bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Mental Flexibility Through Language Tests in Adolescents With Frontal Brain Damage and in Healthy Children in Ages 8-17
Condition: Persons With Frontal Lobe Damage With no Specific Language Disorder
MeSH terms: Language Disorders; Specific Language Disorder
Study type: Observational

Summary: 
      This study aims to shed light on the theoretical concept of mental flexibility and its
      manifestation in adolescents following frontal lobe damage, and to develop a test battery for
      young Hebrew speakers.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A group of children ages 8-17 with frontal lobe damage, who are treated at the children
        rehabilitation center at sheba medical center
The Clinical Outcomes of the Arthroscopic and Open Modified Broström Operation in CLAI and GJL
Condition: Ankle Sprains; Instability, Joint; Joint Hypermobility
MeSH terms: Joint Instability; Ankle Injuries
Study type: Interventional

Summary: 
      Investigators designed this randomized controlled trial to compare the clinical outcomes of
      open and arthroscopic modified Broström operation for the treatment of CLAI and GJL.
    

Detailed description: 
      The open modified Broström operation is the first line to treat chronic lateral ligament
      instability (CLAI). Arthroscopic techniques gain popularity for less invasivity, quick
      recovery to normal and sports activities, and the possibility to treat other intraarticular
      disorders. Studies have shown significantly poor clinical and radiological outcomes and a
      higher rate of failure in patients with generalized joint laxity (GJL) than patients without
      after open modified Broström operation. However, there is no study to compare the open and
      arthroscopic modified Brostrom operation for patients with GJL and CLAI. So, investigators
      designed this randomized controlled trial. The primary outcomes are Karlsson, American
      Orthopaedic Foot & Ankle Society, and visual analogue scales. The secondary outcomes are
      anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.
    

Intervention name(s): Open or arthroscopic Modified Broström operation
Intervention type(s): Procedure
Intervention description(s): Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic lateral ankle instability; generalized joint laxity; modified Brostrom operation; arthroscopic; open
A Clinical Trial of a New Computer Based Intervention for Children With Autism.
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The CLICK-EAST research project is an investigation of the efficacy of a computer based
      learning programme which aims to teach the fundamental components of social attention to
      young children with autism spectrum disorder (ASD). "Social attention" describes the process
      of choosing to look at or listen to social information in the world, normally in preference
      to any other available information. Social information normally refers to people: for
      example, we notice human voices more than birdsong or traffic noise, even if the latter is
      louder. As a rule, children with ASD are less likely to prioritise this kind of social
      information. This is thought to have a significant effect on their development and behaviour.
      For example, a child who doesn't listen to what his parents say may be very slow to learn
      language, and may also fail to follow important instructions. Our goal is to create a new
      learning programme, in the form of an enjoyable computer game, which encourages children to
      practise the skills of looking at and listening to people, despite the presence of
      distracting information. The investigators will develop the game with the input of an
      advisory group of parents and teachers of children with ASD as well as some young adults with
      an ASD diagnosis. Then they will perform a trial of the game with a group of preschoolers
      with ASD and their families, in order to determine whether the game is having a positive
      effect on the children's abilities.
    


Intervention name(s): Click-East app
Intervention type(s): Behavioral
Intervention description(s): Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Deep Radiomics-based Fusion Model Predicting Bevacizumab Treatment Response and Outcome in Patients With Colorectal Liver Metastases
Condition: The Patients With CRLM Who Benefit More From Bevacizumab
MeSH terms: Neoplasm Metastasis
Study type: Observational

Summary: 
      This multi-modal deep radiomics model, using PET/CT, clinical and histopathological data, was
      able to identify patients with bevacizumab-sensitive unresectable colorectal cancer liver
      metastases, providing a favorable approach for precise patient treatment.
    

Detailed description: 
      Accurately predicting tumor response to targeted therapies is essential for guiding
      personalized conversion therapy in patients with unresectable colorectal cancer liver
      metastases (CRLM). Currently, tumor response evaluation criteria are based on assessments
      made after at least 2-months treatment. Consequently, there is a compelling need to develop
      baseline tools that can be used to guide therapy selection. Herein, the investigators
      proposed a deep radiomics-based fusion model which demonstrates high accuracy in predicting
      the efficacy of bevacizumab in CRLM patients. Further, the investigators observed a
      significant and positive association between the predicted-responders and longer
      progression-free survival as well as longer overall survival in CRLM patients treated with
      bevacizumab. Moreover, the model exhibits high negative prediction value, indicating its
      potential to accurately identify individuals who are unresponsive to bevacizumab. Thus, our
      model provides a valuable baseline method for specifically identifying bevacizumab-sensitive
      CRLM patients, which is offering a clinically convenient approach to guide precise patient
      treatment.
    

Intervention name(s): Deep radiomics-based fusion model
Intervention type(s): Diagnostic Test
Intervention description(s): This multi-modal deep radiomics model, using PET/CT, clinical and histopathological data, was able to identify patients with bevacizumab-sensitive CRLM, providing a favorable approach for precise patient treatment.
Other intervention name(s): deep learning model
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        In this multicenter cohort study, the investigators collected 307 patients with colorectal
        cancer liver metastases. The training cohort and negative validation cohort were derived
        from the BECOME study (NCT01972490), for whom baseline PET/CT images were available. The
        internal validation cohort was derived from consecutive metastastic colorectal cancer
        patients of the multi-disciplinary team (MDT) at Zhongshan Hospital (ZSH), share the same
        MDT, surgical team, and PET/CT imaging equipment with training cohort, from 01 January 2018
        to 31 December 2018. The external validation cohort came from the MDT of Zhongshan Hospital
        - Xiamen and the First Hospital of Wenzhou Medical University, from 01 January 2020 to 31
        December 2020
Bioequivalence of An Oral Mercaptopurine Suspension 100 Mg / 5 Ml Versus Tablet in Healthy Male Subjects Under Fasting Conditions
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine whether the test product, mercaptopurine
      oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are
      bioequivalent. For this purpose the PK profile of 6-mercaptopurine (6-MP) will be compared
      after administration of a single dose of each of the two formulations, under fasting
      conditions. The secondary objective is to assess the safety and tolerability of the test
      product, mercaptopurine oral 100 mg/5 mL suspension.
    


Intervention name(s): Mercaptopurine 20mg/ml oral suspension; Mercaptopurine 50mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): 50mg; 50mg
Other intervention name(s): Xaluprine; Purinethol
Intervention MeSH terms: Mercaptopurine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective
      in treatment of moderate to severe ulcerative colitis.
    


Intervention name(s): PF-06651600 or Placebo; PF-06700841 or Placebo; PF-06700841; PF-06651600
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Delivered orally for 8 weeks.; Delivered orally for 8 weeks.; Delivered orally for 24 weeks.; Delivered orally for 24 weeks.
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mayo score
The Influence of Pilates Exercises Training Volume on Metabolic Outcomes in Dyslipidemic Women.
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The aim of the present study was to assess the influence of different volumes of Pilates
      training exercises on metabolic, blood pressure (BP), functional physical fitness (PF) and
      quality of life (QL) outcomes in postmenopausal dyslipidemic women. In total, 26 women
      participated in the controlled clinical trial, being allocated into three groups: high volume
      group (HVG; n=9), low volume group (LVG; n=11) and control group (CG, n=6). HVG performed
      four weekly sessions and LVG performed only twice a week, during 10 weeks with 45 to 55
      minutes per session. Before and after the intervention period, metabolic, BP, PF, QL and
      cardiovascular risk score (CRS) outcomes were measured. The results were described by mean
      values with lower and upper limits (95% confidence interval). Comparisons between groups and
      intra-groups were performed adopting Generalized Estimating Equations (GEE) method, with post
      hoc of Bonferroni and significance level of ɑ=0,05.
    


Intervention name(s): High Volume Group; Low Volume Group; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): Performed four weekly session, during 10 weeks with 45 to 55 minutes per session.; Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.; Did not exercise, during 10 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A CONTROLLED CLINICAL TRIAL
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: training volume; elderly; lipid profile; postmenopausal
Understanding the Role of Genes and Biomarkers in the Inflammation and Blood Clotting Process in Children With Acute Lung Injury
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Lung Injury; Acute Lung Injury
Study type: Observational

Summary: 
      Acute lung injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) is a severe lung condition
      that causes respiratory failure. This study will examine if differences in genes and
      biomarkers involved in the inflammation and blood clotting process may affect the severity of
      and recovery from ALI/ARDS in children hospitalized with the condition.
    

Detailed description: 
      ALI/ARDS is a life-threatening condition that involves inflammation of the lungs and fluid
      accumulation in the air sacs, which leads to low blood oxygen levels and respiratory failure.
      Common causes include pneumonia, sepsis, and lung trauma. Symptoms, including breathing
      difficulty, low blood pressure, and organ failure, usually develop within 24 to 48 hours of
      the original injury or illness. Most patients require immediate care in an intensive care
      unit, and the main form of treatment is mechanical ventilation, which delivers oxygen and a
      continuous level of pressure to the damaged lungs. Although progress has been made in
      understanding how ALI/ARDS develops, it is still unknown why recovery outcomes differ among
      people. Differences in the genetic basis of protein C and fibrinolysis pathways, which both
      play a role in preventing blood clots, may be a factor in determining the severity of and
      recovery from ALI. The purpose of this study is to analyze plasma and DNA from children with
      ALI/ARDS to identify biomarkers and genetic variations that may be related to clinical
      outcomes.

      This study will enroll children who are hospitalized with ALI/ARDS. Participants' medical
      records will be reviewed to gather information about symptoms, physical exam findings,
      mechanical ventilator settings, and laboratory test results. A blood collection will occur on
      Days 1 and 3. Study researchers will analyze plasma biomarkers and use high throughput DNA
      sequencing technology to analyze participants' DNA.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are admitted to the University of California, San Francisco hospital and
        participating sites including Children's Hospital of Oakland with ALI/ARDS.
      
Biospecimen description: 
      Blood and plasma samples will be analyzed
    
Keywords: Acute Lung Injury; Acute Respiratory Distress Syndrome
Long-Term Safety of Symbicort in Asthmatic Children - SAPLING
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in
      asthmatic children aged 6 to 11 years
    


Intervention name(s): budesonide/formoterol (Symbicort); budesonide (Pulmicort)
Intervention type(s): Drug; Drug
Other intervention name(s): Symbicort; Pulmicort
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; children; Symbicort; budesonide/formoterol; Pulmicort; budesonide
The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Primary outcome: Serum creatinine change at 4 hours and 48 hours following 4 doses of
      N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine.

      Secondary outcome: Serum Cystatin C change at 4 hours and 48 hours post 4 doses of
      N-acetylcysteine compared to baseline serum Cystatin C.
    

Detailed description: 
      N-acetylcysteine has been reported to lower serum creatinine in normal individuals. The
      mechanism of this effect is unknown but possible stimulation of tubular secretion of
      creatinine has been hypothesized based upon a lack of effect on Cystatin C levels. If this
      effect also occurs in subjects with chronic kidney disease, interpretation of clinical trials
      using N-acetylcysteine for prophylaxis of acute kidney injury would be confounded. To answer
      whether such confounding occurs, 50 patients with stable chronic kidney disease (Stage 3-5)
      will be given 4 doses of N-acetylcysteine, 1200 mg each, with measurement of serum creatinine
      and Cystatin C before, 4 hours and 48 hours after the last dose. No other interventions,
      including changes in medications, will be permitted during the study.
    

Intervention name(s): N-acetylcysteine
Intervention type(s): Drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Clinical Study of Approved and Investigational Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational
      contact lens with currently-marketed contact lenses. The objective of the study is to
      evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.
    


Intervention name(s): Senofilcon C Contact Lens; Comfilcon A Contact Lens; Lotrafilcon B Contact Lens; Samfilcon A Contact Lens
Intervention type(s): Device; Device; Device; Device
Other intervention name(s): senofilcon C; comfilcon A; lotrafilcon B; samfilcon A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Protein Source, Nutrition Messaging, and Food Intake
Condition: Obesity
Study type: Interventional

Summary: 
      The objective of this study is to determine how the protein source and the physical form of
      food consumed at breakfast impact food intake. Research will be conducted by assessing
      feelings of hunger, food preference and blood glucose in healthy adults following the
      ingestion protein-based (animal versus plant) drinks similar calorie and protein content.
    


Intervention name(s): Whey Protein Beverage; Pea Protein Beverage; Snack Tray Choices
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Intervention description(s): Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.; Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.; Items were selected from a snack tray filled with healthy and unhealthy snacks in order to determine if educational messaging influenced snack choices. Shack choices wre recorded on a check list by a third party observer.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Progressive Muscle Relaxation Effect on Sleep Quality, Depression and Stress in People With Multiple Sclerosis
Condition: Multiple Sclerosis; Depression; Sleep; Stress Psychological
MeSH terms: Multiple Sclerosis; Sclerosis; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on
      stress and depression levels of individuals with multiple sclerosis.
    

Detailed description: 
      Introduction: Multiple sclerosis is a chronic, autoimmune disease, characterized by
      demyelination and neurodegeneration of the central nervous system. The progressive course of
      this disease may cause individuals to develop extreme dependency and create serious
      difficulties both to the individuals themselves and family members and caregivers, since the
      disease brings a number of physical, emotional, psychological and social symptoms. Therefore,
      it is essential to offer healthcare practices that go beyond the usually fragmenting,
      dehumanized care services that focus on the disease bodily processes.

      Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on
      stress and depression levels of individuals with multiple sclerosis.

      Methodology: This is randomized clinical test. The sample was made up of 40 individuals with
      multiple sclerosis (20 in control group and 20 in the experimental group) in outpatient
      follow-up. The progressive muscle relaxation technique was employed. In order to collect the
      data, we adopted the interview with form filling technique, using the Pittsburgh Sleep
      Quality Index, Perceived Stress Scale and Beck Depression Inventory. Blood pressure, heart
      rate and respiratory rate of experimental group were measured before and after the
      progressive muscle relaxation intervention. In order to treat statistical data, we used
      Statistical Package for Social Sciences, version 19.0.
    

Intervention name(s): Progressive muscle relaxation
Intervention type(s): Other
Intervention description(s): Intervention group: 20 patients with relapsing-remitting multiple sclerosis receive five sessions of Progressive Muscle Relaxation under the supervision of a researcher in neurology clinic. Before and after each session of the Progressive Muscle Relaxation They will be measured heart rate, respiratory rate and blood pressure. Participants will be guided to realize the Progressive Muscle Relaxation daily for 8 weeks, the time of day you feel more comfortable. the same receive education and training as the technical as well as a audio and a leaflet with the description the stages of the Progressive Muscle Relaxation. Control group: 20 patients with relapsing-remitting multiple sclerosis only receive traditional treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Integrated Treatment and Prevention for People Who Inject Drugs
Condition: HIV Positive
MeSH terms: HIV Seropositivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the feasibility of a future trial that will assess
      whether an integrated intervention combining psychosocial counseling and supported referrals
      for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for
      HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected
      injection partners, as compared to routine care dictated by national guidelines for
      HIV-infected PWID.
    

Detailed description: 
      This is a multi-site, two-arm, randomized, vanguard study. Network units will consist of an
      HIV-infected index participant and his/her HIV-uninfected network injection partner(s).
      Network units will be randomized to the intervention or standard of care arms in a 1:3 ratio,
      stratified by site. To assess feasibility of the intervention, additional interviews will be
      conducted with study staff (systems navigators and counselors) and clinic-based stakeholders
      at each study site.

      Approximately 500 Index participants and their partners will be enrolled.
    

Intervention name(s): Integrated Intervention
Intervention type(s): Behavioral
Intervention description(s): systems navigation, psychosocial counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention