bioihbjkbjnl/mcl2 huggingface dataset:
Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?
Condition: Complications; Urethral Catheter; Ureteral Catheterization; Ureteroscopy; Lower Urinary Tract Symptoms; Flank Pain
MeSH terms: Lower Urinary Tract Symptoms; Flank Pain
Study type: Interventional

Summary: 
      After semirigid or flexible ureteroscopy operations where a DJ stent was placed, there is
      diversity in practice of placing a urethral catheter. The presence of vesico-ureteral reflux
      due to DJ stents has been proven to exist and can cause flank pain and UTI due to retrograde
      urine flow. The main purpose to place a urethral catheter is to keep a low-pressure bladder
      in order to prevent reflux alongside the DJ stent. However, this practice doesn't have an
      evidence-based support on the literature and some surgeons also advice patients to void
      frequently in the early postoperative period to avoid these aforementioned complications. The
      purpose of this study is to compare the 2 different approaches after ureteroscopy and DJ
      stent placement by evaluating the patient-reported outcomes along with laboratory tests.
    

Detailed description: 
      Ureteral stents and foley catheters are the most commonly used disposables in urological
      practice. Ureteral double J (DJ) stents are frequently used to relieve ureteral obstruction
      and almost as a routine part of the ureteroscopic procedures by many surgeons.

      DJ stent placement has the potential side effects such as flank pain and urinary tract
      infection (UTI) due to retrograde urine flow. As the bladder pressure increases during
      voiding, urine reflux occurs both beside and through the DJ stent. In order to overcome these
      problems, stents with antireflux mechanisms are produced, however these new stents comes with
      higher costs compared to conventional stents.

      Foley catheters are the hands and feet of all urologists and insertion of a foley catheter
      can easily keep the bladder pressures as low as required. The practice of insertion of a
      foley catheter into the urinary bladder after ureteroscopy for kidney or renal stones and DJ
      stent placement doesn't have an evidence-based background and it routinely depends on the
      choice of the surgeon.

      The aim of this study is to evaluate whether routine insertion of a bladder catheter
      following ureteroscopy and DJ stent placement can reduce stent-related problems due to reflux
      and urinary tract infections.
    

Intervention name(s): urethral catheter placement
Intervention type(s): Procedure
Intervention description(s): urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DRA vs PRA for US-guided Radial Artery Catheterization in ICU
Condition: Ultrasonography
Study type: Interventional

Summary: 
      Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane distal
      radial access (IP-DRA) and in-plane proximal radial access (IP-PRA) catheterization.

      For IP-DRA , a linear transducer is placed in the radial fossa, which is known as the
      snuff-box. After obtaining a long-axis view of the radial artery ,the needle is inserted in
      the midpoint of the small footprint transducer. Then,the needle is advanced under real-time
      US guidance until visualizing the tip of the needle inside the artery .

      For IP-PRA , a linear transducer is placed in the standard conventional forearm radial.

      After obtaining a long-axis view of the radial artery ,the needle is inserted in the midpoint
      of the small footprint transducer. Then,the needle is advanced under real-time US guidance
      until visualizing the tip of the needle inside the artery .
    

Detailed description: 
      *Ultrasound-guided catheterization of the radial artery, by proximal approach:

        -  Patient's hand in hyperextension with slight dorsiflexion of the wrist.

        -  The placement of the ultrasound probe initially linear in order to obtain the "short
           axis" image of the artery; then a quarter turn until obtaining a longitudinal "long
           axis" view.

        -  The operator must identify the artery using the pulsed wave Doppler;

        -  Insertion of the needle in the middle of the transducer providing an "in plane"
           orientation. Thus the needle was advanced slowly and its tip was visualized throughout
           the procedure. *Ultrasound-guided catheterization of the radial artery, by distal
           approach:

        -  If the right hand is along the body / if the left hand is on the trunk.

        -  The ultrasound probe placed at the level of the anatomical snuffbox by placing the
           transducer in a linear fashion then rotated coronally until a longitudinal image is
           obtained *In the 2 groups: - The longitudinal "in plane" approach is used - After
           visualization of the penetration of the bevel of the needle into the lumen of the artery
           and the jet of arterial blood into the syringe on aspiration, a flexible metal guide was
           introduced into the artery through the trocar according to the Seldinger's method. - The
           correct positioning of the guide in the artery was then confirmed by ultrasound. Any
           obstacle preventing insertion of the guide system always led to a new puncture.
    

Intervention name(s): IP-DRA vs IP- PRA
Intervention type(s): Procedure
Intervention description(s): Catetherization approach in plane : distal radial artery VS proximal radial artery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Catheter; radial artery
Evaluate the Relevance of the Use of Peripheral Venous Blood Gases for the Care of Patients in the S.A.U.V (Vital Emergency Rooms) of the CHU de Caen
Condition: Critical Illness
MeSH terms: Emergencies; Critical Illness
Study type: Interventional

Summary: 
      concordance between the lactate values on peripheral venous and arterial blood gases in all
      patients receiving an arterial sample on their arrival in the S.A.U.V.
    


Intervention name(s): peripheral venous blood gases
Intervention type(s): Other
Intervention description(s): peripheral venous blood gases
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Exercise in Pregnancy Evaluative Controlled Study
Condition: Pregnancy
Study type: Interventional

Summary: 
      This study aimed to investigate whether there are measurable differences in CHANS function in
      pregnant women who receive only standard antenatal care compared with those who additionally
      undertake a programme of regular physical exercise.
    

Detailed description: 
      The health benefits of physical exercise in the non-pregnant population are generally
      appreciated but its influence during pregnancy has not been clearly demonstrated. The focus
      of this proposal is to obtain for the first time a comprehensive understanding of the
      influence of regular physical exercise during pregnancy on cardiovascular, haemodynamic and
      autonomic nervous system (CHANS) parameters during pregnancy and following childbirth. This
      will involve assessing heart rate variability and cardiac stroke volume. This study will
      allow the investigators to compare CHANS parameters in pregnant women who are randomly
      assigned into three groups: a 'standard care' group and two groups who engage in a supervised
      programme of physical exercise (either land-based or water-based). The investigators will
      assess CHANS parameters at three stages during pregnancy and on one occasion following
      childbirth. This will allow the influence of regular (weekly) physical exercise on CHANS
      physiology to be assessed during advancing gestation. The investigators will thus use this
      study to provide initial evidence of the health benefits of regular and specific forms of
      antenatal physical exercise.
    

Intervention name(s): Physical Exercise Participation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift.
Condition: Maxillary Sinus Floor Augmentation
Study type: Interventional

Summary: 
      The sinus infiltration technique for sinus floor elevation has been used successfully when a
      reduced vertical height is available in the posterior maxilla. However, the effect of the
      different graft material on the volume and on the quality of new bone formed has not been
      fully investigated. The aim of this study is to evaluate the clinical and histological effect
      of a test material, lyophilized equine bone (Bio-gen®), compared with control material,
      deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.
    


Intervention name(s): sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy); Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)
Intervention type(s): Device; Device
Intervention MeSH terms: Cimetidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Maxillary Sinus/surgery; Bone Substitutes; Radiography, Panoramic
Airway Management With Simulated Microgravity Using a Submerged Model
Condition: Airway Management; Emergency Medicine
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      Trained anesthesiologist- or emergency physician-divers will perform an airway management in
      simulated microgravity on a submerged model.
    

Detailed description: 
      Trained anesthesiologist- or emergency physician-divers participate in the study. Simulated
      microgravity during spaceflight is obtained by using a submerged model. Full-torso manikins
      is going to be used for performing airway management. Each diver attempted airway management
      with each device (laryngeal mask, laryngeal tube, orotracheal intubation with video-assisted
      laryngoscope. The time for airway protection will be measured as well as the success rate.
    

Intervention name(s): Airway management with a submerged model
Intervention type(s): Device
Intervention description(s): Airway management with a submerged manikin using different airway devices in randomized order
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Recurrence of Atrial Fibrillation Post Cryoballon Ablation During the 90-day Blanking Period-with and Without Anti-arrhythmic Drug Therapy
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional

Summary: 
      This study is being done to find out if patients taking Anti Arrhythmia Drugs (AADs) after
      cryoballoon ablation for atrial fibrillation, compared to patients who do not take Anti-
      Arrhythmic Drugs after an ablation affect Atrial Fibrillation from coming back. The study
      will also look at the side effects of the AADs.
    

Detailed description: 
      Pulmonary vein isolation (PVI) is a cornerstone ablation strategy used in the management of
      paroxysmal atrial fibrillation (PAF), and it is a class IA indication for anti-arrhythmic
      drug (AAD) refractory symptomatic PAF. However, the consensus statements are vague about the
      utility of AAD management during the 90-day blanking window post-PVI. Moreover, there is no
      specific guidance to cryoballoon users on the usage of AADs during the 90-day blanking period
      that exists anywhere in the published literature. Simply, these studies have not been
      conducted with the cryoballoon procedure.
    

Intervention name(s): No AAD post Ablation.
Intervention type(s): Other
Intervention description(s): Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation
Other intervention name(s): No AAD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Antiarrhythmic Agents; Catheter Ablation, electric; Cardiac Arrhythmias; Anti-Arrhythmia Drugs
Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence
      from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia
      (VIMA). But desflurane can cause airway irritation when it used as a sole induction agent to
      adult or children, so there were many studies about reducing the airway reflex combined with
      desflurane.

      Remifentanil is a short acting opioid and is quickly hydrolyzed by nonspecific esterase in
      the plasma and multiorgan. Several studies suggest the optimal dose of remifentanil for
      reducing airway reflex or cardiovascular response for intubation combined with desflurane.
      But these studies were under 1 Minimal Alveolar Concentration (MAC) of desflurane and this
      point could be a limitation because desflurane concentration over 1 MAC increase airway
      irritation significantly. This study this study was designed to determine a median effective
      effect-site concentration (EC50) of remifentanil to prevent airway irritation during
      desflurane anesthesia over 1 MAC.
    


Intervention name(s): Remifentanil; Desflurane
Intervention type(s): Drug; Drug
Other intervention name(s): Ultiva
Intervention MeSH terms: Remifentanil; Desflurane
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Remifentanil; smooth induction; desflurane
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and
      preliminary therapeutic efficacy of multiple doses of CFZ533 anti-CD40 monoclonal antibody in
      patients with moderately active lupus nephritis.
    

Detailed description: 
      This was a randomized, subject and investigator blind, placebo controlled multicenter study
      with multiple doses of CFZ533 administered by 1-hour intravenous infusion over a 24 week
      treatment period, as compared to matched placebo infusion. The treatment period was followed
      by a 24-week safety follow-up period.The duration of the study (including the screening
      period) for each patient was approximately 53 weeks. The investigational drug or placebo was
      administered on top of standard of care therapy for lupus nephritis.

      Patients were screened within 29 days of the first study drug infusion. Eligibility was
      confirmed at the baseline visit within one week before the first dose. Eligible patients were
      assigned a randomization number and receive the intravenous infusion within 3 days of
      baseline visit.
    

Intervention name(s): CFZ533; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): multiple doses of CFZ533 intravenous infusion; multiple doses of placebo intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: anti-CD40; CFZ533; moderately active lupus nephritis
Efficacy and Safety of Paliperidone ER in First Episode Psychosis
Condition: First Episode Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients
      with first episode psychosis.
    


Intervention name(s): paliperidone ER
Intervention type(s): Drug
Intervention description(s): 8 week prospective study
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Demonstrate Safety and Efficacy of Advagraf in Patients Undergoing Kidney or Liver Transplantation in India
Condition: Kidney Transplantation; Liver Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to demonstrate safety and efficacy of once-daily Advagraf in
      adult population undergoing kidney or liver transplantation in India.
    

Detailed description: 
      This is a phase IV, multi-centre, open label prospective study of once daily Advagraf in 200
      patients undergoing kidney or liver transplantation in India. Adult patients undergoing
      kidney or liver transplantation and meeting all other eligibility criteria will be enrolled
      in the study. Enrolled patients will be administered once daily dose of Advagraf for 12
      weeks. During these 12 weeks a total of 9 regular visits will be undertaken.
    

Intervention name(s): Advagraf
Intervention type(s): Drug
Other intervention name(s): Modified release tacrolimus; FK506
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FK506; Advagraf; Tacrolimus; Transplantation
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Valsartan in Healthy Volunteers
Condition: Healthy; Pharmacokinetics of Valsartan
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the effect of ASP1585 on pharmacokinetics of valsartan in 2x2
      crossover method
    


Intervention name(s): ASP1585; valsartan
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Diovan
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP1585; Drug-drug interaction; valsartan; Healthy volunteer
A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus
      placebo on QTcF.
    

Detailed description: 
      To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701
      free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's
      formula (QTcF) in healthy subjects.
    

Intervention name(s): TR-701 FA 1200 mg; Moxifloxacin 400 mg; TR-701 FA 200 mg plus Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 6 tablet of T-701 FA; 1 tablet 400 mg Moxifloxacin; 1 tablet of TR-701 FA with 5 tablet placebo; 6 placebo tablets
Other intervention name(s): Tedizolid; Tedizolid
Intervention MeSH terms: Moxifloxacin; Tedizolid phosphate; Tedizolid; Oxazolidinones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: volunteer
High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain
Condition: Hemiplegia
MeSH terms: Shoulder Pain; Hemiplegia
Study type: Interventional

Summary: 
      High intensity laser therapy (HILT) has been considered as a treatment option for shoulder
      pain. To our knowledge, the effectiveness of HILT in patients with hemiplegic shoulder pain
      (HSP) with partial thickness rotator cuff tear (PTRCT) is unknown. In this study, we intended
      to investigate the effectiveness of HILT on pain, disability, function and quality of life in
      patients with HSP accompanied by PTRCT.
    

Detailed description: 
      The study was designed as prospective, randomized, controlled trial. Patients with HSP
      accompanied by PTRCT (n=44) were randomly assigned to HILT and control groups. Group 1 (HILT
      group, n=22) received 3 sessions of HILT per week for 3 weeks in addition to the exercise
      program which performed 5 sessions per week for 3 weeks. Group 2 (Control group, n=22)
      received an exercise program for HSP of 5 sessions per week for 3 weeks.

      Participants were evaluated with Visual Analog Scale (VAS), passive Range of Motion (ROM),
      Shoulder Pain and Disability Index (SPADI), Nottingham Health Profile (NHP), Functional
      Independence Measure (FIM) and ultrasonographic PTRCT size.
    

Intervention name(s): High intensity laser therapy; Therapeutic Exercise
Intervention type(s): Device; Other
Intervention description(s): A prospective, randomized, controlled study was undertaken. A total of 44 patients who met inclusion criteria were randomly divided into two groups. HILT group (n=22) received 3 sessions of HILT per week for 3 weeks in addition to the multidisciplinary stroke rehabilitation and exercise program which performed 5 sessions per week for 3 weeks. Control group (n=22) received a multidisciplinary stroke rehabilitation and exercise program for HSP of 5 sessions per week for 3 weeks.; A prospective, randomized, controlled study was undertaken. A total of 44 patients who met inclusion criteria were randomly divided into two groups. HILT group (n=22) received 3 sessions of HILT per week for 3 weeks in addition to the multidisciplinary stroke rehabilitation and exercise program which performed 5 sessions per week for 3 weeks. Control group (n=22) received a multidisciplinary stroke rehabilitation and exercise program for HSP of 5 sessions per week for 3 weeks.
Other intervention name(s): Rehabilitation program; Rehabilitation program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemiplehic shoulder pain; rotator cuff tear; high intensity laser therapy; exercise; ultrasound