bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to asses the compared efficacy, safety and immunogenicity of
      ENERCEPTAN® with ENBREL® in combination with Methotrexate for the treatment of patients with
      rheumatoid arthritis.
    

Detailed description: 
      Randomized, , non-inferiority, two parallel arms, 32 weeks, blind for the assessor.

      Subjects should be with inadequate response to methotrexate with stable dosis ≥ 15 and ≤ 25
      mg/week 28 days before randomization.

      Randomization will be 2:1 Enerceptan® to Enbrel® with concomitant medication of MTX
    

Intervention name(s): Etanercept; Methotrexate
Intervention type(s): Biological; Drug
Intervention MeSH terms: Etanercept; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Enhanced Support for Behavioral Barriers to Learning: An Evaluation of the SCHOOL STARS Program
Condition: Disruptive Behavior Disorder, Childhood Onset; Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder in Children; Disruptive Mood Dysregulation Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity; Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders; Child Behavior Disorders
Study type: Interventional

Summary: 
      This small pilot study will enroll children ages 5-12 years of age with disruptive behavior
      problems at school. These children and their families will be offered an enhanced model of
      primary care, which includes pre-visit record review, standardized content of primary care
      visits, post-visit care coordination by the primary care team, and coordination of services
      between the primary care team and the school. We hypothesize that children receiving this
      enhanced model of care will achieve better behavioral outcomes at both school and home.
    


Intervention name(s): enhanced model of primary care
Intervention type(s): Other
Intervention description(s): The SCHOOL STARS model of care includes pre-visit planning, standardized visit content, post-visit care coordination, and coordination between primary care and school.
Other intervention name(s): SCHOOL STARS care model
Intervention model: Single Group Assignment
Intervention model description: Pre-post within-subject design
Masking: None (Open Label)
Primary purpose: Health Services Research
Basic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction
Condition: Strabismus
MeSH terms: Strabismus; Exotropia
Study type: Interventional

Summary: 
      To evaluate preoperative risk factors for overcorrection and undercorrection following
      surgery for basic intermittent exotropia such as axial length of the globe, refractive error,
      age and sex
    


Intervention name(s): Strabismus surgery
Intervention type(s): Procedure
Intervention description(s): Recession and resection of horizontal extra ocular muscles
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mesalamine in Environmental Enteropathy
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Undernutrition is one of the most important health issues in Kenya. Children who are
      chronically undernourished do not reach their full potential and are at increased risk of
      infectious disease. Stunting occurs in a third of Kenyan children and has severe and
      long-term consequences in terms of health, development, and poverty. Several studies have
      shown that stunting is frequently associated with subclinical inflammation of the bowel, a
      condition referred to as Environmental Enteropathy (EE), previously known as 'tropical sprue'
      or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel diseases
      (IBD), including Crohn's disease. The treatment of IBD routinely involves provision of gut
      immunomodulatory agents, but this approach has never been tried in EE.

      This proposal outlines a pilot double-blind randomised placebo-controlled trial of mesalamine
      (also called mesalazine - the safest immunomodulator used in IBD with least systemic
      activity) in treatment of severely malnourished children with EE.
    


Intervention name(s): Mesalamine; Placebo granules
Intervention type(s): Drug; Drug
Intervention description(s): Mesalamine granules; Provided by Ferring Pharma
Other intervention name(s): Mesalazine, Pentasa (trade name)
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
Condition: Osteoporosis, Post-menopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate how teriparatide or zoledronic acid affects the
      bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone
      biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12
      months of treatment all participants are eligible to participate in an additional 12-month
      open label extension.
    


Intervention name(s): Teriparatide; Zoledronic Acid
Intervention type(s): Drug; Drug
Intervention description(s): 20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.; 5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Other intervention name(s): LY333334; Forteo; Forsteo
Intervention MeSH terms: Zoledronic Acid; Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: osteoporosis; teriparatide; zoledronic acid; histomorphometry; bone biopsy; postmenopausal
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group,
      Clinical Study in the Treatment of Acne Vulgaris
    

Detailed description: 
      A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group,
      Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne
      Vulgaris
    

Intervention name(s): IDP-126 Gel; IDP-126 Component A; IDP-126 Component B; IDP-126 Component C; IDP-126 Vehicle Gel
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Gel; Component A; Component B; Component C; Vehicle Gel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Influence of of Cream With the Silver Fir Wood Extract (Belinal) on Skin
Condition: Wrinkles; Ageing; Photoprotection; Skin Care; Skin Cream
Study type: Interventional

Summary: 
      Objective of the study is to determine the influence of the cream with Silver fir wood (Abies
      alba) extract (Belinal) on the skin parameters and functions in comparison to the placebo
      cream. 10 healthy female subjects will use the test cream on one half and placebo cream on
      the other half of the face and of the gluteal part twice a day for 12 weeks. Various face
      skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12
      weeks of the cream use. To evaluate the photoprotective potential of Belinal the minimal
      erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the cream
      use at the gluteal area.
    

Detailed description: 
      Objective of the study is to determine the influence of the cream with Silver fir wood (Abies
      alba) extract (Belinal; 2% cream) on the skin parameters and functions in comparison to the
      placebo cream. 10 healthy female subjects will use the test cream on one half and placebo
      cream on the other half of the face and of the gluteal area (split-face and split-gluteal
      area ) twice a day for 12 weeks. Face skin parameters will be evaluated before the cream use
      (the baseline), after 6 and after 12 weeks of the cream use. The photoprotective potential of
      Belinal will be evaluated with a determination of the minimal erythema dose (MED) at the
      gluteal area before (the baseline) and after 12 weeks of the cream use. Comparison will be
      done as the mean of the individual ratios. The differences between the before-after condition
      will be analyzed with the statistical test of analysis of variance. In case of failure to
      find homogeneity in the variances the nonparametric ANOVA, the Willcoxon test, will be used.
      The results will be expressed as mean ± standard error for each group with a significance
      level of 0.05 for all the statistical tests.
    

Intervention name(s): Placebo cream; Belinal cream
Intervention type(s): Other; Other
Intervention description(s): Subjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area.; Subjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: skin rejuvenation; anti-ageing effects; minimal erythema dose; dermis structure; physiological skin condition; wrinkling
Chronıc Ankle Instabılıty And Assocıated Factors
Condition: Chronic Ankle Instability
Study type: Observational

Summary: 
      The purpose of this study was to evaluate the prevalence of chronic ankle instability using
      the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated
      factors. The data was collected from adult volunteers by questionnaire including
      sociodemographic information, general medical condition, history of orthopedic surgery, pain
      intensity, and the number of painful areas of the foot.
    

Detailed description: 
      Chronic ankle instability (CAI) is a common condition encountered with persistent symptoms of
      giving way, pain, and weakness and recurrent risk, which may lead to functional
      insufficiency. The purpose of this study was to evaluate the prevalence of chronic ankle
      instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the
      independent associated factors.

      The data was collected from adult volunteers by questionnaire including sociodemographic
      information, general medical condition, history of orthopedic surgery, pain intensity, and
      the number of painful areas of the foot. 273 adult volunteers participated in the study,
      through face to face or online. Subjects are classified as having CAI with a CAIT score ≤27.
    

Intervention name(s): CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:
Intervention type(s): Diagnostic Test
Intervention description(s): Questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The cross-sectional study group consisted of 273 adult volunteers, ranging from 18-78 years
        old, who were recruited via social media to maximize outreach and insure a diverse target
        group.
      
Keywords: Chronic Ankle Instability; Cumberland Ankle Instability Tool; Pain
The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance
Condition: Body Weight; Insulin Resistance
MeSH terms: Insulin Resistance; Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to:

        -  Determine the difference between strong hypo-energetic "standard diet advice" and modest
           hypo-energetic "personal diet advice"; and

        -  Determine the influence of insulin-insensitivity on obesity and weight reduction by
           treating patients with metformin or placebo.
    

Detailed description: 
      The aim of the present study was to determine what the difference is of a strong
      hypo-energetic "standard diet advice" and a modest hypo-energetic "personal diet advice"
      which was determined by the energy needs of a person as calculated with a combination of
      basal metabolic rate (BMR) and physical activity level (PAL) on weight loss and insulin
      sensitivity.

      Secondly, this study wanted to determine what the influence is of insulin-insensitivity on
      obesity and weight reduction by treating the patients with metformin or placebo. The subjects
      were therefore randomised into two double blinded groups receiving either metformin (2 x 850
      mg per day) or placebo in combination with a moderate energy restriction and a exercise
      regimen of 30 minutes per day for 1 year.

      Treatment effects of both diets and the effect of metformin on weight reduction and insulin
      sensitivity were determined after a treatment period of 20 and 52 weeks.

      Insulin sensitivity was quantified using the homeostasis model assessment (HOMA) and the
      OGTT. Body composition was determined with the bioelectrical impedance method.

      Blood was also drawn for hormonal and biochemical analyses after 20 and 52 weeks of
      treatment. Furthermore, the patients had to fill out a 3-day food diary at baseline, after 20
      weeks and after 52 weeks.
    

Intervention name(s): metformin; "standard diet advice"; "personal diet advice"
Intervention type(s): Drug; Behavioral; Behavioral
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Condition: Congestive Heart Failure; Type II Diabetes Mellitus
MeSH terms: Heart Failure; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the effect of vildagliptin on left ventricular function in patients
      with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and
      overall safety and tolerability will also be assessed.
    


Intervention name(s): vildagliptin; placebo of vildagliptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Congestive Heart Failure; CHF, vildagliptin; metabolic disease; cardiovascular disease; T2DM
The Application of Spasmolytic in PCLE Examination of Superior Gastrointestinal Endoscope
Condition: Using Copolamine Butylbromide in Probe-based Confocal Laser Endomicroscopy for Gastroendoscopy Examination
Study type: Interventional
Phase: Phase 1

Summary: 
      Scopolamine butylbromide might be helpful for the outcome of superior gastrointestinal
      endoscope examination.
    

Detailed description: 
      The peristalsis of gastrointestinal tract has a adverse affection on the process of the PCLE
      examination .Scopolamine butylbromide is a widely used spasmolytic，which can reduce the
      peristalsis of gastrointestinal tract effectly.The application of it may benefit the
      images'quality ,the acurrate of diagnosis and shorten the examination time.
    

Intervention name(s): Scopolamine Hydrobromide; normal saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Scopolamine butylbromide PCLE
Validity and Reliability of the Community Integration Questionnaire-Revised in Lower Limb Amputees
Condition: Amputation
Study type: Observational

Summary: 
      The goal of this clinical trial is to determine the validity and reliability of the Community
      Integration Questionnaire-Revised (CIQ-R) scale in lower limb amputees. The main questions it
      aims to answer are:

        -  The Turkish version of the Community Integration Questionnaire-Revised is valid for
           lower extremity amputees.

        -  The Turkish version of the Community Integration Questionnaire-Revised is reliable for
           lower extremity amputees.

      Participants will:

      • Fill out general information, CIQ-R, TAPES, and ABIS forms.
    

Detailed description: 
      The aim of this study is to determine the validity and reliability of the Community
      Integration Questionnaire-Revised (CIQ-R) scale in lower limb amputees. Lower limb amputees
      aged 18-65 years who used prostheses for at least 6 months and volunteered to participate in
      the study were included in the study. The adaptation of amputees to prostheses was evaluated
      with the "Trinity Amputation and Prosthesis Experience Scale" (TAPES), their perception of
      physical appearance with the "Amputee Body Image Scale" (ABIS), and their community
      integration with the CIQ-R. Correlation with TAPES and ABIS and confirmatory factor analysis
      were performed to determine the construct validity of the CIQ-R scale. The test-retest
      reliability of the CIQ-R scale was determined by the intraclass correlation coefficient (ICC)
      method. Internal consistency analysis was evaluated with Cronbach's alpha. 90 amputees were
      included in the study (mean age: 40.96±12.89 years; BMI: 25.55±5.5 kg/m2). The CIQ-R scale
      was reapplied to 18 of the participants 1 week later.
    

Intervention name(s): Validity and reliability study
Intervention type(s): Other
Intervention description(s): Validity and reliability assessment of the Community Integration Questionnaire-revised
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Lower extremity amputees between the ages of 18 and 65 with a prosthesis usage period of
        more than 1 year who can speak and read Turkish.
      
Keywords: lower limb amputees; community integration; social participation; validity; reliability
Effect of a Program of Deep Inspiration Combined to Expiratory Positive Airway Pressure in Asthmatic
Condition: Improvement of Functional Capacity.; Improvement of Quality of Life.; Improvement of Cardiovascular Autonomic Control.
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of a deep inspiration combined to
      expiratory positive airway pressure protocol on respiratory function, quality of life,
      exercise tolerance and heart rate variability in adults with severe asthma.
    

Detailed description: 
      Asthma is associated with high morbidity and significant mortality. This disease has
      functional impact on activities of daily living (ADLs) and according to some studies in the
      United States and Europe, the percentage of asthmatics who have significant restrictions in
      their ADLs is quite significant. Asthma is characterized as a major public health problem,
      not only in Brazil but worldwide. Currently there are few studies reporting the effects of a
      domiciliary program of deep inspiration associated with positive expiratory pressure in the
      airways of asthmatics. This study aims to analyze the benefits of this program on lung
      function, quality of life and response to exercise.
    

Intervention name(s): Deep inspiration and positive expiratory airway pressure
Intervention type(s): Other
Intervention description(s): It was used a device the combines deep inspiration and positive expiratory airway pressure in asthmatic subjects, for 5 weeks, twice a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Menopause and Oral Microbiome
Condition: Menopause
Study type: Observational

Summary: 
      The study examines the saliva and dental plaque microbiome of women aged 35-65 in two groups:
      postmenopausal (case) and premenopausal (control). For this purpose, Illumina Platform to
      sequence 16S rRNA gene regions will be used. The data will be analyzed using the QIIME2
      bioinformatics tool. Serum estradiol levels will be determined by the ELISA method. The
      investigators will examine the relationship between microbiome data (alpha diversity, beta
      diversity, and relative abundance) and menopausal status, estradiol levels, and periodontal
      health status using linear statistical models. Clinical samples of the study will be
      collected at Ege University, and the laboratory studies and sequence analysis will be
      conducted at the Forsyth Institute in Boston.

      To obtain longitudinal data besides the cross-sectional data, the investigators will contact
      the participants of a previous study from 2019, whose saliva, dental plaque, and serum
      samples are currently being stored at -80 °C, and ask them to participate for a second
      sampling.
    


Intervention name(s): Intraoral examination, saliva, dental plaque and serum collection.
Intervention type(s): Diagnostic Test
Intervention description(s): Probing pocket depth will be defined as the distance in millimeters from the gingival margin to the base of the gingival sulcus measured using a manual probe (Michigan 0 probe with Williams Markings) in all the teeth present except for third molars. Similarly, clinical attachment level (CAL) will be measured as distance from cementoenamel junction to the base of pocket and will be recorded manually to the nearest millimeter marking on probe.
1 mililiter of saliva will be obtained by each participant. Subgingival dental plaque will be collected with sterile endodontic paperpoints from mesial sides of each natural teeth without a prostethic restoration. Serum samples will be also collected at the time of visit.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Middle aged women.
A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or
      placebo and will be assessed for safety, tolerability, and pharmacokinetics.
    


Intervention name(s): BRII-196 and BRII-198; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BRII-196 and BRII-198 given intravenously; Placebo given intravenously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COVID-19 phase I; monoclonal antibody