bioihbjkbjnl/mcl2 huggingface dataset:
Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse
Condition: Female Genital Prolapse
MeSH terms: Prolapse
Study type: Interventional

Summary: 
      Definition: To find out complications, objective and subjective outcomes of patients with
      symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine
      Finnish hospitals during September 2010 and August 2013. The study hypothesis is that
      complications are acceptable and both objective and subjective outcomes are satisfying.
    

Detailed description: 
      The aim of this study is to investigate the safety and efficacy of Elevate®Posterior
      transvaginal mesh kit. Secondly the investigators want to evaluate the effect of this
      surgical method on non-affected anterior vaginal compartment as well as patients' outcome.

      This prospective multicenter national study include patients (n=111) with symptomatic
      posterior vaginal wall with or without apical prolapse with stage II or more. Patients were
      recruited at four university hospitals and five central hospitals in Finland between
      September 2010 and August 2013. The study protocol was approved by the Ethics Committees in
      participating hospitals and all attending patients gave written consent after oral and
      written counseling. Baseline evaluation include standardized gynecological examination in
      supine position using the POP-Q system. Detailed information on patients' characteristics and
      medical history is gathered, focusing on especially gynecological issues. Patients fill in
      Pelvic Floor Distress Inventory (PFDI-20) and Pelvic organ prolapse/urinary Incontinence
      Sexual Questionnaire (PISQ-12).

      The operations are performed by qualified surgeons (n=9) familiar with transvaginal mesh
      surgery. Intraoperative data is collected and immediate postoperative problems are
      registered.

      The first follow-up visit take place at three months postoperatively. Gynecological
      examination with POP-Q measurements are performed and complications documented. As
      preoperatively, PFDI-20 and PISQ-12 questionnaires are filled in by the patients.

      The second visit take place at one year postoperatively. Gynecological examination with POP-Q
      measurements are performed and possible late complications documented. PFDI-20 and PISQ-12
      questionnaires are filled in again by the patients.
    

Intervention name(s): Transvaginal posterior mesh
Intervention type(s): Device
Intervention description(s): A trocar-free fixation system with low-weight mesh
Other intervention name(s): Elevate®Posterior
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Female; Prolapse surgery with transvaginal mesh; Subjective outcome
Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars
Condition: Paediatric; Dentistry
Study type: Interventional

Summary: 
      Objectives: The new approach of pediatric esthetic dentistry intended to achieve a healthy
      beautiful smile rather than achieving only a beautiful smile. The objective of this study was
      to assess the clinical performance of ceramic Endocrowns and Zirconia crowns for the
      restoration of pulpotomized primary molars and parental satisfaction toward these crowns.
      Study design: Randomized clinical trial/split mouth design compared the clinical outcomes of
      two coronal restorations, on patients with bilateral carious second primary molars restoring
      one side with Endocrown (IPS e.max Press) and the other side with zirconia crown. Children
      attended Nahda University; Faculty of Dentistry clinics who need restorations screened for
      inclusion criteria till 20 patients are recruited (20 teeth for zirconia crown restorations
      and 20 for Endocrowns restorations). All children fulfilled the inclusion criteria were
      evaluated for factors including restoration integrity, marginal adaptation, marginal
      discoloration, oral health and overall clinical success at 3,6,12 months while parental
      satisfaction at 12 months follow up..
    


Intervention name(s): Endocrowns
Intervention type(s): Other
Intervention description(s): Adhesive monoblock restoration for pulpotomized primary molars
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aesthetic; Endo-crowns; primary; molars; pulpotomy; zirconium; crowns
A Phase Ia Safety and Tolerability Study of BL-001
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety and tolerability of BL-001 in healthy volunteers for 28 consecutive
      days.
    

Detailed description: 
      This is a Phase 1a randomized, parallel-group, double-blind, placebo-controlled,
      single-center, multiple dose study to evaluate the safety and tolerability of BL-001.
    

Intervention name(s): BL-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Live biological product BL-001; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose safety & tolerability Phase Ia study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Bloom Science; Bloom; BL-001; Microbiome; LBP; Live Biological Product; Live Biotherapeutic Product
Impact of Component Design and Fixation in Total Knee Arthroplasty
Condition: Arthroplasties, Knee Replacement
Study type: Observational

Summary: 
      The purpose of this study is to determine implant design and determine if method of fixation
      cemented versus cementless results in different bone loss patterns. The investigators also
      want to determine if clinical outcomes correlate with bone density changes.
    

Detailed description: 
      Patients who present to the clinical practices of Dr. Ryan Nunley and Dr. Robert Barrack and
      are suitable candidates for primary total knee arthroplasty(TKA) type assigned either
      cemented or cementless and Triathlon knee or Depuy by surgeon will be screened for
      eligibility and invited to participate. Data collected for the study will include standard of
      care clinical and radiographic evaluations collected during office visits and surgery, Dual
      Energy X-Ray Absorptiometry(DEXA) Bone density monitoring, as well as study-specific patient
      questionnaires. Clinical, radiographic and questionnaire data will be collected
      pre-operatively, at the time of surgery, and at 6 weeks, 1 year and beyond, and 2 years and
      beyond post-operatively. Patients will complete the following outcomes questionnaires
      preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and
      EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one
      year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten
      Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee
      Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing.
    

Intervention name(s): Depuy total knee implant; Triathlon total knee implant
Intervention type(s): Device; Device
Intervention description(s): patients from Dr Nunley's clinic will get a Depuy implant; patients from Dr Barrack's clinic will get a Triathlon implant
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A. Patients who qualify for a Primary Total Knee Arthroplasty using Stryker Triathlon
        Implant(thin tray) or Depuy Attune(thick tray) Implant
A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1
      part only.

        -  Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose
           study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A)
           administered orally under fasted conditions in healthy adult participants.

        -  Part 2 will be a randomized, open-label, 2 × 4 crossover study (Periods 1, 2, 3, and 4)
           to evaluate the relative bioavailability (RBA) of Formulation A versus Formulation B
           under fasted conditions and explore safety, tolerability, and PK effects of food on
           Formulation A and Formulation B in healthy adult participants.
    


Intervention name(s): CC-92480; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers; CC-92480; Pharmacokinetics
Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm
Condition: Cataracts
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The aim of this study was to compare the intraoperative efficiency, safety and postoperative
      outcomes of cataract surgery with two different "high-fluidic" settings.
    


Intervention name(s): cataract surgery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Efficacy and Safety
What Are the Effects of Lower Limb Dysmetria on Gluteus Medius and Erector Spinae Musculature?
Condition: Muscular Disorders, Atrophic
MeSH terms: Muscular Diseases; Muscular Disorders, Atrophic
Study type: Interventional

Summary: 
      Gluteus Medius (GM) has also been implicated in the development of LBP. GM is one of the main
      pelvic, where he actively participates in control of motion in the frontal and transverse
      plane, and hip , improving stability to the lumbopelvic-hip complex.

      The aim of present study was to investigate whether modifying lower limb length with a
      different foot insoles of 0.5, 1 and 1.5 cm in a normal population has an effect on ES and GM
      activity and as a consequence in LBP. As a secondary objective, in turn, to evaluate whether
      ES and GM activity has an effect on jumping ability as assessed through CMJ.
    

Detailed description: 
      Background: Lengt leg discrepancy (LLD), regardless of its origin, is a very common pathology
      that can contribute to low back pain. Various authors point out its relationship with the
      lack of acti-vation of both the gluteus medius (GM) and the ipsilateral erector spinae (ES).
      The purpose of this study was to identify the activation of Es and GM with different
      simulated LLD, correlating said activation with the LBP. In turn, to evaluate whether ES and
      GM activity has an effect on jumping ability as assessed through CMJ. (2) Method: a sample of
      healthy subjects was selected to whom an artificial LLD was incorporated through a 0.5, 1 and
      1.5 cm insole, measuring with EMGs in these 3 moments while walking and performing a counter
      movement jump (CMJ). The measurement was carried out in random order, in terms of insole
      height, using a Latin Square. Muscle activation patterns were recorded for 30 seconds at each
      of the insole heights while walking at 5.7 km/h and compared with the maximum voluntary
      contraction (MVC), both on the ipsilateral and contra-lateral sides. These muscles were then
      measured under the same circumstances during the de-velopment of the CMJ. (3)
    

Intervention name(s): To evaluate the response of an orthopedic insole; evaluate activation of musculature
Intervention type(s): Other; Other
Intervention description(s): To evaluate the response of an orthopedic insole of different heights on gait.; To evaluate the response caused by an orthopedic insole of different heights on the indicated musculature.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Low Back Pain; electromyography; Leg Length Inequality; lower limb length
Non-invasive Negative Pressure Treatment for Pectus Excavatum
Condition: Pectus Excavatum
MeSH terms: Funnel Chest
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the non-invasive negative pressure
      treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum
      treatment
    


Intervention name(s): Vacuum Bell
Intervention type(s): Device
Intervention description(s): Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chest wall; Chest, funnel; pectus excavatum; congenital abnormality
The Influence of Atropine on Choroidal Thickness
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 4

Summary: 
      Atropine eye drops are increasingly prescribed for the management of progressive myopia or
      short-sightedness. A previous study suggested that the back of the eye or choroid may be a
      part of the mechanism by which it induces its effects.

      The aim of this study is to characterize the effects of atropine on choroidal thickness and
      the influence of time of administration (am vs pm). It is hypothesized that the atropine's
      effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm,
      where thicker baseline thickness will show a reduced choroidal response.
    

Detailed description: 
      Atropine eye drops are increasingly prescribed for the management of progressive myopia or
      short-sightedness. A previous study suggested that the back of the eye or choroid may be a
      part of the mechanism by which it induces its effects. The choroid shows diurnal variation
      and the efficacy of atropine on myopia control in relationship to the patient's baseline
      choroidal thickness is unknown. Thus, the objective of this study is to provide data to
      characterize the influence of atropine on choroid thickness. The study aims are to:

        1. Determine the effect of am or pm atropine application on choroid thickness

        2. Determine the effect of atropine on choroid thickness in relationship to baseline
           thickness

      Participants will be asked to attend a screening session and 13 study visits. Following the
      screening visit, participants will be scheduled to return for 4 visits across 12 hours (4
      hour intervals starting from 8am) in a single day where eye shape measurements will be taken
      to characterize diurnal variations in eye shape.

      Subjects will then be randomized to receive a drop of 1% atropine eye drops in both eyes in
      the morning or a night. Measurements of the shape of the front and back of the eye will be
      taken after approximately 1, 12, 24 and 96 hours after drop instillation. After a 2 week
      washout period, 1% atropine eye drops will be administered either in the morning or at night
      (the visit that was not previously scheduled) and measurements of the shape of the front and
      back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop
      instillation.
    

Intervention name(s): Atropine Sulfate 1% Oph Soln
Intervention type(s): Drug
Intervention description(s): Atropine sulphate 1% ophthalmic solution is both a mydriatic and cycloplegic
Other intervention name(s): 1% atropine eye drops
Intervention MeSH terms: Atropine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Magnetic Resonance Imaging (MRI) Muscle Phenotyping in Mitochondrial Disease
Condition: Mitochondrial Disease
MeSH terms: Mitochondrial Diseases
Study type: Observational

Summary: 
      The purpose of the study is to use a new research imaging technique, a kind of magnetic
      resonance imaging (MRI), to measure important metabolic features of muscle, including
      mitochondrial function, in people with mitochondrial disease and in healthy individuals.
      (Mitochondria are tiny organelles that generate energy for the body.)

      It is hoped that this new strategy will help physicians to understand better the health
      problems of people with mitochondrial disease. Eventually, this could lead to better
      diagnostic and treatment approaches.
    

Detailed description: 
      There are two study-related visits.

      The first visit is a "screening" visit to ensure eligibility. This includes fasting blood
      tests. The second visit is an MRI scanning session. This also takes around 2 - 3 hours, with
      no more than 1.5 hours spent in the actual MRI machine. It may be possible to complete these
      two visits on the same day. Otherwise, the MRI session should occur within 3 months of the
      screening visit. In addition, an optional physical capacity visit will occur on the same day
      as the MRI session.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Two groups of subjects: 1) mitochondrial disease and 2) healthy individuals
      
Biospecimen description: 
      blood
    
Keywords: mitochondrial disease; magnetic resonance imaging; magnetic resonance spectroscopy; creatine; phosphocreatine
Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity Using Metabolomics
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Identification and evaluation of endogenous markers for the assessment of CYP3A activity
      using metabolomics.
    

Detailed description: 
      Eligibility for participation of this study will be determined from demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 3 weeks before study drug administration. Subjects suitable for this study will be
      admitted to the Clinical Trials Center, Seoul National University Hospital on the day before
      dosing, and they were overnight-fasted from 10 p.m. of Day -1. Urine collection is scheduled
      drug 24 hour before midazolam administration. Subjects will be dosed study drug via
      intravenous around at 9 a.m. of Day 1. Subjects performed scheduled procedures including
      clinical laboratory tests, electrocardiograms and pharmacokinetic samplings. Subjects will be
      discharged on Day 2, and visited Clinical Trials Center on Day 5-7 for ketoconazole
      administration. Subjects will be admitted on Day 7 for period 2. Subjects performed scheduled
      period 2 (ketoconazole co-administration phase), and period 3 (rifampicin co-administration
      phase) procedure. Study participation was terminated on post-study visit (Day 30-32).
    

Intervention name(s): midazolam
Intervention type(s): Drug
Intervention description(s): midazolam: 3mg iv
Other intervention name(s): Bukwang midazolam, Korea
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metabolite profiles; pharmacokinetics; CYP3A; metabolomics
Zoledronate for Osteopenia in Pediatric Crohn's
Condition: Crohn's Disease; Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Background:

        -  Up to 30% of children and adolescents with Crohn's disease have decreased bone strength,
           or decrease bone density, called osteopenia.

        -  Bisphosphonates are a group of drugs that have been well studied and found to be
           effective in the treatment of osteopenia in menopausal women.

        -  Zoledronate is a very potent third generation bisphosphonate, that is safe and easy to
           administer, and has been found effective in the treatment of menopausal women with
           osteopenia.

      Hypothesis: The investigators hypothesize that zoledronate can improve bone density in
      children and adolescents with Crohn's disease with osteopenia.
    

Detailed description: 
      -  This study is recruiting 40 children and adolescents, aged 6 to 18, who have a proven
           abnormal bone density as measured on a special type of x-ray called a DEXA-scan.

        -  Participants are allocated at random to one of two groups: either treatment with
           zoledronate, or a placebo.

        -  Neither the participants or the physicians are aware of which group each participant is
           in.

        -  Participants are followed every three months for one year, and assessed with blood
           tests, urine tests, physical examination, diet questionnaire and exercise questionnaire.

        -  Participants have a repeat DEXA scan at 6 and 12 months after beginning the study.

        -  Once all participants are enrolled and followed for one whole year, we will compare the
           bone density of the group treated with zoledronate with the group treated with placebo.
    

Intervention name(s): zoledronic acid; IV saline infusion
Intervention type(s): Drug; Other
Intervention description(s): Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
Other intervention name(s): zoledronate; zometa
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's disease; Osteopenia; Osteoporosis; Bisphosphonates; Zoledronate