bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Effectiveness Study of the Reflection Ceramic Acetabular System
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This Post-Approval study is prospective follow-up study designed to evaluate the long-term
      safety and effectiveness of the Reflection Ceramic Acetabular System.
    

Detailed description: 
      This Post-Approval study is prospective follow-up study designed to evaluate the long-term
      safety and effectiveness of the Reflection Ceramic Acetabular System. Randomized
      Non-inflammatory Arthritis, Randomized Inflammatory and Continued Access Cohorts patients
      previously enrolled in the IDE study will be evaluated annually through five (5) year
      follow-up. In addition, all patients enrolled in the original study cohorts as well as the
      continued access patients will be sent a letter questionnaire annually at the 6-10 year
      postoperative time point to assess the patient's general well-being and if the study
      components are still in place
    

Intervention name(s): Reflection Ceramic-Ceramic Total Hip Replacement; Reflection FSO V Total Hip Replacement
Intervention type(s): Device; Device
Intervention description(s): Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.; Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
Other intervention name(s): Hip Replacement; Reflection; ceramic-ceramic; Hip replacement; Reflection; ceramic-poly
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthritis; Osteoarthritis; Traumatic Arthritis; Degenerative Joint Disease; Avascular Necrosis
Changing the Pulse of Athletics: Applying a Standardized Cardiac Athletic Screening for NCAA Athletes
Condition: Athletes Heart
Study type: Observational

Summary: 
      This is a study supported by Duke Sports Cardiology and Duke Sports Medicine with the intent
      to enhance the cardiovascular screening of collegiate athletes from a regional to nationally
      recognized program to understand and eventually reduce cardiovascular events in athletes. The
      data from this ongoing registry will be used to better understand, refine, and improve the
      current cardiovascular Duke Athlete Screening process and use this experience as a role model
      to expand across the ACC.
    

Detailed description: 
      The purpose of this study is to screen for and determine the prevalence of structural,
      functional, or electrophysiologic cardiac abnormalities in a population of young athletes
      using bedside cardiac ultrasound, electrocardiogram (ECG) and a physical exam.

      The investigators will attempt to answer the question regarding the feasibility of screening
      all collegiate athletes with bedside cardiac ultrasound, ECG, and history/physical exams
      results in a higher sensitivity for abnormalities than screening using ECG and physical exams
      alone. The investigators will also analyze the cost and cost effectiveness of screening the
      young athlete population with bedside cardiac ultrasound. Costs will be calculated to include
      the amount of dollars spent on equipment, gels, and other supplies, but will not include the
      cost of performing the bedside cardiac ultrasound, which will be assumed as part of the
      physical exam. Additionally, the investigators will be gathering a number of data markers
      from the bedside cardiac ultrasound, including but not limited to right ventricular and left
      ventricular cavitary size, septal wall thickness, free ventricle wall on RV, and free
      ventricle wall on LV, in evaluation of the athlete's heart. The importance of these
      measurements is for the continued knowledge and data set analysis collection as there is
      limited known athletic cardiac measurements. There is minimal risk involved in this study.
      The investigators believe that by adding bedside cardiac ultrasound to the history, physical,
      and ECG, it will increase the sensitivity and specificity of screening for these
      life-threatening abnormalities in young athletes, and reduce the morbidity and mortality
      associated with these conditions.
    

Intervention name(s): ECG; bedside cardiac ultrasound
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): 12 lead electrocardiogram used to demonstrate cardiac function; bedside cardiac ultrasound to see 2D images of each participants heart. Without the use of radiation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in NCAA Division 1 collegiate athletics at Duke University are eligible to
        participate in the study.
Effect of Carnitine on Uremic Cardiomyopathy
Condition: Disorder of Fatty Acid Metabolism
Study type: Interventional

Summary: 
      Patients on chronic hemodialysis without obstructive coronary artery disease identified by
      coronary angiography were randomly divided into the two groups: carnitine group and control
      group. SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous
      administration of L-carnitine (1000 mg on every dialysis session). Control group received the
      examination of BMIPP SPECT at the same time of the carnitine group. The effects of chronic
      intravenous administration of L-carnitine on myocardial fatty acid metabolism were
      investigated among this population.
    

Detailed description: 
      Patients on chronic hemodialysis in Toujinkai hospital who had no obstructive coronary artery
      disease identified by coronary angiography and left ventricular dysfunction were randomly
      divided into the two groups: carnitine group and control group. To evaluate the possible
      effect of carnitine administration on myocardial fatty acid metabolism, SPECT using FFA
      analogue, BMIPP, was performed before and one year after intravenous administration of
      L-carnitine (1000 mg on every dialysis session). Control group received the examination of
      BMIPP SPECT at the same time of the carnitine group. Circulating concentrations of total,
      free, and acyl L-carnitine were measured every three months in the carnitine group. Clinical
      data including blood chemistry, blood pressure, or cardiac functions by echocardiography were
      obtained every 6 months in both groups. The effects of chronic intravenous administration of
      L-carnitine on myocardial fatty acid metabolism and cardiac functions were investigated among
      this population.
    

Intervention name(s): Intravenous administration of L-carnitine
Intervention type(s): Drug
Intervention description(s): Chronic intravenous administration of L-carnitine (1000mg on each dialysis session) for 1 year in hemodialysis patients
Other intervention name(s): Chronic intravenous administration of L-carnitine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carnitine; hemodialysis; fatty acid; imaging; heart
Regenerative Endodontics in Mature Permanent Teeth
Condition: Regenerative Endodontics
Study type: Interventional

Summary: 
      this study was designed to compare the clinical and radiographic success of REPs after using
      blood clot scaffold in non-vital mature permanent teeth with or without photobiomodultion
      therapy
    


Intervention name(s): dental regenerative endodontics
Intervention type(s): Procedure
Intervention description(s): regenerative procedures performed in necrotic mature permanent teeth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals
Condition: Ischemic Stroke; Malignant Edema
MeSH terms: Anthrax; Gas Gangrene; Stroke; Ischemic Stroke; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, multi-center, prospective, double blind study. The primary objective is
      to assess the efficacy and safety of glyburide (RP-1127) compared to placebo in participants
      with a severe anterior circulation ischemic stroke who are likely to develop malignant
      edema.This objective will be addressed by comparing the proportion of glyburide treated
      particpants and placebo treated participants with a Day 90 modified Rankin Scale (mRS) ≤ 4
      without decompressive craniectomy (DC). The secondary objective is to assess the efficacy of
      RP-1127 compared to placebo in participants with a severe anterior circulation ischemic
      stroke who were likely to develop malignant edema.
    

Detailed description: 
      The study population consists of participants with a clinical diagnosis of acute severe
      anterior circulation ischemic stroke, a baseline diffusion weighted image (DWI) lesion
      between 82 and 300 cm3, age 18-80 years, and time from symptom onset to start of study
      infusion of ≤10 hours. The study will enroll both participants that do not receive
      intravenous (IV) recombinant tissue plasminogen activator (rtPA) and those that receive IV
      rtPA within 4.5 hours of stroke.

      Enrollment will be randomized controlling for site, age ≤60 (yes/no), and IV rtPA treatment
      at baseline (yes/no). Participants will be randomized equally between glyburide and placebo.

      This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired
      by Biogen.
    

Intervention name(s): Glyburide for Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Other intervention name(s): RP-1127; glibenclamide; glybenclamide
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to investigate effect, tolerability and safety of
      different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis
      patients out of season in an allergen challenge model.
    

Detailed description: 
      A double-blind, placebo controlled, randomised, parallel group phase IIa study to investigate
      the efficacy, tolerability, and safety of different dosing regimens of AZD8848 administered
      intranasally to seasonal allergic rhinitis patients out of pollen season in a nasal allergen
      challenge model
    

Intervention name(s): AZD8848; Placebo; AZD8848 and placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nasal spray solution, intranasal, three times weekly for one month; Nasal spray solution, intranasal, three times weekly for one month; Nasal spray solution, intranasal, three times weekly for one month
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AZD8848; allergic rhinitis; efficacy; tolerability; safety; nasal symptoms
AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether DEB is more effective than common PTA
      balloon using under in long-term vessel patency and inhibiting restenosis in the
      infrapopliteal artery.
    

Detailed description: 
      PTA is an established alternative to open surgical bypass for the treatment of infrainginual
      disease of critical limb ischemia.

      DEBs are designed to promote arterial patency by reducing neointimal proliferation.
    

Intervention name(s): DEB catheter; common PTA balloon catheter
Intervention type(s): Procedure; Procedure
Intervention description(s): DEB catheter (trade name: Litos/Tulip); common PTA balloon catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: drug eluting balloon catheter
Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect that telaprevir and boceprevir has on
      the pharmacokinetics of maraviroc.
    


Intervention name(s): Maraviroc; Maraviroc + Boceprevir; Maraviroc + Telaprevir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Maraviroc 150 mg BID x 5 days with food; Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food; Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food
Intervention MeSH terms: Maraviroc
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: maraviroc; boceprevir; telaprevir; drug interaction; pharmacokinetics; HIV
Acupuncture, Chinese Traditional Medicine, in Embryo Transfer
Condition: Pregnancy
Study type: Interventional

Summary: 
      The aim of the study is to prove that acupuncture applied before and after embryo transfer is
      able to increase pregnancy rates by means of reducing stress and improving endometrial
      vascularization in women receiving in vitro Fertilization (IVF) treatments.
    

Detailed description: 
      Around 75% of all in vitro fertilization (IVF) treatments fail in providing a healthy baby at
      home. Most of the women undergoing those techniques suffer in some extent anxiety, depression
      and stress. Stress make IVF results worse and it has been prove by correlating cortisol,
      adrenaline and noradrenaline levels with failed cycles. Acupuncture has proved its ability to
      reduce stress levels. Moreover, Acupuncture has prove to have an effect inhibitory on the
      sympathetic system and this capacity improves vascularization in uterus and ovaries.
      Available literature concerning these two issues is not conclusive because of studies design.
      Acupuncture´s biological mechanism on controlled ovarian stimulation and embryo transfer has
      not been completely described; if it really has one. Published studies show very different
      designs and inconclusive/contradictory results can be withdrawn making very difficult to take
      the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF)
      patients. If acupuncture really enhance pregnancy rates in IVF cycles still unanswered given
      that no randomized three arms study comparing no intervention to sham acupuncture to
      acupuncture has been published.
    

Intervention name(s): Bed Rest; Acupuncture; Acupuncture
Intervention type(s): Other; Procedure; Procedure
Intervention description(s): Bed rest during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer; Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer; Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acupuncture; in vitro fertilization; embryo transfer
The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effect of silicone hydrogel contact
      lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to
      compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.
    


Intervention name(s): Silicone hydrogel contact lens
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prebiotic and Anti-inflammatory Effects of a Pectin Polysaccharide
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to determine, quantify and understand the potential prebiotic and
      anti-inflammatory effects of the pecticpolysaccharide rhamnogalacturonan I (RG-I). The
      effects of these dietary fibre fractions on barrier function will also be investigated.
    

Detailed description: 
      The dietary fibre fractions from RG-I will be tested first for their prebiotic potential.
      Batch culture fermentation systems containing basal growth medium will be inoculated with
      faecal homogenates obtained from different time points (Task I) and will be used for
      analyzing microbiota composition and microbiota-associated metabolites. Subsequently, the
      collection of colon biopsies through sigmoidoscopy procedure of the same subjects will take
      place and the collected biopsies will be mounted in Ussing Chambers. Supernatants collected
      from Task I will be added to the mucosal side of the biopsy together with a stressor and two
      permeability markers, in order to investigate the effects of the fibre fractions on both
      paracellular and transcellular permeability.Throughout the study subjects will complete
      questionnaires related to their gastrointestinal health and dietary habits
    

Intervention name(s): Fermented product of carrot derived rhamnogalacturonan I
Intervention type(s): Other
Intervention description(s): Stimulation of human colonic biopsies with the fermented product of carrot derived rhamnogalacturonan I
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: paracellular permeability; transcellular permability; rhamnogalacturonan I; prebiotic; gut microbiota
Microvascular Reactivity in Prepubertal Children
Condition: Child, Only; Obesity; Endothelial Dysfunction
Study type: Observational

Summary: 
      This is a cross-sectional study aimed to investigate microvascular reactivity in prepubertal
      children according to adiposity status.
    

Detailed description: 
      The investigators aimed to investigate microvascular reactivity in prepubertal and to compare
      these data in different groups according to adiposity status. Firstly, The investigators
      recruited only children from 5 to 10 years at prepubertal status. After excluding those with
      exclusion criteria and the acceptance (from their parents) to participate in the study, a
      blood sample was collected and an appointment at BioVasc lab was programmed. At this day,
      participants were subject to nail fold videocapillaroscopy. A method used to investigate
      microvascular reactivity by a non-invasive mean. After this, participants children were
      followed to the outpatient's care unit to continue follow-up.
    

Intervention name(s): nailfold videocapillaroscopy; inflammatory biomarkers
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): non-invasive nailfold videocapillaroscopy; blood sample collection to asses leptin and C-reactive protein
Other intervention name(s): controls, overweight and obese groups; controls, overweight and obese groups
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Fifty-two obese (26 girls/26 boys), 18 overweight (13 girls/5 boys), and 28 eutrophic or
        lean prepubertal children (14 girls/14 boys) aged between 5 and 10 years (mean 7.44 ± 1.22
        years) were consecutively selected from our pediatric endocrinology outpatients unit at the
        Pedro Ernesto University Hospital assessed in a cross-sectional study.
The Impact of an Acute Bout of Exercise on Children's Eating Behaviors
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      The purpose of this project is to examine the effects of an acute bout of exercise on
      children's energy intake over the course of a day. Previous studies in adolescents and adults
      have shown exercise to be effective in decreasing short-term energy intake, with some
      variability. Individual characteristics such as habitual physical activity and psychological
      factors may influence the effect of exercise on energy intake, but these factors have yet to
      be examined. The investigators have assembled a multi-disciplinary team of researchers, with
      expertise in eating behavior, exercise, psychology, and clinical research in order to examine
      these questions. First, the investigators will examine the difference in energy intake at
      lunch, snack, and dinner meals in response to 30 minutes of imposed exercise compared to 30
      minutes of rest. Second, the investigators will collect objective measures of children's
      habitual physical activity, child characteristics (body composition, eating behavior traits),
      and individual responses to the controlled exercise bout. The investigators can then examine
      both group and individual differences in the energy intake response to exercise. Children
      (ages 9-12) will be tested over the course of three visits. The key outcome will be
      differences in energy intake in response to exercise vs. rest. Secondary outcomes include the
      influence of differences in habitual physical activity, personal characteristics, and
      responses to the exercise bout on children's energy intake. The long term goal of this line
      of research is to understand the mechanisms behind the interaction between exercise and
      energy intake. The translational potential of this research will be to inform personalized
      childhood obesity prevention strategies in children at risk for overweight.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children ages 9-12 years old