bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Myofascial Release With and Without Thiele Massage
Condition: Dyspareunia; Pain; Quality of Life
MeSH terms: Dyspareunia
Study type: Interventional

Summary: 
      Dysperunia is caused by chronic discomfort during sexual intercourse causing pain during
      vaginal intercourse.Sexual pain causes relationship decreasing quality of life following
      anxiety and depression.Myofascial techniques with and without Thiele massage will be used via
      randomised controlled trial following sample size of 38.
    

Detailed description: 
      Dyspareunia is characterised by recurring or chronic discomfort during sexual intercourse
      that causes distress. Dyspareunia can be superficial, causing pain when vaginal insertion is
      tried, or profound. Women who experience sexual pain are more likely to experience sexual
      dysfunction, relationship distress, decreased quality of life, anxiety, and depression. One
      in five nulliparous women (a female who has never given birth to a baby) experiences moderate
      dyspareunia. Myofascial pain is typically treated using manual manipulation (Manual
      manipulation involves using skilled, hands-on maneuvers to perform soft tissue mobilization,
      myofascial release and more) or Thiele massage. In this study the aim is to find the
      individual and combined effect of these techniques. The study will be Randomized Controlled
      Trial (RCT). Non probabiity convenient sampling technique will be used to assign randomly
      half of patients in group A for the experimental group and half in group B who will meet the
      inclusion criteria. Group A will include participants who will receive myofascial releases
      and Thiele massage. Whereas Group B will include participants who will receive myofascial
      releasing techniques but not Thiele massage.

      Both group will have 1 session per week for 12 weeks. Numeric pain rating scale, Female
      sexual function index, Functional pelvic pain scale would be used as an outcome measure
      tools.

      The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25
    

Intervention name(s): Myofascial release techniques; Thiele massage
Intervention type(s): Other; Other
Intervention description(s): 12 treatment sessions will be given in 12 weeks; 12 treatment sessions will be given in 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dyspareunia; Pelvic floor disorder; Pelvic pain; Myofascial release technique; Pelvic floor
Asthma in the Delta Region of Arkansas: Characterization of Disease and Impact of Environmental Factors
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of the study is to evaluate asthma and examine the homes of children with asthma
      living in rural areas of the state. This study is being done to give investigators more
      information about the presence of allergens and endotoxin in the homes of children with
      asthma living in the delta region of Arkansas.
    

Detailed description: 
      Asthma is the most common chronic disease of children and disproportionately affects minority
      and low-income children. Current pediatric asthma research in this high-risk group focuses on
      children living in inner-city environments. Low-income, minority children with asthma from
      non-urban locales have not been studied extensively. The specific aims of the study will
      examine the impact of home environmental exposure to endotoxin on asthma severity and atopy
      status in the rural setting among predominately African American, low-income asthmatics. This
      study will answer several research questions. The first question involves the relationship
      between asthma severity and exposure to endotoxin among rural children at high risk for
      increased morbidity and mortality. Second, the relationship between atopy and endotoxin
      exposure has been the subject of recent debates among asthma researchers. The hygiene
      hypothesis suggest that the recent rise in atopic disease in Westernized societies is due to
      decreased microbial burden. Last data on atopy and aeroallergen exposure among high-risk
      rural asthmatics will be critical in the design and implementation of future intervention
      programs.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be children with asthma, ages 4-17 years from the Mississippi Delta
        region. The Mississippi Delta has been identified as one of the poorest,
        medically-underserved regions of the United States, and includes the geographic regions of
        Arkansas, Louisiana and Mississippi that are contiguous with the Mississippi River.
        Participants for the study will be recruited from Eudora, Lake Village, Marvell and Elaine
        public school districts. Since June 2008, the Dumas Public School District has been added
        in the recruitment. These districts are located in the Delta region of Arkansas where more
        than one-third of families with children 5-17 years are below the 2000 poverty line (Census
        bureau). Students in these school districts are predominately of a miniority population.
      
Biospecimen description: 
      Optional buccal swab samples will be obtained from participants. This is done by touching the
      inside of the participant's cheek to collect a sample of the cells in his/her mouth with a
      cotton swab type applicator.
    
Keywords: Asthma, Children, Rural Population, Morbidity, Endotoxin
Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Bipolar Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      There is a scarcity of clinical trials assessing the effects of medications in children with
      bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel
      anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder
      comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group
      trial. Patients were randomized to either aripiprazole or placebo.

      The main hypotheses are:

        1. Aripiprazole will significantly reduce maniac scores compared to placebo

        2. Aripiprazole will significantly reduce ADHD scores compared to placebo
    

Detailed description: 
      Bipolar disorder (BD) is a chronic disorder that severely affects the normal development of
      children and adolescents. The disorder is associated with high rates of suicide tentative and
      high-risk behaviors like sexual promiscuity and drug abuse. Bipolar disorder in children is
      also associated with high rates of comorbidity, especially with Attention-Deficit
      Hyperactivity Disorder (ADHD). There is a scarcity of clinical trials assessing the effects
      of medications in children with BD. Moreover, the frequent presence of comorbid ADHD might
      determine lower response to treatment. Aripiprazole is a novel anti-psychotic drug. Its
      mechanism of action seems to be related to a stabilization of dopaminergic transmission,
      acting as a partial agonist especially in dopaminergic D2 receptors. It also has effects in
      5-HT1a serotonergic receptors. Thus, it might have a promising effect in children and
      adolescents with comorbid BD and ADHD. A retrospective chart review, recently published,
      suggests the efficacy of this drug in children with BD. This study aims to assess the
      efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of 50 children and
      adolescents (age range: 08 to 17 years-old) with Bipolar Disorder comorbid with ADHD. The
      study design is an 6-week randomized, double blind, parallel group trial. Patients were
      randomized to either aripiprazole or placebo. The hypotheses are: 1) Aripiprazole will
      significantly reduce maniac scores compared to placebo; 2)Aripiprazole will significantly
      reduce ADHD scores compared to placebo; 3) Aripiprazole will not be significantly associated
      to weight gain compared to placebo.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: clinical trial; aripiprazole; Bipolar Disorder; Attention-Deficit Hyperactivity Disorder; ADHD
Temperature and Healing in Treatment of Gingival Enlargement
Condition: Gingival Enlargement
MeSH terms: Gingival Hyperplasia; Gingival Hypertrophy; Gingival Overgrowth; Hypertrophy
Study type: Interventional

Summary: 
      Aim: Gingival enlargement is a common clinical condition which requires surgical approaches
      to alleviating these enlargement areas. The aim of this study was to investigate
      epithelization, gingival temperature, inflammation and pain levels in post-operative healing
      process in 4 different gingivectomy techniques including Er:YAG laser, Nd:YAG laser,
      electrosurgery and conventional gingivectomy in treatment of chronic inflammatory gingival
      enlargements.

      Material and Method: A split-mouth designed study was conducted on 37 systemically healthy
      patients consisting of 19 females and 18 males, who had gingival enlargement areas on the
      left and right of maxillary and mandibular anterior regions. Gingival crevicular fluid (GCF)
      samples were collected, clinical periodontal parameters and gingival temperature levels were
      recorded at baseline and in the postoperative period. The gingival temperature was measured
      during surgical procedures. Gingival temperature and epithelization levels in 3rd, 7th, 10th
      and 15th days; GCF levels in 15th, 30th, and 90th days and pain levels in 2nd and 8th hours
      and between 1st-7th days of post-operative healing process were evaluated.
    


Intervention name(s): Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery
Intervention type(s): Procedure
Intervention description(s): Er: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) 200 mj, 10 Hz, 2 Watt and VLP (long pulse, 1000 μs); 1.3 mm diameter, 8 mm long cylindrical, a sapphire tip was used with air cooling and water irrigation.
Nd: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) was applied at 4 watts, 50 Hz, 300 μm microfiber tip and SP (short pulse: 180 μs) settings.
Electrosurgical (Servotome Classic System, High Frequency Surgical Equipment, Satelec, France).
Conventional surgical method was applied with hand instruments and gingivectomy knives.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The present study was designed as a controlled clinical study with a randomized design. The study protocol was approved by the local ethical committee of Clinical Studies of Ondokuz Mayis University. The study population consisted of 37 participants (19 women, age 23.10±2.78, 18 men age 21.11±2.63).
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: gingival enlargement, Er:YAG, Nd:YAG, electrosurgery
Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary
      fiber, on clinical symptoms, gut microbiota and the immune status in patients with
      diarrhea-predominant irritable bowel syndrome
    

Detailed description: 
      Patients were randomized to receive either pectin or placebo. Treatment consisted of 6 weeks
      supplementation with pectin (fiber group) or placebo (maltodextrin). We evaluated the
      clinical symptoms, gut microbiota and the immune markers in two groups.
    

Intervention name(s): Pectin; maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Pectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; Gut microbiota; Soluble dietary fiber
Fluoride Administered and Retained After Topical Fluoride Varnish
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The specific aim of the study is to determine the excess urinary fluoride and its time course
      after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15
      month old infants. From these data the investigators can estimate the bioavailable (more
      precisely the equivalent) dose of sodium fluoride and the peak serum fluoride concentration
      that will allow an estimate of the margin of safety of the procedure.
    

Detailed description: 
      Fluoride varnish painted on the teeth is the standard method dentists use to prevent tooth
      decay (cavities) in preschool children in the United States. Fluoride varnish is not FDA
      approved specifically for prevention of cavities, but dentists may legally use it for this
      purpose. We want to study how much fluoride appears in the urine after the painting procedure
      to improve our knowledge of how the varnish works and its safety. The fluoride varnish is
      being used for research purposes for this study by permission of FDA (IND #110869).

      Premier Dental Product Company's Enamel Pro Varnish will be used. Up to six children aged
      12-15 months will be enrolled in this study. We measured urinary fluoride for 5 hours after
      application of fluoride varnish to teeth. Baseline levels were measured on a separate day.
    

Intervention name(s): Fluoride varnish
Intervention type(s): Device
Intervention description(s): Topical application of fluoride varnish on present teeth
Other intervention name(s): Premier Enamel Pro
Intervention MeSH terms: Fluorides; Fluorides, Topical
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: children; fluoride varnish
Effects of Legumes Consumption on Weight Reduction
Condition: Obese
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This is a 12-week, randomized nutritional intervention study to determine the effect of
      legumes consumption on body weight in obese subjects.
    


Intervention name(s): Legume enriched diet group
Intervention type(s): Behavioral
Intervention description(s): Replacing 1/3 refined rice intake with legumes three times per day
Vegetable intake at least six units (30-70 g/unit) per day for sufficient dietary fiber intake
Regular 30-min walk after dinner each day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: legumes; obesity; body weight; adiponectin; 8-epi-PGF2α; insulin resistance
Type 2 Diabetes Primary Prevention for At Risk Girls
Condition: Obesity; Diabetes Mellitus; Prediabetic State
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls.

      The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled
      to tripled in the past two decades, with the highest rates among poor and ethnic minority
      girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in
      overweight children, and more children are manifesting precursors of heart disease and
      stroke.

      Our Two Approaches:

        1. A state-of-the-art nutrition education program with monthly newsletters mailed to girls
           and their parents and quarterly evening lectures/educational events at school sites,
           including cooking demonstrations and games to improve nutrition and increase physical
           activity.

        2. After-school dance classes held five days per week all year long at school sites from
           the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised
           homework study hall each day, and emphasize both traditional ethnic dances and popular
           dance.

      Participants: Second, third and fourth grade girls and their families will be eligible to
      participate. All activities are free of charge. To be able to perform a valid evaluation, to
      be able to accommodate all girls at their own school, and to be fair about which girls
      receive which program, families who wish to participate will be randomly selected to
      participate in either one program or the other (nutrition education or dance classes). Each
      family will participate for two years.

      Evaluation: Trained Stanford staff will perform all evaluation procedures with participating
      families in their own homes at the beginning and every six months. Families will be
      compensated for their participation.
    


Intervention name(s): Nutrition Education; After-school dance class
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: exercise; eating; dance; health education; obesity prevention; diabetes prevention; children
The Effect of a Wearable Hip Assist Robot on Cardiopulmonary Metabolic Efficiency During Stair Ascent in Elderly Adults
Condition: Gait, Unsteady; Health Behavior
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      The aim of this study was to identify the assistance effect of the new wearable hip assist
      robot, gait enhancing mechatronic system (GEMS) developed by Samsung Advanced Institute of
      Technology (Samsung Electronics Co, Ltd., Korea) during stair ascent by comparing the energy
      expenditure of elderly adults with and without the GEMS.
    

Detailed description: 
      Primary objective of this study is to demonstrate the effect of a wearable hip assist robot
      on cardiopulmonary metabolic efficiency during stair ascent in elderly adults.

      Fifteen elderly adults participated in this study. The stair ascent trials were designed to
      climb stairs from the first basement level to the fourth floor of the Proton Therapy Center,
      Samsung Medical Center, Korea. The metabolic energy expenditure was measured using a portable
      cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy) while participants performed
      randomly assigned two different conditions consecutively:, free ascent without the GEMS
      (NoGEMS) or robot-assisted ascent with the GEMS (GEMS). Participants rested for 10 minutes
      between the two trial conditions.
    

Intervention name(s): Wearable hip assist robot
Intervention type(s): Device
Intervention description(s): All participants climbed stairs from the first basement level to the fourth floor of the Proton Therapy Center, Samsung Medical Center, Korea with and without a wearable hip assist robot. During climbing stairs, the metabolic energy expenditure of all participants was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Wearable hip assist robot; Elderly adult; Metabolic energy expenditure; Stair ascent
Attitudes and Understanding of Sodium Claims on Food Labels
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Sodium-related claims on food labels should help people find lower sodium food choices;
      however consumer attitudes and understanding of such claims are unknown.

      The objective of this study was to evaluate: 1) the attitudes and understanding to different
      types of permitted sodium claims and 2) the effect of hypertension on responses to such
      claims.
    


Intervention name(s): Mock package questionnaire
Intervention type(s): Behavioral
Intervention description(s): Within a online questionnaire we exposed participants randomly to 4 mock packages differing only by the nutrition claim it carried and asked participants to answer several questions on attitudes and understanding after each mock package.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A subsection of the Canadian Consumer Monitor Panel - a national representative online
        consumer panel comprised of 30,000 Canadians
      
Keywords: Attitudes and understanding of sodium claims; General canadian population
CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy
Condition: B-cell Leukemia; B-Cell Lymphoma
MeSH terms: Leukemia, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting
      chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy.
    

Detailed description: 
      Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting
      chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy. The CAR consists
      of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3
      zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a
      retrovirus vector. Prior to T cell infusion, the patients will be subjected to
      preconditioning treatment. After the second infusion patients will be subjected to
      immunomodulatory treatment. After T cell infusion, the patients will be evaluated for 24
      months for adverse reactions, persistence of CAR T cells and efficacy.

      Primary outcome:

      - Registration of the safety profile such as inflammation, fever, pain, changes in blood
      pressure, pulse and other adverse events.

      Weekly for the first 6 weeks, then at 3, 6, 9, 12, 15, 18, 21 and 24 months.

      Secondary outcome:

      Tumor response, CAR T cell persistence and immunological profile

        -  Determination of tumor size and the tumor marker CD19.

        -  Determination of the levels of circulating B cells.

        -  Determination of the level of CAR T cells (mRNA and cells) in blood and biopsies.

        -  Determination of activation markers on CAR T cells such as CD107a.

        -  Determination of the presence of immunological markers in blood and biopsies.

      At 1 and 3 weeks then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
    

Intervention name(s): CAR T cells
Intervention type(s): Biological
Intervention description(s): Autologous CD19-targeting, 3rd generation CAR T cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment