bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacogenetics of Hypertriglyceridemia in Hispanics
Condition: Cardiovascular Diseases; Heart Diseases; Hypertriglyceridemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Hypertriglyceridemia
Study type: Observational

Summary: 
      To study the effect of genes on lipid-lowering drug treatment in hypertriglyceridemia.
    

Detailed description: 
      BACKGROUND:

      Increased serum triglycerides are a significant independent risk factor for coronary artery
      disease and myocardial infarction. Besides typical lifestyle modification, the treatment with
      fibrates is standard in patients with hypertriglyceridemia. There is ample evidence that
      genetic factors influence triglyceride levels. Identifying genes, which affect triglyceride
      levels and moreover determining the response to fibrates is of great interest. Hispanics are
      among the populations with the highest prevalence of this disease. Therefore focusing on a
      high-risk population further adds to the overall significance of this study. Identifying
      genes and genetic mechanisms contributing to the treatment response can lead to new or
      improved treatment methods.

      DESIGN NARRATIVE:

      The study tests the hypothesis that differences in therapeutic effects of fibrates are
      related to variations in networks of genes regulating lipoprotein metabolism. An efficient
      approach for identifying and categorizing major gene variants is based on determination of
      sequence haplotypes. Only Hispanics will be studied to provide a homogenous population for
      this genetic study. Furthermore, Hispanics are the fastest growing ethnic group in the U.S.
      and have a higher prevalence of hypertriglyceridemia than other ethnic groups. The
      investigators will measure plasma triglycerides (TG), other lipids and lipoproteins, and
      lipoprotein particle size before and after treatment with fenofibrate in 800 Hispanic
      individuals with hypertriglyceridemia. They will reconstruct the haplotypes of 16 candidate
      genes known to regulate TG metabolism and mediate the effect of fibrates. The associations
      between phenotypes and major haplotypes will be analyzed in a two stage design, with the
      first half of the sample serving a hypothesis-generating function. Those candidate gene
      haplotypes that are found to be associated with quantitative traits and drug responses in the
      first half of the sample will then be tested for confirmation in the second half. In
      addition, data from the full cohort will be analyzed to identify additional pharmacogenetic
      associations that may require greater statistical power. Finally, direct fine mapping will be
      performed in the four most promising genes to identify the responsible variations.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hispanics with hypertriglyceridemia
      
Biospecimen description: 
      Whole blood
Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology
Condition: Cancer
Study type: Interventional

Summary: 
      We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes of
      health related quality of life, disease symptoms, and biological correlates of stress in a
      sample of young adults with cancer. The proposed work will serve as an essential foundation
      for launching a program of clinical stress reduction research with this traditionally
      underserved population and has the potential to lead to the discovery of specific, modifiable
      psychosocial, behavioral, and biological mechanisms from which to address the problem of
      health disparities with this group.
    

Detailed description: 
      Primary Objective Examine the feasibility and acceptability of MBSR with YACs. We hypothesize
      that MBSR will be feasible and acceptable with this population, which will be assessed
      through examination of response rate and study attrition variables.

      Secondary Objectives

        1. Evaluate the effects of MBSR on outcomes of health related quality of life and disease
           symptoms among YACs.

        2. Explore the impact of different forms of eHealth maintenance support following the MBSR
           intervention (instructor-delivered, peer-delivered, no message) to help uphold
           intervention effects over time.

        3. Compare intervention and control groups on changes in biologic measures of stress (blood
           pressure, pulse, salivary cortisol, CRP and IL-6 biomarkers) over a 32-week period.
    

Intervention name(s): MBSR
Intervention type(s): Behavioral
Intervention description(s): Based primarily on the instruction of mindfulness meditation and yoga, MBSR is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations.
Other intervention name(s): mindfulness based stress reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: YACS; cancer; MBSR
The Reliability of Myotonometer in Evaluating the Muscle Tone and Biomechanical Properties of the Forearm Muscles
Condition: Muscular Tone; Viscoelasticity
Study type: Observational

Summary: 
      The primary aim of this study was to evaluate the intra-rater and inter-rater reliability of
      MyotonPRO in measuring muscle tone and mechanical properties of the wrist extensor and flexor
      muscles in healthy young adults. The secondary aim is to examine whether grip strength has
      any effect on muscle tone and biomechanical properties.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults between 18-35 years old
      
Keywords: elasticity; hardness; forearm muscles
A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin
Condition: Platelet Inhibition
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary hypothesis of this study is that concomitant multiple-dose administration of PN
      400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose
      aspirin (81 mg), as measured by serum thromboxane B2 inhibition.
    


Intervention name(s): PN400; ASA; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): naproxen 500 mg/esomeprazole 20 mg oral tablet; Asprin 81 mg enteric coated tablet
Other intervention name(s): Asprin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Thromboxane B2
Safety and Efficacy of Berodual® Respimat® Compared to Berodual® MDI (Metered Dose Inhaler) in Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol
      hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium
      bromide, 1 puff q.i.d.) administered via Respimat® gives a bronchodilator response which is
      not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg
      ipratropium bromide, 2 puffs q.i.d.) administered via MDI and that the safety profile is at
      least as good in asthma patients treated for 12 weeks.
    


Intervention name(s): Berodual® via Respimat®, high dose; Berodual® via Respimat®, low dose; Berodual® via MDI, high dose; Placebo Respimat®; Placebo MDI
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Fenoterol; Fenoterol, ipratropium drug combination; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
An Evaluation of Root Length Measurements Using Intraoral Scan and Panoramic Radiographs
Condition: Root Resorption
MeSH terms: Root Resorption
Study type: Observational

Summary: 
      This study will attempt to validate a method of estimating root length on panoramic
      radiograph by crown measurement on intraoral digital scans.
    

Detailed description: 
      Intraoral digital scans will be taken on patients who have completed orthodontic treatment,
      and measurements will be made on the crown dimensions. These dimensions will then be applied
      onto the same teeth as seen on panoramic radiographs and a mathematical relationship will be
      determined for root length. Changes in root length will be measured from initial records to
      treatment complete panoramic radiographs and these estimates will be compared to actual root
      length changes as measured in CBCT (Cone Beam Computed Tomography) records.
    

Intervention name(s): Intraoral Scan
Intervention type(s): Other
Intervention description(s): All patients will have an intraoral scan performed for measurements to be taken on.
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who have undergone orthodontic treatment, and associated tooth movement, and have
        initial records directly before the initiation of treatment.
      
Keywords: Root Resorption; Panoramic Radiograph
Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial
Condition: Chronic Pelvic Pain Syndrome
MeSH terms: Pelvic Pain
Study type: Interventional

Summary: 
      The goal of this interventional study is to test of efficacy of sacral Transcutaneous
      Electrical Stimulation (TENS) in patients with chronic pelvic pain.

      The main questions it aims to answer are:

        1. Is sacral transcutaneous electrical stimulation (TENS) effective to reduce/relief pain
           in patients with chronic pelvic pain?

        2. Is the effect of TENS comparable to sham stimulation therapy in patients with chronic
           pelvic pain?
    

Detailed description: 
      Our study aiming to test the efficacy of sacral transcutaneous electrical stimulation (TENS)
      intervention in patients with chronic pelvic pain. We aim to test the efficacy and compare it
      with sham stimulation therapy in chronic pelvic pain.
    

Intervention name(s): Sham TENS Stimulation; Sacral TENS Stimulation
Intervention type(s): Device; Device
Intervention description(s): Sacral TENS device without appropriate electrical stimulation have been applied to directly the skin of sacral area.; Sacral TENS stimulation have been applied to directly the skin of sacral area.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We aim to compare sacral TENS in patients with chronic pelvic pain and compare it with sham stimulation therapy.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: transcutaneous electrical stimulation; chronic pelvic pain; sacral; randomized clinical trial
Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Sufficient subjects with a confirmed diagnosis of MS (EDSS score of 6.5 or below), will be
      recruited to ensure that 30 subjects (approx. equal numbers of each gender) complete the
      study. Subjects will undergo a screening visit, then four study days, each separated by a
      washout period of at least 7 days, when the different firategrast batches of drug substance
      will be administered, and a follow-up visit.
    

Detailed description: 
      An open-label, randomised, four period crossover study to investigate the relative
      pharmacokinetic profiles of tablets from three batches of firategrast with different surface
      areas and two different tablet formulations containing the same batch of firategrast, given
      as single 900mg doses to male and female subjects with a diagnosis of Multiple Sclerosis
    

Intervention name(s): Formulation A; Formulation B; Formulation C; Formulation D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Formulation A will contain firategrast drug substance from native drug batch Irvine. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.1 square meter per gram. The tablets will be administered with 240 milliliters of water.; Formulation B will contain firategrast drug substance from native drug batch Tonbridge. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.; Formulation C will contain firategrast drug substance from Tonbridge single pass micronized drug. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 3-4 square meter per gram. The tablets will be administered with 240 milliliters of water.; Formulation D will contain firategrast drug substance from Tonbridge with reduced tablet size. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.
Other intervention name(s): firategrast (SB683699)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PK,; SB-683699,; multiple sclerosis; firategrast,; surface area,
Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      This study compare the results of 2 methods in surgical treatment of Lumbar spine
      stenosis.These are microdecompresssion and open decompression with posterior stabilization.
      100 patients are involved in this study who divided in 2 groups.Each group was treated with
      one method and follow up done which showed both method are effective with better results in
      those patients treated with microdecomppression.
    

Detailed description: 
      This randomized controlled study was conducted between January 2016 and October 2018. One
      hundred patients were involved in this study. All these patients were suffered from radicular
      leg pain with MRI features of multilevel lumbar spinal stenosis and were treated by
      conservative treatment of medical treatment and physiotherapy without benefit for (6) months.
      Those patients were divided into two groups; Group A, (50) Microdecompression, and Group B,
      (50) patients who were treated by open wide laminectomy and posterior stabilization. Both
      groups of patients were followed up with ODI (Oswestry disability index) and VAS (Visual
      analogue score) for the back and leg pain for one year.

      Results: The results showed that both groups got significant improvement regarding Oswestry
      disability index. Regarding back pain, there was a significant improvement in both groups
      with better results in-group A due minimal tissues injury as the advantage of minimal
      invasive technique. In both groups, there were marked improvement of radicular leg pain
      postoperatively.

      Conclusions: Both Microdecompression and wide open laminectomy with posterior stabilization
      were effective in treatment of multilevel lumbar spinal stenosis with superior results of
      Microdecompression regarding less back pain postoperatively with less blood loss and soft
      tissue dissection.
    

Intervention name(s): Microdecompression
Intervention type(s): Procedure
Intervention description(s): comparative surgical treatment
Other intervention name(s): Open decompression with posterior fixation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microdecompression; laminectomy; pain; stenosis
Growth and Tolerance of a Partially Hydrolyzed Infant Formula
Condition: Growth
Study type: Interventional

Summary: 
      The purpose of this research study is to compare the growth and tolerance of infants who
      consume either an infant formula with intact proteins or an infant formula with partially
      hydrolyzed proteins through approximately 12 months of age.
    


Intervention name(s): Cow's milk protein infant formula; Partially hydrolyzed protein infant formula
Intervention type(s): Other; Other
Intervention description(s): A routine cow's milk-based infant formula; A partially hydrolyzed cow's milk protein (PHP) infant formula
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective for this study is to demonstrate bioequivalence between Japanese commercial
      tablet and Japanese commercial image liquid formulation. Secondary objective for this study
      is to estimate the food effect for Japanese commercial image liquid formulation.
    


Intervention name(s): Gabapentin; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): Period I: Tablet in fasting state(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: Liquid formulation in fasting state(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period III: Liquid formulation(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period) in fed state; Period I: Liquid formulation in fasting state(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: Tablet in fasting state(400 mg single doseon Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period III: Liquid formulation(400 mg single doseon Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period) in fed state
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence study; Food effect study; Pharmacokinetics; Gabapentin
Shaping the Health of Adolescents in Zimbabwe
Condition: HIV
Study type: Interventional

Summary: 
      The SHAZ! study was a randomized trial that compared a package of life skills education,
      reproductive health care services, and economic livelihood development to a control package
      of life skills education and reproductive health care services alone. SHAZ! enrolled young
      women 16 to 19 years old who had been orphaned and who were currently out of school and not
      infected with HIV. Individuals participated in the project for up to two years.
    


Intervention name(s): Life skills education; Reproductive health services; Economic livelihoods
Intervention type(s): Behavioral; Other; Behavioral
Intervention description(s): The life skills curriculum drew upon Stepping Stones and CDC-Zimbabwe Talk Time, developed with input from the target population. It consisted of 14 modules delivered to groups of 25 over 4-6 weeks on: HIV/STI and reproductive health; relationship negotiation; strategies to avoid violence;and identification of safe and risky places in the community. Participants also attended a six-weeks-long home-based care training conducted through Red Cross Zimbabwe, to gain skills on safely caring for people living with HIV.; All participants were provided a health screening at every study visit and were treated for treatable STIs and minor ailments. They received condoms, and contraceptive pills or injectable free upon request. Participants who tested positive for HIV were referred to local clinics, where the study team assisted with ART registration including payment for CD4 tests required for enrolment.; The Livelihoods intervention consisted of financial literacy and a choice of vocational training at local training institutes. Courses were 6-months-long, conducted in English, with a practical and a theoretical component. In spite of encouragement to venture outside of accepted gender norms, the most popular courses were hairdressing, garment-making, and receptionist/secretarial and nurse-aid training. Participants who passed developed business plans that were supported with a micro-grant valued at $100US in the form of capital equipment, supplies or additional training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: HIV; adolescents
Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study examines the impact of daily consumption of ½ c pinto beans, compared to a control
      (½ c green beans), on fasting glucose, postprandial glucose and HbA1c concentrations in
      adults with type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      This study utilized a randomized, pretest-posttest, crossover (within-group) design, that
      includes two treatment periods [control period (½ c. green beans each day) and pinto beans (½
      c each day)], each 12-weeks in duration with a 4- week wash-out period to determine the
      impact on fasting glucose, postprandial glucose and HbA1c concentrations. After a baseline
      wash-in period, 16 participants are randomly assigned to 2 treatment periods [control period
      and pinto beans], each 12-weeks in duration. On 28 randomized days during the wash-in period
      and interventions, participants keep diet records and measure a postprandial capillary
      glucose concentration using a glucometer 1 hour after the meal during which the pinto beans
      or control are consumed. Before and after each 12-week intervention, participants provide a
      fasted venous blood sample for glucose and HbA1c analyses.
    

Intervention name(s): Pinto Beans; Green Beans - control
Intervention type(s): Other; Other
Intervention description(s): The intervention was 1/2 cup of pinto beans each day.; The control was 1/2 cup of green beans each day.
Other intervention name(s): Pinto Beans - intervention; Control
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment Crossover design with 2-12 week intervention and comparator phases separated by a 4-week washout.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pulses; legumes; Phaseolus vulgaris L.; glycemic response