible effect on
      endogenous intestinal N losses in humans.
    


Intervention name(s): Intestinal and metabolic exploration; 15N-labelled intact casein; 15N-labelled hydrolyzed casein; mixture of AA
Intervention type(s): Other; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects are studied for 8h following the ingestion of a standard meal containing 15% of energy as protein. Intestinal, blood and urine are collected at regular intervals.; standard mixed meal containing 15% of energy as 15N-labelled intact casein; standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein; standard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy
Condition: Atunomic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Hereditary Sensory and Autonomic Neuropathies
Study type: Interventional

Summary: 
      This project comprises three sets of physiological studies - testing eight specific
      hypotheses - that will contribute new knowledge on proprioception and motor control in a
      genetic disorder that affects specific components of the sensory nervous system.

      I: To investigate the neurophysiological basis for disturbed motor control in Hereditary
      sensory and autonomic neuropathy (HSAN) III II: To investigate the effects of enhancing
      cutaneous feedback on motor control in HSAN III III: To investigate the cortical
      representation of proprioceptive inputs in HSAN III
    

Detailed description: 
      HSAN III patients (n=15) and healthy control subjects (n=15) will lay supine on an MRI bed
      and a tungsten microelectrode inserted percutaneously into a muscle or cutaneous fascicle of
      the right common peroneal nerve at the fibular head, according to standard techniques
      employed by Prof Macefield. Neural activity will be acquired, RMS-processed (200 ms) and
      analysed on computer. The subject's head will be tightly enclosed in a standard clinical
      32-channel SENSE head coil and headphones will be provided to minimize noise and to allow
      communication with the subject. The subject will be placed in the bore of a 3T whole-body
      scanner for 60-90 minutes.
    

Intervention name(s): kinesiology tape around the hip, knee and ankle joints; No kinesiology tape around the hip, knee and ankle joints
Intervention type(s): Other; Other
Intervention description(s): We will also demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III.; Investigators will demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hereditary Sensory Neuropathy; Autonomic Neuropathy; Familial Dysautonomia; proprioception; motor control; sensory nervous system.; HSAN III; IKBKAP gene mutation
Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to assess the immunogenicity, reactogenicity and safety following
      vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been
      vaccinated with two doses of Pandemrix at the age of 6 months-9 years.
    


Intervention name(s): Fluarix™; Havrix™ Junior
Intervention type(s): Biological; Biological
Intervention description(s): One or two intramuscular injections; Two intramuscular injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; H1N1; Fluarix; Pandemrix
Efficacy Of A PVP-I Fluoride Varnish
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish.
      Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
      Subjects will be stratified by early childhood education center and then randomized to
      receive either test varnish or control varnish topically to the teeth. Treatment will be
      administered quarterly for up to 24 months. The primary outcome is surface-level primary
      molar caries increment (d2-4mfs) at 24- months post baseline.
    

Detailed description: 
      Objectives:

      Primary

      - To determine if Advantage Anti-Caries Varnish (test varnish) is superior to a control
      varnish containing only fluoride in the prevention of new caries lesions.

      Secondary

        -  To establish that the response of child participants to the test varnish was not
           inferior to the control varnish
    

Intervention name(s): Test varnish; Standard varnish
Intervention type(s): Drug; Drug
Intervention description(s): Topical application of test varnish to the teeth 4 times per year.; Topical application of test varnish to the teeth 4 times per year
Other intervention name(s): sodium fluoride varnish
Intervention MeSH terms: Fluorides; Sodium Fluoride; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sodium fluoride; povidone iodine; varnish
Serious Game On Stoma Care Education For Nursing Students
Condition: Surgical Stoma; Nursing; Video Games
Study type: Interventional

Summary: 
      Today, rapidly developing technology needs to be integrated into teaching environments and
      reconstructed teaching environments. When virtual reality applications, which are among the
      popular and innovative technologies, are examined, it is seen that participants are used in
      many areas of education. In this randomized controlled study, it was aimed to evaluate the
      impact of stoma care education by designing a serious game based web application that enables
      nursing students to gain skills and practice in psychomotor applications. The universe of the
      study will be students enrolled in the Surgical Diseases Nursing course in the spring
      semester of the 2020-2021 academic year at the Faculty of Health Sciences, Gümüşhane
      University. Students will be divided into two groups as control and experiment by
      randomization method. The data will be collected through introductory features form, 'Stoma
      Care Information Form', 'Stoma Care Skill Checklist' and Computer System Usability Survey. In
      the first stage of the study, the students will be given a 'Stoma Care Information Form'
      (first knowledge). 'Stoma Care Information Form' (second information) and 'Stoma Care Skill
      Checklist' will be applied after completing the theoretical lesson of stoma care and group
      work in the laboratory of students in the experimental and control groups. Unlike the control
      group, of students in the experimental group; A serious game-based web application on stoma
      care prepared as a support for formal education will be installed. After four weeks of the
      students attending formal education, 'Stoma Care Information Form' (third knowledge) and
      'Stoma Care Skill Checklist' (second skill) will be applied. In the experiment and control
      group, two weeks later, the "Stoma Care Information Form" (fourth information) and "Stoma
      Care Skill Checklist" (third skill) will be applied again to test the permanence of the
      methods. Skill measurements of students will be made with an objective structured clinical
      exam. The results obtained after the application will be analyzed and the impact of serious
      game based web application on stoma care education will be determined
    


Intervention name(s): serious game based web application education
Intervention type(s): Behavioral
Intervention description(s): serious game based web application education for nursing students
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Education; Nursing; Student; Surgical stoma; Video games
Massage for Pain Relief During the Active Phase of Labor
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this research is to evaluate the effect of massage therapy as a resource for
      pain relief during the active phase of labor. The research will be of type randomized
      controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral
      Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups
      (lumbosacral massage) and control (routine maternity) and will be assessed before and after
      therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation
      will be performed by numerical category scale, Diagram Location of Pain and Pain
      Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction
      questionnaire.
    

Detailed description: 
      The pain in labor appears as a subjective experience, individual interaction involving a
      broad physiological, psychosocial and environmental influences, representing one of the main
      clinical signs of this phase. Despite presenting an important biological function, is today
      well established the need for their relief, since its persistence is associated with harmful
      effects on mother and fetus. Among the available non-pharmacological resources, we highlight
      the massage therapy that has shown positive effects in relieving pain and promoting the
      comfort of the mother. The objective of this research is to evaluate the effect of massage
      therapy as a resource for pain relief during the active phase of labor. The research will be
      of type randomized controlled trial, consisting of low-risk nulliparous pregnant women
      admitted to the Referral Center for Women's Health in Ribeirão Preto. The mothers will be
      distributed in two groups (lumbosacral massage) and control (routine maternity) and will be
      assessed before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical
      dilation. The evaluation will be performed by numerical category scale, Diagram Location of
      Pain and Pain Questionnaire McGll (reduced form). After delivery will apply a customer
      satisfaction questionnaire. After collecting the data, the groups are statistically analyzed
      using the linear regression model with mixed effects (fixed and random), taking into account
      a value of p <0.05 to obtain the statistical significance of 5%.
    

Intervention name(s): Lumbosacral Massage
Intervention type(s): Other
Intervention description(s): Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: labor; pain; massage