bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Patients With Cerebral Paralysis
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy; Paralysis
Study type: Interventional
Phase: Phase 3

Summary: 
      Cerebral palsy (CP) is described as a group of permanent disorders affecting motor
      development and posture, resulting in activity limitation attributed to nonprogressive
      disturbances of the fetal or infant brain. The prevalence of cerebral palsy has increased
      among the children with low birth-weight, jaundice, respiratory distress and intrauterine
      infection and so on. The incidence of cerebral palsy is increasing gradually with increased
      neonatal survival rate. Although there are many kinds of functional therapy programs
      especially the rehabilitation treatment for cerebral palsy, their effects are limited.
      Increasing cerebral palsy patients become a heavy burden to the family and society. Stem cell
      based therapy, a new prospective therapy for central nervous system disorders, has the
      potential to repair the damaged brain tissue in patients with cerebral palsy.

      In this study, 300 patients with cerebral palsy will be divided into three groups and the
      investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 CP
      patients of them randomly. We will also follow up the other 100 patients who only receive
      rehabilitation treatment and another 100 patients who accept neither stem cell therapy nor
      rehabilitation treatment. On this basis, as the investigators we can compare the efficacy of
      cell therapy and rehabilitation treatments for cerebral palsy patients.

      Multiple sources of assessment were used to ascertain and classify all cases of cerebral
      palsy. Particularly the Gross Motor Function Measure (GMFM) as an important valid and
      reliable outcome measure, has made it possible to evaluate the severity of movement
      disability，change over time and the effects of clinical interventions. It also will be the
      primary outcome measure in follow-up analysis of this study.
    

Detailed description: 
      Patients enrolled in this study need to finish our whole follow-up survey for 12 months,
      which is carried out by clinical doctors, rehabilitators and epidemiologist.
    

Intervention name(s): rehabilitation; stem cell injection
Intervention type(s): Other; Biological
Intervention description(s): Patients only receive rehabilitation of physical therapy and occupational therapy.; Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.
Other intervention name(s): phsical exercise rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; cell transplantation; rehabilitation
Clinical, Biological and NMR Outcome Measures Study for Hereditary Inclusion Body Myopathy Due to Mutation of UDP-N-acetylglucosamine 2-epimerase/N-acetylmannosamine Kinase Gene (GNE)
Condition: HIBM
Study type: Interventional

Summary: 
      The objective of the study is to identify the best clinical and biological outcome measures
      for further therapeutics approaches.
    


Intervention name(s): motor function and strength assessment; NMR assessment; 24h urine and serum collection
Intervention type(s): Other; Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIBM; GNE
Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
Condition: Cholecystectomy
Study type: Observational

Summary: 
      A multi-center retrospective chart review of short-term outcomes associated with
      robotic-assisted cholecystectomies performed during regular hours and after-hours.
    

Detailed description: 
      The study is a retrospective multi-center chart review study of short-term patient outcomes
      through 30 days after robotic-assisted cholecystectomies performed during regular hours and
      after-hours. The primary outcomes include the rate of conversion to open, rate of
      intra-operative adverse events, the rate of post-operative adverse events relating to the
      cholecystectomy within 30 days, and re-admissions and re-operations relating to the
      cholecystectomy within 30 days. In addition, operative time, the rate of use of
      intra-operative imaging, and the hospital length of stay will be collected as secondary
      outcomes.
    

Intervention name(s): Regular Hours; After Hours; Robotic-assisted Cholecystectomy
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.; The after hours cohort includes cholecystectomies performed outside of the day shift at the Institution during Monday through Friday, on the weekend, or during a national holiday.; With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the cholecystectomy according to the surgeon's standard of care.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent a robotic-assisted cholecystectomy procedure and meet all
        eligibility criteria will be considered for enrollment.
Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves evaluating the occupancy of ATI-9242 at steady state at three different
      dose levels on D2 receptors in the brain using [18F] Fallypride PET in up to three cohorts of
      subjects.
    

Detailed description: 
      This study involves evaluating the occupancy of ATI-9242 at steady state at three different
      dose levels on D2 receptors in the brain using [18F]Fallypride PET in up to three cohorts of
      subjects. The first dose evaluated will be 0.5 mg/kg administered as an IV bolus injection.
      The second dose that will be evaluated will be 1.0 mg/kg as an IV bolus injection. The safety
      and occupancy after each dose level will be evaluated prior to moving to the next dose. On
      two separate days, subjects will undergo [18F]Fallypride PET imaging sessions. The plasma
      concentration of ATI-9242 will be obtained prior to and during the course of the imaging
      session to allow determination of the relationship between plasma concentration of ATI-9242
      with in vivo D2 occupancy.
    

Intervention name(s): ATI-9242; [18F]Fallypride Imaging
Intervention type(s): Drug; Radiation
Intervention description(s): Formulated ATI-9242 will be administered as an IV bolus injection (2mg/mL of ATI-9242 in 40% solution of propylene glycol).
Two doses will be tested: single IV bolus injection of 0.5mg/kg and single IV bolus injection 1.0 mg/kg. In the event that a third cohort is needed the IV bolus injection would be 2.0 mg/kg; Subjects will be injected with approximately 250 MBq or 6.75 mCi of [18F]Fallypride [5-6 mCi being the typical range of injected dose].
Intervention MeSH terms: Fallypride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Boston Outcomes of Autism in Toddlers Study
Condition: Autism Spectrum Disorder; Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      The purpose of this research study is to learn more about the outcomes of children who
      received an Autism Spectrum Disorder (ASD) diagnosis when they were toddlers. The study is
      interested in whether an early diagnosis can help children with their cognitive, language,
      social, and behavioral abilities.
    

Detailed description: 
      Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in
      domains of social communication and restrictive and repetitive behavior. There is general
      agreement, in light of knowledge around optimal periods of neural plasticity, that ASD should
      be diagnosed as early as possible since young toddlers are at a critical stage in early
      development when intervention is theoretically most effective. The rate of persistence of an
      ASD diagnosis is heavily debated.Therefore this study attempts:

        1. To determine the rate of persistence of Autism Spectrum Disorder (ASD) diagnosis and
           functional outcomes, as defined by cognitive level, adaptive functioning, language
           skills, persistence of ASD symptoms, and classroom placement at kindergarten age, among
           children who received a DSM-5 ASD diagnosis at < 36 months.

        2. To evaluate predictors of rate of persistence and functional outcomes among kindergarten
           grade level children ages 5-7 years, who received an ASD diagnosis as toddlers.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children diagnosed with Autism Spectrum Disorder through the DSMV as toddlers.
      
Keywords: Asperger's; autism; autism spectrum disorder; ASD
Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension
Condition: Mild Essential Hypertension; Moderate Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The study medication CYT006-AngQb is a vaccine, consisting of angiotensin II (Ang II), the
      naturally occurring octapeptide coupled onto the surface of virus-like particles (VLP). This
      form of presenting Ang II to the immune system induces a B-cell mediated immune response
      characterized by the generation of specific antibodies (IgG and IgM) against Ang II. The
      CYT006-AngQb vaccine is administered by subcutaneous (s.c.) injection. Immunization against
      angiotensin II may offer a valuable alternative to conventional drugs for the treatment of
      hypertension.
    


Intervention name(s): CYT006-AngQb
Intervention type(s): Biological
Intervention description(s): s.c. injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses
Condition: Liver Tumors
MeSH terms: Liver Neoplasms
Study type: Observational

Summary: 
      This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose
      noninvasively focal liver masses. This is a multi-center prospective cohort study of 250
      subjects, which will be performed at four institutions in Canada. Subjects with a focal liver
      mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional
      baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed
      on standard ultrasound scanners with contrast specific imaging capability. The contrast agent
      used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a
      dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the
      standard of care in the institution. Anonymized image files from all imaging will be shown
      independently to two readers, blinded to all clinical and demographic data, who will predict
      malignancy and diagnosis.
    

Detailed description: 
      This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose
      noninvasively focal liver masses. This is a multi-center prospective cohort study of 250
      subjects, which will be performed at four institutions in Canada. Subjects with a focal liver
      mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional
      baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed
      on standard ultrasound scanners with contrast specific imaging capability. The contrast agent
      used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a
      dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the
      standard of care in the institution. Anonymized image files from all imaging will be shown
      independently to two readers, blinded to all clinical and demographic data, who will predict
      malignancy and diagnosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Any patient with an unknown liver mass
      
Keywords: Contrast Enhanced Ultrasound (CEUS); Liver tumors; Hepatocellular carcinoma; Hemangioma; Focal Nodular Hyperplasia; Hepatic metastases
Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional

Summary: 
      Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a
      new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound
      with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly
      hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies.
      The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness
      of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy
      in patient with metastatic colorectal cancer. The primary objective of this study is to
      compare the functional vascular changes related to bevacizumab based chemotherapy and
      evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary
      objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the
      pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases
      evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships
      between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the
      bevacizumab.
    


Intervention name(s): real-time contrast-enhanced ultrasound imaging (CEUS)
Intervention type(s): Device
Intervention description(s): Real time contrast enhanced sonography was performed using an ultrasound dedicated system after bolus injection of 1.2 and 2x2.4 ml Sonovue ® (Bracco, Milan, Italy)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colorectal cancer; hepatic metastases; bevacizumab; anti-angiogenic agent; chemotherapy regimens; tumor vascularity; Contrast-enhanced ultrasound
Pattern Recognition Prosthetic Control
Condition: Prosthesis User; Congenital Amputation of Upper Limb; Amputation; Traumatic, Limb
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      This study investigates whether simultaneous electromyographic (EMG)-based pattern
      recognition control of an upper limb prostheses increases wear time among users. In contrast
      to conventional, seamless sequential pattern recognition style of control which only allows a
      single prosthetic hand or arm function at a time, simultaneous control allows for more than
      one at the same time. Participants will wear their prosthesis as they would normally at home
      using each control style for an 8-week period with an intermittent 1-week washout period (17
      weeks total). Prosthetic usage will be monitored; including, how often participants wear
      their device and how many times they move each degree of freedom independently or
      simultaneously. The primary hypothesis is that prosthetic users will prefer simultaneous
      control over conventional control which will result in wearing their device more often. The
      secondary hypothesis is that simultaneous control will result in more efficient prosthesis
      control which will make it easier for participants to perform activities of daily living. The
      results of this study will help identify important factors related to prosthetic users'
      preferences while freely wearing their device within their own daily-life environment.
    


Intervention name(s): EMG-Pattern Recognition Controller
Intervention type(s): Device
Intervention description(s): Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device.
Other intervention name(s): Coapt Complete Control Gen2
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a randomized crossover home trial consisting of two 8-week periods with an intermittent 1-week washout period (17 weeks total). Participants will use either simultaneous control or convention seamless, sequential control in the first 8-week period followed by using the opposite control style in the second 8-week period.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pattern recognition; home trial; randomized cross-over trial; prosthesis; electromyography
Exercise-based Cardiac Rehabilitation After Thoracoscopic Ablation in Patients With Persisent Atrial Fibrillation
Condition: Atrial Fibrillation, Persistent; Cardiac Rehabilitation; Cardiopulmonary Fitness
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. However,
      the postoperative rehabilitation is very important to prevent early recurrence of atrial
      arrhythmia. The purpose of this study is to evaluate the efficacy of professional cardiac
      rehabilitation in patients after thoracoscopic ablation.
    


Intervention name(s): cardiac rehabilitation
Intervention type(s): Other
Intervention description(s): rehabilitation performed by professional trainers
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent thoracoscopic ablation were included. cardiac rehabilitation was
        performed according to the willingness of each patients.
Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession
Condition: Gingival Recession Localized Moderate
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally
      advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally
      advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap
      will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in
      the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller
      Class I gingival recessions; and as a split-mouth study design one side will be treated with
      (SCTG+CAF), while the other will be treated with (XCM+CAF).
    

Detailed description: 
      The aim of this study is to clinically compare between the subepithelial connective tissue
      graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for
      the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally
      advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as
      it described by (De Sanctis & Zucchelli 2007) with modifications in the the control group.The
      flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split
      thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally.
      Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be
      enrolled in this study. These defects will be distributed randomly into two groups: the test
      group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated:
      Recession depth (REC), change in visible plaque index, recession width (RW), width of
      keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical
      attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of
      patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog
      scale (VAS).
    

Intervention name(s): (XCM)+(CAF); (SCTG)+(CAF)
Intervention type(s): Procedure; Procedure
Intervention description(s): The description of this intervention has been already given before.; The description of this intervention has been already given before.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: split-mouth design.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Xenogenic collagen matrix (XCM).; subepithelial connective tissue graft (SCGT).; coronally advanced flap (CAF).; Root coverage.
Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children
Condition: Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool
      weight, when compared to placebo, in the treatment of acute diarrhoea in children.
    


Intervention name(s): Smecta (Diosmectite), duration of treatment - 7 days
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparison of MR Elastography Methods Without and With Compressed Sensing
Condition: Liver Diseases
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      In this research study, the investigators will compare the liver stiffness results obtained
      from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained
      from a method that uses faster imaging techniques.
    

Detailed description: 
      MR elastography is increasingly used to assess liver stiffness in pediatric and adult
      patients with chronic liver diseases. While numerous tissue abnormalities can affect liver
      stiffness, liver stiffness measured by MR elastography is most often used to predict and
      quantify liver fibrosis. Conventional MR elastography techniques require multiple
      breath-holds that are 12-20 seconds in length. In the pediatric population, reliable
      breath-holding >10 seconds can be challenging. Recently, compressed sensing has become
      available as a method for accelerating image data acquisition, and thus shortening
      breath-holds.
    

Intervention name(s): Magnetic Resonance Elastography
Intervention type(s): Device
Intervention description(s): The investigators plan to prospectively assess the agreement of liver stiffness measurements obtained using standard of care MR elastography techniques vs. MR elastography with varying amounts of imaging acceleration using compressed sensing in adult volunteers
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers