bioihbjkbjnl/mcl2 huggingface dataset:
The Mannitol-Asthma-Ciclesonide-Study
Condition: Asthma, Bronchial
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway
      hyperresponsiveness assessed with mannitol.

      Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of
      hyper-responsive patients compared to 20% only in the placebo group and the group without
      airway hyper-responsiveness.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma
Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative pain is common and particularly outpatients may experience unsatisfactory pain
      relief. This randomized, double-blind, crossover study of postoperative pain in outpatients
      undergoing split-mouth, third lower molar extraction aims to examine whether or not the
      combination of metamizole and ibuprofen is superior to either drug alone.
    


Intervention name(s): Metamizole and Ibuprofen; Metamizole and Placebo; Ibuprofen and Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Metamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours; Metamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours; Ibuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
Intervention MeSH terms: Dipyrone; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Early Oral Feeding for Patients After Pancreaticoduodenectomy
Condition: Pancreatoduodenectomy
Study type: Observational

Summary: 
      This study intends to retrospectively analyze the patients who underwent
      pancreatoduodenectomy and compare the safety and feasibility between early enteral nutrition
      through nasojejunal tube and early oral feeding after pancreatoduodenectomy. This study is
      expected to revise the guidelines for early nutritional support after
      pancreaticoduodenectomy, reduce postoperative complications, and provide better guidance for
      clinical work.
    

Detailed description: 
      Pancreaticoduodenectomy is the standard treatment for periampullary and pancreatic head
      carcinomas, with the high incidence of perioperative complications ranging from 40% to 60%.
      Malnutrition is a relevant predictor of post-operative morbidity and mortality after
      pancreatic surgery. Adequate nutrition is the key to reduce perioperative complications,
      including abdominal infection, poor healing of wounds, and even gastrointestinal anastomotic
      leak. The optimal nutritional support method after Pancreaticoduodenectomy is still
      uncertain, and the current nutritional support methods are diverse. The results of an
      international survey showed that there was very poor or no agreement on postoperative
      strategies for the management of nutrition after Pancreaticoduodenectomy. Therefore, the
      investigators designed this retrospective study to evaluate which was safer and more feasible
      between early oral feeding and nasojejunal early enteral nutrition after
      Pancreaticoduodenectomy, using the method of propensity score weighting.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent pancreaticoduodenectomy in Changhai Hospital.
Comparison of Deep Serratus Anterior Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block
Condition: Pain, Postoperative; Serratus Anterior Plane Block; Multimodal Analgesia; Thoracic Surgery, Video-Assisted
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery.
      Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods
      such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block
      (SAPB) and erector spina plane block (ESPB) are widely used for VATS. Among these methods,
      ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of
      application of plane blocks as a component of multimodal analgesia has been increased. ESPB
      and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB
      (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle. In
      the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the
      serratus anterior muscle. Since it is done by entering from the same point in two
      applications, it is possible to perform these two applications at the same time with a single
      needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery
      operations are also different from each other. Therefore, it may be possible to obtain a more
      effective analgesic effect in patients by combining the mechanism of action of DSAPB and
      SSAPB , as in the multimodal analgesia method. This study seeks to evaluate the effect of
      DSAPB and combined DSAPB-SSAPB pain after VATS.
    


Intervention name(s): Deep block and Combined Block
Intervention type(s): Procedure
Intervention description(s): Deep serratus anterior block and combined deep and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Serratus Anterior Plane Block, Multimodal Analgesia, VATS
Cholesterol Metabolism and Lipid Transfer in Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The diabetic dyslipidemia is one of the most important risk factor in the development of
      coronary artery disease. The low density lipoprotein (LDL)-like nanoemulsions is being used
      to study the clearance of cholesteryl ester and free cholesterol from intravascular in
      patients with advanced coronary artery disease and it was shown a higher removal of free
      cholesterol and higher deposit in vases of this patients. The aim of this study is to analyze
      the plasma kinetics of both forms of cholesterol(free ad esterified) in type 2 diabetes
      patients without a previous history of cardiovascular disease.
    

Detailed description: 
      Hypercholesterolemia is not typical of type 2 diabetes mellitus dyslipidemia, but alterations
      in LDL may occur related to atherogenesis.Cholesterol exist in two main forms in organism:
      free cholesterol and the esterified cholesterol. An artificial model to study this two forms
      of cholesterol is the use of LDL-like nanoemulsion doubly labeled with 14C-cholesteryl esters
      and 3H- cholesterol. This nanoemulsion is made without protein and when in the intravascular
      compartment it is able to acquires apolipoproteins from others lipoproteins, such apos A's,
      C's and E. This model allowed us to use the nanoemulsion particle as a probe to study the
      lipoproteins receptor binding and the cholesterol esterification process.
    

Intervention name(s): Plasma kinetic study
Intervention type(s): Other
Intervention description(s): this study is done with the injection of LDL-like nanoemulsion doubly labeled with 14C- cholesteryl oleate and 3H- cholesterol, with a total radioactivity injection dose of 0.03mSV. Blood sample collected in a pre established period of time in 24 hours.
Other intervention name(s): LDL-like nanoemulsion
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        outpatient of the endocrinology clinics of Hospital das clinicas of University of São Paulo
        Medical school
      
Biospecimen description: 
      whole blood samples
    
Keywords: type 2 diabetes mellitus; dyslipidemia; kinetics
YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) in Elementary Schools
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga,
      Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress
      reduction and concomitant psychological parameters.
    


Intervention name(s): YoBEKA
Intervention type(s): Behavioral
Intervention description(s): The teachers and students of the YoBEKA study arm receive a guided YoBEKA practice from an experienced YoBEKA trainer during the regular 4 month intervention period. The YoBEKA program is based on a combination of different, easy to perform exercises appropriate to the school situation, consisting of postures, verses for speech, song and movement, affirmations in movement to promote balance and coordination, and various rest and silence exercises to promote body awareness and relaxation techniques. The teaching is ideologically neutral and without religious background. The participating teachers receive an initial two-hour YoBEKA introductory course. Every 2 weeks there is a one to two-hour training course. The pedagogical specialists are supported once a week by an experienced YoBEKA trainer. The teachers are encouraged to integrate the learned exercises independently and regularly into their everyday school life.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the
      safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3
      or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S.
      aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be
      enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19
      intermittent carriers complete the study. Each eligible subject will participate in three
      screening visits, a treatment period, and two follow-up visits. Each subject's participation
      in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit.
      Subjects will participate in up to three screening visits to determine S. aureus culture
      positivity and colonization status.
    


Intervention name(s): retapamulin; Retapamulin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200mg BID retapamulin 3 days; 200mg BID retapamulin 5 days; 200mg BID placebo 5 days
Intervention MeSH terms: Retapamulin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Altabax; SB-275833; retapamulin; nasal colonization; PK; tolerability; safety; efficacy
Potential Allergens in Wine: Double-blind Placebo-controlled Trial
Condition: Food Allergy; Anaphylaxis
MeSH terms: Hypersensitivity; Food Hypersensitivity; Anaphylaxis
Study type: Interventional

Summary: 
      This study is designed to identify whether wines which are produced using the common
      potential food allergens such as proteins derived from fish, milk or egg are likely to
      contain sufficient food allergens to cause allergic reactions in susceptible individuals.
    

Detailed description: 
      Recent international legislation requires labelling of wines made using potentially
      allergenic food proteins "casein", egg white, isinglass ( fish derived), milk or evaporated
      milk where "there is detectable residual processing aid". However it is not clear whether the
      final wine contains concentrations of residual added food proteins that can provoke allergic
      reactions.

      Comparison:This study is a double blind, placebo-controlled trial to determine whether adults
      known to be allergic to eggs, fish, milk and/or nuts exhibit allergic reactions following
      consumption of Australian commercial wines fined with food allergens.
    

Intervention name(s): Administration of wine fined with potential food allergens
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Food allergy; wine; milk allergy; egg allergy; nut allergy; fish allergy
Outpatient Antibiotic Treatment for a Cystic Fibrosis Pulmonary Exacerbation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This study plans to learn more about the effect of oral antibiotics for an outpatient
      pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung
      function, airway inflammation and quality of life. In this study subjects will perform
      pulmonary function tests, provide a sputum sample and complete a questionnaire at two
      separate clinic visits. If a subject is unable to cough up sputum in clinic he or she will be
      asked to breathe in a salt water solution to help cough up sputum. The first sputum sample
      will be obtained at the first visit (within 48 hours of starting antibiotics). Pulmonary
      function testing and the questionnaire will also be completed at this time. Subjects will
      complete a two week course of oral antibiotics at home. During these two weeks subjects will
      be asked to write down the times antibiotics are taken and airway clearance (vest treatment)
      is performed. Within one week of completing the antibiotic course subjects will return to
      clinic for a second visit. At that time a sputum sample will be obtained again and if
      subjects are unable to cough up sputum they will again be asked to breathe in salt water
      solution to help cough up sputum. Pulmonary function testing and the questionnaire will also
      be completed at this second visit. Sputum samples will be tested for infections with bacteria
      and viruses. Sputum samples will also be used to measure markers of airway inflammation
      (swelling). The investigators hypothesize that the use of two weeks of oral antibiotics for
      the treatment of a pulmonary exacerbation will result in a decrease in the amount of bacteria
      measured in sputum. Additionally the investigators hypothesize that treatment with
      antibiotics will lead to an improvement in lung function, a decrease in airway inflammation
      and an improvement in quality of life measurements.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 patients with cystic fibrosis will be recruited from the University of Colorado and
        Children's Hospital Colorado pediatric cystic fibrosis clinic.
An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
Condition: Diabetic Autonomic Neuropathy
MeSH terms: Diabetic Neuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects
      the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN
      may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.
      Three medications will be tested for their effectiveness in DAN.
    


Intervention name(s): ORAL ANTIOXIDANT
Intervention type(s): Drug
Intervention description(s): Comparison of triple antioxidant combination therapy vs placebo.
Other intervention name(s): Allopurinol (300mg daily),; ALA (600mg twice daily); nicotinamide (750 mg twice daily)
Intervention MeSH terms: Niacinamide; Allopurinol; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Oxidative Stress; Diabetic Complications; Neuropathy
EXTENSION OF THE EUROPEAN E-BUG PROJECT
Condition: Vaccination Failure
Study type: Observational [Patient Registry]

Summary: 
      Bacterial resistance to antibiotics is a growing concern in Europe, vaccination coverage is
      inadequate, and young adults, who are the highest antibiotic consumers, have the lowest level
      of knowledge. Extension of the e-Bug project, a European educational school programme
      concerning microbes, antibiotics and vaccination, to 15-18-year-olds implies the development
      of educational resources based on social marketing to promote sustainable behavioural
      changes. The objectives of the present study, which is part of the needs assessment in
      France, are to explore the attitudes, knowledge and behaviour of 15-18-year-olds concerning
      antibiotics and vaccination and their health education needs.

      Individual semi-structured interviews were conducted using purposeful sampling of 15- to
      18-year-olds, until data saturation, and were transcribed and analysed.
    


Intervention name(s): Individual semi-structured interviews
Intervention type(s): Behavioral
Intervention description(s): Individual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The recrutement and the conversations were realized on a voluntary basis in the crossroads
        health young people of Nice, structure dedicated to the grown-up young adolescentset from
        12 to 25 years old.
Pivot Breath Sensor Human Factors and Usability Study
Condition: Smoking Cessation; Smoking, Tobacco
Study type: Interventional

Summary: 
      Prospective, observational open label, single center study enrolling up to 15 subjects to
      evaluate human factors and usability of the Pivot Breath Sensor.
    

Detailed description: 
      The objectives of this Human Factors/Usability study are to:

        -  Ensure that representative intended users are able to operate the Pivot Breath Sensor
           independently

        -  Validate appropriate mitigations of use related hazards identified in risk management
           documentation

        -  Uncover previously unforeseen use errors

      This human factors and usability testing is conducted to demonstrate that the Pivot Breath
      Sensor can be used by the intended users without serious use errors or problems, for the
      intended uses and under the expected use conditions.
    

Intervention name(s): Pivot Breath Sensor
Intervention type(s): Device
Intervention description(s): The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men
Condition: Neoplasms, Prostate
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the effect of dutasteride on the inhibition of
      low-risk, localized prostate cancer progression in men who would otherwise receive no active
      therapy (expectant management).
    


Intervention name(s): Dutasteride; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dutasteride 0.5mg; Matching placebo
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dutasteride Prostate Cancer Expectant management REDEEM
Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia
Condition: Visual Acuity
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      This is a single-masked, dispensing clinical trial. A total of approximately 48 myopic and 32
      hyperopic eligible subjects will be targeted to complete the study. Subjects will be fit in
      the study lens, optimized if required and worn for approximately 2 weeks. Subjects will then
      have a washout period of approximately 1 week and be refit in the lenses and be dispensed for
      an additional 2 weeks of wear.
    


Intervention name(s): ACUVUE® OASYS with Transitions™
Intervention type(s): Device
Intervention description(s): JJVC Marketed Contact Lens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Effects of Aerobic Exercises and Progressive Muscle Relaxation Exercises on Pain and Quality of Life
Condition: Pain Syndrome; Anxiety
Study type: Interventional

Summary: 
      Premenstrual syndrome is the clinical condition in which reproductive age females suffer from
      emotional and physical symptoms not related to any disease, starting usually 5 days before
      the menstrual cycle for 3 consecutive cycles.
    

Detailed description: 
      Premenstrual syndrome is the clinical condition in which reproductive age females suffer from
      emotional and physical symptoms not related to any disease, starting usually five days before
      the menstrual cycle for three consecutive cycles. As menstrual cycle starts in females these
      symptoms vanish on 4th day of menstruation. Around 10% to 53% of female adults suffer from
      this condition. This condition limits activities of daily life and adversely effects the
      quality of life therefore, the administration of proper medical intervention is very
      important. Aerobic exercises and progressive muscle relaxation exercises have been effective
      in the treatment of premenstrual syndrome previously in a few studies. However, these two
      interventions have never been compared to test their effects on pain, and functional
      performance.
    

Intervention name(s): Aerobic exercises; Progressive muscle relaxation
Intervention type(s): Other; Other
Intervention description(s): To compare the effects of aerobic exercise and progressive muscle relaxation exercises on pain and quality of life in premenstrual syndrome; progressive muscle relaxation exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment