bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Effectiveness of Bariatric Surgery Versus Medical Management to Induce Diabetes Remission in Diabetic Patients With BMI 30-35
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Specific Aims & Hypothesis Primary Aim: To evaluate laparoscopic bariatric surgery versus
      intensive medical weight management on indices of insulin resistance and resolution of type 2
      diabetes among patients with BMI 30-35.

      Hypothesis: Bariatric surgery is the most effective treatment to induce diabetes remission in
      obese diabetic patients BMI 30-35.

      The primary outcomes will be assessed at 6 months: (1) within-patient change in insulin
      resistance after either bariatric surgery or initiation of intensive medical weight
      management, and (2) remission of diabetes, (i.e., fasting glucose <126mg/dL and glucose
      <200mg/dL two hours after a standard 75g oral glucose load without the use of
      anti-hyperglycemic medications). Insulin resistance will be assessed at randomization and at
      6 months with the homeostatic model assessment of insulin resistance (HOMA IR) based on
      insulin and fasting glucose, as well as oral glucose tolerance tests with
      area-under-the-curve (AUC) measurement for insulin values. Medication discontinuation will be
      derived from electronic health records and patient self-report at 6 months. Secondary
      outcomes will include changes in HBA1c, weight, blood pressure, waist circumference, and
      levels of fasting lipids.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Bariatric Clinic at Bellevue Hospital
      
Keywords: bariatric surgery; diabetes; sleeve gastrectomy; gastric bypass; gastric banding
Effects of Stretching on Strength of Proximal and Distal Group of Muscles - A Comparative Study
Condition: STRETCHING
Study type: Interventional

Summary: 
      Muscular flexibility is believed to prevent injuries and improve movement therefore most
      coaches include stretching exercises in their pre-competition and pre-exercise warm-up
      routines. One question arises here, should sports persons avoid stretching exercises prior to
      sporting events thereby exposing themselves to musculoskeletal injuries, or should they
      continue stretching exercises prior to sporting events and risk losing the maximal
      performance? The aim of this study is to compare the effects of 2, 4, and 8 min of static
      stretching (SS) on isometric maximum voluntary contraction (MVCF) force between proximal
      (Hamstrings) and distal group (Calf) of muscles.
    

Detailed description: 
      OBJECTIVE: To compare the effects of 2, 4, and 8 min of static stretching (SS) on isometric
      maximum voluntary contraction (MVCF) force between proximal (Hamstrings) and distal group
      (Calf) of muscles.

      DESIGN: Two-group pretest-posttest experimental design. METHODS: Each subject visited the
      Rehabilitation center on three days: On day-I for static stretching for 2 minutes (SS2),
      day-II for 4 minutes (SS4), and day-III for 8 minutes (SS8). Isometric Maximum Voluntary
      Contraction Force (MVCF) measurement was done prior (Pre), 0-min, 10-min, and 20-min
      post-intervention (i.e. stretching). Each visit was separated by a gap of at least 3-4 days.
      On each visit, each subject underwent (a). Pre-intervention evaluation, (b). Intervention,
      (c). Post-intervention evaluation. Subjects performed stretching exercises under the
      supervision of expert Physical Therapist. The outcome assessor who was kept blind to study
      protocol did all measurements.
    

Intervention name(s): Muscle static stretching
Intervention type(s): Other
Intervention description(s): On day-I: Static Stretching done for 2 minutes (SS2), on day-II: Static Stretching done for 4 minutes (SS4), and on day-III: Static Stretching done for 8 minutes (SS8).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Muscle strength; muscle stretching exercises; strain gauge
Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
Condition: Focus Chronic Kidney Disease With Hypertension
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The general objective of the study is to investigate the effect of regular aerobic exercise
      on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease and
      hypertension.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Blended supervised-home based walking exercise 3-4 times per week for 30-45 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; blood pressure; chronic kidney disease
Subcutaneous Administration of Otelixizumab to T1DM Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the subcutaneous administration of otelixizumab to T1DM patients. The
      study will provide safety, tolerability, pharmacodynamic and pharmacokinetic information
      which will enable the identification of appropriate safe and well-tolerated subcutaneous
      dosage regimens to be used in subsequent clinical studies. This study will consist of a
      screening phase, followed by an in-house phase whereby otelixizumab will be administered to
      cohorts that will be staggered at each dose level.
    

Detailed description: 
      Otelixizumab is a humanized, aglycosyl, non-mitogenic, anti CD3 monoclonal antibody (MAb)
      directed against the ε domain of the human lymphocyte antigen CD3, which is currently
      undergoing phase III clinical trials in adult new-onset type I diabetes mellitus patients and
      has been evaluated in rheumatoid arthritis and psoriasis patients in small exploratory
      studies. In previous studies, otelixizumab has been administered by intravenous infusion.
      This study is a randomised, single-blind, placebo-controlled, study of otelixizumab
      administered subcutaneously in Type 1 Diabetes Mellitus (T1DM) subjects.

      The assessment of otelixizumab in T1DM subjects will provide safety, tolerability,
      pharmacodynamic and pharmacokinetic information following subcutaneous administration which
      will enable the identification of appropriate safe and well-tolerated subcutaneous dosage
      regimens to be used in subsequent clinical studies. This study will consist of a screening
      phase, followed by an in-house phase whereby otelixizumab will be administered to cohorts
      that will be staggered at each dose level. Approximately 6 dose levels, covering up to a
      10-fold dose range, will be evaluated. A single subcutaneous dose of otelixizumab will be
      administered on Day 1 and, serial blood samples will be obtained for clinical laboratory
      testing, determination of pharmacodynamic markers, serum otelixizumab PK parameters, and
      immunogenicity. Safety and pharmacodynamic data from the previous dose(s) will be evaluated
      prior to dose escalation or modification to ensure safety and to achieve target systemic
      peripheral blood pharmacology. Adverse events, laboratory values, vital signs and ECG's will
      be monitored closely during this study. All subjects in the study will undergo long-term
      follow-up out to 48 months to monitor and ensure patient safety.
    

Intervention name(s): Otelixizumab
Intervention type(s): Drug
Intervention description(s): A humanized, aglycosyl, non-mitogenic, anti CD3 monoclonal antibody (MAb) directed against the ε domain of the human lymphocyte antigen CD3.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus
The Physical Effects of Pain Catastrophizing in Labor
Condition: Pregnancy
Study type: Observational

Summary: 
      The purpose of this study is to determine whether labor self-efficacy (as determined by
      scores for the Lederman PSEQ II (self-efficacy scores) impacts the second stage 2 length
      (nromal vs. prolonged) as determined by quartile ranges for our sample. Other studies have
      shown that women who experience intense pain in the earliest stages of labor have a higher
      risk of complications. The investigators want to know if negative thoughts can predict this
      outcome.
    

Detailed description: 
      Subjects will complete questionnaires at three timepoints: during the prenatal period, within
      24-48 hours of giving birth, and 4-8 weeks postpartum. The questionnaires will measure pain
      catastrophizing, depression, maternal support, support and control in birth, and childbirth
      satisfaction. Chart review following delivery will record data such as length of labor,
      medication used, need for augmentation or surgical delivery, complications.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Nulliparous women attending the prenatal clinic at Oregon Health & Science University
      
Keywords: pregnancy; birth; labor; labor pain; catastrophizing
Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients
Condition: Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Influenza virus is an important cause of morbidity in the transplant population and can lead
      to viral and bacterial pneumonia and contribute to the development of rejection. Although the
      annual influenza vaccine is recommended for transplant patients, studies have shown that a
      single intramuscular dose has poor immunogenicity. There are no studies that define the
      effect of intradermal doses in this population. We plan to study the immunogenicity of two
      different administration routes of the influenza vaccine in 200 solid organ transplant
      patients during the 2010-2011 season. Patients will be randomized to receive influenza
      vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive
      the intradermal influenza vaccine will significantly reach a higher response to the vaccine.
      This study advances research on the prevention of serious viral infections in transplant
      recipients. Results from this study have the potential to directly improve patient care. If
      the use of the intradermal influenza vaccine is successful, this strategy may lead to a
      significant reduction in burden of disease, hospitalizations, and long-term morbidity.
    


Intervention name(s): Influenza vaccine: Vaxigrip or Fluviral and Intanza
Intervention type(s): Biological
Intervention description(s): Patients will be randomized to receive either one intradermal dose of 0.1 mL or one intramuscular injection of 0.5 mL of the standard influenza vaccine in the deltoid muscle of the nondominant arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: adult solid organ transplant patients
Spatial Skill Training for Robot-assisted Surgery
Condition: Spatial Learning
Study type: Interventional

Summary: 
      Surgical residents from a single tertiary medical center were divided into 2 groups. All
      residents performed 2 tasks on a Da Vinci robotic simulator system after which they were
      either given a real training session in spatial skills (study group) or shown a short
      presentation regarding robotic surgery. After training/watching the presentation, they
      repeated the for mentioned tasks on the robotic simulator. Improvement in surgeon
      performance, especially regarding tissue damage was documented.
    

Detailed description: 
      Importance: Robot-assisted surgery is becoming the mainstay of modern surgery. Efficient
      training techniques are essential for enhanced performance. Optimal performance during a
      surgical task is key to successful surgery and minimal adverse events.

      Objective: To introduce and examine a single session of spatial skill training as an
      efficient means of improving surgical suturing performance in robot-assisted surgery.

      Design: Forty-one surgical residents will be randomly assigned to training and control
      conditions. (1) participants will perform two da-Vinci skills simulator (dVSS) tasks to
      determine baseline performance. (2) the training group will undergo computer-based simulator
      training of spatial skills while the control group will engage in a neutral activity. (3) two
      dVSS tasks will be performed within 2 days of training completion to evaluate post-training
      performance. The experiment will be conducted until December 2018.

      Participants: A convenience sample comprised of 41 surgical residents with non-robotic
      surgical suturing skills.
    

Intervention name(s): Computerized spatial skill training; Watching a presentation regarding robotic surgery
Intervention type(s): Other; Other
Intervention description(s): The spatial skills training session consisted of six practice trials that were run in a sequence. The objective of each practice was to manipulate the simulated robotic arm to grab the cubes and move them to a desired location using keyboard keys. The participant was required to reach a decision based on the visual-spatial information, before initiating subsequent movements of the simulated robotic arm. Each practice trial presented an initial state of the cubes in front of the robotic arm, and a target position of the cubes.; Watching a 20-35 minute long power-point presentation regarding the history of robotic surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Relationship Between Atelectasis on Ultrasound and PaO2/FiO2
Condition: Atelectasis, Postoperative
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding
      on intraoperative lung ultrasound.
    

Detailed description: 
      Patients aged 20~65 with ASA class (American Society of Anesthesiologists physical status
      classification) 1 or 2 who are scheduled to undergo general anesthesia by using endotracheal
      intubation and arterial line cannulation will participate in this study. The patients with
      abnormal chest x-ray finding, pregnancy, arrhythmia, ischemic heart disease will be excluded
      from this study as well as the patients who are scheduled to undergo lung or heart surgery.

      After 5 minutes preoxygenation, patients will be monitored with pulse oxymetry, noninvasive
      blood pressure. General anesthesia will be proceeded with typical method and endotracheal
      intubation and arterial cannulation will be proceeded. After ventilator adjustment (tidal
      volume as 8 times of the patient's ideal body weight), airway pressures(peak and plateau)
      will be recorded. Subsequently, arterial blood sampling will be proceeded while examination
      of the atelectasis findings on lung ultrasound before surgery. Lung ultrasound examination
      will be proceeded on 6 sections of patient's basal segments of the lung, including anterior,
      lateral, posterior segment. Juxtapleural consolidation, loss of A lines, presence of B lines,
      air bronchogram, loss of sliding sign and presence of pulse sign on lung ultrasound finding
      will be investigated and recorded.

      Same ultrasound examination and arterial blood sampling will be followed after surgery ends.

      The results of PaO2/FiO2 on arterial blood samplings will be compared with findings on lung
      ultrasound before and after surgery.
    

Intervention name(s): ultrasound
Intervention type(s): Device
Intervention description(s): Juxtapleural consolidation, loss of A lines, presence of B lines, air bronchogram, loss of sliding sign and presence of pulse sign on lung ultrasound finding will be investigated and recorded.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Atelectasis; Postoperative; Lung ultrasound
CARE Canadian ALS Riluzole Evaluation
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of
      riluzole-treated subjects who experienced death, permanently assisted ventilation (PAV) or
      tracheostomy, to a group of recent historical controls for the treatment of amyotrophic
      lateral sclerosis (ALS).
    


Intervention name(s): Riluzole
Intervention type(s): Drug
Intervention MeSH terms: Riluzole
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Class II Invariant Chain HCV Vaccine Study
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is aimed at assessing the safety and immunogenicity of HCV prime-boost vaccinations
      ChAd3-hliNSmut and MVA-hliNSmut, administered intramuscularly in healthy volunteers and DAA
      treated patients.
    

Detailed description: 
      Hepatitis C currently infects more than 180 million people worldwide and is associated with
      the development of liver cancer, liver failure and liver cirrhosis. Although drug treatments
      are available these are expensive and prolonged. Furthermore patients often only present to
      health care professionals at late stages when liver disease has already progressed.
      Therefore, vaccination remains the optimal method of preventing infection. To date this has
      proved extremely difficult due to the enormous variation in HCV strains around the world.

      Researchers at the University of Oxford in collaboration with industry, have developed novel
      candidate vaccines against HCV ('NSmut'). These vaccines have been inserted into the carrier
      viruses Chimpanzee Adenovirus (ChAd) and modified vaccinia virus Ankara (MVA), both of which
      have excellent safety records. These vaccines have been given to hundreds of healthy
      volunteers and are now being tested for effectiveness.

      In this study we are hoping to increase the immune response against the HCV virus. We will do
      this by inserting a gene in the vaccine (class-II invariant gene). In animal studies, this
      approach has been shown to be safe and to significantly to enhance the immune response
      against HCV.

      During this study 15 healthy adults and 10 volunteers who were previously treated for HCV
      infection, aged 18-65 years, will receive either two intramuscular injections over a period
      of two months. All participants will be followed up for a further 6 months (12 visits in
      total) and will be asked to give a blood sample at each clinic visit.

      The aims of the study are to assess the safety of the vaccine and to see if the vaccine can
      induce a strong immune response against the hepatitis C Virus.
    

Intervention name(s): ChAd3-hliNSmut; MVA-hliNSmut
Intervention type(s): Biological; Biological
Intervention description(s): Attenuated chimpanzee adenovirus (ChAd) vectored vaccine against HCV; Modified Vaccinia Ankara (MVA) vectored vaccine against HCV
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Each group will be sequentially recruited over a period of two months to allow for safety review.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis; Vaccine; Adenoviral-vector; human invariant chain
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
Condition: Cystic Fibrosis; Bronchiectasis Adult; Non-Tuberculous Mycobacteria
MeSH terms: Mycobacterium Infections; Cystic Fibrosis; Bronchiectasis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG)
      vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy
      volunteers.
    

Detailed description: 
      This single-site, open-label clinical trial to investigate the immune effects of BCG
      vaccination in adults with cystic fibrosis, non-cystic fibrosis bronchiectasis and healthy
      volunteers by measuring pre and post vaccination immune responses, BCG uptake and protection
      against infections, including nontuberculous mycobacteria (NTM). This study will also gather
      data on study feasibility, tolerability, and safety.
    

Intervention name(s): BCG TICE Vaccine
Intervention type(s): Biological
Intervention description(s): Intradermal vaccination with BCG TICE
Intervention MeSH terms: BCG Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BCG vaccine; Cystic fibrosis; Bronchiectasis; Non-tuberculosis mycobacteria
Effect of Systemic Cooling in Vasospasms
Condition: Vasospastic Syndrome
Study type: Observational

Summary: 
      This study tests whether women with Vasospastic Syndrome (VS) react more intensive than
      controls with distal vasomotions and choroidal blood flow changes to internal cooling/warming
      and external cooling/warming.
    

Detailed description: 
      Distal vasomotions and choroidal blood flow changes to internal cooling/warming and external
      cooling/warming was studied in VS and controls.Core cooling was induced by drinking of 250g
      ice/water mixture (4°C). Core warming was induced by drinking of 250g warm water (55°C). The
      study was controlled with respect to posture and room temperature.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        vasospastic women
      
Keywords: vasospastic women; controls; core cooling; core warming; external cooling; external warming; LDF; choroidal blood flow; temperature; vasospastic subjects; normal subjects