bioihbjkbjnl/mcl2 huggingface dataset:
DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?
Condition: Lung Disease
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Lung Diseases
Study type: Interventional

Summary: 
      This study is being conducted to find out if the use of inhaled corticosteroids has an affect
      on upper airway (UAW) collapsibility and sleep apnea risk. An inhaled corticosteroid is a
      common asthma controller medication like Flovent. Sleep apnea or sleep deprived breathing
      (SDB) is when someone stops breathing for a short period of time during sleep. For some
      reason, people with asthma have more sleep apnea and upper airway (UAW) collapsibility
      (weakness) than the general population. There are many possible reasons for this and one
      might be related to the use of inhaled corticosteroids.

      The overall hypothesis of this study is to determine whether inhaled fluticasone propionate
      (FP) increases UAW collapsibility and to assess tongue (genioglossus muscle) dysfunction as a
      potential underlying mechanism.
    

Detailed description: 
      To address this hypothesis, we specifically aim is to determine the effects of 16 weeks of
      treatment with inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 880 mcg
      twice daily, on:

      Specific Aim 1: UAW collapsibility, as measured by Pcrit during NREM sleep; Specific Aim 2:
      Severity of obstructive SDB and sleep quality, and quality of life related to sleep apnea
      assessed on validated questionnaires (Sleep Apnea scale of the Sleep Disorders Questionnaire
      [SA-SDQ], Epworth Sleepiness Scale [ESS]) and Pittsburgh Sleep Quality Index [PSQI], and
      Sleep Apnea Quality of Life Index [SAQLI]); Specific Aim 3: Tongue strength and fatigability
      (assessed using the Iowa Oral Performance Instrument)
    

Intervention name(s): FP 220 mcg 2 puffs BID
Intervention type(s): Drug
Intervention description(s): The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
Other intervention name(s): Fluticasone propriante
Intervention MeSH terms: Fluticasone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; sleep apnea
Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques
Condition: Adult Healthy Volunteers
Study type: Interventional

Summary: 
      The primary objective is to admix a radiolabel with albuterol sulphate for incorporation into
      the Handihaler® device for inhalation studies. This will allow for the investigators to
      determine the regional lung deposition of drug inhaled from the standard Handihaler® device
      compared to a novel modification of the device to provide more effective dispersion and
      aerosolization of the coated albuterol powder. The new mechanism of action for
      proof-of-concept testing consists of a bead (5.1 mm; expanded polystyrene foam) coated with
      drug powder, as opposed to the standard lactose formulation-filled capsule.
    


Intervention name(s): modified Handihaler DPI; standard Handihaler DPI
Intervention type(s): Device; Device
Intervention description(s): subjects randomized to receive 1 inhaled dose on 2 separate days, each dose delivered 2-3 days apart. The radiolabeled albuterol drug powder will be dispersed from either the DET bead-HandiHaler prototype or via the established HandiHaler device standard with the lactose-albuterol formulation provided to us by the sponsor.; subjects randomized to receive 1 inhaled dose on 2 separate days, each dose delivered 2-3 days apart. The radiolabeled albuterol drug powder will be dispersed from either the DET bead-HandiHaler prototype or via the established HandiHaler device standard with the lactose-albuterol formulation provided to us by the sponsor.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Relationship of Position Sense With Gait and Balance in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational [Patient Registry]

Summary: 
      Balance and gait disturbances are among the most common problems in patients with Multiple
      Sclerosis (MS). There is evidence of decreased foot sole sensation in MS patients. Studies
      conducted in healthy individuals have revealed the relationship between balance and foot sole
      sensation. These studies have demonstrated that sensory feedback from the cutaneous receptors
      of the foot sole plays an important role in maintaining balance. However, it is not yet known
      clearly to what extent the sensory impairment seen in MS patients affects balance and gait
      disorders.

      The aim of this study is to examine the relationship between lower extremity position sense
      and foot sole sense with gait and balance in MS patients.
    

Detailed description: 
      Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)
      and healthy individuals of similar age and sex to patients will be included in the study. The
      balance, gait, lower extremity position sense, and foot sole sense will be evaluated.

      The researchers will use t-tests to compare for quantitative variables and chi-square for the
      categorical variables between groups. In addition, the researchers will examine the
      correlations between balance, gait, lower extremity position sense, and foot sole using by
      Pearson bivariate correlations.
    

Intervention name(s): assessment
Intervention type(s): Other
Intervention description(s): Assessments of balance, gait, lower extremity position sense, and foot sole sense
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ambulatory sample
      
Keywords: Multiple Sclerosis; Gait; Balance; Sensation
Neuropathic Pain Management
Condition: Diabetic Neuropathies; Polyneuropathies
MeSH terms: Neuralgia; Diabetic Neuropathies; Polyneuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3
      clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined
      with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with
      chronic distal diabetic polyneuropathy.
    

Detailed description: 
      Subjects will be assigned to one of the two arms of the study, after having been deemed
      eligible during the screening visit in random double-blind design. Subjects will be evaluated
      for a 4 week period.

      OBJECTIVES

        -  To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of
           Life (QOL) of subjects with diabetic neuropathy through a current and validated
           neuropathic pain scale along with the QOL questionnaire.
    

Intervention name(s): F0434; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2).; Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2)
Other intervention name(s): Gabapentin with thiamine and cobalamin; Gababion; Gavindo
Intervention MeSH terms: Thiamine; Vitamin B 12; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Polyneuropathy; Diabetes Mellitus; Diabetic peripheral neuropathy
Evaluation of Preventive Regimens With Different Toothpastes vs Fluoride Varnish & Toothpaste in High Caries Patients
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study will be conducted in order to determine the prevention effect of caries preventive
      regimen using herbal toothpaste and regimen using fluoride toothpaste versus fluoride
      toothpaste and fluoride varnish on the caries risk of patients with high caries risk.
    

Detailed description: 
      Dental caries is highly predominant worldwide. So, in addition to treating this caries,
      patients should be managed to avoid new caries. Preventive measures could be applied to the
      patients who are most expected to develop dental caries who are identified by caries risk
      assessment. Thus, effective caries risk assessment is essential to control new caries
      development.

      Dental caries can be prevented by conducting appropriate measures; therefore, it is crucial
      to identify those who are most likely to have dental caries by caries risk assessment and
      giving them the essential preventive measures. Though some caries preventive measures have
      showed success in descriptive clinical trials, there is little information on their
      practicality with high caries risk groups in everyday usage.

      Oral health is an essential part of general well being, people have used herbs in order to
      prevent dental diseases for centuries. In 2008 the Federal Council of Dentistry approved the
      use of medicinal plants for oral healthcare.

      Medicinal plants can heal bacterial diseases as it is full of antimicrobial agents. They are
      becoming more popular than chemicals due to the side effects of synthetic antibiotics and the
      antibiotic resistance in microorganisms.

      Studies propose that herbal extracts are highly effective against significant microorganism
      which cause dental caries like Streptococcus mutans. Herbal toothpaste decreases dental
      caries through combined effects of antibacterial agents, oral acid neutralisers and decreased
      plaque bacterial enzyme inhibitors present in the herbal toothpaste.
    

Intervention name(s): Himalaya complete care toothpaste; Signal toothpaste; Signal toothpaste and fluoride varnish
Intervention type(s): Other; Other; Other
Intervention description(s): Herbal toothpaste as a part of a caries preventive regimen; fluoride based toothpaste as a part of a caries preventive regimen; application of fluoride varnish and using fluoride based toothpaste
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms
Condition: Upper Gastrointestinal Symptoms
Study type: Interventional

Summary: 
      A prospective single blinded, tandem study, comparing a magnetically controlled capsule with
      or without a tether (MCC or MCC-T) with conventional upper endoscopy for the diagnosis of
      patients with upper abdominal symptoms.
    

Detailed description: 
      In the US patients commonly undergo esophagogastroduodenoscopy (EGD) for upper abdominal
      symptoms to try to resolve whether they have gastroesophageal reflux disease or functional
      dyspepsia, if they are older than the age of 60 with symptoms, or have alarm symptoms such as
      unexplained weight loss, persistent nausea and vomiting or if they have symptoms that are
      refractory to acid suppression therapy. Given the increasing burden of digestive disease in
      the US, the use of EGD is increasing in volume nationwide. EGD usually requires either
      conscious sedation or monitored anesthesia sedation, which has put an additional cost burden
      on the healthcare system. Since MCC or MCC-T does not require sedation, it offers an
      attractive option for both patients and clinicians alike.

      The aim of this study is to compare in the same patient the accuracy of the MCC and MCC-T and
      EGD in patients presenting with upper abdominal symptoms.
    

Intervention name(s): MCC/MCC-T; Standard gastroscopy
Intervention type(s): Device; Device
Intervention description(s): Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract; Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum
Other intervention name(s): Magnetic controlled capsule endoscopy with/without tether; EGD
Intervention model: Single Group Assignment
Intervention model description: Tandem study
Masking: None (Open Label)
Primary purpose: Diagnostic
Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective,
      Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last
      and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA
      concomitantly treated with MTX during the Core Study Period.
    


Intervention name(s): rituximab
Intervention type(s): Biological
Intervention description(s): 1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RA, Biosimilar
The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients
Condition: Difficult Airway, Videolaryngoscopes
Study type: Observational [Patient Registry]

Summary: 
      Obese patients may have difficulty in airway management.Patients who have body mass index >
      35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be
      reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of
      difficult airway.This study is designed to evaluate the differences and the effects of
      different laryngoscopes.
    


Intervention name(s): c-mac laryngoscope
Intervention type(s): Device
Intervention description(s): type of laryngoscopes
Other intervention name(s): mc-grath laryngoscope
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing elective surgery and have body mass index > 35
Effects of Acarbose on Endothelial Function After a Mixed Meal in Newly Diagnosed Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Endothelial dysfunction (ED) has been suggested as a possible causal link between
      postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent
      trials demonstrated a reduction of cardiovascular events by treatment with the alpha
      glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions.
      We were interested whether patients with newly diagnosed type 2 diabetes showed postprandial
      ED and if so whether acarbose was able to improve this condition.
    


Intervention name(s): acarbose; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg (tablets) t.i.d.; one tablet t.i.d.
Intervention MeSH terms: Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016.
      ESPB has aroused the interest of many nerve block experts. The benefits of ESPB are not yet
      demonstrated. The specific mechanism is still controversial. Some believe that ESPB can block
      the posterior root of the spinal nerve and produce part of the para-spinal block effect with
      the diffusion of the drug solution.

      The present study will carried out to compare the performance of the erector spinae plane
      block combined with general anesthesia in addicts versus non addicts' patients regarding the
      local analgesic effect, recovery after surgery and side effects.
    


Intervention name(s): Bupivacain
Intervention type(s): Drug
Intervention description(s): Patients will be placed in left lateral position. A low-frequency curved array ultrasound transducer will be used. The ultrasound transducer will be placed in a longitudinal orientation 2-3 cm lateral to the midline to identify the hyperechoic line of the transverse process. After identification of muscles superficial to the transverse process and local infiltration of anesthesia into the superficial tissues, a block needle will be inserted in a craniocaudal direction until contact will be achieved with the transverse process where the tip will lay in the interfascial plane below the erector spinae muscle. A small bolus of local anaesthetic should be given through the block needle; the erector spinae muscle should be visualized, separating from the transverse process. A total of 20 mL bupivacaine 0.25% will be injected into the interfacial plane deep to the erector spinae muscle bilaterally. Forty minutes after the ESPB, the cutaneous sensory block will be assessed.
Intervention MeSH terms: Bupivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lumber surgery; Postoperative analgesia; Erector spinae pain block
Efficacy of Daptomycin Plus Fosfomycin Versus Daptomycin for Treatment of MRSA Bacteremia
Condition: Staph Aureus Methicillin Resistant Bacteremia
MeSH terms: Bacteremia
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that the combination of daptomycin and fosfomycin is superior to daptomycin
      alone in the treatment of methicillin resistant Staphylococcus aureus (MRSA) bacteremia.
    

Detailed description: 
      The mortality associated to MRSA bacteremia remains higher than 30% of episodes despite the
      availability of new antibiotics. Objective: To demonstrate that the combination of daptomycin
      and fosfomycin is superior to daptomycin alone in the treatment of methicillin resistant
      Staphylococcus aureus (MRSA) bacteremia. Design: Randomized, open-label and multicenter
      study. Intervention: Patients with MRSA bacteremia will be randomized (1:1) in Group 1:
      daptomycin 10mg/Kg/24h intravenous (iv) and Group 2: daptomycin 10 mg/kg/24 iv plus
      fosfomycin and 2g/6h iv. Duration of therapy will be 10-14 days for uncomplicated bacteremia
      and up to 42 days for complicated bacteremia. Follow up: There will be a clinical and
      microbiological evaluation at baseline, during treatment and at week 6 after the end of
      therapy (test of cure visit, TOC). Complicated bacteremia was considered if: a) persistence
      of a positive blood culture at 72-96 h from the start of antibiotic, b) evidence of spread of
      infection (metastatic infection) c) infection involving a non-removable device in less than 4
      days. Sample size: Assuming 60% cure rate with daptomycin and a 20% difference in cure rates
      between both groups, we estimated that 103 patients will be needed for each group (α:0.05, ß:
      0.2). Main endpoint: clinical and microbiological response at the TOC visit. Treatment
      success was defined as the resolution of clinical signs and symptoms and negative blood
      culture. Treatment failure was defined if any of the following situations: a) lack of
      clinical response at 72 h or more after initiation of the study therapy b) persistent
      bacteremia (positive blood culture on day 7 after randomization), c) withdrawal of treatment
      due to adverse effects or for any other reason based on clinical judgment. d) relapse of MRSA
      bacteremia before the TOC visit e) death for any reason before the TOC visit. Secondary
      endpoints: evaluation in both groups of clinical and microbiological response at end of
      therapy (EOT visit); mortality at EOT and TOC visit; persistent MRSA bacteremia; recurrence
      of MRSA bacteremia (positive blood culture when previous ones were negative); emergence of
      daptomycin or fosfomycin resistance and severe adverse effects.
    

Intervention name(s): Fosfomycin 2gr/6h iv; Daptomycin 10mg/kg/24h iv
Intervention type(s): Drug; Drug
Intervention MeSH terms: Daptomycin; Fosfomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MRSA; bacteremia; therapy
A Phase 1 Study to Investigate the Effects of Talampanel on the Heart Rhythm
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess whether multiple doses of Talampanel increase the QT
      interval when compared to placebo
    


Intervention name(s): Talampanel; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): titrated to 50mg three times a day over 9 days and a single dose administered on Day 10; Placebo administered three times a day over 9 days and a single dose of moxifloxacin administered on Day 10; administered three times a day over 9 days and a single dose administered on Day 10
Other intervention name(s): TV-7600, GYKI 53773; Avelox
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thorough QT Study; Talampanel; Cardiac Repolarizatiom; Healthy Volunteers