bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Hydroxy-apatite Coated Hip Stems
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      In this study, the investigators propose to randomize 80 subjects to receive either the
      Avenir cementless hip stem or a competing, HA-coated hip stem (Corail, DePuy-Synthes) and
      follow these patients for a period of 2 years post-surgery. The investigators aim to
      determine if the Avenir cementless hip stem has equivalent or better fixation and clinical
      outcomes compared to a predicate hip stem with longer clinical history.
    

Detailed description: 
      This is a multi-center, randomized controlled trial of patients undergoing primary total hip
      arthroplasty. This study will be focused on enrollment at a single site with possible
      expansion to additional centers should patient enrollment occur at a slower than expected
      rate. Decision to expand the study to additional centers will be mutually agreed upon by both
      the clinical site and the study sponsor.

      Patients will be randomized to two study groups:

        1. Zimmer Avenir cementless, HA-coated femoral hip stem with matching Trilogy IT cup;

        2. DePuy-Synthes Corail cementless, HA-coated, non-collared femoral hip stem with matching
           Pinnacle cup Patient allocation to the study groups will occur following a randomized
           4-block design.
    

Intervention name(s): Avenir cementless hip stem; Corail HA-coated hip stem
Intervention type(s): Device; Device
Intervention description(s): Avenir cementless hip stem vs Corail HA-coated hip stem; Avenir cementless hip stem vs Corail HA-coated hip stem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to study a device called an electroencephalograph (EEG)
      in the diagnosis of treatment of attention deficit hyperactivity disorder (ADHD) in adults.
      People with ADHD have symptoms such as difficulty sustaining attention, organizing, and
      managing impulsivity. They can have trouble in school, at work, and at home. Subjects with
      ADHD who participate in this study will be given a once daily stimulant medication called
      osmotic release methylphenidate (Concerta) for 6 weeks, and have EEG testing done before and
      after the treatment period. Subjects will perform a computer based cognitive task during EEG
      testing. The U.S. Food and Drug Administration has approved osmotic release methylphenidate
      (Concerta) for the treatment of ADHD in adults and children. Similar procedures, without
      medication, will be performed with a sample of healthy adults without ADHD.
    


Intervention name(s): Osmotic Release Methylphenidate
Intervention type(s): Drug
Intervention description(s): During a 6 week treatment period, adult subjects with ADHD are prescribed, in an open label fashion, once daily doses of osmotic release methylphenidate to a maximum daily dose of 144 mg. Efficacy and tolerability assessments are completed, in addition to EEG and cognitive testing. Healthy adults without ADHD will not receive medication.
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ADHD; Adults; Electroencephalography (EEG); Concerta
Dynamic Light Scattering to Study Crystalline Proteins in Young Normal Lenses
Condition: Healthy
Study type: Observational

Summary: 
      This study will use a method called dynamic light scattering (DLS) to study the lens of the
      eye in young normal subjects. The DLS device uses a very dim laser light to study the lens of
      the eye. It detects proteins in the lens, identifying early changes that may make the device
      useful in future cataract studies. This study will use DLS to examine the characteristics of
      proteins in healthy young lenses that can be used for comparison with lenses in older people
      and people with cataracts.

      Normal volunteers aged 5 to 21 years may be eligible for this study. Participants undergo the
      following procedures:

      Medical history

      Eye examination with dilation to include:

        -  Measurement of visual acuity

        -  Examination of pupils and eye movements

        -  Examination of the front of the eye (cornea, lens) with a slit lamp bio-microscope

        -  Examination of retina with an ophthalmoscope (instrument with a strong light and
           magnifying lens)

        -  Dynamic light scattering
    

Detailed description: 
      The NASA-NEI Dynamic Light Scattering (DLS) device detects early molecular lens changes
      before clinical means are able to detect any lens changes in animal and limited human
      studies. This ability will make it very useful in future clinical studies of cataract
      etiology as well as treatment. A recently concluded clinical cross sectional study of lenses
      (in vivo) using the DLS device showed good reproducibility and good correlation with clinical
      cataract grading. It also detected remarkable changes in the lens crystalline proteins with
      aging and with cataract formation. We therefore propose to study the characteristics of the
      crystalline proteins in pristine young normal lenses with DLS for comparison with aging and
      cataractous lens findings. We will examine 30 young normal subjects, perform undilated eye
      examinations, and obtain DLS measurements of their lenses. We will then use these DLS
      measurements for comparison with the previously obtained aging and cataract DLS measurements,
      to obtain normative data for future lens and cataract clinical studies.
    

Keywords: Cataract; Normal Lenses; Lens Crystallines; Dynamic or Quasielastic Light Scattering (DLS); Eye Examinations; Healthy Volunteer; HV; Eye Examination
Effect of Probiotics on Oral Homeostasis During Sugar Stress
Condition: Dental Caries; Probiotics; Gingivitis
MeSH terms: Gingivitis; Dental Caries
Study type: Interventional

Summary: 
      The present study is a double-blinded randomized clinical trial with a duration of 28 days.
    

Detailed description: 
      The present study is a double-blinded randomized clinical trial with a duration of 28 days.

      80 orally and systemically healthy participant will be allocated in the test (probiotic) and
      the control (placebo) group at baseline.

      The intervention is sugar stress, which will be applied at baseline and continue through day
      14, followed by 14 days without sugar stress.

      Clinical measurements and sampling will be performed at baseline, day 14 and day 28

      Primary endpoint: Changes in microbial composition.

      Secondary endpoints: Changes in clinical and immunological parameters
    

Intervention name(s): Sugar stress
Intervention type(s): Behavioral
Intervention description(s): Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded randomized clinical trial with a test and placebo group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Cerebellum or Supplementary Motor Area Functional Inactivation on Gait and Balance Control
Condition: Transcranial Magnetic Stimulation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In human, the physiology of gait and balance is not clearly established. By using functional
      imaging and electrophysiological techniques, various brain regions from the cortex to the
      midbrain area, including the cerebellum, have been identified as involved in such control.
      The specific role of these structures in both the capacity to go forward (locomotion) and
      stand upright (balance), but also in the different phases of the gait initiation process, are
      not known, however. In this study,the investigators aimed to assess the specific role of both
      the supplementary motor area (SMA) and the cerebellum in postural control during the
      initiation of gait. For this purpose, the investigators plan to study the gait initiation in
      20 healthy subjects before and after functional inactivation (using inhibitory repetitive
      transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic
      and electromyographic parameters of the gait initiation will be recorded using a force
      platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG
      electrodes.
    


Intervention name(s): transcranial magnetic stimulation
Intervention type(s): Other
Intervention description(s): comparison of different conditions of transcranial magnetic stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cerebellum; supplementary motor area
A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, open-label, crossover study will evaluate the relative bioavailability of
      ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc
      combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects
      will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an
      FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a
      crossover design, subjects will participate in 3 study periods with at least a 7-day washout
      between periods. In Part 2, single dose administration of film-coated FDCs will be compared
      to reference tablets.
    


Intervention name(s): danoprevir; danoprevir; ritonavir; ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fixed dose combination tablet with ritonavir, single oral dose; Reference tablet, single oral dose; Fixed dose combination tablet with danoprevir, single oral dose; Reference tablet, single oral dose
Intervention MeSH terms: Ritonavir; Lactams
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Polyp Artificial Intelligence Study
Condition: Software Analysis on Polyp Histology Prediction
MeSH terms: Polyps
Study type: Observational

Summary: 
      Background We are developing artificial intelligence based polyp histology prediction (AIPHP)
      method to automatically classify Narrow Band Imaging (NBI) magnifying colonoscopy images to
      predict the non-neoplastic or neoplastic histology of polyps.

      Aim Our aim was to analyse the accuracy of AIPHP and NICE classification based histology
      predictions and also to compare the results of the two methods.

      Methods We examined colorectal polyps obtained from colonoscopy patients who had polypectomy
      or endoscopic mucosectomy. Polyps detected by white light colonoscopy were observed then by
      using NBI at the optical maximum magnificent (60x). The obtained and stored NBI magnifying
      images were analysed by NICE classification and by AIPHP method parallelly. Pathology
      examinations were performed blinded to the NICE and AIPHP diagnosis, as well. Our AIPHP
      software is based on a machine learning method. This program measures five geometrical and
      colour features on the endoscopic image.
    


Intervention name(s): artificial intelligence diagnosis
Intervention type(s): Other
Intervention description(s): artificial intelligence prediction of colorectal polyp histology
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with symptoms of colorectal polypoid laesions, colorectal cancer screening
        patients
Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and
      effective in reducing the amount of narcotic pain medication needed to control pain during
      the first 24 hours after abdominal hysterectomy surgery.
    

Detailed description: 
      Hysterectomy is the second most common surgery among women in the United States (US).
      According to the National Center for Health Statistics, there were 617,000 hysterectomies
      performed in the US in 2004. Effective postoperative pain management after hysterectomy is
      important in ensuring that surgical subjects have a smooth and successful recovery after
      their operation. Morphine and other narcotic pain medications are often used to help control
      pain after hysterectomy, but the large quantities required can lead to fatigue, nausea and
      vomiting, as well as the inability to walk around much because of drowsiness. Reducing
      narcotic pain medication use can reduce these negative side effects.

      Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile.
      Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin
      flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When
      inserted into a surgical site, the collagen breaks down and bupivacaine is released at the
      site but very little is absorbed into the blood stream. The high levels of bupivacaine at the
      surgical site may result in less pain for several days after surgery.

      This study will compare the amount of narcotic pain medication required after surgery in
      patients who receive the CollaRx Bupivacaine implant, a plain collagen implant or no implant
      at all.
    

Intervention name(s): Bupivacaine Collagen Sponge (CollaRx®); placebo
Intervention type(s): Drug; Drug
Intervention description(s): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.; The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
Other intervention name(s): CollRx Bupivacaine Implant
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Post Operative Pain; Hysterectomy
Strados System at Center of Excellence
Condition: Copd; Asthma; Covid19
Study type: Observational

Summary: 
      Listening to breath sounds with the stethoscope/auscultation is used by pulmonary physicians
      in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic
      testing to admit, follow and discharge patients from hospital. Of these, only auscultation
      routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown
      that for more than a decade, readmission after discharge for an exacerbation of COPD or
      severe asthma (or chronic heart failure) remains a major problem. The Strados System has been
      designed to extend the range of lung sound recording both geographically and temporally to
      improve the standard of care when access to continuous monitoring has been replaced by
      periodic or no monitoring. The primary purpose of this study is to assess the clinical
      utility of the Strados System in enabling periodic recording and reviewing of breath sounds
      in patients with chronic respiratory diseases, either in the ICU, or in less continuously
      monitored settings, including after inpatient discharge.
    


Intervention name(s): RESP
Intervention type(s): Device
Intervention description(s): The RESP device will be placed on the patient for periodic recording of auscultory sound.
Other intervention name(s): Strados System
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are admitted for exacerbation of chronic airway disease (COPD or severe
        asthma) or for respiratory distress symptoms associated with SARS-COV-2 infection for 1 to
        3 weeks to ICU or specialty floor with access to telemedicine monitoring
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox
      vaccine ALVAC-HIV MN120TMG (vCP205) versus control followed by boost with rgp120/HIV-1 SF2
      vaccine in HIV-negative volunteers.

      Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic
      T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can
      produce immunological responses comparable to those obtained in other trials of ALVAC-HIV
      vCP205.
    

Detailed description: 
      Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic
      T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can
      produce immunological responses comparable to those obtained in other trials of ALVAC-HIV
      vCP205.

      Volunteers are randomized to receive immunization with either ALVAC-HIV vCP205 or ALVAC-RG
      rabies glycoprotein (vCP65) at days 0, 7, 14, and 21, followed by boost with rgp120/HIV-1 SF2
      at days 28 and 84. A third cohort receives ALVAC-HIV vCP65 on the same schedule followed by
      boost with placebo.
    

Intervention name(s): ALVAC-HIV MN120TMG (vCP205); ALVAC-RG Rabies Glycoprotein (vCP65); rgp120/HIV-1 SF-2
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: polysaccharide-K
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; Avipoxvirus; HIV Preventive Vaccine
Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency
Condition: Iron-deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      The study evaluates the efficacy and safety of >Your< Iron Syrup, a novel iron-containing
      dietary supplement, in the management of dietary iron deficiency in children. The study is a
      randomized, double-blind, placebo-controlled intervention conducted in 16 research centers in
      Slovenia, collectively enrolling 92 eligible children. Eligibility of children for
      participation in the study will be determined by screening for hemoglobin and ferritin
      (combined with C-reactive protein) levels in a sample of capillary blood. Eligible children
      will receive basic dietary advice on how to increase the consumption of dietary iron and will
      be invited to participate in the study. Enrolled children will be randomized to either >Your<
      Iron Syrup arm or to placebo arm in a 3:1 ratio, respectively. Changes in body iron stores
      (ferritin) and in hematological indices as well as occurence of any adverse events will be
      monitored after 4 and 12 weeks of once-daily supplementation with either >Your< Iron Syrup or
      placebo.
    


Intervention name(s): >Your< Iron Syrup; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Once daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks; Once daily dose of placebo syrup for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Iron Supplement; Iron Deficiency; >Your< Iron Syrup
Immunity Duration of Rabies Vaccine and Booster Dose Effects at 10 Years Post-primary Vaccination
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional

Summary: 
      A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua
      Biological Products Co.,Ltd is used to prevent human rabies. The vaccine was completed in the
      Phase III clinical trial from August 2008 to February 2009 in Lianshui County, Jiangsu
      Province (Approval of Drug Clinical Trial No. 2008L03156). A total of 1200 subjects aged
      10-60 years were randomly assigned trial group (Kanghua vaccine group, 600 participants) and
      control groups (Pasteur vaccine group, 600 participants). The result showed that this vaccine
      could provide good immunogenicity and mild adverse reactions. On April 28, 2012, the drug
      registration approval was obtained (Approval No. 2012S00222).

      To disclose the effects of booster immunization of human diploid cell rabies vaccine (HDCV)
      after eight years of primary vaccination. Sixty subjects who had participated the phase Ⅲ
      clinical trial of freeze-dried HDCV were selected and given booster immunization after eight
      years of primary vaccination. The result showed that the freeze-dried HDCV has good immune
      effects with one-dose of booster immunization after eight years of primary vaccination． In
      order to find a ten years of immunization persistence and booster dose immune effect, the
      investigators decided to perform this immunization persistence and booster immunity trial
      among these subjects who had received five doses of rabies vaccine vaccines (around ten years
      after the fundamental immunity). The investigators do the recruitment among these subjects
      who had participated in the previous phase Ⅲ trail and the subjects were divided into two
      layers, such as trial group (Kanghua vaccine group) and the control group (Paste vaccine
      group). Each layer of the subjects randomly received one booster dose (Day 0) and two booster
      doses (Day 0, 3) the freeze-dried HDCV in a ratio of 1:1.
    


Intervention name(s): Chengdu Kanghua (one booster shot); Chengdu Kanghua (two booster shots)
Intervention type(s): Biological; Biological
Intervention description(s): A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0; A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0 and 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention