bioihbjkbjnl/mcl2 huggingface dataset:
Right Ventricular Function in Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to determine whether patients with obstructive sleep apnea have
      any changes in right ventricular function evaluated by three dimensional echocardiography.
    

Detailed description: 
      Several studies have reported the association between sleep disorders to an increased risk to
      the development of cardiac disease. However, there is no substantial that about the influence
      of Obstructive Sleep Apnea on the right ventricular function. Objective: to analyse the right
      ventricular function in patients with Obstructive Sleep Apnea by means of Real-Time Three
      dimensional Echocardiography.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Initially, 56 patients with obstructive sleep apnea (OSA) and 50 non-OSA controls underwent
        real-time three-dimensional echocardiography. 30 Patients with moderate and severe OSA
        underwent to continuous positive airway pressure treatment over 6 months. Echocardiogram
        will be repeated on the third and sixth months from the treatment onset.
      
Keywords: Obstructive Sleep Apnea; Right Ventricular Function; Pulmonary Hypertension
Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia
Condition: Secondary Dystonia
MeSH terms: Neoplasm Metastasis; Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      The disability inflected by dystonia encouraged the development of many neurosurgical
      procedures.

      This is a prospective study included 120 patients suffering from intractable secondary
      dystonia.

      They were subjected to different neurosurgical treatments and were assessed through the
      follow up period
    

Detailed description: 
      Background:

      Secondary dystonia are the syndromes that have dystonic symptoms due to brain insult which
      can be associated with neonatal encephalopathy syndromes, trauma, vascular injury,
      infections, demyelinations, or hereditary disorders associated with neurodegenerative
      process. The disability inflected by dystonia encouraged the development of many
      neurosurgical procedures in order to improve the quality of life of these patients.

      The aim of this study was to compare the outcomes of different Neuroablative and modulation
      techniques in treatment of secondary dystonia.

      Patients and methods This is a prospective study included 120 patients suffering from
      intractable secondary dystonia. Ablative techniques included the brain lesioning procedure
      and combined anterior and posterior lumbar rhizotomy (CAPR). Modulation techniques included
      deep brain stimulation (DBS) and intrathecal baclofen therapy (ITB). Patients with focal
      dystonia were included in the Botulinum toxin injection group. Patients with generalized
      dystonia were included in either of the brain lesioning or the deep brain stimulation, and
      patients with predominant affection of both lower limbs were included in either of the (CAPR)
      or the (ITB) groups.

      Assessment measures included the evaluation of the muscle tone, range of motion, and the
      Burke-Fahn-Marsden dystonia rating scale through a follow up period of one year.
    

Intervention name(s): Brain Lesioning; Combined anterior and posterior lumbosacral rhizotomy; Deep brain stimulation; Intra-thecal baclofen infusion
Intervention type(s): Procedure; Procedure; Device; Device
Intervention description(s): Stereotactic radiofrequency lesioning of the pallidum or thalamus; Combined anterior and posterior lumbosacral rhizotomy; Bilateral DBS; Intra-thecal Baclofen infusion
Other intervention name(s): DBS; ITB
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial
Condition: Symptomatic Periapical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      the study was to evaluate the effect of intra-canal cryotherapy on post-endodontic pain and
      interleukin-6 expression in teeth with symptomatic apical periodontitis using different
      irrigation protocols.
    


Intervention name(s): Cryotherapy
Intervention type(s): Other
Intervention description(s): cold application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cryotherapy; Interleukins; Postoperative pain; Sodium hypochlorite
Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood
      glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the
      ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination
      therapy
    


Intervention name(s): Lantus, Amaryl
Intervention type(s): Drug
Other intervention name(s): insulin glargine,glimepiride
Intervention MeSH terms: Insulin Glargine; Glimepiride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Environmental Factors to Increase Patient Comfort During Urodynamics Testing
Condition: Lower Urinary Tract Symptoms; Urologic Diseases
MeSH terms: Urologic Diseases; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      Urodynamics is a comprehensive study of the lower urinary tract. Although the information
      obtained from urodynamics answers several questions and assists in guiding therapies for
      patients, the testing environments is unnatural and may be distressing for patients. This may
      impact the results of the study, as it is not uncommon for patients to be unable to void for
      the test due to their distress. Often to alleviate the distress, music or soothing noises are
      used in the background. The study aims to identify simple environmental factors which may
      improve patient experience with urodynamic testing. The population will include patients with
      existing appointments for urodynamics testing at the Mayo Urology Clinic. The investigators
      plan to assess patient satisfaction and comfort during this assessment using a visual analog
      scale questionnaire. The environmental variables will include music of the patients'
      preference, the sound of running water, or no background noise at all. By asking patients to
      complete a questionnaire, The investigators will be able to assess ways to improve patient
      comfort in a commonly used urologic assessment.
    


Intervention name(s): Background Sounds
Intervention type(s): Other
Intervention description(s): Background music or sound of running water
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing urodynamics
Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue
Condition: Mental Competency; Mental Fatigue
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy and safety of Pharmaton? PHL 00749 in improving cognitive function and
      allevi ating mental and physical stress in healthy male and female subjects leading demanding
      lifestyles.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomised, parallel group trial in healthy male
      and fem ale subjects in regular employment. The duration of dosing will be 28 '(+/- 1)' days
      and assessments w ill be made on two visits (visits 2 and 3) with a training on the CDR
      system at the screening visit.

      The subjects will receive one bottle with 35 tablets [of either Ginseng G115 40 mg,
      multivitamin, mu ltimineral '+' Paullinia cupana extract PC102 75 mg (Guarana) or placebo]
      from the pharmacy at the in vestigational site. The subjects should take the study drug from
      day 0 to day 28 '(+/- 1)' Subjects will be assigned to one of the two treatment groups
      randomly. The allocation ratio is 2:1..

      Study Hypothesis:

      H0: No difference exists between the treatment and the placebo groups in terms o f
      baseline-adjusted change in Power of Attention after 28 days and averaged over 4 and 6 hour
      time point. H1: A difference exists between the treatment and the placebo groups in terms of
      baseline-adjusted change in Power of Attention after 28 days and averaged over 4 and 6 hour
      time point. The null and alternative hypotheses for the secondary endpoints are set up accor
      dingly. The statistical testing will be carried out at the 0.05 level of signifi cance. The
      test will be performed two-tailed.

      Comparison(s):

      The comparator is a matching placebo film-coated tablet without active ingredien ts.
    

Intervention name(s): Pharmaton PHL 00749; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
Condition: Gram-negative Bacterial Infection
MeSH terms: Infections; Bacterial Infections; Gram-Negative Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile
      of an antibacterial compound for treatment of hospital acquired Gram negative infection.
    

Detailed description: 
      Single-center, randomized, placebo-controlled, double-blind study to determine the safety,
      tolerability and pharmacokinetic profile of compound in single and multiple doses in young
      healthy males.
    

Intervention name(s): AN3365; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LP, 600 mg vial; reconstituted in Normal Saline; 0.9% sodium chloride for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gram negative; bacteria; infection
The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors
Condition: Bacterial Vaginoses
MeSH terms: Vaginosis, Bacterial
Study type: Observational

Summary: 
      The investigators aim to examine the endometrium with state of the art sequencing techniques
      to investigate the endometrial microbiota. The endometrial microbiota has been perceived to
      be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is
      to compare the rate of ascending infection from the vagina to the endometrium and to
      investigate which bacteria are capable of inhabiting these environments in healthy oocyte
      donors. These results will be compared to equivalent samples of IVF patients.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy oocyte donors
      
Biospecimen description: 
      Vaginal, Cervical and endometrial samples taken with the Eswab (Copan), eNAT (Copan) and Tao
      brush (Cook medical). Although there will be Human DNA in samples, we aim to isolate
      bacterial DNA for further analysis. No analyses are planned on Human DNA.
GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess bioequivalence (BE) of newly developed Glucophage® XR
      (GXR) reduced mass (RM) tablet (metformin hydrochloride 500 milligrams (mg) test tablet) and
      marketed Glucophage ® XR tablet (metformin hydrochloride 500 mg reference tablet) following
      single oral dose administration under fasted and fed conditions by comparing
      pharmacokinetics, safety and tolerability between test and reference in healthy participants.
    


Intervention name(s): Glucophage® XR RM Test; Glucophage® XR Reference
Intervention type(s): Drug; Drug
Intervention description(s): Participants received a single oral dose of 500 mg of test Glucophage® XR RM tablet under fasting or fed conditions.; Participants received a single oral dose of 500 mg of reference Glucophage® XR tablet under fasting or fed conditions.
Other intervention name(s): Metformin hydrochloride; Metformin hydrochloride
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes Mellitus; Glucophage Extended Release; Bioequivalence Study
A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      PC786 is a new medicine being developed for treatment of respiratory syncytial virus. The
      main purpose of this study is to evaluate the antiviral activity of PC786 in healthy adults
      infected with RSV virus in a viral challenge study.
    


Intervention name(s): PC786; Placebo/vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Repeat doses; Repeat doses
Intervention MeSH terms: PC-786
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
GnRH Antagonist to Prepare Recipients for Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers
      (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical
      protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap
      Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD
      Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with
      ART treatment, and its usage decreases significantly the number of injections that the
      patient receives with treatment. The working hypothesis for this study is that the GnRH
      antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation
      in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the
      markedly fewer injections required.
    


Intervention name(s): GnRH Antagonist (Cetrotide)
Intervention type(s): Drug
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Frozen embryo transfers (FET).; Egg donation (ED).; IVF.; ART.; Implantation.; GnRH antagonist.; Cetrotide.; Endometrial response.; Infertility treatments:; Transfer of embryos from egg donation (ED) to recipients.
RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies
Condition: Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed
      and/or refractory T/NK-cell hematologic malignancies. And to evaluate the efficacy and
      pharmacokinetics of RD13-01 in patients.
    


Intervention name(s): RD13-01 cell infusion
Intervention type(s): Drug
Intervention description(s): Universal CAR-T cells targeting CD7
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy
Condition: Bronchoscopy
Study type: Interventional

Summary: 
      This study was aimed to determine whether narcotrend monitoring was better than bispectral
      index monitoring during sufentanil-midazolam anesthesia for bronchoscopy under conscious
      sedation. Patients were randomised to receive Narcotrend, Bispectral Index(BIS) monitoring or
      without monitoring. Midazolam was given by non-anaesthetist physicians to achieve moderate
      levels of sedation as assessed by the narcotrend index (NI; B and C) or bispectral index
      (BIS; between 70 and 85) or according to patient's tolerance assessed by physician . The
      primary end-point was dosage of midazolam. Other end-points included adverse events, patient
      tolerance and physician satisfaction.
    


Intervention name(s): Narotrend; BIS; Sufentanil; Lidocaine; Midazolam
Intervention type(s): Device; Device; Drug; Drug; Drug
Intervention description(s): Narcotrend motoring; Bispectral index monitoring; sufentanil is applied.; Topical Anesthesia; midazolam is applied.
Intervention MeSH terms: Lidocaine; Midazolam; Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Narcotrend; Bispectral index; Bronchoscopy; Conscious Sedation
Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
Condition: Dental Restoration Failure of Marginal Integrity
Study type: Interventional

Summary: 
      ABSTRACT Objective The aim of this study was to evaluate the clinical performance of one
      microhybrid and two bulk-fill resin composites in Class II cavities for up to two years.

      Materials and methods In total, 75 Class II restorations were made in 25 patients, using
      three restorative materials: two nanohybrid bulk-fill resin composites, Sonic Fill (SF) and
      x-tra fil (XF), and a microhybrid composite, Filtek Z-250 (FZ). The restorations were blindly
      evaluated by two examiners at baseline and at 6, 12, and 24 months, using U.S. Public Health
      Service (USPHS) criteria. The restoration groups for each category were compared using the
      Pearson chi-square test, and the Cochran Q-test was used to compare the changes across
      different time points within each restorative material (p <0.05).
    


Intervention name(s): Bulk-Fill and Microhybrid Composite Resins
Intervention type(s): Other
Intervention description(s): Clinical Comparison of Composite Restorations (Two Bulk-Fill and one Microhybrid Composite Resin) to the USPHS Criterias
Other intervention name(s): Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinical study; USPHS criteria; bulk-fill; resin composite; Class II
Sympathetic Neural Outflow During Xenon Anesthesia in Humans
Condition: Sympathetic Nervous System
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the hypothesis that sympathetic neural outflow to
      muscles as well as a sympathetic baroreflexes are not altered during xenon anesthesia in
      Healthy Volunteers.
    

Detailed description: 
      Objectives for this study :

        -  Main Objective : Influence of Xenon anesthesia on Sympathetic Nervous Activity

        -  Secondary Objectives : Security under LENOXe™ (xénon 100 % v/v) anesthesia
    

Intervention name(s): xenon
Intervention type(s): Drug
Intervention description(s): Inhalational gas; dose allowed max.70 Vol.% in 30 % oxygen; the duration of the treatment will be to 30 minutes
Intervention MeSH terms: Xenon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Xenon Anesthesia; LENOXe™ (xénon 100 % v/v) anesthesia; Muscle Sympathetic Activity; Baroreflex reagibility
Effects of the Oral Stimulation Program in Extreme Preterm Infants
Condition: Infant, Premature; Feeding Behavior
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether oral stimulation program are effective to
      improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized
      classification of the subjects into to experimental and a control group.
    

Detailed description: 
      Recent studies have suggested that an oral stimulation program applied to preterm infants
      facilitates their oral feeding progress, improve breastfeeding rates in preterm infants and
      decreases the length of hospital stay. The objective of this study will evaluate the effect
      an oral stimulation program on the performance feeding, the length of the transition oral
      feeding, length of hospital stay and breastfeeding rates upon discharge.

      Primarily, will be evaluated the effect an oral stimulation program on the performance
      feeding. All infants will be assessed by a speech pathologist blinded as to the group
      randomization.

      Secondarily, will be observed the length of the transition oral feeding of the preterm
      infants, conducted by medical team and will be observed length of hospital stay. Both groups
      will be monitored from when they were assigned to participate in the study until hospital
      discharge.

      All statistical will be conducted using Statistical Package for Social Sciences® version
      18.0. The data will be analyzed for treatment group differences with chi-square or Fisher's
      exact tests for the categorical variables and with non-parametric tests for the continuous
      variables.
    

Intervention name(s): Intervention group; Control group
Intervention type(s): Other; Other
Intervention description(s): Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.; sham stimulation program consists of the same researcher placing her hands for 15 minutes.
Other intervention name(s): Oral stimulation program; Sham stimulation program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Infant, Premature