bioihbjkbjnl/mcl2 huggingface dataset:
Vocal Warm-up and Respiratory Muscle Training
Condition: Voice Disorders
MeSH terms: Voice Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effects of two speech-pathology interventions:
      vocal warm-up and respiratory training in teachers who work in a public school of the city of
      Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and
      the hypothesis is that both approaches can produce positive voice changes, but the Vocal
      Warm-up will produce the most significant changes.
    

Detailed description: 
      Randomized Clinical Trial where participants were allocated into groups: Vocal Warm-up (to
      perform exercises of resistance and flexibility for 13 minutes before teaching, during six
      weeks) and Respiratory Muscle Training (to perform exercises to strengthen the respiratory
      muscles through the use of incentive respiratory equipment. Five repetitions of exhales with
      an interval of thirty seconds between each one were performed. It was requested rest for two
      minutes, repeating the procedure four times with the total of five series. These exercises
      were performed for 13 minutes before teaching, during six weeks).

      Outcomes analyzed: demographics and teaching activity characteristics; symptoms, habits and
      factors associated with voice disorders; self-reported voice handicap (Voice Handicap
      Index-VHI-10); vocal severity rating (Vocal Severity Scale); and acoustic parameters through
      the computerized acoustic voice analysis program VoxMetria (CTS Informatics).
    

Intervention name(s): Vocal Warm-up; Respiratory Muscle Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.; Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Voice training; Education; Voice; Faculty
Pioglitazone Incretin Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Incretin hormones are hormones produced by the gut in response to food intake. These hormones
      help the body to control the metabolism of glucose (sugar). In particular, two incretin
      hormones (GLP-1 and GIP) cause the pancreas to secrete more insulin in response to high blood
      glucose levels. This helps the body to metabolize the glucose more effectively, lowering
      blood sugar levels. GLP-1 and GIP do not work as well in patients with type 2 diabetes (T2DM)
      as in subjects who do not have diabetes. This study tests whether a medicine called
      pioglitazone (Actos), which is commonly used to treat T2DM, improves the ability of GIP to
      increase insulin secretion.

      To address this question the investigators will recruit patients with T2DM whose diabetes is
      controlled with either diet and exercise or with metformin (another medicine commonly used to
      treat T2DM). Subjects will undergo measurement of body fat by DEXA scanning and a series of
      studies to characterize their metabolism. These studies include an oral glucose tolerance
      test (a test sometimes used to diagnose diabetes), a mixed-meal challenge (to measure how
      much GLP-1 and GIP are produced in response to a meal) and measurement of insulin secretion
      in response to glucose and GIP given through a vein. The investigators will also obtain small
      samples of fat (from just under the skin of the belly) using a needle to measure levels of
      the receptor for GIP. Subjects will then be randomly assigned to 12 weeks of treatment with
      either pioglitazone or matching placebo (an inactive tablet that does not contain
      medication). The dose of pioglitazone will be increased during the first 4 weeks to the
      maximum prescribed dose of 45 mg per day. Subjects will be seen every 2-4 weeks during the
      treatment phase of the study. After 12 weeks of treatment all studies performed at the
      beginning of the study will be repeated. The pioglitazone treatment will continue until the
      end of testing, approximately 4 weeks.

      The results of this study may give us information about why glucose control deteriorates in
      T2DM. This information might also lead to new ways to prevent or treat T2DM.
    


Intervention name(s): Pioglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose at 15 mg for two weeks, then titrated up to 45 mg in the subsequent 2 weeks.; placebo
Other intervention name(s): Actos (brand name for pioglitazone)
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Diabetes; pioglitazone; GIP
Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite recent advances in the treatment of NSCLC overall survival within these patients
      remains dismal and there is yet an unmet medical need for additional treatment options. In
      this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and
      bevacizumab) is tested to determine the objective response rate in patients with unresectable
      and advanced non-small cell lung cancer. This response rate will be compared with historical
      data.
    


Intervention name(s): Bevacizumab; Cisplatin; Docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging
-> further 3 cycles BCD Q3W -> Bevacizumab Q3W until progression; 3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging
-> further 3 cycles BCD Q3W; 3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging
-> further 3 cycles BCD Q3W
Other intervention name(s): Avastin; Taxotere
Intervention MeSH terms: Bevacizumab; Docetaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AGMT; NSCLC; non-small cell lung cancer; bevacizumab; Avastin; Cisplatin; Docetaxel; Taxotere; Inoperable; stages IIIB and IV
Sympathetic Nerve Response Incited by Biodiesel Exhaust Exposure
Condition: Healthy; Exposure to Pollution
Study type: Interventional

Summary: 
      The adverse effects of current ambient air pollution on cardiovascular and respiratory health
      have been demonstrated in an extensive series of epidemiological, observational and
      experimental studies. Similar cardiovascular responses seen post diesel exposure have been
      shown to occur following biodiesel exhaust exposure as well. In the current project the
      investigators aim to determine whether an acute exposure to biodiesel exhaust (rapeseed
      methyl ester) causes impacts on sympathetic nervous system activation in healthy volunteers.
    

Detailed description: 
      Brief as well as chronic exposures to ambient air pollution have been linked with increases
      in cardiovascular morbidity and mortality. Evidence suggests that the strongest associations
      between air pollution exposure and adverse cardiovascular effects are found for
      combustion-derived particulate matter, especially in the fine and ultrafine ranges such as is
      found in diesel engine emissions as well as biodiesel exhaust (RME, rapeseed methyl ester).
      Despite a greater understanding of the cardiovascular effects of air pollution, the
      underlying mechanism through which exposure to fine and ultrafine particulate air pollution
      alters vascular function has yet to be determined. Microneurography is a method that records
      nerve impulse traffic in human peripheral nerves, allowing for the assessment of sympathetic
      nervous activity. The current study will employed microneurography techniques to evaluate
      autonomic function in association with inhaled biodiesel exhaust exposure in healthy human
      volunteers.
    

Intervention name(s): Biodiesel exhaust exposure
Intervention type(s): Other
Intervention description(s): Evaluation of sympathetic nervous system activity as assessed by microneurography recording during an acute exposure to dilute biodiesel exhaust via mask.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: air pollution; microneurography; MNSA; Biodiesel; RME
Clinical Study to Investigate the Safety and Efficacy of MLC601 in 150 Iranian Patients After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese
      Medicine on motor recovery after ischemic stroke.
    

Detailed description: 
      This is a double-blind, placebo-controlled clinical trial study on 150 patients with a recent
      (less than 3 month) ischemic stroke. All patients will give either MLC601 (100 patients) or
      placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard medication of post
      stroke for 3 months. Motor improvement will be monitored using Fugl-Meyer Assessment FMA.
    

Intervention name(s): MLC601; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month; group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Efficacy; MLC601; motor recovery
Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.
Condition: Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Observational

Summary: 
      This study evaluates the presence and quantity of non-caloric sweeteners in newborns
      umbilical cord blood, and in their mother's breast milk at delivery, at 2 months, 4 months
      and 6 months of age. Microbiota composition will be evaluated in milk and in feces of both
      mother and child.
    

Detailed description: 
      The consumption of non-caloric sweeteners (ENC) is increasingly common in our country due to
      its wide use in all types of food and beverages, even those not labeled as "diet". Despite
      its widespread use and being an alternative to the consumption of sugars, several studies
      have shown that frequent ENC users are also at risk of excessive weight gain, type II
      diabetes, and cardiovascular diseases. In addition to this, the consumption of ENC in the
      early stages of life may predispose to the development of metabolic disorders later in
      life.The ENC have been shown to have effects on the health of those who consume them, causing
      metabolic disorders, weight gain and changes in the microbiota. The newborns, in whom gut
      microbiota is in the process of being established, influenced by the vaginal and intestinal
      microbiota of the mother, as well as by the mother's milk, are a vulnerable population in
      whom the effect of ENC consumption has not been investigated. This makes it relevant to study
      the prevalence of ENC in breast milk and umbilical cord blood of their newborns and to
      evaluate the composition of the intestinal and milk microbiota in order to identify changes
      attributable to the consumption of ENC.
    

Intervention name(s): No intervention.
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women in labor who come to the service of gynecology and obstetrics General Hospital
        Mexico. Usually, they are residents from Mexico City and metropolitan area (Mexico State).
      
Biospecimen description: 
      Plasma Feces Breast milk Urine
    
Keywords: Non-caloric sweeteners; microbiota; breast milk; umbilical cord
Comparison of Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors
Condition: Proprioceptive Postural Control
Study type: Observational

Summary: 
      The purpose of this study is to determine the concurrent validity of a newly developed
      pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator
      in the stimulation of muscle proprioceptors.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Young Flemish Volunteers
Drug-Drug Interaction Study With PF-05089771
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the potential for PF-05089771 to interact with a cocktail of drugs
    


Intervention name(s): Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771
Intervention type(s): Drug
Intervention description(s): PF-05089771 450mg single dose and titration from 150mg BID to 450mg BID Pravastatin 10mg dingle dose, Midazolam 7.5mg single dose, Losartan 25mg single dose, Caffeine 100mg single dose, Omeprazole 20mg single dose
Intervention MeSH terms: Losartan; Midazolam; Caffeine; Omeprazole; Pravastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Condition: Perennial Allergic Rhinoconjunctivitis; House Dust Mite Allergy
MeSH terms: Dust Mite Allergy; Conjunctivitis; Conjunctivitis, Allergic; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in
      patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a
      double-blind, placebo-controlled setting
    


Intervention name(s): CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10); House dust mite allergen extract in combination with CYT003-QbG10-placebo; CYT003-AllQbG10 in combination with house dust mite allergen extract placebo; CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): subcutaneous injections at 6 visits; subcutaneous injections at 6 visits; subcutaneous injections at 6 visits; subcutaneous injections at 6 visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Patients undergoing cardiac surgery, specifically a coronary artery bypass graft and/or heart
      valve replacement surgery, are at a higher risk for post-procedure atrial fibrillation (AF).
      AF is a condition in which the upper chambers of the heart do not contract normally and
      results in an irregular heartbeat. Recent studies have shown that tragus stimulation
      decreases the likelihood of AF in animals and humans. It has also been shown to reduce
      inflammation which may be related to post-procedure AF. Tragus stimulation involves
      stimulating a part of the outer ear, called the tragus, by sending a microcurrent through a
      small alligator clip. It is believed that tragus stimulation can affect the nervous system,
      which may reduce heart rate and lead to prevention of AF. The purpose of this study is to
      determine whether tragus stimulation in subjects undergoing cardiac surgery will lead to
      shorter occurrences, or even prevention, of AF.
    

Detailed description: 
      This was a single-blind study where patients were randomized tragus stimulation versus sham
      procedure and remained blinded to their treatment allocation. Both treatment options utilized
      similar equipment, namely the use of alligator clips which will be placed on the tragus and
      earlobe of the right ear for patients.

      Prior to cardiac surgery, the discomfort threshold of both left and right tragus stimulation
      was determined for all participating patients. Intermittent electrode signals, or
      microcurrents, were delivered at 20 Hz with100 µsec pulse width with variable microampere
      (mA) output. The discomfort threshold was defined as the stimulation intensity in mA at which
      point patients experience discomfort. The stimulation intensity used in the study was set
      below the sensation and discomfort threshold. The clip was placed on the patient's ear at the
      end of surgery. Stimulation then continued, one ear alternating with the other, every 4 hours
      for a total of 48 hours. If the patient showed any sign of discomfort from stimulation, the
      intensity of stimulation was reduced to a level at which signs of discomfort disappears.

      Follow-up was performed with a 14-day event monitor at the time of discharge, as clinically
      indicated. Echocardiography were assessed prior to study initiation and when clinically
      available in follow-up.
    

Intervention name(s): Parasym
Intervention type(s): Device
Intervention description(s): Tragus stimulation was done using the Parasym device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Postoperative Atrial Fibrillation; Tragus Stimulation
Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL
      2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline
      for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as
      reference.
    


Intervention name(s): Inflexal V; Inflexal V
Intervention type(s): Biological; Biological
Intervention description(s): vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart; Inflexal V 0.5 mL administrated once only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Virus; Vaccination; Immunisation
Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus
Condition: Uremic Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single blind randomized trial to compare efficacy and side effects of Gabapentin
      with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint
      George Hospital University Medical Centre were included in this study. Patients were divided
      into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after
      each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were
      treated reversley. Pruritus severity and its effect on quality of life will be assessed by
      using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index
      (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2
      and week4
    

Detailed description: 
      Pruritus is one of the frustrating skin manifestations of advanced renal failure. Many
      options have been used for the management of uremic pruritus (UP) such as Pregabalin,
      Gabapentin, Doxepine and Desloratidine. Gabapentin, a GABAergic drug, has been found to be
      effective in the treatment of uremic pruritus. Doxepin, a potent antihistamine drug, is used
      orally or topically in many pruritic conditions such as UP, idiopathic pruritus, atopic
      dermatitis, neurogenic, or psychogenic pruritus and, in the management of the UP in
      hemodialysis patients.

      No comparative head to head study between Gabapentin and Doxepine has been conducted to date.
      The aim of this study was to compare Gabapentin and Doxepin in treatment of uremic pruritus
      in hemodialysis patients.
    

Intervention name(s): Doxepin; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Doxepin for 4 weeks; dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks
Other intervention name(s): Silenor; Sinequan; Adapin; Neurontin; Gralise; Gabarone; Fanatrex
Intervention MeSH terms: Gabapentin; Doxepin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Human Mass Balance Study With Bilastine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to define the absorption and excretion kinetics of
      bilastine in man following oral administration, and to investigate the nature of the
      metabolites present in plasma and excreta. The secondary objective of the study is to assess
      the safety and tolerability of bilastine
    

Detailed description: 
      Primary Endpoints are: Whole blood and plasma concentrations of total radioactivity and
      parent drug. Urine and faecal recovery of total radioactivity. Characterisation and
      identification of metabolites in plasma, urine and faeces.
    

Intervention name(s): [14C]-bilastine
Intervention type(s): Drug
Intervention description(s): Single oral dose of 20 mg [14C]-bilastine. 1 capsule. 1 day dosing only
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mass Balance; Metabolism; Absorption; Excretion; Pharmacokinetics
Rivastigmine Capsules in Patients With Probable Vascular Dementia
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this research study is to evaluate, in the open-label extension phase, the
      effectiveness, tolerability and safety of rivastigmine capsules in males and females between
      the ages of 50 and 85 years old with probable vascular dementia.
    


Intervention name(s): Rivastigmine
Intervention type(s): Drug
Intervention MeSH terms: Rivastigmine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dementia; Vascular; Rivastigmine; Stroke; Memory loss