bioihbjkbjnl/mcl2 huggingface dataset:
Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers
Condition: Muscle Strength; Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce
      the number of subjects with impaired muscle strength following adductor canal block. We
      hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps
      strength compared with an adductor canal block with 30 ml.
    


Intervention name(s): Adductor canal block with ropivacaine 0.1%
Intervention type(s): Procedure
Intervention description(s): US-guided adductor canal block
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adductor canal block; healthy volunteers; US-guided peripheral nerve block; lower limb
A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
Condition: Ocular Hypertension; Open Angle-glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to compare the safety, tolerability, and mean change
      from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to
      latanoprost 0.005% following ocular instillation once every evening for 28 days.
    


Intervention name(s): ONO-9054; Latanoprost
Intervention type(s): Drug; Drug
Other intervention name(s): Xalatan®
Intervention MeSH terms: Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-9054; ocular hypertension (OHT); Open angle-glaucoma (OAG); Glaucoma; Eye Diseases; Mild to moderate
Sensory Integration Versus Fine Motor Intervention in Children With Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Clinically, infants with Autism spectrum often display gross motor delays in supine, prone,
      and sitting skills in their first year of life.
    


Intervention name(s): fine motor skills; sensory integration
Intervention type(s): Other; Other
Intervention description(s): stretching and strengthening exercises in addition to exercises to enhance fine motor skills; Tactile stimulation
Proprioceptive stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Quality of life; sensory integration; fine motor skills
Prevention of Preterm Birth With a Pessary in Twin Gestations
Condition: Premature Birth; Short Cervix
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall
      perinatal mortality. Twins are at increased risk for PTB. The number of twins births has
      risen substantially due to the increased use of assisted reproductive technology. The rate of
      twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and
      2004. The increased rate of PTB in twins is associated with increased morbidity and mortality
      rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United
      States are twins, as are one in six infants who die in the first month of life. Cervical
      shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length
      is a reliable screening test for prediction of PTB. There is currently no effective treatment
      to decrease the incidence of PTB in women with twin gestations, but there is some evidence
      that the use of a cervical pessary in women with a short cervix has promise. If effective
      this approach would be particularly appealing because of the wide availability of pessaries,
      ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm
      effectiveness; a well designed, properly powered, prospective randomized trial is warranted
      prior to widespread implementation in clinical practice. We propose such a trial to study the
      effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia
      population.
    


Intervention name(s): Bioteque cup pessary
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Premature birth; Premature delivery; Short cervix; Pessary
Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM"
Condition: Invasive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This is a prospective examination of tumor material of breast cancer patients randomized into
      the FinHer-trial (= (= Comparison of vinorelbine and docetaxel and trastuzumab as adjuvant
      treatments of breast cancer patients wirh a high risk of cancer recurrence).

      The formalin-fixed, paraffin-embedded tissue samples will be analysed for Estrogen receptor 1
      (ESR1), progesterone receptor (PgR), Human epidermal growth factor receptor 2 (HER2) and
      Antigen Ki-67 (Ki-67) with the molecular in vitro diagnostic kit MammaTyper™.

      According to the new subtyping the 5 year Distant disease free survival (DDFS) and Overall
      survival (OS) will be re-evaluated.
    

Detailed description: 
      Despite the fact that reliable measures for the markers ESR1, PgR, HER2, Ki-67 are necessary
      with the currently used methods up to 20% of determinations are inaccurate and especially
      Ki67- measures are not very reproducible. Therefore new evaluation systems or new methods are
      necessary to improve diagnostic.

      At least 4 subtypes can be distinguished to date depending on the expression of ESR, PgR,
      Her2 and Ki-67:

        -  Luminal A-type

        -  Luminal B-type

        -  Her2-type

        -  Triple-negative-type

      MammaTyper™ uses a new approach. Instead of detection of the marker proteins, the messenger
      ribonucleic adic (mRNA) of marker proteins is quantitated. This prospectively planned
      diagnostic study will investigate the potential of subgrouping of patients at baseline
      according to results of MammaTyper™ methodology for predicting survival.

      Patients will be subgrouped according to the new marker determination and the DDFS and OS
      will be evaluated and compared to the DDFS and OS of subgrouping with former marker
      determination.
    

Intervention name(s): MammaTyper™
Intervention type(s): Device
Intervention description(s): MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Subtyping of Invasive breast cancer
Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Behavioral intervention at Kindergarten setting aiming at increased fruit and vegetable
      consumption, decreased intake of high energy foods, snacks, sweets, increased intake of
      water/low energy drinks, decreased intake of high energy drinks. Physical activity should be
      more than 1 hour/day and TV/media consumption less than 1 hour/day.

      Main questions are:

      Do children differ in intervention and control kindergartens according to their nutrition
      behaviour? Do children in the intervention kindergartens have a higher physical training than
      such in the control kindergartens? Data were collected with a standardised questionnaire.

      Do children differ in intervention and control kindergartens according to their body mass
      index?
    

Detailed description: 
      The program is based on actual cognitions and methods of the early education science. In the
      initial phase study part I (2003-2006) we will study over three years in 75 kindergartens of
      four administrative districts in Bavaria, Germany: Bamberg, Günzburg, Ingolstadt and
      Schwandorf.

      The objective of the study part II is to evaluate the effects of the TigerKids intervention
      program on overweight prevalence in childhood. Data concerning BMI, nutrition behavior and
      physical activity are assessed both at baseline (September/October 2007) and after 10 months
      intervention in > 450 control- and intervention-kindergartens in Bavaria.
    

Intervention name(s): attitude change; adiposity prevention program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): TigerKids: setting based prevention program to reduce obesity risk factors in children; The behavioral intervention aimed at modifying physical activity and food and drink choices at the kindergarten setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: infant; kindergarten; obesity; adiposity
Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at the pharmacokinetics of a new formulation of
      deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.
    

Detailed description: 
      This is a single-center, open-label, randomized, 4-period crossover study of the
      pharmacokinetics of a new formulation of deferiprone, delayed release tablets in twenty
      healthy volunteers. In each study period, blood samples for pharmacokinetics assessment will
      be collected pre-dose and over 24 hours post-dose. Safety will be assessed throughout the
      study.
    

Intervention name(s): Deferiprone delayed release tablet formulation; Deferiprone oral solution
Intervention type(s): Drug; Drug
Intervention description(s): Deferiprone 600 mg delayed release tablet formulation; Deferiprone 100 mg/mL oral solution
Other intervention name(s): Deferiprone; Ferriprox
Intervention MeSH terms: Deferiprone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: deferiprone; deferiprone delayed release formulation; pharmacokinetics
Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions Laparoscopic Operations
Condition: Neuromuscular Blockade
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      Neuromuscular block improves operation conditions during laparoscopic surgery. In this study,
      a new measurement tool is assessed: the degree of abdominal distension during the time course
      of the neuromuscular block is measured and compared with a standardized score (surgical
      rating score).
    


Intervention name(s): measuring tape; neuromuscular block; Surgical rating score
Intervention type(s): Other; Other; Other
Intervention description(s): measurement of change in abdominal wall length [cm] during neuromuscular block with a measuring tape.; Measurement of the time course of the neuromuscular block: neuromuscular transmission is measured by assessment of the post tetanic count and the train of four ratio using acceleromyography (TOF Watch SX™, Essex Pharma GmbH, Munich, Germany) at the right adductor pollicis muscle with transcutaneous Ag/AgCl electrodes (electrocardiogram electrodes; Ambu Inc., MD 21060 USA);; assessment of operating conditions by means of a standardized score: surgical rating score:
extremely poor conditions
poor conditions
acceptable conditions
good conditions
optimal conditions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kanitinib in Treating Patients With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety , tolerability, pharmacokinetics of
      Kanitinib and determine the optimal dose in patients with recurrent or metastatic solid
      tumors.
    

Detailed description: 
      Evaluation of recurrent or metastatic solid tumor patients on Kanitinib single dose and
      continuous multiple dose safety and tolerability, and to determine the maximum tolerated
      Connie imatinib dose (MTD) or the phase II trial recommended dosage.
    

Intervention name(s): Kanitinib
Intervention type(s): Drug
Intervention description(s): Oral administration of Kanitinib tablets.
Other intervention name(s): CX1003
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Is Masseteric Nerve Block Effective in Myofascial Pain
Condition: Myofascial Pain - Dysfunction Syndrome of TMJ; Myofascial Trigger Point Pain; Local Anesthesia
MeSH terms: Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The aim of the present study was to compare the efficacy of three different treatment methods
      in the management of myofascial pain: masseteric nerve block (MN), trigger point
      injection(TrP) with local anesthetic (LA) and dry needling (DN).Study Design: 45 subjects
      aged 18-54 years were randomly assigned to the MN group (n= 15), LA group (n=15) and DN group
      (n=15).
    

Detailed description: 
      The study sample consisted 45 patients with masseter muscle originated myofascial pain, were
      selected in accordance with the following criteria:

      Patients were grouped according to the treatment they received: dry-needling (DN), TrP
      injections with local anesthetic (LA) and masseteric nerve block (MNB). Localization of the
      masseteric trigger points (MTPs) was based on clinician's sense and patients' expressions of
      pain. Local twitch response was not observable in all case. This procedure was completed by
      using digital palpation (1.5 Kg), and the clinical examiner's palpation was calibrated using
      a pressure algometer.
    

Intervention name(s): masseteric nerve block; trigger point injection; dry needling
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): regional bloc of masseter; trigger point injection with local anesthetic; needling with acupuncture needles of trigger points in masseter
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized parallel controlled
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; injections; anesthetics
The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be
      exposed to pollen and their symptoms observed.
    


Intervention name(s): PF-03654764; Allegra; PF-03654764; Allegra-D; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-03654764 single dose 5 mg; Fexofenadine single dose 60 mg; PF-03654764 single dose 5 mg; Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose; Placebo single dose
Intervention MeSH terms: Fexofenadine; Terfenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinitis Environmental exposure unit
Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety
      of BI 144807.
    


Intervention name(s): Ketoconazole; BI 144807; BI 144807
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ketoconazole 400 mg / day; BI144807 oral solution, intermediate dose; BI144807 oral solution, intermediate dose
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Cefzil 250 mg/5 ml oral suspension fed
      conditions.
    


Intervention name(s): Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria); Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cefprozil; Cephalosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic
Recording Methods of Muscle Activity "Onset".
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Delayed anticipatory muscle activity response in deep low back and abdominal muscles has been
      observed in patients with low back pain, indicative of a pathological condition. Muscle
      activity onset is traditionally recorded by intramuscular electromyography, but there is a
      need for a less cumbersome recording method in large clinical studies. The purpose of this
      experimental study is to explore whether high-frame rate m-mode ultrasound and tissue
      velocity imaging could measure anticipatory muscle responses ("onset") in the abdominal
      muscles reliably and comparably accurate to intramuscular EMG.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy men and women between 30-65 yrs with no recent low back pain
      
Keywords: Low back pain; Neuromuscular control; Anticipatory motor control; Musculoskeletal Physiologic Processes; Muscle, Skeletal; Ultrasonography; Electromyography
Vibration in Boys With a History of Fracture
Condition: Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Boys aged 9-12 years, with a history of facture will be asked to stand on one of two
      vibrating platforms for 10 minutes on 5 consecutive days. The investigators will take blood
      samples before and after the vibration to measure changes in the bone cells.
    

Detailed description: 
      Fractures in children are common, accounting for 10% of attendances in Accident and Emergency
      Departments. Research into risk factors for fracture has found that children who have
      narrower bones and a low bone mass are more likely to fracture than children with larger
      bones. Studies in postmenopausal women, young women with low bone mass and children with
      disabling conditions such as cerebral palsy, have shown that up to 10 minutes a day stood on
      a vibrating platform can significantly increase bone mass.

      However little is known of the immediate response of bone to whole body vibration (WBV). The
      investigators previously investigated the acute bone response in healthy pre-pubertal boys to
      standing on one of two vibrating platforms for 10 minutes on 1, 3 or 5 consecutive days. This
      showed a platform dependent reduction in the bone resorption marker CTx pre to post
      vibration, with an increase in the bone formation marker P1NP over the 8 day study. The
      investigators would like to look at the response of bone to WBV in pre-pubertal boys who have
      a history of fracture(s). The investigators will compare this to the investigator's previous
      data to determine if bone in boys who have previously fractured responds in the same way as
      bone in boys who have not.

      The investigators plan to recruit 24 boys aged 9-12 years who have had a previous fracture to
      stand on one of two vibrating platforms for 10 minutes on 5 consecutive days. Before and
      after the period of vibration on days 1, 3, 5, and on days 8 and 12 the investigators will
      take a blood sample to measure changes in the bone cells. The boys will be asked about the
      amount of exercise they have participated in over the previous seven days. The findings of
      this study will be used to direct further research.
    

Intervention name(s): vibrating platform
Intervention type(s): Device
Intervention description(s): Use of two different types of vibrating platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis
Condition: Pain; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit
      of Tramadol OAD tablets versus Placebo.
    


Intervention name(s): Tramadol Once a day; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Normative Assessment of Adaptable Mouthguards.
Condition: Oral Manifestations
MeSH terms: Oral Manifestations
Study type: Interventional

Summary: 
      The aim of this study is to the validate adaptable mouthguards prototypes, patented by
      Bordeaux University and Bordeaux University Hospital.
    

Detailed description: 
      The current state of knowledge in the areas of mouthguards shows that type II (adaptable)
      models account for 90% of the mouthguards of the sporting population. But a majority of these
      devices do not appear to comply with the European Directive 89/686 / European Economic
      Community.

      A previous work consisted of the production of prototypes of mouthguards meeting the
      essential requirements of the directive. These prototypes were the subject of a patent filed
      by the Bordeaux University and the Bordeaux University Hospital.

      The aim of this study is to the validate the prototypes for a future launch on the market.
    

Intervention name(s): Adaptable mouthguards
Intervention type(s): Device
Intervention description(s): Validate a prototype of Adaptable Intra-Oral Protections patented by Bordeaux University and Bordeaux University Hospital according to 3 levels (ventilation, comfort, cervical muscle activity).
Intervention model: Single Group Assignment
Intervention model description: Single
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Prototype; Adaptable mouthguards