bioihbjkbjnl/mcl2 huggingface dataset:
Oral Alkali Production and Caries Prevention in Children (Longitudinal)
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      The fact that dental caries remains a major public health problem mandates that oral-health
      researchers explore new strategies for assessment of caries risk, as well as for caries
      prevention and management. Dental caries occurs when acids produced by bacterial glycolysis
      of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of caries
      research has been on identifying and characterizing acid-generating bacteria and the
      mechanisms of acid resistance. The purpose of this study is to investigate over time the
      relationship between alkali production and caries.
    

Detailed description: 
      This study will require a total of 6 study visits over a 2 to 3 year period. The first study
      visit will last about one hour. At this study visit, parent-administered questionnaires will
      be used to collect information on the following: (a) the participant's demographic background
      (age, gender, and race), (b) socio-economic status (parents' income and housing condition),
      (c) participant's oral health practice (feeding histories, diet habits, oral hygiene
      measures, and dental attendance), and (d) systemic diseases. During the study visit, the
      participant's complete medical and dental history will be obtained and reviewed, and a dental
      exam will be performed in order to determine participants' caries status, and intraoral
      pictures may be taken of participants' teeth. At this visit and remaining visits participants
      will not be allowed to brush or clean teeth using any type of oral hygiene procedures for 8
      hours prior to the visit. Saliva and plaque (the solf white-yellowish material on the tooth
      surface) will be collected at each visit. The Investigator will use a small probe to measure
      the pH of the dental plaque that builds up on the teeth. The participant will be asked to dip
      one finger into a glass containing a buffer solution and the probe will be placed on the
      teeth from which plaque will be taken. Plaque samples will be collected by gently scrapping
      the tooth using a sterile instrument. If the participant does not have enough plaque samples,
      they will be asked to return on the following day.
    

Intervention name(s): Oral Samples
Intervention type(s): Other
Intervention description(s): Oral samples of saliva, dental plaque and DNA will be collected between the two groups.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population will consist of unrelated children aged between 2 and 5 years with
        different levels of caries experience.
      
Biospecimen description: 
      Saliva and Plaque
    
Keywords: Plaque; Saliva; Caries
The Effect of Sitting and Standing Posture on Trunk Rotation in Patients With Idiopathic Scoliosis
Condition: Scoliosis Idiopathic
MeSH terms: Scoliosis
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to investigate the acute effect of activities of daily living on
      trunk rotation in patients with adolescent idiopathic scoliosis.
    

Detailed description: 
      Patients with AIS who applied to Bandırma Onyedi Eylül University Physiotherapy and
      Rehabilitation Department will be included in this study.

      Individuals diagnosed with AIS, whose Cobb angle is between 20º -50º, who do not have any
      chronic diseases that require neurological or psychiatric medication, and who volunteer to
      participate in the study will be included. Individuals with any contraindications for
      exercise, previous spine surgery, thoracic apex curvature of 6 or more, mental problems,
      non-idiopathic scoliosis but with different causes will be excluded from the study.

      To determine the demographic characteristics of the participants, age, gender, weight,
      height, presence of chronic disease, age at first diagnosis, exercise habits, treatments, and
      brace use will be questioned. The ATR will be used to measure degrees of trunk rotation to
      monitor the effects of treatment without radiographic evaluation.

      On the first day, the demographic characteristics of the participants will be questioned,
      Cobb angles, Risser findings, and ATR degrees will be recorded. After the first day, all
      postural activities and measurements will be taken on different days (at least three days
      apart) not to affect the degrees of trunk rotation in patients with AIS.
    

Intervention name(s): Corrected Sitting postures; Natural / relaxed sitting postures; Corrected Standing posture; Natural / relaxed standing postures
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Change after being in Corrected Sitting postures; Change after being in relaxed sitting postures; Change after being in Corrected Standing posture; Change after being in relaxed standing postures
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with adolescent idiopathic scoliosis.
Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever
Condition: Subarachnoid Hemorrhage; Severe Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      When fever is present in patients with stroke, traumatic brain injury (TBI), or brain
      hemorrhage, it has been associated with worse outcomes including larger areas of tissue
      death, increased length of stay, worse degree of coma, lower ability to function, and higher
      mortality. Both adult and pediatric TBI national guidelines state that maintenance of normal
      body temperature should be a standard of care. However, no further standards or options are
      presented to specifically guide practice. The current ischemic stroke guidelines state that
      fever should be treated with fever-reducing agents and offer "cooling devices" as an option
      but do not provide specifics to guide practice. Over 50% of patients in the Neurosurgical
      Intensive Care Unit (ICU) at Harborview Medical Center develop fever during the course of
      their stay. With elevated temperatures the body consumes more oxygen than if the temperature
      was normal, causing less oxygen to be available to the brain. This may lead to injury of the
      brain cells and a diminished capacity for healing. Thus, temperature management in
      neurologically vulnerable patients is both a prevalent and problematic challenge. Based on
      this information the goal of the present proposal is to evaluate if 1) A standardized,
      step-wise approach to temperature management using a Normothermia Protocol is successful in
      achieving and maintaining normal temperature in Neurosurgical ICU patients; and 2) If
      maintenance of normal temperature will be associated with fewer episodes of diminished
      responsiveness in their neurological exams as evidenced by a measure of depth of coma, as
      measured by the Glasgow Coma Score (GCS) compared to a control group treated according to
      usual care.
    


Intervention name(s): Stepwise normothermia protocol; Ibuprofen; Acetominophen
Intervention type(s): Other; Drug; Drug
Intervention description(s): Use of standard care interventions in a protocolized/step-wise fashion instead of ad hoc based on nurse decision making which may include antipyretics, physical cooling measures.; It is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol.; It is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol.
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of escalating doses of
      ODM-103 when given to healthy male volunteers.
    

Detailed description: 
      The study is divided into two parts. Part one is a crossover study where healthy volunteers
      will receive two doses of ODM-103 and one dose of placebo. Part II of the study is a multiple
      ascending dose parallel group study where healthy volunteers will receive ODM-103 three times
      daily for seven days. Healthy volunteers taking part in Part II of the study will also
      receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in
      addition to ODM-103 on day 9. The study will also look at the pharmacokinetic(how the body
      handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-103.
    

Intervention name(s): ODM103; Placebo; Entacapone; Levodopa/carbidopa
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: volunteer; study
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine
    

Detailed description: 
      1. Primary insomnia will be diagnosed according to DSM-IV-TR

        2. After consenting, cases will be divided (double blind randomization)in to two arms 2.1
           sleep hygiene with placebo group 2.2 sleep hygiene with Quetiapine group

        3. outcome measurement: sleep diary, sleep satisfaction visual analog scale and sleep
           satisfaction likert scale

        4. statistical method: dependent T test
    

Intervention name(s): Quetiapine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary insomnia; Quetiapine; Randomized controlled trial; Double blind
Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli
Condition: Anxiety Disorders; Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Post Traumatic Stress Disorder; Agoraphobia; Simple Phobia
MeSH terms: Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Panic Disorder; Phobia, Social; Agoraphobia
Study type: Interventional

Summary: 
      This study will evaluate the effects of Mindfulness-Based Stress Reduction (MBSR) on
      physiological reactivity. This study will focus on individuals with anxiety who will
      participate in an 8-week MBSR class. The investigators will test participants' reactivity to
      both predictable and unpredictable stimuli before and after the class to understand the
      physiological changes that may occur after to the intervention. Secondary measures include
      psychometric instruments and a delay discounting task.
    

Detailed description: 
      Mindfulness-Based Stress Reduction (MBSR) is a manualized, systematic training in mindfulness
      meditation that has been found to have beneficial health effects, such as decreased stress
      and anxiety. The current protocol aims to examine the effects of MBSR on several
      physiological and behavioral measures in people with anxiety disorders, which may help us
      understand the effects of the intervention on anxiety. The investigators will use the NPU
      task as developed by the NIH, which measures an individual's response to threatening stimuli
      (mild shock) paired with non-threatening stimuli (geometric shapes). Individuals with anxiety
      disorders will be recruited to participate in this study, and will be randomized to a control
      (waitlist) or MBSR intervention group. Other secondary measures will examine the effects of
      mindfulness meditation on decision-making, and stress and anxiety symptoms.
    

Intervention name(s): Mindfulness-Based Stress Reduction; Waitlist
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The MBSR course teaches mindfulness meditation skills. This 8-week course meets in person once a week for 2.5 hours. Participants are expected to complete practice assignments at home.; This group will wait 8-16 weeks after their first testing visit and after their second study visit is completed they will be able to participate in an 8-week MBSR course.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mindfulness; meditation
Lesinurad Tablet Relative Bioavailability
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the relative bioavailability of lesinurad tablets, manufactured at two
      different sites.
    

Detailed description: 
      A change in manufacturing site of lesinurad tablets has been implemented. This study is
      intended to evaluate the clinical comparability of lesinurad tablets manufactured at the two
      different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.
    

Intervention name(s): Lesinurad 400 mg (Site 1); Lesinurad 400 mg (Site 2, Lot A); Lesinurad 400 mg (Site 2, Lot B)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158
Condition: Ischemia
MeSH terms: Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to get more information on using BMS747158 (the study
      drug),a drug with small amounts of radioactivity to allow for heart imaging, during a PET
      scan which can then be compared to other images such as SPECT. The safety and quality of
      images will be studied.
    

Detailed description: 
      The primary objectives of this study are:

        -  To acquire data for the development of one-day rest/stress cardiac PET perfusion imaging
           protocols for BMS747158 with comparable diagnostic image quality to a two-day
           rest/stress PET protocol

        -  To assess the safety of multiple doses of BMS747158

      The secondary objectives of this study are:

        -  To assess PET imaging parameters and image quality following administration of BMS747158
           at rest and at stress (pharmacologic or exercise) same day (at different time intervals)
           and 16-48 hours after the rest injection

        -  To assess feasibility of gated cardiac PET imaging with BMS747158 for left ventricular
           function assessment

        -  To assess agreement of one and two day rest/stress PET imaging with BMS747158 in
           patients with reversible ischemia with rest/stress single photon emission computed
           tomography (SPECT) imaging

        -  To perform a preliminary assessment of the diagnostic accuracy of one-day and two-day
           rest/stress PET perfusion imaging with BMS747158 as compared with invasive coronary
           angiography or computed tomography angiography (CTA) for detection of
    

Intervention name(s): BMS747158
Intervention type(s): Drug
Intervention description(s): dosages at rest and at stress were not to exceed a total of 14 mCi.
Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period.
Cohort 2: Patients to recieve IV bolus injections of BMS747158:
For the Pharmacologic (Adenosine) Stress:
Doses at rest were to range between 2.9 and 3.4 mCi.
Doses under stress were to be a factor of 2.0 to 2.4 greater than the rest dose, resulting in a range of stress doses between 5.8 and 8.2 mCi.
For the Exercise Stress:
Doses at rest were to range between 1.7 and 2.0 mCi.
Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi.
Other intervention name(s): There are no other names
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Myocardial Perfusion; PET imaging; SPECT imaging; Coronary artery disease; Subjects that are male and nonpregnant female patients; presenting with reversible ischemia as characterized by a; rest/stress SPECT imaging study using; Technetium(99mTc)-labeled tracers
Botulinum Toxin A for Idiopathic Toe-walking
Condition: Idiopathic Toe-walking
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether botulinum toxin A (BTX) adds a favourable
      effect to treatment of idiopathic toe-walking with below knee walking casts. The specific
      hypothesis to be tested is that a combination of BTX and casting is more effective than
      casting treatment alone in reducing toe-walking in 5-15 year old children. Evaluation methods
      include 3-D gait analysis, parents' perception of toe-walking frequency, passive joint range
      of motion measurements, and strength of ankle dorsal extension.
    


Intervention name(s): Botulinum toxin A
Intervention type(s): Drug
Intervention description(s): The children in Group 2 underwent bilateral treatment with a total of 12 units/kg bodyweight Botox® (Allergan, California, USA). Four injection sites in each calf - two in the proximal third of the lateral and medial gastrocnemius bellies and two distally in the gastrocnemius-soleus complex - were administered. All injections were performed with electromyogram amplifier guidance to ensure intramuscular position. Children in both groups were treated with four weeks of below knee walking casts. Children in group 2 received the casts 1-2 weeks after botulinum toxin A treatment.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gait
Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction
Condition: Myocardial Infarction; Cardiac Anxiety; CBT; Exposure
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Myocardial infarction (MI) is one of the leading cause s of health loss globally,
      representing a large proportion of general disability. Anxiety and depression occur in 20-30
      percent of patients following MI and have been identified as risk factors for recurrent
      adverse cardiac event. The purpose of our this study is to develop and evaluate a disease
      specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression,
      increase physical inactivity and quality of life (Q oL) in patients following MI
    

Detailed description: 
      The study will include 30 patients. The MI-specific CBT lasts for 8 weeks and is therapist
      guided and delivered via internet via a secure digital platform by licensed psychologists
      expertise in CBT for cardiac disease or final year psychologist under supervision. During
      treatment, the psychologists will have direct access to a cardiologist assigned to the
      project and treatments are conducted in close interdisciplinary collaboration to ensure
      patient safety
    

Intervention name(s): MI-CBT
Intervention type(s): Behavioral
Intervention description(s): Education of MI and common reactions, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Amino Acid and Intestinal Protein Metabolism : Working Study
Condition: Transduction Pathway; Proteinic Synthesis; Proteolytic System
Study type: Observational

Summary: 
      Gut protein metabolism that could be influenced by protein supply is involved in the
      regulation of several physiological functions such as gut barrier function and represents a
      major contribution in the whole-body protein turnover. Intracellular pathways implicated in
      the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of
      the present project is to evaluate and to understand the effects of amino acids (glutamine,
      leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Biospecimen description: 
      whole blood duodenal tissue
Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
Condition: Major Depressive Disorder; Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label
      fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.
    


Intervention name(s): Duloxetine hydrochloride
Intervention type(s): Drug
Intervention description(s): Duloxetine 30 milligram (mg) once daily (QD) orally (PO) for 1 week, then duloxetine 60 mg QD PO for 11 weeks
Other intervention name(s): LY248686; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration
Condition: Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
Study type: Interventional

Summary: 
      1. Appropriate sedation is needed for medical diagnosis, treatment, and the safety for
           patients. In non-surgical approaches, benzodiazepines are broadly used for ideal sedated
           status for patients.

             -  However, especially in bronchoscope procedure, continuous monitoring of oxygen
                saturation is needed to prevent hypoxia due to respiratory distress induced by
                benzodiazepine.

             -  A alpha-2 agonist, dexmedetomidine, which has similar sedative effect, but has less
                adverse effect of respiratory distress compared to previous agents, was introduced.

        2. It is necessary to compare the efficacy and safety of dexmedetomidine with that of
           midazolam in ultrasound guided transbronchial needle aspiration (EBUS-TBNA).

             -  Double blind randomized trial

             -  Primary outcome: The number and duration of desaturation, volume of sedative, any
                use of rescue midazolam, and Ramsay Sedation Scale (RSS) score (for efficacy), and
                hypertension, tachycardia, any need for mandible support or manual ventilation, and
                any need for intubation (for safety).
    


Intervention name(s): midazolam; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other