bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of 11C-MET PET/MRI Imaging in Pediatric Brain Fossa Tumors
Condition: Posterior Brain Fossa Tumors in Children
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      Brain tumors are the most common solid tumors in children and are the second most common
      cause of cancer-related death among this population. Posterior brain fossa tumors represent
      about 50% of children brain tumors.

      Recently, knowledge in molecular biology has permitted to identify different tumors subgroups
      of very different prognosis. Today, surgery removal of the tumor is the mandatory.
      Neuro-oncological treatment differs depending on the histological and molecular subgroup.
      With classical Magnetic Resonance Imaging (cMRI), distinction between different types of
      posterior fossa tumors remains difficult.

      Positron Emission Tomography combined with MRI (PET/MRI) has proven its benefits for the
      management of brain tumors. The direct spatiotemporal correlation makes possible the
      assessment of metabolic, anatomical and functional information. PET/MRI would provide
      precisions on the pre-therapeutic characterization of tumors, which could permit to modify
      the patients' care.

      L- [methyl-11C] methionine (11C-MET) is currently the gold-standard tracer used in
      neuro-oncology, but few data exists in children. 11C-MET PET/MRI assessment seems promising,
      but has not been studied enough. To the best of our knowledge, there is no specific study on
      primary brain tumors of the posterior fossa in children using 11C-MET PET/MRI.

      The primary objectives of this first pilot study is to evaluate the practical feasibility of
      11C-MET PET/MRI imaging (machine accessibility and imaging interpretability) before surgery
      in a population of children older than 5 years old with posterior fossa tumors.

      The secondary objectives aim to describe :

        -  the PET/MRI parameters of the different tumors studied,

        -  and the patient's participation acceptation.

      This feasibility study will allow us to standardize the PET/MRI measurements; this could
      allow us to discriminate, in a larger study, the different tumor subgroups before surgery.
    


Intervention name(s): 11C-MET PET/MRI
Intervention type(s): Procedure
Intervention description(s): Except PET/MRI imaging, all the examinations will be done according to the patient's usual care.
PET/MRI imaging will be realized within max 7 days after children enrollment, and the surgery (usual care) will be performed within max 4 days after PET/MRI imaging.
PET/MRI imaging will include the following sequences: T1axial, Diffusion, Magnetic susceptibility post-Gadolinium injection, 3DT1 pre and post-Gadolinium injection, and Arterial Spin Labelling Imaging (ASL).
Intervention MeSH terms: Carbon-11 methionine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: PET/MRI; 11C-MET; posterior brain fossa tumors; children; surgery; feasibility
Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to elucidate whether combination of usual pulmonary
      rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise
      capacity in patients affected by chronic obstructive pulmonary disease (COPD).
    

Detailed description: 
      Neuromuscular electrical stimulation (NMES) has been extensively used as technique to improve
      muscle function in different areas of rehabilitation, however it seems to be more appropriate
      in critical care situation, while its use in more able patients is of uncertain benefit. In
      other words, NMES seems to be particularly effective in severely deconditioned and bed ridden
      patients. We therefore carried out a randomised trial to compare the efficacy of combination
      of NMES and PR (NM+PR) with combination of sham stimulation and PR (SS+PR) in a large
      population of moderately impaired COPD patients. Primary outcome was evaluation of effect of
      NMES on quadriceps strength and on exercise capacity. Secondary outcome was evaluation of
      effect of NMES on symptoms (dyspnoea) and quality of life.
    

Intervention name(s): neuromuscular electrical stimulation (NMES); Sham electrical stimulation
Intervention type(s): Other; Other
Intervention description(s): NMES was applied by means of a commercially available four channel electrostimulator which generated a symmetrical biphasic pulsed current. Each session lasted 30 minutes and was performed 5 days/week for 5 weeks.; Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.
Other intervention name(s): pulmonary rehabilitation; pulmonary rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD
ADME Study of [14C]- Larotinib in Healthy Male Subjects
Condition: Healthy Adult Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Evaluate the Mass Balance and Biotransformation of Single Dose
      [14C]-Larotinib（Z650）in healthy male subjects.
    


Intervention name(s): [14C]-Larotinib
Intervention type(s): Drug
Intervention description(s): Patients will receive single dose of orally [14C]-Larotinib on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus
      Erythematosus (SLE) disease activity improvement achieved by a brief course of
      disease-suppressing steroid therapy
    


Intervention name(s): XmAb5871; Placebo to match XmAb5871
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized (1:1, no stratification), Double-Blinded, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Translating Healthy Lifestyle Interventions for Cancer Survivors
Condition: Diabetes Mellitus, Non-Insulin-Dependent; Breast Cancer; Endometrial Cancer
MeSH terms: Endometrial Neoplasms; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Investigators proposed to refine and test the feasibility and acceptability of a 4-month
      multi-modal lifestyle intervention in African American female breast or endometrial cancer
      survivors diagnosed with type 2 diabetes.
    

Detailed description: 
      Recent systematic reviews and meta-analyses of cohort studies show that physical activity can
      reduce mortality and morbidity in diabetes and obesity-related cancers. Yet, there have been
      few efforts to promote physical activity within the context of female cancer survivorship,
      particularly among women with diabetes. In response, investigators proposed to refine and
      test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in
      African Americans (AA) with diabetes and who are breast or endometrial cancer survivors. This
      web-based, lifestyle intervention, coupled with coaching calls and in-person exercise
      sessions, may be an effective way to promote physical activity and healthy survivorship. The
      primary goal is for participants to participate in 30 minutes of moderate-to-vigorous
      physical activity five times a week. The investigators' aims : i) refine a theory-driven
      healthy lifestyle intervention, that is delivered via computer technologies and periodic
      in-person group exercise sessions with appropriate content, literacy demand and graphics, ii)
      assess the preliminary effects of the intervention on the primary outcome of level of
      moderate to vigorous physical activity (MVPA), as measured by accelerometry; weight,
      glycosylated hemaglobin and evaluate the effect of eating behaviors, wellbeing/functioning
      (quality of life, depressive symptoms, self-efficacy), compliance/adherence to protocol and
      acceptability on response to the intervention.
    

Intervention name(s): Standard Behavioral Weight Change Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants enrolled in Phase 2 of the study will meet once a month for 75 minutes over the course of 4 months. Within this 75 minutes, they will complete 25 minutes of physical activity with a licensed physical activity instructor that is very experienced with working with this population, review and discuss various topics/lessons that relate to diabetes, nutrition, survivorship and physical activity with the study's interventionist and Group Leader
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cancer; Breast Cancer; Endometrial cancer,; Type 2 Diabetes
Can Fecal Calprotectin Be Used as a Biomarker of Non-alcoholic Fatty Liver Disease In Obese Adolescents?
Condition: Obesity, Childhood; NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Pediatric Obesity
Study type: Interventional

Summary: 
      The incidence of non-alcoholic fatty liver disease (NAFLD) is increasing with obesity, and it
      is believed that ongoing inflammation in obesity and alterations in the enterohepatic axis
      contribute to this process. This study aimed to determine the role of fecal calprotectin
      (FCP) as an inflammatory biomarker in course of obesity and NAFLD.
    

Detailed description: 
      Obesity is a significant public health issue worldwide. With the increasing prevalence of
      obesity, the prevalence of metabolic syndrome in adolescents is also on the rise.
      Non-alcoholic fatty liver disease (NAFLD), a major cause of chronic liver disease, is the
      hepatic component of metabolic syndrome. The prevalence of NAFLD is not precisely known, but
      in some studies, it is between 22.5% and 52.8% in children with obesity, constituting 2.6% of
      all children. Although the mechanisms involved in the development of obesity-related
      metabolic complications and NAFLD are not well understood, it is believed that intestinal
      inflammation, changes in the microbiota, and alterations in the gut-liver axis (GLA) may play
      a role in the development of low-grade chronic inflammation in NAFLD associated with obesity.
      Fecal calprotectin (FCP), which has become increasingly important in demonstrating intestinal
      inflammation in recent years, is a widely used test, particularly in the diagnosis and
      monitoring of inflammatory bowel disease and various gastrointestinal disorders. In our
      study, the utility of FCP as an inflammatory biomarker in the course of NAFLD in obese
      adolescents has been investigated. The study was approved by our hospital's ethics committee
      in 15.11.2022 and another ethics committee approval was taken in 08.06.2023 for title change
      of study. This study conducted under the Helsinki Declaration.
    

Intervention name(s): Fecal Calprotectin Test
Intervention type(s): Diagnostic Test
Intervention description(s): Fecal samples are taken fom obese and healthy adolescents for study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy of CJ-12420, once daily (QD),
      compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)
      classification grades A to D at Week 8
    

Detailed description: 
      This is a double blind, randomized, active controlled, phase 3 study. Subjects will be
      randomly assigned to one of the two treatment groups (CJ-12420 100 mg or esomeprazole 40 mg).

      All subjects will be asked to take two tablets at the same time each day throughout the
      study, and also all subjects will be asked to record daytime and nighttime symptom in a
      subject diary on a daily basis.
    

Intervention name(s): CJ-12420 100 mg QD; Esomeprazole 40 mg QD
Intervention type(s): Drug; Drug
Intervention description(s): CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100 mg.; Esomeprazole 40 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40 mg.
Other intervention name(s): Not yet decided; Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)
Condition: Mucopolysaccharidosis (MPS); Hunter Syndrome
MeSH terms: Mucopolysaccharidosis II; Mucopolysaccharidoses; Syndrome
Study type: Observational

Summary: 
      Hunter syndrome (Mucopolysaccharidosis II, [MPS II]) is a rare, genetically linked lysosomal
      storage disease (LSD) caused by deficiency of the enzyme, iduronate-2-sulfatase (I2S). Most
      MPS II patients will present with some degree of neurodevelopmental involvement, ranging from
      severe cognitive impairment and behavioral problems to mildly impaired cognition. This is an
      observational study; no investigational treatment will be administered. The primary objective
      of this study is to evaluate the neurodevelopmental status of pediatric patients with MPS II
      over time and to gain information to guide future treatment studies in this patient
      population.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male MPS II patients between 2<18 years of age at time of informed consent
      
Biospecimen description: 
      Genotyping of the iduronate-2-sulfatase gene will be required ONLY for those patients who
      have not had a previous genotyping sample analysis performed at the selected diagnostic
      laboratory.
    
Keywords: Neurodevelopmental Status; Pediatric Hunter syndrome patients; Central Nervous System (CNS) involvement; Observational study; Cognitive impairment
Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of accelerated hypofractionated
      three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy
      for patients with unresectable stage III non-small cell lung cancer.
    

Detailed description: 
      Increasing the biological effective dose (BED) of radiotherapy for non-small cell lung cancer
      (NSCLC) can increase local control rates and improve overall survival. Compared with
      conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield
      higher BED, shorten the total treatment time, and theoretically obtain better efficacy.
      However, currently, there is no optimal hypofractionated radiotherapy regimen. Based on phase
      I trial results, we performed this phase II trial to further evaluate the safety and
      preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation
      therapy(3-DCRT) combined with concurrent chemotherapy for patients with unresectable stage
      III NSCLC.

      Patients with previously untreated unresectable stage III NSCLC received 3-DCRT with a total
      dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed
      within 4.6 weeks. At the same time, platinum doublet chemotherapy was applied.
    

Intervention name(s): Hypofractionated radiation/chemotherapy
Intervention type(s): Radiation
Intervention description(s): Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: accelerated hypofractionated radiotherapy; three-dimensional conformal radiation therapy; concurrent radiochemotherapy
Efficacy of Maxillo-facial Treatment on Cleft Lip and Palate Patients Faces: Aesthetic Considerations
Condition: Cleft Lip and Palate; Growth and Development; Cicatrix; Randomized Controlled Trial
MeSH terms: Cleft Lip; Cicatrix
Study type: Observational

Summary: 
      The aim of the study is to analyze the esthetic outcome of the first surgical repair of cleft
      lip and palate (CLP) patients.

      The aim of the study is to identify differences in the aesthetic evaluation of full-face and
      nasolabial region 3-D images of CLP patients following primary lip repair by laypeople.
    

Detailed description: 
      The management of cleft lip and palate patient's generally involves the soft palate
      reconstruction as well as the repair of lip and nasal soft tissue defects.

      From an esthetic point of view, the primary repair, usually performed between 9 and 18 months
      of age, prepares the patients to grow into childhood and succeed in life without focusing on
      their deformity.

      An increasing number of outcome measure rating systems has been raised, suggesting a lack of
      consensus to a reliable, validated and reproducible scoring system for facial aesthetics in
      cleft patients. Many templates and lay panel scoring systems have been described, yet never
      fully validated. Advanced 3D imaging technologies may produce validated outcome measures in
      the future, but presently there remains a need to develop a robust method of facial aesthetic
      evaluation based on standardised patient photographs.

      The aim of the study is to to determine and compare the level of agreement among examiners'
      subjective aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients
      following primary lip repair by laypeople, developing some recommendations for a consistent
      scoring protocol.
    

Intervention name(s): VAS scale (from 1 to 10) esthetic assessment of facial 3-D images
Intervention type(s): Other
Intervention description(s): The rating process is biphasic: firstly a 3-D model is showed to the raters, who can orientate the vultus, familiarize with the 3-D technology and have a first glance evaluation. Secondly, the judges are asked to rate each of the following patient views: right profile, left profile, frontal, neck hyperextension and hyperflexion views Two weeks after the first assessment, the same judges assessed the same number of pictures, once again in random order.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The lay panel consisted of 50 undergraduate students who had little or no training in cleft
        palate or cranio-facial treatment. All panelists were recruited from the Catholic
        University of Sacred Heart. The participation of the study is voluntary. A preliminary
        assessment of raters' knowledge has been performed through an oral examination.
      
Keywords: Reconstructive surgical procedures; Therapy, soft tissue; Treatment outcome; Outcome Assessment (Health Care); Photogrammetry; Physical Appearance, Body
The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
Condition: Post Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      This study is designed to evaluate the effect of pacing on post-MI patients.
    


Intervention name(s): Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System
Intervention type(s): Device
Intervention description(s): No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pacing
The Effect of Lower Limbs Neural Mobilization in Subjects With Cervical Pain.
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      No studies have investigated the effects of a Sciatic nerve mobilization in subjects with
      neck pain. This study aims to determine the immediate effects of a lower limbs neural
      mobilization on cervical range of motion and on the perception of pain in the most common
      trigger points located in the cervical musculature.
    

Detailed description: 
      A convenience sample will be used to obtain subjects The subjects will be recruited through
      posted advertisements on social networks. The inclusion and exclusion criteria will be
      applied to the volunteers. The sample wil comprise university students and administrative
      workers with neck pain. The subjects will be screened by a screening questionnaire and all of
      them, they will be required to sign an inform consent before participating to the study.
      After signing it, they will be randomly divide into control group subject to a placebo
      technique and the intervention group subject to an active mobilization of the sciatic nerve.

      To assess changes in cervical articular range, will be used, a cervical goniometer (CROM) and
      for changes in pressure pain threshold of the trigger points will be used a mechanical
      algometer. Furthermore, to asses changes in pain perception will be used a visual numerical
      scale. The statistical analysis will be performed using the statistical program SPSS 25.0,
      comparing the results between both groups.
    

Intervention name(s): Active neck mobilization; Active Mobilization of the sciatic nerve
Intervention type(s): Other; Other
Intervention description(s): The subjects, receive an active neck mobilization intervention.; The subjects, receive an active sciatic nerve mobilization intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study sample will be randomly divide into 2 groups, a control group subject to a placebo technique and an intervention group subject to an active mobilization of the sciatic nerve.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Neck pain; Neural mobilization; Myofascial trigger point; Sciatic nerve