bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the safety of the investigational study product and
      see how well it works to relieve signs and symptoms of children with mild to moderate Atopic
      Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product.
      This study was conducted to assess the safety of the investigational new study product and
      how well it works to treat AD in children, by making AD visually better, and reducing the
      amount of itch.
    

Detailed description: 
      This was a multi-center, double-blind, randomized, active-controlled trial in children 2 to
      12 years of age with mild to moderate AD. A sufficient number of subjects were screened to
      ensure that approximately 80 subjects were randomized, to yield 70 completed subjects.
      Subjects were randomized to one of the two treatment groups: the J&J Device or Atopiclair®.
      All subjects were to return to the clinical site for clinical assessments at baseline (Day 1)
      and at Days 3, 8, 15, 22, 29 and 43 after initial investigational product application. The
      investigational products were used topically during the duration of the study.
    

Intervention name(s): F# 11054-010; F# 10495-053
Intervention type(s): Device; Device
Intervention description(s): Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.; Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.
Other intervention name(s): Investigational Device; Atopiclair® Skin and Wound Emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: eczema
BIIR Gene to Manage Heart Allograft Patients
Condition: Cardiac Transplant Failure
Study type: Observational

Summary: 
      This is a single center observational study. Duration of the study is 1 year. Participants
      will be followed in 2 groups. Group 1 will include all patients who have undergone a heart
      transplant, through the first year post transplant. Group 2 will include heart transplant
      recipients from 1 year to 2 years post transplant. Groups will be enrolled simultaneously. It
      is anticipated each group will have 25 participants.
    

Detailed description: 
      Application of the BIIR gene expression profile approach to heart transplantation clinical
      diagnostic issues is likely to create new means to detect rejection at the earliest stages,
      to help prevent progression through earlier treatment, to discover new avenues targets for
      treatment of heart graft rejection, and to reduce the cost of post-transplant health care
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        heart transplant patients from Baylor University Medical Center,Dallas
      
Biospecimen description: 
      To create new means to detect rejection at the earliest stages, to help prevent progression
      through earlier treatment, to discover new avenues targets for treatment of heart graft
      rejection, and to reduce the cost of post-transplant health care
    
Keywords: post tranplant heart allograft
The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research is a clinical trial of administering mesenchymal stem cell secretome to
      rheumatoid arthritis patients.
    

Detailed description: 
      This research is experimental. The research subjects were 30 rheumatoid arthritis patients.
      The control group received a placebo, and the treatment group received mesenchymal stem cell
      secretome on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th. The data collected
      were erythroblastic acidity, hsCRP, interlukin 6, DAS-28, and assessment of drug side effects
      before and after therapy. Statistical test with paired difference test with p<0.05
    

Intervention name(s): Messenchymal stem cell secretome; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mesenchymal stem cell secretome obtained from Kalbe Pharma Company; NaCl 0,9% infusion
Other intervention name(s): Messenchymal stem cell Concitioned Media; NaCl 0,9% infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis, Messenchymal stem cell secretome
Long-term Results of Pediatric Flexor Tendon Injuries
Condition: Hand Injuries; Flexor Tendon Injury
MeSH terms: Wounds and Injuries; Tendon Injuries; Hand Injuries
Study type: Observational

Summary: 
      Hand and upper extremity injuries are among the most common causes of admission of children
      to the emergency department since they are the most frequently injured part of body following
      head in pediatric and adolescent population. Although upper extremity fractures and
      contusions are the main reasons of pediatric hand injuries, tendon injuries are not also
      uncommon. There are limited data in the literature about the long-term results of children
      with flexor tendon injury. Therefore, the aim of this study was to evaluate the long-term
      functional outcomes of children with flexor tendon injury.
    

Detailed description: 
      Hand and upper extremity injuries are among the most common causes of admission of children
      to the emergency department since they are the most frequently injured part of body following
      head in pediatric and adolescent population. Although upper extremity fractures and
      contusions are the main reasons of pediatric hand injuries, tendon injuries are not also
      uncommon. While extensor tendon injuries have been reported to be most frequent than flexor
      tendon injuries for all age groups, the ratio of flexor to extensor tendon injuries is higher
      in pediatric population than adults and in children younger than 10 years old flexor tendon
      injuries are more common than extensor tendon injuries.Despite some challenges in the
      treatment of flexor tendon injuries of children, the outcomes have been reported to be better
      in children than adults since they have better blood supply, more rapid tendon healing and
      better remodeling ability of scars and adhesions. However, there is still a risk of permanent
      morbidities such as significant scarring and stiffness which can cause worse functional
      outcomes.There are limited data in the literature about the long-term results of children
      with flexor tendon injury. Therefore, the aim of this study was to evaluate the long-term
      functional outcomes of children with flexor tendon injury.
    

Intervention name(s): Screening
Intervention type(s): Other
Intervention description(s): The patients who agreed to participate to the study were assessed with a survey which included age, gender, height, weight and hand dominancy questions. Sensory, motor and functional assessments of the bilateral hand were performed.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with flexor tendon injury
      
Keywords: flexor tendons; children; functional outcome; hand injury
Sun Protection for Florida's Children
Condition: Skin Cancer
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      Purpose of the project is to develop a school-based intervention aimed at increasing hat use
      when children are outside at home and at school. The intervention is targeted to fourth grade
      children in Hillsborough County, Florida and is based on Theory of Reasoned Action and
      Planned Behavior. It is structured to accomplish the following goals: (a) increase sun
      protection knowledge of children in regards to hat use,(b) foster more positive attitudes in
      regard to wearing hats,(c) change the subjective norms of wearing hats (d) target persons
      that children perceive as controlling their behavior of wearing hats(parents,teachers) and
      increase the use of hats when children are outdoors at school(primary outcome) and when
      outdoors at times other than school(secondary outcome).
    

Detailed description: 
      Intervention is aimed at encouraging students to use a wide brim hat when participating in
      outdoor activities. To accomplish this goal our approach will be multifaceted and will
      include:

        1. individual sessions with school principals to facilitate a school policy that encourages
           hat use when children are outdoors.

        2. sessions with fourth grade teachers that explains the importance of sun protection and
           hat use, and that addresses potential concerns by teachers.

        3. classroom sessions with fourth grade children that improves sun protection knowledge,
           fosters more positive attitudes about hat use. and that changes the subjective norm of
           wearing hats when at school.

        4. follow-up sessions in which children are provided free hats with a customized design
           that represents their school.

        5. sun protection educational materials that are mailed to the parents of targeted
           children.
    

Intervention name(s): Increasing hat use
Intervention type(s): Behavioral
Intervention description(s): Sun protection intervention that address sun protection knowledge, attitudes, social norms, and perceived behavioral controls. Intervention also provides free wide brimmed hats
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children's behavior towards hat use
Xolair in Patients With Chronic Sinusitis
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair
      (omalizumab), will improve objective and subjective evidence of chronic sinusitis.
    

Detailed description: 
      At its most basic level, sinusitis is defined as an inflammation of the lining membrane of
      the paranasal sinuses. Sinusitis affects all age groups, including 17% of people above the
      age of 65 years. On the basis of national population surveys and insurance-reimbursement
      claims, sinusitis is one of the most common health problems in the U.S. Thus, each year,
      billions of dollars are spent on direct medical costs for the treatment of this enigmatic
      illness.

      Despite the enormous cost of the problem, there are no definite studies of treatment and
      management. There are some data indicating that intranasal steroids are effective, and
      recently Nasonex was approved for the treatment of nasal polyps. All other treatments are
      empirically based.

      There is evidence that IgE antibodies play a role in chronic sinusitis. The investigators
      have shown that total IgE levels correlate with the severity of sinusitis, as assessed by CT
      scan. Staphylococcus enterotoxins cause local increases in total IgE in over 50% of nasal
      polyp patients. Allergies occur more frequently in patients with chronic sinusitis than in
      the general population. Elevations in total IgE have been shown to occur in patients with
      allergic fungal sinusitis and the levels of total IgE decrease with successful treatment.
      Thus, the investigators speculate that IgE contributes significantly to the pathogenesis of
      chronic sinusitis.

      The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair,
      will improve objective and subjective evidence of chronic sinusitis.
    

Intervention name(s): Anti-IgE antibody omalizumab or placebo
Intervention type(s): Drug
Intervention description(s): given subcutaneously oce or twice monthly depending on dose
Other intervention name(s): Xolair or placebo
Intervention MeSH terms: Omalizumab; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic sinusitis
A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol
Condition: Healthy Volunteers; Pharmacokinetics of ASP1941
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in
      healthy volunteers.
    

Detailed description: 
      This will be a randomized, open-label, 3-way crossover design study to assess the drug-drug
      interaction between a single oral dose of ASP1941 and a single oral dose of Miglitol in
      healthy adult male volunteers. Each subject will receive "ASP1941 alone", "Miglitol alone"
      and "ASP1941 + Miglitol".
    

Intervention name(s): ASP1941; Miglitol
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Seibule
Intervention MeSH terms: Ipragliflozin; Miglitol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP1941; Miglitol
Tiotropium in Combination With Concomitant Cimetidine or Ranitidine in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of an inhibition of the renal cationic drug transporter on
      single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical
      Chronic Obstructive Pulmonary Disease (COPD) population
    


Intervention name(s): Cimetidine + Tiotropium; Ranitidine + Tiotropium; Tiotropium
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ranitidine; Ranitidine bismuth citrate; Cimetidine; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes
      mellitus.
    

Detailed description: 
      Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal
      models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in
      petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of
      type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta
      cell function in patients with recently diagnosed type 1 diabetes mellitus.
    

Intervention name(s): pioglitazone; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone daily; dose varies with size; Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
Other intervention name(s): Actos; Actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Insulin dependent diabetes; Juvenile onset diabetes; pioglitazone
Metabolism of the Insecticide Permethrin
Condition: Pharmacokinetics; Metabolism
Study type: Interventional

Summary: 
      Military personnel are exposed to the insecticide permethrin when using the DOD Insect
      Repellent System. A urinary metabolite of permethrin that is in high abundance and is
      relatively stable may be an ideal biomarker of exposure to this pesticide. Monitoring such a
      biomarker can prevent over-exposure. The objectives are to identify the most abundant human
      urinary metabolite following dermal exposure; to utilize this information to develop rapid
      laboratory-based and field portable methods to monitor the degree of an individual's exposure
      to permethrin.
    

Detailed description: 
      Permethrin is applied to the forearm of the subject and remains for 8 hours. The exposed area
      is then washed with soap and water several times. 24 hour urine samples are collected at
      daily intervals for 192 hours. Blood and saliva samples are taken at pre-dose, 1, 3, 6, 9 12,
      24, 48, 72, 96, 120, 144, 168 and 192 hours. Subjects must return to the clinic daily to drop
      off urine collections and have blood and saliva samples taken.
    

Intervention name(s): permethrin insecticide
Intervention type(s): Other
Intervention description(s): 25 mg neat carbon-14 labelled permethrin applied dermally in isopropyl alcohol, once for 8 hours containing 1 microcurie of carbon-14
Intervention MeSH terms: Permethrin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: permethrin; pyrethroid; pharmacokinetics; metabolism; accelerator mass spectrometry; human exposure
Resveratrol for the Treatment of Non Alcoholic Fatty Liver Disease and Insulin Resistance in Overweight Adolescents
Condition: NAFLD; TYPE 2 DIABETES; METABOLIC SYNDROME
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2; Overweight; Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The current project is designed as a 30-day pilot trial to demonstrate the safety and
      tolerability of resveratrol therapy in overweight adolescents to decrease liver fat, and
      improve insulin sensitivity to prevent type 2 diabetes.
    

Detailed description: 
      Pilot study of 10 overweight or obese children with MRS determined fatty liver randomized to
      resveratrol or placebo. Primary outcome measures include change in liver triglyceride content
      as determined by MRS and improvement in insulin resistance as determined by the area under
      the curve of glucose excursion during a 75 gram oral glucose tolerance test.
    

Intervention name(s): Resveratrol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): All adolescents will receive standardized lifestyle counselling at enrolment designed and disseminated by a registered dietitian as well as a licensed physiotherapist who both have experience working with overweight adolescents. The lifestyle component will be goal-based and tailored to each participant. The overall content and messaging will be consistent for all participants with nutritional recommendations based on Canada Food Guide and physical activity counselling aligning with the Healthy Active Living Recommendations of the Canadian Pediatric Society and Health Canada's Physical Activity Guidelines.; All adolescents will receive standardized lifestyle counselling at enrolment designed and disseminated by a registered dietitian as well as a licensed physiotherapist who both have experience working with overweight adolescents. The lifestyle component will be goal-based and tailored to each participant. The overall content and messaging will be consistent for all participants with nutritional recommendations based on Canada Food Guide and physical activity counselling aligning with the Healthy Active Living Recommendations of the Canadian Pediatric Society and Health Canada's Physical Activity Guidelines.
Other intervention name(s): ResVida (Registered Trademark of DSM)
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Resveratrol as ResVida (TM) compared to a placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pediatrics; Adolescents; NAFLD; Spectroscopy; Type 2 diabetes
Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      Objective: to evaluate the effects of a speech therapy exercises program in the treatment of
      Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography
      (PSG) parameters.

      Methods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index < 35
      kg/m2 and scores of Epworth Sleepiness Scale > 9. Patients will be divided into four groups:
      I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent
      placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent
      speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or
      placebo. The speech therapy include isometric and isotonic exercises to improve posture,
      mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of
      tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck,
      without therapeutic purpose. Both therapies are applied for three months, three times a day,
      lasting 20 minutes each session. During the treatment, the subjects will be monitored in
      weekly meetings, for orientation and description of the exercises and return of the fulfilled
      exercises diary. The subjects will also be followed at the CPAP clinic in returns after one
      week, a month and at the end of the study. Conduct assessments before and after treatment and
      after twenty one days washout, including: assessing the upper airway, anthropometric
      investigation of the facial skeleton and speech of Orofacial, questionnaires (Epworth
      Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring), Psychomotor
      Vigilance Test and PSG.
    


Intervention name(s): Continuous Positive Airway Pressure (CPAP)
Intervention type(s): Device
Intervention description(s): mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; oropharyngeal exercises; speech therapy