bioihbjkbjnl/mcl2 huggingface dataset:
Dual Energy X-ray Absorptiometry (DXA) Comparison Hip Resurfacing Versus Total Hip Arthroplasty (THA)
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Observational

Summary: 
      This study compares the change (loss) of bone mineral density (BMD) that occurs in the
      proximal femur after hip resurfacing and total hip replacement.
    

Detailed description: 
      This study compares the change (loss) of bone mineral density (BMD) that occurs in the
      proximal femur after hip resurfacing and total hip replacement. The goal is to evaluate the
      bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to
      the bone loss in the proximal femur resulting from total hip arthroplasty.
    

Intervention name(s): Hip Resurfacing; Total Hip Arthroplasty
Intervention type(s): Device; Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients undergoing hip replacement or resurfacing for osteoarthritis
      
Keywords: Total Hip Replacement; Hip Resurfacing; Femoral Remodeling; Bone Loss; Bone Mineral Density; BMD; DXA; DEXA; THA
Home Use of Cupping Massage in Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this randomized controlled study is to determine the effectiveness of cupping
      massage as home use for patients with chronic nonspecific neck pain compared to relaxation
      exercise.
    

Detailed description: 
      see above
    

Intervention name(s): cupping massage; Progressive muscle relaxation
Intervention type(s): Procedure; Procedure
Intervention description(s): the upper back is covered in massage oil the cupping glass is drawn along the back muscles; standardized programme on muscle relaxation according to Jacobson
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of AeroForm Tissue Expander for Breast Reconstruction
Condition: Breast Cancer; Breast Reconstruction
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study is intended to support previous positive results of the AeroForm™ Patient
      Controlled Tissue Expander System for breast reconstruction
    

Detailed description: 
      The objective of this study is to provide performance and safety data to support the clinical
      use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a
      patient population with a broad selection criteria
    

Intervention name(s): AeroForm Breast Tissue Expander
Intervention type(s): Device
Intervention description(s): Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide
Other intervention name(s): AeroForm; AeroForm Tissue Expander; AirXpander; AirXpander Tissue Expander; AirXpanders Breast Tissue Expander
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Breast Reconstruction; Breast Tissue Expansion; Breast Tissue Expander; Two Stage Breast Reconstruction
A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention
Condition: Mobility Limitation
MeSH terms: Mobility Limitation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in
      Veterans 65 years and older. This study will also examine the neuromuscular and cognitive
      attributes that contribute to clinically meaningful improvements in mobility; and determine
      whether a novel mode of cognitive training can enhance cognition among mobility limited
      primary care Veterans 65 years and older.
    

Detailed description: 
      This study is a randomized control pilot study. All participants will receive rehabilitative
      exercise addressing mobility skills. In addition, one group will be will receive additional
      cognitive training. Randomization is stratified according to screening mobility and cognitive
      score.
    

Intervention name(s): InVEST: Increased Velocity Exercise Specific to Task; TAPAT: Tonic and Phasic Alertness Training
Intervention type(s): Other; Other
Intervention description(s): Functional Power Training; Computerized cognitive training.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Pilot Study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Rehabilitation; Aging; Mobility Skills; Cognitive Training
A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional

Summary: 
      Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack
      and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an
      implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's
      rhythm back to normal by electrically stimulating the heart but in doing so gives the patient
      painful and debilitating shocks. The first ICD shock after implantation appears to be a
      powerful predictor of subsequent shock therapy as well as being a predictor of of increased
      mortality in patients with primary prevention ICDs. In patients who receive repeated shocks
      VT ablation is performed to 'burn' the abnormal area of the heart that causes the problem.
      However, it is often only performed as a last resort as it is technically challenging. We
      believe that performing VT ablation using the robotic system early after the first episode of
      VT after ICD implantation, may reduce the number of painful shocks received by the patient
      and possibly increase life expectancy and quality of life.

      200 patients from 5 european countries will be recruited in a prospective, open, randomised
      trial. Eligible, consenting patients who have experienced their first episode of VT since ICD
      implantation, will be randomised in a 1:1 manner into treatment arms of either VT ablation or
      standard 'conventional' therapy and followed-up every 4 months over two years to assess the
      number of subsequent ICD shocks, hospitalisation, mortality and quality of life.
    


Intervention name(s): Robotic VT Ablation; Conventional Therapy
Intervention type(s): Procedure; Other
Intervention description(s): Robotic VT Ablation; Review of ICD programming to ensure that detection and therapy will occur appropriately
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ventricular Tachycardia; Implantable Cardioverter Defibrillator; Catheter Ablation; Robotic
Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion
Condition: Acute Pain
MeSH terms: Acute Pain; Sprains and Strains; Contusions
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the effectiveness of once daily application of a
      diclofenac sodium topical patch in reducing acute pain due to mild to moderate wrist sprain,
      strain or contusion when applied to the painful area.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, parallel group study will be conducted in
      patients with a mild to moderate wrist sprain, strain or contusion.

      Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment to
      either the diclofenac topical patch or a matching placebo patch to be applied once daily for
      7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up
      assessment will be conducted on Day 14. Patients will complete an electronic diary in which
      assessments including pain intensity, pain relief and functional disability will be recorded
      twice daily. Ratings of the quality of sleep will also be recorded in the diary each morning,
      and the use of study treatment and rescue medication will be recorded in the diary each day.
    

Intervention name(s): Diclofenac Sodium Patch; Matching Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): Topical 1% diclofenac sodium patch, applied once daily for 7 days; Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: wrist; sprain; strain; contusion; diclofenac; patch; acute pain; acute pain due to mild to moderate wrist sprain, strain or contusion
Accuracy of Detection of Methemoglobin With Pulse Oximetry
Condition: Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia
MeSH terms: Methemoglobinemia; Hypoxia
Study type: Observational

Summary: 
      The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels
      in affected individuals without requiring blood samples or laboratory testing. Nonin Medical
      Inc, has recently developed a multi-wavelength device that measures carboxyhemoglobin and
      methemoglobin non-invasively. The primary objective of this study is to validate %MetHb and
      SpO2 accuracy performance of the study device. Evaluations will be for the range of 0 to 15%
      MetHb with 95-100% SaO2 as assessed by CO-oximetry, and 0-15% MetHb accuracy under conditions
      of elevated HHb (SaO2 80-100%) as assessed by CO-oximetry, and SpO2 with 80-100% SaO2 during
      elevated MetHb as assessed by CO-oximetry.
    

Detailed description: 
      The goal of this study is to collect data with induced hypoxia, with induced
      methemoglobinemia, and with induced hypoxia and methemoglobinemia. This will be accomplished
      in three runs with 24 to 28 plateaus total. The number of plateaus will be dependent on the
      subject's tolerance of the study procedure. The first run will be strictly induction of
      hypoxia down to approximately 70% saturation. The second run will be induction of hypoxia
      down to approximately 80% saturation with mild hypoxia at 7% MetHb. The third run will be
      induction of hypoxia down to approximately 80% saturation with a target MetHb of 11-15%.
    

Intervention name(s): Sensor to spot check blood levels
Intervention type(s): Device
Intervention description(s): Sensor to check blood levels, not used as intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A minimum of 12 subjects with a minimum of 200 data points for each primary and secondary
        objective will be enrolled in the study. The subject population will include both male and
        female subjects and will include a variety of skin tones.
Study of Prophylactic Vs Preemptive Valganciclovir
Condition: Cytomegalovirus Infection
MeSH terms: Infections; Cytomegalovirus Infections
Study type: Interventional

Summary: 
      This is a study of prophylactic Vs preemptive oral valganciclovir for management of
      cytomegalovirus infection in adult renal transplant recipients looking at clinical and
      pharmacoeconomic outcomes
    

Detailed description: 
      This is a study of prophylactic Vs preemptive oral valganciclovir for management of
      cytomegalovirus infection in adult renal transplant recipients looking at clinical and
      pharmacoeconomic outcomes. Patients at risk for CMV (D+/R-, D+/R+, D-/R+) were randomized to
      prophylaxis (valganciclovir 900 mg qd for 100 days, n=49) or preemptive therapy (900 mg bid
      for 21 days, n=49) for CMV DNAemia (CMV DNA level >2000 copies/ml in ≥ 1 whole blood
      specimens by quantitative PCR done weekly for 16 weeks then at months 5, 6, 9, and 12.
      Clinical and virologic outcomes were measured and pharmacoeconomic outcomes will be analyzed
    

Intervention name(s): Valganciclovir
Intervention type(s): Drug
Intervention MeSH terms: Valganciclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cytomegalovirus; kidney; transplantation; valganciclovir; preemptive
SARS Cov_2 Incidence of Healthy Health Workers
Condition: SARS COV-2 IgG Levels on Health Workers
Study type: Interventional

Summary: 
      Since the severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) first emerged in
      Wuhan, China, on 12 December 2019, it has spread rapidly across the world and developed into
      a pandemic. The pandemic has affected over 100 countries and regions, with over 132 million
      confirmed cases of COVID-19. The rapid spread of SARS-CoV-2 has caused considerable harm to
      public health and the economy. Alongside other laboratory tests and clinical findings of the
      COVID-19 infection, serological testing may be beneficial for epidemiological monitoring and
      outbreak control. The determination of antibodies enables confirmation of the SARS-CoV-2
      infection in asymptomatic patients in addition to those with typical symptoms. In this study,
      we aimed to determine the SARS-CoV-2 seroprevalence and the IgG antibody levels among
      healthcare workers who frequently encountered COVID-19 patients in our hospital.
    


Intervention name(s): Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2
Intervention type(s): Diagnostic Test
Intervention description(s): Blood level of spike protein (S) or the nucleocapsid (N) of SARS-CoV-2
Intervention MeSH terms: Myeloma Proteins; Paraproteins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
The Peripheral Intravenous Catheterisation
Condition: Pain
Study type: Interventional

Summary: 
      Pain management during medical care is considered to be a basic human right and also affects
      patient satisfaction. In addition, effective management of acute pain contributes to improved
      patient outcomes. Patient satisfaction is a subjective state that indicates whether the
      healthcare provided has met the patient's needs and expectations. Many nurse theorists,
      including Florence Nightingale, have expressed the importance of providing comfort and relief
      for patients. In fact, comfort has been a crucial aspect of patient care since Nightingale's
      days, and has been considered an indispensable constituent of integrated nursing care.
      Studies to improve comfort may contribute to improving individuals' health outcomes,
      enforcing health-improvement behaviors, and improving healthcare quality as well as
      satisfaction and contentment of the individual and the nurse in the process of administering
      healthcare. In the literature, although the efficacy of various pharmacological methods for
      reducing pain associated with the insertion of PIC has been evaluated in adults, studies on
      nonpharmacological methods are limited. However, most of the studies were performed in
      healthy adults. Easy, inexpensive, and fast methods with unlikely side effects are needed to
      control pain and distress due to the PIC insertion in adults. Therefore, this study was
      performed to evaluate the effectiveness of distraction methods.
    


Intervention name(s): Distraction
Intervention type(s): Behavioral
Intervention description(s): Distraction-1 Group: Cards containing approximately six optical illusion pictures were shown to the patients and as a method of distraction during the PIC insertion procedure they were asked what they saw in these cards.
Distraction-2 Group: Underwater 3D audial videos were played with visual reality (VR) goggles during PIC insertion until the procedure was completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Corneal Opacities in Children
Condition: Corneal Opacities
MeSH terms: Corneal Opacity
Study type: Observational

Summary: 
      A prospective observational study on corneal opacities in infants and children (1 month to 18
      years old) will be conducted at CHLA. Most of these cases will be due to congenital corneal
      opacity (e.g. Peter's anomaly, mucopolysacharidoses) or scarring due to infectious keratitis.
      Sixty (60) subjects will be recruited. The children will be examined under anesthesia with a
      portable slit-lamp and OCT. An iVue OCT system (Optovue) attached to an operating
      microscope-style mount at CHLA will be used for the intraoperative scans. Both
      cross-sectional and 3-D OCT scans will be performed to assess opacity depth, pachymetry map,
      endothelial defects, and any abnormal adhesion between the cornea, iris and lens. The
      anterior chamber angle will also be imaged with cross-sectional OCT to assess angle depth,
      trabecular meshwork, Schwalbe's line, and possible peripheral iridocorneal adhesion or
      posterior embryotoxon. OCT of the crystalline lens will be obtained to assess the presence of
      cataract. Slit-lamp photography will be obtained, and gonioscopy will be performed if
      indicated. Corneal diameter will be measured with a caliper, and intraocular pressure will be
      measured with a tonopen (Reichert).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infants and children (1 month to 18 years of age) with corneal opacity requiring a thorough
        eye examination.
      
Keywords: corneal opacities; Optical coherence tomography
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate if intramuscular PEG-asparaginase administered
      either at six or two week intervals from day 92 until 8 months from diagnosis for patients
      with non-HR ALL will result in equal probability of Event Free Survival
    

Detailed description: 
      20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and
      research protocol that aims to improve the overall outcome of Nordic children and adolescents
      with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.

      The specific and primary objectives of the randomised study is:

      To test if intramuscular PEG-asparaginase administered either at six or two week intervals
      from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal
      probability of EFS. As secondary endpoints asparaginase antibody production and toxicity
      including allergic reactions in the treatment-arms will be analysed
    

Intervention name(s): PEG Asparaginase at six weeks interval; PEG Asparaginase at two weeks interval
Intervention type(s): Drug; Drug
Intervention description(s): PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy); PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)
Other intervention name(s): Oncaspar (PEG-Asparaginase); Oncaspar (PEG-Asparaginase)
Intervention MeSH terms: Asparaginase; Pegaspargase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute lymphoblastic leukemia; child; PEG-Asparaginase; EFS; efficacy; childhood acute lymphoblastic leukemia
Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results
Condition: Breast Cancer
Study type: Observational

Summary: 
      First Sense Medical®, LLC is a medical device company developing a novel breast cancer
      screening tester called the First Sense Breast Exam® Tester. This radiation free tester is
      being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory.
      When the tester is in production, a test will take approximately 7 minutes and will be
      performed in a doctor's office.
    

Detailed description: 
      This study is designed to evaluate the First Sense Breast Exam® test and the analysis by
      Therma-Scan. The First Sense Breast Exam® test is an adjunct to a mammogram. Currently,
      mammography is the standard of care in screening for breast cancer, and manual thermology is
      an adjunctive screening method. All of the study costs will be incurred by the sponsor and
      the subject will incur no costs to participate in the study. The First Sense Tester is a
      non-significant risk device where the tester's imaging camera makes no contact with the
      subjects during the entire procedure.
    

Intervention name(s): First Sense Medical®
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is comprised of adult women who are having a diagnostic or screening
        mammogram.