bioihbjkbjnl/mcl2 huggingface dataset:
Sit-to-stand With Feedback in SCI Patients
Condition: Injuries, Spinal Cord
MeSH terms: Spinal Cord Injuries; Spinal Injuries
Study type: Interventional

Summary: 
      -  Does the utility of external feedback in terms of goal-directed LLL approach during STS
           training immediately improve functional ability relating to walking in ambulatory
           patients with SCI?

        -  Does the utility of LLL feedback improve functional ability relating to walking in
           ambulatory patients with SCI after 2-week training?
    

Detailed description: 
      -  To compare immediate effects of STS training with and without LLL feedback on functional
           ability relating to walking in ambulatory patients with SCI

        -  To compare 2 weeks effects of STS training with and without LLL feedback on functional
           ability relating to walking in ambulatory patients with SCI.
    

Intervention name(s): feedback
Intervention type(s): Other
Intervention description(s): Sit to stand training with external feedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: feedback
Occlusal Reduction Effect on Postendodontic Pain
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      The aim of this study, thus, was to assess the effect of occlusal reduction on postendodontic
      pain after the first (post-instrumentation) and the second (post-obturation) visit in
      mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to
      percussion treated in two visits.
    

Detailed description: 
      The purpose of this randomized clinical trial was to evaluate the effect of occlusal
      reduction on post-instrumentation and post-obturation pain in mandibular posterior teeth with
      symptomatic irreversible pulpitis and sensitivity to percussion treated in two visits. Three
      hundred and eight patients were included in this study. Inclusion criteria were posterior
      mandibular teeth having symptomatic irreversible pulpitis with sensitivity to percussion.
      Patients were randomized into two equal groups. In the intervention group, occlusal reduction
      was done, while, in the control group, the occlusal surfaces were left intact. Conventional
      endodontic treatment was performed in two visits using a rotary nickel-titanium system
      followed by the lateral-condensation obturation technique. Post-instrumentation pain was
      assessed after 6, 12, 24 and 48 hours following the first visit, and post-obturation pain
      after 6 and 12 hours following the second visit. Each patient received a pain diary to record
      their pain levels and rescue medication intake.
    

Intervention name(s): Occlusal reduction; Sham occlusal reduction
Intervention type(s): Procedure; Procedure
Intervention description(s): Occlusal contacts on the functional and non-functional cusps were reduced.; The occlusal surface left intact. No actual occlusal reduction.
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms
Condition: Human Microbiome; Eating Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of replacing usual snacks with
      alternative snack foods on gut health in a population of habitual snackers with low fibre
      intake.
    

Detailed description: 
      Diet is a crucial target for the improvement of human health. In the modern world, diets are
      diverse and diet related diseases are becoming more and more common. In particular, it is
      becoming increasingly apparent that the bacteria that live in the gut are strongly linked to
      both diet and health. Bacteria in the gut can be beneficial or harmful, and the health of the
      gut relies on the beneficial bacteria outnumbering the harmful ones. Diet has a great impact
      on the bacterial composition of the gut. In turn, the gut bacteria play diverse roles in
      human health, influencing not only the gut but also the health of the immune system, heart
      and brain. Therefore, optimising the composition of the gut bacterial is vital to human
      health and wellbeing.

      It has been shown that snacks between meals contributes 420 - 480 calories per day, almost a
      quarter of the recommended intake. Therefore, snack choices are an area of diet and lifestyle
      that have the potential to influence diet and in turn the health of our gut and gut bacteria.
      We would like to assess the effect of replacing usual snacks with alternative snack foods
      that we believe have benefits for gut health.

      The primary aim of the study is to investigate whether the replacement of usual snacks has an
      effect on gut bacterial composition, specifically the abundance of Bifidobacteria. Secondary
      aims include the effect of the intervention snacks on additional measures of gut health such
      as gut transit time, the frequency and consistency of bowel movements and gut symptoms e.g.
      heartburn, nausea, belching etc. The effect of snack foods on metabolites in the blood (e.g.
      glucose, insulin, lipids) will also be determined. Finally the impact of snack replacement on
      mood and quality of life will be assessed.
    

Intervention name(s): Intervention snack 1; Intervention snack 2; Control snack
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): To be eaten instead of regular snacks twice a day for 4 weeks.; To be eaten instead of regular snacks twice a day for 4 weeks.; To be eaten instead of regular snacks twice a day for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gut Microbiota; Microbiome; Gut Health; Snack
Tobacco Intensive Motivational and Estimate Risk
Condition: Severe Mental Disorder; Smoking Cessation; COPD
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Randomized, open label, prospective study with a 12-month follow-up period. The primary
      objective evaluates the effectiveness of an intensive anti-smoking programme that informs
      patients of their individual risk of lung damages and the possibilities of prevention. The
      main measurement will be having given up smoking in month 12, measurement of self-reported
      abstinence on the 7 previous days and confirmed by a CO-oximeter test< 10 ppm, between the
      intervention and control group. A total of 9 urban and rural mental health centres will
      participate in the study. The intervention group will undergo spirometry and presence and the
      degree of respiratory obstruction will be assessed. Participants will be given individual
      information to generate a motivational message about the possibilities of prevention and the
      information will be maintained for three months by sending text messages (SMS) to their
      mobile phones. The efficacy of the method and the pulmonary damage variables will be
      evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the
      COPD diagnosis and the severity of the staging for disease will be assessed
    


Intervention name(s): personalized information about lung damage
Intervention type(s): Device
Intervention description(s): Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: schizophrenia; bipolar disorder; tobacco; COPD
Study to Assess Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adults With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose-response study to determine how various measurements of airway inflammation
      respond to high and low dose FlutiForm®, and compared to placebo.
    

Detailed description: 
      The study consists of two 4-week treatment periods, each preceded by a 14-21 wash-out period.
      Subjects will be randomised to receive two of the three study treatments - FlutiForm® pMDI
      50/5 µg, FlutiForm® pMDI 250/10 µg, or placebo (dummy inhaler). During the wash-out periods,
      subjects will take only salbutamol, if required, as rescue medication.

      Subjects will record a daily diary for PEFR, study medication use, rescue medication use,
      asthma symptom scores, and sleep disturbance due to asthma. Assessments performed at study
      clinic visits include inhaled adenosine 5'-monophosphate (AMP) challenge test, induced sputum
      test, exhaled nitric oxide (eNO) test, and spirometry tests. Safety will be assessed by lab
      tests, vital signs, ECG and adverse events.
    

Intervention name(s): Fluticasone propionate / Formoterol fumarate
Intervention type(s): Drug
Intervention description(s): 2 dose strength vs. placebo
Intervention MeSH terms: Fluticasone; Xhance; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma
Correction of V-pattern Strabismus by Graded Recession of Inferior Oblique Muscle .
Condition: V Pattern Esotropia; Monocular Exotropia With V Pattern
MeSH terms: Strabismus; Exotropia; Esotropia
Study type: Interventional

Summary: 
      V pattern strabismus is the commonest of alphabet pattern. Its identification is essential to
      plan a proper surgical management. Graded recession is a very logical approach to treat
      inferior oblique overaction (IOOA). The aim Is to evaluate the efficacy of graded recession
      of inferior oblique muscle for correction of different grades of V pattern.
    

Detailed description: 
      prospective interventional study for forty patients with V pattern strabismus and primary
      inferior oblique overeaction will be evaluated by prism cover test to assess the grade of
      IOOA and amplitude of V-pattern. Graded recession of IO muscle depends on the amplitude of
      the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild
      IOOA (10 or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11-15 or +2)
      and maximum recession for amplitude more than 15 degree and marked IOOA ( more than 15 degree
      or +3). Simultaneous correction of the horizontal deviation will be performed at the same
      sitting. Follow up after I week,1 month ,3 month and 6-month.
    

Intervention name(s): graded recession of inferior oblique muscle
Intervention type(s): Procedure
Intervention description(s): . Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 degree or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA (more than15 degree or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty patients from 3 to 18 years old with V pattern strabismus and primary IOOA were evaluated by prism cover test to assess the grade of IOOA and amplitude of V-pattern. Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5to 10 degree and mild IOOA (10 degree or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 degree or +2) and maximum recession for amplitude more than 15 degree and marked IOOA (15 or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting. Follow up after one week,1 month ,3 month and 6-month.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vpattern strabismus; inferior oblique overaction; graded recession; Dissociated vertical deviation
Developing Accessible mHealth Programs for Depression Management in Bolivia
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the feasibility and potential impact of an automated
      phone system in monitoring and improving self-care and health outcomes among patients with
      depression in Bolivia.
    

Detailed description: 
      All patients will receive a weekly 10-15 minute automated phone call to their cell phone for
      disease assessment and self-care support for up to 12 weeks. During enrollment, the research
      team will explain how to use the automated phone system. During patients' automated calls,
      they will be asked questions about their self-care relevant to their diagnosis, symptoms of
      depression, and medication adherence (if patients are prescribed an anti-depressant). Based
      on the patient's self-report, they will receive targeted suggestions for how to improve their
      self-management. At the end of each automated call, patients will hear the phone number of
      their clinic, which they can call for a health problem or to disenroll from the program. At
      the time of recruitment, if possible, an initial automated call will be sent to the patient's
      phone so that they can learn what to expect and have the chance to ask questions of the
      research associate who will be present.

      In the event that the patient reports a health or self-care problem during their call (i.e.,
      the patient reports rarely or never taking their medication), a report will automatically be
      generated and sent by email to the research team plus the patient's designated clinician so
      that follow-up can take place. The secure email address will be verified with each clinician,
      and be password protected.

      The intervention will last up to 12 weeks, after which the patient will have a follow-up
      meeting with the research team and will complete a survey about the program. All follow-ups
      will take place either in person or over the phone.
    

Intervention name(s): Automated disease assessment & self-care support phone calls
Intervention type(s): Other
Intervention description(s): Automated disease assessment & self-care support phone calls for up to 12 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Depression; mHealth; Interactive Voice Response; Bolivia; Mental health
Assessment of Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea.
Condition: Diarrhea
MeSH terms: Irritable Bowel Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess elemental impurities level after dministration of dioctahedral
      smectite in subjects with functional diarrhea or irritable bowel syndrome with predominant
      diarrhea. Male or female subjects aged between 19 and 60 years will participate in the study.
      The study design is an opne-label, randomized, multiple dose paraller study. The patients
      were randomly assigned to DWJ1230 or DWB2001. It is intended that a total of 60 subjects will
      be enrolled to ensure that at least 24 subjects will complete the study.
    


Intervention name(s): DWJ1230; DWB2001
Intervention type(s): Drug; Drug
Intervention description(s): Daewoong Pharmaceutical; Daewoong Bio
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Conformal Prague Study
Condition: Non-valvular Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      A prospective, single center, open-label, single arm, study to evaluate the safety and
      technical performance of the CLAAS system for closure of the left atrial appendage.
    

Detailed description: 
      The primary objective of the study is to evaluate feasibility of ICE as primary imaging
      modality for device success in patients with non-valvular atrial fibrillation at increased
      risk for stroke and systemic embolism who are recommended for oral anticoagulation (OAC)
      therapy but have an appropriate rationale to seek a non-pharmacological alternative to OAC.
      TEE will be used to confirm the ICE evaluation.
    

Intervention name(s): Left Atrial Appendage Closure
Intervention type(s): Device
Intervention description(s): Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the LAAC device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Older Adults
Condition: Cognitive Function; Mood; Well-being; Cerebral Blood Flow
Study type: Interventional

Summary: 
      Dietary intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs) is inversely associated
      with cognitive decline and dementia (e.g. Kalmijn et al. 2004, Heude et al. 2003, Morris et
      al. 2005, Dullemeijer et al. 2009). Recently, the effects of supplemental docosahexaenoic
      acid (DHA) on behavioural outcomes in older adults has been explored, however two trials
      addressing this issue have published conflicting results regarding the efficacy of DHA
      supplementation, with one reporting a benefit of treatment on cognitive performance
      (Yurko-Mauro et al. 2010), while the other did not (Dangour et al. 2010).

      One area of research that has yet to be explored in this cohort is the effects of n-3 PUFAs
      on brain function in physiological terms. It is also possible that n-3 PUFAs, in combination
      with other compounds, may be more beneficial than treatment with n-3 PUFAs in isolation. The
      current study will explore several separate hypotheses within the same cohort. These are that
      Efalex Active 50+ may have a beneficial effect on:

        -  Cognitive performance

        -  Mental fatigue in response to cognitively demanding tasks

        -  Self-reported mood/well-being

        -  Task-related cerebral blood flow response

      The proposed study therefore has two aims; the primary aim is to evaluate the cognitive and
      mood/well-being effects of Efalex Active 50+, a dietary supplement containing a number of
      potentially cognition enhancing components including DHA, phosphatidylserine, vitamin B12,
      folic acid and Ginkgo biloba, compared with placebo in a sample of older adults aged 50-70
      years (Cognitive Study). The second is to evaluate the cerebral haemodynamic effects of the
      same treatment formulation in a sample drawn from the same population, with the addition of a
      third DHA-only arm (Hemodynamics Study). The intervention period will be 6 months.
    


Intervention name(s): Efalex active 50+; DHA rich fish oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 4 x 500 mg Efalax Active 50+, to be taken daily for 6 months.; 4 x 500 mg DHA rich tuna oil to be taken daily for 6 months; 4 x 500 mg capsules to be taken daily for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Docosahexaenoic acid; omega 3; cerebral blood flow; Near Infrared spectroscopy; cognitive function; mood
Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      The aim of the present study is to a) determine the comparative efficacy of the brief
      capnometry-assisted respiratory therapy (CART) and standard cognitive behavioural therapy
      (CBT), and b) to determine moderators and mediators.

      With the data collected from the study, the investigators will test the following hypotheses:
      (a) CART will be as effective in treating PD/A as CBT, albeit in shorter time, b) patients
      with greater respiratory dysregulations, especially hyperventilation, at pretreatment will
      benefit more from CART, whereas patients with greater cognitive dysregulation will benefit
      more from CBT. CART, but not CBT, will result in reversal of hyperventilation.
    


Intervention name(s): Cognitive Behavioral Therapy (CBT); Capnometry Assisted Respiratory Training (CART)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBT teaches a set of cognitive and somatic coping skills to manage panic and anxiety as patients conduct repeated exposure to feared situations and sensations.; CART has four major treatment components: educating patients about the etiology and maintenance of PD according to a hyperventilation centered rationale, directing patients' attention to potentially aberrant respiratory patterns, instructing patients in respiratory control techniques, and instructing patients in home breathing exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eradication Rates of Helicobacter Pylori and Its Affecting Factors
Condition: Helicobacter Infections
MeSH terms: Helicobacter Infections
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to investigate the trend of eradication rates of first-line
      triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect
      the eradication in Korean.
    

Detailed description: 
      A PPI triple regimen combining a proton pump inhibitor(PPI) with two antibiotics (amoxicillin
      and clarithromycin) is currently considered the gold standard therapy for eradication of H.
      pylori. However, recently the eradication rate with first-line treatment has a tendency to
      decrease because of increasing antibiotics resistance. In addition, PPI is mainly metabolized
      by cytochrome p450 2C19 (CYP2C19) in the liver and several reports have suggested that
      differences in th CYP2C19 genotype are associated with H. pylori eradication failure. Thus,
      the first aim of this study is to investigate the trend of eradication rates of first-line
      triple therapy in recent ten years. And the second aim is to analyze the antibiotics
      resistance rate for H. pylori by using culture minimal inhibitory concentrations(MICs) result
      and to analyze the association between CYP2C19 genotype and eradication rate of H.pylori. And
      also investigate the other clinical factors (age, gender, underlying disease, cigarette
      smoking and alcohol use) that affect the eradication rate.
    

Intervention name(s): PPI triple therapy
Intervention type(s): Drug
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        H. pylori positive patient