bioihbjkbjnl/mcl2 huggingface dataset:
Validation of a Diagnostic Method for Quantification of Sleep Bruxism
Condition: Sleep Bruxism; Diagnosis
MeSH terms: Bruxism; Sleep Bruxism
Study type: Interventional

Summary: 
      This study aims to validate a new diagnostic method for quantification and monitoring of
      sleep bruxism.
    

Detailed description: 
      Sleep bruxism has characteristically been defined by the American Academy of Sleep Medicine
      as 'an oral activity characterized by grinding or clenching of the teeth during sleep,
      usually associated with sleep arousals'. For sleep bruxism diagnosis, to date the
      polysomnographic recordings represent the highest standard for sleep bruxism diagnosis, but
      they are concomitantly associated with disadvantages which include technical complexity,
      limited availability, and the fact that they are time-consuming and cost-intensive. Recently,
      a prototype of a diagnostic plate has been developed which allows a fully-automatic,
      computer-based quantification of abrasion thereupon for the assessment of sleep bruxism
      activity. The results of the pilot study were promising, and therefore, the aim of the
      present study is to refine and validate this new diagnostic method for quantification and
      monitoring of sleep bruxism.
    

Intervention name(s): DIABRUX
Intervention type(s): Device
Intervention description(s): All participants receive an individually fabricated diagnostic plate, viz the DIABRUX, for the upper or lower jaw to be worn for five consecutive nights. After use a newly developed analyzing software quantifies the abrasion on the diagnostic plate, thus resulting in a score, viz the Pixel score. This represents a quantitative measure of sleep bruxism activity.
Other intervention name(s): Diagnostic plate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, national, double-blind, controlled clinical trial with parallel group design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: sleep bruxism; diagnosis; validation study; assessment
Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers
Condition: Healthy Human Volunteers
Study type: Interventional

Summary: 
      Hibiscus sabdariffa tea is commonly used all over the world by healthy individual but the tea
      is also employed by patients in the management of chronic diseases such as hypertension
      diabetes, high cholesterol, liver disease etc. Several studies in humans and animal have
      proved the efficacy of Hibiscus sabdariffa tea in lowering blood pressure, blood glucose
      level and serum total cholesterol. But no study exists on the effect of daily consumption of
      this tea on blood pressure, blood glucose, total cholesterol and other biochemical and
      hematological parameters in healthy humans. Hence this study.
    

Detailed description: 
      Several studies have been carried out on the effect of the water beverage of Hibiscus
      sabdariffa, most focus on hypertensive patients, diabetic patients and obese patient and some
      studies investigated the hypolipidemic a effect of the water beverage of Hibiscus sabdariffa
      as well as its effect on haematological parameters but mice were used for these studies.
      Little or no investigation has been done to assess the safety of daily consumption of this
      water beverage of hibiscus sabdariffa on humans.

      Hence, this study aims at investigating the safety in the daily consumption of Zobo in
      humans, monitoring lipid profile, blood pressure, blood glucose, body mass index and
      haematological parameters such as haematocrit, haemoglobin, total white blood cells and also
      hepatic indices.
    

Intervention name(s): Standardized Hibiscus sabdariffa tea
Intervention type(s): Dietary Supplement
Intervention description(s): Daily consumption of Standardized Hibiscus sabdariffa tea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Teach Back Method in Individuals With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study will be conducted to determine the effect of the training given to indivuduals
      with heart failure by teach back method on their symptom control, adherence to treatment and
      self care behaviours.
    

Detailed description: 
      İntroduction: At least 40 million individuals worldwide live with heart failure. Although it
      is progressive, heart failure symptoms can be controlled through pharmacological treatment
      and self-care practices. The aim of heart failure treatment is to improve the quality of life
      of patients, prolong their lifespan, and prevent the progression of symptoms of the disease
      and re-admission to the hospital. Heart failure guidelines state that patient education and
      post-discharge follow-up are necessary for successful management of symptoms.

      Purpose:This study will be conducted to determine the effect of the training given to
      indivuduals with heart failure by teach back method on their symptom control, adherence to
      treatment and self care behaviours.

      Method:This study will be conducted using a randomized controlled research design. The
      research sample will consist of 58 with heart failure in the cardiology department of a
      training and research hospital. Research data will be collected using introductory
      information form, the Morsky Treatment Compliance Scale, European Heart Failure Self-Care
      Behavior Scale-12, Heart Failure Symptom Status Scale. Training and consultancy services
      based on the teach-back method will be provided to individuals in the training group using
      the "Heart Failure Training Guide" in the form of 3 follow-ups in the cardiology clinic and
      telephone counseling. Telephone interviews were conducted by the researcher in the first week
      after discharge, it will be held in the first month and 3rd month. In addition, patients will
      receive counseling by calling the researcher if necessary. After the patients are discharged,
      they will be called 1 week later, at the end of the 1st month and at the end of the 3rd
      month, and training will be repeated and counseling will be provided in line with the issues
      needed. Research posttest data will be collected 3 months after discharge.
    

Intervention name(s): Teach Back Method
Intervention type(s): Other
Intervention description(s): Training and consultancy services based on the teach-back method will be provided to individuals in the training group using the "Heart Failure Training Guide" in the form of 3 follow-ups in the cardiology clinic and telephone counseling. Telephone interviews were conducted by the researcher in the first week after discharge, it will be held in the first month and 3rd month. In addition, patients will receive counseling by calling the researcher if necessary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: patient; education
Characterization of Aerosol Generation and Transport in the Human Lung
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study is aiming at evaluating whether the number and size of exhaled particles changes
      during the increase and decrease of bronchial constriction in subjects with mild intermittent
      asthma.
    

Detailed description: 
      Particle emission demonstrates high reproducibility within subjects while
      between-subject-variability is large. Methacholine challenge in subjects with mild
      intermittent asthma will provide data from repetitive measurements in the same subject with
      variable airflow obstruction.
    

Intervention name(s): Metacholine challenge
Intervention type(s): Other
Intervention description(s): Exhaled breath analysis following metacholine challenge
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by
      mouth, twice a day for up to 18 weeks to prevent migraines.
    

Detailed description: 
      This study is for subjects who have been diagnosed with migraine for at least one year and
      who are currently taking an effective abortive medication(s).
    

Intervention name(s): Lacosamide; Placebo; Lacosamide
Intervention type(s): Drug; Other; Drug
Intervention description(s): Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart; Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart; Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.
Other intervention name(s): LCM; Vimpat; LCM; Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lacosamide; migraine prophylaxis; Vimpat
A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the amount of ABT-614 in the cerebral spinal
      fluid and blood after administration of a single dose and after administration of daily doses
      for 14 days in healthy volunteers.
    


Intervention name(s): ABT-614
Intervention type(s): Drug
Intervention description(s): Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Volunteers
The Effect of Embryo Culture Under Low Oxygen Tension on Pregnancy Rates
Condition: Low Oxygen Tension
Study type: Interventional

Summary: 
      This study will determine whether the use of low oxygen tension during "in vitro" embryo
      culture may increase the pregnancy rates in women undergoing egg donation.
    

Detailed description: 
      As far as oxygen (O2) tension is concerned, both oocytes and embryos from different mammalian
      species included the human are normally surrounded by values which are much less than half of
      atmospheric O2, ranging from high (8.7% O2) in the rabbit oviduct, rabbit and hamster uterus,
      to as low as 11 mm Hg (1.5% O2) in the monkey uterus. Even in the preovulatory follicle,
      oocytes are bathed within follicular fluids containing oxygen that range from > 1 to 5.5 %
      The aim of this study was to evaluate the impact the effect of low oxygen tension after day-3
      embryo transfer in our egg donation programme on pregnancy and implantation rates.
    

Intervention name(s): Decreased oxygen concentration
Intervention type(s): Other
Intervention description(s): The oxygen concentration is decreased during the "in Vitro" embryo culture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive Impairment in Parkinson's Disease (PD)
Condition: Parkinson's Disease With Cognitive Impairment
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study aims to assess the therapeutic role of rTMS on parkinson's patients with cognitive
      impairment. Patients diagnosed with Parkinson's Disease and cognitive impairment will be
      recruited. All patients will be admitted and will be allocated randomly into two groups one
      of which will receive real sessions of high frequency rTMS for each hemisphere for 10
      consecutive sessions totally over period of 10 days with repeated booster sessions every
      month during the period of follow up. The other will receive sham sessions.
    

Detailed description: 
      This study aims to assess the therapeutic role of rTMS on parkinson's patients with cognitive
      impairment. Thirty PD patients with cognitive impairment using United Kingdom (UK ) bank
      criteria for PD will be recruited from outpatient clinic in Assiut University. All patients
      will be admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut,
      Egypt.Each patient fulfilled the inclusion criteria as having score less than 24 on
      Mini-Mental Status Examination will be recruited. The patients will be allocated randomly
      into two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with
      intensity of 80% of resting motor threshold detected from the hand motor area, with total
      2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days
      with repeated booster session every month during the period of follow up among three months.
      The other will receive sham sessions. All subjects will be followed up by selected clinical
      rating scales at different intervals pre session, post 10 sessions, and after one, two and
      three months.
    

Intervention name(s): repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): By defining intensity of 80% of the resting Motor Threshold detected from motor area for Rt Abductor digiti minimi (ADM), we will apply repetitive Transcranial Magnetic Stimulation (rTMS) using 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magnetic Stimulator with high frequency (25Hz), Stimuli will be delivered for total 2000 pulse (divided on 50 trains with 40 pulses per train with inter-train interval 30 seconds) for each hemisphere (coil placed tangential over the optimal position of hand motor area detected for Real group and the same coil placed perpendicular with hand of coil pointing upward over occipital cortex for Sham group). Sessions will be consecutive for ten days period with repetition of consecutive 5 sessions as boosting doses on 5 days period over the follow up visits every month for the next 3 months.
Other intervention name(s): rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pivotal Response Treatment for Individuals With Intellectual Disabilities
Condition: Intellectual Disabilities; Speech Delay; Language Disorder
MeSH terms: Intellectual Disability; Language Disorders; Language Development Disorders
Study type: Interventional

Summary: 
      The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the
      treatment of communication deficits in children with intellectual disabilities. By collecting
      information about parent and child functioning before and after PRT, The investigators will
      be able to determine whether the intervention is effective in improving child communication
      and reducing parent stress.
    


Intervention name(s): Pivotal Response Treatment (PRT)
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intellectual Disabilities; Speech Delay; Language Disorder
Tying Devices as a Means of Increasing Exercise
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators propose that healthy behaviors such as exercise could be increased through
      the use of tying devices - mechanisms that force a coupling of addictive activities
      (listening to the next chapter of a page-turner novel) with engagement in a healthy behavior
      (exercise).
    

Detailed description: 
      The study will test the effect of the following treatments as a means of increasing gym
      attendance over 10 weeks: 1. Participants receive access to 4 iTunes audio novels on their
      own iPods and prompted to listen to those novels only when exercising at the gym; 2:
      Participants receive 4 iTunes audio novels for a loaned iPod that they will only have access
      to at the gym; 3: Participants receive weekly emails asking them about their exercise.
    

Intervention name(s): Control; Suggested Tying Intervention; Forced Tying Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Receive weekly emails asking participants about their exercise and receive cash.; Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym; Participants receive cash and also 4 iTunes audio novels for a loaned iPod accessible only at the gym to listen to only at the gym.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Interest in exercising more
Retinoid 9cUAB30 in Preventing Cancer in Healthy Volunteers
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized phase I trial studies the side effects and best dose of retinoid 9cUAB30 in
      preventing cancer in healthy volunteers. The use of retinoid 9cUAB30 may keep cancer from
      forming in healthy volunteers.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the toxicities and recommended phase II dose of 9cUAB30 (retinoid 9cUAB30).

      II. To characterize the urine and plasma single dose and steady state pharmacokinetics of
      9cUAB30 in normal volunteers.

      SECONDARY OBJECTIVES:

      I. To correlate the pharmacokinetics of 9cUAB30 with toxicity. II. To compare observed
      toxicity between placebo controls and each dose level. III. To assess for any change in
      single dose pharmacokinetics (PK) after repeat dosing (day 1 vs. day 36).

      OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment
      arms.

      ARM I: Participants receive retinoid 9cUAB30 orally (PO) once daily (QD) on days 1 and 8-36.
      Treatment continues in the absence of unacceptable toxicity.

      ARM II: Participants receive a placebo PO QD on days 1 and 8-36.

      After completion of study treatment, patients are followed up at 7 and 30 days.
    

Intervention name(s): Laboratory Biomarker Analysis; Pharmacological Study; Placebo; Retinoid 9cUAB30
Intervention type(s): Other; Other; Other; Drug
Intervention description(s): Correlative studies; Correlative studies; Given PO; Given PO
Other intervention name(s): placebo therapy; PLCB; sham therapy; 9cUAB30
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain
Condition: Low Back Pain, Mechanical, Biofeedback, Pain, Chronic
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus
      muscles is the most important cause of the chronic nonspecific low back pain (CNLBP).
      Recently, applications sre developed that generates audio and vibrant stimuli in response to
      anteroposterior and mediolateral rotations and can be adapted according to subject-specific
      movement sensitivity.

      Objective. The objective of this study was to compare effects of a biofeedback application
      that is alternative to physiotherapist feedback in core stabilization training of patients
      with chronic nonspecific low back pain.

      Design. This study was a parallel group randomized controlled trial with outcome assessment.

      Patients. The participants were 38 patients with chronic (≥12 weeks) nonspecific low back
      pain.

      Interventions. Patients were randomly assigned to receive either physiotherapist feedback or
      Perfect Practice (Level Belt Pro Inc.) biofeedback. Patients in both groups received 12
      sessions, 30 minutes of three weekly graded functional core education trial.

      Measurements. Primary outcome measures were muscle strength (transversus abdominus and
      multifidus) pain intensity (Visual Analog Scale) and functional level (Revised Oswestry
      Disability Index); secondary outcomes were flexibility (modified Schober test), range of
      motion (universal goniometer), proprioception (Active Reposition Test), patient beliefs (Fear
      Avoidance Beliefs Questionnaire), psychological status (Beck Depression Index), and quality
      of life(36 Item Short-Form Health Survey questionnaire [SF-36]).

      Limitations. Outcome measures for muscle strength did not include objective assesment.

      Keywords. Chronic low back, core stabilization training, biofeedback, pain, function
    


Intervention name(s): Biofeedback
Intervention type(s): Other
Intervention description(s): The aim of this study is to investigate effects of a biofeedback application that is alternative to physical therapist feedback in core stabilization training of patients with CNLBP.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low Back Pain, Mechanical, Biofeedback, Pain, Chronic
Effects of Intense Exercise on Neural Responses to Food.
Condition: Neural Responses; Appetite Hormones; Subjective Appetite Sensations
Study type: Interventional

Summary: 
      The primary aim of this study was to determine the effects of an acute bout of high intensity
      exercise on the brains response to viewing pictures of food using functional magnetic
      resonance imaging (fMRI).
    

Detailed description: 
      It is clear that intense exercise impacts on peripheral appetite regulation, however very
      little is known about the impact of high-intensity exercise on central appetite regulation.
      This study aimed to investigate the effects of high-intensity exercise on both central and
      peripheral responses to images of food. Functional magnetic resonance techniques were used to
      assess the brains response to images of high and low calorie foods, following a short bout of
      high-intensity exercise. Appetite hormone concentrations were also measured. It was
      hypothesized that, due to the known effects of high-intensity exercise on appetite regulatory
      hormones and subjective appetite ratings, the activation of reward-related brain regions to
      visual food cues would be modulated following intense physical activity.
    

Intervention name(s): Exercise; Rest
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science