bioihbjkbjnl/mcl2 huggingface dataset:
Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide
Condition: Halitosis
MeSH terms: Halitosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Previous research has shown the oxidizing properties and microbiological efficacies of
      chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological
      efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the
      inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary
      periodontal and malodorous bacteria using for 7 days.
    

Detailed description: 
      Background: Previous research has shown the oxidizing properties and microbiological
      efficacies of chlorine dioxide (ClO2). Its clinical efficacies on oral malodor have been
      evaluated and reported, however, no clinical studies have investigated its microbiological
      efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the
      inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary
      periodontal and malodorous bacteria using for 7 days.

      Methods: A randomized, double blind, crossover, placebo-controlled clinical trial was
      conducted among 15 healthy male volunteers, who were divided into 2 groups. In the first test
      phase, the group 1 subjects (N = 8) were instructed to rinse with the experimental mouthwash
      containing ClO2 twice per day for 7 days, and those in group 2 (N = 7) to rinse with the
      control (placebo) mouthwash without ClO2. In the second test, phase after a one week washout
      period, each group had used the opposite mouthwash for 7 days. At baseline and after 7 days,
      oral malodor was evaluated with OM, and concentrations of hydrogen sulfide (H2S), methyl
      mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S), the main VSCs of human oral malodor, were
      evaluated with GC. Clinical outcome variables included plaque and gingival indices, and the
      Winkel Tongue Coating Index(WTCI). The samples of saliva were microbiologically investigated.

      Outcome variables were compared by t-test and Mann-Whitney test.
    

Intervention name(s): Chlorine Dioxide
Intervention type(s): Other
Intervention description(s): Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)
Other intervention name(s): ClO2 Fresh®
Intervention MeSH terms: Chlorine dioxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: chlorine; dioxide; mouthwash; halitosis; bacteria; saliva
Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz)
      versus placebo in the field-directed treatment of mild to moderate actinic keratosis with
      photodynamic therapy (PDT) when using the BF-RhodoLED lamp.
    

Detailed description: 
      The study was performed as a randomized, multicentre, double-blind, placebo- controlled,
      parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A
      total of 94 patients were screened in this study; 87 were randomized (55 patients received
      BF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at
      3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp
      BF-RhodoLED.
    

Intervention name(s): BF-200 ALA gel; Placebo to BF-200 ALA gel; Photodynamic therapy with BF-RhodoLED
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): BF-200 ALA was applied over 1-2 fields of approximately 20 cm² in total, allowed to dry for approximately 10 minutes, and covered with occlusive tape material for 3 h.; The reference product was a placebo (a nanoemulsion gel formulation similar to the Investigational Medicinal Product (IMP), but without the active ingredient). The placebo was packaged, assigned to each patient, and administered in the same way as the IMP.; After cleaning the lesions, the entire treatment field(s) were illuminated using the novel narrow spectrum BF-RhodoLED lamp, a red light illumination source (approximately 635 nm) developed by Biofrontera, until a total light dose of 37 J/cm² (per treated field) was achieved.
Other intervention name(s): Ameluz; PDT
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Photodynamic Therapy; Field-directed Treatment
Treatment of Patients With Idiopathic Membranous Nephropathy
Condition: Glomerulonephritis, Membranous
MeSH terms: Kidney Diseases; Glomerulonephritis; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with idiopathic membranous nephropathy at risk for renal failure can be identified
      in an early stage by measuring urinary low molecular weight proteins and urinary
      immunoglobulin G (IgG). This study evaluates the possible benefit of early start of
      immunosuppressive therapy in these high-risk patients.
    

Detailed description: 
      Inclusion Criteria:

        -  patients with idiopathic membranous nephropathy

        -  nephrotic syndrome

        -  normal renal function (serum creatinine [Screat] < 1.5 mg/dl)

        -  elevated urinary beta2-microglobulin and IgG

      Immunosuppressive therapy consisting of:

        -  cyclophosphamide 1.5 mg/kg/day for 12 months

        -  prednisone orally, 0.5 mg/kg on alternate days for 6 months

        -  i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122

      Study Groups:

        -  early: immediate start of immunosuppressive therapy at the time patient is identified as
           high-risk

        -  late: start of therapy after deterioration of renal function (increase of Screat > 25%
           and Screat > 1.5 mg/dl)

      Main Outcome Parameters:

        -  serum creatinine

        -  remission of proteinuria

        -  period of nephrotic proteinuria

        -  major side effects: hospitalisations, infections
    

Intervention name(s): Cyclophosphamide and steroids
Intervention type(s): Drug
Intervention description(s): comparison of difference in time of start of therapy
Other intervention name(s): prednisolone; endoxan
Intervention MeSH terms: Prednisolone; Cyclophosphamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: membranous nephropathy; cyclophosphamide; prednisone
Gastrointestinal Toleration of Inulin Products
Condition: Healthy
Study type: Interventional

Summary: 
      The intake of inulin products has been linked to multiple health benefits which has lead to
      inulin fortification in food products.

      The investigators hypothesis that doses of up to 10 grams of inulin products should be well
      tolerated and not result in a significant increase in gastrointestinal symptoms.
    

Detailed description: 
      0, 5, and 10 grams of inulin
    

Intervention name(s): Inulin Fiber Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Orange juice fortified with 0, 5g, and 10g of 2 inulin products
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: fiber; inulin; gastrointestinal tolerance
Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis; Ultrasonography and Magnetic Resonance Imaging Findings
Condition: Carpal Tunnel Syndrome; Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Carpal Tunnel Syndrome; Syndrome
Study type: Observational

Summary: 
      This study aimed to investigate relationship between CTS diagnosis with electrodiagnostic
      studies and median nerve's cross-sectional area measered by US and MRI in PsA patients.
    

Detailed description: 
      Carpal tunnel syndrome (CTS) is a type of entrapment neuropathy, caused by compression of the
      median nerve in the carpal tunnel at the wrist1. It accounts for about 90% of all entrapment
      neuropathies. But there is no gold standard technique for diagnosing CTS. Electrodiagnostic
      studies (EDS) are generally used in differential diagnosis because the symptoms may be
      difficult to interpret. Unfortunetely EDS has some limitations. The factors can limit EDS are
      that it is not comfortable for patients and physicians, may require interventional
      procedures, need patient cooperation, provide limited information on the etiology of CTS,
      time consuming, and can not be used in some patient groups such as patients with
      dermatological contraindications. Recent years, magnetic resonance imaging (MRI) and
      ultrasonography (US) have facilitated the diagnosis of CTS. The median nerve cross-sectional
      area (CSA) measured by US or MRI has been found to be associated with CTS. However, there are
      studies with conflicting results regarding the median nerve CSA in patients with rheumatic
      diseases. Psoriatic arthritis (PsA), a kind of rheumatic disease, occurs in up to 30% of
      people with psoriasis and can have serious debilitating effects on the peripheral joints,
      spine, tendon insertions, and fingers. To our knowlage, any study didn't assess MRI
      measurements of median nerve CSA in PsA patients. In this study we aimed to assess CTS's US
      and MRI findings in patients with PsA and compare them healty controls.
    

Intervention name(s): Ultrasonography, Magnetic resonance imaging
Intervention type(s): Diagnostic Test
Intervention description(s): The cross-sectional area of the median nerve was measured with US and MRI.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        PsA patients according to the CASPAR criteria who consecutively applied to the FTR
        outpatient clinic for PsA follow-up and healthy volunteers who applied to the FTR
        outpatient clinic enrolled in the study.
      
Keywords: Carpal Tunnel Syndrome; Psoriatic Arthritis; Ultrasonography; magnetic resonance imaging
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This single arm study will evaluate the safety and efficacy of MabThera in patients with
      active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an
      inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg
      i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a
      clinically relevant response to the first course of treatment may be eligible to receive one
      re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study
      treatment is 3-12 months, and the target sample size is 100 individuals.
    


Intervention name(s): Methotrexate; rituximab [MabThera/Rituxan]
Intervention type(s): Drug; Drug
Intervention description(s): As prescribed; 1000mg iv on days 1 and 15
Intervention MeSH terms: Rituximab; Methotrexate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Whey Protein Micelles and Thermogenesis in Overweight Subjects
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The main objective of the trial is to measure the thermogenic effect of two different doses
      of whey protein microgels.

      It will be a randomized crossover double-blind design conducted in 20 subjects.
    

Detailed description: 
      Primary objective and outcome:

      The primary objective of the trial is to measure the thermogenic effect of two different
      doses of whey protein microgels (WPM).

      Secondary objectives and outcomes:

      Explore the mechanism of action of WPM on thermogenesis including:

      Protein turnover in response to the dose and the source of protein (WPM versus casein)
      Insulinemic and glycemic response to the dose and source of protein (WPM versus casein)

      Design: The proposed study is a randomized double-blind, placebo-controlled, single center,
      crossover design.

      At the start of the study, subjects will be randomly assigned to 4 different groups in a
      crossover design, where they will be asked to consume a beverage containing Product 1: 0g of
      protein (maltodextrin control) Product 2: 30g of WPM Product 3: 50g of WPM Product 4: 50g of
      micellar casein (MC) Number of subjects: The number of subjects will be 15. Sufficient
      subjects should be recruited to provide a 30% drop-out rate. Therefore 20 subjects will be
      needed including drop-outs.
    

Intervention name(s): Control (WPM 0); WPM 30; WPM 50; MC 50
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 85.0 % maltodextrin,15.0% fat, 0% WPM; 43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM; 16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM; 16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: whey protein microgels; thermogenesis
A Study to Evaluate ALN-AGT01 in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and
      pharmacodynamic (PD) effects of subcutaneous (SC) ALN-AGT01 (zilebesiran) in participants
      with hypertension. The study will be conducted in 4 parts: Part A will be a single ascending
      dose (SAD) phase in hypertensive participants, Part B will be a single dose (SD) phase in
      hypertensive participants with controlled salt intake, Part D will be a MD phase in
      hypertensive participants who are obese, and Part E will be an open-label SD phase with
      co-administration of irbesartan in hypertensive patients.
    


Intervention name(s): ALN-AGT01; ALN-AGT01-Matching Placebo; Irbesartan; Irbesartan-Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ALN-AGT01 will be administered by subcutaneous (SC) injection.; Normal saline (0.9% NaCl) matching volume of ALN-AGT01 doses will be administered SC.; Irbesartan will be administered orally.; Irbesartan-matching placebo will be administered orally.
Other intervention name(s): Zilebesiran
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy Smokers
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study to verify the same effectiveness and safety profile for the test
      products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products,
      Nicorette Mint 2 mg gum and Nicorette Mint 4 mg gum (reference products), in a standardized
      mode. This verification is done in a so-called bioequivalence study, which means that the
      same amount of the same active substance (nicotine), in the same dosage form, for the same
      route of administration, and meeting the same or comparable standards is performed.

      During the study visits, blood samples will be drawn to measure the level of the substance in
      the blood to verify that the two test products are comparable to the reference products.

      Tolerability of the treatments will be evaluated based on reported and observed adverse
      events.
    

Detailed description: 
      This is a single-center, randomized, single-dose open-label, cross-over study in 76 healthy
      males and females in total. The investigational products (IPs), i.e., Nicorette Extra Mint
      Gum 2 and 4 mg, and Nicorette Mint Gum 2 and 4 mg, will be given as single doses at separate
      treatment visits. Investigational treatments will be separated by at least 36 hours.

      Blood samples for determination of nicotine will be drawn pre-dose (within 5 minutes of
      administering, i.e., start of chewing) and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well
      as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

      Used gums will be collected and analyzed to determine the amount of remaining nicotine.

      Any Adverse Events (AEs) that may occur will be registered.
    

Intervention name(s): Nicorette Extra Mint 2 mg Gum; Nicorette Mint 2 mg Gum; Nicorette Extra Mint 4mg Gum; Nicorette Mint 4 mg Gum
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.; A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.; A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.; A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: single-center, randomized, single-dose, open-label, cross-over study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence
Type 2 Diabetes and the Brain in Adolescents
Condition: Type 2 Diabetes Mellitus; Obesity; Pediatric Obesity; Insulin Resistance; Dysglycemia; Hyperglycemia
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Insulin Resistance; Hyperglycemia; Pediatric Obesity
Study type: Interventional

Summary: 
      This study evaluates differences in brain function and cognitive performance in adolescents
      with type 2 diabetes (T2D) compared to non diabetic controls (both obese and lean) and
      correlates these changes with obesity, insulin resistance, and glycemic control in youth with
      T2D.
    

Detailed description: 
      This is a cross-sectional study examining neurocognitive function and brain activity in
      resting state and during working memory and executive function tasks using blood oxygen level
      dependent (BOLD) functional MRI (fMRI) during hyperinsulinemic euglycemic and hyperglycemic
      clamps in obese adolescents with T2D compared to non-diabetic obese and lean controls. The
      investigators will measure glycemic control (acute hyperglycemia during clamps and glycemic
      variability) and insulin resistance to examine their association with neurocognitive metrics
      and brain functional activity.

      There will be one screening visit and three study visits for subjects with T2D. One visit
      will consist of neurocognitive testing and dual energy X-ray absorptiometry (DEXA) of the
      whole body to assess body composition including fat mass. In the other two visits, subjects
      with T2D will undergo normal and high glucose clamps during fMRI.

      Obese and lean control subjects will have one screening visit and two study visits, one for
      neurocognitive testing and DEXA and another for fMRI without glucose clamps. All subjects
      will have a blood sample obtained at the screening visit.

      Only adolescents with type 2 diabetes will wear a continuous glucose monitor (CGM) for 6 days
      prior to neuroimaging to determine glycemic variability. A1C will be assessed at baseline.

      Parents of subjects will also have abbreviated IQ testing.
    

Intervention name(s): Hyperglycemic clamp; Hyperinsulinemic Euglycemic clamp
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects with T2D will receive IV Dextrose infusion to maintain plasma glucose at ~250 mg/dL during fMRI.; Subjects with T2D will receive IV Dextrose and Insulin infusion to maintain plasma glucose at approximately 90 mg/dL during fMRI.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cognition; MRI; Functional MRI; Pediatric Obesity; Type 2 Diabetes Mellitus; Adolescents; Continuous Glucose Monitoring; Insulin Clamp
Evaluation and Validation of Novel Diagnostic Tool for Allergists (AbioSCOPE)
Condition: Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      In this study, investigators evaluated for the first time the diagnostic efficacy of
      abioSCOPE® versus Phadia Laboratory System as an aid in the diagnosis of allergic diseases.
      Investigators targetted the agreement between test results obtained in abioSCOPE® and a
      laboratory reference method (Phadia Laboratory System, ThermoFisher Scientific, Uppsala,
      Sweden), considered as a quasi-gold standard in IgE (immunoglobulin E) antibody assays.
      Investigators also reported the medical decision taken by a panel of allergy experts who had
      access to patient history, skin tests and IgE antibody assay, but blinded to the method used,
      i,e, the reference method or the abioSCOPE® .
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with history of allergic rhinitis and asthma
      
Biospecimen description: 
      Venous blood collection prepared to obtain serum
    
Keywords: IgE; skin prick tests; diagnosis; rhinitis; asthma; allergy; laboratory
Virtual Reality in Lower Limb Adult Burn
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      To investigate the potential effects of Wii fit rehabilitation programs on functional
      capacity, mobility, balance and muscle strength in lower limb burn patients after hospital
      discharge.
    

Detailed description: 
      The use of virtual reality technology in burn conditions improved joint flexibility and
      reduced pain associated with physical therapy, dressing changes, and wound debridement.
      However, the primary concern of burn rehabilitation is not only survival but also maximizing
      functional outcome and decreasing the time for return to work.
    

Intervention name(s): virtual reality; Standard of care
Intervention type(s): Other; Other
Intervention description(s): Wii Fit balance board (Nintendo Inc., Kyoto, Japan).; physical therapy and occupational therapy exercises either at their own home or a gym
Other intervention name(s): interactive video games; routine physical therapy protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: burns; lower limb burns; virtual reality
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed
      conditions.
    


Intervention name(s): Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria); Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cefdinir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic