bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Performance of Glass Ionomer Versus Resin Composite Restorations
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical
      trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and
      nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in
      patients at risk for salivary contamination.
    

Detailed description: 
      Occlusal carious lesions on the right and left mandibular second molars of 56 patients (26
      females, 30 males) were restored in a split-mouth design. A high-viscosity glass ionomer
      (Hv-GIC) (Equia, GC) was used to restore the carious lesions in patients in the treatment
      group, while a nano-hybrid composite resin (GSO) (GrandioSO, Voco) was used for patients in
      the control group. Clinical evaluations of the restorations were performed at 1-week,
      6-month, 1-year, and 2-year follow-up appointments, according to the FDI criteria. Data were
      analysed using the Friedman's analysis of variance and Mann-Whitney U tests (α=0.05).
    

Intervention name(s): dental restoration
Intervention type(s): Other
Intervention description(s): Restoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One of the Glass ionomer restorative or Resin composite restorative materials were applied to carious mandibular 2nd molar teeth.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: restorative glass ionomer
Bi-Polar Radio-Frequency and Electrical Muscle Stimulation for Symptoms of Mixed Urinary Incontinence (MUI)
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The objective of this trial is to evaluate the safety and efficacy of the combined FormaV and
      VTone Applicators for Symptoms of Mixed Urinary Incontinence.

      Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone
      Applicators according to the study protocol.

      The subject will return for 3 follow-up visits: 4 weeks (1M FU), 3 months follow up (3M FU),
      6 months follow up (6M FU) after the treatment.
    


Intervention name(s): FormaV and VTone
Intervention type(s): Device
Intervention description(s): Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy
Condition: Late Second Trimester Termination of Pregnancy
Study type: Interventional
Phase: Phase 2

Summary: 
      Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second
      Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections
    

Detailed description: 
      this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus
      Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple
      Cesarean Sections to assess safety and efficacy of theses methods.
    

Intervention name(s): MisoprostoL; Foley Catheter
Intervention type(s): Drug; Device
Intervention description(s): Vaginal MisoprostoL; Misoprostol Plus Foley Catheter
Other intervention name(s): CYTOTEC
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fatty Acid Levels and Memory in Breastfed Children
Condition: Cognitive Development
Study type: Observational

Summary: 
      Purpose: To explore the relation between breastmilk nutrients and the cognitive abilities of
      breastfed infants.

      Phase 1: Near 3 months of age child and mother saliva samples for DNA obtained with breast
      milk sample.

      Phase 2: At 6 months of age child participates in electrophysiology session to test
      recognition memory.

      Phase 3: At 26 or 38 months of age, children will complete behavioral, dietary, and physical
      assessments.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breastfeeding infants and their mothers
      
Biospecimen description: 
      saliva, blood
    
Keywords: Fatty acids; Breast milk nutrients; Cognitive development; Electrophysiology; Long-term assessment
Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim of this study is to estimate the effect of Kinesio tape (KT) combined with supervised
      exercise programs compared to exercise alone on pain, lumbar range of motion, and
      self-reported disability of adults with mechanical low back pain (LBP).

      Methods: This was a randomized, controlled clinical trial carried out on 60 individuals with
      mechanical LBP. Participants were randomly assigned to the control group (n=30) that received
      McKenzie exercises for 7 days or experimental group (n=30) that received KT application in
      addition to McKenzie exercises for 7 days. Pain measured by visual analogue scale, lumbar
      range of motion, and the disability measured by Oswestry Disability Index (ODI) were used as
      outcome measures. Pre and Post measurements were taken at baseline and after 7 days.
    


Intervention name(s): McKenzie Exercises; Kinesio Tape Application
Intervention type(s): Other; Other
Intervention description(s): McKenzie exercises: The McKenzie set consists of 5 exercises.
Prone-lying
Prone-extension
Prone press ups
Progressive extension with pillows
Standing extension; Kinesio Tape (KT) application: Participants in the experimental group received additional taping using KT by an experience therapist with prior training in KT application. The tape was applied using the method proposed for the sacrospinalis muscle (Kase, 1996). Y-shaped tape was applied as shown in Figure 1. While the participant was in standing position, the origin of the Y-shaped tape was attached over the centre of the sacrum without stretching the tape and afterward subjects gradually bent forward. A 5-degree angle was maintained within the valley of the Y tape. The tape was changed on the fourth day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Comparing Blood Levels of Fatty Acids After Consuming Two Forms of Cod Liver Oil
Condition: Growth and Development
Study type: Interventional

Summary: 
      This study is designed to compare the incremental area under the curve from 0 to 24h
      (iAUC0-24h) of plasma levels of n-3 fatty acids (sum of total and free eicosapentaenoic acid
      (EPA) and docosahexaenoic acid (DHA)) after ingestion of an emulsified product and a
      non-emulsified reference control of free flowing cod liver oil at the lowest appropriate dose
      that is practically acceptable, and as near as possible to the test products' recommended
      daily dose.
    

Detailed description: 
      Many dietary lipids are in the form of triglycerides, ethyl esters or phospholipids. During
      digestion these lipids are subject to hydrolysis, in particular by pancreatic triglyceride
      lipase. To facilitate the action of the enzyme, lipids are emulsified by the action of bile
      salts. By increasing the surface area of the fat globules, emulsification increases access to
      the lipids by pancreatic triglyceride lipase. This study is designed to compare iAUC0-24h of
      plasma levels of n-3 fatty acids (sum of total and free EPA and DHA) after ingestion of an
      emulsified product and a non-emulsified reference control of free flowing cod liver oil at
      the lowest appropriate dose that is practically acceptable, and as near as possible to the
      test products' recommended daily dose.
    

Intervention name(s): Emulsified cod liver oil product; Non-emulsified cod liver oil product
Intervention type(s): Other; Other
Intervention description(s): Participants are required to consume the dose (30 mL) within 1 min, followed by up to 300 mL of apple juice which needs to be consumed within 2 min; Participants are required to consume the dose (5.8 mL) within 1 min, followed by up to 300 mL of apple juice which needs to be consumed within 2 min
Intervention MeSH terms: Cod Liver Oil; Liver Extracts
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalency Study of Ibuprofen 200 mg and Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg +
      Pseudoephedrine HCL 30 mg under fasting conditions.
    

Detailed description: 
      This study assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets
      of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare in healthy
      human adult subjects with the single oral administration under fasting conditions with a
      washout period of 7 days.
    

Intervention name(s): Ibuprofen + Pseudoephedrine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Ibuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets
Other intervention name(s): Advil® Cold and Sinus
Intervention MeSH terms: Ibuprofen; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Ibuprofen and Pseudoephedrine
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
Condition: Bottle Feeding
Study type: Interventional

Summary: 
      -  The primary objective of the study was to compare stool composition (stool soap and
           non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of
           infants randomized to receive either standard formula, or 1 of 2 innovative formulas
           containing a new fat blend or the new fat blend plus fiber.

        -  The secondary objectives were to evaluate among the feeding groups, stool
           characteristics (stool consistency and frequency), GI tolerance assessed by the Infant
           Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and
           8-hydroxy-2'-deoxyguanosine [8-OHdG], and urine osmolality and specific gravity).

        -  The primary safety objective was to describe the frequency of adverse events (AEs) among
           the formula-fed (FF) groups.

        -  The secondary safety objective was to describe anthropometric measures (weight, length,
           and head circumference) among the feeding groups.
    


Intervention name(s): Infant formula
Intervention type(s): Dietary Supplement
Intervention description(s): Infant formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)
Condition: Ebola Virus
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has
      affected several thousand people. There is no approved effective way to treat or prevent
      Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola
      vaccine BPSC-1001 to see if it is safe and to see how it affects people's immune system.
    

Detailed description: 
      Between 1994 and the present, there have been many Ebola viruses (EBOV) outbreaks affecting
      mostly central Africa. However, the 2014 West African outbreak significantly exceeds all
      previous outbreaks in geographic range, number of individuals affected and in disruption of
      typical activities of civil society.

      This is a Phase 1 safety and tolerability study to evaluate a novel vaccine to Ebola using a
      live replicating vesicular stomatitis virus (VSV) replacing the gene encoding the G envelope
      glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola
      (VSVΔG-ZEBOV also known as V920 and BPSC-1001).
    

Intervention name(s): V920 Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^3, 3x10^4, 3x10^5, 3x10^6, 9x10^6, 2x10^7, or 1x10^8 pfu.; 0.9% Saline
Other intervention name(s): BPSC-1001
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study comprised two separate cohorts. Cohort 1 consisted of the 4 lower V920 dose groups (3x10^3 pfu, 3x10^4 pfu, 3x10^5 pfu, and 3x10^6 pfu). Cohort 2 consisted of the 3 higher V920 dose groups (9x10^6 pfu, 2x10^7 pfu, 1x10^8 pfu) plus a bridging group that received vaccine at the highest dose evaluated in Cohort 1 (i.e. 3x10^6 pfu). Both Cohorts 1 and 2 had a placebo group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Sleep in Pregnancy Study
Condition: Pregnancy Related; Sleep Disordered Breathing; Obesity
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes
Study type: Observational

Summary: 
      Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin
      resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm
      birth, growth restriction, gestational hypertension, and preeclampsia. Despite the fact that
      sleep disturbances are common during pregnancy, SDB remains under-recognized,
      under-diagnosed, and poorly understood, particularly in pregnancies affected by obesity.
      Sixty percent of pregnancies are now affected by obesity, yet the relationship between SDB,
      patterns of glycemia, and insulin resistance (IR) in obese pregnant women is a neglected area
      with major therapeutic implications to improve maternal and infant health. Using a
      prospective design in which diet and gestational age are highly controlled, the investigators
      propose to measure SDB (apneas/hypopneas) in obese pregnant women using an ambulatory sleep
      monitoring system. In parallel, robust patterns of glycemia will be measured with a
      continuous glucose monitoring system (CGMS), followed by a 75g oral glucose tolerance test to
      measure insulin action. The investigators global hypothesis is that worse SDB in part
      accounts for higher 24-hour patterns of glycemia in obese normal glucose tolerant (NGT)
      pregnant women in their 3rd trimester. The Investigators will test the hypothesis that: 1) In
      obese NGT pregnant women at 32-34 weeks gestation on a controlled eucaloric diet, higher
      apnea hypopnea index (AHI) will be positively associated with 24-hour glycemia measured by a
      CGMS and that, 2) Higher AHI in obese NGT pregnant women at 32-34 weeks gestation on a
      eucaloric controlled diet will be associated with higher insulin resistance measured by a 75g
      oral glucose tolerance test (Matsuda Model). Early identification and treatment has the
      potential to decrease long-term maternal cardiovascular morbidity and mortality.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women who are 32-34 weeks pregnant who live in the Denver Metro Area
Effect of Glutamine on Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The objective of this study is to determine to effect of additional oral glutamine to Kegel
      exercises on pelvic floor strength and clinical parameters of urinary incontinence in females
      with either urinary incontinence (stress and/or urgency) and pelvic prolapse.
    

Detailed description: 
      Urinary incontinence is a prevalent and costly condition that affects approximately 38% of
      older community-dwelling women (age>60 years). Incontinence predisposes patients to other
      health problems, contributes to depression and social isolation, is a significant source of
      dependency among the elderly, and is widely cited as a factor in nursing home admissions.
      Sarcopenia is age-related and is characterized by loss of muscle mass, strength and
      endurance. There is not only a decrease in the number of muscle fibers, but also atrophy in
      the remaining ones. Several studies indicate glutamine supplementations lead to better muscle
      performance by stimulate muscle producing in extremities. Similarly, we assume glutamine
      supplementation could increase pelvic muscle mass and improve the pelvic floor strength. From
      this point, using glutamine supplementation may effect positively on stress, urge or mixed
      incontinence, and pelvic prolapse.
    

Intervention name(s): glutamine supplementation; fantomalt supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 30 g/day glutamine supplementation for three months; 30 g/day fantomalt supplementation for three months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Roy Adaptation Model in People With Type 1 Diabetes
Condition: Type 1 Diabetes; Adolescent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study was conducted to determine the effect of Roy adaptation model-based education on
      disease compliance and metabolic control in adolescents with Type 1 diabetes.
    

Detailed description: 
      This study was designed as a randomized controlled study. A total of 60 adolescents, training
      (n=30) and control (n=30) that meet the research criteria were divided by random method.
      Pre-training data of the groups were collected using the "Sociodemographic Form", "Diabetes
      Information Evaluation Form" and "Roy Adaptation Model Interview Form" and HbA1c values were
      recorded. The training group was trained on the Roy Adaptation Model by a month break, in two
      sessions. After the training, the adolescents in the training group were given a curvature
      booklet based on the Roy Adaptation model. The control group was not intervened. After the
      training, the diabetes Information Assessment Form and the Roy Adaptation Model Discussion
      Form have applied to both groups again and the values of HbA1c were recorded.
    

Intervention name(s): Roy adaptation model-based nursing education
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
Condition: Bacterial Infection Due to Streptococcus, Group B
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this extension study is the initial assessment of safety and immunogenicity
      of the second dose of GBS Trivalent Vaccine following the time interval that is close to the
      inter-pregnancy interval observed in the general population.
    


Intervention name(s): GBS Trivalent Vaccine
Intervention type(s): Biological
Intervention description(s): Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 .
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
Condition: Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose for this protocol is to perform an open-label parallel-arm clinical study in
      healthy subjects to evaluate the efficacy of a nutraceutical product on chronic pain,
      vascular health, inflammation, and overall wellness.
    

Detailed description: 
      This is an open-label proof-of-concept human clinical study on the effects of consumption of
      a nutraceutical blend. Data collection will include a core set of data pertaining to chronic
      pain and inflammatory markers. Additional data collection will include blood pressure,
      weight, and overall wellness.

      An open-label study design will be used to evaluate the effects of consumption of the
      nutraceutical product CytoQuel. The product is marketed broadly for many types of
      inflammation-related health issues. The study is of 8 weeks' duration, with evaluation at
      baseline, 2, and 8 weeks of product consumption. Study participants will be randomized to one
      of two groups, taking either 3 caps once daily, or two caps twice daily.

      At each visit, the following measurements and procedures are performed: Blood pressure and
      ankle brachial index, questionnaires pertaining to pain and activities of daily living, and a
      blood draw. The blood is used for testing of cytokines and vascular health related
      biomarkers.
    

Intervention name(s): CytoQuel; CytoQuel
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 capsules daily.; 2 capsules twice daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo Avaluation
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of photoirritation and
      photosensitization potential of the product Dermacyd PHDETINBACK Sweet Flower.
    


Intervention name(s): Dermacyd PH_DETINBACK (Lactic Acid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Radial Artery Cannulation and Perfusion Index
Condition: Peripheral Perfusion
Study type: Interventional

Summary: 
      This study aims to investigate if radial artery cannulation of the dominant hand affects its
      peripheral perfusion during cardiac surgery using cardiopulmonary bypass.
    

Detailed description: 
      Invasive blood pressure monitoring is mandatory in cardiac surgeries. Radial artery
      cannulation is the most common technique used for monitoring of invasive blood pressure and
      for arterial blood gas analysis.

      Perfusion index derived from pulse oximetry is a new method for monitoring of peripheral
      perfusion.

      this study aims to investigate if radial artery cannulation affects the intra-operative
      peripheral perfusion in the dominant cannulated hand
    

Intervention name(s): Radial artery cannulation
Intervention type(s): Procedure
Intervention description(s): Radial artery cannulation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Perfusion index; Cardiac Surgery; Radial artery cannulation