bioihbjkbjnl/mcl2 huggingface dataset:
Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19
Condition: COVID19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This randomized, Phase I/II feasibility study will evaluate the safety and efficacy of the
      RD-X19 device in SARS-CoV-2 infected individuals with uncomplicated COVID-19.
    

Detailed description: 
      This is a randomized, sham-controlled dose escalation and bioeffect study. The primary goal
      of the study is to evaluate the safety of the RD-X19 device in SARS-CoV-2 infected
      individuals with outpatient COVID-19 and to assess the reduction of SARS-CoV-2 viral load in
      each dose group compared to sham controls.

      The primary safety measure is absence of device-related serious adverse events or patterns of
      severity ≥2 device-related adverse events. Safety and tolerability (local reactogenicity)
      will be assessed actively on each clinic visit by review of potential adverse events (AEs)
      and targeted physical examination, as required. Metabolic, liver, kidney and hematological
      laboratory evaluations will be performed at baseline and at Day 8 or early termination (and
      potentially during unscheduled) clinic visits.

      Methemoglobin assessments will be performed at baseline and Day 8.

      Various efficacy assessments will explore the impact of RD-X19 treatment on the reduction in
      log10 SARS-CoV-2 viral load and alleviation of symptoms associated with COVID-19. Both the
      magnitude of reduction as a function of dose as well as time to clearance will be assessed.
    

Intervention name(s): RD-X19
Intervention type(s): Device
Intervention description(s): Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study will be conducted as a randomized, double-blind, sham-controlled study in SARS-CoV-2 infected individuals with outpatient COVID-19. Subjects will be randomized 2:1 RD-X19 to Sham Device treatment arms.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Effects of Bacillus Containing Oral Hygiene Products on Gingivitis: a Randomized Controlled Trial
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Aim: Evaluating the clinical effects of a Bacillus subtilis, Bacillus megaterium and Bacillus
      pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in patients
      with generalized gingivitis.

      Materials and methods: In this double-blind placebo-controlled randomized clinical trial
      generalized gingivitis patients who were systemically healthy and who did not smoke were
      included. They used a placebo or probiotic Bacillus containing toothbrush cleaner for 8
      weeks. Primary outcome measures of interest were plaque and gingivitis index, secondary
      outcome measures were pocket probing depth and bleeding on probing.
    

Detailed description: 
      The administration of micro-organisms to improve the human health was already promoted by the
      Nobel prizewinning scientist Eli Metchnikoff in the beginning of the 20th century. However,
      it took several decades for this subject to become a topic of interest in medicine. At this
      moment these micro-organisms are called "probiotics" and defined as "living microorganisms
      which, when administered in adequate amounts, confer a health benefit for the host"
      (http://www.who.int/foodsafety/publications/fs_management/en/probiotics.pdf). Over the past
      decade probiotics have been extensively investigated from the perspective of oral health. It
      was shown that probiotics have the capacity to reduce mutans streptococci counts in saliva
      and/or plaque during their usage, that they have a positive influence on bad breath and that
      they can improve the results of scaling and root planing in periodontitis patients. A
      positive effect of probiotic usage on plaque accumulation and gingivitis measurements in
      gingivitis patients was also shown.To the investigators knowledge, at this moment no trials
      are available describing the effect of other probiotic genera on gingivitis. Since it is
      clear that probiotic effects are strain, dosage and mode of application dependent, the aim of
      this study was to evaluate the use of a probiotic toothpaste, mouthwash and toothbrush
      cleaner with Bacillus subtilis, Bacillus megaterium, and Bacillus pumulus versus a placebo in
      patients with generalized gingivitis.
    

Intervention name(s): probiotic oral hygiene products with Bacillus (PIP, Chrisal); oral hygiene products without Bacillus
Intervention type(s): Other; Other
Intervention description(s): products with Bacillus probiotics; products without Bacillus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingivitis; gingival inflammation; probiotics; Bacillus
Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty
Condition: Nasal Obstruction; Nasal Septum; Deviation; Nasal Mucosa Hypertrophy
MeSH terms: Nasal Obstruction; Hypertrophy
Study type: Interventional

Summary: 
      Pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal
      hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction
      and are often an indication for surgery.

      The aim of the study is to examine nasal airflow parameters after septoplasty and
      turbinoplasty .
    

Detailed description: 
      Pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal
      hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction
      and are often an indication for surgery.

      The aim of the study is to examine nasal airflow parameters at pre-defined intervals in
      patients after septoplasty and turbinoplasty .
    

Intervention name(s): Rhinomanometry in patients after septoplasty and/or turbinoplasty; Acoustic rhinometry in patients after septoplasty and/or turbinoplasty
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.; Acoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be divided into three parallel groups, depending on the indicated surgery - septoplasty, turbinoplasty, and septoplasty plus turbinoplasty.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: nasal obstruction; septoplasty; turbinoplasty; nasal mucosa; nasal septum
Comparative Effect of 3 Different Cranberry Extracts on Cystitis Related Urinary Comfort in Women
Condition: Recurrent Cystitis
MeSH terms: Cystitis
Study type: Observational

Summary: 
      Urinary discomfort includes a set of signs such as an urgent need to urinate, high frequency
      of urination per day, discomfort / difficulty or burning sensation when urinating, smelly
      urine. This urinary discomfort represents in women 2 to 5% of the reasons for consultation
      (Berg, 1991) and can have various etiologies but the bacterial origin is the most frequent.
      Cranberries are traditionally used for urinary comfort and the prevention of urinary
      disorders with bacterial origin.

      The study objective is to collect in real life efficacy and tolerance data from the
      consumption of 3 cranberry extracts in order to highlight the qualitative and quantitative
      characteristics of these extracts which are directly involved in the improvement of urinary
      discomfort or situation of recurrent cystitis symptomatic episodes in women.
    


Intervention name(s): X; Y; Z
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): exocyan; exocyan; exocyan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The first 216 women of the CEN Nutriment (Clinical Investigation Center) volunteer panel
        corresponding to the selection criteria and wishing to participate in the study.
Experiencing Transplant With Stories From Survivors
Condition: Cancer
Study type: Interventional

Summary: 
      Allograft transplants are offered to people with haematological cancers sometimes as the best
      chance of a cure. However, the survival rates for these procedures can be quite poor, as the
      transplant, in itself, can be lifethreatening.

      In addition, these procedures usually involve a period of lengthy hospitalisation accompanied
      by a host of debilitating conditions which patients must cope with in isolation due to their
      increased risk of serious infection. Perhaps unsurprisingly, there is considerable evidence
      that mood plays a role in the way people recover.

      I wish to investigate the psychological impact of providing testimonies from survivors of
      transplants to patients undergoing the procedure.

      The plan is initially to collect about 10-15 testimonials from past transplant patients using
      a videotaped structured interview then to collate these testimonials into a booklet format
      and DVD.

      This booklet and DVD would be used as an intervention where 40 consecutive patients who are
      going ahead for transplant are invited to receive the testimonial intervention.

      Patients will be asked to complete one mood measure (the HADS), the Life Orientation Test
      (LOT), and a questionnaire about expectations of treatment in clinic once a decision to
      proceed to transplant has been made. Patients will receive the testimonies upon admittance to
      the transplant unit and then receive the HADS and a structured interview within the first
      week of being admitted to the transplant ward (just prior to receiving the transplant) and
      within the first two weeks following the transplant.

      Comparative analyses of the measures between the three time points would be performed and
      qualitative analysis of the structured interview data.

      Around 80 people undergo transplant each year, it is estimated that the project will be
      completed by September 2016. The intention would be to publish following completion.
    


Intervention name(s): Providing testimonies from survivors of transplants to patients
Intervention type(s): Other
Intervention description(s): Patients will be asked to complete one mood measure (the HADS), the Life Orientation Test (LOT), and a questionnaire about expectations of treatment in clinic once a decision to proceed to transplant has been made.
Patients will receive the testimonies upon admittance to the transplant unit and then receive the HADS and a structured interview within the first week of being admitted to the transplant ward (just prior to receiving the transplant) and within the first two weeks following the transplant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
MRA and ABR as Early Predictors of Bilirubin-Induced Neurologic Dysfunction in Full-term Jaundiced Neonates
Condition: Neonatal Hyperbilirubinemia
MeSH terms: Neurologic Manifestations; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Observational

Summary: 
      The aim of the research was to define the role of MRS and ABR as early predictors of
      bilirubin-induced neurologic dysfunction (BIND) in full-term neonates who required
      intervention (phototherapy or exchange transfusion).
    

Detailed description: 
      Neonatal jaundice is a prevalent condition. It's typically a harmless phase that occurs as
      the body adjusts to bilirubin levels after birth, representing a balance between its
      production and elimination. When there's an increase in bilirubin production and a decrease
      in elimination, infants become at risk for dangerous hyperbilirubinemia, potentially leading
      to bilirubin encephalopathy.

      The range of neurological issues caused by excessive bilirubin is referred to as
      bilirubin-induced neurologic dysfunction. Detecting this condition early is crucial to
      prevent irreversible brain damage. Some of the neurological effects include gliosis,
      demyelination, and interference with glutamate uptake by astrocytes in the basal ganglia.
      Magnetic resonance spectroscopy (MRS) is an advanced imaging technique that holds promise for
      identifying these metabolic changes and aiding in the diagnosis and evaluation of neonates
      with hyperbilirubinemia.

      Bilirubin neurotoxicity particularly affects the auditory system, starting with the brainstem
      cochlear nuclei, followed by the auditory nerve. This damage can occur even without the
      classic signs of bilirubin encephalopathy and is known as auditory neuropathy spectrum
      disorder (ANSD). ANSD is characterized by abnormal auditory neural function, while cochlear
      microphonics and otoacoustic emissions remain normal.

      The impact on hearing can vary from subtle issues in sound processing to complete deafness.
      Abnormal results in auditory brainstem response (ABR) tests can indicate the presence of
      acute bilirubin encephalopathy (ABE), serving as the most common and earliest sign of ABE.
    

Intervention name(s): MRS and ABR
Intervention type(s): Device
Intervention description(s): Magnetic Resonance Spectroscopy and Auditory Brain- stem Response Audiometry
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study included term, appropriate for gestational age (AGA) neonates with pathological
        unconjugated hyperbilirubinemia who were candidates for intervention (Intensive
        phototherapy versus Exchange transfusion) using the American Academy of Pediatrics
        guidelines; 2004. In addition, 20 healthy, age-matched neonates were included as controls.
Efficiency of Hypervolt Device Application in the Treatment of Shoulder Impingement Syndrome
Condition: Shoulder Impingement
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of exercise and Hypervolt Device on pain,
      muscle strength and normal joint movement in the treatment of shoulder impingement syndrome.
    

Detailed description: 
      The study was planned as a randomized controlled trial. The study sample will be divided into
      two groups by simple randomization method. Only exercise will be applied to 30 individuals
      diagnosed with shoulder impingement in the first group of the study. In the second group, 30
      individuals with shoulder impingement diagnosis will be given a Hypervolt Device in addition
      to the exercise. Disabilities of the Arm, Shoulder and Hand Questionnaire, Visual Analog
      Scale and Lawton Daily Living Activities Questionnaire will be applied to the participants
      before and after the treatment. The obtained data will be analyzed statistically.
    

Intervention name(s): Physiotherapy; Hypervolt Device
Intervention type(s): Other; Other
Intervention description(s): manual therapy stretching exercises strengthening exercises electrotherapy applications; The painful area will be applied with a massage tool, and the frequency and mode of the tool will be adjusted in a way that does not disturb the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Exercise therapy and Applying a Hypervolt massager
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
Condition: Severe Hypertriglyceridemia (sHTG)
MeSH terms: Pancreatitis; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to determine the change in Triglyceride (TG) levels following 12
      weeks of repeated Intravenous (IV) doses of evinacumab.
    


Intervention name(s): evinacumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by Intravenous (IV); Administered by Intravenous (IV)
Other intervention name(s): REGN1500
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Measure the Sun Protection Factor (SPF) and Ultraviolet-A Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The purpose of this study is to determine the SPF and UVAPF of four sunscreen formulations
      using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF.
    

Detailed description: 
      This study consist of two steps. Step 1: determination of the SPF of the test products which
      will be performed as a single-center, randomized, evaluator blind, intra-individual
      comparison, no treatment and positive controlled clinical study as per ISO24444:2010. And
      Step 2: determination of the UVAPF of the test products which will be performed as a single
      center, open-label, negative and positive controlled technical test as per ISO24443:2012
      (using test plates for assessing UV transmittance of four developmental sunscreens).
    

Intervention name(s): NGBUV000A, (Expected SPF 30); NGBUV000B, (Expected SPF 30); NGBUV000C, (Expected SPF 30); NGBUV000D, (Expected SPF 30); P3 Standard, (Expected SPF 16); Sunscreen formulation S2; Glycerin
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): A total of 2.0 ± 0.05 mg/cm2 (milligram per centimeter square of test site area) NGBUV000A (test product 1) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 1 will be applied to the test plates.; A total of 2.0 ± 0.05 mg/cm2 NGBUV000B (test product 2) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 2 will be applied to the test plates.; A total of 2.0 ± 0.05 mg/cm2 NGBUV000C (test product 3) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 3 will be applied to the test plates.; A total of 2.0 ± 0.05 mg/cm2 NGBUV000D (test product 4) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 4 will be applied to the test plates.; A total of 2.0 ± 0.05 mg/cm2 reference P3 standard will be spread at the topical test sites on the back of each participant.; A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates.; A total of 1.3 mg/cm2 of glycerin will be applied to the test plates.
Intervention MeSH terms: Sunscreening Agents; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Contribution of Image Fusion in Percutaneous Left Atrial Occlusion procédures (Fusion Image)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Atrial fibrillation is the most common rhythm disorder, affecting 2 to 3 percent of the
      population. One of the major complications is the occurrence of thromboembolic events, the
      thromboembolic risk can be predicted by the ChadsVasc score. Anticoagulant treatment is
      therefore almost always indicated, however, in view of the target population, anticoagulant
      treatment is sometimes contraindicated, justifying the appearance of alternative treatment
      such as occlusion of the left auricle by surgical or percutaneous means, with the placement
      of a prosthesis in the left auricle.

      Image fusion is a new imaging technique aimed at improving the spatial view of 2D images
      (made during a catheterization session) by repositioning in real time a 3D model obtained by
      reconstruction from scanner images of the structure of interest. Once the model has been
      redesigned, it follows all the consequences that the hemodynamicist wants to take and thus
      guides the gesture as well as possible.

      The purpose of this project is to evaluate the contribution of image fusion to per cutaneous
      occlusion procedures of the left atrium. This contribution will be evaluated by comparing the
      procedure time, the irradiation time, the amount of contrast material used between the
      procedures performed with the image fusion technique and without this new technique.
    


Intervention name(s): No interventional study
Intervention type(s): Other
Intervention description(s): No interventional study
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This is an elderly population with multiple co-morbidities (hypertension, renal failure,
        diabetes, etc.), with a major thromboembolic and haemorrhagic risk, and with a formal
        contraindication to anticoagulant therapy.
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess whether children with moderate to severe bronchiolitis
      treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven
      nebulization will have improvements in measurements of airway more rapidly than those treated
      with conventional air-oxygen driven nebulization.
    


Intervention name(s): heliox; oxygen
Intervention type(s): Drug; Drug
Intervention description(s): continuous heliox therapy; continuous oxygen therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heliox; bronchiolitis; racemic epinephrine