bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients
Condition: Airway Complication of Anaesthesia
MeSH terms: Paralysis
Study type: Interventional

Summary: 
      The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways
      in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak
      pressure. The investigators also studied their relative ease of insertion, time to insertion
      and complications of use as secondary outcome measures.
    

Detailed description: 
      A total of 105 patients scheduled for elective gynaecological laparoscopic procedures in our
      Inonu University Medical Faculty Hospital were recruited.They were equally randomized into
      three groups: PLMA, supreme and i-gel groups. All three devices were compared with regard to
      oropharyngeal leak pressure, number and duration of insertion attempts and complications of
      airway. Oropharyngeal leak pressure will evaluate including to start,trendelenburg and
      postoperative at period. Fiberoptic evaluation of the LMA's position were performed after
      successful insertion and determination of the airway pressures. After one hour patients were
      evaluated by a blinded independent observer for postoperative complications ( sore throat,
      dysphonia and dysphagia).
    

Intervention name(s): PROSEAL LMA; SUPREMA LMA; I-GEL LMA
Intervention type(s): Device; Device; Device
Intervention description(s): Size 3,4 or 5 supraglottic device with orogastric drainage tube; Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube; Size 3,4,5 disposable supraglottic device with noninflatable cuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: airway management
Semantic Memory, Financial Capacity, and Brain Perfusion in Mild Cognitive Impairment (MCI) (CASL)
Condition: Alzheimer Disease; Dementia
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops.
      Dementia is considered to be present when a person can no longer handle complex activities of
      daily living, such as managing finances. This study will investigate the relationship between
      changes in the ability to manage finances and brain perfusion, which will be measured using
      continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo
      neuropsychological tests focusing on several types of memory and thought process, with
      special emphasis on semantic memory. An important question to be addressed is whether changes
      in function are better predicted by the neuropsychological tests or by the brain scan.
    

Detailed description: 
      Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops.
      Dementia is considered to be present when a person can no longer handle complex activities of
      daily living, such as managing finances. This study will investigate the relationship between
      changes in the ability to manage finances and brain perfusion, which will be measured using
      continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo
      neuropsychological tests focusing on several types of memory and thought process, with
      special emphasis on semantic memory. An important question to be addressed is whether changes
      in function are better predicted by the neuropsychological tests or by the brain scan.
      Participants will undergo a single MRI scan, baseline financial capacity instrument (FCI) and
      cognitive evaluation, and then will be followed approximately annually to repeat the
      functional and cognitive assessments. Linear mixed effects models will be used to fit a model
      predicting financial capacity based on baseline cognitive tests. Measures from the MRI scan
      will be added to the model to determine whether imaging improves the predictions.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        160 subjects are anticipated, with the expectation that initial cognitive evaluations will
        exclude about 60 subjects. We intend to maintain and follow 100 subjects, 40 with
        non-dementia memory impairment (meeting criteria for amnestic MCI) and 40 with no cognitive
        impairment, and 20 with mild Alzheimer disease
      
Biospecimen description: 
      N/A- no biospecimens
    
Keywords: Magnetic Resonance Imaging; Alzheimer disease; Mild cognitive impairment; Continuous arterial spin labeling; Semantic memory
A Relative Bioavailability Study of LY3209590 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted in two parts (part A and part B). The main purpose of this study
      is to compare the amount of LY3209590 that gets into the blood stream and how long it takes
      the body to get rid of it, when self-administered at different body sites, abdominal wall,
      upper arm and thigh (part A), when administered by two different routes of injection,
      subcutaneously or intravenously (part B) in healthy participants.

      The study may last up to 65 (part A) and 184 (part B) days, respectively.
    


Intervention name(s): LY3209590 (SC); LY3209590 (IV)
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered IV.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part A is Parallel design and Part B is a crossover design
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Injection sites
Efficacy Study of the Music Glove Patients With Spinal Cord Injuries
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Investigators are trying to determine the therapeutic effect of the music glove and
      conventional hand exercise program to patients with spinal cord injuries. All participants
      will be randomized into two groups: AB and BA. They will all exercise at least 3 times a week
      for 3 weeks with minimum of 3 hours of exercise time per week. Participants will receive the
      other intervention at their 3 week post-therapy follow-up visits. Clinical evaluations will
      be performed at baseline 1 and 2 (3 to 10 days apart), post-therapy after the first
      intervention, 3-week post-therapy follow up, post-therapy after the second intervention, and
      3-week post-second intervention follow up visits.
    


Intervention name(s): Music Glove; Conventional Hand Exercise Program
Intervention type(s): Device; Other
Intervention description(s): Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimum of 3 hours per week.; Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimum of 3 hours per week.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of the Effect of Imagery Rehearsal Therapy (IRT) of Nightmares
Condition: Nightmares; Anxiety Disorders; Mood Disorders; Personality Disorders
MeSH terms: Anxiety Disorders; Personality Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether Imagery Rehearsal Therapy(IRT) is effective
      in the reduction of the number of nightmares and the nightmare distress in a population of
      patients with psychiatric disorders.
    

Detailed description: 
      Within the normal population 4-8% of the people suffer regularly from nightmares. Clinical
      observations show that nightmares are a common problem for patients who suffer from all kinds
      of psychiatric disorders, and not just for the patients diagnosed with PTSD. Often nightmares
      can lead to sleep disorders, which have a negative impact on emotional well-being and
      cognitive functioning during the day. As well as this a strong relationship between severity
      of nightmares and severity of psychopathology has been found. This gives a strong argument
      for treatment of nightmares as a symptom, separate from the psychiatric disorder.

      A few controlled studies of the treatment of nightmares have been published, in which
      behavioral therapy, relaxation techniques, exposure and systematic desensitization have been
      studied, all of which have shown positive results. But these techniques do not seem to reduce
      the number of nightmares in patients who suffer from PTSD. These last few years more
      controlled studies of a cognitive behavioral technique called 'Imagery Rehearsal Therapy'
      (IRT) have been published. With IRT patients have to change the script of their nightmares
      into a different outcome, and rehearse this new script using cognitive imagery a few times a
      day.

      Comparisons: treatment of nightmares with IRT compared to a waitlist control group who do not
      get IRT until 6 months later.
    

Intervention name(s): Imagery Rehearsal Therapy (IRT)
Intervention type(s): Behavioral
Intervention description(s): Imagery Rehearsal Therapy is given by psychologists, psychotherapists or psychiatrists. The IRT therapists are all trained by Annette van Schagen, principal investigator.
IRT consists of six 1-hour sessions. The six sessions are given in a period of three months. Each session is described in the IRT Manual. The IRT Manual is devised by the principal investigator Annette van Schagen in colaboration with Victor Spoormaker PhD. There is a patient version of the IRT manual available for the patients, which includes descriptions of the IRT sessions and homework assignments.
Other intervention name(s): IRT
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: nightmare; sleep disorder; sleep; imagery rehearsal; anxiety disorders; mood disorders; personality disorders
Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate
      controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and
      Food effect on the pharmacokinetics of sarpogrelate CR.
    


Intervention name(s): Anplag; UI03SPG300CT
Intervention type(s): Drug; Drug
Intervention description(s): Sarpogrelate HCl 300mg once a day or 100mg three times a day; Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other intervention name(s): UI03SPG300CT
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation
Condition: Allograft; Allogeneic Cell Transplantaion; Hematological Malignancy; Solid Tumor
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a prospective comparison between 2 popular regimens based on reduced intensity
      or non-myeloablative approaches to define the optimal myeloablative and/or
      immu-nonsuppressive association for reduced intensity conditionings (RIC).

      Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2
      days) and Thymoglobuline (2.5 mg/m²/1day).

      Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation
      (TBI).

      A randomization of 2 phase study according to the methodology developed by Liu et al (Liu,
      1993 and 2001) for the evaluation of multiple innovative approaches.

      Primary endpoint is one year overall survival (OS). Stopping rules included excessive
      engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an
      independent safety review board (ISRB).

      Inclusion criteria are patients presenting a hematological malignancy, eligible for non
      myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable
      HLA identical sibling. All patients and donors are included after giving written informed
      consent.

      Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular
      therapies committee (national agency).
    


Intervention name(s): reduced intensity conditionings
Intervention type(s): Drug
Intervention description(s): comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Joint Mobilization on Alpha Motoneuron Reflex Excitability
Condition: Muscle Spasticity; Spinal Cord Injury; Stroke; Craniocerebral Trauma
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Craniocerebral Trauma
Study type: Interventional

Summary: 
      Objective: To determine the effect of ankle joint mobilization on the alpha motoneuron reflex
      excitability of the soleus muscle in people with spasticity.

      Subjects and Methods: A controlled clinical trial with crossover design and simple masking
      was conducted in 24 randomized subjects to initiate the control or experimental group.
      Traction and rhythmic oscillation were applied for five minutes to the ankle joint. Alpha
      motoneuron reflex excitability was assessed by measuring H wave amplitude (Hoffmann reflex -
      H reflex), stimulating the tibial nerve at the level of the popliteal fossa and recording in
      the soleus muscle. In each subject 12 measurements were taken: basal rate, during and after
      mobilization. Changes in alpha motoneuron reflex excitability were calculated in relation to
      basal measurement. For each measurement a hypothesis test was performed (Student t test).

      Results: In groups of patients with brain injury (BI) and incomplete spinal cord injury
      (ISCI), a significant difference was found between measurements of both studies, concerning
      variation in alpha motoneuron reflex excitability during the application of joint
      mobilization techniques, with a decrease in the experimental group and an increase in the
      control group. In contrast, no significant differences were found after mobilization therapy.
      Patients with complete spinal cord injury (CSCI) showed no significant differences in any
      measurements.

      Conclusion: We demonstrate the effectiveness of passive movement in the decrease of muscle
      tone during the mobilization maneuver in patients with BI or ISCI, but no residual effect
      after completion of the trial. This research project showed no evidence regarding spasticity
      reduction in complete spinal cord injuries. This suggests that therapeutic interventions to
      decrease muscle tone, based on the passive exercise and stimulation of proprioceptors should
      be reconsidered.
    


Intervention name(s): joint mobilization techniques
Intervention type(s): Other
Intervention description(s): In the experimental group, ankle joint mobilization was applied for five minutes, using grade II joint traction rhythmic oscillation (Mailland Scale) with the knee in 15° of flexion, subtalar in neutral and ankle in resting position (10º plantarflexion). During the control study, participants were placed under the same conditions as those of the experimental group but only the hands of the evaluator were placed in the foot, in the position of joint traction simulation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal manipulations; Muscle spasticity
Web Based Follow up Intervention in Obesity Treatment for Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study is designed to verify that web based follow up intervention after a classic
      multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise
      self-efficacy, improve drop out rate and advance sustainability after weight loss of obese
      women.

      Research Questions and Hypotheses

        -  How does a web based follow up intervention change self-efficacy of women participating
           in an obesity intervention?

        -  How does a web based follow up intervention affect the drop out rate of women
           participating in an obesity intervention?

        -  How does a web based follow up intervention influence sustainability of women
           participating in an obesity intervention?
    


Intervention name(s): Follow Up Support
Intervention type(s): Behavioral
Intervention description(s): inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dietary habits and obesity; exercise habits and obesity; cognition and obesity
Effects on Experimental Dyspnea of High Flow Nasal Cannula
Condition: Dyspnea; Healthy Volunteers
MeSH terms: Dyspnea
Study type: Interventional

Summary: 
      To develop an experimental model of dyspnea by external thoraco-abdominal elastic strapping
      at rest in order to study the mechanisms involved in the relief of dyspnea by the
      administration of high flow by nasal cannula (HFNC).
    

Detailed description: 
      This study will measure the effect of HFNC on an experimental model of dyspnea induced by
      thoraco-abdominal elastic strapping on healthy subjects at rest.

      The study will also compare the effects on dyspnea of the administration of high flow nasal
      cannula with and without oxygen added.
    

Intervention name(s): Optiflow with an inspired fraction of oxygen of 100%; Optiflow with an inspired fraction of oxygen of 21%
Intervention type(s): Device; Device
Intervention description(s): Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 100%; Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 21%
Other intervention name(s): High flow nasal cannula with oxygen added; High flow nasal cannula without oxygen added
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dyspnea, High flow nasal cannula
Randomized Controlled Trial of eScreen for Problematic Drug Use
Condition: Problematic AOD Use
Study type: Interventional

Summary: 
      Objectives: This study compared the efficacy of eScreen in a two-armed randomized controlled
      design, measuring outcomes in terms of changes in problematic drug use up to one year after
      study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug
      use offers self-screening, in-depth self-reporting, personalized feedback and treatment
      recommendations as well as an electronic diary. Progress over time is shown in diagrams
      detailing consumption levels.

      Method: Participants with only problematic drug use according to the Drug Use Disorders
      Identification Test (DUDIT),(DUDIT >0 for both men and women) or both problematic alcohol use
      according to the Alcohol Use Disorders Identification Test (AUDIT), (AUDIT >7 for men and
      AUDIT >5 for women) and drug use were randomized to T1 (n=101) or the control group (n=101).
      Outcomes on alcohol and/or drug use as well as health-related symptoms were assessed after 3,
      6 and 12 months.

      Hypotheses that were tested in this study are 1) that both groups would reduce their drug
      consumption and drug-related problems at follow-ups compared to the baseline level and 2)
      that participants in the eScreen group would reduce their drug consumption and drug-related
      problems to a higher extent than participants in the control group (no intervention) at
      follow-ups.
    

Detailed description: 
      Background: The aim of this study is to investigate the effects of an Internet-based
      screening and brief intervention (SBI) site for problematic alcohol and drug use among
      illicit drug users.

      Method: Individuals searching for information about alcohol or drugs online who scored over 0
      on the Drug Use Disorders Identiﬁcation Test (DUDIT) and were 15 years or older were
      recruited for this trial and randomized into one group receiving Internet-based screening and
      brief intervention via eScreen.se(n = 101) or one assessment-only control group (n = 101).
      Both groups were screened at baseline and followed up at 3 and 6 months. The primary outcome
      measure was the DUDIT-C score and secondary outcome measures were DUDIT, AUDIT-C (Alcohol Use
      Disorders Identiﬁcation Test-C) and AUDIT scores.Additional outcomes included the proportion
      of drug abstainers and those who made a clinically signiﬁcant change in their alcohol and
      drug use. Four statistical models of analysis were used to conservatively assess results.
    

Intervention name(s): eScreen
Intervention type(s): Behavioral
Intervention description(s): Web based self-monitoring of problematic alcohol and drug use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Randomized Controlled Trial; Alcohol; Drugs; Internet; Screening; Brief intervention
Topography-guided LASIK Surgery
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The investigators are analyzing outcomes of topography-guided LASIK surgery in participants
      with myopia and myopic astigmatism
    

Detailed description: 
      The investigators are analyzing outcomes of topography-guided LASIK surgery in participants
      with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior
      segment optical coherence tomography epithelial thickness maps. The investigators will
      compare preoperative maps to postoperative maps at one, three, six and twelve months. In
      addition, the investigators will measure changes in epithelial maps from postoperative month
      through twelve months to help understand what is happening to the corneal epithelium to try
      to explain why UDVA and CDVA improves over time
    

Intervention name(s): Topography-guided LASIK
Intervention type(s): Procedure
Intervention description(s): LASIK surgery
Intervention model: Single Group Assignment
Intervention model description: Topography guided
Masking: None (Open Label)
Primary purpose: Treatment