bioihbjkbjnl/mcl2 huggingface dataset:
Oral Habits Effect on Orofacial Dysfunction and Oral Health Related Quality of Life.
Condition: Oral Habits; Oro-Facial Dysfunction
Study type: Observational

Summary: 
      The aim of the present study is to determine the effect of oral habits on orofacial
      dysfunction and oral health related quality of life among a group of Egyptian children.
    

Detailed description: 
      Child's OHRQoL is assessed in terms of four main categories: oral symptoms as pain and
      discomfort, functional limitations as reduced masticatory efficiency due to malocclusion,
      emotional limitations as reduced self-esteem and social limitations as being teased by other
      children.

      Deleterious Oral Habit is believed to be associated with emotional disturbances and orofacial
      dysfunction which will certainly affect child's OHRQoL.

      Sucking habits, mouth breathing habits and tongue thrusting habits are found to be the most
      deleterious habits, especially in the selected age group of (5-7) years. It was found that
      these three deleterious habits are the most practiced habits among Egyptian children aging
      from 6-9 years (19.6%).

      Up to the investigator's knowledge, there are very scanty studies investigating the effect of
      orofacial dysfunction on OHRQoL in children, only one of them was conducted on children
      practicing oral habits, but none of them was conducted on Egyptian children.
    

Intervention name(s): Practicing oral habits
Intervention type(s): Behavioral
Intervention description(s): children who practice one or more of the specified oral habits ( mouth breathing, object sucking, or tongue thrusting) are considered exposed.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Healthy Egyptian children aging from 5 to 7 years old.
Garlic Intake And Biomarkers Of Cancer Risk
Condition: Healthy Men; Healthy Women
Study type: Interventional

Summary: 
      This study is being done to study the healthful benefits of eating garlic. Previous studies
      suggest that garlic may help prevent cancer. The investigators are recruiting healthy
      volunteers to participate in a study to determine the ways in which eating garlic may reduce
      cancer risk.
    

Detailed description: 
      A crossover design will be utilized with each participant completing each treatment phase;
      participants will be randomly assigned to a sequence of dietary treatments. There will be a
      17-day washout period in between diet periods. Participants will consume a garlic-free diet
      for the first 10 days of each diet period. The dietary treatments will be administered on day
      11 of each diet period. Dietary treatments will be incorporated into food as follows: 1) 5 g
      (0.175 oz.) of garlic mixed with 15 g margarine on top of 270 kcal white bread, served as
      breakfast, or 2) 15 g margarine on top of 270 kcal white bread, served as breakfast.
    

Intervention name(s): Control; Garlic treatment
Intervention type(s): Other; Other
Intervention description(s): Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine.; Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine and 5 g crushed garlic.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Garlic; Cancer biomarkers; Gene expression; Oxidative stress; DNA damage
Effect of Microbial Exposure on Health, Particularly Immune System
Condition: Immune System Disorders
MeSH terms: Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The effect of microbial exposure on healthy human subjects will be investigated. Changes in
      cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial
      exposure increases the measured responses.
    

Detailed description: 
      The effect of microbial exposure on healthy human subjects will be investigated. The
      volunteers will either receive material containing a microbial inoculum, or they will receive
      nothing. Changes in cytokine and IgE and vaccine response will be measured. Subjective
      well-being will be recorded. Changes in microbial community will be followed. The hypothesis
      is that microbial exposure increases the measured responses.
    

Intervention name(s): microbial inoculate
Intervention type(s): Biological
Intervention description(s): volunteers will regularly receive microbial inoculate that they do not use orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: vaccine response; immune system activity
Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the relative osseomechanical strength of a novel
      coated pin/screw in a clinical model.
    

Detailed description: 
      The pin fixation and the risk for pin loosening and pintract infection is intimately
      connected Moroni et al., Magyar et al. Toksvig-Larsen and W-Dahl) The pin performance ratio
      for insertion to extraction torque (PPI) varies significantly between screw types.

      The extraction torque force is the most important value and it is estimated that a removal
      torque around 300 Nm probably will be the best bon-pin fixation in clinical practice.

      In animal studies and even in clinical studies the hydroxyapatite (HA) coated screw retained
      the highest level of osseointegration. However, the fixation for HAscrews is, especially in
      diaphyseal bone, the risk for too tight fixation, with extreme difficulties to remove the
      screws in few cases as a result ( high pain and seldom it is impossible to remove the screw)
      Coating by biphosphonate is a new novel technique with preclinical appealing performance,
      which theoretically should make this coating very appealing in clinical practice. The theory
      behind this technique is that it create a good pinfixation reasonable easy to remove.

      The current most used cortical screw designs performed poorest in terms of fixation (PPI)

      Method

      Using the hemicallotasis technique for correction in high tibial osteotomies today, HA coated
      (Osteotite) conical 130/50 screws is used in the proximal tibia - the metaphysic - and plain
      (standard) cortical conical screws 110/40 is used in the diaphysis.

      To study the effect of an improved pin coating a study including 30 patients randomised to
      the standard procedure today or the novel technique using biphosphonate coated screws.

      In the metaphysic, the randomisation will be between the HA coated (Osteotite) screws and the
      biphosphonated coated screws 130/50 (screw thread 50mm) In the diaphysis the randomisation
      will be between the plain standard 110/40 screws and the biphosphonate 110/40 coated screws

      Totally 30 patients will be studied which means totally 120 pins. This has been based on
      power calculations resulting in 23 patients in each group and calculated on extraction torque
      force. This is a clinical study and 30 patients is estimated due to expected drop out.
    

Intervention name(s): Biphosfonate; Hydroxylapatit
Intervention type(s): Device; Device
Intervention description(s): External pins coated by biphosfonate.; External pins coated by Hydroxylapatit.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pin fixation; Osteotomy; hemicallotasis
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
Condition: Obstructive Sleep Apnea; Central Sleep Apnea; Mixed Sleep Apnea; Cheyne-Stokes Respiration
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central; Cheyne-Stokes Respiration
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for
      diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology
      in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes
      respiration (CSR).
    

Detailed description: 
      This is a multi- center, open label study to evaluate the accuracy of Somnarus device when
      compared with overnight polysomnographic measurements.

      The study includes the following steps:

      Screening the database or advertising among cardiologists, neurologists, pulmonologists and
      Ear Nose and Throat (ENT) specialists to identify potential subjects.

      Initial visit, includes:

        1. Consent discussion and signature

        2. History, vital signs, and physical exam

      Night study

      a. A polysomnogram is conducted and, at the same time, a SomnaPatch device is used.

      Additional visits If side effects occur, or if the data collection fails, or at the request
      of the sponsor to repeat the sleep study for further data collection and comparison.
    

Intervention name(s): SomnaPatch; Polysomnography
Intervention type(s): Device; Device
Intervention description(s): SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.; Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: apnea; hypopnea; polysomnography; respiratory; cheyne
Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.
Condition: Focus Type 2 Diabetes Related Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies
Study type: Interventional

Summary: 
      The general objective is to investigate the effect of a 12 week walking exercise program on
      vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers
      in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Blended supervised-home based walking program 3-4 times per week for at least 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Diabetic kidney disease; vascular function; physical function
An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once
      daily in combination with paroxetine 20mg once daily compared to saredutant placebo in
      combination with paroxetine 20mg once daily in patients with major depressive disorder. The
      study also includes a double-placebo group (saredutant placebo in combination with paroxetine
      placebo).
    


Intervention name(s): saredutant (SR48968); paroxetine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration,capsules; oral administration, capsules; oral administration, capsules
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Major Depressive Episode; Antidepressant
Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, open-label, randomized, 3-way crossover study to evaluate PK, safety,
      and tolerability of a new tablet formulation of CPI-444 and to evaluate the effect of food on
      single oral doses of CPI-444 tablets in healthy male and female subjects. Potential subjects
      will be screened to assess their eligibility to enter the study within 28 days prior to the
      first dose administration.
    


Intervention name(s): CPI-444 Capsules; CPI-444 Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 100mg Capsule; 100mg Tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Phase 2, Two-Part Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Two-Part Evaluation of the Efficacy
      and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
    


Intervention name(s): HTX-011; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of LY03003 in Patients With Early-stage Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to characterize the pharmacokinetics and to evaluate the safety as well as
      tolerability of LY03003 following multiple escalating intramuscular injections
    


Intervention name(s): Rotigotine, extended-release microspheres; Placebo, extended-release microspheres
Intervention type(s): Drug; Drug
Intervention description(s): Four stable dose levels of LY03003 at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:
Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks.
Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks.
Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks.
Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks.; Four stable dose levels of placebo at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:
Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks.
Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks.
Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks.
Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks.
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson disease; LY03003
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
Condition: Healthy Volunteers (Meningococcal Infection)
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the immunogenicity and describe the safety of MenACYW
      conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric
      vaccines to healthy infants and toddlers in the US.
    

Detailed description: 
      The duration of each subject's participation in the trial will be approximately 16 to 19
      months (Subgroup 1a) and 19 to 22 months (Subgroup 1b and Group 2), which includes a safety
      follow up contact at 6 months after the last vaccinations.
    

Intervention name(s): MenACYW conjugate vaccine; MenACYW-135 conjugate vaccine; DTaP-IPV//Hib vaccine; Pneumococcal 13-valent conjugate vaccine; Pentavalent rotavirus vaccine; Hepatitis B vaccine; Measles, mumps, rubella (MMR) vaccine; Varicella vaccine; Hepatitis A vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular; Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular; DTaP-IPV//Hib vaccine at 2, 4, and 6 months of age, Intramuscular; Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular; Rotavirus vaccine at 2, 4, and 6 months of age, oral solution; Hepatitis B vaccine at 2 and 6 months of age, Intramuscular; MMR vaccine at 12 months of age, Subcutaneous; Varicella vaccine at 12 months of age; Hepatitis A vaccine at 15 to 18 months of age
Other intervention name(s): MENVEO®; Pentacel®; PREVNAR 13®; RotaTeq®; ENGERIX-B®; M-M-R® II; VARIVAX®; HAVRIX®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningococcal meningitis; MenACYW conjugate vaccine; Quadrivalent meningococcal vaccine
Safety Study of Ch-mAb7F9 for Methamphetamine Abuse
Condition: Methamphetamine Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the safety and tolerability of single, ascending
      intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse
      event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.Phase 1a,
      randomized, placebo-controlled, first-in-human (FIH) study of intravenously administered
      ch-mAb7F9. The study will be a double-blind, dose-escalation study. Each subject will receive
      a single dose of ch-mAb7F9 or placebo (saline).
    

Detailed description: 
      There will be 5 dose groups. At the beginning of dosing in each group, 1 subject will receive
      the normal saline placebo and 1 will receive the active dose. The remainder of the dose group
      will receive their doses beginning 48 hr later, after safety evaluations. Dosing of the
      remaining subjects in each dose group will occur 1 at a time, with dosing in each subsequent
      subject separated by a minimum of 24 hr. Subsequent dose groups will receive their doses
      beginning approximately 2 weeks after dosing in the preceding group, pending safety analyses.

      The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg,
      respectively. The starting dose will be 0.2 mg/kg, and the highest dose will be 20 mg/kg (up
      to a maximum of 1,500 mg), which is at least 20-fold lower than the no observable adverse
      effect level (NOAEL) in rats to ensure subject safety.

      Ch-mAb7F9 will be administered intravenously (IV) with a saline flush to clear the
      administration tubing of residual ch-mAb7F9. Each dose of ch-mAb7F9 will be diluted in 225 ml
      of saline and given over two hours.
    

Intervention name(s): normal saline; ch-mAb7f9
Intervention type(s): Biological; Biological
Intervention description(s): saline 225 ml; The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. Volume to be administered 225 ml
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: methamphetamine; monoclonal antibody
Enhancement of Emmetropization in Highly Hyperopic Infants
Condition: Hyperopia
MeSH terms: Hyperopia
Study type: Interventional

Summary: 
      Infants do not usually wear glasses because they usually do not need them to see clearly.
      Most infants are born with a moderate amount of farsightedness. Most infants then undergo a
      natural process called 'emmetropization' that reduces the amount of farsightedness. However,
      up to 10% of infants don't emmetropize and end up with very farsighted prescriptions.
      Farsighted infants must use extra focusing effort to see clearly, which may make their eyes
      cross and perhaps cause a "lazy eye". If infants avoid this effort and their vision stays
      blurred into childhood, they may develop two lazy eyes. Farsightedness in school-aged
      children makes reading and learning more difficult. New studies in animals and in humans show
      that infant eyes will emmetropize best if they have just a normal, moderate amount of
      farsightedness. The infant eye must be in this normal target zone in order to emmetropize. If
      a baby were given glasses with the full prescription to correct all of his farsightedness,
      the eyes would also be out of the target zone and would not receive any signal to grow. The
      best strategy might be to give a partial spectacle correction for the farsightedness, just
      enough to put them in the zone that is most effective for emmetropization.

      The purpose of this project is to determine if emmetropization can be enhanced in very
      farsighted babies. We will give them glasses with a partial correction and accommodative (eye
      focusing) training. The partial correction is an amount that is less than their full degree
      of farsightedness but enough to put them in the zone of effective emmetropization. As changes
      in farsightedness occur, the power of the glasses will be reduced to keep the farsightedness
      within the target zone. If an infant reaches a normal amount of farsightedness, the glasses
      will be discontinued. The comparison group will be farsighted babies who receive the current
      standard of care, namely no correction. The main outcome of the study will be whether there
      is a significant difference in the decrease of farsightedness between the two groups when the
      infants are 18 months of age.

      If emmetropization can be enhanced in very farsighted babies, the risk of developing crossed
      or lazy eye will be reduced. The lifelong need for spectacles, contact lenses, or refractive
      surgery for high amounts of farsightedness would also be reduced. Positive results might also
      make infant eye examinations more common and place a new therapeutic option in clinicians'
      hands.
    


Intervention name(s): Glasses
Intervention type(s): Device
Intervention description(s): Partial refractive correction in a pair of glasses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Emmetropization; Refractive Error; Glasses; Accommodation