bioihbjkbjnl/mcl2 huggingface dataset:
Exploring the Feasibility of Social Skills Training in People With Psychosis
Condition: Focus of Study
Study type: Interventional

Summary: 
      Reduced social and community functioning is a predominant and enduring feature in people
      experiencing severe mental illness such as psychosis. The large majority of interventions
      (mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and
      delusions) but poorly address functional and social consequences of the illness.

      This study attempts to fill this gap by assessing the feasibility and acceptability of a
      psychological intervention targeting social cognition deficit in people with psychosis. The
      intervention is a group psychological treatment facilitated by a clinical psychologist
      targeting competencies such as emotion recognition, social situation appraisal and guessing
      people's intentions and mental states. The group therapy takes advantage of audiovisual
      material to illustrate strategies and thinking styles that may help participants to overcome
      difficulties in social settings.

      A second objective of this study is to test a new method to measure social cognition. Recent
      research showed that interview and performance based tests are poorly associated with every
      day activity of people with schizophrenia. This study is planning to evaluate the feasibility
      of new assessment methods for social cognition in everyday life using portable electronic
      devices (Experience Sampling Method and an activity watch). These devices will be carried by
      participants in their everyday life and will ask about feelings and levels of social
      activities at random times and record basic physiological and activity levels.
    


Intervention name(s): Social Cognition therapy ( Psychological Therapy)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Simple Sodium Alignment on Clinical Outcomes
Condition: Complication of Hemodialysis
Study type: Observational

Summary: 
      A difference between dialysate and serum sodium concentration leads to diffusive sodium
      transfer across the dialyzer membrane. The consequences of diffusive sodium flux into the
      patient can be chronic sodium overload leading to overhydration, hypertension, cardiovascular
      disease, and other problems. Diffusive sodium flux out of the patient can lead to
      intradialytic blood pressure instability. A simple strategy for alignment of dialysate and
      serum sodium concentrations was implemented starting in April/May 2010 in order to minimize
      the problems particularly associated with chronic sodium overload.
    

Detailed description: 
      The purpose of this database analysis is to assess the impact that this operational change
      has had in the short, medium and long term on key clinical and laboratory parameters in the
      patients, including blood pressure, body weight, interdialytic weight gain, serum
      electrolytes, intradialytic saline administration, missed treatments, hospitalizations,
      medication, inflammatory markers, etc. All subjects included in the final dataset will be
      matched with dialysis patients receiving treatment in other dialysis clinics of the Renal
      Research Institute who were not subject to the operational change. This will lead to the
      development of a matched cohort of equal size unexposed to dialysate to serum sodium
      alignment.

      The analysis is planned to investigate treatment effects, and test the effects of dialysate
      to serum sodium alignment for interactions and associations between those laboratory and
      clinical parameters. The extent and magnitude of sodium alignment (the operational change)
      will also be assessed.
    

Intervention name(s): Dialysate and serum sodium concentration aligned
Intervention type(s): Other
Intervention MeSH terms: Dialysis Solutions
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All subjects on hemodialysis
      
Keywords: hemodialysis; dialysate and serum sodium
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Condition: Intracranial Arteriovenous Malformations
MeSH terms: Hemangioma; Intracranial Arteriovenous Malformations; Arteriovenous Malformations; Congenital Abnormalities
Study type: Interventional

Summary: 
      To evaluate the clinical benefits and risks of hybrid operating techniques in management of
      cerebral arteriovenous malformations.
    

Detailed description: 
      Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in
      management of cerebral arteriovenous malformations(AVMs). Meanwhile, as a new cooperative
      interventional modality, optimized workflows, technical key knots and operation routines will
      be explored in the study.

      Objects: Patients with cerebral arteriovenous malformations, coincident with inclusion and
      exclusion criterion and admitted in participating organizations.

      Methods: Patients will be distributed into 2 groups, including traditional therapy
      group(control group) and hybrid operating group(trial group), and conduct with traditional
      neurosurgical management or one-stage hybrid operating management correspondingly. Residual
      rate of AVM is considered to be the primary observing indicator, and morbidity rate of
      post-operative complications, post-operative mortality rate, and morbidity rate of neural
      functional deterioration are secondary indicators.The information of operations will be
      recorded in detail as evidence of optimization of workflow and technical key knots.
    

Intervention name(s): hybrid operating techniques
Intervention type(s): Procedure
Intervention description(s): A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other intervention name(s): endovascular interventional embolisation; endovascular interventional balloon occlusion; microsurgical resection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Traditional therapy group：traditional management of AVMs, such as unsimultaneous endovascular interventional embolisation, radiotherapy followed by microsurgical resection, will be conducted to patients involved in this group.
Hybrid operation group: A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously to patients in this group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intracranial Arteriovenous Malformations
AF Septal Pacing (Clinical Investigation Plan)
Condition: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this non-randomized, non-controlled, acute, single-arm research study is to
      evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on
      the interatrial septum. The possibility to terminate atrial arrythmias will also be
      evaluated.
    

Detailed description: 
      The evidence of treating AF by pacing is limited, although these algorithms are of interest,
      since they appear to be safe and usually add little additional cost.

      Using a computer model, a new dual-stage septal pacing has been developed.The proposed septal
      pacing algorithm could suppress AF reentries in a more robust way than classical single site
      rapid pacing. The feasibility of pacing both atria simultaneously from a single lead placed
      in the interatrial septum has been previously demonstrated clinically. The septal pacing
      concept has also been successfully tested in a computer model of AF and in a pig model .
      Experimental studies are now needed to determine whether similar termination mechanisms and
      efficacies can be observed in humans.

      The purpose of this non-randomized, non-controlled, acute, single-arm research study is to
      evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on
      the interatrial septum
    

Intervention name(s): Pulmonary vein ablation
Intervention type(s): Procedure
Intervention description(s): After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well as AF termination.
Intervention model: Single Group Assignment
Intervention model description: Approximately 15 subjects with AF indicated for ablation of the pulmonary vein will be enrolled in the study. Participants will attend the Baseline visit and the Procedure visit. The baseline visit can be on the same day as the ablation procedure. Since it is an acute study, no follow-up visit will occur. The research procedure will be performed during an already scheduled ablation procedure. Subjects will be enrolled over a period of approximately 18 months
Masking: None (Open Label)
Primary purpose: Treatment
Breath Analysis in Healthy Controls
Condition: Exhaled Breath; Mass Spectrometry; Healthy Subjects
Study type: Observational

Summary: 
      The purpose of this study is to detect a specific profile of breath in healthy subjects by an
      untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
    


Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy subjects will be included according to the predefined inclusion and exclusion
        criteria. They will be recruited from the general population by printed flyers, newspaper
        advertisements and personal communication.
Salt Reduction on Blood Pressure and Cardiovascular Organ Damage
Condition: Hypertension
MeSH terms: Hypertension; Prehypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of a modest reduction in salt intake on
      blood pressure in white, black and Asian individuals with hypertension or prehypertension,
      and also to determine whether a modest reduction in salt intake has beneficial effects on the
      surrogate markers of target organ damage in cardiovascular disease.
    

Detailed description: 
      The average salt intake for adults in the UK is approximately 10-12 g/day. The current
      recommendations are to reduce salt intake to 5-6 g/day or less. Many randomised trials have
      shown that this reduction in salt intake has a significant effect on blood pressure, however,
      most previous trials were carried out in white individuals, fewer in blacks, and none in
      Asians.

      Increasing evidence from epidemiological studies in humans and experimental studies in
      animals suggest that that our current high salt intake may have other harmful effects on
      cardiovascular health e.g. a direct effect on stroke, left ventricular hypertrophy,
      progression of renal disease and proteinuria independent of and additive to salt's effect on
      blood pressure. However, no well-controlled trials have studied whether a modest reduction in
      salt intake has beneficial effects on the surrogate markers of target organ damage in
      cardiovascular disease.

      We propose to carry out a double-blind randomised trial to study the effects of a modest
      reduction in salt intake, as currently recommended, on blood pressure and target organ damage
      assessed by the measurements of 24 hour urinary albumin excretion, left ventricular mass,
      left ventricular diastolic function, pulse wave velocity and capillary density, in white,
      black and Asian individuals with hypertension or prehypertension.

      Comparisons: Usual salt intake compared to reduced salt intake.
    

Intervention name(s): Reduce salt intake
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Blood pressure; Sodium; Dietary; Hypertension or prehypertension
Electronic Monitoring Combined With Weekly Feedback and Reminders
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      A total of 96 recruited children (aged 6 months to 3 years) with mild or moderate persistent
      asthma who were on regular inhaled corticosteroids (ICS) were randomly allocated to receive
      electronic monitoring combined with instant messaging software -based weekly feeding back
      adherence and reminders to keep taking the ICS (intervention group) and to receive electronic
      monitoring only (control group). The device-monitored adherence rates and caregiver-reported
      adherence rates were analyzed.
    


Intervention name(s): intervention group
Intervention type(s): Behavioral
Intervention description(s): All the device-monitored adherence data from the previous week were downloaded from the background database and calculated by a qualified asthma nurse. Through free IMS (WeChat; Tencent, Shenzhen, CHN) available on mobile, the nurse offered feedback to the caregivers weekly according to the adherence rate and reminded them to keep taking the ICS. Caregivers were asked monthly "Has our child inhaled the medicine according to the doctor's instructions?" and "How about the frequency?" by telephone.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The Study of Asthma Adherence study was a multicentre, single-blind, parallel group randomised controlled trial, with an allocation ratio of 1:1.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: pediatric; asthma adherence; electronic device
Trait Anxiety and Defensive Networks
Condition: Healthy
Study type: Interventional

Summary: 
      to examine the association between trait and defensive network connectivity and the
      modulatory effect of oxytocin on it
    

Detailed description: 
      Individuals with high trait anxiety show stable anxiety proneness even in the absence of real
      threat, which could be a result of intrinsic hyper-connectivity in the defensive systems. In
      the present study, healthy subjects' trait anxiety levels will be assessed by the sub-trait
      inventory of the State-Trait Anxiety Inventory. Then two experiments using resting-state fMRI
      technique will be conducted to first map how hubs in the defensive systems organized in high
      anxious individuals in a stimuli-free situation (Experiment 1) and then we will examine the
      modulatory effect of the intranasal administration of oxytocin on functional connectivity in
      these independently defined defensive networks (Experiment 2).
    

Intervention name(s): trait anxiety scale; Oxytocin; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): splitting subjects into 2 groups according to scores of the trait anxiety scale; intranasal administration of oxytocin; intranasal administration of placebo
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: brain functional connectivity changes
Drug Interaction Study Between AZD3355 and Nexium
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or
      not, i.e. show the same or altered plasma concentration profiles when co-administered
      compared to administered alone.
    


Intervention name(s): AZD3355; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg bid, oral, 7 days; 40 mg od, oral, 7 days
Other intervention name(s): Lesogaberan; Nexium
Intervention MeSH terms: Esomeprazole; Lesogaberan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Reflux Inhibitor; GERD; PPI Interaction
Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To determine the effects of ultrasound therapy and neuromuscular electrical stimulation on
      the muscle architecture and functional capacity of patients with knee osteoarthritis.
    

Detailed description: 
      All participants who were satisfied with the inclusion criteria were randomly assigned to one
      of two study groups: Group 1- ultrasound therapy group; Group 2 - the neuromuscular
      electrical stimulation group. Group allocation was randomized in two blocks of 30 sealed
      envelopes without external marks, which were mixed and numbered from 1 to 30, containing a
      piece of paper with the group allocation. The researchers responsible for outcome measures
      and ultrasonograhic measurements were blinded to the patients' diagnosis or intervention.
    

Intervention name(s): ultrasound therapy; neuromuscular electrical stimulation application
Intervention type(s): Other; Other
Intervention description(s): Group 1, ultrasound therapy ;1 watt/cm² dose, 1 MHz, 5 minutes; Group 2, neuromuscular electrical stimulation application;20 mins/session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee osteoarthritis; neuromuscular electrical stimulation; ultrasound therapy
New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic
      resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the
      University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and
      optimized for the equipment at UVA. These sequences will need to be evaluated in healthy
      adults for comparison with results obtained and in adults with lung diseases to optimize the
      sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to
      be optimized for the parameters of a human MR coil and the gas exchange characteristics in
      healthy and diseased lungs.

      Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to
      monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting
      beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of
      the current COPD therapeutics. The investigators will characterize the functional changes of
      the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment
      after a three-month trial. Also the investigators will compare corresponding results obtained
      by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based dynamic
      contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed tomography
      (HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The investigators
      anticipate that the results from this project will greatly improve the investigators
      understanding of the lung functional responses of COPD subjects to current therapeutics.
      Also, the investigators expect that this project will provide evidence to consider Xe129 MRI
      as a diagnostic strategy to assess and monitor therapeutic responses of existing and new
      pharmaceuticals, and thus Xe129 MRI will stimulate development of novel therapies for COPD in
      the future
    


Intervention name(s): Xenon129 MRI imaging; Gadolinium MRI; Advair (250mcg/50mcg) one puff twice a day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): subjects will receive at baseline and 3 month post Advair intervention (See next intervention); subjects will receive at baseline and 3 month post Advair intervention (See next intervention); subjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI.
Intervention MeSH terms: Xenon; Fluticasone-Salmeterol Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: COPD
Neck Motion and Motor Control in Chronic Neck Pain and Associations With Clinical Symptoms
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      The primary purpose of this study is to investigate if there is altered motor control of head
      and neck in chronic neck pain patients compared with healthy persons. In addition,
      associations between neck pain, motor control, disability and function, and clinical symptoms
      will be studied in patients following physiotherapy treatment in primary health care.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Neck pain patients referred to physiotherapy treatment in primary health care
      
Keywords: Neck movement; motor control; disability; psychological variables; Head Movements; Physical therapy; Fear avoidance; Self Efficacy; Catastrophizing; Fly test; Postural sway
A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy
      adult Chinese participants after both single and multiple dose administration.
    

Detailed description: 
      The drug being tested in this study is called TAK-438. TAK-438 is being tested in healthy
      participants in order to evaluate the PK of single and multiple oral dose.

      The study will enroll approximately 36 healthy participants. Participants will be assigned to
      one of the three treatment groups:

        -  TAK-438 10 mg tablet once daily

        -  TAK-438 20 mg tablet once daily

        -  TAK-438 20 mg tablet twice daily All participants will be asked to take TAK-438 tablet
           at the same time on Day 1 and Days 3-9.

      This single-centre trial will be conducted in China. The overall time to participate in this
      study is 18 days. Participants will remain confined to the clinic from Day 1 up to Day 11 and
      will be followed-up by telephone or visit on Day 18.
    

Intervention name(s): TAK-438
Intervention type(s): Drug
Intervention description(s): TAK-438 tablets.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy