bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess and compare the short-term post-operative continence recovery rate in two cohorts
      of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo
      RARP with Vattikuti Institute technique or Retzius sparing technique.
    

Detailed description: 
      Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to
      the bladder. This technique necessitates the dissection and/or manipulation of many
      structures, which might compromise post-operative urinary continence recovery. These
      structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and
      veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed
      described. This approach passes posteriorly to the bladder, through the space of Douglas,
      which should minimize the damaged to the aforementioned structure. Theoretically, the latter
      technique should improve post-operative urinary continence recovery. However, a randomized
      comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.
    

Intervention name(s): Retzius sparing radical prostatectomy; Vattikuti Urology Institute radical prostatectomy; da Vinci Surgical System
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique; Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique; The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: prostate cancer; Urinary continence; robotic assisted radical prostatectomy; Vattikuti Urology Institute (VIP) radical prostatectomy; Retzius sparing radical prostatectomy
Diurnal Variation of Uremic Solutes in Peritoneal Dialysis
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Study on the daytime variation of uremic retention solutes and markers of bone-mineral
      metabolism in patients with end-stage kidney disease treated with peritoneal dialysis
    

Detailed description: 
      Many epidemiological studies have pointed to the association between serum parameters of
      phosphate metabolism (phosphate, FGF23) and microbiotic protein fermentation (p-cresyl
      sulphate [PCS], indoxyl sulphate [IS]) on the one hand and increased risk of all-cause and
      cardiovascular death on the other hand.

      Hypothesis: Due to failing feed-back mechanisms, diurnal variation of serum concentrations of
      serum phosphate and fermentation metabolites will be more pronounced in dialysis patients,
      especially in those with negligible residual kidney function.

      Clinical studies assessing this issue are scarce to non-existing.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Peritoneal dialysis patients Healthy volunteers
      
Biospecimen description: 
      whole blood, serum, urine and dialysate
    
Keywords: diurnal variation; peritoneal dialysis; uremic retention solutes; phosphorous; indoxyl sulfate; p-cresol sulfate
Continuous Glucose Monitoring in Diabetes and Prediabetes
Condition: Diabetes Mellitus, Type 2; PreDiabetes; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior
      modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM,
      nutrition and exercise education, participants will be able to monitor their blood sugar in
      real time for 2 sessions . Education on how to interpret CGM in the setting of food choices
      and exercise coupled with nutrition and exercise information should lead to improved weight
      and other nutritional and exercise changes.
    


Intervention name(s): DEXCOM G6 RT-CGM
Intervention type(s): Device
Intervention description(s): CGM is a way to measure glucose levels in real-time. A tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. A small plastic piece of tube remains inserted in the skin. It is connected to a transmitter that sits on top of the skin. It is approved for use on the abdomen for 10 days. It either records the sugars downloaded in the clinic (blinded part of the study) or it sends the information via wireless radio frequency to a monitoring/ display device or to a cellular phone so participants can see data. DEXCOM G6 is FDA approved for use in patients with diabetes and will be used in accordance with instructions as approved for diabetes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
Condition: Lower Back Pain
MeSH terms: Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if two sustained released formulations of
      carisoprodol are more effective than placebo.
    

Detailed description: 
      Methodology:

      This will be a randomized, double-blind, double-dummy, placebo-controlled, parallel-group
      study in subjects 18-70 years of age with acute, painful, muscle spasm of the lower back. The
      study consists of a baseline screening (Study Day 1), during which subjects will be evaluated
      for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1
      through Study Day 7). Subjects will be randomly assigned to be dosed twice daily with one of
      the following double-blind treatments: SR carisoprodol 500-mg tablets, SR carisoprodol 700-mg
      tablets, or placebo.

      Subjects will be evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remain
      symptomatic on Study Day 7 will be allowed to continue in the study for a 7-day, double-blind
      extension period at the discretion of the Investigator. Subjects will be contacted by
      telephone for a safety follow-up 7 days after the last dose of study medication.

      A pharmacokinetic (PK) substudy will be conducted at selected sites. These sites will obtain
      blood samples for PK analysis at the end of the 7-day treatment period and the 14-day
      treatment period, if applicable.
    

Intervention name(s): Carisoprodol SR 700 mg; Carisoprodol SR 500 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 700 mg twice daily tablet; carisoprodol SR 500 mg tablet; placebo tablet
Other intervention name(s): no other name; no other name; no other name
Intervention MeSH terms: Carisoprodol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.
Condition: Acellular Pertussis; Tetanus; Diphtheria; Poliomyelitis
MeSH terms: Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV
      vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children
      5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine
      according to the "3-5-11" month schedule recommended in Italy.

      In this study, MMRV vaccine will also be co-administered to all children.
    


Intervention name(s): Boostrix Polio™ 711866; Priorix Tetra TM 208136; Tetravac TM
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single dose, intramuscular administration.; Single dose, subcutaneously.; Single dose, intramuscular administration.
Other intervention name(s): dTpa-IPV; MMRV; DTPa-IPV
Intervention MeSH terms: Pentetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Boostrix Polio; dTpa-IPV
Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients
Condition: Neuromuscular Disease
MeSH terms: Neuromuscular Diseases
Study type: Interventional

Summary: 
      Validation of a measure specifically suitable to evaluate the residual function of upper
      limbs of non-ambulant neuromuscular patients, especially with Duchenne muscular dystrophy and
      spinal muscular atrophy.

      This approach is of fundamental importance for clinical monitoring and preparing the future
      therapeutic trials.
    

Detailed description: 
      The main objective is the continuous measurement of muscle activity in a standardized setting
      and in the non ambulatory patient's natural environment. This measure uses an innovative
      technology based on accelerometer and magneto-inertial sensors. The system is intended to
      measure the physical activity of patients from the extraction of data recorded by the sensors
      in the three space axes.

      The non ambulatory patients will be included and evaluated at baseline and 14 days later. The
      patients wear the accelerometer device during some standard evaluations and also at home
      continuously for 14 days.

      With this protocol the investigators want to try to find the best variable that characterizes
      the movement of the upper limbs of non-ambulant neuromuscular patients.

      The aim of Pre-Acti is to propose a primary outcome measure that may be used in clinical
      monitoring of patients.
    

Intervention name(s): Different standardized tasks with an accelerometer device
Intervention type(s): Other
Intervention description(s): Patients will perform tests like hand grip (MyoGrip), pinch (MyoPinch), Moviplate, box and block test of hand function, Minnesota Manual Dexterity Test. The tests will be performed with the accelerometer device worn on the wrist.
Other intervention name(s): MyoGrip; MyoPinch; Moviplate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: accelerometry; neuromuscular disease
A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in Children
Condition: General Anesthesia; Supraglottic Airway Devices
Study type: Interventional

Summary: 
      Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The
      pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices
      for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The
      air-Q is a new single-use device that may optimise the airway seal while reducing the
      potential for postoperative complications such as sore throat. The overall structure of the
      air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The
      aim of this randomized trial was to compare the clinical performance of the i-gel and the
      air-Q SP.
    


Intervention name(s): Insertion of I-gel; Insertion of air-Q
Intervention type(s): Device; Device
Intervention description(s): After induction of general anesthesia, I-gel will be inserted according to randomly allocated group.; After induction of general anesthesia, air-Q was inserted according to randomly allocated group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: supraglottic airway devices; the i-gel; the self-pressurised air-Q intubating laryngeal airway,; children
IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the follow-up of study IMCY-T1D 001 (EudraCT: 2016-003514-27, NCT03272269) in
      which patients with recent onset T1D have been treated with IMCY-0098 or placebo.

      At the end of the primary 6 month study, patients will be proposed to enter this follow-up
      study to evaluate up to 12 months (V3 - Week 48) the safety, the immune responses and the
      clinical parameters.

      The study involves a follow-up of 6 months after the end of the initial participation to the
      IMCY-T1D-001 study. Subjects will undergo visits at 24 weeks, 36 weeks and 48 weeks post
      first study product administration in study IMCY-T1D-001.

      For each patient, the study comprises a total of 3 visits occurring over a period of
      approximately 24 weeks (from study entry). The patients will undergo planned assessments and
      procedures as outlined in the table of study procedures.
    

Detailed description: 
      In this Long-Term Follow-Up (LTFU) study, the below objectives will be assessed 36 and 48
      weeks after the first injection of IMCY-0098 in the study IMCY-T1D-001, in patients treated
      with IMCY-0098 at three doses or placebo:

      Primary Objective The primary objective of this study is to assess the long-term safety.
      Secondary Objective The secondary objective of this study is to evaluate the clinical
      response to IMCY-0098 by assessing disease activity.

      Exploratory Objectives

        -  To evaluate the proinsulin-specific cytolytic CD4+ T cells induced by IMCY-0098

        -  To evaluate the impact of IMCY-0098 on autoreactive T-cell responses specific for
           autoantigens expressed by islet β-cells (proinsulin, GAD65, IGRP) on the longer-term.

        -  To evaluate the impact of IMCY-0098 on autoantibodies against GAD65, IA 2, ZnT8 and
           insulin

        -  Transcriptomic analysis on mRNA extracted from samples collected for Immunogenicity
    

Intervention name(s): IMCY-0098 or placebo
Intervention type(s): Drug
Intervention description(s): Long-term follow-up
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Long-term follow-up (LTFU), no study treatment administered.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Tai Chi for Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of this study was to study the impact of Tai Chi group exercise on physical
      function, health and disease activity of patients with RA, and to examine the patients'
      experience and perception of Tai Chi.
    

Detailed description: 
      Rheumatoid arthritis (RA) is a chronic, inflammatory and systemic disease that mainly affects
      the musculoskeletal system. The disease is often progressive and may result in reduced
      physical function, pain, fatigue, and joint destruction. Exercise programs are reported to
      improve physical functioning in patients with RA.

      Tai Chi is a traditional Chinese martial art that was developed in the 13th century, and
      combines slow and gentle movements with mental focus.

      The aim of this study was to examine the impact of a 12 weeks standardized Tai Chi group
      exercise program on disease activity, physical function and health status in patients with RA
      attending. Further, the patients experiences of possible effects of Tai Chi were to be
      obtained in a focus group interview.
    

Intervention name(s): Physical exercise
Intervention type(s): Other
Intervention description(s): Tai Chi exercise, twice a week during 12 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Physical function; Rheumatoid arthritis; Tai Chi
SIS Graft and Traditional Repair in Vaginal Wall Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate surgical treatment of anterior vaginal wall
      prolapse using the sis graft or traditional repair. This a randomized and prospective study.
      Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in
      quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with
      FSFI and possible complications.
    

Detailed description: 
      The objective of this study is to evaluate surgical treatment of anterior vaginal wall
      prolapse using the sis graft or traditional repair. This a randomized and prospective study.
      Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in
      quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with
      FSFI and possible complications
    

Intervention name(s): Traditional correction of anterior vaginal wall prolapse; Biologic Graft (SIS)
Intervention type(s): Procedure; Procedure
Intervention description(s): Traditional repair.
Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.; Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.
Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pelvic Organ Prolapse; Surgical Treatment
Circulating microRNAs for Discriminating Obese Preschoolers at Risk of Diabetes
Condition: Discriminate Obese Children at Risk for Diabetes.
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Childhood obesity certainly increases susceptibility to type 2 diabetes (T2D) in adulthood.
      Recently, microRNAs (miRNAs) are closely related to various diseases and have been suggested
      as valuable biomarkers. Here, we sought to identify potential miRNAs to discriminate obese
      children at risk for diabetes in future.
    

Detailed description: 
      This study was designed to screen the circulating miRNAs in association with progression from
      children obesity to type 2 diabetes (T2D) in adulthood. Serum samples were evaluated in a 3
      step procedure: 1) discovery study, in which samples from obese children and healthy controls
      were pooled for miRNA sequecing experiment; 2) cross-sectional validation study, in which
      miRNAs of interest were validated in all individuals (obese children, overweight children and
      normal controls); 3) longitudinal validation study, in which the candidate miRNAs were
      estimated in newly diagnosed diabetes patients and normal glucose tolerance controls (NGT).
      The final determined miRNAs were further confirmed though primary function studies.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children recruiters were categorized into three groups: obesity, overweight and normal
        control based on World Health Organization child growth standards. Adults with type 2
        diabetes were defined if the individual had a fasting plasma glucose (FPG) level ≥ 7.0
        mmol/L.
      
Biospecimen description: 
      Whole blood, Serum
    
Keywords: Circulating microRNA; Childhood obesity; Adulthood diabetes
Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography and Correlation to Imaging Data in Young Athletes
Condition: Healthy
Study type: Observational

Summary: 
      This study aims to compare measurements obtained through the e-VOG application (mobile
      application, usable on smartphones or tablets, to record eye movements) with measurements
      from the standard video-oculography device (Eye-Tracker®T2), in young athletes. This study
      also aims to correlate these measurements with volumetric data from cerebral imaging (if MRI
      done in routine care at the same period, more or less 1 month).
    

Detailed description: 
      e-VOG Young athletes is a collaborative study between the Memory Center of the Rainier III
      Center (Princess Grace Hospital, Monaco), the Neurology Department of Nice University
      Hospital (France), and the AS Monaco Football Academy medical team.

      Memory Center of the Rainier III Center is expert in eye-tracking and is equipped with a
      standard video-oculography device (Eye-Tracker®T2), which records eye movements at a high
      frequency and measures saccades parameters (latency, speed, amplitudes etc...).

      e-VOG is a mobile application, home-developed by the Neurology Department team of Nice
      University Hospital, to measure eye movements.

      In the continuity of the e-VOG(YA) study (NCT05211752), we set-up study named e-VOG-Young
      Athletes-Extension. This study will increase the number of assessments carried out (standard
      video-oculography assessment versus e-VOG digital assessment) in a population of athletes
      without major health problems, and who have not presented concussion, in order to meet more
      powerfully the main objective of the e-VOG(YA) study. It will also make it possible to
      observe whether there is a correlation between disturbed oculomotor movements, oculomotor
      anomalies and volumetric data measured by cerebral MRI (obtained using automatic segmentation
      software on cerebral regions specifically involved in the eye movement control).
    

Intervention name(s): eVOG (Mobile VideoOculoGraphy)
Intervention type(s): Other
Intervention description(s): Eyes movements assessed with e-VOG (mobile application developed on an iPad, that uses the face detection features of the front camera to detect and record eye movements).
Study duration is about 20 minutes, the day the subject performs his standard video-oculography examination in routine care (using Eye-Tracker®T2)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Young athletes for whom a standard video-oculography exam is prescribed by the AS Monaco
        Football medical Team as part of a preventive and follow-up approach performed in routine
        care.
      
Keywords: Young athletes