bioihbjkbjnl/mcl2 huggingface dataset:
Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional

Summary: 
      This will be the first multidisciplinary, randomized, longitudinal trial of a tailored,
      parent- and child-focused physical activity program for children (ages 4- <19 years) with
      newly diagnosed ALL. It will test the ability of the intervention to prevent or diminish
      early physical function limitations and improve health-related quality of life (HRQL). The
      intervention will be tested for its effect on: 1) physical function outcomes (muscle
      strength, range of motion, endurance, gross motor skills), bone density and bone mineral
      content (end of therapy only); and 2) HRQL. This multi-site trial will test the intervention
      in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo
      "minimal movement" standard care strategy).
    

Detailed description: 
      An advanced practice nurse (APN) will meet twice weekly with the patient and family for the
      first 4 weeks of the intervention to initiate the motivation-based dialogue and therapeutic
      interaction; this will be followed by once weekly visits during weeks 5-8 of the
      intervention; and monthly visits during weeks 9-through end of therapy. The physical
      therapist (PT) will meet at least once weekly with the patient and family during weeks 1-4 to
      initiate the prescriptive tailored exercise program; subsequent visits to reinforce and
      modify the program will occur at least once every other week during weeks 5-8, and at least
      once monthly during weeks 9-135 of the intervention. The PT will visit at least once weekly
      during weeks 1-4, at least once every other week during weeks 5-8, and at least once monthly
      during weeks 9-135. During weeks 9-135 of the intervention, the APN will call between the
      monthly in person-visits, if needed to those randomized to the MAP group to assure fidelity
      to the intervention and to provide booster support to the intervention where needed.
    

Intervention name(s): Physical Therapy; Support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Each patient in this group will have physical therapy performed. The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL.; Visits with an Advanced Practice Nurse to support sustained motivation.
Other intervention name(s): Physical Activity to Modify Sequelae and in Childhood ALL.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Standing Behavior After Installation of Height-Adjustable Desks
Condition: Office Workers; Sitting Occupations
Study type: Interventional

Summary: 
      The purpose of this research study is to determine whether height-adjustable desks change
      sitting and standing time at work and away from work, engery expenditure, dietary intake, and
      body composition. Intermittent peroids of standing made possible by height-adjustable desks
      may help to impart long-term health benefits.
    


Intervention name(s): Height-Adjustable Desk Intallation in Office
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: height-adjustable desk; office workers; sitting occupations; energy expenditure; BMI; Weight; Lower fat diet
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
Condition: Degenerative Disc Disease; Back Pain
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus
      in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two
      levels. These subjects will present with degenerative conditions in the lumbar spine that are
      amenable to surgical treatment and will be screened prior to study enrollment. Subjects will
      receive Osteocel Plus during their XLIF operation. Subjects will be followed for 24-months
      following surgery to determine the number of study subjects that are solidly fused at or
      before 24 months postoperatively, and to determine the mean time to fusion. This data will be
      compared to published and/or retrospective data for autograft, synthetic ceramics and Bone
      Morphogenetic Protein (BMP).
    

Detailed description: 
      Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells
      (MSCs) which is intended to mimic the biologic performance of autograft without the morbidity
      associated with the autograft harvest. Mesenchymal stem cells, like those found in Osteocel
      Plus, are naturally occurring in the body and can differentiate into a variety of tissue
      types, depending on the local environment. Once implanted, MSCs can differentiate into
      osteoblasts, which produce new bone matrix. MSCs also naturally secrete bone-inducing growth
      factors that signal the patient's endogenous cells to migrate and participate in the bone
      formation process. Osteocel Plus is different from other orthobiologic products such as DBM
      and allograft cancellous bone because it contains living stem cells, which provide osteogenic
      potential. The cells include mesenchymal stem cells from an adult human donor; they are not
      from an embryonic source.

      This study is being conducted to determine the percentage of patients with solid spinal
      fusions after being treated with Osteocel in an XLIF procedure. Due to the unique processing
      conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the
      allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be
      comparable to published data for autograft. The Osteocel product family has already been used
      in approximately 15,000 cases worldwide.
    

Intervention name(s): biologic, Osteocel Plus
Intervention type(s): Biological
Intervention description(s): Osteocel® Plus
Other intervention name(s): Osteocel® Plus
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Existing clinic patients
      
Keywords: degenerative disc disease; lumbar spine; XLIF; Degenerative conditions
The Effect of Watching Relaxing Video During Cystoscopy
Condition: Pain; Anxiety; Urological Nursing; Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms; Anxiety Disorders
Study type: Interventional

Summary: 
      The cystoscopy procedure may cause pain and anxiety in patients. Since cystoscopy causes more
      pain in men, studies on pain and anxiety during cystoscopy are more common in men than women.
      The aim of this study was to evaluate the effect of watching relaxing video during cystoscopy
      on the pain and anxiety levels of female patients.
    

Detailed description: 
      Cystoscopy is a safe procedure with low risk of morbidity commonly used to evaluate lower
      urinary tract symptoms such as hematuria, voiding disorders, irritant bladder symptoms,
      anatomical disorders. Patients experience pain and anxiety when cystoscope is inserted into
      the bladder. The various methods (drug or non-drug) are used for pain and anxiety during the
      cystoscopy. Although there are a lot of studies on male patients, there are limited studies
      evaluating pain severity in the female patients during urological procedures. In addition,
      there wasn't found any randomized controlled study for video use from non-drug methods to
      distract attention in these patients. Based on the study results in the literature,
      investigators aimed to evaluate the effect of watching relaxing video on the pain and anxiety
      levels of female patients during rigid cystoscopy.
    

Intervention name(s): Video group
Intervention type(s): Other
Intervention description(s): Patients in the video group started to watch the relaxing video about 5-10 minutes before cystoscopy, and continued to watch video during the whole procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: anxiety; cystoscopy; female; nursing; pain; video
Acid-Base Balance, Metabolism and Minerals
Condition: Acid-Base Balance Disorder; Metabolic Acidosis
MeSH terms: Acidosis
Study type: Interventional

Summary: 
      Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to
      latent acidosis at tissue level with further negative implications. Food supplements with
      alkaline salts are available and popular pretending to prevent these changes.

      Within a randomized double-blind placebo-controlled trial, the investigators tested the
      hypotheses 1) that a 4-week protein-rich diet induces a latent tissue acidosis and 2) an
      alkaline supplement can compensate this. Acid-base balance and important metabolic parameters
      were determined before and after 4 weeks of supplementation by peripheral blood samples,
      indirect calorimetry and muscle microdialysis before and after a protein-rich test meal.
    


Intervention name(s): alkaline salt mixture; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): blood and tissue alkalinisation; no blood and tissue alkalinisation
Other intervention name(s): Basica
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acid-base balance; energy metabolism; protein-rich diet; alkaline supplementation; calorimetry; microdialysis; randomized placebo-controlled trial
A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the time of onset of Vyvanse compared to
      placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and
      Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with
      Attention-Deficit/Hyperactivity Disorder (ADHD).
    


Intervention name(s): Vyvanse (lisdexamfetamine dimesylate); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Following completion of the open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day).; Placebo
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sleep Subtypes in Adolescent Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to compare sleep neurophysiology and behavior in adolescents
      with MDD with hypersomnia (MDD-HYP) and insomnia (MDD-INS) with healthy controls (HC). In
      addition, the investigators will test the efficacy of a simple behavioral sleep restriction
      on mood and sleep in their sample.
    

Detailed description: 
      The World Health Organization has identified depression as the leading cause of burden of
      disease amongst young people. Subjective sleep complaints are often a core symptom of
      depression and highly prevalent with 60-90% of depressed adolescents suffering from disrupted
      sleep. This sleep disruption often takes the form of insomnia (e.g., difficulty falling or
      staying asleep, or waking too early) or hypersomnia (prolonged sleep episodes or excessive
      daytime sleepiness). The aim of the trial is to examine the efficacy of a simple behavioral
      sleep restriction two weeks in duration on mood and sleep in adolescents ages 14 to 17 years
      with and without major depressive disorder. During this period sleep is objectively measured
      using actigraphy and monitor mood using self-report. The results of the study will inform
      whether a simple behavioral sleep restriction beneficially impacts mood and sleep.
    

Intervention name(s): Behavioral Sleep Restriction
Intervention type(s): Behavioral
Intervention description(s): Participants will be instructed to go to bed 30 minutes later than their usual bedtime. On the other hand, wake up time will be unchanged resulting a nightly sleep restriction of 30 minutes. This protocol will be followed for two weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Capivasertib China PK Study
Condition: Advanced Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 2-part Phase I study to assess the PK, safety and tolerability of
      capivasertib as monotherapy and in combination with paclitaxel in Chinese participants with
      advanced solid tumours
    

Detailed description: 
      A Phase I study is designed to assess the PK, safety and tolerability of single-dose and
      multiple-dose capivasertib as monotherapy (Part A) and in combination with paclitaxel (Part
      B) in approximately 16 Chinese participants with advanced solid tumours and to detect any
      differences in the PK profile between Chinese and Caucasian participants due to ethnicity.
      Descriptive summary will be conducted on the PK analysis set and safety analysis set.The
      evaluation of capivasertib PK data will be based on the PK analysis set.The assessment on
      safety and tolerability will be based on the safety analysis set.
    

Intervention name(s): Capivasertib; Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): Part A Cycle 0: Single dose 480 mg(3 x 160 mg tablets) on Day 1 of Cycle 0 Cycle 1 (monotherapy): 480 mg(3 x 160 mg tablets) twice daily given on an intermittent weekly dosing schedule (4 days on, 3 days off for 7 days) Part B Cycle 2 (in combination therapy with paclitaxel): 400 mg (2 x 200 mg tablets) twice daily given on an intermittent weekly dosing schedule. Patients will be dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Capivasertib treatment will continue until disease progression, unacceptable toxicity or the participant requests to stop treatment.; Part B Cycle 2: Patients will receive 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.
Paclitaxel treatment will continue for at least 6 cycles, unless the participant experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel, or disease progression.
Other intervention name(s): AZD5363
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Tolerability; Capivasertib; Chinese
Excess Skin and Physical Activity
Condition: Obesity
Study type: Observational

Summary: 
      Introduction: Currently, bariatric surgery appears to be the most effective treatment to
      improve the health of morbidly obese population. However, the massive weight loss induced by
      this intervention can create excess loose skin in various parts of the body contributing to
      the feeling of failure in their desire to feel better in some patients. Several studies show
      that people are once again disappointed and dissatisfied with their body appearance due to
      the mass of unsightly loose skin that disrupts their quality of life. However, very few
      studies have focused on the barriers that this excess skin could create in everyday physical
      activity. The aim of the investigators pilot study is to assess the impact of excess skin on
      the practice of physical activity in women who underwent bariatric surgery and evaluate if
      there is a relationship between physical activity and the level and location of excess skin.
      Also, the investigators will explore, the benefits of plastic surgery in patients who had
      this intervention.

      Materials and methods: About twenty women who underwent bariatric surgery and a dozen who had
      subsequent plastic surgery will be included in this pilot study. Anthropometry, weight loss
      post bariatric and plastic surgery, motivational stage on the practice of physical activity,
      usual practice of physical activity, functional and physical ability, perceived benefits and
      barriers of physical activity, self-esteem and quality of life will be assessed. After
      analyzing the results, a group discussion will be established to further evaluate the impact
      of excess skin on the practice of physical activity. The evaluation will be identical for
      monitoring the effects of plastic surgery but the discussion group will also address the
      benefits and satisfaction related to plastic surgery.

      Expected results: Excess skin could be a barrier to physical activity by limiting the
      functional and physical capacity. Thus, plastic surgery could improve the practice of
      physical activity with a direct improvement of functional discomfort, the subjects'
      motivation to be physically active, perceived benefits and barriers to physical activity,
      self-esteem and quality of life.

      Issue project: This pilot project will generate data that will allow us, depending on the
      relevance of the results, to continue the investigators investigation with a larger cohort.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A group of 20 people who underwent bariatric surgery and a group of 10 people who underwent
        bariatric surgery and one or several plastic surgery
      
Keywords: Post-bariatric surgery; Excess skin; Physical fitness; Physical activity; Barriers to physical activity; Plastic surgery; Quality of life; Self-esteem
Evaluation of the Signaling Path of Emiline1-TGFβ in the Myogenic Tone of Resistance Arteries in a Population of Normotensive and Hypertensive Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Aim of this study is to enhance the knowledge of myogenic tone alterations in hypertensive
      patients and to better understand the mechanisms controlling the myogenic tone. Evaluations
      will be performed through ex vivo studies of peripheral arterioles in human adipose tissue
      from lumbar muscle, isolated from biopsies. This will allow investigators to evaluate the
      myogenic function in response to progressive blood pressure increases, in order to correlate
      myogenic function to arterial hypertension and to the molecular mechanisms already identified
      in the preclinical models.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects will be selected from patients hospitalized in the Department of Neurosurgery of
        the IRCCS Mediterranean Neurological Institute Neuromed, according to specific inclusion
        criteria and undergoing surgery for disc disease. Subjects included in the study will be
        normotensive and hypertensive patients. Approximately 70 subjects of both genders (35
        normotensive, 35 hypertensive) aged between 30 and 70 years old will be included in the
        study. All the enrolled patients must have an indication for neurosurgical intervention.
      
Keywords: hypertension; myogenic tone
Effects of Ozone Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The objective of this study is to evaluate of ozone therapy on both clinical and biochemical
      effects in periodontally patients.
    

Detailed description: 
      This study is evaluated clinical and biochemical effect of ozone therapy at 8 weeks in
      periodontitis patients.
    

Intervention name(s): ozone
Intervention type(s): Other
Intervention description(s): gaseous ozone was applied on periodontal pocket two times in one week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of an investigational meningococcal B
      rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in
      assay development.
    


Intervention name(s): meningococcal B rLP2086 vaccine candidate; Blood draw
Intervention type(s): Biological; Procedure
Intervention description(s): vaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months; Blood draw
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: MnB; rLP2086; blood collection; vaccination
Exploring the Psychophysics of Keratoconus Using the Moorfields Acuity Chart
Condition: Keratoconic Subjects
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      The measurement of visual acuity is made using black letters of varying size superimposed on
      a uniform white background. The objective is to determine the smallest letter, or optotype,
      that can be correctly identified. One limitation of current tests is the variability of
      measurements, this making it difficult for clinicians to determine if changes in visual
      acuity are related to ocular disease. This variability has been attributed to the design of
      current optotypes, in particular their differing legibilities. Our group has recently
      demonstrated that a new type of letter chart (Moorfields Acuity Chart), containing letters
      with a black core and a white border presented on a grey background, reduces the variability
      of visual acuity measurements. In this study the investigators wish to determine if changes
      in vision owing to keratoconus, a disease that causes the cornea to adopt an irregular shape,
      may be detected more easily using the Moorfields Acuity Chart compared with conventional
      letter charts.
    


Intervention name(s): Moorfields Acuity Chart
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This in a basic science exploratory study to examine the effect of keratoconus on visual acuity as measured using pseudo-high-pass filtered optotypes. The MAC will be compared with the standard charts currently used to monitor visual acuity (logMAR chart) and contrast sensitivity (Pelli-Robson). "Researcher effects" and "researcher bias" will be controlled by setting a written protocol for all testing procedures. Each procedure will be standardised and random checks will be made by the chief investigator on all anonymous record sheets. Neither the chief investigator nor the co-researchers will act as participants for this study.
Masking: None (Open Label)
Primary purpose: Basic Science