bioihbjkbjnl/mcl2 huggingface dataset:
Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether non-alcoholic fatty liver disease (NAFLD) is
      associated with hepatic glucagon resistance and hyperglucagonemia.
    

Detailed description: 
      Hyperglucagonemia is a common condition in obesity, prediabetes and type 2 diabetes. It
      increases the hepatic glucose production, thus contributing to type 2-diabetic hyperglycemia.
      In the current study we wish to examine whether non-alcoholic fatty disease (NAFLD) results
      in hepatic glucagon resistance. This could result in hyperglucagonemia through a feedback
      mechanism acting on the level of pancreatic alpha cells. Cirrhosis and type 1 diabetes,
      respectively, has previously been shown to be associated with hepatic glucagon resistance but
      it has not been examined in relation to NAFLD in humans so far.
    

Intervention name(s): Liver biopsy; Pancreatic clamp
Intervention type(s): Procedure; Other
Intervention description(s): One ultrasound guided liver biopsy; I.v. infusions of somatostatin and insulin (basal rate) for will be adminstered for 3 hours. Glucagon will administered for 3 hours in total with infusion rates at a basal and a high physiological rate for 1.5 hours each.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Robotic-assisted Pedicule Screw Placement
Condition: Lumbar Degenerative Spinal Disease
MeSH terms: Spinal Diseases
Study type: Interventional

Summary: 
      The main objective of the study is to evaluate the feasibility of using the robotic assisted
      device ROSA™ for pedicle screws placement. This device is currently used in cranial
      neurosurgery but its applications can be extended to other fields, such as spinal surgery. In
      the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and
      safety of surgery for the patient.
    

Detailed description: 
      The medical device subject of this research is the surgical robot ROSA™ designed for cranial
      surgery, and used here in another application, spinal surgery - more specifically for the
      placement of pedicle screws.

      It is intended for spine surgeons to treat diseases requiring the placement of pedicle screws
      through posterior open surgery approach or minimally invasive surgery.

      The system allows the precise guidance of instruments as defined by the surgeon on patient
      radiological images. The expected performance is a good rate of pedicle screws placement,
      increasing the performance observed with the conventional method. This system can be
      transported from one operating room to another, and stored in a storage room.

      It interfaces with the most common intra -operative surgical imaging systems (mobile C-arms
      available at Montpellier University Hospital). Further versions of the device will enable the
      use of 3D intra-operative imaging systems such as the O-arm from Medtronic.

      The main objective of the study is to evaluate the feasibility of using the robot ROSA™ for
      pedicle screws placement. In this study, the robot will be used with an open surgery
      approach, which is a first step in demonstrating the potential of the robot.
    

Intervention name(s): The ROSA™ robot
Intervention type(s): Device
Intervention description(s): The ROSA™ robot can assist in identifying the pedicle entry point and in controlling the screw trajectory through a system of continuous monitoring of patient motion. This process strengthens the accuracy of pedicle screws implantation.
Stabilisation in treatment for spine degenerative disease
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spine; Accurancy; Robotic; Screw placement; Degenerative
BIO|CONCEPT.BIOMONITOR III
Condition: Atrial Fibrillation; Syncope; Tachyarrhythmia
MeSH terms: Syncope; Atrial Fibrillation; Tachycardia
Study type: Interventional

Summary: 
      The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III
      system. Furthermore, the insertion procedure, the use and handling of the incision and
      insertion tools and the sensing quality of the BIOMONITOR III will be assessed.
    


Intervention name(s): BIOMONITOR III
Intervention type(s): Device
Intervention description(s): Patients with ICM indication receive a third-generation implantable cardiac monitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Implantable Cardiac Monitor
Development and Validation Phase of Diffusion Tensor Imaging and Arterial Spin Labelling at 3 Tesla Using a Long-term Effort Model Applicable to Skeletal Muscle Characterization.
Condition: Marathoners
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate and quantify the micro architecture and micro
      vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and
      arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow
      parameters will be registered before and after the long-distance run on the lower leg. Axial
      T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and inflammatory
      markers will be collected in blood and urine samples and compare with both MRI and
      Near-infrared spectroscopy (NIRS).
    


Intervention name(s): Magnetic Resonance Imaging (MRI)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Skeletal muscle; Marathon; MRI
Effect of Pulse Fractions on Indices on Cardiovascular Disease and Diabetes Risk Factors
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if whole and fractionated yellow pea flour,
      administered at USDA recommended dosages (50 g/day), improve risk factors associated with
      cardiovascular disease and diabetes.
    


Intervention name(s): Whole yellow pea flour; Fractionated pea flour; White wheat flour
Intervention type(s): Other; Other; Other
Intervention description(s): Whole pea flour was administered at 50 g/day.; Fractionated pea flour was administered according to the level of fiber in whole pea flour treatment. 12 g/day; White wheat flour will be administered at 50 g/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Peas; Cardiovascular; Diabetes; Insulin; Insulin resistance; Abdominal fat
Study Evaluating the Safety and Tolerability of NSA-789
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first time that NSA-789, a new compound being developed for schizophrenia, will
      be given to humans. Each healthy subject will receive a single dose, except for 8 subjects
      who will receive 2 doses-- one dose under fasting conditions and one dose after eating food.
    


Intervention name(s): NSA-789; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: ascending single-dose study; healthy subjects
Efficacy and Tolerability of Zolmitriptan Nasal Spray
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and tolerability (the ability not
      to experience ill effects from the study drug) of a zolmitriptan nasal spray, 5.0 mg,
      compared with placebo (inactive drug) for 2 migraine headaches for up to 12 weeks in adult
      subjects with migraine headaches
    


Intervention name(s): Zolmitriptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg Nasal Spray
Other intervention name(s): Zomig
Intervention MeSH terms: Zolmitriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Zolmitriptan; ZOMIG; migraine; headache response; headache; headache pain
The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns
Condition: Hand Burn
MeSH terms: Burns
Study type: Interventional

Summary: 
      No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hand
      function and hypertrophic scar characteristics. To investigate ESWT effects on burned hands,
      the investigators compare the results of ESWT combined with manual therapy group to the
      results of matched conventional(CON) rehabilitation combined with manual therapy group.
    

Detailed description: 
      Hands are the most frequent injury sites caused by burn, and appropriate rehabilitation is
      essential to ensure that good functional recovery is achieved. In burn patients, the wound
      healing process may lead to a fibrotic hypertrophic scar, which is raised, red, inflexible
      and responsible functional and cosmetic impairments.

      This randomized, controlled trial involved 40 patients with burns and dominant right-hand
      function impairment. Patients were randomized into a ESWT or a CON group. Each intervention
      was applied to the affected hand for 4 weeks once per week. Hand function was evaluated using
      the Jebsen-Taylor hand function test (JTT), grasp and pinch power test, and Michigan Hand
      Outcomes Questionnaire (MHQ). These assessments were evaluated pre-intervention and 4 weeks
      post-intervention.
    

Intervention name(s): Extracorporeal shock wave therapy
Intervention type(s): Other
Intervention description(s): ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen,Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave. ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 4 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients' burn scars had re-epithelialized after aseptic care or skin graft. We included patients aged ≥18 years with a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands, with joint contracture(hand and wrist), having been transferred to the rehabilitation department after acute burn treatment, and less than 6 months since the onset of the burn injury. Selected patients had a history of hand surgery resulting in painful, retracting scarring on hands.
Masking: None (Open Label)
Primary purpose: Treatment
High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome
Condition: Tourette's Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial
      consequences in some patients. The pathophysiology is still unknown. Some data suggest an
      dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the
      effect of high frequency stimulation of the internal part of the globus pallidus and/or
      parafascicular-median centre of the thalamus, two structures implicated in the limbic
      circuit, in patients with severe Tourette's syndrome.
    


Intervention name(s): high frequency stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Tourette's syndrome; High frequency stimulation; Globus pallidus; Thalamus
Elastic Abdominal Binder Following Gynecologic Cancer Surgery
Condition: Gynecologic Cancer
Study type: Interventional

Summary: 
      Surgery is the primary treatment for gynecologic malignancies. The surgical approach provides
      opportunities for removal of the affected organs and complete assessment of extent of cancer
      spread. However, the procedures are often associated with significant morbidity. This is
      especially true with open laparotomy, the most frequently employed approach in developing
      countries. Delayed functional recovery influenced by pain and immobilization are important
      contributing factors for increased morbidity. Elastic abdominal binder, a wide elastic belt
      that is wore around the patient's abdomen to support surgical incision after surgery, has
      been employed by clinicians for pain relief, wound complications prevention, improved
      pulmonary function, and stabilization. Benefits of the abdominal binder use in this patient
      population have not been properly examined.

      The aim of this study is to examine the effect of postoperative elastic abdominal binder use
      on recovery by comparing pain scores and mobility function (through the 6-minute walk test
      [6MWT]) in postoperative gynecologic cancer patients who use versus do not use the elastic
      abdominal binder to support incisional site.
    


Intervention name(s): Elastic abdominal binder
Intervention type(s): Device
Intervention description(s): Each woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder. The patients are encouraged to wear binders at all time. However, periods of break from wearing the binder are allowed at their convenience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Sleep Disorders in Pediatric Dialysis
Condition: Chronic Kidney Disease (CKD)
MeSH terms: Sleep Wake Disorders; Parasomnias; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with
      a reported prevalence of 60-80%. To date three studies have reported on SDs in children with
      CKD but these have all been based on questionnaire data alone. The findings were not
      confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a
      validated tool to assess the sleep/ wake cycle over a prolonged period in the home. This is
      highly relevant given the poor sensitivity and specificity of even validated questionnaires
      alone. The effect of untreated pediatric SD is pervasive. This study will provide the first
      objective assessment of SDs using PSGs in children with severe CKD, both on and off dialysis.
      Therefore, we will recognize and when possible treat SD in this severe CKD cohort potentially
      contributing to their immediate management (eg improved control of hypertension, improved
      school performance), while improving their Quality of Life (QOL) and helping ensure they
      achieve their full potential.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The two study cohorts will be age and sex matched and constructed as follows:

          1. Pre-dialysis: Stage 4 CKD with an estimated GFR of 15-30 ml/min/1.73m2 based on IDMS
             Schwartz GFR

          2. Dialysis: CKD receiving outpatient hemodialysis (HD) or peritoneal dialysis (PD) for a
             minimum of 1 month. The PSG will be completed after the longest inter-dialytic
             interval for HD patients. Patients on PD will undergo PSG while on their usual cycler
             nocturnal dialysis regimen.
      
Keywords: Chronic Kidney Disease (CKD); Pediatrics; Sleep Disorders
rTMS for PTSD Comorbid With Major Depressive Disorder
Condition: Posttraumatic Stress Disorder; Major Depressive Disorder; Transcranial Magnetic Stimulation, Repetitive
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to see how well a treatment called "Repetitive Transcranial
      Magnetic Stimulation" works for patients who struggle with symptoms of both posttraumatic
      stress disorder and major depressive disorder.
    

Detailed description: 
      This study aims to evaluate the safety and efficacy of repetitive transcranial magnetic
      stimulation (rTMS) for adults with comorbid posttraumatic stress disorder (PTSD) and major
      depressive disorder (MDD). Although standard rTMS uses stimulations delivered to the left
      prefrontal cortex at 10 pulses per second, prior work has shown that other stimulation
      frequencies may work for both PTSD and MDD. In this study, we examine the efficacy of
      left-sided 5Hz in patients with PTSD and MDD, hypothesizing that this lower frequency will
      improve PTSD and MDD symptoms.
    

Intervention name(s): Transcranial Magnetic Stimulation (TMS)
Intervention type(s): Device
Intervention description(s): Up to 40 sessions of TMS delivered with the first 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper schedule over 3 weeks. Treatment is adjunct to ongoing stable pharmacotherapy.
Other intervention name(s): Neuronetics' NeuroStar TMS Therapy System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; MDD; TMS; 5Hz
The Tetrad BMI, Leptin, Leptin/Adiponectin (L/A) Ratio and CA-15-3 is a Reliable Biomarker of Breast Cancer
Condition: Female Breast Carcinoma
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Objective:

      Evaluate body mass index (BMI), leptin, Leptin/adiponectin (L/A) ratio and cancer antigen
      (CA) 15-3 together as reliable biomarkers for breast cancer.

      Patients:

      Consecutive patients aged between 40 - 60 years, with breast disease and informed consent.

      Interventions:

      Patients' Anthropometric and laboratorial characteristics classified by BMI in the group of
      cancer and patients with benign breast disease as well as biochemical tests of leptin,
      adiponectin,CA 15-3, hemoglobin, glucose low-density lipoprotein cholesterol (LDLC),
      high-density lipoprotein cholesterol (HDLC) levels were obtained as well as a blood sample to
      analyze CA 15-3 levels with a electrochemiluminescence immunoassay.

      Hypothesis:

      Using together leptin, L/A ratio, CA 15-3 and BMI could offer a reliable approach to detect
      high risk women to develop breast cancer.
    

Detailed description: 
      Serum levels of leptin, adiponectin and CA 15-3, as well as anthropometric and biochemical
      parameters were analyzed in 88 female patients attending mammography study. Predictive values
      of BMI, leptin, L/A ratio and CA 15-3 were determined with 95% confidence interval (CI).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cross-sectional prospective study conducted at the Maternal-Perinatal Hospital "Mónica
        Pretelini" (HMPMP), State of Mexico Health Institute (ISEM), Toluca, Mexico, from January
        to October 2011.
      
Biospecimen description: 
      serum
    
Keywords: biomarker; BMI; breast cancer; CA-15-3; leptin
Safety and Efficacy Study of Mix Vaccine in Pancreatic Carcinoma Patient
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).
      Enrolled patients will receive standard treatment according to National Comprehensive Cancer
      Network (NCCN) guide line with or without combining MV injection. The efficacy and side
      effect will be compared between the two groups.
    

Detailed description: 
      In the study, after evaluation of the general and physical status, eligible patients will be
      enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients
      will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN)
      guide line (control group) and in experimental arm, patients will be receiving simultaneous
      standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease
      progression.

      Blood sample will be obtained at baseline and every week before MV injection for the
      assessment of clinical hematology, biochemistry measurements and immunology index (including
      immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout
      the study. Side effect, progression free survival, immunology index and general status will
      be recorded.
    

Intervention name(s): MV; Standard Treatment
Intervention type(s): Biological; Other
Intervention description(s): MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.; Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mix vaccine, pancreatic neoplasms, immunotherapy