bioihbjkbjnl/mcl2 huggingface dataset:
Retromolar Route Access With and Without A Retromolar Gap
Condition: Airway Management
Study type: Interventional

Summary: 
      Retromolar Intubation is a successful option for intubation in patients with an existing
      retromolar gap in the case that the conventional method fails.

      Therefore the investigators want to test if the retromolar gap is essential for performing
      the retromolar intubation technique.
    

Detailed description: 
      For successful endotracheal intubation an optimal visualisation of the vocal cords is
      essential. A study comparing retromolar and conventional laryngoscopy showed in patients with
      an existing retromolar gap, that the retromolar technique is superior for endotracheal
      intubation especially in patients with a failed 'conventional' intubation attempt. The aim of
      the following study is to test if a retromolar gap at the right mandible is necessary for the
      successful performance of the retromolar laryngoscopy technique.

      Therefore, 20 patients with and 20 patients without a retromolar gap will be investigated.

      The anesthesiologist will visually determine the view of the vocal cords and score it
      according to Cormack & Lehane. For an improved view a backward, upward, right-ward pressure
      (BURP) will be performed, if needed, and scored again.

      Finally, endotracheal intubation will be performed by the 'conventional' intubation method.
      If, however, intubation is not possible, then the retromolar technique will be used. In the
      case that both methods fail, then any (other) intubation method will (can) be used.
    

Intervention name(s): Retromolar laryngoscopy and scoring of the visualisation of the vocal cords according to Cormack & Lehane
Intervention type(s): Procedure
Intervention description(s): To facilitate the insertion of the straight blade laryngoscope (Miller #4) the head of the patient will be turned to the left side. The blade will be inserted and then pushed laterally rightwards until the retromolar space will be finally reached. Thereafter the epiglottis will be lifted up in order to achieve the best direct view to the vocal cords and scored according to Cormack & Lehane .
This score will be assessed at least 2 minutes after muscle relaxation:
Once without a backward, upward, rightwards pressure maneuver (=BURB) and immediately thereafter (i.e. 5-10 seconds later):
If 100% visualization of the vocal cords is not possible a BURP maneuver will be performed and the scored again.
Intubation will then be performed by the conventional method using a Macintosh blade #3. In the case that intubation with the conventional method is not successful the retromolar technique will be used.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Retromolar Intubation
The Effect of Visual Input in Athletes With Chronic Ankle Instability
Condition: Ankle Injuries
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of neuromuscular training on balance by
      using stroboscopic glasses in athletes with chronic ankle instability.
    

Detailed description: 
      Lateral ankle sprain (LAB) is one of the most common musculoskeletal injuries of 15% of all
      injuries reported in all sports.Chronic ankle instability (CAI) is characterized by life-long
      persistent symptoms in 40% of people with recurrent LAB sprain.

      It has been reported that there is a change in sensorimotor function in the activity of
      individuals with CAI, and they are more dependent on visual information in balance parameters
      on one leg.While the somatosensory input was clinically feasible; The obstruction of the
      visual input has been limited in two ways, the eyes being fully open or fully
      enclosed.However, this changing dynamic has provided a means for the prevention of visual
      input during more sporty maneuvers, to directly reach compensatory neuroplastic sequelae
      after injury and to function in a functional way to train the neuromuscular system.This
      technological innovation makes this possible by reducing the visual input without completely
      eliminating it.This innovation, called stroboscopic goggles technology, provides a mechanism
      to disrupt to any degree between eyes closed and open in the visual system.

      Stroboscopic vision, characterized by intermittent vision obstruction, can be a clinical tool
      that allows clinicians to study sensory feedback in a progressive manner without fully seeing
      visual information. So use stroboscopic goggles to prevent visual information, you can
      improve the functionality by emphasizing the somatosensor information.In particular, visual
      manipulations can significantly influence the healthy adult electrocortical dynamics and
      balance control by triggering the contradiction between visual adult, vestibular and
      proprioceptive inputs.

      The aim of this study, which was planned for this purpose, will be to evaluate the effects of
      neuromuscular exercises performed on stroboscopic environment on equilibrium, neural feedback
      and running mechanics.
    

Intervention name(s): Neuromuscular Training; Strobe Glasses
Intervention type(s): Other; Other
Intervention description(s): The experimental group will perform neuromuscular exercise for 6 weeks.
The other experimental group will perform neuromuscular exercises with strobe glasses.; Stroboscopic glasses, which is characterized by intermittent vision obstruction, is a clinical tool that allows clinicians to examine sensory feedback in a progressive manner without fully seeing visual information.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: balance; chronic ankle instability; function; running
Pharmacokinetic Study of the HCV Protease Inhibitor Boceprevir and the HIV Integrase Inhibitor Raltegravir
Condition: HIV Infections; HCV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of boceprevir (steady state) on the
      pharmacokinetics of a single dose of raltegravir. The effect on the boceprevir
      pharmacokinetics of a single dose raltegravir will also be evaluated (compared to historical
      controls). Furthermore, the safety profile of the combination is studied.
    

Detailed description: 
      A considerable percentage of HIV infected patients is also infected with the hepatitis C
      virus (HCV). HIV/HCV co-infected patients are likely to simultaneously use treatment for
      their HIV infection as well as HCV treatment. Therefore, it is important to know if drug-drug
      interactions occur when combining those treatments.

      Raltegravir is an HIV integrase inhibitor and approved by the FDA in 2007. Boceprevir is a
      potent HCV NS3 serine protease inhibitor and is currently in Phase III clinical development.

      Combined use of boceprevir and raltegravir is not expected to give a major drug-drug
      interaction as raltegravir is not a CYP3A substrate and thus will not be affected by the
      strong inhibition of CYP3A by boceprevir. Raltegravir is metabolized by UGT but boceprevir is
      not known to influence UGT. However, recent data indicate that raltegravir is a P-gp
      substrate and boceprevir is a substrate and a moderate inhibitor of P-gp in vitro.

      Even when no drug interaction is expected, it may be recommended to collect sufficient
      evidence that this is the case as in many cases un-expected drug-drug interactions have been
      observed in the past.

      The current study is designed to evaluate the effect of steady state boceprevir on the
      pharmacokinetics of a single dose of raltegravir and the safety profile when used in
      combination. Furthermore the effect of a single dose raltegravir is studied on the
      pharmacokinetics of steady state boceprevir in comparison with historical controls.
    

Intervention name(s): boceprevir; raltegravir
Intervention type(s): Drug; Drug
Intervention description(s): 10 days of boceprevir 800mg TID; raltegravir 400mg single dose
Other intervention name(s): Isentress
Intervention MeSH terms: Raltegravir Potassium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV infections; HCV infections; interaction; pharmacokinetics; raltegravir; boceprevir
A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fasting Condition
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioequivalence study comparing valacyclovir
      hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX®
      caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy,
      adult, male, human subjects under fasting condition.
    

Detailed description: 
      Following an overnight fast of at least 10 hour, a single oral dose of valacyclovir
      hydrochloride 1 gram of either test or reference investigational product was administered
      during each period of the study, along with 240 mL of drinking water at ambient temperature
      under low light condition and under supervision of trained study personnel. Both test and
      reference products were administered to all the study subjects, one in each period (except
      subject numbers 04, 21 and 27 who dropped out from the study).

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Adverse event monitoring was done
      throughout the study. Laboratory parameters of hematology and biochemistry (except blood
      glucose and cholesterol) were repeated at the end of the study.
    

Intervention name(s): Valacyclovir hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Valacyclovir hydrochloride fasting study
Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the safety, pharmacokinetics and food effect of
      DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants.

      DS102 capsules will be orally administered for up to 4 weeks, and will be compared against
      placebo.

      The study will enrol approximately 56 adult subjects.
    

Detailed description: 
      There will be 7 cohorts enrolled, each consisting of 8 subjects.

      Cohorts 1 - 4 will be orally administered up to 2000mg single doses of DS102 on Day 1.

      Cohorts 5 - 7 will be orally administered up to 2000mg multiple daily doses of DS102 for 28
      days.

      The primary objective is to assess the safety and plasma pharmacokinetics of single and
      multiple daily oral doses of DS102.
    

Intervention name(s): DS102; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Safety; Pharmacokinetics; Food Effect
A Reliability and Validity Study of Urdu Version of Lysholm Knee Scoring Scale.
Condition: Anterior Cruciate Ligament Injuries
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      The study will be intended to translate and check if the Urdu Version of Lysholm Knee Scoring
      Scale is reliable and valid in the Pakistani patients with anterior cruciate ligament
      injuries.
    

Detailed description: 
      A detailed research will be conducted on nearly 100 patients after ethical approval from the
      Ethical Review Board of Riphah International University Faisalabad Campus. A total of 100
      patients with Anterior Cruciate Ligament injuries will be selected from different areas of
      community and rehabilitation centers. Informed consent will be taken from each patient. The
      tool will be used three times in the same Pakistani population with Anterior Cruciate
      Ligament injuries to check inter and intra-observer reliability of the final Urdu-LKS. The
      Lysholm questionnaire translation will be carried out in 6 steps by the guidelines of the
      early researches and the Consensus-based Standards for the selection of health Measurement
      Instruments standard. Statistical Package of Social Sciences 23 will be employed to do data
      analysis.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pakistani population with anterior cruciate ligament injuries was included in the study.
      
Keywords: Lysholm Knee Scale; Anterior Cruciate Ligament Injuries; Knee disorders; Validity; Urdu Version; Reliability; Arthroscopic Knee
N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation for Gastric Variceal Hemorrhage
Condition: Gastric Variceal Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to test the hypothesis by comparing the efficacy of
      cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute GVH in liver
      cirrhotic patients with or without concomitant hepatocellular carcinoma (HCC).
    

Detailed description: 
      Gastric variceal hemorrhage (GVH) has a poorer prognosis than esophageal variceal hemorrhage.
      However, data on its optimal treatment are limited. We designed a prospective study to
      compare the efficacy of endoscopic band ligation (GVL) and endoscopic N-butyl-2-cyanoacrylate
      injection (GVO). Liver cirrhotic patients with or without concomitant hepatocelluar carcinoma
      (HCC) and patients presenting with acute GVH were randomized into two treatment groups.
      Forty-eight patients received GVL, and another 49 patients received GVO. Both treatments were
      equally successful in controlling active bleeding (14/15 vs. 14/15, P = 1.000). More of the
      patients who underwent GVL had GV rebleeding (GVL vs. GVO, 21/48 vs. 11/49; P = .044). The
      2-year and 3-year cumulative rate of GV rebleeding were 63.1% (95% confidence interval [CI],
      44.5%-81.7%), 72.3% (95% CI, 51.3%-93.3%) for GVL and 26.8% (95% CI, 12.5%-41.1%), 26.8% (95%
      CI, 12.5%-41.1%) for GVO; P = .0143, log-rank test. The rebleeding risk of GVL sustained
      throughout the entire follow-up period. Multivariate Cox regression indicated that
      concomitance with HCC (relative hazard: 2.453, 95% CI: 1.036-5.806, P = .041) and the
      treatment method (GVL vs. GVO, relative hazard: 2.660, 95% CI: 1.167-6.061, P = .020) were
      independent factors predictive of GV rebleeding. There was no difference in survival between
      the two groups. Severe complications due to these two treatments were rare. In conclusion,
      the efficacy of GVL to control active GVH appears to have no difference with GVO, but GVO is
      associated with a lower GV rebleeding rate.
    

Intervention name(s): cyanoacrylate injection to treat gastric variceal hemorrhage
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric varices; liver cirrhosis; hepatocelluar carcinoma; rebleeding; long-term
Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)
Condition: Aneurysmal Subarachnoid Hemorrhage; Hydrocephalus; Cerebral Vasospasm
MeSH terms: Subarachnoid Hemorrhage; Hydrocephalus; Vasospasm, Intracranial; Hemorrhage
Study type: Observational

Summary: 
      In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH)
      increase with age. In patients older than 70 years, the occurrence of SAH exposes them to
      high risk of morbidity and a poor quality of life.

      In this age bracket, the single randomized which compared endovascular coiling to
      microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased
      after coiling. Moreover, some prospectives studies about endovascular coiling described
      favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a
      procedural complication rate in 13% to 19%. From prospectives series, the proportion of
      favorable outcome after microsurgical clipping was estimated around 66% but the procedural
      complications are few reported. The outcome for patients treated conservatively was
      catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of
      patients.

      The study hypothesis is that, in this age class, no difference exists between the 2
      obliteration procedures.

      An accurate evaluation of result in term of functional disability, quality of life and
      prognosis predictive factors seems a judicious question.
    

Detailed description: 
      The aim of our study was to determine a significant difference in terms of functional
      disability between microsurgical clipping and endovascular coiling in the elderly population.

      Randomized multicenter trial: 2 randomized arms (clipping and coiling) plus 3 observational
      prospective arms (clipping, coiling, conservative).

      Inclusion time: 48 months. Follow up: 12 months. Monitoring: 6 months. Duration of the trial:
      66 months. Major end point: proportion of patients with unfavourable outcome at 12 months
      (mRS > 2).

      Secondary end point: Quality of life at 12 months (EORTC scale), causes of morbidity (mRS >
      2) and mortality, Dysautonomia according to the ADL and IADL scales.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary cara clinic in differents countries of France
      
Biospecimen description: 
      2 randomized arms (clipping and coiling) and 3 prospective observational arms (clipping,
      coiling, conservative) For the randomized arms, we anticipated 20 patients in each arm.
    
Keywords: Subarachnoid hemorrhage; Cerebral aneurysm; Elderly
Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma
Condition: Oral Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Observational

Summary: 
      This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in
      oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an
      example of oral potentially malignant lesions) and normal individuals, and to show its
      relation to miR-106a. A total of 36 participants were included.
    

Detailed description: 
      This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in
      oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an
      example of oral potentially malignant lesions) and normal individuals, and to show its
      relation to miR-106a. A total of 36 participants were included, subdivided into 3 groups:
      Group I: 12 patients diagnosed with OSCC. Group II: 12 patients diagnosed with OLP. Group
      III: 12 systemically free individuals with no oral mucosal lesions. statistical analysis and
      ROC analysis were performed
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        - patients recruited from the outpatient clinic of departments of oral diagnosis and
        medicine and periodontology Fayoum, Beni-Suef and Ahram-Candian universities
      
Biospecimen description: 
      saliva
    
Keywords: Oral squamous cell carcinoma, oral potentially malignant disorders, saliva, LINC00657, miR-106a.
Effect of BIBW 2948 BS in COPD
Condition: Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic
MeSH terms: Bronchitis; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis
    


Intervention name(s): BIBW 2948 BS; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule; Capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population
Condition: Pain; Surgery
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Objective: This study was conducted to explore the possible correlation between some gene
      related to pain sensation and individual basal pain perception and postoperative pain
      intensity in the general population. Methods: Patients receiving elective surgery under
      general anesthesia were recruited into this study. The investigators measured their
      preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). Pain intensity
      at rest and movement after the operation was evaluated . And the PCA drug consumption were
      recorded. Also there were healthy college students volunteer be recruited into this study.
      The investigators measured their experimental pain sensitivity including pressure pain
      threshold (PPT) and pressure pain tolerance (PTO), etc. Then genotyping was carried out.
    

Detailed description: 
      Subjects with the following diseases were excluded: known history of chronic disease,
      psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular
      diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy
      smoker, Pregnancy or at lactation period .
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        anticipative 500 healthy volunteers and 1000 surgical patients
      
Biospecimen description: 
      Heparin anti-coagulated blood (5 ml) was collected from the periphery venous of subjects and
      all blood samples were stored at -80℃. Genomic DNA was extracted from the blood samples using
      a guanidinium isothiocyanate method.
    
Keywords: gene polymorphism; pain perception; postoperative pain