bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Skit Video to Improve Oral Hygiene Status of Children With Hearing Impairment
Condition: Hearing Impaired Children
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      Introduction: Oral health is considered as a vital component of overall health and its
      importance in children may not be disregarded. In children with hearing impairment,
      communication barriers may hamper their understanding of oral hygiene practices, making them
      particularly vulnerable to dental problems. Objective: The objective of this study was to
      compare effectiveness of skit video, pictorial and sign language interventions to improve
      oral hygiene status of children with hearing impairment. Methods: Sixty children were
      completed the study and allocated randomly into each group with twenty children as follows:
      group A: Skit video, group B: Pictorial, and group C: Sign language. Mean gingival and OHI
      scores were recorded before and after implementation of interventions. Oral hygiene habits,
      oral hygiene and gingival index scores were recorded by structured questionnaire.
    


Intervention name(s): Skit video, Pictorial, Sign language
Intervention type(s): Behavioral
Intervention description(s): Three oral health educational intervention groups, group A (skit video), group B (pictorial) and group C (sign language) by using Sequentially Numbered Sealed Opaque Envelopes (SNOSE). Children picked a sealed envelope randomly and assigned to oral health education intervention group A, B and C. Participants in group A were assigned a skit video method of oral hygiene intervention and shown 5 minute video on what to eat and how to brush their teeth. The video included that what is good and bad for teeth, and how to brush which includes method, time and duration of tooth brushing. Participants assigned to group B and C was provided same instructions for tooth brushing and eating habits in the form of pictures and sign language respectively. The children of Group A received instructions in the form of laminated cards and asked to take with them at home. Participants in group C were received instructions in sign language in the presence of teacher.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Selenium and Immune Function
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to investigate the relationship between dose and form of selenium on
      immune function, and to identify functional markers of selenium status.
    

Detailed description: 
      One of the proposed consequences of marginal selenium status is impaired immune function.
      Establishing the potential role of selenium as an enhancer of immune response in vivo may
      provide evidence-base for public health policy, with important consequences for preventing
      influenza and similar diseases in the elderly.

      The project consists of a placebo controlled selenium supplementation study and a dietary
      intervention with un-enriched and selenium enriched onions. In a parallel group design,
      subjects will be given either one of three doses of Selenomethionine (50, 100 or 200µg
      selenium/day) or a placebo per day or selenium enriched or un-enriched onions (in the form of
      test meals) for 12 weeks. Changes in the expression of Se-responsive genes and proteins in
      blood will be measured and compared with changes in plasma Se concentration and selected
      selenoproteins. The relationship between dietary Se intake and systemic and mucosal immune
      responses to influenza vaccine will be examined. Changes in immune cell populations and the
      influence of Se on NK and CD8 cytotoxicity will be determined by flow cytometry.
    

Intervention name(s): 50ug selenium enriched yeast; 100ug selenium enriched yeast; 200ug selenium enriched yeast; Control onion; Enriched onion; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Selenomethionine supplement (50ug/d Se) for 12 weeks; Selenomethionine supplement (100ug/d Se) for 12 weeks; Selenomethionine supplement (200ug/d Se) for 12 weeks; 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks; 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks; Placebo supplement for 12 weeks
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Immune response; Selenomethionine; Selenium enriched foods; Selenium status; Selenium biomarkers
Oxygen Concentration During Alveolar Recruitment
Condition: Atelectasis, Postoperative Pulmonary
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of oxygen concentration during
      alveolar recruitment on absorption ateletasis.
    


Intervention name(s): FiO2_1.0; FiO2_0.4
Intervention type(s): Procedure; Procedure
Intervention description(s): Alveolar recruitment is performed with 100% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.; Alveolar recruitment is performed with 40% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Absorption atelectasis; Lung sono; Oxygen concentration
The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of oxandrolone on the function and
      quality of life of patients with chronic spinal cord injury.
    

Detailed description: 
      Spinal cord injury results in significant loss of muscle mass. Oxandrolone, a derivative of
      testosterone, is an anabolic steroid shown to promote gain in body weight and muscle mass
      after trauma, severe illness, surgery, burns, and stress. To date there are no studies that
      have evaluated the effect of oxandrolone in persons with chronic spinal cord injury. This
      study will assess the effect of oxandrolone on strength, metabolic rate, lean body mass,
      pulmonary function, and ambulation in persons with chronic SCI. This study has the potential
      to yield valuable information concerning the use of oxandrolone after SCI.
    

Intervention name(s): Oxandrolone
Intervention type(s): Drug
Intervention MeSH terms: Oxandrolone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: oxandrolone; oxandrin; lean body mass; functional recovery; resistance training
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
Condition: Foramen Ovale, Patent; Migraine
MeSH terms: Migraine Disorders; Foramen Ovale, Patent
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate effectiveness and safety of transcatheter patent
      foramen ovale closure for migraine.
    


Intervention name(s): transcatheter patent foreman ovale closure
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Foramen Ovale, Patent; migraine; transcatheter patent foramen ovale closure; contrast-enhanced transcranial Doppler; Transthoracic Echocardiography
Effects of Ozone Therapy as an Adjunct to Periodontal Treatment
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      This randomized, placebo controlled, split-mouth clinical study trial evaluates the effects
      of Ozone therapy on clinical and biochemical parameters. Total of 20 participants completed
      the study . Periodontal parameters were evaluated at baseline and 3 months following
      periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was
      applied into periodontal pockets. Gingival crevicular fluid pentraxin-3 (PTX-3),
      interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.
    

Detailed description: 
      Ozone therapy (OT) is very popular in medicine. Especially it use for wound healing and
      antibacterial properties. This randomized, placebo controlled, randomized split-mouth
      clinical study evaluates the effects of ozone therapy on clinical and biochemical parameters.
      Total of 20 participants completed the study (10 males, 10 females). Periodontal parameters,
      including plaque index (PI), gingival index (GI), probing depth (PD), percentage of bleeding
      on probing, percentage of pockets deeper than 5 mm and clinical attachment level (CAL), and
      percentage of ≥3 mm clinical attachment level. Periodontal parameters were evaluated at
      baseline and 3 months following periodontal therapy. All participants were treated
      non-surgically. Topical gaseous ozone was applied into periodontal pockets twice a week for 2
      weeks during active periodontal therapy. Gingival crevicular fluid pentraxin-3 (PTX-3),
      interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.
    

Intervention name(s): Ozone application with the Ozonytron XL device
Intervention type(s): Device
Intervention description(s): An ozone generator (Ozonytron; Bionix, Munchen, Germany) with an KPX probe (CA Probe; Ozonytron, Bionix, Munchen, Germany) was used for OT. Topical gaseous ozone was applied into the periodontal pocket twice a week for 2 weeks based on the manufacturer's instructions. Ozone applications were at 75% power for 30 seconds (75 µg/ml). Ozone applications were performed by an experienced investigator. Ozone applications in the control side were simulated without starting the ozone generator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study the investigators select the split mouth study design to eleminate host effects on healing.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth
      Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed
      conditions.
    

Detailed description: 
      This was an open-label, randomized, fully replicated crossover, 2-sequence bioequivalence
      study under fed conditions.
    

Intervention name(s): Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
Intervention type(s): Drug
Intervention description(s): Single dose crossover BE study
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Single dose crossover BE study
Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain Injured Patients.
Condition: Severe Brain Injury
MeSH terms: Brain Injuries
Study type: Observational

Summary: 
      Severe brain-injured patients require prolonged mechanical ventilation. Weaning these
      patients from mechanical ventilation is challenging. During neurologic recovery, brain
      injured patients usually present satisfactory respiratory autonomy. However, the exact timing
      of extubation is unknown and is frequently delayed because of potential inhalation.

      To date, there are no clinical signs available in the current literature that can help the
      attending physician in the decision-making process of extubation in brain-injured-patients
    


Intervention name(s): Collection of medical data from ICU patients
Intervention type(s): Other
Intervention description(s): A code will be applied to each patient included. Medical data such as demography, ISS, clinical exam at time of extubation, extubation failure, tracheotomy, will be collected during ICU stay.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients hospitalized in ICU for severe brain injury
      
Keywords: brain-injury; extubation
Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations
Condition: Healthy Smokers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetic profile of nicotine following a
      single oral administration of three new nicotine lozenge formulations (V0474) in comparison
      with two reference products. The clinical and biological safety of V0474 and the lozenge
      acceptability will also be assessed.
    


Intervention name(s): V0474 - A mg; V0474 - B mg; V0474 - C mg; V0018 - B mg; Niquitin® Fresh Mint 4 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral administration; Single oral administration; Single oral administration; Single oral administration; Single oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Nicotine; Tobacco Use Disorder; Central Nervous System Agents
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected
      individuals without prior antiviral treatment, and to investigate the pharmacokinetic
      characteristics of infected patients.
    


Intervention name(s): Lipovirtide Injection
Intervention type(s): Drug
Intervention description(s): Single dosage of Lipovirtide Injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Dry Needling in Shortened Triceps Surae Muscle
Condition: Trigger Point Pain, Myofascial; Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome
Study type: Interventional

Summary: 
      To date, there are not studies about the effectiveness of dry needling versus ischemic
      compression in the triceps surae trigger points. A randomized clinical trial is carried out.
      A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic
      compression (n = 15). Outcome measurements such as dorsal flexion range of motion, plantar
      pressures, temperature, superficial muscle activity and trigger points pressure pain
      threshold are measured immediately before and after treatment.
    


Intervention name(s): Dry needling; Ischemic compression
Intervention type(s): Other; Other
Intervention description(s): Trigger point deep dry needling; Trigger point ischemic compression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Scleral Self-indentation Chandelier-assisted Peripheral Vitrectomy Under Air Rhegmatogenous Retinal Detachment.
Condition: Retinal Detachment
MeSH terms: Retinal Detachment; Dissociative Disorders
Study type: Observational

Summary: 
      The investigators compared the incidence of trimming-induced retinal breaks, retinal
      redetachment rate, and final LogMAR BCVA; between scleral self-indentation and
      non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with
      primary retinal detachment. Self-indentation enables complete trimming of the vitreous base
      without causing iatrogenic retinal breaks, with a higher retinal reattachment rate, and with
      less need for chandelier shift than with non-indentation approach.
    

Detailed description: 
      Retrospective cohort study. One hundred and thirty eyes of 130 participants with primary
      rhegmatogenous retinal detachment were identified. All the participants had undergone a
      chandelier-assisted peripheral vitrectomy under air. Scleral self-indentation had been used
      in 68 eyes (study group) (Indentation group), while non-indentation had been used in 62 eyes
      (comparison group) (Non-indentation group). Outcome variables included: Trimming-induced
      retinal breaks (TIRB), retinal redetachment rate, final LogMAR BCVA, and intraoperative
      complications.
    

Intervention name(s): chandelier-assisted peripheral vitrectomy under air
Intervention type(s): Procedure
Intervention description(s): chandelier-assisted peripheral vitrectomy under air for management of peripheral vitreous during RD vitrectomy; whether using indentation or non-indentation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a retrospective cohort study that was done on eyes (participants) with
        rhegmatogenous retinal detachment (RRD) for whom chandelier-assisted peripheral vitrectomy
        under air (CPVA) had been performed; whether using scleral self-indentation (Exposure), or
        without scleral self-indentation (control)
      
Keywords: scleral indentation; chandelier light; air vitrectomy; rhegmatogenous retinal detachment
Comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone Levels Pre-post Omentectomy
Condition: Gynecologic Cancer
Study type: Interventional

Summary: 
      Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in
      treatment of gynecological malignancy especially ovarian cancer and some advanced stage
      endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
      secrete from adipose tissue. These regulate matabolic process.

      We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin,
      Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with
      gynecological malignancy performed omentectomy or not
    

Detailed description: 
      Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in
      treatment of gynecological malignancy especially ovarian cancer and some advanced stage
      endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
      secrete from adipose tissue. These regulate matabolic process.

      We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin,
      Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with
      gynecological malignancy performed omentectomy or not. Blood sample will study after 4000 rpm
      centrifugal for 10 minutes
    

Intervention name(s): Preoperative level
Intervention type(s): Other
Intervention description(s): Blood sample
Other intervention name(s): Postoperative level
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an
      efficacious malaria vaccine that is deliverable through the existing system, the Expanded
      Program on Immunization (EPI) of WHO. This study has been designed to:

        -  Investigate the safety and immunogenicity of 7 infant immunization schedules of the
           experimental malaria vaccine integrated with an EPI regimen.

        -  Investigate how to maximize the antibody response to the experimental malaria vaccine.
    


Intervention name(s): GSK Biological's Investigational Malaria Vaccine 257049; Engerix-B; Tritanrix HepB Hib; BCG; OPV; Rouvax
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age; 1 dose, intramuscular route: left antero-lateral thigh at birth (=< 7 days of age); 3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age; 1 dose, intradermal route, in shoulder at birth (=< 7 days of age); 4 doses, orally, at birth (=< 7 days of age) and at 6, 10 and 14 weeks of age; 1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
Other intervention name(s): GSK257049; RTS; S/AS01E; HBV; DTPwHepB/Hib; Bacille Calmette Guerin tuberculosis vaccine; Polio Sabin; Measles; measles vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Africa; malaria vaccine; schedule; EPI; Plasmodium falciparum
Ultrasound Guided Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction (ACL)
Condition: Anterior Cruciate Ligament; Surgery
Study type: Interventional

Summary: 
      Anterior Cruciate Ligament ACL reconstruction can be performed under the combination of
      posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same
      outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks.
      More specifically under the combination of sciatic nerve block plus femoral nerve block plus
      obturator nerve block.
    


Intervention name(s): Sciatic, femoral, obturator nerve blocks; Sciatic nerve block, posterior lumbar plexus block
Intervention type(s): Other; Other
Intervention description(s): Ultrasound guided blocks with ropivacaine; Ultrasound and neurostimulator nerve blocks with ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: anterior cruciate ligament reconstruction; obturator nerve block; sciatic nerve block; femoral nerve block; posterior lumbar plexus block; ultrasound guided nerve block