bioihbjkbjnl/mcl2 huggingface dataset:
Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease
Condition: Colitis, Ulcerative; Crohn's Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases; Colitis, Ulcerative
Study type: Interventional

Summary: 
      Individuals with IBD are at risk for nutrient deficiencies. This prospective, non-randomized,
      open-label study will assess the effect of a nutrition support product on nutritional status
      in adults with IBD. Up to ten adults with ulcerative colitis or Crohn's disease will be
      enrolled in the study and asked to take the product for 12 weeks. The primary measures of the
      study are several blood markers of nutritional status.
    

Detailed description: 
      It is estimated that 1-1.3 million people in the United States suffer from the Inflammatory
      Bowel Diseases (IBD) Crohn's disease (CD) and Ulcerative colitis (UC). The pathophysiology of
      IBD involves malnutrition, malabsorption, altered intestinal permeability, inflammation, and
      gut flora alterations. Individuals with IBD are at risk for nutrient deficiencies due to
      decreased intake, decreased absorption and/or increased enteral losses. The most common
      deficiencies involve many micronutrients including vitamins and minerals; less commonly,
      adults may also be at risk for macronutrient deficiencies involving protein and total energy
      intake. The product being studied is a comprehensive nutrition support product that was
      formulated to meet the nutritional needs of individuals with digestive complaints. This study
      will assess the effect of the study product on blood markers of nutritional status in adults
      with IBD.
    

Intervention name(s): Nutrition support product
Intervention type(s): Other
Intervention description(s): Nutrition support product contains macronutrients, micronutrients, phytonutrients, prebiotics, and glutamine. Product is in powder form and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Inflammatory Bowel Disease
Study of the Relationships Between Apolipoprotein B-48 Kinetics and Expression of Genes That Regulate Intestinal Lipid Metabolism in Men With the Metabolic Syndrome (SMB48)
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      Several lines of evidence indicate that a significant proportion of cardiovascular disease
      (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and
      perturbations, defined as the metabolic syndrome. It has been estimated that approximately
      25% of the North American adult population is living with the metabolic syndrome. Recent
      studies show that overaccumulation of atherogenic triglyceride-rich lipoproteins (TRL) seen
      in insulin-resistant patients is partly due to increased production rate of intestinally
      derived apolipoproteinB-48-containing lipoproteins. This is of interest because substantial
      evidence exists indicating that elevated levels of intestinal lipoproteins are associated
      with increased CVD risk. However, as indicated in the body of this grant proposal, the
      underlying mechanisms that lead to intestinal overproduction of lipoproteins in
      insulin-resistant states are poorly understood.

      The general objective of the proposed research is to investigate the mechanisms by which the
      metabolic syndrome affects apolipoproteinB-48 secretion in human. The primary hypothesis is
      that insulin resistance will be associated with higher levels of intestinal lipoproteins
      because of an increased secretion of these particles.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      Serum Plasma Intestinal tissue
Using Herbs and Spices to Increase Children's Acceptance and Intake of Vegetables in School Lunches
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Herbs and spices offer one potential solution to the recent decline in children taking school
      lunch because they can increase the palatability of foods without adding salt and fat.
      However, there is currently limited evidence on how to successfully integrate herbs and
      spices into the school lunch menu. Developing evidence-based methods to teach school
      cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs
      and spices is a research priority. The investigators hypothesize that herbs and spices can be
      used to increase acceptance, intake, and participation in the school lunch program among 6th
      - 12th grade students from Central Pennsylvania.
    

Detailed description: 
      What this study will add to the literature: Herbs and spices offer one potential solution to
      the recent decline in children taking school lunch because they can increase the palatability
      of foods without adding salt and fat. However, there is currently limited evidence on how to
      successfully integrate herbs and spices into the school lunch menu. Developing evidence-based
      methods to teach school cafeteria workers to prepare healthy and tasty vegetable dishes with
      the addition of herbs and spices is a research priority. This research will provide evidence
      that herbs and spices can be used to increase acceptance, intake, and participation in the
      school lunch program among 6th - 12th grade students from Central Pennsylvania.
    

Intervention name(s): Spice Intervention
Intervention type(s): Other
Intervention description(s): Spice Intervention:Novel herb and spice blends will be used in cafeteria recipes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Electromagnetic Stimulation Combined With Visceral Manipulation on Stress Urinary Incontinence In Postmenopausal Women
Condition: Stress Urinary Incontinence; Postmenopausal Disorder
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      To examine the effect of electromagnetic stimulation combined with visceral manipulation on
      stress urinary incontinence in postmenopausal women
    

Detailed description: 
      According to the authors' knowledge, no prior studies that included MS with a VMT maneuvers
      to improve the success rates of stress urinary incontinence (SUI) treatment. Consequently,
      the purpose of this study was to assess the effect of electromagnetic field stimulation with
      VMT and PFMT in treatment of postmenopausal women with SUI.
    

Intervention name(s): Electromagnetic device; visceral manipulation therapy; General advice; pelvic floor muscle training
Intervention type(s): Device; Other; Other; Other
Intervention description(s): Health wave's generator (Manufactured with Simeds S.r.l. by Machiavelli, Italy, with serial number "11492".) with two separate emission channels and asynchronous operation was employed, along with 100 saved and storable programs that could be altered by the user (intensity, frequency and phase time). The different associated applicators are recognized automatically. Magnetic field strength up to "100" Gauss and output frequency from (1 - 100) Hertz are programmable.; for the pelvic reproductive organs and their related structures (ligaments and fasciae) was applied one session/week for 12 weeks. Each patient was was advised to evacuate her bladder before starting the treatment session, mobility and motility testing of pelvic organs, together with the assessment of fascial tension, was then performed, with detecting restrictions, treatment was applied according to Hebgen; were directed for both groups in term of the following: Perform pelvic floor exercises regularly ; avoid constipation and straining; treat the cause of any chronic cough and infection of urethra or bladder; stop smoking; maintain a healthy weight; drinking sufficient amounts of healthy fluids (water); decrease the caffeine intake; and decrease the amount of acidic and spicy foods.; consisted of 24 sessions of 45-60 min each, twice a week, for 12 weeks. The PFMT was divided into four phases. Proprioceptive (3 weeks): where the woman has gained adequate perception of PFM and performed fast and slow contractions; Simple (3 week): performed with the objective of promoting control of fast and slow contractions associated with small functional exercises; Elaborated (3 week): where the exercise evolved into functional exercises of greater amplitude; and Power (3 week): where the maximum voluntary contraction of the pelvic floor was promoted during efforts. In all sessions, contractions were performed for slow and fast fibers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment of Osteoarthrosis of the Knee With Platelet Rich Plasma, Comparative Study With Hyaluronic Acid
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare changes in functionality and pain level using questionnaires EVA, Lequesne and
      WOMAC in patients treated with 4 doses of 8 ml of autologous Platelet Rich Plasma every 15
      days applied through intra-articular infiltration and patients treated with an
      intra-articular infiltration of 1 dose of SYNVISC-ONE ® 6 ml pre-filled syringe, placed
      according to standard protocol, in patients with OA grade II-IV.
    

Detailed description: 
      28 participants with grade II-IV knee OA who met all the inclusion criteria and none of the
      exclusion criteria were recruited and selected. They were randomized into two groups, one
      received 4 doses of PRP and the other conventional hyalurinic acid treatment. Each patient
      underwent an evaluation of their baseline condition and physical examination of the affected
      knee by applying the functional and pain level questionnaires: WOMAC, VAS and LEQUESNE, after
      which each of the treatments was applied, respectively. The control group received 1 dose of
      SYNVISC-ONE, placed according to the standard intra-articular infiltration protocol, and
      group 2 received 4 intra-articular infiltrations of activated autologous PRP placed every 15
      days. The patients were assessed at 3, 6 and 12 months by physical examination and the same
      surveys were applied to determine the progress and efficacy of the treatments using the same
      surveys. Finally, a statistical analysis was performed to compare the results between the two
      treatments.
    

Intervention name(s): Platelet Rich Plasma; Hyaluronic Acid
Intervention type(s): Biological; Drug
Intervention description(s): intra-articular infiltration of 8 ml of autologous PRP every 15 days.; intra-articular infiltration of a single dose of HA
Other intervention name(s): PRP; HA
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open, cohort, prospective controlled, randomized study with one year of follow-up.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gonarthrosis
Periarterial Injection Versus Multiple Periveural Injection
Condition: Contusion Wrist or Hand; Crush Injury Wrist or Hand
MeSH terms: Contusions; Crush Injuries
Study type: Interventional

Summary: 
      In the transarterial technique for axillary brachial plexus block, the axillary artery is
      intentionally punctured to indicate placement of the needle within the neurovascular sheath;
      local anesthetic is then injected deep and superficial to the axillary artery.
    

Detailed description: 
      To lessen the risk for hematoma and intravascular injection, several modifications, such as
      the multi-injection perineural technique, have become popular. These techniques require a
      high degree of technical skill and multiple needle passes, and also carry potential for
      injury. In this study, the investigators will compare an ultrasound-guided equivalent of the
      transarterial technique (periarterial injections) to a commonly used multi-injection
      perineural technique.
    

Intervention name(s): US-guided periarterial techique; US-guided multi-injection technique
Intervention type(s): Procedure; Procedure
Intervention description(s): The needle will be inserted in the axillary fossa in-plane (cranial to caudal) close to the intersection of the pectoralis and biceps muscles. Two separate injections of local anesthetic will be made deep and superficial to the axillary artery; The median, ulnar and radial nerves will be identified by ultrasound. Local anesthetic will be injected adjacent to each nerve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
CKD-391 Pharmacokinetic Study Phase I
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety
      CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
    

Detailed description: 
      To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe
      combination in health male subjects is the purpose of this trial.

      Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.
    

Intervention name(s): CKD-391; Atrovastatin and Ezetimibe combination therapy
Intervention type(s): Drug; Drug
Intervention description(s): Investigational product is prescribed to all of randomized subjects for two times.; Investigational products are prescribed to all of radomized subjects for two times.
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyslipidemia; CKD-391; Atorvastatin; Ezetimibe
The Promotion Plan of Moxibustion on Ulcerate Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis
Study type: Interventional

Summary: 
      To evaluate the efficacy of Moxibustion in the treatment of Ulcerative Colitis, thus the
      scientific foundation for rational use of Moxibustion in clinical usage, in order to find
      admission of the Acupuncture and Moxibustion and even medicine field, accomplish
      popularization and application.
    

Detailed description: 
      A total of 128 patients with UC were randomly divided into the following 2 groups: a)
      Herb-partition moxibustion (Treatment Group) and b) Sham herb-partition moxibustion (Control
      Group). All patients in the trial will be treated with moxibustion 3 times a week, once a day
      for 30 minutes, for a total of 12 weeks. After treating the treatment had ended and the 52nd
      week of follow-up to observe the clinical therapy effect of Moxibustion in UC patients.
      Tissue morphology and molecular biology tests will be conducted to observe the regulation in
      the intestinal mucosa of UC patients. All these steps will be done in order to provide
      clinical usage for the effects of herb-partition moxibustion in the treatment of UC.
    

Intervention name(s): Herb-partitioned moxibustion; Sham herb-partitioned moxibustion
Intervention type(s): Other; Other
Intervention description(s): Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.; Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
Other intervention name(s): Treatment Group; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Mind Body Intervention for COVID-19 Long Haul Syndrome
Condition: COVID-19 Long Haul Syndrome
MeSH terms: COVID-19; Syndrome
Study type: Interventional

Summary: 
      The present study is a feasibility study in which we will determine if a mind-body program
      that we have previously developed for chronic back pain can improve the multiple somatic
      complaints associated with the COVID Long Haul Syndrome.
    

Detailed description: 
      This study is a pilot and feasibility study to determine if a mind-body program that we have
      previously developed for chronic back pain can improve the multiple somatic complaints
      associated with the COVID Long Haul Syndrome in patients without evidence of ongoing tissue
      injury. We will perform a 12-week intervention consisting of a series of classes which will
      focus on knowledge therapy, desensitization, emotional expression, and stress reduction.
    

Intervention name(s): Mind Body Syndrome Therapy for Long Covid
Intervention type(s): Behavioral
Intervention description(s): The intervention consists of a mind-body based intervention for the COVID long haul syndrome. The components of the intervention include knowledge therapy, desensitization, emotional expression, and stress reduction techniques.
Intervention model: Single Group Assignment
Intervention model description: Feasibility/pilot Study
Masking: None (Open Label)
Primary purpose: Treatment
Propolis Effects in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine the impact of Propolis on proteinuria reduction and
      protection of the glomerular filtration rate in chronic renal failure patients.
    


Intervention name(s): Propolis; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses; Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses
Intervention MeSH terms: Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Proteinuria; Propolis; Chronic Kidney Disease
Study of Atenolol Influence on Blood Pressure During Resistance Exercise
Condition: Blood Pressure; Exercise
Study type: Interventional
Phase: Phase 4

Summary: 
      The study was designed to investigate if atenolol is able to blunt blood pressure increase
      during resistance exercise in hypertensive subjects.
    

Detailed description: 
      The study compared intra-arterial blood pressure responses during leg-extension resistance
      exercise performed to fatigue at 40, 80 and 100% of 1 RM in hypertensive patients receiving
      placebo (first) and atenolol (second) on a single blind manner.
    

Intervention name(s): atenolol
Intervention type(s): Drug
Intervention description(s): 25 mg/day, twice a day for 6 weeks
Other intervention name(s): beta-blockers
Intervention MeSH terms: Atenolol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: resistance exercise; beta-blockers; blood pressure
Vitamin D and Calcium Study
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Vitamin D aids in the body's ability to absorb calcium, it is a vital component in bone
      formation and break down. Reduced levels of vitamin D can indicate a vitamin deficiency and
      may depress serum calcium levels. The following is a list of common causes of vitamin D
      deficiency: lack of dairy products, alcohol usage, elderly, lack of exposure to sunlight,
      individuals with reduced mobility, GI malabsorption problems, dark complexion, severe liver
      damage, and renal failure. Many of these factors can be found in individuals with spinal cord
      injury. SCI results in disuse bone loss after acute injury, which continues with duration of
      injury. The goal of this study is to determine the effects of vitamin D and calcium
      supplements on calcium metabolism and vitamin D deficiency in individuals undergoing
      functional electrical stimulation (FES) stand retraining (SRT).
    


Intervention name(s): Vitamin D and Calcium
Intervention type(s): Dietary Supplement
Intervention description(s): 2000 IU/day Vitamin D3 (cholecalciferol) and 1.3 g/day calcium carbonate will be taken for 15-20 weeks.
Intervention MeSH terms: Vitamin D; Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury; Vitamin D deficiency; Functional Electrical Stimulation
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
Condition: Primary Immunodeficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether biweekly (every 2 weeks) administration of
      Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
      produces a steady-state area under the concentration versus time curve (AUC) of total
      Immunoglobulin G (IgG) that is non-inferior to that produced by weekly administration of IGSC
      20% in treatment-experienced participants with primary immunodeficiency (PI).
    


Intervention name(s): IGSC 20%
Intervention type(s): Biological
Intervention description(s): SC infusion pump.
Other intervention name(s): Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified
Intervention MeSH terms: Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Single sequence crossover design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunologic Deficiency Syndromes; Immune System Diseases; Immunoglobulins