bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
Condition: Autism; Gastrointestinal Symptoms
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Autistic Disorder
Study type: Interventional

Summary: 
      Doctors at MassGeneral Hospital for Children (MGHfC) are doing a research study to learn if a
      gluten free-dairy free (GFCF) diet is helpful in improving gastrointestinal symptoms
      associated with autism.

      Hypothesis: The gluten free/casein free diet (GFCF) will result in a higher proportion of
      subjects having reduction in gastrointestinal (GI) symptoms associated with autism spectrum
      disorders (ASD).

      Primary Study Objective:

        -  To assess the effect of a GFCF diet on GI symptoms associated with ASD.

      Secondary Objectives:

        -  To assess if improvements in GI symptoms result in improvements in autistic behavior
           when using a GFCF diet in the dietary management of GI symptoms associated with ASD

        -  To determine the nutritional impact of a GFCF restrictive diet

        -  To assess the role of food allergies in the manifestation of GI symptoms

      This is a 14-week study that requires between 5 & 9 office visits. All study related
      activities -including physical exams, blood samples and allergy testing - and an amino acid
      based supplement drink, are at no cost. Research study visits will take place at MGHfC in
      Boston, or at Newton Wellesley Hospital in Newton, or at Lurie Center/LADDERS in Lexington.
    


Intervention name(s): GFCF product with GFCF diet; product containing gluten and casein (milk protein) with GFCF diet
Intervention type(s): Other; Other
Intervention description(s): Group I: will receive the test product (product free of gluten and casein) with GFCF Diet for the 1st 6-weeks.
Group II: will receive the test product (product free of gluten and casein) with GFCF diet for the 2nd 6-weeks.; Group I: will receive the control product (product containing gluten and casein) with the GFCF diet for the 2nd 6-weeks.
Group II: will receive the control product (product containing gluten and casein) with the GFCF diet for the 1st 6-weeks
Other intervention name(s): test product; GFCF; gluten free- casein free diet; control product; product containing gluten and casein; GFCF diet
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autism; Gastrointestinal Disorders; Food Allergy; Gluten free, casein free diet; Diarrhea; Constipation; Reflux; Abdominal pain; Pain after eating; Self injurious behavior
Comparison of Different Walk and Performance Test in Detecting Silent Hypoxia
Condition: Hypoxia; COVID-19 Pneumonia; Oxygen Saturation; Pulmonary Rehabilitation
MeSH terms: Hypoxia
Study type: Observational [Patient Registry]

Summary: 
      Healthcare systems around the world have been dealing with COVID 19. One of the main
      manifestations of this infection is lung involvement of varying degrees, causing a spectrum
      of diseases from mild lower respiratory tract infection to severe Adult Respiratory Distress
      Syndrome (ARDS). One of the important clinical parameters is to detect hypoxia early in order
      to initiate a higher level of care at the earliest. The presence of silent or latent hypoxia
      has made this task difficult in COVID 19. Besides, critical findings such as silent hypoxia
      that is not at rest but triggered by effort can be revealed by some practical field tests
      such as the 6-minute walk test or the 1-minute chair sit and stand test. Moreover, these
      simple tools also help to investigate the patient's readiness for discharge. In this way, it
      will be useful to evaluate their usability in discharge decisions or in determining the
      post-discharge cardiopulmonary reserves of the patients and therefore their rehabilitation
      needs. Although walk and performance tests can be performed naturally, safely and simply,
      more similarly to movements in daily living activities compared to cardiopulmonary exercise
      tests, the interest in these tests has increased over the years, especially in subjects such
      as exercise capacity, mortality and morbidity expectation, or oxygen desaturation in patients
      with chronic cardiopulmonary pathology. The number of studies in 19 patients is quite
      limited. For this reason, the necessity of new studies on different field tests to detect the
      presence of latent hypoxia, which expresses the oxygen desaturation triggered by effort, and
      to evaluate the exercise tolerance status before discharge, has been emphasized in recent
      reviews.The aim of this study is to determine the presence of silent hypoxia, which expresses
      the oxygen desaturation triggered by effort, in Covid-19 patients and to compare the
      different short-term walk and performance tests, which the investigators consider easier and
      applicable in the conditions of the pandemic environment, with the classical gold standard
      test ( Six minute walk test) in order to evaluate the exercise tolerance status of the
      patients before discharge.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study will consist of Covid-19 patients hospitalized in the pandemic wards of Kütahya
        Health Sciences University Physical Medicine and Rehabilitation Additional Service
        building.

        All volunteer patients who meet our inclusion and exclusion criteria will undergo walking
        field tests with at least 2 hours between them after their written consent is obtained.
Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden
Condition: Autologous Mesenchymal Stem Cells; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety of a single dose of IV infusion of bone-marrow derived autologous
      Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.
    


Intervention name(s): Autologous mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): IV therapy with autologous bone-marrow derived mesenchymal stem cells
Intervention model: Single Group Assignment
Intervention model description: Open-label phase 1, single-center, pre-post comparison study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal Stem Cells; Multiple Sclerosis
hBET for Pain and Sleep Feasibility
Condition: Pain, Chronic; Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias; Chronic Pain
Study type: Interventional

Summary: 
      Long-term pain affects one-third of the United Kingdom population and can be very disabling.
      People experiencing long-term pain often suffer from disturbed sleep because of their pain
      symptoms, and disturbed sleep can then make their pain symptoms worse. Managing long-term
      pain is also very costly to the National Health Service. The most common treatment is
      prescribed medicines, but these do not always work and can have serious side-effects for some
      patients.

      The investigators have been developing an alternative approach for treating long-term pain.
      This approach uses simple non-invasive tools to promote some kinds of brain activity over
      others. It involves patients using headphones to listen to some specific sounds, or a headset
      with lights flashing at particular frequencies. The studies undertaken so far seem to show
      that doing this can change how the brain responds to pain. It potentially offers an
      inexpensive yet effective way of reducing pain and improving sleep for patients with
      long-term pain. There are a few small studies that support this approach and more work is
      needed. The next step is to find out whether these tools can be reliably used in home
      settings, how people feel about using this approach, and to gather information to design a
      larger trial of this technology.

      Therefore the aim of this study is to test the suitability and acceptability of these
      home-based tools with individuals with long-term pain. Up to 30 participants with long-term
      pain and pain-related sleep disturbance will use the tools for at least 20 minutes at bed
      time every day for 4 weeks. The investigators will interview them to ask about their
      experiences of using the tools, and their feedback and suggestions on how the approach should
      be developed. The investigators will measure changes in the nature of participants' pain,
      sleep, fatigue and mood.

      These findings will inform the planning and design of a future much larger study to test this
      technology. The investigators will make sure that findings from this study are shared widely
      within the National Health Service and beyond among patient groups, professionals, charities,
      specialist centres and commissioners.
    


Intervention name(s): home-based Brainwave Entrainment Technology
Intervention type(s): Device
Intervention description(s): Smartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: audio-visual stimulation; brainwave entrainment
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center study will be conducted in the United States with up to 80 healthy adult
      subjects. Subjects will be scheduled to receive a total of two (2) injections with 1
      injection each administered.

      Subjects will be randomized according to a randomization scheme.
    

Detailed description: 
      All subjects will be followed up for 60 days post-randomization and through the influenza
      season. Following the influenza season, a subset of the subjects will receive a booster
      vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days,
      15 days, 30 days and 6 months following the booster vaccination.
    

Intervention name(s): Influenza A Vaccine: ACAM FLU-A; Influenza A Vaccine: ACAM FLU-A; Influenza A Vaccine: ACAM FLU-A; Saline placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular; 0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular; 0.5 mL ACAM FLU-A low dose, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): ACAM FLU-A; ACAM FLU-A; ACAM FLU-A; USP Saline
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Medication Adherence Monitoring Trial Using Smart Clinical Trial Application and Smart Watch
Condition: Compliance, Medication
Study type: Interventional

Summary: 
      The study will investigate the effect of smart monitoring on medication adherence.
    

Detailed description: 
      In this study, multiple medication monitoring procedures will be performed: self-reporting,
      pill counting, smart monitoring and concentration monitoring. Subjects will take vitamin D
      supplement on the market which enables validated concentration monitoring. The study will
      last for 3 months.
    

Intervention name(s): Self monitoring; Smart watch assisted monitoring; Vitamin D
Intervention type(s): Other; Other; Drug
Intervention description(s): Self monitoring using smart clinical trial application; Smart watch-assisted adherence monitoring; Vitamin D self-administration for 3 months
Other intervention name(s): DIARY; SMART WATCH; VITAMIN
Intervention MeSH terms: Vitamin D; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: smart device; compliance monitoring; vitamin D
Role of B2 Adrenergic Receptors in Labor Pain
Condition: Pain; Pain Threshold; Labour Pain
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      The study aims to understand why labor is more painful for some women compared to others. The
      study will study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor
      genotype is related to her pain in labor for the birth of a first child.
    

Detailed description: 
      Other than parity, and infant size, the etiology of the great variability in labor pain us
      unknown. Previous studies have demonstrated that baseline pain sensitivity is related to
      postoperative pain and narcotic requirement. We hypothesize that baseline pain sensitivity is
      related to pain in labor. The study will determine baseline sensitivity to heat, cold and
      pressure as measurement of pain sensitivity. Furthermore, b2 adrenergic genotype has recently
      been identified as a potential determinant of pain sensitivity. The investigators will
      determine whether B2 receptor haplotype is an independent predictor of pain experienced in
      labor.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Nuliparous women anticipating NSVD
      
Biospecimen description: 
      DNA identified by subject number will be retained for analysis.
    
Keywords: Genetic; pain; obstetrical
Morphine Consumption in Thoracotomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Importance of effective postoperative pain management is well known. The undesired effects of
      pain can be prevented with multimodal analgesia for the patient. Thoracotomy operations are
      associated with high levels of pain. With the use of ultrasound, many regional anesthesia
      techniques were described to provide effective postoperative analgesia. The aim of this study
      was to compare the postoperative effect of paravertebral block (PVB) and erector spinal plane
      block (ESPB) in thoracotomies.
    


Intervention name(s): PVB; ESPB
Intervention type(s): Procedure; Procedure
Intervention description(s): Paravertebral block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.; Erector spinae plane block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative pain; Thoracotomy; Paravertebral block; Erector spina plane block
Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity, mortality
      and disability throughout the world, leading to a heavy social and economic
      burden.Bronchodilators, the most commonly used drugs in COPD patients, have been shown to
      reduce dyspnea, improve exercise tolerance and improve health status. However,conventional
      lung function parameters such as forced vital capacity (FVC) and forced expiratory volume in
      one second (FEV1) frequently fail to detect significant functional responses to
      bronchodilators in patients with chronic airflow obstruction. It is necessary for clinical
      and scientific reasons to develop a new tool to objectively assess the effect of different
      treatments including bronchodilator on COPD. Our previous study showed that Ventilation-drive
      coupling may be more sensitive and accurate to evaluate the efficacy of inhaled
      bronchodilators in patients with COPD because it could better reflect the pathological and
      physiological characteristics of COPD.

      Based on the above conclusion, the present study were performed using the experimental
      methods of placebo and self-controlled. We aimd to explore the value of ventilation-drive
      coupling in evaluating the efficacy of bronchodilators on COPD and provide a reasonable basis
      for the clinical application of this index.
    

Detailed description: 
      Patients were randomly assigned to one of two intervention groups:

        1. Group A: Patients inhaled placebo, ipratropium 80μg, salbutamol 400 μg in sequence;

        2. Group B: Patients inhaled placebo, salbutamol 400μg, ipratropium 80 μg in sequence.

      The data were collected in 30 minutes after patients inhaled placebo,in 30 minutes after
      ipratropium and in 15 minutes after salbutamol.
    

Intervention name(s): Placebo; ipratropium bromide; salbutamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): physiological saline; 80 µg inhalation once; 400 µg inhalation once
Other intervention name(s): Physiological Saline 9 mg/ml; atrovent; Ventolin
Intervention MeSH terms: Bromides; Albuterol; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: COPD, central drive, bronchodilators
Sexual Habits Affect Penis Size in Adulthood
Condition: Observational Study
Study type: Observational

Summary: 
      Purpose: to assess in Kazakh adult males erect penis sizes, and study an influence of their
      natural physiological events and behavioral habits during their growing ages on their penile
      sizes nowadays.

      Study Design: An observational cross-sectional survey pilot study using a correlational
      design with the intention-to-treat principle.
    

Detailed description: 
      Participants. A total of 282 adult Kazakh males from the Republic of Kazakhstan and who have
      been visited at the urology units of three university centers in the biggest cities of the
      Republic of Kazakhstan (Astana, Almaty, and Karaganda) were prospectively included in the
      study, which took place between January 2020 and January 2021.

      Measurements of the penis erect length and girth were by two doctor-urologists according to
      the method of Veale D et al. (2015).

      Statistical analysis. Two-tailed Student's t-test, Pearson correlation and multivariate tests
      of the MANOVA and MANCOVA (body height as covariate) were used.

      Sample size estimation. In a cross-sectional observational study in assessment of erect penis
      size of Kazakh adult males we supposed that the primary interest lies in assessment of erect
      penis sizes in the three cities (k=3). The investigators wish to be 95% sure of detecting
      when the mean erect penis sizes not exceed 1 mm (i.e., 1-β=0.95, and m1=1, m2=0). The
      standard deviation of erect penis size is likely to be 1.56 mm (i.e. SD=1.56) with a
      statistical power of 95% and significance level of 2.5% with the Bonferroni correction based
      on one-sided hypothesis testing. At the 5% Type I error rate (i.e., α=0.05), the sample size
      of the survey is 196.
    

Intervention name(s): measurements and questionnaire
Intervention type(s): Other
Intervention description(s): paper-based survey administration; erect penis length and girth measurements
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 282 adult Kazakh males from the Republic of Kazakhstan and who have been visited
        at the urology units of three university centers in the biggest cities of the Republic of
        Kazakhstan (Astana, Almaty, and Karaganda) were prospectively included in the study, which
        took place between January 2020 and January 2021.
      
Keywords: penis size; frequency of erection; masturbation; coitus; sexual abstinence; body growth
Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health
Condition: Glucose Metabolism; Lipid Metabolism
Study type: Interventional

Summary: 
      The effects of a 10g/day collagen hydrolysate for a period of 4 weeks on glycemic control and
      cardiovascular health in a parallel design study using overweight/ obese men and women who
      are likely to have a disturbed lipid and glucose metabolism and increased risk to develop
      cardiovascular disease and/or Type- 2 diabetes.
    

Detailed description: 
      Food-derived bioactive peptides represent a source of health-enhancing components that have
      been reported to have cardiovascular health benefits in humans and may be incorporated in
      functional foods. Up till now studies using collagen hydrolysates particularly addressed
      issues around joint health, however, there are some preliminary indications that other
      health-related targets might be affected as well. We here propose to focus on the potential
      effects of collagen hydrolysates on glycemic control, and characteristics of the
      microcirculation, both important parameters for the assessment of future cardiovascular
      disease (CVD) risk.
    

Intervention name(s): 10 g of collagen hydrolysate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Before breakfast, participants consume 1 sachet every day for 4 weeks. The sachet contains 10-gram collagen protein hydrolysates + 5-gram erythritol and it has to be dissolved in 250 ml of water.; Before breakfast, participants consume 1 sachet every day for 4 weeks. The sachet contains 5-gram erythritol (placebo) and has to be dissolved in 250 ml of water.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A 4-weeks randomized, controlled trial with a parallel design. Before the 4-weeks intervention, there is a 2-weeks run period.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Collagen hydrolysate; Glucose metabolism; Dietary patterns; Cardiometabolic health