bioihbjkbjnl/mcl2 huggingface dataset:
Pursed Lip Breathing in Interstitial Lung Disease
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      This randomized, cross-over study aims at describing the effect of pursed lip breathing on
      exercise-induced dyspnea and exercise capacity in patients with interstitial lung disease.
    

Detailed description: 
      The use of pursed lip breathing (PLB) to improve exercise tolerance in COPD patients has been
      widely documented. However, its efficacy in patients with interstitial lung disease (ILD) has
      yet to be confirmed. This study aims to determine if PLB improves perceived exertion and
      exercise capacity during a six-minute walk test (6MWT) in patients with ILD. To achieve this,
      a prospective randomized crossover trial will be performed, in which patients with ILD and
      restrictive ventilatory defect will be recruited via the ILD clinic of Hôpital Notre-Dame.
      The study will be performed in a single visit, on the day where patients attend a routine
      physician-prescribed follow-up 6MWT. Patients will be asked to perform a total of two 6MWT.
      Patients will be randomized to perform the first test with or without using PLB, and the
      order will be reversed for the second test, with patients serving as their own control.
      During tests, ventilatory variables will be continuously measured using a portable metabolic
      cart. The observed parameters will be: perceived exertion using the Modified-Borg Scale,
      respiratory rate, minute-ventilation, heart rate, peripheral oxygen saturation, and 6-minute
      walk distance (6MWD). It is expected that the use of PLB will be associated with a decrease
      of at least one unit on the Modified Borg Scale, which would be clinically significant.
      Moreover, it is expected that the decrease in dyspnea with PLB will be related to a decrease
      in respiratory rate minute ventilation during 6MWT. The clinical impact of this study could
      be significant as therapies allowing the improvement of dyspnea in patients with ILD are
      scarce.
    

Intervention name(s): Pursed lip breathing
Intervention type(s): Behavioral
Intervention description(s): Pursed lip breathing will be taught to the participants following the chronic obstructive pulmonary disease (COPD) Foundation recommendations:
Breathe in through your nose (as if you are smelling something) for about 2 seconds.
Pucker your lips like you're getting ready to blow out candles on a birthday cake.
Breathe out very slowly through pursed-lips, two to three times as long as you breathed in.
Repeat.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pursed lip breathing; interstitial lund disease; exercise physiology
Entacapone Augmentation for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment
      can be beneficial in schizophrenic patients with negative symptoms.
    


Intervention name(s): Entacapone
Intervention type(s): Drug
Intervention description(s): Entacapone 600mg BID
Intervention MeSH terms: Entacapone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia; negative symptoms; entacapone
A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults
Condition: COVID-19 Prevention
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune
      responses after 6 dose levels of Ad26.COV2.S.
    


Intervention name(s): Ad26.COV2.S
Intervention type(s): Biological
Intervention description(s): Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
Other intervention name(s): JNJ-78436735; Ad26COVS1; VAC31518
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
Condition: Rosacea; Acne Vulgaris; Atopic Dermatitis; Seborrheic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Acne Vulgaris; Rosacea; Dermatitis, Seborrheic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an evaluation of the role of topical dissolved oxygen to lessen visible signs
      of photodamage using a select regimen of topical dissolved oxygen containing cosmeceutical
      products. Evaluation of the overall skin tolerability of topical dissolved oxygen (safety)
      utilizing the regimen of products.
    


Intervention name(s): Topical oxygen; Topical oxygen; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5% concentration of Topical oxygen; 0.25% concentration topical oxygen; no O2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Topically dissolved oxygen; inflammatory cutaneous disease; rosacea; acne vulgaris; atopic dermatitis; seborrheic dermatitis; photodamage
Will Listening to Music Make it Easier to Take a Visual Field Test?
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      The purpose of this study is to examine if there is a difference between glaucoma patients
      having background music and not having background music before visual field testing.
    

Detailed description: 
      Glaucoma is one of the leading causes of blindness in the United States. Over 2.5 million
      people in the United States have glaucoma. The goal of ophthalmologists is two-fold: 1) to
      detect glaucoma early, and 2) to stop the progression of disease and subsequent visual loss.

      Many parameters are used to detect and follow glaucoma over the patient's lifetime including
      optic nerve appearance, intraocular pressure by applanation and visual field perimetry
      testing results. Perimetry testing aims to detect visual field loss that may be associated
      with glaucoma and institute more aggressive treatment measures when necessary. However, it is
      suspected that 50% or more of the optic nerve fibers are already irreversibly damaged before
      a visual field defect can be identified on testing. Furthermore, the patient's ability to
      take a visual field test is paramount in the doctor's ability to interpret the test. That is,
      if a visual field test taker performs the test with low reliability (i.e. too many false
      positive, false negative or fixation losses), the interpretability of the test by the
      ophthalmologist is difficult or impossible.

      Interestingly, a recent study in the British Journal of Ophthalmology suggested the positive
      effect Mozart music has on visual field test taking ability. This study showed better first
      time automated perimetry performance in normals immediately following exposure to the first
      10 minutes of Mozart's Sonata for Two Pianos in D Major. The music group had 20 times fewer
      fixation losses, three times fewer false positive responses and 10 times fewer false negative
      responses.

      No study has determined if Mozart music improves the reliability indices of Humphrey visual
      field testing for glaucoma patients or experienced test takers. In efforts to improve
      patient's reliability on visual field testing, we propose a randomized controlled trial to
      determine if listening to music before field testing improves testing reliability.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        glaucoma service
      
Keywords: primary open angle glaucoma; pigmentary glaucoma; exfoliative glaucoma; angle closure glaucoma; low tension glaucoma
The Effect of Hot Cereal on Digestive Health in Children
Condition: Subjective Measures of Digestive Health Post Consumption
Study type: Interventional

Summary: 
      The objective of this study is to examine the effects of 2 servings of hot cereal per day
      over 2 weeks on digestive health in children that typically eat low fiber diets.
    

Detailed description: 
      Participant eligibility will be screened at visit 1. The study will be a single-arm
      intervention design. The study procedures will include a pre-study visit, a pre-intervention
      baseline data collection period, a 14 day intervention period, and an end of study visit.
    

Intervention name(s): Hot cereal contain 3 g dietary fiber
Intervention type(s): Other
Intervention description(s): Intervention involves consumption of a hot cereal over 14 day period
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
Condition: Helminth Infections
MeSH terms: Infections; Communicable Diseases; Helminthiasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with
      placebo in pediatric participants with Helminth infections.
    

Detailed description: 
      This will be a double-blind (neither physician nor participant knows the treatment that the
      participant receives), randomized (the study drug is assigned by chance), multi-center,
      parallel-group study (each group of participants will be treated at the same time) to
      evaluate the efficacy and safety of mebendazole (a drug currently being investigated for
      Helminth gastrointestinal infections) compared with placebo (an inactive substance that is
      compared with a drug to test whether the drug has a real effect in a clinical trial) in
      children (including pre-school and school-aged children) with Helminth infections. The study
      will consist of 3 phases: a screening phase, a double-blind treatment phase, and a
      post-treatment (or follow-up) phase. A pharmacokinetic (explores what a drug does to the
      body) open-label substudy (asks a separate research question from the parent study while
      using the same participant population but does not contribute to the parent study's
      objectives) will be included in the parent study to measure the level of mebendazole in the
      blood. Safety assessments will be performed throughout the study. Each participant will take
      part in the study for approximately 30 days.
    

Intervention name(s): Mebendazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mebendazole will be administered as a single-dose 500 mg chewable tablet. For children 1 year to <36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child.; Matching placebo will be administered as a single-dose chewable tablet. For children 1 year to <36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child.
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Helminth infections; Helminths; Pediatric; Preschool aged; School aged; Mebendazole; Vermox; Placebo
Burs Versus Curettes in Root Planing.
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the efficacy of diamond burs and Gracey curettes in non-surgical
      periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical
      parameters and scanning electron microscopic investigations on root surfaces. Two quadrants
      of each of the 12 patients were treated with diamond burs whereas other 2 quadrants were
      treated with Gracey curettes. Also 21 hopeless teeth received root planing either with
      diamond burs or curettes or no treatment at all and were then extracted for microscopic
      evaluations.
    

Detailed description: 
      Gracey curettes are the most widely used instruments for root planing and regarded as the
      gold standard, but their usage is technic sensitive and time consuming for the clinician and
      efficacy reduces in deep pockets, root irregularities, and furcations. Alternative sonic,
      ultrasonic and rotary instruments have been investigated for potential benefits in improving
      mechanical access. Sonic and ultrasonic instruments are used for scaling, but they cannot
      provide smooth root surfaces.

      Intensiv Perio Set is a rotating diamond bur system developed for odontoplasty, scaling and
      root planing. It is used only in right angle hand piece, at rotation speeds of 6000 rpm, with
      reduced pressure application. These burs have two different head types for morphologically
      different areas; flame or tapered, three different grains; 75, 40, or 15 μm, with either a
      short or long neck for each unit. Burs with 75 μm grain are used only in odontoplasty,
      whereas, 40 and 15 μm burs are used for scaling and root planing.
    

Intervention name(s): Intensiv Perio Set; Gracey curette
Intervention type(s): Device; Device
Intervention description(s): Diamond burs for root planing
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-surgical periodontal debridement; root planing/instrumentation; cytokine(s); dental plaque; microscopy, electron, scanning
Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells
Condition: SYSTEMIC SCLERODERMA; ALLOGENEIC MESENCHYMAL STEM CELLS; ADULT
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main ailm of this phase I-II study is to evaluate toxicity and efficacy of allogenic
      mesenchymal stem cell therapy to treat severe systemic sclerosis. In practice this treatment
      will be given to patients with a rapidly evolutive disease or refractory to cyclophosphamide.
    


Intervention name(s): INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SYSTEMIC SCLERODERMA; TRANSPLANTATION; ALLOGENEIC MESENCHYMAL STEM CELLS; ADULT
High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis
Condition: Non-invasive Ventilation; Pediatric Pulmonary Disease
MeSH terms: Bronchiolitis
Study type: Observational

Summary: 
      Objective: The investigators aimed to compare the heated humidified high-ﬂow nasal cannula
      (HHHFNC) flow rate of 1-L/kg/min (1L) with 2-L/kg/min (2L) in patients with severe
      bronchiolitis presenting to the pediatric emergency department.

      Study design: The investigators performed a study in which all patients were allocated to
      receive these two flow rates. The primary outcome was admitted as treatment failure, which
      was defined as a clinical escalation in respiratory status. Secondary outcomes covered a
      decrease of respiratory rate (RR), heart rate (HR), the clinical respiratory score (CRS),
      rise of peripheral capillary oxygen saturation (SpO2) and rates of weaning, intubation and
      intensive care unit (ICU) admission.

      Keywords: Bronchiolitis, Emergency department, High-flow nasal cannula, Flow rate
    


Intervention name(s): Heated humidiﬁed high-flow nasal cannula
Intervention type(s): Device
Intervention description(s): Non-invasive ventilation with a nasal cannula
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients with a clinical diagnosis of severe bronchiolitis, aged less than 24 months
        and presenting to the emergency department
      
Keywords: Bronchiolitis; Emergency department; High-flow nasal cannula; Flow rate
Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
Condition: Chronic Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of the investigators study is to assess conventional repetitive transcranial
      magnetic stimulation (rTMS) in patients with chronic severe tinnitus. A randomized,
      double-blind, sham-controlled procedure, with four increasing levels of magnetic
      "pseudo-dose" has been designed, in order to characterize the effectiveness of rTMS while
      controlling its safety and tolerability. By combining various rTMS protocols with a
      twelve-month follow-up, and using an effect modeling, the study aims at: (i) specify the
      effective values of rTMS parameters, with an adequate tolerance; (ii) determine the expected
      benefit and the persistence of effect; (iii) assess the practical feasibility of this kind of
      therapeutic management.
    


Intervention name(s): transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling); Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)
Intervention type(s): Device; Device
Intervention description(s): The study is based on a dual procedure consisting of comparisons between active and sham rTMS on the one hand and between four increasing levels of magnetic "pseudo-dose" on the other hand. Each level comprises 16 patients randomly assigned to active rTMS group (12 patients) or sham rTMS group (4 patients). The transition from one level to another is authorized by an independent oversight committee charged with checking the tolerability of rTMS sessions for the tested level. The neuronavigated rTMS use either active or sham figure-eight coil and is centered over the primary auditory cortex contralateral to the perceived predominant side of tinnitus. This target is located through anatomical brain MRI and neuronavigated brain system. According to the stimulation parameters, each rTMS session can last from 5 to 112 minutes and the whole rTMS intervention from 1 to 20 weeks. The follow-up is spread over twelve months.; Same sound level as active rTMS, but magnetic field strongly attenuated
Other intervention name(s): Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling); Medtronic © MagPro X100 (with MagOption) stimulator and Placebo Butterfly Coil MCF-P-B65 (shielded figure-8 coil with fluid cooling)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuro-otology; Chronic tinnitus; Sensory disability; Repetitive transcranial magnetic stimulation; Dose escalation
Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib
Condition: Liver Diseases; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at
      highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose
      or two lower doses) and 8 healthy matched controls to each of this two groups.
    


Intervention name(s): Afatinib; Afatinib; Afatinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet, once qd in the morning; 1 tablet, once qd in the morning; 1 tablet, once qd in the morning
Intervention MeSH terms: Afatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Condition: Anxiety Disorders,Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder
      (GAD) and evaluated using standard questionnaires as having at least moderate severity of
      GAD. Participating minors will be assigned to receive either the study drug escitalopram or a
      pill without any drug in it called a placebo. The purpose of this research is to study the
      safety and effectiveness of escitalopram in minors with GAD.
    


Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 8-weeks of treatment followed by 1-week taper down period; Matching oral administration of inactive substance once daily
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
Condition: Candida
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates
      with suspected candida infection
    

Detailed description: 
      Subjects will be stratified by weight to receive one of two doses of study drug
    

Intervention name(s): Micafungin
Intervention type(s): Drug
Intervention description(s): IV Administration
Other intervention name(s): Mycamine; FK463
Intervention MeSH terms: Micafungin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Micafungin; Candida; Neonates; Mycamine; FK463