bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the PK of single dose of Vedolizumab SC 108 milligram
      (mg) administered as PFS vs investigational device.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab SC. The study will compare the PK
      of a vedolizumab SC in a PFS to an investigational device.

      This study will include 2 different device delivery presentations in 2 treatment groups.
      Participants in each treatment group will be randomized to one of the three administration
      sites: Abdomen, thigh, or arm. The study will enroll approximately 102 participants per group
      (a total of 204 participants), including 34 participants allocated to each administration
      site within each treatment group. Participants will be randomly assigned (by chance, like
      flipping a coin) to one of the two treatment groups:

        -  Group A: Vedolizumab SC PFS

        -  Group B: Vedolizumab SC Investigational Device

      All participants will receive a single dose of study drug on Day 1.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 196 days. Participants will be contacted by
      telephone on Day 168 after their last dose of study drug for a follow-up assessment which
      will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey.
    

Intervention name(s): Vedolizumab SC
Intervention type(s): Drug
Intervention description(s): Vedolizumab SC liquid.
Other intervention name(s): MLN0002, ENTYVIO, KYNTELES
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
Ultrasound Guided Caudal Block for Benign Anal Surgery
Condition: Anal Fissure; Anal Fistula; Hemorrhoids; Pain, Postoperative
MeSH terms: Hemorrhoids; Rectal Fistula; Fissure in Ano; Fistula; Pain, Postoperative
Study type: Interventional

Summary: 
      Interventional study that evaluate analgesia and side effects of Ultrasound guided Caudal
      block preoperatively in benign canal anal surgery
    

Detailed description: 
      Postoperative pain is an important symptom in patients after benign anal canal surgery.
      Caudal block has been described to decrease postoperative pain in this type of surgery.
      Ultrasound is a tool that facilitates its performance and increases the rate of a successful
      block.

      Objective:

      To determine the usefulness of ultrasound guided caudal block in anesthesia and postoperative
      analgesia in patients scheduled for benign anal surgery. Methods : Interventional study in
      adult patients that received ultrasound caudal anesthetic block before benign anal surgery.
      The investigators evaluated analgesic efficacy of this intervention by mean of numeric rating
      scale ( NRS) for pain after 6, 12 and 24 hours of surgery, rescue analgesia, motor block,
      urinary retention, surgical conditions and patient satisfaction in postoperative period.
    

Intervention name(s): Ultrasound Guided Caudal Block
Intervention type(s): Procedure
Intervention description(s): Using an external ultrasound probe, the investigators guided a 18 gauge epidural needle into the caudal space and injected a local anesthetic solution consisting in bupivacaine 0.25%, lidocaine 1% and dexamethasone 8mg in the caudal space.
Intervention model: Single Group Assignment
Intervention model description: interventional
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ultrasound guided caudal block; anal surgery
Male Breast Cancer Summa Health System/Akron City Hospital Experience 1995-2007
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Breast Neoplasms, Male
Study type: Observational

Summary: 
      The primary goal of this retrospective study is to evaluate the male breast cancer patient
      population at Summa Health System/Akron City Hospital over a period of 18 years and compare
      the findings to historical data.

      The objectives are to:

        -  identify risk factors.

        -  evaluate stage and histology at the time of presentation.

        -  document treatment modalities and outcomes.

        -  analyze outcomes for comparison to historical data.
    


Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Males with breast cancer.
      
Keywords: male breast cancer; Male breast cancer patients diagnosed and/or; treated at Summa Health System/Akron City Hospital; from the reference year of 1995 through 2007.
Follow up of Nasolacrimal Intubation in Adults
Condition: Lacrimal Apparatus Diseases; Dacryocystitis
MeSH terms: Dacryocystitis; Lacrimal Apparatus Diseases
Study type: Observational

Summary: 
      For patients with chronic epiphora, Dacryocystorhinostomy is currently the gold standard
      treatment, with a success rate of 80-90% according to literature. Another available
      treatment, which is far less used, in nasolacrimal intubation, using a silicone tube.

      In our study, we would like to find the efficacy of nasolacrimal duct intubation, which was
      performed in our medical center on a few hundred patients with mild epiphora.

      Study hypothesis: nasolacrimal intubation in adults, with a clinically mild epiphora, is
      close in it's efficacy to the Dacryocystorhinostomy procedure.
    

Detailed description: 
      Under normal conditions, the amount of tears excreted from lacrimal glands to the eye is
      equal to the amount drained through the tear duct. Epiphora in adults usually involves a
      blockage of the lacrimal sac or the nasolacrimal duct. Epiphora causes tearing in patients,
      which can be treated sympthomatically in a conservative way (antibiotic treatment, probing of
      the tear duct, pressure irrigation of the tear duct) or therapeutic in an invasive way. The
      invasive treatment includes one of the following:

        1. Dacryocystorhinostomy - surgery for reconstructing an alternative path for tear
           drainage.

        2. Nasolacrimal intubation - inserting a silicone tube through the tear duct. The tube is
           usually removed after 3-6 months.

      Currently, there are only a few reports regarding the efficacy of nasolacrimal intubation,
      all with a small number of research subjects. Also, these reports have stratified the
      patients according to the location of the tear duct blockage, and didn't take into account
      the severity of the blockage (ie the severity of symptoms) prior to performing the
      intubation.

      In our research, we would like to find the efficacy of nasolacrimal intubation which was
      performed in our medical center on a few hundred patients with mild epiphora, and to compare
      in with the efficacy of the Dacryocystorhinostomy - which is 80-90% according to literature.
    

Intervention name(s): Silicone tube
Intervention type(s): Device
Intervention description(s): Silicone tube which is inserted into the tear duct through the punctum in the eyelid, then passed through the tear duct till it enters the nose and secured in place using a surgical knot. The tube remains in place for 3-6 months, than take out by the surgeon.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient who underwent nasolacrimal intubation in Maccabi Healthcare, due to mild epiphora,
        during the years 2000-2007.
A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Condition: Chronic Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a
      threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the
      safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects
      with chronic ITP for.
    

Detailed description: 
      The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of
      subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response
      >60%. The secondary objectives are: 1) to determine the safety of GAMMAPLEX at the dosage
      used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in
      subjects with chronic ITP for a period of time similar to that of a published data.
    

Intervention name(s): Gammaplex, intravenous immunoglobulin
Intervention type(s): Biological
Intervention description(s): Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG).
The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
Other intervention name(s): Gammaplex
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Idiopathic Thrombocytopenic Purpura; Bleeding disorders; Immune System and Disorders
Infraclavicular or Supraclavicular Brachial Plexus Blocks for Elbow Surgery
Condition: Cubital Tunnel Syndrome; Biceps Tendon Rupture
MeSH terms: Cubital Tunnel Syndrome; Rupture
Study type: Interventional

Summary: 
      This study compares the infraclavicular approach to supraclavicular approach of brachial
      plexus block for elbow surgery.
    

Detailed description: 
      Traditionally, infraclavicular as well as supraclavicular approaches to brachial plexus have
      been recommended for elbow surgery. Supraclavicular approach is considered to have a more
      rapid onset. However, investigators have noticed that the supraclavicular approach needs more
      supplementation if it is used for elbow surgery. Therefore more and more anesthesiologists
      now choose the infraclavicular approach for elbow surgery (though both approaches are
      recommended in the text books).

      None of the published studies have addressed if one approach is indeed superior to the other
      specifically for elbow surgery. Therefore the investigators propose to undertake a study that
      will evaluate the two approaches to the brachial plexus specifically for elbow surgery.
    

Intervention name(s): Supraclavicular; Infraclavicular
Intervention type(s): Procedure; Procedure
Intervention description(s): Brachial plexus block with supraclavicular approach; Brachial plexus block with infraclavicular approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: elbow
The Footwork Step Technique in Flamenco Dancing
Condition: Kinesics; Kinematics; Injuries
Study type: Observational

Summary: 
      A professional flamenco dancer will perform a ZAP 3 test, a sequence of single strikes of the
      feet performed continuously for 15 sec. Kinetic and kinematic studies will be recorded during
      the performance.
    

Detailed description: 
      Flamenco is a highly emotional and sensitive dance, which is one of the most characteristic
      elements of Spanish culture. It is both physically and mentally demanding, with the emphasis
      on footwork technical execution and the aesthetic of arms and trunk movements. Years of
      training are necessary to achieve any level of proficiency as professional flamenco dancer.

      Therefore proper execution of the movements minimize the risk of injury accompanying foot -
      ground contact which was reported by several studies. The most suffering parts of the
      dancer's body are the cervical and lumbar spine, knee and foot.

      Despite the growing number of studies on flamenco dancing, there is a lack of investigations
      focused on understanding how does the flamenco dancer's body work to mitigate an injury risk.
      Therefore, the purpose of this study is to examine the parameters related to this issue:
      vertical Ground Reaction Force, Centre of Mass displacements and knee joint kinematics of the
      supporting leg They will be registered and analyzed during footwork performance.

      A female professional flamenco dancer will perform a footork test called ZAP-3. It is a
      sequence of single strikes of the feet performed continuously for 15 seconds as fast as
      possible. 3D lower extremity kinematic data is used to collected using a five-camera motion
      analysis system (Vicon; Oxford Metrics Ltd., Oxford, UK). Kistler force platform will use to
      record the Ground reaction forces .
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Female profesional flamenco dancer
      
Keywords: Professional Flamenco Dancer; Footwork step; Ground Reaction Force; Center of mass
Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Video Assisted Thoracoscopic Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block
      for thoracic and abdominal surgery. It was first described by Forero et al. in 2016,
      effectiveness being reported in four cases. The paravertebral block has been successfully
      used in various surgical patient groups for purposes of anesthesia or postoperative pain
      management such as thoracotomy, breast surgery and abdominal surgery. The aim of this study
      is to compare the analgesic effects of erector spinae plane block and paravertebral block in
      patients undergoing video assisted thoracoscopic surgery.
    


Intervention name(s): Bupivacaine Hcl 0.25% Inj
Intervention type(s): Drug
Intervention description(s): Single shot 20 ml 0.25 bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries.
Condition: Spinal Surgery
Study type: Interventional

Summary: 
      Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance
      and metabolic acidosis in critically ill patients. The aim of this investigation is to
      compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and
      electrolytes in healthy patients undergoing major spine surgeries.
    


Intervention name(s): 0.9% normal saline; plasmalyte
Intervention type(s): Other; Other
Intervention description(s): In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.; In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: metabolic acidosis, plasmalyte solution, 0.9% normal saline
Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait
      using an unstable shoe (Intervention group) and a conventional stable control shoe (Control
      Group).

      Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients
      with Low Back Pain.
    

Detailed description: 
      Background: An unstable shoe was developed as a walking device to strengthen the lower
      extremity muscles and reduce joint loading. A large number of studies have reported increased
      electromyographic (EMG) activity throughout the gait cycle in most of the lower limb muscles,
      and significant kinematic changes in the lower extremity. However, no studies have
      investigated the effects of wearing (1 month) unstable shoes on 1) spine kinematics, 2) trunk
      muscle activity and 3) Low Back Pain (LBP) during gait in Patients with chronic LBP.

      Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait
      using an unstable shoe (Intervention group) and a conventional stable control shoe (Control
      Group).

      Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients
      with Low Back Pain.
    

Intervention name(s): Unstable shoe
Intervention type(s): Other
Intervention description(s): Wearing Unstable shoes during 1 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Unstable Shoes;Trunk muscles;Lumbar lordosis;Low Back Pain
Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure
Condition: Anesthesia; Tolerance
Study type: Observational

Summary: 
      Deep sedation or general anesthesia is frequently required for infant that need radiotherapy
      to treat malignancies. As radiation therapy usually consist of several sessions, these
      patients are exposure to several consecutive anesthetic exposures (e.g. for some central
      nervous system tumors 30 sessions of radiotherapy are required). In our center, this 30-min
      anesthetic exposure are with sevoflurane. Considering that repeated daily exposure to such
      potent drugs, as general anesthetics, may induce tolerance, it is reasonable to explore
      whether this phenomenon is occurring in this population.

      The aim of this observational study was to determine if a repeated exposure to sevoflurane is
      associated with the development of clinical and electroencephalographic tolerance.

      We will enroll 16 pediatric patients, and we will measure the time needed to appropriately
      place the laryngeal mask (clinical effect) and we also will compare the
      electroencephalographic signal under anesthesia across the different sessions
      (electroencephalographic effect).
    

Detailed description: 
      The purpose of this study is to evaluate the development of tolerance to sevoflurane in
      children undergoing repeated drug exposure.

      We will evaluate the development of tolerance in two ways:

      Clinical: as the time needed to perform the inhalation induction, with a standardized
      protocol.

      Electroencephalographic: we will record every 3 sessions the electroencephalographic activity
      of the patients. We will perform classical spectral analysis, and coherence analysis as well.

      This observational study will be mainly exploratory since there are no other previous report
      in this topic
    

Intervention name(s): Sevoflurane
Intervention type(s): Drug
Intervention description(s): Describe how a reiterative anesthesia exposure could induce tolerance to the anesthetic.
Intervention MeSH terms: Sevoflurane
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutive pediatric patients schedule for radiotherapy treatment under general
        anesthesia.
      
Keywords: Anesthesia; Electroencephalogram; Spectral analysis
EBMT ADWP Prospective Non Interventional Study : AutoHSCT in SSc Patients
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Observational

Summary: 
      The purpose of this study is to assess the effectiveness of Autologous Hematopoietic Stem
      Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis (SSc)
      as currently performed by different study protocols used across Europe in various EBMT
      centres through the careful recording and analysis of routinely collected clinical and
      biological data.
    

Detailed description: 
      Different protocols are used in the different centres, it is not yet clear which approach
      will be the most efficient and the safest. Every centre will follow its own local protocol
      for AHSCT which usually refers to the recent update of the EBMT Guidelines for HSCT in
      autoimmune disease. Patient selection for AHSCT treatment technique with regard to the
      risk/benefit balance has to be carefully addressed by standard patient pretransplant
      evaluation, whereas treatment local regimen, follow-ups evaluation, supportive medication and
      prophylaxis will be recorded and analysed.
    

Intervention name(s): Autologous HSCT
Intervention type(s): Procedure
Intervention description(s): 1st AHSCT
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with autologous HSCT for severe systemic sclerosis
      
Keywords: Autoimmune diseases; Systemic sclerosis; Autologous Hematopoietic stem cell transplant
Post Operative Pain Control: Morphine vs Fentanyl
Condition: Post Operative Analgesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Aim of this study is to compare benefits and disadvantages in using continuous infusion of
      morphine or fentanyl for post operative analgesia.
    


Intervention name(s): Morphine; Fentanyl
Intervention type(s): Drug; Drug
Other intervention name(s): Fentanest
Intervention MeSH terms: Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: post operative analgesia, morphine, fentanyl