bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly
Condition: Skeletal Muscle Mitochondrial Dysfunction in the Elderly
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a Phase 2, randomized, double-blind, placebo-controlled study, enrolling 41 elderly
      subjects with previous evidence of mitochondrial dysfunction to evaluate whether the
      administration of MTP-131 (elamipretide) will change either hand skeletal muscle energetics
      or muscle performance in age-related skeletal muscle mitochondrial dysfunction.
    

Detailed description: 
      This was a Phase 2, randomized, double-blind, placebo-controlled study, enrolling 41 elderly
      subjects with previous evidence of mitochondrial dysfunction to evaluate whether the
      administration of MTP-131 (elamipretide) will change either hand skeletal muscle energetics
      or muscle performance in age-related skeletal muscle mitochondrial dysfunction.

      Subjects were randomized 1:1 to receive either elamipretide at 0.25 mg/kg/hr intravenously at
      a rate of 60 mL/hr for 2 hours, or placebo (lyophilized excipients without elamipretide)
      intravenously at a rate of 60 mL/hr for 2 hours. Each treatment group went through three
      distinct periods: Screening (up to 28 days), Treatment (1day), and Observation (7 days).
    

Intervention name(s): Elamipretide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours; Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
Other intervention name(s): MTP-131; Bendavia™; elamipretide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skeletal muscle dysfunction, MTP-131, Bendavia™; elamipretide
Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children
Condition: Scoliosis Idiopathic; Sleep Disordered Breathing; Obstructive Sleep Apnea
MeSH terms: Scoliosis; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration
Study type: Observational

Summary: 
      This study aimed to investigate the prevalence and clinical significance of sleep-disordered
      breathing (SDB) in children with mild-moderate idiopathic scoliosis (IS).
    

Detailed description: 
      Idiopathic scoliosis (IS) is the most common pediatric musculoskeletal disorder that causes a
      three-dimensional spinal deformity affecting 2 to 4% of adolescent subjects. It can be
      progressive (in 3 out of 10 cases) and severe involving serious effects (spine pain,
      cardiopulmonary compromise, deformed torso, psychosocial issues) and heavy treatments
      (corset, surgery). However, there is still no reliable criteria to predict the occurrence and
      progression of IS, while the etiology of IS remains unclear.

      Sleep-disordered breathing (SDB) in children is a common condition characterized by recurrent
      events of upper airway obstruction during sleep. The major symptom is snoring or noisy
      breathing. Preliminary evidence suggests that SDB in children is associated with low bone
      mass and postural stability, which might be mechanisms in the development of scoliosis.
      However, the influence of SDB on the progression of IS remains unknown.

      To fill those gaps, investigators will perform a prospective, unrandomized, observational
      cohort study to determine the prevalence and significance of SDB in children with
      mild-moderate IS. All subjects will be screened with a designated sleep questionnaire (PSQ),
      and children with either severe daytime sleepiness or frequent snoring or any degree of sleep
      pause will be requested to undergo further evaluation and an overnight polysomnography (PSG).
      Routine follow-up visits will be scheduled 6 months apart up to 24 months to assess the curve
      progression of scoliosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with suspected or known idiopathic scoliosis that were referred to
        the Second Affiliated Hospital of Wenzhou Medical University
A Study of Therapeutic Amplitude-modulated Electromagnetic Fields in Advanced Tumors
Condition: Cancer; Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may
      modify cell growth. We have identified specific frequencies that may block cancer cell
      growth. We have developed a device delivering low levels of amplitude-modulated
      electromagnetic fields. The device is connected to a spoon-like coupler, which is placed in
      the patient's mouth during treatment. We will conduct a feasibility study consisting of three
      daily ambulatory treatments until disease progression.
    

Detailed description: 
      Background: In vitro studies suggest that low levels of amplitude-modulated electromagnetic
      fields may modify cell growth. We have identified specific frequencies that may block cancer
      cell growth. We have developed a portable and programmable device delivering low levels of
      amplitude-modulated electromagnetic fields. The device is connected to a spoon-like coupler,
      which is placed in the patient's mouth during treatment.

      Methods: We will conducted a feasibility study consisting of three daily treatments. All
      patients with advanced solid tumors and measurable disease will be eligible, irrespective of
      prior treatments. Patients will be assessed with laboratory exams (complete blood count,
      comprehensive profile, tumor markers), imaging studies every other month for the first six
      months, every third month thereafter.
    

Intervention name(s): Low levels of amplitude-modulated electromagnetic fields; Emitter of low levels of amplitude-modulated electromagnetic fields
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: cancer; electromagnetic fields; treatment
Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies
Condition: Mitochondrial Diseases
MeSH terms: Mitochondrial Diseases
Study type: Interventional

Summary: 
      The major steps forward of the neurosciences in recent years have linked psychiatric
      diseases, neuropsychological symptoms and brain dysfunctions. The cerebral functioning
      requiring a big quantity of energy, mitochondria, essential organelles in the cellular energy
      processes, are at present considered as a way of research for big interest in neurology and
      in psychiatry. Thus, an increasing number of studies describe potential links between
      mitochondrial dysfunction and psychiatric symptomatology. The clinical symptomatology of
      children with mitochondrial cytopathy is varied. Well described neurologically and
      somatically, it is significantly less in its psychiatric aspects. However, psychiatric
      symptoms are frequently associated and this symptom has already been described in adult
      patients. The symptoms mainly include depressive and anxiety disorders, or even tables
      suggestive of psychotic disorders, which would precede the diagnosis of mitochondrial disease
      of 13 years on average.

      Neuropsychological disorders refer to disorders of the higher functions following a cerebral
      anomaly (language, praxis, motricity, gnosis, visual spatial processing, memory, attention,
      intelligence, executive functions ...). Tests validated in French and adapted to children and
      adolescents can identify neuropsychological disorders in these populations.
    


Intervention name(s): Psychiatric assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Psychiatric assessment and neuropsychological tests
Test : Wechsler Intelligence Scale for Children (WISC-V)
Test :Behavior Rating Inventory of Executive Function (BRIEF) : BRIEF-Parents, BRIEF-Teacher
Global Assessment of Functioning Scale
Scale : Brief Psychiatric Rating Scale (BPRS)
Test : Children Depression Inventory (CDI)
Scale : Revised-Children's Manifest Anxiety Scale (R-CMAS)
Survey : Pediatric Quality of Life Inventory Version 4.0 (PedsQL™ 4.0)
Scale : Conners' scale (parents and teachers)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Poor Responders Infertile Patients -A Great Clinical Challenge
Condition: Invitro Fertilization
Study type: Interventional

Summary: 
      infertile , poor responders patients who underwent ICSI. The participants were divided into 2
      groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules
      while group II started with 6 ampoules
    

Detailed description: 
      Participants will be randomized to start induction with 4 or 6 ampoules of gonadotropins from
      day 2 till the day of human chorionic gonadotropin (HCG), dose adjusted according to ovarian
      response monitored by serum E2 and ultrasound evaluation. All patients were followed up by
      TVUS scan daily or on alternate days according to the ovarian response to treatment starting
      on treatment cycle day 6 for folliculometry and endometrial thickness and pattern. Cetrotide
      (MerckSerono, Germany) 0.25 subcutaneously will be added when the leading follicle (DF)
      reaches >12 mm and HCG 10 000 IU intramuscularly (Pregnyl, Merck Sharp, United Kingdom)will
      be given only if we have at least 3 mature follicles >14 mm and the leading one >17 mm; then,
      ovum pickup (OPU) was done after 36 hours of HCG and metaphase II ocytes were analyzed. The
      intracytoplasmic sperm injection (ICSI) procedure will be performed in all cases to avoid low
      fertilization rate by conventional IVF. Fertilization was assessed 16 to 18 hours after ICSI,
      and embryo quality will be evaluated 2 and 3 days after ICSI according to the number of
      blastomeres and the degree of fragmentation and multinucleation. Oocytes were collected and
      embryos will be cultured in ISM1 culture medium (Origiomedicult media, Denmark). Transfer of
      cleaving embryos will be done on day 3 after oocyte retrieval (using Labotect semirigid
      catheter; labotect GmbH, Germany), when the woman has at least 1 embryo (GI) otherwise
      canceled embryo transfer (ET). The ET was done by 1 person in each center. Both of the
      transferring consultants have more than 5 years experience in IVF unit. . All patients will
      receive luteal support in the form of daily progesterone cyclogest (Actavis, United Kingdom)
      800 mg daily starting from day of ovum retrieval till day of hCG testing. Serum b hCG level
      was assessed on day 14 after ET and considered positive if >5 mIU/ml. The TVUS was performed
      28 days after ET to confirm ongoing pregnancy by visualization of intrauterine sac.
    

Intervention name(s): Gonadotropins
Intervention type(s): Drug
Intervention description(s): Human menopausal gonadotropin 75 IU ampoules start at cycle day 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of estramustine, docetaxel, and carboplatin
      in treating patients who have prostate cancer that has not responded to hormonal therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin
           and estramustine in patients with hormone refractory prostate cancer.

        -  Determine the safety and efficacy of this regimen in this patient population.

      OUTLINE: This is a dose escalation study of docetaxel.

      Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on
      day 2 of weeks 1-3. Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only.
      Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity
      or disease progression.

      Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 5 patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 12 months.
    

Intervention name(s): carboplatin; docetaxel; estramustine phosphate sodium
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Carboplatin; Docetaxel; Estramustine
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer
Neuro-urological Outcome After Spinal Cord Injury
Condition: Urinary Bladder Neurogenic Dysfunction
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Neurogenic
Study type: Observational

Summary: 
      Most patients with spinal cord injury suffer from bladder dysfunction which may - especially
      in the long-term - impair renal function. Improved treatment during the last decades improved
      life expectancy and quality of life. This study evaluates the bladder function in the
      long-term after spinal cord injury.
    

Detailed description: 
      Bladder dysfunction is a common consequence of spinal cord injury and depends on the
      completeness and the level of the lesion. Patients with suprasacral injury usually suffer
      from neurogenic detrusor overactivity mostly combined with detrusor sphincter dyssynergia.
      Without adequate treatment, this adverse combination puts the upper urinary tract at risk due
      to high intravesical pressure often causing vesico-ureteral reflux. Based on improved
      therapeutic options in the last decades, life expectancy and quality of life constantly
      increased in spinal cord injury patients. The investigators aim to evaluate the bladder
      function in the long-term after spinal cord injury.
    

Intervention name(s): Video-urodynamic examination
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Ages Eligibility: minimum 18 years old Genders Eligibility: female and male
      
Keywords: neurogenic detrusor overactivity; detrusor sphincter dyssynergia; compliance; video urodynamic; spinal cord injury
Safety Evaluation of Advantage Anti-Caries Varnish
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.
    

Detailed description: 
      This is an open-label Phase 1 study. The active ingredients are Povidone Iodine and Sodium
      Fluoride [Therametrics Technologies, Inc, Noblesville, IN, USA]. The oral soft tissues and
      teeth of the children will be examined and the test varnish to the teeth. The child will be
      re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. At the
      follow-up, a qualified dental provider will ask questions focused on adverse events.
    

Intervention name(s): Varnish
Intervention type(s): Drug
Intervention description(s): Topical application to the teeth
Other intervention name(s): Advantage Anti-Caries Varnish
Intervention MeSH terms: Imidacloprid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery
Condition: Performance and Safety of an Airway Management Device
Study type: Interventional

Summary: 
      The investigators have performed a number of studies on novel airway devices. In this
      randomized controlled trial he investigators would like to compare the performance of a new
      double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard
      double lumen tube.
    

Detailed description: 
      Single lung ventilation is frequently carried out to facilitate surgery on the lungs and
      pleura. In most instances this is achieved by insertion of a double-lumen endotracheal tube
      and then selectively ventilating one lung or both. Precise positioning of these tubes is
      essential for optimal performance. It has become the standard of care to perform bronchoscopy
      to confirm tube position.

      A new double lumen endotracheal tube (Vivasight DL) has recently been developed. It has all
      the features of a standard double lumen endotracheal tube but also incorporates an internal
      camera which, when connected to an external screen, allows continuous confirmation of tube
      position.

      This is randomized, single blinded controlled trial. The participants will be allocated to
      two study groups (Vivasight DL or standard DLT), in which the primary airway management
      device will be respectively Vivasight DL double lumen tube or a standard double lumen
      endotracheal tube.

      Clinical Research Ethics Committee approval has been obtained. Suitable participants will be
      recruited after written informed consent.

      Standard anesthetic preassessment and anesthesia will be provided.

      Consenting patients passing the inclusion and exclusion criteria will be randomly allocated
      to either of the 2 study groups.

      Protocol for attempts at placement and tube position confirmation will be followed.

      The investigators will monitor a number of parameters, including time and ease of tube
      insertion, ability to verify tube position with the primary imaging modality for each group,
      need to perform tube position adjustment maneuvers, need to use fiberoptic bronchoscope
      during the case, quality of lung collapse, problems with ventilation and other.

      The primary hypothesis is that the new Vivasight DL tube system will provide a comparable
      optical view to the fiberoptic scope view obtained via standard double lumen endotracheal
      tube in order to confirm optimal position.
    

Intervention name(s): double lumen endotracheal tube placement and use
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Vivasight DL; double lumen endotracheal tube; fiberoptic confirmation of tube position
Socio-economic, Meteorological and Environmental Factors Associated With the Incidence of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Socio-demographic factors in relation to the diagnosis of COVID cases are increasingly
      mentioned in the role of transmission, but unfortunately with a small number of conclusive
      publications on French data. Our objective is to analyse the distribution of cases according
      to these factors and their possible role during the first 6 weeks of 2021 when the Alpes
      Maritimes was the department with the highest incidence rate. The collaboration between ARS06
      and the Public Health Department in the field of COVID-19 has made it possible to have a
      departmental bulletin for monitoring the evolution of the epidemic (incidence, screening,
      hospitalisation). Knowledge of the socio-demographic, meteorological and environmental
      factors associated with the transmission of SARS-CoV2 would make it possible to reflect on
      how to act on these factors and to implement a public health policy.
    


Intervention name(s): COVID-19 infection
Intervention type(s): Other
Intervention description(s): All persons of legal age or not resident in the Alpes-Maritimes between 03/01/2021 and 14/02/2021 with a COVID-19 diagnosis.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Population of legal age or not residing in the Alpes Maritimes department between
        03/01/2021 and 14/02/2021, i.e. 1078729 inhabitants in the Alpes Maritimes, including
        342979 in the city of Nice
Use of Insorb Absorbable Vicryl Staples in Skin Closure for Cesarean Section
Condition: Wound Infection
MeSH terms: Wound Infection
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the incidence of wound breakdown or wound infection
      following skin closure with Insorb subcuticular absorbable staples versus metal staples after
      cesarean section through a retrospective chart analysis.
    

Detailed description: 
      Procedures:

      A list will be compiled of patients who underwent cesarean section at Memorial Hermann
      Hospital in the Texas Medical Center from January 1st 2010 through January 1st 2011. Only UT
      patients who had their skin closed with Insorb or metal staples will be included in this
      list. Patients' clinical charts will be reviewed for post-operative follow-up, and notes will
      be made of the wound assessment. Any complications such as infection, seroma, hematoma, and
      wound separation or delayed healing will be recorded. Additional notes will be made of any
      co-morbid conditions, including, but not limited to, >30 BMI, chronic hypertension, diabetes
      mellitus, HIV, history of tobacco use.

      Once the data is gathered, it will be compared with published national averages to determine
      if there is an increased risk of wound separation or wound infection at our institution. In
      addition, rated of infection and wound breakdown following closure with either absorbable or
      metal staples will be compared by Fisher's exact test, to determine statistical significance.

      Course of Study: Data will be obtained from UT patients who underwent cesarean section from
      January 1st, 2010 through January 1st, 2011. Only patients who had skin closure with InSorb
      or metal staples will be included in analysis.
    

Intervention name(s): There is no intervention for this study
Intervention type(s): Other
Intervention description(s): None, no intervention made.
Other intervention name(s): This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing cesarean section who have their skin incision closed with staples.
      
Keywords: Absorbable vicryl subcuticular staples; metal staples; wound healing; cesarean section