bioihbjkbjnl/mcl2 huggingface dataset:
Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System
Condition: Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study
      conducted in the United States
    

Detailed description: 
      This study is designed to demonstrate that the FRESCA Airbox Positive Airway Pressure System
      is non-inferior to the existing FRESCA Positive Airway Pressure System. Subjects meeting the
      inclusion and exclusion criteria will be randomized to one sleep night with the existing
      FRESCA device programmed to fixed pressure and one sleep night with the investigational
      FRESCA device programmed to auto-adjusting pressure and exhale pressure relief.
    

Intervention name(s): positive airway pressure system
Intervention type(s): Device
Intervention description(s): Positive Airway Pressure System
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective, open-label, randomized crossover assignment, multi-center study conducted in the United States
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Fiber and Insulin Sensitivity
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Based on previous research of the investigators group, the investigators hypothesize that
      slowly fermentable fibers with a high degree of polymerization that increase SCFA
      specifically in the distal colon are expected to have higher potential for influencing host
      metabolism and metabolic health by improving adipose tissue function, preventing lipid
      overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin
      sensitivity.

      The objective of this randomized clinical trial is to test, whether the a dietary fiber
      product containing different physiological acting fibers reverses peripheral and hepatic
      insulin resistance in overweight/obese insulin resistant participants.
    


Intervention name(s): Placebo; Whole fiber product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplementation period 12 weeks; Supplementation period 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging
Condition: Photoaging
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      Photoaging is a common concern within the cosmeceutical industry with many products that are
      available. One frequently used product is hydroquinone that is used to even skin tone.
      However, hydroquinone has several shortcomings. The ingredient is controversial for its
      potential safety issues and it has been banned in Europe. An alternative ingredient that has
      emerged for its potential use is hexyresorcinol for evening skin tone. Additionally,
      hexylresorcinol may have other photoaging benefits such as the reduction in the appearance of
      fine lines.

      Therefore, the aim of this study is to assess how hexyresorcinol may compare to the use of
      hydroquinone in the setting of photoaging.
    


Intervention name(s): Hexylresourcinol; Hydroquinone
Intervention type(s): Other; Other
Intervention description(s): Emulsion containing hexylresorcinol as an active; Emulsions containing hydroquinone as an active
Intervention MeSH terms: Hydroquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Condition: Glioma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help
      the body build an effective immune response to kill tumor cells.

      PURPOSE: This trial is studying the safety and effectiveness of autologous gp96 treatment of
      glioblastoma and to see how well it works in treating patients with newly diagnosed
      supratentoria glioma.
    


Intervention name(s): gp96
Intervention type(s): Biological
Intervention description(s): vaccination of autologous gp96 derived from tumor tissue + basal treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: supratentoria glioma
Length of Cook Catheter Placement and Induction of Labor
Condition: Induction of Labor
Study type: Interventional

Summary: 
      The goal of this study is to compare cook catheter placement for 6 vs. 12 hours to see if
      there is faster time to delivery for people admitted to labor and delivery undergoing
      induction of labor.
    

Detailed description: 
      Upon presentation to labor and delivery the participant will have a cook catheter inserted
      digitally or by direct visualization with a speculum. The uterine component of the balloon
      will be inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle
      traction. In both groups participants will be started on hospital-based oxytocin protocol.
      This protocol beings with 2 milliunits/min of oxytocin, increasing by 2 milliunits every 15
      minutes until regular uterine contractions occur. The maximum dose of oxytocin is considered
      to be 30 milliunits. The cook catheter will then be removed at 6 vs. 12 hours based on
      randomization. At that point health care providers will manage active labor. Health care
      providers many perform amniotomy at any point during the induction process with
      recommendation for amniotomy with cervix more than 4cm dilated. Labor interventions are at
      the discretion of the healthcare provider. The participants will have continuous fetal
      monitoring throughout their induction, labor and delivery. Need for operative delivery or
      cesarean section will be at the discretion of the health provider.
    

Intervention name(s): Foley catheter length
Intervention type(s): Device
Intervention description(s): see arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maternal outcomes; Neonatal Outcomes
The Role of Sulfur Amino Acids in Risk of Kwashiorkor
Condition: Kwashiorkor
MeSH terms: Kwashiorkor
Study type: Observational

Summary: 
      This observational cross-sectional study is investigating if young children in populations
      with higher prevalence of kwashiorkor malnutrition have lower dietary sulfur amino acid
      intake than populations with lower prevalence of kwashiorkor, controlling for multiple
      potential confounding factors. Intake is estimated through diet recalls during interviews
      with a child's caregiver, analysis of urine samples and analysis of food samples for their
      amino acid profiles.
    

Detailed description: 
      Kwashiorkor is one of two categorizations of severe acute malnutrition, but its etiology
      remains unclear. Although kwashiorkor is found only where diets are low in quality protein,
      comparisons of total dietary protein of individual children with and without kwashiorkor has
      been inconclusive. This study aims to compare amino acid profiles of the diets, not just
      total protein.

      Evidence has shown that children with kwashiorkor consistently have very low circulating
      levels of sulfur amino acids (cysteine and methionine). Typical staple foods in regions with
      endemic kwashiorkor are generally poor in sulfur amino acids and the signs characterizing
      kwashiorkor can plausibly be explained by a shortage of sulfur amino acids.

      In eastern Democratic Republic of the Congo, certain populations have chronically higher
      prevalence of kwashiorkor than neighboring populations with similar livelihoods, religion,
      environment, language and ethnicity. This study will compare these two populations to
      understand what differences between them may explain the difference in prevalence.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population, both groups, live within a 3 mile by 3 mile square in rural eastern
        Democratic Republic of the Congo.
      
Keywords: sulfur amino acid
Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this randomized study is to assess the efficacy of a mobile application for
      the improvement of blood pressure and insulin resistance in people with metabolic
      abnormalities.
    

Detailed description: 
      The purpose of this randomized study is to assess the efficacy of a mobile application for
      the improvement of blood pressure and insulin resistance in people with metabolic syndrome.

      This study is a 24 week follow up randomized prevention trial. Participants visit for a
      screening test, then eligible participants are randomly assigned for one of the following
      arms; 1 intervention group using a mobile application to monitor their life style behaviors,
      1 intervention group using a mobile application for personal coaching on purpose of improving
      their life style behavior, and 1 control group providing education about managing life style
      behaviors.
    

Intervention name(s): Mobile application for self monitoring; Education; Mobile application for personal coaching
Intervention type(s): Other; Other; Other
Intervention description(s): Participants in this group will be introduced to use a mobile application to self record and monitor their life style behaviors. They will be also be provided education same as the control group.; Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).; Participants in this group will be introduced to use a mobile application. Personal coaches such as dietitian, sports manager encourage to improve their life style behaviors. They will be also be provided education same as the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      The INSIGHT ('Insight into Real-world Practice of Management of HCC in Asia-Pacific')
      registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with
      HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea,
      Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore).
      Approximately 30% of the sample size will be identified retrospectively and 70% will be
      identified prospectively from the start date of the registry (October 2016), with an even
      distribution of consecutively diagnosed patients within the different years.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with HCC between 1st January 2013 and 31st December 2019 in nine
        countries (i.e., South Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New
        Zealand and Singapore).
Study of E7389 for Advanced or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate
      the safety of patients who continue to receive E7389 after completing the Phase II clinical
      study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed
      breast cancer by intravenously administering E7389.
    

Detailed description: 
      Study 224 (Extension Period) was designed to evaluate the safety and efficacy of E7389 by
      collecting data from subjects who continued receiving E7389 after being transferred from
      Study 221 (Core Period). Thus, efficacy analyses performed in Study 221 were updated and
      reported with the additional data collected in Study 224. Objective response rate (ORR) and
      the number of subjects with adverse events are reported as outcome measures because these
      were the outcome measures of Study 221 which is a main study in the combined data. Also,
      safety analyses performed in Study 221 were updated and reported with the additional data
      collected in Study 224.
    

Intervention name(s): Eribulin Mesylate
Intervention type(s): Drug
Intervention description(s): Eribulin mesylate 1.4 mg/m^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; breast cancer; neoplasm; E7389; Eribulin
Study to Evaluate the Acute Bioavailability of EPA and DHA From a DietarySupplement in Healthy Men and Women
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study was to evaluate and compare the acute bioavailability of EPA and
      DHA in wax ester form provided as a dietary supplement compared to a well-studied and defined
      ethyl ester formulation in generally healthy men and women.
    

Detailed description: 
      A randomized, controlled two-period crossover study included one screening/baseline visit
      (visit 1, day -7) with four test visits during Period I (visits 2, 3, 4, and 5; days 0, 1, 2,
      and 3) and four tests visits during Period II (visits 6, 7, 8, and 9; days 14, 15, 16, and
      17) with at least a 7-d washout between test periods. Eighteen healthy adults with fasting
      TAG concentrations <200 mg/dL were randomly assigned to one of two treatment sequences:
      receive 8 capsules containing Calanus oil® (Calanus AS, Tromso, Norway) supplying a total of
      4 g of oil providing 260 mg EPA and 156 mg/day DHA primarily as wax esters, followed by 1
      capsule supplying 1 g of oil providing 465 mg EPA and 375 mg DHA as ethyl esters (Lovaza®,
      GlaxoSmithKline, Research Triangle Park, NC); or, to receive Lovaza followed by Calanus Oil.
      Product was dispensed in-clinic with an standardized EPA- and DHA- free breakfast meal (t=0).
      Blood samples were obtained in-clinic at t= -30 min, and 1, 2, 4, 6, 8, 10 and 12 h
      timepoints. Subjects were provided a standardized EPA- and DHA-free meal at t=4 h and t=8.
      Subject were dismissed from the clinic after t-12 h blood draw and returned the morning of
      days 1, 2 and 3 (days 15, 16 and 17) for a 24 h, 48 h and 72 h fasting blood draw.
    

Intervention name(s): Wax Ester Marine Oil; Ethyl Ester Marine Oil
Intervention type(s): Other; Other
Intervention description(s): Wax ester marine oil (Calanus oil; 4 g providing 260 mg EPA and 156 mg DHA; 8 capsules) consumed once, in clinic, at t=0.; Ethyl ester (EE) marine oil (Lovaza OM3 EE; 1 g providing 465 mg EPA and 375 mg DHA; 1 capsule), consumed once, in clinic, at t=0
Other intervention name(s): Calanus Oil; marine copepod Calanus finmarchicus; Lovaza
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Fatty Acids; Fish Oil; Marine Copepod; Fatty Acid Absorption
Quality of Life for Children With Zirconium Anteroir Crowns Versus Strip Composite Crowns
Condition: Caries
Study type: Interventional

Summary: 
      Early Childhood Oral Health Impact Scale (ECOHIS) will be used for detection of oral health
      related quality of life for children using strip composite crowns versus zirconium crowns at
      6 and 12 months
    


Intervention name(s): Zirconium crowns; Strip composite crowns
Intervention type(s): Other; Other
Intervention description(s): Prefabricated pirmary anteroir teeth zirconium crowns; Strip composite crowns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cross Correlation of Pain Hypersensitivity and Clinical Features and Electromyography in Low Back Pain Patients
Condition: Low Back Pain
MeSH terms: Hypersensitivity; Back Pain; Low Back Pain
Study type: Observational [Patient Registry]

Summary: 
      Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully
      understood.Increased pain sensitivity in the primary area of pain (local pain) is considered
      a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low
      back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas is
      considered to present a more central phenomenon. It is suggested that pat ents with enhanced
      pain sensitivity report high level of disability. Despite fact that pain and disability are
      associated in chronic LBP the exact mechanisms of sensitivity contribution in LBP disability
      is unknown. It has also been suggested that muscle function changes may be driven by pain.
      The possible role and contribution of trunk muscles function to pain and disability phenomena
      remain unknown.

      This study was aimed to estimate prevalence and possible correlation among pain
      hypersensitivity and functional and electromyography parameters of trunk muscles in patients
      reporting early phase of chronic LBP.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with subacute LBP from tertiary rehabilitation clinic
VS-Sense Result Reading Clarity
Condition: Vaginitis
MeSH terms: Vaginitis
Study type: Observational

Summary: 
      This study is designed to demonstrate the result reading clarity of the VS-SENSE is
      substantially equivalent to the result reading clarity of the Nitrazine pH Paper test for
      vaginal secretions.
    

Detailed description: 
      Once informed consent has been signed, the clinician will perform the following:

      Record baseline variables in the CRF. The 1st clinician will obtain a vaginal secretion
      sample by using the VS-SENSE swab. The 1st clinician will obtain the specimen by separating
      the labia to expose the vagina. The yellow tip of the VS-SENSE swab will be inserted into the
      vagina approximately 5 cm/ 2". The 1st clinician will use the VS-SENSE according the
      instructions for use - attachment 1 to the protocol.

      The 1st clinician will read the VS-SENSE results and record them on the designated form
      (Clinician Report - VS-SENSE Result form), and fill out the table regarding the VS-SENSE
      reading clarity on the same form.Vaginal examination (including speculum examination) - will
      be performed by a 2nd clinician, masked from the results of the 1st clinician test.

      The 2nd clinician will use a vaginal swab for pH measurement by Nitrazine pH Paper test. The
      Nitrazine pH Paper test will be performed according to strict manufacturer's instruction.

      The 2nd clinician will read the results of the Nitrazine pH Paper test result, document it on
      the Clinician Report - pH Test Result form, and fill out the table regarding the pH test
      reading clarity on the same form.
    

Intervention name(s): vs-sense
Intervention type(s): Device
Intervention description(s): detection swab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Symptomatic and asymptomatic women, ages 18 and above.
      
Biospecimen description: 
      VAGINAL DISCHARGE
    
Keywords: vaginal infection, color appearance
OCT and OCTA Deep Learning in Waldenström's Macroglobulinemia Patients
Condition: Waldenstrom Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Study type: Observational [Patient Registry]

Summary: 
      This study evaluates the ability of deep learning to improve the knowledge about structural
      and vascular retinal changes in Waldenström's Macroglobulinemia patients, using optical
      coherence tomography angiography.
    

Detailed description: 
      Waldenstrom macroglobulinemia (mak-roe-glob-u-lih-NEE-me-uh) is a rare type of cancer that
      begins in the white blood cells.

      The optical coherence tomography angiography represents a novel and noninvasive diagnostic
      technique that allows a detailed and quantitative analysis of retinal and choriocapillary
      vascular features. The study evaluates the changes in optical coherence tomography
      angiography features in Waldenstrom macroglobulinemia, elaborating these data with artificial
      intelligence.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 18 years with diagnosis of Waldenstrom Macroglobulinemia.
        They did not present other ophthalmological disease
Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment
Condition: Menorrhagia; Metrorrhagia
MeSH terms: Menorrhagia; Metrorrhagia; Hemorrhage
Study type: Observational

Summary: 
      Dydrogesterone is a retroprogesterone with a molecular structure similar to natural
      progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low
      antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic
      activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.

      In this study, women suffering from menorrhagia and who are treated with dydrogesterone will
      be observed for impact on QoL with the reduction in severity of bleeding.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with heavy menstrual bleeding
      
Keywords: Metrorrhagia; Menorrhagia
Effects of Whole Body Vibration Exercise on Metabolic Systems in Latino Boys
Condition: Effects of Whole Body Vibration Exercise on Metabolic Systems
Study type: Interventional

Summary: 
      The purpose of this study is to determine if whole body vibration exercise improves
      insulin/glucose dynamics and bone metabolism in Latino Boys.
    


Intervention name(s): Exercise intervention
Intervention type(s): Other
Intervention description(s): Whole body vibration exercise 3 times per week
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Latino; Hispanic; Boys