bioihbjkbjnl/mcl2 huggingface dataset:
Study for the Assessment of the Quality of Echocardiographic Clips.
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      This study main objective is to evaluate the safety and efficacy of the UltraSight AI
      Guidance software. The investigational product is a software that guides the user to capture
      a high quality ultrasound image. The study will include healthcare professionals, not
      specialized in echocardiography, who will perform echocardiography by using UltraSight AI
      Guidance software, on subjects in the medical centers cardiac units.
    

Detailed description: 
      This pivotal study is a multi-center, multi-reader multi-case (MRMC) study, designed to
      assess the quality of the clips obtained by novice users when using the UltraSight AI
      Guidance software. Prior to the study start, there will be a pre-study training phase for
      training the novice users.

      During the study, eligible subject will undergo the echocardiography examination twice on a
      single study visit (same day): once by one of the novice users when using the UltraSight AI
      Guidance software, and once by an expert sonographer without the aid of the software.

      Each novice user will perform the examination on at least 20 subjects (with the aim that the
      number of examinations by each novice will be similar). All examinations will be sent to
      multiple Board certified cardiologists for their quality evaluations.
    

Intervention name(s): Echocardiographic.
Intervention type(s): Device
Intervention description(s): Echocardiographic test.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        male and female adults confirmed as eligible according to eligibility criteria.
Lipids of the Human Tear Film and Their Effect on Tear Stability
Condition: Blepharitis
MeSH terms: Blepharitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective, randomized, comparative clinical trial evaluates the effect of either oral
      doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of
      the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.
    

Detailed description: 
      Subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion
      prior to beginning treatment with either oral doxycycline or topical azithromycin solution.
      Doxycycline is dosed at 100 mg bid; topical azithromycin is delivered once per day as a 1%
      solution. Treatment with doxycycline is for two months; treatment with topical azithromycin
      is for one month. Following treatment, meibomian glands are again expressed and the lipids
      measured by spectroscopy (FTIR, MALDI-TOF, NMR)for characterization of structure and
      function. Analysis for presence of doxcycline or azithromycin is also performed. Changes in
      lipid parameters are correlated with clinical signs and symptoms of disease.
    

Intervention name(s): doxycycline; azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Oral doxycycline 100mg bid; topical 1% azithromycin daily to eye
Other intervention name(s): Minocycline; Azasite
Intervention MeSH terms: Azithromycin; Doxycycline; Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Meibomian gland dysfunction; Lid margin disease; doxycycline; azithromycin; essential fatty acid
A Cross Sectional Observational Study on Relation Between Oral Manifestation and Hepatitis C in Egypt
Condition: Hepatitis C; Oral Manifestations; in Egyptian Population
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Oral Manifestations
Study type: Observational

Summary: 
      Hepatitis C virus (HCV) is the major cause of chronic liver disease and has a long-term
      resultant complications4 and it considered as a major endemic medical health problem in
      Egypt. It affects multiple organs and reflect various manifestations on oral cavity.The
      purpose of this study is to assess the prevalence of oral mucosa conditions, type of oral
      manifestation and gingival lesions in patients with hepatitis C
    

Detailed description: 
      Study design: It is a cross sectional observational study. Sample size estimation: 100
      patients (50 in each groups) A total of 100 adult participants of both genders above 18 years
      will be included in the study, patients was able and willing to participate in the study. 50
      patients will be recruited for study group from consecutive patients previously diagnosed by
      hepatitis C regardless of the etiology of the condition and regularly attending at Soad Kafay
      hospital. Participants with history of smoking and alcoholism that could affect their oral
      health status were excluded. The control group populations will be randomly recruited from
      the out-patient of dental diagnosis clinic in Misr University For science & technology
      university to include total 50 clinically healthy participants, with no history of liver
      disease, or any other chronic debilitating illness, or habit of smoking or drinking, , as
      well as history of an intervention or condition that could affect the oral mucosa (e.g.,
      history of radiotherapy and/or not receiving any medication that could affect oral health.

      Changes in the oral cavity was recorded on the entire mucosal surface recording signs,
      symptoms, and oral lesion absence or presence. All the information will be recorded and the
      data will be analyzed after the end of the study . The prevalence of various oral
      manifestations in hepatitis C patients will be documented.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        hepatic (virus C) and non hepatic patients on Egyptian population
Protective Effects of Exercise Training
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Rationale. Sleep loss is a risk factor for cardiovascular events mediated through endothelial
      dysfunction.

      Objective. To determine if 7 weeks of exercise training can limit cardiovascular dysfunction
      induced by total sleep deprivation (TSD) in healthy young men.

      Methods: 16 subjects will be examined during 40-h TSD, both before and after 7 weeks of
      interval exercise training. Vasodilatation induced by ACh, insulin and heat (42°C) as well as
      pulse wave velocity (PWV), blood pressure and heart rate (HR) will be assessed at baseline,
      during TSD, and after one night of sleep recovery. Biomarkers of endothelial activation,
      inflammation, and hormones will bemeasured from morning blood samples at 07:00
    


Intervention name(s): Sleep deprivation
Intervention type(s): Other
Intervention description(s): 40 hours of continuous wakefullness
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise training; Endothelial function
Relative Bioavailability of Ambroxol Hydrochloride Lozenge in Comparison to Ambroxol Hydrochloride Syrup (Mucosolvan®) in Healthy Female and Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge
      compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation
    


Intervention name(s): Ambroxol hydrochloride - lozenge; Ambroxol hydrochloride - syrup
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ambroxol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions
Condition: Oppositional Defiant Disorder
MeSH terms: Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      The proposed research will focus on the development of a brief emotion-coaching (EC)
      parenting program (which directly targets child emotion awareness/recognition and affective
      empathy), that will be combined with a well-established parent management training program
      (Helping the Noncompliant Child; HNC) for treating oppositional defiant disorder (ODD) in
      children who also have limited prosocial emotions (e.g., lack of guilt and empathy, callous
      use of others).
    


Intervention name(s): Parent Training plus Emotion Coaching; Parent Training only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting program.; This intervention will consist of a parent management training program called Helping the Noncompliant Child.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children with ODD and low prosocial emotions
Meclizine as a Potential Smoking Cessation Treatment
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether meclizine, an antihistamine used to prevent
      or treat motion sickness, can help smokers quit smoking. This study will also investigate the
      potential relationship between genes you have inherited and success in quitting smoking.
    


Intervention name(s): Meclizine; Nicotine Patch; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.; Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.; Pre-Quit Period: In this group, participants will take placebo capsules daily during the three week pre-quit period. The placebo will be taken in two doses daily, one capsule with breakfast and one with dinner.
Other intervention name(s): Antivert; Nicoderm
Intervention MeSH terms: Meclizine; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Smoking Cessation; Cigarette Smoking; Meclizine; Nicotine Patch
Charlson Comorbidity Index and Outcome of Cardiopulmonary Resuscitation in Geriatric Patients in Hong Kong
Condition: Comorbidities and Coexisting Conditions; Cardiopulmonary Resuscitation; Geriatrics
Study type: Observational

Summary: 
      The goal of this observational study is to learn about the factors affecting the outcome
      (survival) of cardiopulmonary resuscitation in older persons in a hospital. The main
      questions it aims to answer are:

        -  Whether age would affect outcome

        -  Whether Charlson Comorbidity Index would affect outcome

        -  Whether the conditions (e.g. heart rhythm) immediately before resuscitation would affect
           survival.

      Researchers would compare the patients who deceased with the patients who survived.
    

Detailed description: 
      The goal of this review was to investigate the impact of age, existing medical conditions.
      and other factors before cardiac arrest in predicting outcome of in-hospital cardiopulmonary
      resuscitation (CPR) of older persons.

      It was conducted on all patients aged ≥ 65, who underwent CPR in acute medical and geriatric
      wards (excluding Intensive Care Unit) in United Christian Hospital from January 2017 to
      December 2018.
    

Intervention name(s): Cardiopulmonary resuscitation
Intervention type(s): Procedure
Intervention description(s): cardiac compression, endotracheal intubation, defibrillation, and use of cardiovascular medications, to restore circulation in patients with cardiac arrest
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All adults aged 65 or above with in-hospital cardiac arrest and undergoing CPR in wards of
        Department of Medicine and Geriatrics (excluding Intensive Care Unit (ICU)) in United
        Christian Hospital (a regional acute hospital with total bed 1,174 with 16 ICU beds) in
        Hong Kong from 1 January 2017 to 31 December 2018
Spinal Abnormalities in Neurofibromatosis Type 1 (NF1)
Condition: Neurofibromatosis Type 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Congenital Abnormalities
Study type: Observational

Summary: 
      The purpose of this study is to determine the incidence and clinical history of
      neurofibromatosis type 1-related spinal abnormalities.
    

Detailed description: 
      Neurofibromatosis type 1 (NF1) is a common genetic disorder that is associated with spinal
      abnormalities which are varied and may include scoliosis, neurofibromas, meningoceles, and
      vertebral defects. Skeletal abnormalities occur in more than one third of individuals with
      the disorder. These abnormalities are unpredictable and the pathogenesis, natural history,
      and clinical outcome remain relatively unclear.

      The primary objective of this study is to determine the incidence and clinical history of
      NF1-related spinal abnormalities in children with NF1, over a 3-year period.

      In the study, researchers will enroll children between ages 6 and 9 years who have been
      diagnosed with NF1 to look at changes in the spine. Participants in the study will be
      followed yearly for a total of 4 evaluations. Evaluations may include bone scans, spinal
      x-rays, magnetic resonance imaging (MRI), computed tomography (CT) scans, and urine samples.

      Information gained from this study may lead to a better understanding of the causes of bone
      disease in NF1, and improved treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The cohort will be recruited from a primary care clinic.
      
Biospecimen description: 
      Urine
    
Keywords: neurofibromatosis type 1; spinal abnormalities; scoliosis
A Study of the Effect of Food on LY3537982 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in
      the bloodstream and how the body handles and eliminates LY3537982 after meals and on an empty
      stomach. The study will also evaluate the safety and tolerability of LY3537982. Participants
      will stay in the research center during the study, which will last about one week, not
      including screening.
    


Intervention name(s): LY3537982
Intervention type(s): Drug
Intervention description(s): Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS).
      The purpose of the study is to investigate which of the 2 administered doses is the lowest
      effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for
      contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5
      years
    

Detailed description: 
      Drop out-rate will be covered in Participant flow section.
    

Intervention name(s): LCS12; LCS16
Intervention type(s): Drug; Drug
Intervention description(s): Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h; Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; Intrauterine; IUD; IUS
Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians
Condition: Osteoporosis; Osteopenia; Fragility Fractures
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk.
      Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis
      treatment by providing an absolute fracture risk. FRAX combined with a decision aid may
      promote a shared decision making approach with patients, allowing the clinician and patient
      to weigh potential fracture risk (without treatment), versus risk reduction with medication
      (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:

        -  FRAX

        -  FRAX + decision aid

        -  Usual care (no decision aid and no FRAX given to clinician)
    


Intervention name(s): FRAX + Decision Aid; FRAX estimated fracture risk
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Clinicians will present patient's with their individualized risk of osteoporotic fracture in 10 years, based on the FRAX risk calculator, as well as sharing a decision aid with them, which shows their risk of fracture, risk reduction on medications, as well as the downsides of the medications.; The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX
Other intervention name(s): Decision Support; Risk estimate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Decision Aid; Shared Decision Making; Shared Medical Decision Making
Effects of Hydrotherapy on Physical Function and Quality of Life of Women With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia Syndrome (FS) is one condition that most affects functional performance,
      especially in women, due to alterations in the entire musculoskeletal system. Given that,
      Physical Therapy (PT) studies the human movement and its dysfunctions, and that FS, because
      of its complex chronic characteristic, impairs the affected individual's activities causing
      movement disorders, a PT professional must be part of the multidisciplinary team involved in
      the FS treatment. Nonetheless, as explained in the present proposal, several aspects still
      need clarification related to the PT role in this syndrome. Particularly, studies that
      analyze the biomechanical, sensorial and cardiorespiratory adaptations in individuals who
      undergo PT intervention still lack; those studies would contribute with scientific evidence
      to the clinical practice. According to recent systematic reviews, one of the most used
      therapies with positive effects on FS subjects is the hydrotherapy, which combines exercises
      and the water relaxing effects. Other alternative treatments have also been searched, in an
      attempt to decrease the painful picture presented, as the FS etiology and pathophysiology are
      not well known. The aim of this study is to evaluate the efficacy of different physical
      therapy resources in the FS, in two subprojects. The first will verify if hydrotherapy is
      effective in modifying movement variables (scapular kinematics and electromyography) and
      autonomic modulation. Other variables, such as pain level and quality of life in women with
      FS, will also be analyzed. The second study will evaluate the efficacy of the Shiatsu massage
      on pain, sleep quality, balance and quality of life of subjects with FS.
    

Detailed description: 
      Subjects were invited to take part in several assessments before starting the actual
      Hydrotherapy Treatment. These assessments were:

        1. Three-dimensional scapular evaluation

        2. Questionnaires (FIQ, SF-36, Beck Depression Inventory, Beck Anxiety Inventory,
           Pittsburgh Quality of Sleep Index)

        3. Pain (pressure pain threshold and trigger points) Subjects were evaluated 3 times one
           month before starting treatment, one time in the middle of treatment and after treatment
           completion.

      Treatment lasted 16 weeks and consisted of 2 weekly 45' hydrotherapy sessions.
    

Intervention name(s): Hydrotherapy
Intervention type(s): Other
Intervention description(s): Hydrotherapy, monitored by physical therapists, performed in groups of up to 10 volunteers, for 45 min per session, twice a week, for 16 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kinematics; Fibromyalgia; Physical Therapy; 3D Kinematics; Heart Rate Frequency; Hydrotherapy
An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Cytomegalovirus Retinitis; Retinitis
Study type: Interventional

Summary: 
      To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12
      years). To determine the safety and tolerance of a 2 to 3 week induction course of
      ganciclovir IV in immunocompromised children receiving treatment for life- or
      sight-threatening cytomegalovirus infections.
    


Intervention name(s): Ganciclovir
Intervention type(s): Drug
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Retinitis; Ganciclovir; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Immunocompromised Host