bioihbjkbjnl/mcl2 huggingface dataset:
Reading Problems in Children Living in Urban Areas
Condition: Dyslexia
MeSH terms: Dyslexia
Study type: Interventional
Phase: Phase 3

Summary: 
      The first line of defense against reading disabilities is good classroom reading instruction.
      This study describes how characteristics of students, teachers, and instruction relate to
      academic achievement in inner-city kindergarten through Grade 4 classrooms.
    

Detailed description: 
      Recent studies show that the incidence of reading disability can be significantly reduced by
      improving classroom instruction. Effective reading instruction in the primary grades includes
      explicit instruction in the alphabetic principle, reading for meaning, and opportunities to
      practice reading and writing. To learn more about the development of literacy skills in urban
      settings, students in 17 schools in Houston and Washington, D.C., were followed from
      kindergarten through Grade 4. Schools were selected based on similar demographics:
      predominantly African-American student population (95%) and high participation in the federal
      lunch program (85% to 100%). Each school was provided with grade-appropriate reading programs
      that focused on phonics and spelling. These programs included direct, integrated, classroom,
      and individual instruction modules.

      Approximately 1400 children and 114 teachers participated each year in this four-year study.
      The design was cross-sequential so that the majority of teachers in a grade participated for
      two years. All children participating in regular education were included in the study.
      Children below the 25th percentile on a standardized reading test were tutored individually
      by retired teachers, using materials from the classroom reading program. A variety of reading
      curricula were in place in the classrooms across these two sites. In order to help teachers
      implement these materials effectively, an ongoing research-based professional development
      model was employed, with curriculum consultants and coaches working with the teachers in the
      classroom. Researchers observed in each classroom four to six times during the year using
      on-the-minute recordings of content. Observers also completed ratings of teaching
      competencies. Teachers completed surveys of knowledge, experience, attitudes, and
      instructional strategies. A random selection of eight to ten students were assessed four
      times during the year for growth in literacy-related skills and once at the end of the year
      for achievement in reading, spelling, and writing.
    

Intervention name(s): Reading Instruction
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Reading disabilities; Inner-city; Urban
Myocarditis Treatment Trial
Condition: Cardiovascular Diseases; Heart Diseases; Myocarditis
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocarditis
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether immunosuppressive treatment improved cardiac function in patients with
      biopsy-proven myocarditis.
    

Detailed description: 
      BACKGROUND:

      Heart failure due to myocarditis can be a devastating illness. At the same time,
      immunosuppressive therapy is associated with considerable risks of untoward side effects.
      Clinicians did not know whether, under what circumstances, or in what form, this hazardous
      treatment should be used in such critically ill patients. In addition, if immunosuppressive
      therapy was of benefit, then endomyocardial biopsy in patients suspected of having
      myocarditis was a justified procedure. The trial also provided information concerning the
      side effects of immuno-suppressive therapy in such patients.

      DESIGN NARRATIVE:

      Patients were randomized into two treatment arms consisting of conventional therapy alone for
      congestive heart failure or combined with a twenty-four week regimen of immunosuppressive
      therapy. Immunosuppressive therapy consisted of prednisone with either cyclosporine or
      azathioprine. The primary outcome measure was a change in the left ventricular ejection
      fraction at twenty-eight weeks. Secondary endpoints included survival, failures of therapy,
      requirements for conventional therapy, assessments of symptoms, myocardial histology, and
      arrhythmias.

      The study completion date listed in this record was obtained from the Query/View/Report (QVR)
      System.
    

Intervention name(s): cyclosporine; prednisone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclosporine; Prednisone; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression
Condition: Major Depression; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy of duloxetine in reducing depressive symptoms,
      abdominal pain, and other symptoms of Irritable Bowel Syndrome (IRS) in a population of
      outpatients with Major Depressive Disorder MDD and clinical symptoms of IBS.
    

Detailed description: 
      This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the
      treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder
      (MDD).

      Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive
      duloxetine to see if it helps their major depression and Irritable Bowel symptoms. Upon study
      completion at 12 weeks, they will receive an additional 3 months of free medication treatment
      at our clinic.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depression; Irritable Bowel Syndrome; Somatization; Cymbalta; Duloxetine
A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets
      of daridorexant in healthy male and female Japanese participants
    


Intervention name(s): Daridorexant 10 mg; Daridorexant 25 mg
Intervention type(s): Drug; Drug
Intervention description(s): Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg.; Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      A trial, investigating the influence of injection speed and volume on the perception of
      subcutaneous injection pain.
    


Intervention name(s): 0.9% NaCl (sodium chloride)
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Children´s Foot and Footwear Temperatures
Condition: Thermography
Study type: Observational [Patient Registry]

Summary: 
      This research aims to find thermal differences in foot in a group of children, detecting the
      most suitable footwear to acquire optimal foot temperature and taking into account that
      children in school age usually wear sports shoes instead of school shoes in most dimensions
      of daily life. It is assumed by general population that sports shoes increase sweating and
      provide less perspiration apart from biomechanical criteria, so for this reason the
      investigators are going to examine which thermal pattern offers each variety of footwear.
    

Detailed description: 
      Infrared thermal image allows detecting object´s temperature visually in a non-contact way.
      That makes the technique useful for different applications like in construction/ building,
      ecology, industry and medicine. Evolution of thermographic equipments makes it more
      accessible. It is a non- contact, non- invasive technique that helps researchers monitoring
      body temperature. So that, it is used to investigate ocular, liver, kidney and brain
      diseases, dental diagnosis, breast cancer detection or even sports injuries.

      It is increasing the use of thermographic imaging in podiatry, so the main trials concerned
      to diabetes mellitus, vascular disorder or dermatological applications.

      Nevertheless, there is little known about children´s foot temperature. Main studies are
      related to core temperature or variations in temperature among different parts of the body of
      enfants.

      In consequence, the investigators found a lack of information related to such a significant
      topic, not only for podiatrists, but also for population in general.
    

Intervention name(s): Infrared thermography
Intervention type(s): Other
Intervention description(s): Temperature observation in foot and footwear in healthy children
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The thermal images were taken from 162 children who were 9- 10 years old in two schools in
        Mérida (Badajoz), Spain. Their parents or legal guardians were informed and signed an
        informed consent. All children were taken infrared images, so that skin temperature was
        evaluated, by dividing the thermograms in regions of interest in dorsal and plantar images
        of each foot. Shoes were divided into two regions of interest. The measures were taken in
        two different days: the first day, children wore school footwear and the second sports
        shoes.
      
Keywords: Thermography; Children; Foot; Shoes
Comparison of Weight Loss Programs for Individuals With Severe Obesity
Condition: Obesity; Weight Loss
MeSH terms: Obesity; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a technology-based system (the
      Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40
      kg/m2). The investigators will compare two 6-month interventions: 1) a standard behavioral
      weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of
      the Body Media FIT system (SBT+FIT). The Body Media® FIT system is a novel weight loss tool
      consisting of an armband that measures energy expenditure, a digital display watch that
      provides "real time" physical activity and energy expenditure feedback, and access to a
      system website which allows individuals to track their food intake and set exercise and
      dietary goals. We will examine differences in physical activity, weight loss, and program
      adherence between groups.
    


Intervention name(s): Standard behavioral treatment; SBT + technology system (SBT+FIT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants receive a standard behavioral weight loss program similar to that used in other large trials such as Look AHEAD and the Diabetes Prevention Program. Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors.; Participants will receive a standard behavioral weight loss program and will also be asked to use the Body Media FIT system as part of their weight loss intervention. Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors. Participants in this group will also wear an armband that measures energy expenditure and they will log their food intake on the internet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight loss; Exercise; Intervention studies
The Role of OCTA in Patients Affected by Beta Thalassemia
Condition: Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Observational

Summary: 
      To investigate, using optical coherence tomography angiography (OCTA), the retinal and
      choriocapillaris vascular features in patients affected by Beta Thalassemia. Moreover we
      analyzed the structural retinal parameters (ganglion cell complex and retinal nerve fiber
      layer), using optical coherence tomography (OCT) in these patients
    

Detailed description: 
      Beta Thalassemia is one of the most common genetic hemoglobinopathy characterized by a
      defective β globulin chain synthesis leading to hemolysis and ineffective erythropoiesis.

      The study investigated the changes in retinal and choriocapillaris vascular features using
      optical coherence tomography angiography, a novel and noninvasive diagnostic technique that
      allows a detailed analysis of retinal and choriocapillaris blood flow.
    

Intervention name(s): Optical coherence tomography angiography
Intervention type(s): Diagnostic Test
Intervention description(s): Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 35 years with diagnosis of Beta Thalassemia. They did not
        present other ophthalmological diseases.
A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin
      or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate
      the safety and efficacy of Caelyx in combination with cyclophosphamide in women with
      metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.
    


Intervention name(s): Pegylated Lyposomal Doxorubicin; Cyclophosphamide
Intervention type(s): Drug; Drug
Intervention description(s): Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.; Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
Other intervention name(s): SCH 200746
Intervention MeSH terms: Cyclophosphamide; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Insulin Pump Treatment and Multiple Daily Insulin Injections in Diabetic Type 1 Children
Condition: Diabetes Mellitus, Type 1; Child
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison between insulin pump treatment and multiple daily insulin injections in 38
      children with type 1 diabetes4-16 years old. Outcome metabolic control, quality of life,
      impact of disease and cost effectiveness.

      We hypothesised that insulin pump treatment would give a better metabolic control and quality
      of life.
    

Detailed description: 
      The current standard of insulin treatment in type 1 diabetes is multiple daily insulin
      injection therapy (MDII). In the seventies, continuous subcutaneous insulin infusion (CSII)
      was introduced. CSII has been gaining popularity, perhaps because of technical advances
      resulting in improved patient comfort. In children five randomised studies(1-5) were
      completed to compare MDII and CSII. No data were gained about quality of life and impact of
      disease.

      In our trial we focussed on quality of life next to metabolic control.

      The trial was an open-labelled,randomised trial. Both efficacy and safety data were
      collected. The trial started with a 14 weeks run in phase, during all patients started
      MDII.In the following randomisation phase patients were randomised to continue MDII or to
      CSII.This phase lasted 14 weeks.In the phase thereafter all patients used CSII for 14 weeks.
      The trial was concluded by a 14 weeks allocated patient preference phase.

      Patients were type 1 diabetic children 4-16 years old with poor metabolic control.hypothesis:
      better metabolic control in CSII, better quality of life in CSII.
    

Intervention name(s): Insulin pump (CSII)
Intervention type(s): Device
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: quality of life; child diabetes mellitus type 1; Continuous subcutaneous insulin infusion(CSII); metabolic control
Microbiome Effect of Omadacycline on Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to assess microbiome changes associated with omadacycline vs.
      comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy
      volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days
      1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin
      125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and
      at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool
      and used for qPCR biomass and microbial metagenomic experiments. Results from the study will
      provide definitive data on the microbiome effects of omadacycline versus comparator
      antibiotics.
    


Intervention name(s): Omadacycline; Vancomycin Pill; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10-day course; 10-day course; 10-day course
Intervention MeSH terms: Moxifloxacin; Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: omadacycline; microbiome; healthy volunteer
Muscle Fatigue and Foot Biomechanics
Condition: Foot, Flat
MeSH terms: Flatfoot; Fatigue
Study type: Interventional

Summary: 
      Medial longitudinal arch (MLA) is a curve of the foot located at the medial side of the body
      and protection of the height of the MLA is an important factor for limb health.

      This study was planned with the aim of investigating the response of the MLA height to the
      repetitive muscle activity and determine the gender-related differences.
    


Intervention name(s): repetitive heel rise activity
Intervention type(s): Other
Intervention description(s): Participants will perform a maximal number of single-legged heel rises on a 10 degrees incline board. Participants will be permitted to apply for fingertip support at shoulder height on a wall in front of them. The test will be terminated when participants could no longer lift their heels from the incline board. The number of correct heel rises will be counted for each leg and will be used as Heel Rise Test score.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: medial longitudinal arch; foot
Therapeutic Substance Abuse Treatment in Pregnancy - 1
Condition: Alcohol Abuse; Cocaine Abuse; Marijuana Abuse
MeSH terms: Marijuana Abuse; Alcoholism; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is... To assess whether a behavioral treatment that combines
      motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective
      than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g.
      marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using
      and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer
      gestations and greater birth weight).
    

Detailed description: 
      We propose an integrated system of counseling services onsite in primary care obstetrical
      clinics, comparing a manualized brief advice (closely approximating "treatment as usual") to
      manualized motivationally enhanced cognitive behavioral therapy. Treatment providers are
      obstetrical nurses. Therapy patients are taught skill sets designed to enhance motivation to
      abstain from drugs of abuse, as well as designed to prevent relapse during the perinatal
      period. It is our hypothesis that therapy patients will be more successful at achieving
      stated study aims than those receiving brief advice.
    

Intervention name(s): MI-CBT; Brief Advice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Motivationally-enhanced cognitive behavioral skills counseling; Advice and education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment