bioihbjkbjnl/mcl2 huggingface dataset:
Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Condition: Interstitial Cystitis; Bladder Pain Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      This study is a randomized controlled trial. Subject population is adult patients with
      Hunner-type interstitial cystitis. The objective of this study is to compare the therapeutic
      effect between the two surgical modality; TUF (transurethral fulguration of the Hunner
      lesion) versus TUF+HD(addition of bladder hydrodistension prior to transurethral fulguration
      of the Hunner lesion).
    

Detailed description: 
      Subject patients are randomly allocated to 1:1 ratio using Permuted block randomization. For
      TUF group, only fulguration on the Hunner lesion is performed. For TUF+HD group
      hydrodistension is performed for 8 minutes at pressure of 80cmH2O, and then fulguration on
      the Hunner lesion is performed. Therapeutic effect is evaluated using Visual Analogue Scale
      (VAS) pain score, O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q), Pelvic pain
      urgency/frequency patient symptom scale (PUF), frequency volume chart parameters, EQ-5D
      Health Questionnaire, Brief Pain Inventory-short form (BPI-sf), Patient Global Assessment
      (PGA) at the point of 1, 2, 4 and 6 months after operation. During the observational period,
      subject patients are not provided with any additional medical, physical or surgical treatment
      for symptom relief. Subject patient who complains of symptom requiring medical, physical or
      surgical intervention during the study period, is dropped from the study. Comparison of
      therapeutic efficacy between the two groups is performed using independent two sample t-test.
    

Intervention name(s): Transurethral fulguration of the Hunner lesion; Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion
Intervention type(s): Procedure; Procedure
Intervention description(s): Hunner lesion of the bladder is fulgurated with electronic surgical device under cystoscopic inspection. For the intervention, general or spinal anesthesia is required.; Prior to Hunner lesion fulguration, bladder hydrodistension is performed for 8 minutes at pressure of 80cmH2O. And then transurethral fulguration is performed on the Hunner lesion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 allocation with Permuted block randomization
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interstitial Cystitis; Painful Bladder Syndrome; Hydrodistension; Transurethral Fulguration
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of brexanolone
      in participants with tinnitus following a single 6-hour continuous intravenous (IV) infusion.
    


Intervention name(s): Brexanolone
Intervention type(s): Drug
Intervention description(s): Brexanolone IV infusion
Other intervention name(s): Allopregnanolone; ZULRESSO®; SAGE-547
Intervention MeSH terms: Pregnanolone; Brexanolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tinnitus
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Condition: Tuberculosis; AIDS-related Complex
MeSH terms: Tuberculosis; AIDS-Related Complex
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb)
      infection and will modulate that response with interferon-gamma.
    

Detailed description: 
      BACKGROUND:

      Mtb infects one-third of the world's population and ranks seventh in terms of global
      morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary
      disease, and persistently positive sputum smears pose a special risk for treatment failure
      and/or relapse.

      DESIGN NARRATIVE:

      Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention.
      The outcome of this study will be the changes in mycobacteriology, chest radiography, and
      bronchoalveolar lavage (BAL) cells.

      The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.

      The key secondary outcomes of this study will include a chest computerized tomography (CT)
      scan and BAL to measure the flow of cytometry and cytokine levels. Both outcomes will be
      measured at baseline and at Month 4.
    

Intervention name(s): Aerosol Interferon-Gamma; Subcutaneous interferon-gamma; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants will receive aerosol interferon-gamma.; Patients will receive subcutaneous interferon-gamma
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Sevoflurane Effect on Left Atrial Performance: A Transoesophageal Echocardiographic Study
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Observational [Patient Registry]

Summary: 
      The left atrial performance is affected by the preload as well as the afterload. The LA
      active pumping is increased by stretching of the LA but within limits, after which the active
      pumping declines. The LV stiffness acts as the LA afterload. Whenever the LV stiffness
      increases, the overall emptying fraction becomes more pumpdependent
    

Detailed description: 
      The echocardiographic assessment of the LA was frequently overlooked. While left atrial
      performance reflects both systolic and diastolic functions of the LV, it looks like more
      studies are being conducted to detect the effect of different interventions on the left
      atrial size and function. Other studies focus on the prognostic value and the ability to risk
      stratify different cohorts of patients, based on the early recognition of deranged LA
      performance.

      Many studies were conducted on the effect of inhalational anesthetics on the left atrial
      function. Yet the results are inconclusive and sometimes contradictory. In a study on dogs,
      Gare Meir and his colleagues proved that desflurane, sevoflurane, and isoflurane depress left
      atrial contractility, delay relaxation, reduce chamber stiffness, preserve reservoir and
      conduit function, and impair left atrial-left ventricular coupling in vivo. Volatile
      anesthetics may cause impairment of both left atrial (LA) and left ventricular (LV)
      contractility. The mechanisms suggested were a decrease in the influx of calcium via voltage
      gated calcium channels as well as a decrease in calcium availability from sarcoplasmic
      reticulum.Echocardiographic assessment of the LA volumetric measures is comparable to that of
      Cardiovascular Magnetic Resonance (CMR) with clinically irrelevant difference. This makes
      echocardiographic assessment of LA volumes reliable, cheaperand easier to obtain.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients of any sex,40-75 years, maintaining sinus rhythm undergoing elective with
        preserved left ventricular systolic function.
HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This study aimed to assess the correlation between HCG levels after ovulation triggering and
      ICSI outcomes, affected by HCG formulation and dose
    

Detailed description: 
      The aims of this study are:

        1. To assess the correlation between serum human chorionic gonadotropin (hCG) level after
           ovulation triggering and intracytoplasmic sperm injection (ICSI) outcome including:
           oocyte maturity and quality, good quality embryo rate, blastocyst formation rate and
           pregnancy rate

        2. To determine if there is an association between type and dose of the trigger and ICSI
           outcome.
    

Intervention name(s): uHCG; rHCG; uHCG and GnRHa
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon); Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle); Final oocyte maturation will be triggered by combined SC administration of 0.1 mg of GnRHa (Decapeptyl, Triptorelin) and IM administration of 2500 IU of uHCG (Choriomon)
Other intervention name(s): Choriomon; Ovitrelle; Decapeptyl and Choriomon
Intervention MeSH terms: Triptorelin Pamoate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist
        protocol with ovulation triggering, according to the risk of OHSS, by: 1) urinary HCG
        (uHCG); 2) recombinant HCG (rHCG); or 3) a combination of GnRHa and HCG (dual trigger)
      
Keywords: Ovulation triggering; uHCG; rHCG; GnRH; Dual trigger
Cognitive Remediation Therapy and Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Objectives:

      The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy
      (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with
      schizophrenia.
    

Detailed description: 
      Methods:

      In a 2 arms blind study versus sham,80 patients with schizophrenia were enrolled in a program
      consisting of 14 training sessions of 4 cognitive functions (attention/concentration,
      topological memory, logical reasoning, executive functions)by means REHACOM® software.
      Measures of cognitive functioning using the Cogtest® battery as well as social autonomy
      (Social Autonomy Scale, EAS) and schizophrenia symptoms (Positive And Negative Syndrome
      Scale, PANSS) were undertaken at the beginning and the end of the meetings of remediation.

      Among those 80 participants, 30 patients to (15 active / 15 sham) were randomized to
      participate in an fMRI study in order to investigate the impact of such CRT program on brain
      functioning (n-back task before CRT and 3 months later).
    

Intervention name(s): cognitive remediation therapy; non-CRT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software; waiting list
Other intervention name(s): CRT; behavioral intervention; no intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: cognitive deficits
Continuous Pectoral Nerve Block in Breast Cancer Surgery
Condition: Nerve Blocks; Breast Surgery; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of continuous pectoral nerve block on
      postoperative analgesia consumption in breast cancer surgery.
    

Detailed description: 
      Pectoral nerve block has been developed as an alternative to thoracic paravertebral and/or
      thoracic epidural blocks in recent years. It is frequently applied for postoperative
      analgesia in breast cancer surgery.
    

Intervention name(s): PECS group; Control group
Intervention type(s): Procedure; Other
Intervention description(s): Pecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed.; Standard pain follow up and monitorization will be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Controlled
Masking: Single (Participant)
Primary purpose: Other
Keywords: pectoral nerve block (pecs block); breast cancer; postoperative pain; numeric rating scale score (NRS score)
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 474121 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect on the exposure of BI 474121 in
      plasma when given as oral single dose together with multiple oral doses of itraconazole
      (Test, T) as compared to when given alone as oral single dose (Reference, R).
    


Intervention name(s): BI 474121; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): BI 474121 oral solution; Itraconazole oral solution
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management
Condition: Ambulatory Surgery; Coughing
MeSH terms: Cough
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to evaluate the effectiveness of fentanyl for reducing
      coughing during the perioperative period (i.e., insertion of an LMA [Laryngeal Mask Airway]
      device, maintenance period during surgery, and awakening [emergence] from general anesthesia)
      for ambulatory surgery procedures. Also to assess the effects of fentanyl on the
      postoperative outcomes, (e.g., pain, postoperative nausea and vomiting, return of bowel
      function [constipation], resumption of normal activities of daily living).

      Fentanyl is one of the most common used anesthetic adjuncts for ambulatory surgery because of
      its anesthetic-sparing effects and alleged ability to reduce coughing during instrumentation
      of the patient's airway.
    

Detailed description: 
      This research study is designed to evaluate the effects of fentanyl when administered as an
      adjuvant to standard anesthetic and analgesic drugs on coughing (during insertion of an LMA
      device, during maintenance and emergence from general anesthesia) and on the postoperative
      adverse outcomes (i.e., side effects).

      All patients will receive local anesthetics and commonly used non-opioid pain relieving
      medications during surgery.
    

Intervention name(s): Saline; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 2 ml at induction 1-2 ml boluses as needed; Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
Other intervention name(s): placebo
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Ambulatory surgery; Pain management; Perioperative outcomes; Fentanyl; Coughing during insertion of an LMA; Ambulatory surgery procedures
Effect of Gutamine Administration in the Innate Immune System Response in ICU Patients.
Condition: Moderate to Severe Trauma, as Defined by an; Injury Severity Score (ISS) > 12 Points Were Included in the Study.
Study type: Interventional

Summary: 
      Glutamine is the most abundant nonessential amino acid in the human body. Besides its role as
      a constituent of proteins and its importance in amino acid transamination, glutamine may
      modulate immune cells.

      The innate immune system is the first line of host defence against pathogens and in most
      cases sufficient to eliminate invading microbes. Mammalian Toll-like receptors (TLR) comprise
      a family of germ line-encoded trans-membrane receptors which activation leads to the
      induction of inflammatory responses, phagocytosis but also to the development of antigen
      specific adapative immunity.

      It has been postulated though not formally proven yet that glutamine beneficial effect could
      be due to a positive effect on the innate immune system. Given the importance of TLRs and
      TLRs-dependent signalling in host defence against infections we hypothesized that glutamine
      may increase the expression and/or functionality of TLRs which in turn may have beneficial
      effects to clear infections.
    

Detailed description: 
      Objective: To evaluate whether glutamine supplementation alters the expression and
      functionality of TLR2 and TLR4 in circulating monocytes of trauma patients admitted to the
      ICU. Specifically the next variables were measured:

        -  Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow
           cytometry

        -  To study the functionality of TLR2 and TLR4, monocytes were stimulated with TLR specific
           agonists and cytokines were measured in cell culture supernatants. We determined the
           concentration of IL-1β, IL-6, TNFα and IL-10 in cell culture supernatants using a bead
           array ELISA.

        -  To determine the phagocytic capability of monocytes, live Escherichia coli expressing
           green fluorescent protein was added to 100 μL of whole blood collected in
           K2-anticoagulation medium tubes. Bacteria were added at a ratio of 100 bacteria per
           monocyte. The analyses were carried out in an Epics XL flow cytometer.
    

Intervention name(s): Total Parenteral Nutrition with Glutamine; Total Parenteral Nutrition without glutamine
Intervention type(s): Dietary Supplement; Other
Intervention description(s): daily glutamine supplement of 0.35 g/kg weight as N2-L-Alanyl-L-Glutamine (0.5 g/kg/d - Dipeptiven Fresenius Kabi España) during five days.; The control group received a supplemental volume of the basic TPN solution to achieve an isocaloric an isonitrogenated formula with the study group.
Allocation: Randomized
Masking: Single (Outcomes Assessor)
A Study of LY3025876 in Participants With Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the safety and tolerability of LY3025876 given
      alone (Part A) and in combination with liraglutide (Part B) in participants with type 2
      diabetes mellitus (T2DM).
    

Detailed description: 
      This study will also evaluate how much of the study drug enters the blood stream and how long
      it takes for the body to remove the study drug. Information about any side effects that may
      occur will also be collected. Participants will continue their usual diet and exercise
      program and may remain on their physician-prescribed dose of metformin.

      Each part of the study is expected to last 10 to 12 weeks on average, not including
      screening. Participants may only enroll in one part.
    

Intervention name(s): LY3025876; Placebo; Liraglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SQ; Administered SQ; Administered SQ
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Endotracheal Tube Audible Leak Test
Condition: Anesthesia Intubation Complication; Mechanical Ventilation Complication
Study type: Observational

Summary: 
      The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed
      assessment to verify appropriate tube size in neonates, infants and children. However, many
      factors are known to influence the audible leak test. Even though the test is widely
      performed, the accuracy has not been evaluated.
    

Detailed description: 
      The endotracheal tube (ETT) leak test (LT), or audible leak when the peak airway pressures
      reach 15-30 cmH2O, is a commonly performed assessment to confirm that an endotracheal tube
      size is appropriate for a child in order to minimize the risk of airway injury and adverse
      events after removal of ETT. Many factors are known to affect the results of the leak test
      and variation in results among experienced anesthesiologists may be as great as 38%, but the
      accuracy of the audible leak test by directly observing the presence of a leak around the ETT
      has not been evaluated. This study will attempt to use direct visualization of the air leak
      to correlate to and assess the accuracy of the audible air leak test.
    

Intervention name(s): Assess for Audible Endotracheal Leak; Assess for Endotracheal Leak with direct visualization under rigid bronchoscope
Intervention type(s): Other; Other
Intervention description(s): In supine position, the head will be positioned in neutral position. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed and pressure in the inspiratory circuit is slowly increased until an audible leak is heard at the mouth. That pressure will be recorded.; In the same patient position, a flexible nasal laryngoscope will be inserted and positioned superior to the laryngeal inlet by the surgeon. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed, the pressure in the inspiratory circuit will be increased slowly until a leak around the TT will be visualized by inspecting the supraglottic area for bubbles or air movement around the TT. The peak pressure at which leak is observed physically will be recorded. This is the end of the study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring
        general anesthesia with an endotracheal tube.
      
Keywords: intubation; ventilation; airway; airleak