bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2a Study on Intravenous Infusion of Autologous Osteoblastic Cells in Severe Osteoporosis
Condition: Severe Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Osteoporosis is a systemic skeletal disease characterized by low bone mass and
      microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility
      and susceptibility to fracture.

      Osteoporosis is one of the most common and debilitating chronic diseases, and a global health
      concern with a high prevalence not only in Western countries, but also in Asia and Latin
      America. Most efficacious anti-osteoporotic treatments either inhibit bone resorption like
      bisphosphonates or denosumab or increase bone formation like teripartide an anabolic agent.
      Anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in bone mass
      and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of treatment (Black
      et al., 1996; Neer et al., 2001; Meunier et al., 2004). Despite the availability of
      pharmacological treatments, osteoporosis remains a significant health problem for patients
      who do not respond to the available treatments or fail to comply with their regimens.

      The present phase 2a study aims to demonstrate the safety and efficacy of PREOB®, a
      proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic
      patients who do not respond to pharmacological treatments.
    


Intervention name(s): PREOB® Intravenous Infusion
Intervention type(s): Drug
Intervention description(s): Each patient will undergo a single intravenous administration of PREOB®.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bone Diseases; Metabolic Bone Diseases; Osteoporosis; Bone Fractures; Osteoporotic Fractures; Musculoskeletal Diseases
Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents
Condition: Advanced Cancer; Relapsed Cancer; Refractory Cancer
Study type: Interventional

Summary: 
      This study will evaluate the effects of animal-assisted interactions (AAI) on stress,
      anxiety, and quality of life in children with a life-threatening condition and their parents.
      It is anticipated to be a milestone in understanding the human-animal bond.
    

Detailed description: 
      Objectives:

        1. Examine the feasibility of animal-assisted interactions sessions for children with a
           life-threatening condition and primary caregiver to:

             -  Identify and document modifications for a safe and feasible intervention,

             -  Obtain recruitment estimates and determine potential recruitment barriers

             -  Evaluate elements of implementation fidelity (design, training, delivery/receipt of
                Treatment, enactment)

             -  Verify safety.

           H1-1: Children and parents (>60%) will complete the interventions and provide positive
           acceptability data. H1-2: Implementation fidelity can be achieved with the proposed
           methodology

        2. Determine the preliminary efficacy of animal-assisted interactions sessions for:

             -  Children with a life-threatening condition (LTC) for the outcome of health-related
                quality of life

             -  Children with a LTC and their primary caregivers for the outcomes of stress and
                anxiety

      H2-1 Children with a life-threatening condition who receive animal-assisted interactions will
      experience improved health-related quality of life (HRQOL) more than patients who do not
      receive animal-assisted interactions.

      H2-2a Children with life-threatening condition who receive animal-assisted interactions will
      experience decreased stress and anxiety more than parents of children who do not receive
      animal-assisted interactions.

      H2-2b Primary caregivers of children with a life-threatening condition who receive
      animal-assisted interactions will experience decreased stress and anxiety more than parents
      of children who do not receive animal-assisted interactions.
    

Intervention name(s): Animal-Assisted Interactions
Intervention type(s): Behavioral
Intervention description(s): Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.
Other intervention name(s): AAI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pilot Study to Test Dietary Fat Delivery
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      The average American diet consumed by a significant proportion of the adult population,
      supplies excessive calories and large amounts of saturated fat. Saturated fats can be cleared
      and used in skeletal muscle, but in obese individuals, biomarkers of saturated fat are found
      in the blood, along with markers of poor muscle metabolism.

      Both fats and amino acids are processed by the same metabolic pathways in muscle, and the
      investigators hypothesize that meals with greater amounts of saturated fat slow muscle
      metabolism. A better understanding of the interaction of these to metabolites will allow for
      the development of future medications to treat muscle loss in sick individuals and the
      elderly.
    

Detailed description: 
      This study includes two parts, a baseline study and a three-week dietary study. The baseline
      study will be performed to test how the body absorbs and stores meal fat after a meal. In the
      three-week dietary study, the subjects will consume only the meals provided by the
      investigators for three weeks before the tests, and then participate in a hospital stay. The
      three-week dietary study is to test the chronic effect of a high fat diet on how body absorbs
      and stores the fat.
    

Intervention name(s): high-fat diet
Intervention type(s): Other
Intervention description(s): Subjects consume a high-fat diet for three weeks before the in-hospital stay.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy and insulin resistant subjects.
      
Biospecimen description: 
      Plasma and muscle biopsy samples are kept in Dr. Parks' lab for further study analysis.
    
Keywords: stable isotopes; triacylglycerol
Efficacy Emollient on Xerosis in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local,
      immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are
      dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is
      associated with skin barrier dysfunction that facilitates an easier allergen penetration into
      the skin with an increased irritation and subsequent cutaneous inflammation. A lack of
      important stratum corneum intercellular lipids and an inadequate ratio between compounds
      enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy
      usually twice daily improves dryness and subsequently pruritus during the treatment of atopic
      dermatitis and especially improves the barrier function. Emollients make part of basic
      therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and
      Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration,
      measured by skin hydration, is a key element for evaluation of emollient treatment efficacy.

      The primary objective of this study is to demonstrate the efficacy of the tested product
      (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient
      formula during 28 days.
    


Intervention name(s): V0034CR01B; Vehicle cream; desonide 0.1% cream; Foaming gel
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days; Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days; cream, once a day (in the evening) during flares; for the washing and cleaning
Other intervention name(s): Locapred; Pediatril
Intervention MeSH terms: Desonide; V0034CR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: xerosis; dry skin; dermatitis; pruritus; eczema; emollient; corticosteroid
Safety and Efficacy of Glibenclamide Combined With Rt-PA in Acute Cerebral Embolism
Condition: Acute Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to evaluate the safety and efficacy of oral glibenclamide in acute
      ischemic stroke patients who under intravenous rt-PA thrombolysis.
    


Intervention name(s): Glibenclamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glibenclamide is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.; Placebo is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute ischemic stroke; glibenclamide; rt-PA; blood-brain barrier; brain edema
A Probiotic That Improve Intestinal Flora
Condition: Intestinal Flora
Study type: Interventional

Summary: 
      Purpose: to verify the physiological properties of Lactobacillus rhamnosus LRa05.

      Bacterial count:100 billion Test Objective: to test and collect the changes of intestinal
      flora before and after the daily use of LRa05 product.
    

Detailed description: 
      In order to validate the physiological properties of the 100 billion probiotic Lactobacillus
      rhamnosus LRa05 product and to gather sufficient evidence to test the changes in the
      intestinal flora before and after the daily use of the probiotic product, the test was
      conducted on 110 college students aged 18-25 years.

      The primary outcome was to investigate the increase in the diversity of the gut flora and the
      increase in the peak levels of beneficial bacteria in the gut, and the secondary outcome was
      to investigate whether there was a significant improvement in the PSQI Pittsburgh Sleep
      Quality Index and the ISI Insomnia Severity Index.
    

Intervention name(s): Lacticaseibacillus rhamnosus LRa05
Intervention type(s): Other
Intervention description(s): Bacterial count:100 billion CFUs Take one sachet per day for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Left Ventricular Function and Therapeutic Effect of CPAP in Patients With OSAS by 3D STE
Condition: OSA; Left Ventricular Dysfunction
MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Observational

Summary: 
      The changes of left ventricular function in patients with sleep apnea were studied by
      three-dimensional speckle-tracking echocardiography to evaluate the changes of left
      ventricular function after CPAP treatment
    

Detailed description: 
      Research purposes: (1) Use 3D speckle tracking echocardiography to measure the diastolic and
      systolic strains of the left atrium and left ventricle of OSAS patients, in order to evaluate
      the impact and degree of OSA on left ventricular function.

      (2) By comparing the changes in the three-dimensional ultrasound strain index of the left
      ventricle of patients before and after CPAP treatment, and in patients receiving and not
      receiving CPAP treatment, to evaluate whether CPAP treatment contributes to the improvement
      of cardiac function in patients with OSAS, and to infer the best suitable intervention
      population and using time, providing reference basis for clinical treatment.

      (3) Discovery of serological indicators that predict the severity of the disease and predict
      the impairment of heart function Study design: This study is a prospective, observational
      controlled study. It is planned to include 30 cases of newly diagnosed OSAS patients in the
      Peking University Third Hospital and a control group selected according to age and gender
      matching. The three-dimensional strain of the left atrium and left ventricle of the crowd is
      measured by the 3D speckle tracking technology, and the serological indicators are detected.
      The OSAS group and the control group were followed up during the course of receiving or not
      receiving CPAP.
    

Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): CPAP ventilator was worn at nigh
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with OSA who underwent sleep monitoring at the Sleep Medicine Center of Peking
        University Third Hospital were selected for the study.OSA met the diagnostic criteria of
        obstructive sleep apnea in the United States Classification of Sleep Diseases in
        2014.Exclusion criteria from this study included previously diagnosed patients with heart
        failure,coronary artery disease,valvular disease,cardiomyopathy,arrhythmia,chronic
        obstructive/ restrictive pulmonary disease, thyroid dysfunction (including hypothyroidism
        or hyperthyroidism), already treated with CPAP, and poor image quality of echocardiography.
        Healthy subjects who underwent sleep monitoring to exclude OSA were selected as the control
        group during the same period.
      
Keywords: OSA; CPAP; left ventricular dysfunction
Preventing Weight Gain and Unhealthy Behaviors in Children
Condition: Obesity
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      This study will address engagement in unhealthy behaviors, low levels of self-regulation, and
      unhealthy weight gain for children from low-income households.
    

Detailed description: 
      Evidence suggests that components within structured days (e.g., school days) have a positive
      influence on children's obesogenic behaviors (i.e., diet, sleep, physical activity, sedentary
      behaviors) and self-regulation. In this pilot study children will be randomized to two arms:
      attend a structured summer camp, not attend a camp. The investigators hypothesize that
      children attending the summer camp will engage in more healthy obesogenic behaviors, display
      higher levels of self-regulation, and subsequently will experience less weight gain than
      children not attending the summer camp. To test this hypothesis the following specific aims
      will be accomplished: Aim 1 (Primary): Compare changes in BMI z-scores and fitness among
      children from low-income households attending a structured summer day camp and those not
      attending a structured summer day camp. Aim 2 (Secondary): Compare changes in obesogenic
      behaviors among children attending a structured summer day camp and those not attending a
      structured summer day camp. Aim 3 (Exploratory): Explore changes in self-regulation and the
      moderating effect of these changes on primary and secondary outcomes among children attending
      and not attending a structured summer day camp.
    

Intervention name(s): Summer Camp
Intervention type(s): Behavioral
Intervention description(s): The intervention camps will operate according to routine practice, with no assistance from the investigative team. The camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks. All camp meals will adhere to the United States Department of Agriculture Summer Food Service Program nutrition guidelines. The camps employ 1 staff member for every 12 children - which is consistent with childcare regulations in the state of operation and operate daily (Mon-Fri) for 8 weeks during the summer. The camps open at 7am and close 6 pm daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Screen-detected Coeliac Disease, a Population Based Study
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine the prevalence of previously undiagnosed coeliac
      disease based on a health survey from Tromsø, Norway. Moreover, the health impact of
      undiagnosed coeliac disease will be examined.
    

Detailed description: 
      Few population-based studies have examined the prevalence of coeliac disease and the impact
      of undiagnosed coeliac disease on health. Moreover, the number of people with undiagnosed
      coeliac disease is much higher than the number who know their diagnosis.

      The purpose of this study is to determine the prevalence of coeliac disease and the impact of
      undiagnosed coeliac disease on health.

      In a health survey of the population of Tromsø Norway, serological markers of coeliac disease
      (transglutaminase 2, TG2 and deamidated gliadin antibody test) have been analyzed.
      Individuals with increased level of one of these markers, will be invited for upper endoscopy
      with small bowel biopsy examination to confirm the diagnosis of coeliac disease. All persons
      with screen detected coeliac disease, will be advised to start a gluten free diet.

      Health status and Quality of Life will be examined by means of the Gastrointestinal Symptoms
      Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI) respectively.

        1. At baseline GSRS and PGWBI will be analyzed in persons with screen detected and biopsy
           verified coeliac disease and compared with a group of healthy control persons from the
           health-survey cohort.

        2. In a prospective study of the persons with screen detected coeliac disease, health
           status (GSRS) and Quality of Life will be compared before and after one year on a gluten
           free diet.
    

Intervention name(s): Gluten-free diet
Intervention type(s): Other
Intervention description(s): Dietary advice by clinical dietitian
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Quality of life; Celiac Disease/diet therapy; Celiac Disease/diagnosis; Prospective Studies
Pelvic and Hip Morphometry in Piriformis Syndrome
Condition: Piriformis Muscle Syndrome; Anthropometry
MeSH terms: Piriformis Muscle Syndrome; Syndrome
Study type: Observational

Summary: 
      In this case-control study, 23 patients diagnosed as PS by diagnostic injection with
      ultrasound guidance were selected as the study group. 22 patients who were excluded from the
      diagnosis of PS and had anteroposterior (AP) direct radiographic imaging were evaluated as
      the control group. On the AP Pelvic graph, the femoral neck-shaft angle, the distances
      between predetermined bony landmarks were measured blindly without knowing the diagnosis, and
      the findings were compared statistically.

      This study aims to evaluate whether the anatomical structure of the pelvis predisposes to the
      etiopathogenesis of the piriformis syndrome.
    

Detailed description: 
      Piriformis syndrome (PS) is a neuromuscular disorder consisting of pain and symptoms caused
      by compression of the sciatic nerve and other structures that pass under the piriformis
      muscle (PM). Due to difficulties in diagnosis, PS is confused with other pathologies such as
      lumbar disc pathology, lumbosacral radiculopathy, and sacroiliac dysfunction. As a result,
      patients are exposed to unnecessary and ineffective treatments, even surgery. The main
      problems in the PS diagnosis are the absence of objective physical examination findings,
      radiological findings, and a clear etiology. When the pathophysiology and etiology of PS are
      considered, there is no identifiable cause in most patients. Previous studies suggest that
      trauma, anatomical variations, and the trigger point in the muscle may cause PS. No study in
      the literature radiologically examined the pelvis or hip bone morphological features in PS to
      the best of our knowledge. This study aims to determine whether pelvic or hip bone morphology
      features pose a risk for PS in this study.
    

Intervention name(s): Ultrasound guided diagnostic injection
Intervention type(s): Diagnostic Test
Intervention description(s): 4 cc lidocaine %2 injection into the piriformis muscle was performed for the diagnosis of piriformis syndrome. It was performed by the ultrasound-guidance to increase the accuracy of the injection.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The physical medicine and rehabilitation outpatient clinic of Fatih Sultan Mehmet Training
        and Research Hospital
      
Keywords: Anthropometry; Pelvic Bones; Muscle Syndrome, Piriformis; Prospective Studies; Case-Control Studies; femur neck / pathology