bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Fluid Challenge on Intracranial Pressure
Condition: Fluid Challenge; Increased Intracranial Pressure
MeSH terms: Intracranial Hypertension
Study type: Interventional

Summary: 
      Fluid challenge is frequently used in fluid management of critically ill patients. Assessing
      whether there is a preload reserve that can be used to increase the stroke volume by
      delivering a small amount of fluid in a short period of time. Optimization of fluid therapy
      is very important in intensive care patients. Inappropriate fluid therapy can cause
      significant morbidity and even mortality. Increased intracranial pressure is one of these
      important complications. In the present study, we planned to evaluate the effect of a fluid
      challenge on intracranial pressure by measuring the optic nerve sheath diameter (ONSD).
    

Detailed description: 
      The fluid challenge is a simple volume resuscitation evaluation method that provides an
      indication of the patient's likelihood of benefiting from an increase in the intravenous
      fluid volume. Both the fluid challenge and fluid responsiveness are evaluated by interpreting
      the change in hemodynamic parameters after 500 mL of crystalloid (or 250 mL of colloid)
      solution is infused over 10-15 min. This is done in an attempt to regulate the fluid therapy
      of hemodynamically unstable patients in order to prevent fluid overload. In the present
      study, we aim to investigate the effect of the fluid challenge maneuver on intracranial
      pressure in ICU patients with hemodynamic instability through measuring the optic nerve
      sheath diameter by ultrasonography.

      Patients in the intensive care unit undergoing a fluid challenge were included in this
      prospective observational study. A fluid challenge is defined as a 500 mL crystalloid
      infusion administered over 10 min, and fluid responsiveness is defined as a subsequent
      increase in stroke volume of at least 15%. The ONSD and hemodynamic variables will be
      measured by ultrasonography before (T0), at the end (T1), and 30 min after the fluid
      challenge (T2). The primary outcome of the study is the change in intracranial pressure
      associated with the fluid challenge, and the secondary outcome is the relationship between
      fluid responsiveness and the change in ONSD.
    

Intervention name(s): Measurement of optic nerve sheath diameter
Intervention type(s): Diagnostic Test
Intervention description(s): The fluid challenge effects of optic nerve sheath diameter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: optic nerve sheath diameter, fluid challenge
The Placenta Previa and Fetal Weight
Condition: Placenta Previa
MeSH terms: Placenta Previa; Fetal Weight
Study type: Observational

Summary: 
      Placenta previa is a placenta that implants at lower uterine segment, it occurs in about
      0.3-0.5% of pregnancies at term. It is a significant risk for development of maternal
      morbidity, as well as maternal mortality secondary to maternal hemorrhage . Also, this
      abnormal placenta has a negative concern about fetal well being due to prematurity and
      perinatal mortality, in addition to its undesirable effect on fetal growth. Several factors
      may be behind of the effect of placenta previa on fetal growth. Firstly, the blood supply to
      the lower uterine segment is less than at the upper segment apparently resulting in less
      feto-placental blood perfusion . Secondly, recurrent bleeding attacks from placental previa
      may affect fetal oxygenation and fetal growth.

      In spite of above evidences; many studies in literature denied the relation between placenta
      previa and fetal growth and concluded that the association between low birth weight and
      placenta previa is mainly due to preterm delivery and to a lesser extent with fetal growth
      restriction. However; the major drawback of all these studies is lacking of reporting the
      effect of placenta previa of feto-maternal blood flow representing in studying of Doppler
      blood flow in both uterine and umbilical artery in those patients. The uterine artery blood
      flow is usually affected by the presence of placenta previa and placenta accreta which
      reflected on feto-placental blood flow. So the uterine artery Doppler velocimetry is a useful
      tool for predicting placenta accreta .

      So in the light of above evidences; we aimed, in the current study, not only to investigate
      the effect on placenta previa on fetal weight but also to walk around the effect of placenta
      previa on the uterine and umbilical arteries blood flow in trial to explore this conflicting
      issue. To our knowledge, no previous trial had studied this interesting subject before.
    


Intervention name(s): placenta previa patient; normal women
Intervention type(s): Other; Other
Intervention description(s): women had placenta previa either major or minor degree; those women had not placenta previa
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        placenta previa patients
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is evaluating the potential antidepressive effect of a 4 week treatment protocol
      using the H-coil deep TMS device in bipolar depression.
    


Intervention name(s): H1 -coil TMS device
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ECG Optimization of CRT: Evaluation of Mid-term Response
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated,
      such as the use of the electrocardiogram.

      In this prospective, double-blind, study, the investigators will evaluate:

      Primary endpoint: To compare the clinical response to CRT in patients with the programming
      optimized by QRS versus the nominal suggested by the device.

      Secondary endpoints:

        1. To compare cardiac remodeling in patients with the programming optimized by QRS versus
           the nominal suggested by the device.

        2. To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS)
           with respect to the intrinsic rhythm.

        3. To evaluate the echocardiographic improvement in left ventricular (LV) filling in both
           groups.

        4. To evaluate the differences in the optimal atrioventricular (AV) delay with atrial
           sensing or atrial pacing.

      For that, 180 patients with an indication for CRT will be randomized to nominal programming
      of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and
      echocardiographic evaluation will be done at baseline, 6 and 12 months.
    


Intervention name(s): Device programming: nominal; Programming optimization by QRS
Intervention type(s): Other; Other
Intervention description(s): CRT device is programmed to nominal values; CRT device is programmed by QRS optimization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac; Resynchronization; Therapy
The Ideal Length of the Nasotracheal Tube Considering Nasotracheal Tube Size
Condition: Nasotracheal Intubation for General Anesthesia
Study type: Observational

Summary: 
      The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the
      surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are
      often not fitted in anatomy of Korean people because of small nostril. When the size of the
      tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the
      glottis. The aim of this study is to evaluate the appropriateness of the tube depth and to
      suggest the ideal length of the nasotracheal tube during the intubation of the selected
      tracheal tube in consideration of the size of the nasal cavity in Koreans. 146 patients (73
      males and 73 females) who are scheduled for nasal intubation for general anesthesia will be
      enrolled. The primary outcome is the ideal length of tube that allows the distance from the
      vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of
      the intubated tube to be located 5 ± 2 cm above the tracheal carina. The size of nostril,
      length from the nare to the carina and vocal cord are measured.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are scheduled for nasotracheal intubation for general anesthesia
      
Keywords: Intubation; Intratracheal; Nasopharynx
Corneal Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneas
Condition: Surgical Procedure, Unspecified
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate safety and efficacy of corneal cross-linking and
      photorefractive keratectomy for refractive correction in patients with bilateral asymmetric
      topography.
    

Detailed description: 
      Corneal cross-linking (CXL) by the photosensitizer, riboflavin (vitamin B2), and ultraviolet
      A (UVA) light increases corneal rigidity and has been described as an effective method for
      stabilizing the cornea in patients with progressive keratoconus. The photochemical reaction
      in this procedure causes the collagen to form additional covalent connections between its
      fibers, which stabilizes the stromal collagen fibers, improving the collagen's structure and
      the cornea rigidity. It is a relatively safe procedure with low rates of complications
      Photorefractive keratectomy (PRK) it is a traditional technique for refractive surgery. In
      cases of irregular corneas or re-operation normally the favorite ablation profile chosen is
      the guided surgery, topography guided or wavefront guided, showing better results. This
      technique is also relatively safe procedure with low rates of complications. One of the most
      unwanted complications of this surgery and also rare is corneal ectasia.

      Combining PRK and CXL is already done in patients with keratoconus and suspected keratoconus.

      This combined procedure uses the principle that CXL stiffen the cornea making it possible to
      reduce corneal thickness with PRK without weakening corneal strength. Literature show better
      results, in keratoconus, with simultaneous procedures. Guedj et al performed PRK in
      keratoconus suspects and within 5 years he did not found any corneal ectasia.
    

Intervention name(s): CXL + PRK group; PRK group
Intervention type(s): Procedure; Procedure
Intervention description(s): Corneal cross-linking with subsequent photorefractive keratotomy after 6 months was performed in one eye; Photorefractive keratotomy alone was performed in contra lateral eyes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractive Surgical Procedures; Photorefractive Keratectomy; Aberrometry
Salivary Inflammatory Biomarkers: Predictors & Comparative Effects of Sonicare/Elite-Flexcare in Stages of Perio Disease
Condition: Inflammation; Periodontitis
MeSH terms: Periodontitis; Inflammation
Study type: Interventional

Summary: 
      This research study has 2 aims. One aim is to see if saliva testing can show if a person has
      healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate, or
      severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush on
      periodontitis.
    

Detailed description: 
      Randomized controlled trial to determine clinical and inflammatory benefits of Sonicare
      Flexcare tooth brushing following experimental induction of biofilm overgrowth in various
      periodontal conditions.

      This research study has both a Diagnostic Aim and a Treatment Aim. Aim #1 is to examine the
      utility of candidate inflammatory biomarkers within saliva to discriminate between health,
      gingivitis, mild, moderate and severe periodontis; and to discriminate between active versus
      inactive states of periodontal disease to see if these basal levels can predict the clinical
      response to biofilm overgrowth among various periodontal conditions; Aim #2 is to extend the
      claim of the anti-inflammatory and anti-infective efficacy of the Sonicare/Elite-Flexcare as
      compared to manual brushing to include 4 levels of periodontal disease [BGI-G, P1, P2 and
      P3].

      The devices used in this study are subject only to Class I (general controls) and considered
      exempt from the premarket notification procedures and not subject to section 510(k), 515, or
      520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the
      definition of an Applicable Clinical Trial.
    

Intervention name(s): Sonicare/Elite-Flexcare Toothbrush; Manual Toothbrush
Intervention type(s): Other; Other
Intervention description(s): Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles; traditional (non-mechanical) toothbrush with nylon bristles and plastic handle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Other
Keywords: Inflammatory biomarkers; Periodontitis
Colonoscopy in the Prone Position for Patients With BMI Greater Than 30
Condition: Obesity
Study type: Interventional

Summary: 
      In the United States, colonoscopy has become the most commonly used screening test for
      colorectal cancer. Colonoscopy is typically performed with the patient starting in the left
      lateral decubitus position, however there is little data to support this practice and
      starting position is variable amongst individual gastroenterology physicians.

      The investigators plan to randomize patients with Body Mass Index >30 that are presenting to
      the University of Virginia for colonoscopy to either the prone or left lateral decubitus
      position. The investigators will then record and compare cecal intubation times as well as
      amount of sedation used and complications to help determine which position is superior for
      this patient population.
    

Detailed description: 
      Patients that have been scheduled for colonoscopy will undergo chart review. Patients who
      meet inclusion criteria will be invited to participate at the time consent is obtained for
      the colonoscopy. Participants will then be randomized to one of two colonoscopy starting
      positions.

      After randomization, patients will begin the colonoscopy in either the prone position or left
      lateral decubitus position.

      It is common practice to re-position the patient during endoscopy (including supine and prone
      positions) and some endoscopists commonly employ prone starting position for obese patients,
      although there is no estimate in the literature as to the prevalence of this practice.

      No additional interventions will be performed for research purposes. During the colonoscopy,
      the endoscopist will be allowed, as usual, to adjust patient position as needed to complete
      the procedure. Cecal intubation time, amount of sedation used, and any intra-procedural
      complications (hypoxia, hypotension, etc) will be recorded for data analysis. This
      information is standardly recorded in the procedure report in the patient's medical record.
      The study will not affect any interventions performed during the colonoscopy such as polyp
      removal or biopsies as, clinically indicated. Per endoscopy unit protocol, patients will be
      monitored in the recovery area and discharged home with supervision. The study requires no
      further direct patient interaction after the colonoscopy is completed. Charts will be
      reviewed at 30 days to assess for any delayed and unexpected complications.
    

Intervention name(s): Position during colonoscopy
Intervention type(s): Procedure
Intervention description(s): Position during colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: colonoscopy
Iterative Beta Testing of Videos for the DIPPer Academy
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this research is to develop DIPPer Academy, a parent-focused, mobile health
      (mHealth) behavioral intervention to promote glycemic control in young children.
    

Detailed description: 
      Because many young children with T1D have glucose levels that exceed targets, investigators
      need to develop efficacious, accessible, and readily disseminable interventions to help them
      to improve their glycemic control. To do this, the investigators need efficacious
      interventions that specifically address the challenges that parents of young children face in
      daily T1D management. Providers need mHealth interventions that minimize barriers that
      parents experience when trying to access face-to-face or in clinic interventions. Finally,
      interventions are needed that are packaged to be easily deployable by other diabetes centers.
      The investigator's proposed intervention, DIPPer Academy, will include all of these
      recommended advancements.
    

Intervention name(s): DIPPer Academy; Standard of Care
Intervention type(s): Behavioral; Other
Intervention description(s): The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.; Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by the diabetes team.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery
Condition: Total Knee Replacement Surgery
MeSH terms: Thromboembolism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a single administration
      of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.
    

Detailed description: 
      Currently available anticoagulant therapies for the prevention of VTE include low molecular
      weight heparins, pentasaccharides and vitamin K antagonists, all of which have inherent
      limitations(1-3).

      Improved anticoagulant agents are therefore required(4). A novel antithrombotic agent
      requires demonstration of both efficacy and safety in relevant populations. Phase II studies
      are frequently performed in patients undergoing total hip replacement and/or total knee
      replacement because of the high and well documented incidence of deep vein thrombosis in the
      absence of adequate thromboprophylaxis(5-7).

      In this study, we assess the safety and efficacy of TB-402, a novel antithrombotic agent that
      partially inhibits factor VIII, in the prevention of VTE in patients undergoing total knee
      replacement surgery.
    

Intervention name(s): TB-402; Enoxaparin
Intervention type(s): Drug; Drug
Intervention description(s): TB-402 administered as single bolus 18-24 post total knee replacement surgery.; Enoxaparin 40mg/day sc injection for at least 10 days post-surgery
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: TKR; VTE; DVT
Video-Based Task Oriented Activity Training in Patients With Juvenile Idiopathic Arthritis
Condition: Video-based Task Oriented Activity Training
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      Juvenile idiopathic arthritis (JIA) is most common chronic rheumatic disease in childhood.
      The upper extremity involvement in JIA causes muscle imbalance, joint destruction, pain,
      stiffness and limitations on daily living activities (DLA) in varying degrees. However, the
      information about prevalence of symptoms, disorders, DLA limitations, participation
      restriction and options of treatments for upper extremity involvement in JIA are limited. It
      has been reported that improvements of upper extremity functions were achieved by video-based
      games (VBG) in various disease groups. However, in the literature, no study has been found
      about effectiveness of WBG in children with arthritis. The aim of the study was to
      investigate effects of task-oriented activity training (TOAT) with VBG versus activity
      training in real life on activity performance and participation in children with arthritis.
      Participants with upper limb involvement in JIA were randomly assigned to the activity
      training in real life group (group I) and TOAT with VBG in real life group (group II). The
      actual materials and rehabilitation kits will be used for activity training in group 1, the
      DLA that expected to gain independence will be trained with VBG in group 2. Upper extremity
      muscle strength and grip, range of motion, upper limb functions, activity, participation and
      quality of life will be evaluated. The hypothesis of this study is that TOAT with VBG
      improves the activity performance and physical functions and increases the participation, via
      being stimulative and interactive in order to provide feedback and to increase interest and
      motivation.
    


Intervention name(s): activity training
Intervention type(s): Other
Other intervention name(s): exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: activity performance; juvenile idiopathic arthritis; virtual reality
A Study of the Pharmacokinetics of Uprifosbuvir (MK-3682) and Ruzasvir (MK-8408) in Participants With Moderate and Severe Hepatic Insufficiency (MK-3682-029)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-randomized, open-label, single-dose study to evaluate the pharmacokinetics (PK)
      of uprifosbuvir (MK-3682), the M5 and M6 metabolites of uprifosbuvir, and ruzasvir (MK-8408),
      in participants with moderate hepatic insufficiency (HI), participants with severe HI, and
      age-matched healthy control participants.
    


Intervention name(s): Uprifosbuvir; Ruzasvir
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of uprifosbuvir 450 mg (given as three 150-mg tablets) taken by mouth.; A single dose of ruzasvir 60 mg (given as six 10-mg capsules) taken by mouth.
Other intervention name(s): MK-3682; MK-8408
Intervention MeSH terms: Ruzasvir; Uprifosbuvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment