bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Botulinum Toxin to Hallux Valgus in Addition to Total Contact Insole
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Bunion
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A
      (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by
      binding presynaptically to high-affinity recognition sites on the cholinergic nerve terminals
      and decrease the release of acetylcholine, causing a neuromuscular blocking effect. The
      investigators hypothesize that BTA injection may help to decrease the hallux valgus angle by
      decrease adductor hallucis muscle activation. Thereby enhance the therapeutic result of
      hallux valgus treated with total contact insole. The outcome measurement may shed light in
      treating patient with painful hallux valgus and document evidence for plantar pressure
      changes in acute, sub-acute and chronic stage.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled prospective study to assess the
      influence and efficacy of intramuscular (IM) Botulinum Toxin Type A (BTA) injection in
      patients with painful hallux valgus with the use of total contact insole.

      Fifty feet with painful hallux valgus will be collected. Informed consent is obtained
      according to the hospital's medical ethics and the human clinical trial committee. The feet
      will be randomized into 2 groups: Group A (n=25, treatment group) and Group B (n=25, control
      group). Clinical diagnosis of hallux valgus is made based on observation of great toe lateral
      deviation. Inclusion criteria were hallux valgus with angle of at least 20°, single or
      bilateral hallux valgus. To obtain the hallux valgus angle, foot roentgenography in AP and
      sesamoid views under the weight bearing condition will be obtained. The angle formed by lines
      drawn to bisect the first metatarsal bone and the proximal phalanx of the great toe will be
      measured. The exclusion criteria include history of foot operations, rheumatoid and gouty
      arthritis, and any contraindication to BTA administration. Subjective data such as the Foot
      Function Index will be collected.
    

Intervention name(s): BOTOX; Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): once injection of BTA 3oU into hallux oblique and transverse heads each; Normal saline 0.3ml to oblique and transverse heads each
Other intervention name(s): BOTOX (Allergan, Irvine, CA)
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: botulinum toxin type A; hallux valgus angle; foot function index; VAS pain scale
Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced
      osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed
      as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by
      2030.
    

Detailed description: 
      There have been several studies regarding efficacy of peri articular infiltration. IPACK
      block is a novel technique gaining popularity where one injects local anesthesia safely under
      ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.

      There have been no studies till date comparing the efficacy between IPACK block and
      Periarticular Infiltration (PAI).
    

Intervention name(s): Ipack; Bupivacaine; Peri Articular Infiltration
Intervention type(s): Device; Drug; Procedure
Intervention description(s): IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.; 20 cc of bupivacaine(o.25%) injection; Adductor Canal Catheter and Peri Articular Infiltration
Other intervention name(s): PAI
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total knee arthroplasty; Peri articular infiltration; Pack block; Adductor canal catheter
ACOART Intracranial de Novo:DCB in the Treatment of Symptomatic Intracranial Atherosclerotic de Novo Stenosis
Condition: Intracranial Atherosclerosis; Stroke
MeSH terms: Intracranial Arteriosclerosis; Atherosclerosis
Study type: Interventional

Summary: 
      The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating
      intracranial de novo stenosis.
    

Detailed description: 
      This trial is a prospective, multi-center, 1:1 randomized using paclitaxel coated balloon
      versus stent to treat intracranial stenosis of 70-99% degree. And primary endpoint is
      angiographic restenosis at 6 months post-procedure.
    

Intervention name(s): drug coated balloon; stent system
Intervention type(s): Device; Device
Intervention description(s): paclitaxel coated balloon catheter for intracranial PTA treatment; The Intracranial Stent System comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.The product, APOLLO™ stent system, has the indication of endovascular treatment for intracranial stenosis approved by NMPA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intracranial Atherosclerosis; Stroke; drug coated balloon
Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.
Condition: Hepatitis C Infection; Viruses; Hepatocellular Carcinoma; Hepatitis, Viral, Human; Liver Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis, Viral, Human; Hepatitis; Liver Cirrhosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the safety and efficacy of Civacir® to prevent the
      recurrence of Hepatitis C Virus (HCV) after liver transplant.
    

Detailed description: 
      Civacir® 10%, Hepatitis C Immune Globulin Intravenous (Human) is a high-titer human
      polyclonal immune globulin (IgG) containing a diversity of antibodies that target and bind
      the hepatitis C virus (HCV) to prevent infection. Subjects who reduce their viral load to
      less than 100 IU/ml HCV RNA through up to 24 weeks of antiviral therapy prior to liver
      transplant are enrolled in the study. There is no requirement to reach undetectable virus
      prior to transplant as the function of Civacir® is to neutralize any remaining virus in
      circulation.

      Subjects randomized to Civacir® treatment arms receive study drug infusions starting on the
      day of liver transplant followed by 15 doses over a 10 week period to prevent the recurrence
      of quantifiable Hepatitis C Virus (HCV) after liver transplant. The study will evaluate
      dosing arms ranging from 200 mg/kg to 300 mg/kg compared to a control arm. For the primary
      endpoint, efficacy is defined as persistent viral load suppression maintaining HCV RNA levels
      below the lower limit of quantitation as determined by central laboratory Polymerase Chain
      Reaction (PCR) at 22 weeks post-liver transplant and then at 34 weeks post-liver transplant
      to demonstrate durability of effect.
    

Intervention name(s): Civacir® 10%
Intervention type(s): Biological
Intervention description(s): The active ingredient is Human Immunoglobulin G (IgG) which is a normal constituent purified from human source plasma containing a diversity of antibodies targeting the Hepatitis C Virus.
Other intervention name(s): Civacir®; Hepatitis C Immune Globulin Intravenous (Human); human polyclonal immune globulin (IgG); HCIg
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HCV Liver Transplant Immunoglobulin PCR SVR
Detection of Lymphnodes Using ICG During RARP
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to investigate, whether the detection of lymph nodes by means of
      intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical
      prostatectomy is higher than without the use of indocyanine green (ICG).
    

Detailed description: 
      ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the
      near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected
      into the tumor or directly surrounding tissue.
    

Intervention name(s): ICG
Intervention type(s): Procedure
Intervention description(s): Improvement of detection of positive lymphnodes
Other intervention name(s): indocyanine green powder; Pulsion Medical Systems, München, Germany
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety and tolerability of dabigatran etexilate solution in children and
      to obtain preliminary pharmacokinetic/pharmacodynamic data
    

Detailed description: 
      Purpose:
    

Intervention name(s): dabigatran etexilate
Intervention type(s): Drug
Intervention description(s): Experimental dose chosen based on age and weight
Intervention MeSH terms: Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids
Condition: III Degree Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional
Phase: Phase 3

Summary: 
      Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of
      less postoperative pain compared with excisional surgery, however a still relevant percentage
      of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler
      device has been designed to overcome these drawbacks by modifying the stapled sutures and by
      increasing the space for mucosal resection in the case of the stapler.

      This randomized controlled study was aimed to demonstrate whether the new EEA stapler
      Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03
      Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if
      the modified stapled sutures can ensure better intraoperative hemostasis by measuring the
      number of overstitches required to get perfect hemostasis during the operation.
    


Intervention name(s): stapled hemorrhoidopexy; stapled hemorrhoidopexy
Intervention type(s): Procedure; Procedure
Intervention description(s): stapled hemorrhoidopexy will be performed using the EEA stapler Covidien; stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemorrhoids; circular staplers; mucosal resection; hemostatic suture
Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital
Condition: Aortic Dissection
MeSH terms: Aortic Dissection
Study type: Observational

Summary: 
      Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic.
      Global mortality remains high even if it decreased last years. This is probably due to
      improvement of diagnostic techniques and the evolution of surgical practices. It is however
      important to have medical data and statistics obtained in past years in order to better
      understand the factors influencing peroperative mortality and thereby to continue this
      improvement.
    


Intervention name(s): Acute aortic dissection
Intervention type(s): Procedure
Intervention description(s): Acute aortic dissection treatment include Bentall procedure, Tyrone David procedure, Yacoub procedure or ascendant aortic replacement with or without aortic valve replacement, ascendant aortic root remodelling (all are standard of care procedures)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital
        since the 01 January 2007 and the 31 december 2017.
Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in
      patients with Primary Sclerosing Cholangitis.
    


Intervention name(s): NGM282; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neural Mechanisms of CBT for Anxiety in Autism (Open Pilot Study)
Condition: Autism; Autism Spectrum Disorder; Anxiety
MeSH terms: Anxiety Disorders; Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This is an open, pilot study of neural mechanisms of cognitive-behavioral therapy for anxiety
      in children with high-functioning autism spectrum disorder (ASD). In addition to the core
      symptoms, approximately forty percent of children with ASD exhibit clinically significant
      levels of anxiety. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in
      children with high-functioning ASD, but the neural mechanisms of this treatment have not been
      studied. CBT teaches emotion regulation skills such as cognitive reappraisal, followed by
      behavioral exposure to anxiety-provoking situations. The investigators propose to investigate
      the neural mechanisms of CBT for anxiety by evaluating fMRI indices of socioemotional
      functioning before and after treatment in children, ages 8 to 14, with high-functioning ASD.
      Dysfunction of the amygdala and its connectivity with prefrontal cortex has been implicated
      in co-occurring ASD and anxiety. In the investigators research, compared to typically
      developing controls, children with ASD have shown lower activation in several regions of
      prefrontal cortex and a lack of down-regulation in the amygdala during a task of emotion
      regulation. Based on these observations, the investigators propose that a positive response
      to CBT for anxiety in children with ASD will be associated with increased activation of
      several regions in the prefrontal cortex as well as increased functional connectivity between
      prefrontal regions the amygdala during the task of emotion regulation. The primary aim of
      this pilot study is to examine the effects of CBT on the neural basis of anxiety in ASD by
      collecting fMRI data during emotion regulation, face perception, and rest before and after
      treatment. The investigators hypothesize that CBT will increase prefrontal activity, decrease
      amygdala reactivity, and enhance amygdala-prefrontal functional connectivity during emotion
      regulation. The investigators also hypothesize that CBT will decrease amygdala reactivity
      during perception of emotional faces. Additional analyses will be conducted to explore change
      in resting-state functional connectivity before and after CBT for anxiety in children with
      ASD.
    


Intervention name(s): CBT for anxiety in autism
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CBT; autism; anxiety; treatment; fMRI
Retrospective Review of Mechanically Ventilated Patients Using a Continuous Data Collection System.
Condition: Mechanical Ventilation; Acute Respiratory Distress Syndrome; Hypoxic Respiratory Failure
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury
Study type: Observational

Summary: 
      Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic
      monitoring are under-utilized when translating research into decision support. Current
      medical informatic capabilities can be leveraged to calculate trends in measured parameters
      to initiate a paradigm shift in critical care from reaction-based treatment to proactive and
      plausibly preventative care. Therefore, the purpose of this study is to develop baseline
      understanding of our practice and how data collection utilizing a newly implemented system
      called T3. We would like to retrospectively review mechanically ventilated patients in which
      we have collected continuous data to test a newly developed analytic platform. Additionally
      we would like to compare these results to our standards of practice established by clinical
      practice guidelines.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All mechanically ventilated patients in our medical surgical ICU.
      
Keywords: ARDS; ALI; mechanical ventilation
Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study
Condition: Gastroesophageal Reflux Disease; Dyspepsia
MeSH terms: Gastroesophageal Reflux; Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to provide evidence that Compound Sodium Alginate Double Action
      Chewable Tablets are effective in managing the symptoms of heartburn, acid regurgitation and
      dyspepsia in patients with Gastroesophageal Reflux Disease (GERD).
    


Intervention name(s): Compound Sodium Alginate Double Action Chewable Tablets; Matching placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): 2 tablets four times daily; 2 tablets four times daily
Other intervention name(s): Gaviscon Double Action Tablets; Placebo
Intervention MeSH terms: Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease; GERD; Dyspepsia; Indigestion; Heartburn; Acid reflux; Compound Sodium Alginate Double Action Chewable Tablets; Gaviscon Double Action Tablets
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
Condition: Prostate Cancer; Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms; Adenocarcinoma; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant
      metastases from prostate cancer. This clinical trial is studying how this imaging test may
      help influence the choice and extent of initial treatments, and subsequent treatments.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in
           the initial and subsequent management of patients with prostate cancer at intermediate
           or high risk for recurrence after initial curative therapy.

        -  Compare the value of AC-PET in predicting recurrence of prostate cancer with that of
           conventional approaches (e.g., pre-operative clinical staging, prostate-specific
           antigen, Gleason score, prostate and lymph node histology) in these patients.
    

Intervention name(s): C11-Sodium Acetate
Intervention type(s): Drug
Intervention description(s): PET Imaging with C11-Sodium Acetate
Other intervention name(s): C11 Acetate PET; Carbon 11; AC-PET
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: intermediate; high; risk; radiation; therapy; planning; surgical; immunotherapy; chemotherapy; hormone
New Glucose Sensor Pediatric
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to assess performance of a new subcutaneous glucose sensor over
      a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In
      addition performance of the new sensor will be calculated for use of the new sensor with
      proposed new devices using new calibration algorithms.
    

Detailed description: 
      The first generation Medtronic MiniMed Subcutaneous Glucose Sensor (Sof-Sensor) was
      originally approved by the FDA for commercialization as part of the Continuous Glucose
      Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The Sensor is composed of a
      microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible
      membrane. This same sensor was used as part of subsequent continuous glucose monitoring (CGM)
      systems, such as the Guardian REAL-Time and Paradigm REAL-Time sensor augmented insulin pump.
      The current configuration of sensor has undergone in vitro and in vivo testing. A new
      second-generation glucose sensor (herein referred to as the Comfort Sensor) has been
      developed. The first-generation glucose sensor was approved with reported sensor accuracy
      (MAD) of 18%; it was labeled for maximum use duration of 72 hours, using only the abdomen as
      an insertion site. The new sensor is shorter and has a smaller diameter, with a smaller gauge
      introducer needle. The new sensor inserter is designed to be used with the new sensor. The
      objectives of this study are to 1) Assess performance of the Comfort Sensor when used over a
      period of seven days with currently available devices, and 2) Assess performance of the
      Comfort Sensor when used over a period of seven days using new calibration algorithms
      (post-processed with algorithm for future devices). Accuracy data will be calculated based on
      comparing calibrated glucose sensor values to glucose meter values during in-home testing.
      The devices that will be used for gathering sensor data during this study will be: 1) the
      Comfort Sensor, 2) the MiniLink (Transmitter), and 3) the Guardian REAL-Time Display Device.
    

Intervention name(s): Sensor wear
Intervention type(s): Device
Intervention description(s): All subjects to wear sensors
Other intervention name(s): Enlite Sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: diabetes; glucose; sensor