bioihbjkbjnl/mcl2 huggingface dataset:
Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity; Body Weight; Bone Diseases, Metabolic; Fractures, Bone; Osteoporotic Fractures; Osteoporosis; Quality of Life; Fall; Musculoskeletal Diseases
MeSH terms: Osteoporosis; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Metabolic Diseases; Body Weight; Fractures, Bone; Osteoporotic Fractures
Study type: Observational

Summary: 
      Background: Osteoporotic fractures are a major public health issue. They cause substantial
      disability, loss of autonomy, morbidity and excess mortality. Diabetes is also associated
      with increased risk for falls and fractures through a direct impact of elevated blood glucose
      on the skeleton and on muscles.

      Research project overview: The investigators propose a cross-sectional study that will
      involve 2 research centers in the province of Quebec. The investigators will recruit 20 obese
      participants, without diabetes, who have not undergone bariatric surgery, for one-time
      measurements to be compared with baseline measurements (pre-surgery) from participants in the
      bariatric obese diabetic groups with type II diabetes mellitus from the ongoing study BODI
      study (NCT03455868). Bone Mineral Density as well as muscle quality, strength and function
      will be evaluated at a single study visit.

      Relevance: This data will permit the evaluation of the bone-muscle unit in patients with
      obesity with and without diabetes, and assess whether the presence and duration of diabetes
      impacts further on clinical and functional musculoskeletal outcomes (falls, fractures and
      mobility and strength) in this population. AGEs, if associated with muscle and bone
      deterioration, might become an easily accessible biomarker of musculoskeletal health in the
      clinical setting.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This is a multi-center, cross-sectional, observational study comprising of two groups of
        participants with obesity either with or without diabetes (n=20/group). The diabetic groups
        will include 20 adult men and women with obesity and type 2 diabetes, and the non-diabetic
        group will consist of 20 age- and sex- matched individuals with obesity and normoglycemia.
      
Keywords: Advanced glycation end products; Advanced imaging; Mobility; Strength
Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests
Condition: Asthma; Cough Variant Asthma
MeSH terms: Asthma; Cough
Study type: Interventional

Summary: 
      Cough is a common, disruptive and at times disabling symptom which often prompts patients to
      seek medical attention. Determining the cause(s) of chronic cough can be challenging, and
      costly. Asthma and other airway disorders are among the most common causes of chronic cough;
      and cough can be the sole symptom of asthma. Little is known about why some patients with
      asthma primarily cough and do not develop the other symptoms of asthma such as shortness of
      breath or wheeze. Improved understanding of the reasons for these different manifestations
      may lead to new and more effective treatment strategies. We have notices differences in
      pressure measurements inside the chest in patients who mostly cough during induced
      bronchoconstriction, which might be part of the explanation for varying symptoms. This study
      will compare lung mechanical responses during methacholine and mannitol-induced induced
      airway narrowing between typical asthma, cough variant asthma (CVA) and an airway
      inflammatory disorder that is not asthma.The purpose of this research is to explore the
      pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and
      methacholine-induced cough but normal airway sensitivity using mannitol and high-dose
      methacholine bronchoprovocation testing.
    


Intervention name(s): high-dose methacholine challenge test; mannitol challenge test
Intervention type(s): Drug; Other
Intervention description(s): nebulized liquid inhalation, 0.0625 - 256 mg/mL, doubling doses; inhaled powder, 0 - 635 mg, increments of 5,10, 20 and 40 mg
Other intervention name(s): Provocholine; Aridol
Intervention MeSH terms: Mannitol; Methacholine Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Asthma; Cough Variant Asthma; Mannitol; Methacholine; Cough; Hypersensitivity
Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Cancer
Condition: Stereotactic Body Radiotherapy; PD-1 Inhibitors; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      The goal of this observational study is to investigate the efficacy and safety of
      stereotactic body radiotherapy combined with PD-1 blockers for LAPC and LRPC. The patients,
      diagnosed with locally advanced pancreatic cancer (LAPC) or locally recurrent pancreatic
      cancer (LRPC). LRPC or LAPC, undergoing SABT and PD-1 blockers in our hospital from December
      2020 to April 2023 were reviewed consecutively. All patients provided written informed
      consent before treatment. The study was conducted in accordance with the Declaration of
      Helsinki, and it was approved by the Institutional Ethics Committee of Peking University
      Third Hospital.
    

Detailed description: 
      The goal of this observational study is to investigate the efficacy and safety of
      stereotactic body radiotherapy (SBRT) combined with PD-1 blockers for LAPC and LRPC. The
      patients, diagnosed with locally advanced pancreatic cancer (LAPC) or locally recurrent
      pancreatic cancer (LRPC). LRPC or LAPC, undergoing SBRT and PD-1 blockers in our hospital
      from December 2020 to April 2023 were reviewed consecutively. The schedule of SBRT is 25 to
      50 Gy in 5 fractions and the PD-1 blockers are monoclonal antibodies targeted to PD-1
      molecules on the T lymphocytes.

      All patients provided written informed consent before treatment. The study was conducted in
      accordance with the Declaration of Helsinki, and it was approved by the Institutional Ethics
      Committee of Peking University Third Hospital.
    

Intervention name(s): Stereotactic body radiotherapy (SBRT); PD-1 blocking antibody
Intervention type(s): Radiation; Drug
Intervention description(s): All the patients first received SBRT with the dose of 25Gy up to 50Gy in five fractions.; All the patients first received SBRT with the dose of 25Gy up to 50Gy in five fractions and then received the treatment of PD-1 blockers including pembrolizumab (200 mg every 3 weeks), carelizumab (200 mg every 3 weeks), tislelizumab (200 mg every 3 weeks), sintilimab (200 mg every 3 weeks), zimberelimab (240 mg every 3 weeks) until the tumor progressed or the side effects became intolerable.
Intervention MeSH terms: Antibodies; Antibodies, Blocking
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients, diagnosed with LRPC or LAPC, undergoing SABT and PD-1 blockers in our
        hospital from December 2020 to April 2023 were reviewed consecutively. All patients
        provided written informed consent before treatment. The study was conducted in accordance
        with the Declaration of Helsinki, and it was approved by the Institutional Ethics Committee
        of Peking University Third Hospital.
Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
Condition: Female Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates
      comparable to those obtained by retropubic suburethral tape, becoming the first line
      treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not
      exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In
      addition it is commonly performed under general or regional anesthesia1-3. The
      single-incision mini-slings (SIMS) were developed to reduce the risk of complications by
      avoiding the blind passage of the trocars through the obturator space. In addition, the use
      of SIMS could enable surgeons to perform the procedure truly under local anesthesia.

      Different devices for SIMS procedure are available. However, the evidence about their
      efficacy is controversial4-7. The main limitation of these devices could be the predetermined
      length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows
      adjusting the length of the sling to each individual woman and provides a robust fixation
      into the obturator membrane. Recent prospective studies on the efficacy and safety of the
      sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use
      SIMS in the context of research studies10.

      The objective of this study is to establish if the effectiveness of the SIMS Ajust® is
      non-inferior to that of a standard TOT, as well as to compare the comorbidity of both
      procedures. Owing to the new appearance and fast evolution of these procedures, randomized
      comparative studies with SIMS are required in order to determine its place in the treatment
      of SUI.
    


Intervention name(s): Ajust sling; Classical transobturator sling
Intervention type(s): Device; Device
Intervention description(s): Control group
Other intervention name(s): Align®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress urinary incontinence.; Suburethral sling.; Single-incision suburethral sling.; Ajust.; Transobturator tape.
Endoscopic Overlay Tympanoplasty for TM Perforation
Condition: Tympanic Membrane Perforation
MeSH terms: Tympanic Membrane Perforation
Study type: Interventional

Summary: 
      Minimally invasive surgery is becoming more common in many surgical fields. The wide view of
      endoscope allows for minimally invasive transcanal approach instead of large postauricular
      opening. The investigators conduct this study to compared post operative pain score (by
      Visual Analogue Scales) between conventional microscope lateral placing tympanoplasty and
      endoscopic lateral placing tympanoplasty.
    

Detailed description: 
      A main part of tympanoplasty is repair of perforated tympanic membrane. There are two popular
      way to approach tympanic membrane, transcanal or postauricular approach. There are two
      grafting techniques are applied in tympanoplasty which includes the lateral technique
      (overlay) and medial technique (underlay).

      The lateral technique is widely used in our institute which involves placement of a graft
      lateral to the tympanic annulus and the fibrous layer of the tympanic remnant. The most our
      preferred approach in previous experience is the postauricular approach for tympanoplasty
      because the transcanal approach is not enough for adequate exposure. Moreover, the
      visualization straight through transcanal provide by the microscope is difficult by a limited
      view of the perforation edge due to narrowing and curved external ear canal. Postauricular
      approach cause many layers of tissue are violated along with a significant postoperative
      pain.

      The author proposed this study with the aim of determining the alleviation of postoperative
      pain by new technique and the efficacy of endoscope for tympanoplasty.
    

Intervention name(s): Endoscopic Technique; Microscopic Technique
Intervention type(s): Device; Device
Intervention description(s): Endoscopic Technique; endoscopic transcanal lateral graft tympanoplasty using An endoscope (Karl Storz, Tuttlingen, Germany) and A microdrill (Skeeter Otologic Drill System; Medtronic Xom ed Surgical Products, Inc., Jacksonville, FL, USA); Microsopic surgical approach using a Zeiss Opmi 111 (Carl Zeiss, Jena, Germany) operating microscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endoscope; microscope; transcanal
Physiologic Growth Hormone Effects in HIV Lipodystrophy
Condition: AIDS; HIV Infections
MeSH terms: Lipodystrophy
Study type: Interventional

Summary: 
      This study will investigate long-term, low-dose growth hormone administration in HIV-infected
      patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We
      hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will
      include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood
      pressure,bone density, cardiovascular risk and safety parameters.
    

Detailed description: 
      This study will investigate long-term, low-dose growth hormone administration in HIV-infected
      patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We
      hypothesize that low-dose growth hormone will reduce visceral fat preferentially over
      subcutaneous fat, and increase lean body mass. Secondary endpoints will include measures of
      IGF-1, glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and
      safety parameters. Dosing of growth hormone will be based on patients' IGF-1 levels and will
      not exceed 6mcg/kg/day.
    

Intervention name(s): recombinant human growth hormone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months; placebo subcutaneously once a day, 18 months
Other intervention name(s): Serostim
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; lipodystrophy; growth hormone; visceral fat; IGF-I; Treatment Experienced
Prevalence of Hypertension Using Telemedical Home Blood Pressure Measurements
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to determine the prevalence of hypertension among citizens of
      Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the
      insufficiently treated, and to estimate the prevalence of white coat and masked hypertension
      using home blood pressure measurements with telemedical data transmission.
    


Intervention name(s): Telemedical home blood pressure measurements
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A population study in the municipality of Holstebro, which has 57.000 inhabitants. Using
        the Civil Registration System, we invite all citizens aged 55-64 years.
IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent,
      and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a
      temporary immunosuppression; furthermore, an improvement of AD has been observed during
      measles infection.

      This trial is aimed at demonstrating that measles vaccine is able to create an
      immunomodulation and to improve AD symptoms.

      30 adult patients of both sexes with moderate to severe AD will be randomly assigned to
      measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days.

      The primary outcome is the effect of anti-measles vaccination on the T cell responses in
      patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the
      evolution of blood level of measles specific IgE and antibodies; evolution of other
      biomarkers and phenotypic characteristics of T lymphocytes.
    

Detailed description: 
      Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent,
      and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a
      temporary immunosuppression; furthermore, an improvement of AD has been observed during
      measles infection.

      This trial is aimed at demonstrating that measles vaccine is able to create an
      immunomodulation and to improve AD symptoms.
    

Intervention name(s): ROUVAX; placebo
Intervention type(s): Biological; Biological
Intervention description(s): Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.; Vehicle (water for injection), 0.5 ml, once
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Atopic Dermatitis; immunosuppression; Measles vaccine; T lymphocytes; Atopic Dermatitis in adults
Gastric Layering Study
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This comparative study is designed to compare the gastric layering and rates of emptying and
      by inference rates of digestion of two food emulsions. Two types of dairy based foods will be
      used, one which will sediment in the stomach and one that will not. On each of two study
      days, a total of 9 post drink MRI scans will be taken to assess gastric layering and
      emptying. Cannulation will allow blood samples to be taken periodically for subsequent
      analysis for the presence of specific digestion related hormones. A total volume of 36 ml of
      blood will be removed and volunteers will also be asked to complete a questionnaire at
      predetermined times to assess feelings of satiation.
    


Intervention name(s): sedimenting meal
Intervention type(s): Other
Intervention description(s): The active system quickly forms a sedimenting layer of small particles that contain most of the caloric content of the system. This system is made by adding finely grated cheese (particle size 0.5-2 mm) to yoghurt and consumption is followed by drinking 327 ml water.
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: emulsion; emptying; protein; layering
"Generation Fit and Exerlearning With In the Groove"
Condition: Obesity
Study type: Interventional

Summary: 
      In middle schools participating in a statewide program called "Take Time", we are randomizing
      youth to a 10-12 week intervention using the dance mat games on the Playstation2 (like Dance
      Dance Revolution). This program is testing feasibility of using the dance mats as a way to
      increase activity during the school day. We are using "Groove Masters" as a peer-mentored
      mechanism to keep track of the activity of youth in the intervention compared to the control
      group. Our main objective is increase in activity time.
    

Detailed description: 
      We met with administrators and teachers and obtained consent and assent for this study. After
      assessing baseline measures (end-of-grade test scores, absenteeism, Pediatric Quality of
      Life, physical fitness, GEMS Activity Rating Scale, Dennison's measure of sedentary screen
      time, Physical Activity Enjoyment Scale, BMI%ile, (with a small subset assayed for fasting
      lipids and glucose, with a smaller subset wearing ActiGraphs for objective measures of
      activity) we randomized to the intervention or control group.

      In our intervention, youth play a dance game at school called "In the Groove", with the goal
      of 40 additional minutes each week of physical activity during the school hours.

      We will obtain change scores and compare the groups to find an effect size for future
      studies, this this proves acceptable and feasible in Maine schools.
    

Intervention name(s): Physical Activity, reduced sedentary behavior
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dance; Peers; middle school-based; feasibility
Impact of Nutritional Supplementation on Sleep Quality and Gut Microbiome Composition in Older Adults
Condition: Sleep; Gut Microbiome
Study type: Interventional

Summary: 
      The aim of this study is to assess the impact of 5-hydroxytryptophan (5-HTP) supplementation
      on sleep quality and gut microbiome composition in older adults with normal cognition vs.
      mild cognitive impairment (MCI) using a randomized controlled trial.
    

Detailed description: 
      This is a 12-wk parallel, single-bind (investigator), prospective study design with subjects
      randomly assigned to consume 100 mg of 5-HTP or does not consume 5-HTP. Fifty older men and
      women (aged 60-85y, approximately half men and half women, approximately half subjects with
      MCI) will be recruited with the expectation that ≥ 40 subjects (≥ 10 subjects per group) will
      complete the study. Body size, blood pressure, urinary melatonin, sleep quality, cognitive
      function and mood (including depression and anxiety), gut microbiome, and short chain fatty
      acids will be assessed. Blood amino acid concentration will be measured as an indicator of
      compliance to the 5-HTP consumption from the collected blood samples.

      Relevance to Singapore: The results from the proposed research will assist a practical
      guidance of nutritional behavior changes providing gut and brain health promoting effects to
      Singapore older individuals with or without MCI and may result in reducing cost and manpower
      for cognitive decline care.
    

Intervention name(s): 5-HTP; Without 5-HTP
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 5-HTP that have Good Manufacturing Practice certification will be used and participants will be suggested to be take the 5-HTP supplementation at bedtime.; Subject will not take 5-HTP
Intervention MeSH terms: 5-Hydroxytryptophan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nutritional supplementation; Sleep quality; Cognitive function; Gut microbiome