bioihbjkbjnl/mcl2 huggingface dataset:
Simulator of Pompage Technique for Physiotherapists
Condition: Musculoskeletal Pain; Contracture
MeSH terms: Musculoskeletal Pain; Contracture
Study type: Interventional

Summary: 
      Parameterize the Pompage technique with an anatomical model cervical region to simulate
      specific procedures. Quantify the times, displacements, and facilitate the training of
      students and professional of physical therapy.
    

Detailed description: 
      Manual techniques are taught and trained with practical demonstration without technology
      support to measure them, so they are difficult to reproduce. This difficulty increases in
      Pompage technique because the student is not able to estimate the displacement on the skin.
      In this research, to parameterize and train the technique was developed and validated an
      anatomical model of the cervical region, with silicone and latex rubber. The anatomical model
      simulates the soft tissues and a plastic resin structure represents the cervical spine bone.
      An optical sensor was used to measure the displacements performed on simulated skin versus
      time. The Likert scale was used for assessing the similarity of the anatomical model relative
      to the size, shape, texture, elasticity and displacement of the skin as well as the curvature
      of the cervical spine. Five experienced professionals (GP) in the technical performed five
      series of Pompage technique. With the mean of data collected were determined benchmarks for
      technical and implemented in a standard guide to train the volunteers. Twenty-six volunteers
      (GE) with no experience performed the Pompage technique, with the anatomical model following
      the standard guide. A physical therapist (VE) was selected to evaluate the volunteers (GE)
      before and after training in the simulator.
    

Intervention name(s): Simulator's construction; Model Features; Parameterization technique; Simulator training; Training Evaluation
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Model to build the mold for the simulator; Volunteers to determine the elasticity of the skin and cirtometry neck to compare with the simulator.; Evaluation of the simulator features and parameterization of the Pompage technique in the simulator.; Training of pompage technique using the simulator.; Evaluation of volunteers from GE group before and after training with the simulator.
Other intervention name(s): VF; GT; GP; GE; VE
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pompage
Muscle Fatigue and Scapular Sensorimotor System
Condition: Muscle; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aims of this study are to investigate the effects of scapular muscle fatigue on scapular
      joint position sense and neuromuscular performance (scapular muscle strength, the kinematics
      data and muscle activity of shoulder during scaption (arm elevation in the scapular plane)).
      The investigators hypothesize that scapular muscle fatigue would increase scapular reposition
      error and affect neuromuscular performance of the scapular during scaption.
    


Intervention name(s): muscle fatigue
Intervention type(s): Other
Intervention description(s): Modified push-up plus exercise:
the participants first supported by both knees and the single elbow, and then performed sustained scapular protraction for three minutes with ten repetitions in males and two minutes with five repetitions in females with forty-five seconds rest between.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: sensorimotor system; scapular joint position sense; fatigue
Neurologic Examination of Wide and Narrow Tourniquets
Condition: Nerve Compression
Study type: Interventional

Summary: 
      Nerve injury is a serious potential complication associated with the clinical use of
      exsanguinating tourniquets in surgery. Recently, a novel narrow tourniquet has been proposed,
      with the claim that it may cause less compression of the nerves. We performed an in vivo
      comparison of a standard wide tourniquet with the new, narrow tourniquet. Our study
      specifically looked at neurologic markers in the upper extremity.
    

Detailed description: 
      The HemaClear ™ OHK Medical Device HemaClear™, approved by FDA, consists of a silicon ring
      wrapped in a stockinet sleeve and pull straps (Fig.1). It performs three functions - blood
      removal (exsanguinations), arterial flow occlusion, and placement of sterile stockinet 30.
      The ring is placed on the extremity and then straps are pulled proximally. The silicone ring
      rolls up the limb while the stockinet sleeve unfolds onto the limb. During the rolling up
      process, the ring exerts pressure and squeezes the blood away from the limb. Application of
      the device takes less than a minute.

      The technique behind this device is fundamentally different from classic pneumatic
      tourniquets, as pressure is exercised by only a single silicon ring so that the profile is
      very small.

      Zimmer A.T.S.®3000 The A.T.S.®3000 is an automatic broad tourniquet system with a Limb
      Occlusion Pressure (LOP) feature. It is the latest innovation in tourniquet technology and
      has FDA approval. It was invented by McEwen 4 and the basic function is described in several
      clinical trials and publications 28. The main difference to other pneumatic tourniquets is
      the LOP and the Recommended tissue pressure (RTP) feature. These parameters are suitable to
      optimize the pressure force on the tourniquet for each individual patient. The LOP is
      detected before inflating the tourniquet and the RTP is the LOP plus a safety margin to
      guarantee a blood free field (Operator & Service Manual Zimmer A.T.S.® 3000 Automatic
      tourniquet system REF 60-3000-101-00).
    

Intervention name(s): MRI
Intervention type(s): Radiation
Intervention description(s): MRI- imaging on the upper arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion
Condition: Concussion
Study type: Observational

Summary: 
      The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the
      Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.
    

Detailed description: 
      This is a prospective, non-randomized, blinded, matched control study of young athletes (ages
      10-25 years old) in competitive sports (Cohort A: higher-risk of concussion, Cohort B:
      lower-risk of concussion) to assess the effectiveness of the Nautilus BrainPulse device when
      used as an aid in the diagnosis of concussion.

      The Nautilus BrainPulse is intended for use on a patient's head to non-invasively detect,
      amplify and capture the brain pulse, the brain motion caused by pulsatile blood flow from the
      cardiac cycle. The Nautilus BrainPulse analyzes the captured data to provide an aid in
      diagnosing an episode of concussion.
    

Intervention name(s): Nautilus BrainPulse Recording
Intervention type(s): Device
Intervention description(s): Comparison of Nautilus BrainPulse recordings in subjects who have a concussive event (Cohort A) to Nautilus BrainPulse recording in subjects who do not experience a concussive events (Cohort B or matched subjects to Cohort A). Recordings are obtained over a 2 week period every 2 to 3 days (at least 5 recordings per subject).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort A: High-Risk of Concussion Middle school, high school and college athletes of either
        gender participating in sports where high-risk of concussion is anticipated: football,
        soccer, lacrosse, hockey, basketball, ice hockey, field hockey, rugby, cheerleading,
        boxing, and gymnastics.

        Cohort B: Low-Risk of Concussion Middle school, high school and college athletes of either
        gender participating in sports where low-risk of concussion is anticipated: swimming,
        track, volleyball, baseball, softball and golf.
      
Keywords: Concussion
Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)
Condition: Respiratory Syncytial Virus (RSV)
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to learn about the safety, pharmacokinetics and antiviral
      activity of the study medicine (RV299) for the potential treatment of respiratory syncytial
      virus (RSV). RSV is a highly contagious virus that can lead to serious lung infections in
      patients with reduced ability to fight infection. Most vulnerable populations include babies,
      the elderly and patients that have received a bone marrow transplant.
    

Detailed description: 
      This study is seeking healthy participants who are:

      Healthy adult male and female participants aged between 18 to 55 years, with a total body
      weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2 and who have been screened to
      be sero-suitable for infection with the RSV-A Memphis 37b virus challenge virus.

      A total of 80 participants is planned: 40 participants on RV299 and 40 participants on
      placebo.

      The study is divided into 3 phases:

        -  Screening phase: from Day -90 to Day-3 pre-human viral challenge (HVC).

        -  Inpatient phase: Participants will be resident in the quarantine unit for approximately
           15 days (from Day -2 to Day 12).

             -  Post RSV-A Memphis 37b virus inoculation on Day 0, participants will be randomized
                to receive RV299 or matched placebo.

             -  Administration of RV299 or placebo will be twice daily (~12 hours interval) for 5
                consecutive days and will start on confirmation of RSV infection.

        -  Outpatient phase: Day 28 (±3 days)
    

Intervention name(s): RV299; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Suspension; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Anti-viral; Challenge
Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography
Condition: Intubation, Intratracheal
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to
      monitor the position of the intubation probe.

      The primary assessment criterion is of study the position of the intubation probe with two
      examinations carried out independently :

        -  sonography

        -  chest radiography

      A correct position of the intubation probe will be considered if there is :

        -  Highlighting of the extremity of the intubation probe in endo tracheal

        -  Highlighting bilateral lung sliding
    

Detailed description: 
      Oesophageal intubation can cause death. Selective intubation can induce a poor ventilation,
      hypoxemia, atelectasis etc… It's not rare in paediatric intubation. The prevalence of
      malposition of endotracheal tube is 30 to 40% in babies and infants less than 1 year old.
      Currently doctors try to detect malposition of intra-tracheal tube by auscultation and
      capnograms and chest radiography is needed to confirm it. The Chest X ray is the gold
      standard.

      The aim of the study is to confirm the good positioning of the tube with a lung
      ultrasonography.

      After each intra-tracheal intubation, for patients with qualifying criteria, a lung
      ultrasonography will be performed, in bed, by two trained doctors (senior and junior) to
      determine if the position is right. Then, the chest radiography will be performed as usual.
    

Intervention name(s): lung ultrasound
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Intubated and ventilated minors
      
Keywords: Lung ultrasound; Sliding lung; Probe position
Flourish HEC to Prevent Recurrence of BV
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional

Summary: 
      In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial
      vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for
      prevention of BV recurrence over six months of use.
    

Detailed description: 
      BV treated with metronidazole or clindamycin recurs within 3 months in at least 43% of women,
      requiring additional rounds of antibiotics. Preliminary data show that the use of a
      commercially available 3-component kit can dramatically reduce BV recurrence over 11 weeks of
      use. This study tests a similar kit with one component altered - the intravaginal gel is
      composed of hydroxyethylcellulose rather than aloe, making it less likely to trigger
      reactions in women with sensitive tissues. The study will examine recurrence of BV, vaginal
      pH, and vulvovaginal symptoms as in the prior study, though extended to 6 months.
      Additionally, this study examines changes in the vaginal microbiome using targeted
      next-generation sequencing with the use of the Flourish HEC system.
    

Intervention name(s): Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)
Intervention type(s): Device
Intervention description(s): see arm description
Intervention model: Single Group Assignment
Intervention model description: A single group of women with recurrent bacterial vaginosis who elect to participate in the study will be assessed before and after using a vaginal care system.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BV recurrence; probiotic; intravaginal gel; vaginal pH; vulvovaginal symptoms questionnaire
Lung Recruitment Improves Right Ventricle Performance
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      This study test whether a lung recruitment maneuver improves the right ventricle performance
      after cardiopulmonary bypass. Half of the patients received an standard protective
      ventilation and the other half the same ventilatory pattern after a lung recruitment
      maneuver.
    

Detailed description: 
      Atelectasis is developed in 90% of anesthetized patients after surgery.

      Protective ventilation with low tidal volumes and positive-end expiratory pressure (PEEP)
      promotes atelectasis with the potential right ventricle dysfunction induced by the increment
      in afterload (activation of the pulmonary hypoxic vasocontriction reflex).

      Lung recruitment can improve the right ventricle performance caused by atelectasis because
      the pulmonary hypoxic vasocontriction reflex desapear in a normal aerated lungs.
    

Intervention name(s): Lung recruitment maneuver
Intervention type(s): Procedure
Intervention description(s): The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (20 cmH2O of PEEP + 20 cmH2O of driving pressure) for 10 breaths.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of
      risankizumab as induction treatment in subjects with moderately to severely active ulcerative
      colitis (UC), and to identify the appropriate induction dose of risankizumab for further
      evaluation in Sub-Study 2.

      The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared
      to placebo in inducing clinical remission in subjects with moderately to severely active UC.
    


Intervention name(s): risankizumab IV; placebo for risankizumab; risankizumab SC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): risankizumab intravenous (IV) infusion; placebo for risankizumab; risankizumab subcutaneous (SC) injection
Other intervention name(s): ABBV-066; BI 655066; ABBV-066; BI 655066
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ABBV-066; BI 655066
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
Condition: Kidney Transplantation, Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte
      (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant
      recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte
      orally daily for up to 200 days post-transplant and will be followed for 52 weeks
      post-transplantation.
    


Intervention name(s): valganciclovir [Valcyte]
Intervention type(s): Drug
Intervention description(s): Oral, daily for up to 200 days.
Intervention MeSH terms: Valganciclovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)
Condition: Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain
MeSH terms: Low Back Pain; Nociceptive Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
    

Detailed description: 
      Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or
      HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue
      to require daily administration of an NSAID for the next 6 months will receive treatment with
      the same study medication received while participating in HZ-CA-301 or HZ-CA-303.
    

Intervention name(s): HZT-501; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks; Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effectiveness of Eating Disorder Treatment
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Family-based treatment (FBT), a form of family therapy for eating disorders (ED) in young
      patients, has proven to be effective in numerous large-scale studies. This study aims to
      evaluate outcomes of the treatment for anorexia nervosa (AN) in a 'real-world' setting in a
      specialized outpatient clinic in Helsinki, Finland. Fifty-two young female patients seen for
      treatment between June 2013 and December 2017 were included in the study. Demographic and
      treatment characteristics, weight, and ED symptoms before and after treatment are reported
    

Detailed description: 
      Aim: The naturalistic outcome of outpatient FBT for adolescent AN was investigated.

      Methods: Fifty-two female patients and their families who received FBT at a tertiary eating
      disorders unit participated in the study. Data on their pre-treatment parameters, treatment
      details, and condition at the end of treatment (EOT) was collected from their medical records
    

Intervention name(s): Family-based treatment
Intervention type(s): Behavioral
Intervention description(s): FBT is carried out by a family therapist who has received FBT training. The duration of FBT is commonly 6-12 months, in most cases comprising 10-20 sessions. At the beginning of treatment, there are weekly sessions; later in treatment, the sessions are less frequent. The patient and their family meet their psychiatrist every four to six weeks, and the family therapist also takes part in these meetings. The treatment is implemented in accordance with the FBT treatment manual.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Ile-Pro-Pro (IPP) on Endothelial Function in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      This study will investigate whether the lacto-tripeptide Ile-Pro-Pro (IPP) improves the
      function of the endothelium in patients with coronary artery disease. The study has a
      crossover design. Participants will be treated with a protein hydrolysate rich in IPP for 12
      weeks and placebo for 12 weeks with a four-week rest period between treatment periods. The
      investigators will use ultrasound to test the function of the endothelium in the brachial
      artery before, after 6 weeks, and after 12 weeks of each treatment. Blood will be collected
      before and after each treatment. The investigators hypothesize that IPP will improve
      endothelial function.
    


Intervention name(s): IPP; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Protein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day; Matching placebo capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Lurasidone Low-Dose - High-Dose Study Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in
      subjects with an acute exacerbation of schizophrenia.
    

Detailed description: 
      The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in
      subjects with an acute exacerbation of schizophrenia. This study will also evaluate the
      efficacy and safety of lurasidone 80 mg/day and160 mg/day versus placebo in subjects who are
      early non-responders (operationally defined per protocol) to lurasidone 80 mg/day.
    

Intervention name(s): Lurasidone; Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lurasidone 20 mg once daily; Lurasidone 80 mg once daily; Once Daily
Other intervention name(s): Latuda; Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Lurasidone; Latuda