bioihbjkbjnl/mcl2 huggingface dataset:
Comprehensive Shoulder System Nano IDE
Condition: Joint Disease
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      The purpose of this clinical study is to determine the safety and efficacy of the
      Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty
      (TSA).
    

Detailed description: 
      The purpose of this clinical investigation is to establish the safety and efficacy of the
      Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty.
      Safety and efficacy of the device will be measured by collection and analysis of the
      following data at the two-year or greater time point (22 months post-operative or longer):

        1. American Shoulder and Elbow Surgeons (ASES) Score

        2. Single Assessment Numeric Evaluation (SANE)

        3. Constant Score

        4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence

        5. Comparison of overall adverse event rates including rates of removal/revision and other
           serious adverse events.
    

Intervention name(s): Mini Stem; Nano
Intervention type(s): Device; Device
Intervention description(s): The humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.; The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Shoulder; Joint; Osteoarthritis
Comparison of Extended Release Tacrolimus (Advagraf) and Cyclosporine A Microemulsion on Renal Function in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the effects of steady state tacrolimus vs.
      cyclosporine on renal pharmacodynamics in healthy volunteers.
    

Detailed description: 
      This study seeks to evaluate the renal physiological responses of short-term maintenance
      level doses of CNIs in healthy volunteers to determine if daily perturbations in renal
      physiology exist, and if confirmed, whether they differ between CNIs and thus may contribute
      by different mechanisms to the progression of CAN.
    

Intervention name(s): extended release tacrolimus; cyclosporine A microemulsion
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Advagraf®; FK506E; MR4; Neoral®
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Tacrolimus; cyclosporine A; renal plasma flow; glomerular filtration rate; human; pharmacodynamics; pharmacokinetics; Pharmacodynamics of tacrolimus
Usage, Usability & Effect on Adherence and Clinical Outcomes of Text Message Reminders for Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this randomized crossover study is to determine the efficacy of participant
      designed medication reminders on asthma control, asthma related quality of life,and
      medication adherence. In addition, this study will provide data regarding the usage,
      usability, acceptability of an online system designed for creating text message reminders. It
      is hypothesized that the teens receiving text message reminders will report having greater
      quality of life related to their asthma, a reported increase in the control of their asthma,
      and increased adherence to their medication regimen compared to those teens that are not
      receiving the text message reminders.
    

Detailed description: 
      Adolescents are typically less adept at managing chronic illnesses and adhering to treatment
      plans than are parents of younger children. Adolescents are also typically "early adopters"
      to technological solutions and text messages are integral in today's teen culture. Text
      messages are gaining acceptance in health care both as appointment reminders and direct
      inquiries. The purpose of this randomized crossover study is to examine the effect of
      participant designed medication reminders on asthma control, asthma related quality of life,
      and medication adherence. In addition, this study will provide data regarding the usage,
      usability, and acceptability of an online system designed for creating text message
      reminders.
    

Intervention name(s): Text Message Reminders
Intervention type(s): Other
Intervention description(s): During baseline (Participant 1st Arm) or Month 3 Visit (Comparison 1st Arm), the study staff member will demonstrate for the teen how to log-on to the calendar system and set up reminders. Teens will be able to set their own reminders and add other reminders in addition to those that are asthma related.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion
Condition: Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      Delineation of the anatomical location, cellular origin and molecular basis of gut-derived
      glucagon secretion
    

Detailed description: 
      Aim: to delineate the anatomical origin, the molecular structure and precursors, the
      regulation and the (patho-) physiological implications of gut-derived glucagon.

      Eight totally pancreatectomised patients, eight type 2 diabetes patients and eight healthy
      controls (age 18-80, BMI <30) with normal kidney and liver parameters and hgb> 6.5 - will be
      included. The participants will each undergo one screening day and one study day including a
      gastroduodenoscopy. Multiple biopsies will be taken at several predefined locations in the
      upper gastrointestinal tract. These biopsies will be analysed with different techniques
      including immunohistochemical staining, quantitative polymerase chain reaction (qPCR-)
      analyses and more to search for glucagon. After the last biopsy has been collected, 50 g of
      glucose dissolved in 100 ml water is infused through the enteroscope into the most proximal
      part of the small intestine. Hereafter blood samples for glucagon and gut hormone analyses
      will be collected 15, 30 and 45 min after the glucose infusion.
    

Intervention name(s): Oral glucose tolerance test
Intervention type(s): Other
Intervention description(s): Oral glucose tolerance test and biopsies
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function
Condition: Healthy Males
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomized, study at a single clinical site investigating the effect
      of methylnaltrexone and naloxone versus placebo in healthy males who have received a
      short-acting opioid, remifentanil.
    


Intervention name(s): Naloxone; IV Methylnaltrexone (MNTX); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Naloxone; Methylnaltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519(CKD-519 FDI)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose this study investigate the effect of food on the
      pharmacokinetics/pharmacodynamics and safety of CKD-519
    


Intervention name(s): CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
Condition: Healthy
MeSH terms: Skin Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy
      volunteers.
    


Intervention name(s): Avagard; Purell Surgical Scrub
Intervention type(s): Drug; Drug
Intervention description(s): Topical solution, 6 mL, 6 applications/day for 14 days.; Topical solution, 4 mL, 6 applications/day for 14 days.
Other intervention name(s): Purell Surgical Scrub with Moisturizers
Intervention MeSH terms: Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Skin health
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the
      Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult
      Subjects with a Functioning Ileostomy.
    

Detailed description: 
      This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy
      subjects between the ages of 18 and 80 years, inclusive, with functioning ileostomies were
      planned to be enrolled. In the first treatment period (Period 1) all subjects received an IV
      infusion of 1 g ceftriaxone. Subjects had a 3 - 7 day washout period between Period 1 and
      Period 2. In the second treatment period (Period 2) all subjects received an IV infusion of 1
      g ceftriaxone and 2 oral doses of either 75 or 150 mg of SYN-004, according to the
      randomization schedule, which were administered 30 minutes before and 5.5 hours after the
      start of the ceftriaxone infusion.
    

Intervention name(s): Period 1 - Treatment Sequence AB; Period 1 - Treatment Sequence AC; Period 2 - Treatment Sequence AB; Period 2 - Treatment Sequence AC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004; Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004; Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg; Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg
Other intervention name(s): ribaxamase; ribaxamase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique
Condition: Myocardial Protection in TOF Repair
MeSH terms: Tetralogy of Fallot
Study type: Interventional
Phase: Phase 4

Summary: 
      Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair:
      a randomized study of Two cardioplegic techniques.
    

Detailed description: 
      Del Nido cardioplegia has not been used for myocardial protection and clinical outcome in
      patients undergoing tetralogy of Fallot repair, so the investigators hypothesized that a del
      Nido cardioplegia technique may be beneficial in the pediatric patients undergoing tetralogy
      of fallot repair.
    

Intervention name(s): blood cardioplegia; del nido cardioplegia
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: tetralogy of fallot, cardioplegia
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-mcg Dose
Condition: HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety of and immune response to vaccinia-derived HIV-1 recombinant envelope
      glycoprotein (gp160) at a dose of 200 mcg in human volunteers; to evaluate duration of
      antibody response and its relationship to the dose and frequency of inoculation.

      Although recent advances have been made in antiviral therapy against AIDS, there is currently
      no cure for AIDS. It is likely that the ultimate control of the disease depends on the
      development of safe and effective vaccines against HIV.
    

Detailed description: 
      Although recent advances have been made in antiviral therapy against AIDS, there is currently
      no cure for AIDS. It is likely that the ultimate control of the disease depends on the
      development of safe and effective vaccines against HIV.

      Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are
      randomly assigned to receive three injections of either 200 mcg gp160 vaccine or a placebo.
      At each participating site, four volunteers receive vaccine and two volunteers receive
      placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in
      an outpatient setting. Volunteers are closely monitored for the first 2 weeks
      postimmunization (primary and boosters), and extensively followed for 2 years. Volunteers may
      be offered an additional booster of the same preparation at 12 months.
    

Intervention name(s): gp160 Vaccine (Immuno-AG)
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV-1; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Pilot Clinical Evaluation of Approved Contact Lenses
Condition: Vision Disorders
MeSH terms: Vision Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot evaluation to assess the feasibility of using novel imaging process to
      characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and
      blink; and conjunctival microvasculature including fractal analysis of microvascular
      perfusion maps and blood flow velocity.
    

Detailed description: 
      This is a pilot evaluation to assess the feasibility of using ultra-high resolution optical
      coherence tomography (OCT) to image and characterize lens edge and limbal epithelial
      thickness profile; lens movement with gaze and blink; and conjunctival microvasculature
      including fractal analysis of microvascular perfusion maps and blood flow velocity.
    

Intervention name(s): Marketed Contact Lens 1; Marketed Contact Lens 2; Marketed Contact Lens 3; Marketed Contact Lens 4
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).; Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).; Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).; Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
Other intervention name(s): etafilcon A; nelfilcon A; narafilcon A in 8.5 base curve; narafilcon A in 9.0 base curve
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Directly Observed Therapy in HIV Infected Adolescent Focus Groups
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to help researchers use information from HIV infected
      adolescents to design a directly observed therapy (DOT) program that will help adolescents
      take their anti-HIV medications correctly.
    

Detailed description: 
      The rate of HIV infection among adolescents is increasing at an alarming rate. Adherence to
      antiretroviral therapy has been a major challenge in achieving and maintaining adequate
      control of the disease in this population. DOT has been shown effective in individuals with
      tuberculosis (TB), but DOT in HIV infected populations has not been thoroughly examined. This
      study will collect information from HIV infected adolescents in order to establish a DOT
      program that will increase successful adherence to HIV treatment and will benefit the public
      by preventing development of viral resistance and reducing the risk of transmission.

      Adolescent participants in this study will be assigned to one of three 2-hour focus group
      sessions, each at a different site. The participants will complete a questionnaire and will
      give input about designing a DOT intervention model that will be accepted by adolescents. The
      model will then be used in a pilot study to determine the feasibility of implementing DOT
      programs in the community to help HIV infected adolescents.
    

Time perspective: Prospective
Keywords: Treatment Experienced
Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers
Condition: Melatonin; Pharmacokinetics; Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      We will investigate the safety and pharmacokinetics of melatonin, when administered rectally,
      intravesically, vaginally and transdermally. We will recruit 10 healthy female volunteers.
      The volunteers will have melatonin administered over 5 days; intravenously, rectally,
      intravesically, vaginally and transdermally. The participants will be followed for 24-48
      hours with blood samples and questions about adverse events. There will be a wash-out between
      each session of a minimum of 7 days.
    


Intervention name(s): Melatonin 25 mg
Intervention type(s): Drug
Intervention description(s): 24-48 hour monitoring of plasma melatonin as well as adverse events.
Intervention MeSH terms: Melatonin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Each volunteer will have melatonin administered through all five routes of administration, and will have a wash-out of a minimum of 7 days between each administration.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Melatonin; Safety; Pharmacokinetics
Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus
Condition: Post-operative Ileus
MeSH terms: Ileus
Study type: Interventional

Summary: 
      Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in
      resolving postoperative ileus.
    


Intervention name(s): olive oil; olive oil and chewing gum; chewing gum; water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Spinal Muscular Atrophy and Cardiac Autonomic Function
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional

Summary: 
      Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal
      muscular atrophy (SMA). Air stacking is a clearance airway technique frequently used but its
      effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear.

      Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic
      function in patients with spinal muscular atrophy types II and III.

      Methods: Patients with spinal muscle atrophy type II and III will be recruited.
      Electrocardiogram signals will be recorded for analyses of heart rate variability during air
      stacking in supine and sitting position.
    

Detailed description: 
      Background: Respiratory dysfunction is the major cause of morbidity and mortality in patients
      with spinal muscular atrophy. Air stacking is a clearance airway technique frequently used
      but its effects on cardiac autonomic function in patients with spinal muscle atrophy is not
      clear.

      Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic
      function in patients with spinal muscular atrophy types II and III.

      Methods: Patients with spinal muscle atrophy type II and III will be recruited.
      Electrocardiogram signals will be recorded for analyses of heart rate variability during air
      stacking in supine and sitting position. Data will collected before, during and after air
      stacking and will be compared using Anova Repeated Measures or Kruskal-Wallis Anova on Ranks,
      followed by Tukey test. The relationship between heart rate variability indexes and age will
      be evaluated by Pearson correlation. Significant level will be set at 5%.
    

Intervention name(s): Air stacking manuever
Intervention type(s): Procedure
Intervention description(s): Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position
Other intervention name(s): HRV during air stacking
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal muscular atrophy; heart rate variability; posture; air stacking
Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery
Condition: Muscle Disorder; Postoperative Pain; Shoulder Injuries; Immobilization; Asymmetric Limb Muscle Stiffness
MeSH terms: Muscular Diseases; Shoulder Injuries
Study type: Interventional

Summary: 
      This study is an observational cross-sectional study. Post-operative patients need an
      immobilization period for a certain period of time after surgery. Kinetic chain changes due
      to immobilization can affect the symmetry of the core muscle. Therefore, in this study, core
      muscle asymmetry (CMA) is measured using a whole body tilt device for inpatients who have
      undergone arthroscopic shoulder surgery. We would like to make a clinical suggestion for
      post-operative rehabilitation by identifying the characteristics of CMA according to the left
      or right site.
    


Intervention name(s): whole body tilt device (Spine Balance 3D)
Intervention type(s): Device
Intervention description(s): The symmetry of the deep muscle was evaluated using a whole body tilt device (Spine Balance 3D, Cyber Medic Co., Ltd., Korea). Spine Balance 3D can evaluate the maintenance strength and maximum strength of the core muscles, and perform a personalized core muscle training program based on the evaluated results.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment