bioihbjkbjnl/mcl2 huggingface dataset:
Dialysis Membranes and Hemodynamic Tolerance
Condition: Dialysis Membranes and Hemodynamic Tolerance
Study type: Interventional

Summary: 
      Background:

      High- and low-flux dialysis membranes made of different materials may correlate with various
      hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and
      incidence of hypotensive episodes by comparing some of the most commonly used high- and
      low-flux dialyzers.

      Methodology:

      The study was designed as an open label, randomized, cross-over investigation, including 25
      patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A (Revaclear,
      Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux,
      Fresenius), were compared with each other. The hemodynamic profile was assessed with a
      non-invasive technique and patients were asked to provide tolerance feedback through a
      questionnaire.
    


Intervention name(s): Revaclear; Helixone high flux; Xevonta; Helixone low flux
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other; Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other; Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other; Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other
Other intervention name(s): -Revaclear, Gambro 1.8 m2; Helixone high flux, Fresenius 1.8 m2; Xevonta, BBraun 1.8 m2; Helixone low flux, Fresenius 1.8 m2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodynamics; intradialytic hypotension; subjective tolerance; dialysis membranes; high flux; low flux; hemodialysis
Use of Recombinant Factor VII as a Prophylactic Therapy for Adolescent Females With Heavy Menstrual Bleeding
Condition: Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug Intervention
MeSH terms: Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      the study is conducted on adolescent females proved to be Glanzmanns Thrombaesthenia with
      heavy menstrual bleeding by the use of 3 doses of recombinant factor VII in the first day of
      their cycles. bleeding profile and quality of life were assessed before and 1year after this
      regular recombinant factor VII administration.
    


Intervention name(s): Proph7
Intervention type(s): Drug
Intervention description(s): Prophylactic recombinant FVII for heavily menorrhagic adolescent Glanzmanns Thrombaesthenia females
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adolescent females known Glanzmanns Thrombaesthenia with heavy menstrual bleeding
Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of
      fundoplication are performed, each has advantages and disadvantages. The Nissen operation is
      the most frequently performed procedure in the U.K., however it can be associated with
      post-operative dysphagia. The relative benefits between Nissen and other fundoplication
      techniques in children are still uncertain.

      The aim of our study was to compare the long-term outcomes following laparoscopic Nissen
      fundoplication with laparoscopic Thal fundoplication in children.
    


Intervention name(s): laparoscopic Nissen/laparoscopic Thal
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: laparoscopy; fundoplication; Nissen; Thal; children; operative treatment of gastro-oesophageal reflux disease in children
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is
      safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the
      current off-label-use practice; and 2) demonstrate that an optimum effect can be rapidly
      obtained with VentaProst titration.
    

Detailed description: 
      Part I:

      This part of the study is designed to demonstrate the dose equivalence between off-label
      aerosolized epoprostenol and VentaProst using a patient's hemodynamic parameters.

      Part II:

      This part of the study is designed to establish a dose response relationship of VentaProst to
      hemodynamic effect by dose escalation in patients who have had cardiac surgery with CPB.
    

Intervention name(s): VentaProst
Intervention type(s): Combination Product
Intervention description(s): Part I - an equivalent dose of VentaProst compared to conventionally-administered aerosolized epoprostenol with subsequent dose titration to achieve a clinically significant hemodynamic response Part II - Dose titration to achieve a clinically significant hemodynamic response.
Other intervention name(s): epoprostenol for inhalation via custom drug delivery system
Intervention MeSH terms: Epoprostenol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiac surgery; Cardiopulmonary bypass; Epoprostenol
High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.
Condition: Ultrasonography; Peroneal Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Peroneal Neuropathies
Study type: Observational

Summary: 
      This study establishes reference material of selected lower extremity nerves at pre-defined
      sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound
      of patients with common fibular compression neuropathy and patients with type 2 diabetic
      polyneuropathy involving the common fibular nerve will be examined and compared to healthy
      controls. High-resolution ultrasound measurements will be correlated with history, clinical
      information and electrophysiological data.
    

Detailed description: 
      The usual diagnostic work-up of patients referred for lower-extremity neuropathy includes
      clinical examination, biochemical tests (blood and cerebrospinal fluid), electrophysiological
      assessment and if necessary nerve biopsy. The electrophysiological assessment usually
      consists of nerve conduction studies (NCS) and electromyography (EMG). While
      electrophysiological measurements generally give information about the function of nerves,
      high-resolution ultrasound may provide information about the structure of nerves.

      High-resolution ultrasound examination has shown promising results as a supplementary tool in
      the diagnostic work-up of various peripheral neuropathies. The clinical utility of ultrasound
      in the diagnosis of common fibular neuropathies, however, calls for further elucidation.

      This study establishes reference material of selected lower extremity nerves at pre-defined
      sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound
      of patients with common fibular compression neuropathy and patients with type 2 diabetic
      polyneuropathy involving the common fibular nerve will be examined and compared to healthy
      controls, as well as each other. High-resolution ultrasound measurements will be correlated
      with history, clinical information and electrophysiological data.
    

Intervention name(s): Ultrasound protocol
Intervention type(s): Diagnostic Test
Intervention description(s): High-resolution ultrasound protocol at pre-defined sites bilaterally. Pre-defined sites: Sciatic nerve (proximal and distal), tibial nerve (proximal and distal), common fibular nerve (proximal and distal), superficial fibular nerve (proximal and distal) and sural nerve (proximal and distal).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with common fibular compression neuropathy and patients with type 2 diabetes
        polyneuropathy involving the common fibular nerve
      
Keywords: Ultrasound reference material; Sensitivity; Specificity; Common fibular compression neuropathy; Type 2 diabetes polyneuropathy; Intra-rater reliability; Inter-rater reliability
Blueberry Effects on Dark Vision and Glare Recovery
Condition: Blindness and Low Vision
MeSH terms: Blindness; Vision, Low
Study type: Interventional

Summary: 
      Clinical evidence for effects of plant anthocyanins on vision, and particularly night vision
      is controversial. Two clinical trials were conducted to investigate whether blueberry juice
      consumption affected visual dark adaptation, functional night vision, and recovery after
      photo-bleaching of the retina. One trial (S2) employed a 3 week intervention and washout
      period, and two doses of blueberries plus a placebo. The other trial (L1) employed a 12 week
      intervention plus an 8 week washout and tested one blueberry juice dose against a juice
      placebo.
    

Detailed description: 
      Vision Tests: 1. Dark adaptometry, 2. scotopic visual acuity, 3. scotopic contrast
      sensitivity, 4. rod/cone conversion, 5. recovery after retinal photobleaching
    

Intervention name(s): Blueberry Juice S2; Blueberry Capsules S2; Placebo Capsule S2; Placebo Juice L1; Blueberry Juice L1
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Blueberry Juice S2 was commercially prepared single strength blueberry juice composed of a 50:50 blend of Rubel (Vaccinium corymbosum L.) and Tifblue (Vaccinium ashei Reade) cultivars. Colorimetric analysis showed that S2 juice contained 6.04 (SD=0.20) mg anthocyanins (C3G) eq/g dry mass.; Commercially prepared single strength blueberry juice composed of a 50:50 blend of Rubel (Vaccinium corymbosum L.) and Tifblue (Vaccinium ashei Reade) cultivars was freeze dried then powdered and encapsulated in gelatin capsules. Colorimetric analysis indicated an anthocyanin concentration in the powder of 2.37(SD=0.18) mg C3G eq per capsule.; Placebo Capsule S2 (containing no anthocyanins) were prepared by freeze drying red beets and grinding them to fine powder before encapsulating in gelatine capsules. Red beets do not contain anthocyanins.; Placebo juice was prepared from water, sugars, citric acid, sodium citrate, and artificial colors and flavours, then pasteurized. The placebo juice contains no anthocyanins.; Blueberry Juice L1 was commercially prepared single strength blueberry juice composed of a 50:50 blend of Rubel (Vaccinium corymbosum L.) and Tifblue (Vaccinium ashei Reade) cultivars. Colorimetric analysis showed that L1 juice contained 6.83 (SD=0.20) mg cyanidin-3-glucoside equivalents (C3GE)/g dry mass at the start of the study, declining to 5.52 (SD=0.09) mg C3GE/g dry mass after 3 months refrigerated storage.
Other intervention name(s): Single-strength blueberry juice, commercially prepared; freeze-dried blueberry juice powder; Red beet powder; single strength blueberry juice, commercially prepared
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: blueberry; anthocyanin; dark vision; photo bleaching; Visual Perception; Photic Stimulation
Long-term Treatment Outcome for Stage III NPC Patients and Risk Grouping by Plasma EBV DNA
Condition: Nasopharyngeal Carcinoma; EBV Related Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Observational

Summary: 
      No previous study reported the treatment outcome of stage III nasopharyngeal carcinoma (NPC)
      patients. The investigators try to investigate the long-term treatment outcome of stage III
      NPC patients and do risk grouping by plasma Epstein-Barr virus (EBV) DNA assay for future
      therapy improvement.
    

Detailed description: 
      The stage III NPC patients were the majority group of the patient population of NPC. But most
      clinical trials focused on the treatment of American Joint Committee on Cancer (AJCC) 7th
      edition stage IVA/IVB treatment for high risk of recurrence or metastasis. No previous study
      reported the treatment outcome of stage III NPC patients. The investigators tried to
      investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by
      plasma EBV DNA assay for future therapy improvement.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Tissue proven stage III NPC patients and received curative treatment in our institute.
        Pre-treatment and post-radiotherapy plasma EBV DNA will be obtained.
      
Biospecimen description: 
      We collected the pre-treatment and post-treatment plasma EBV DNA. The plasma EBV DNA assay
      was analyzed by real time PCR.
    
Keywords: Nasopharyngeal Carcinoma; plasma EBV DNA
Study of T-Regulatory Cells in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      To study whether the immune response as directed by regulatory T cells is different between
      obese asthmatics, normal weight asthmatics and healthy controls.
    

Detailed description: 
      The investigators hypothesize that the increase in asthma severity in obese patients is, at
      least in part, related to a defective number or function of regulatory T cells (Tregs). That
      is in the obese asthmatic subject a defective Treg profile would augment the inflammation of
      asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect
      asthma independently (an additive effect). To test these hypotheses, the investigators plan
      to conduct an observational controlled study to compare Treg profile in obese and
      normal-weight individuals with and without asthma.

      This is an exploratory study to investigate the following:

        1. To determine whether Treg number and function differs between obese and normal-weight
           individuals with and without asthma.

        2. To determine whether serum leptin levels differ between obese and normal-weight
           individuals with and without asthma.
    

Intervention name(s): blood draw, breathing test
Intervention type(s): Biological
Intervention description(s): A blood draw,breathing test will be performed on every participant
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females in good health between the ages of 18-50, with or without asthma.
      
Biospecimen description: 
      T regulatory cells are isolated in the blood specimens
Closed Aspiration on Hemodynamic Changes and Pain
Condition: Aspiration
Study type: Interventional

Summary: 
      The study was planned to determine the effects of closed aspiration on arterial blood
      pressure, heart rate, respiratory rate, oxygen saturation level and pain in intensive care
      patients connected to mechanical ventilators. IThe effects of the closed aspiration system on
      hemodynamic parameters and pain will be determined and the results will be important in terms
      of the usability of the closed system in the clinical environment and raising awareness in
      nursing practices in order to create minimum complications for the patient.
    

Detailed description: 
      The research iss carried out in a single group pretest posttest quasi-experimental design in
      order to determine the effects of closed aspiration on arterial blood pressure, heart rate,
      respiratory rate, oxygen saturation level and pain in intensive care unit patients with
      mechanical ventilation. The research is carried out in Anesthesiology and Reanimation
      Intensive Care Unit. The sample of the study is patients who was intubated, not sedated,
      systolic arterial blood pressure 110-140 mmHg, diastolic arterial blood pressure between
      60-90 mmHg, heart rate between 60-100/min, respiratory rate between 12-20/min, oxygen with
      saturation level (SpO2) >86%. Data is collected from the hospital's electronic patient record
      system and observationally before and after the aspiration. "Patient Description Form",
      "Hemodynamic Status and Pain Monitoring Form", "Behavioral Pain Scale" is used to collect
      research data.
    

Intervention name(s): Closed system aspiration
Intervention type(s): Other
Intervention description(s): Aspiration catheter; it is part of the ventilator and the ventilator circuit. The catheter is stored in a protective sheath. Therefore, the catheter can be used repeatedly during the day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Closed aspiration; Pain; Hemodynamic parameters
Effect of a Low-calorie and High-protein Diet Specially Rich in Animal Protein Compared to a Low-calorie and High-protein Diet Specially Rich in Plant Protein on Glucose Metabolism in Subjects With Prediabetes or Type 2 Diabetes and Overweight or Obesity.
Condition: Diabetes Mellitus, Type 2; Overweight and Obesity; PreDiabetes
MeSH terms: Diabetes Mellitus; Obesity; Overweight; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The aim of the study is to explore the effect of a low-calorie diet rich in protein (with a
      content of 35% of the total calories of the diet), mostly coming from animal sources (75% of
      total protein), compared to a hypocaloric diet rich in protein (with a content of 35% of the
      total calories of the diet), mostly coming from plant sources (75% of total proteins), in
      subjects with prediabetes or type 2 diabetes and overweight or obesity, on body composition,
      glucose and lipid metabolisms, after 6 months of intervention.

      To achieve the objective, a nutritional intervention study is carried out by randomizing
      participants to: a) a hypocaloric and high-protein diet (35% of total calories), mostly of
      them coming from animal sources (75% of total protein); b) a hypocaloric and high-protein
      diet (35% of total calories), mostly of them coming from plant sources (75% of total
      protein). The study has a total duration of 6 months and include the assessment of clinical,
      anthropometric, biochemical and lifestyle parameters, at the beginning of the study and after
      3 and 6 months of intervention.
    


Intervention name(s): Low-calorie and high-protein diet with the majority of protein coming from animal sources.; Low-calorie and high-protein diet with the majority of protein coming from plant sources.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Diet was prescribed to the participant and menus and recipes were also provided.; Diet was prescribed to the participant and menus and recipes were also provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone
Condition: Esotropia; Exotropia
MeSH terms: Strabismus; Exotropia; Esotropia
Study type: Interventional
Phase: Phase 4

Summary: 
      Two different treatments were given to large angle horizontal strabismus (eso and exotropia)
      adult patients who agree to participate of the study. Inform consents were required for
      participants. Group 1 (12 patients) received conventional recess-resect surgery plus
      intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only
      conventional recess-resect surgery. The patients were randomly located in one of the groups.
      The angles of horizontal deviation were compared between the groups before and six months
      after treatment.
    

Detailed description: 
      Patients underwent recess/resection surgery on the non-fixating eye using conventional
      technique under local anesthesia. The extent of surgery was determined based on our usual
      amounts. Before re-attaching the recessed muscle to the sclera, 5 units of botulinum toxin in
      0.1 ml of hyaline solution were, or 0.1 ml of hyaline solution alone were was injected into
      the posterior muscle belly by the surgeon who was unaware of the contents of each syringe.
    

Intervention name(s): Botulinum Toxin Type A; saline solution
Intervention type(s): Drug; Drug
Intervention description(s): injection of 5U in 0.1ml of saline solution will be given to the recessed muscle; injection of 0,1ml of saline solution will be given to the recessed muscle
Other intervention name(s): BTA; saline
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: strabismus surgery; botulinum toxin; esotropia; exotropia; blepharoptosis