bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Study Evaluating Intranasal GSK256066 and Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis (SAR)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of
      intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects
      with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for
      enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety
      assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will
      be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape
      and allergen challenge assessments will also be performed at various time points throughout
      the study.
    


Intervention name(s): GSK256066; fluticasone propionate
Intervention type(s): Drug; Drug
Intervention description(s): 200mcg bd,; 200mcg od,100mcg bd
Other intervention name(s): GSK256066
Intervention MeSH terms: Fluticasone; Xhance; 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Vienna Challenge Chamber; Seasonal Allergic Rhinitis,
A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose of this study is to describe patient functioning and examine associations between
      depressive symptoms and measures of the various roles of functioning.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from outpatient clinics (General Practitioner (GP) or
        psychiatrist)
      
Keywords: MDD; Non-interventional study; Observational study
Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic
Condition: Denture Stomatitis; Wear of Denture Teeth
MeSH terms: Stomatitis; Tooth Wear; Stomatitis, Denture
Study type: Observational

Summary: 
      This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the
      wear of denture teeth.
    

Detailed description: 
      Denture stomatitis is a prevalent disease among removable denture wearers. The cause of this
      disease stems from a myriad of factors including host immunity and poor oral hygiene. Denture
      acrylic material is very conducive for the growth and adhesion of bacteria because of its
      porous nature. The application of plasma enhanced chemical vapor deposited (PECVD) coatings
      on the surface of acrylic dentures can produce a less porous surface which may minimize the
      adhesion of bacteria and therefore colonization. The goal is the application of these
      coatings will help minimize the occurrence of denture stomatitis.

      Another issue of removable dentures is the low wear resistance of denture teeth. The
      application of these coatings on denture teeth should minimize wear of these teeth and
      prolong the life of removable dentures.
    

Intervention name(s): PECVD coating
Intervention type(s): Device
Intervention description(s): SiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients seeking care in a Dental Clinic who have removable dentures.
Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)
Condition: Hypertension; Ischemic Heart Disease; Congestive Heart Failure; Stroke
MeSH terms: Hypertension; Heart Failure; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor
      Blocker, on top of the conventional treatment in high risk patients in Japan with
      hypertension in terms of the morbidity and mortality.
    

Detailed description: 
      Although many reports show that ACE inhibitors and angiotensin II receptor blockers (ARB) are
      superior for prevention of cardiovascular events, previous data are not enough for the
      patients who have more than one risk factor and for anti-atherosclerotic effects of ARB. In
      Japan, there were only a few large-scale trials for cardiovascular disease prevention, and it
      has not been clarified whether the evidence in Western countries could be unqualifiedly
      applied to Japanese patients as a long-range strategy. The KYOTO HEART Study is to assess the
      add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional
      treatment in high risk patients with hypertension in terms of the morbidity and mortality.
    

Intervention name(s): Valsartan; Non-ARB
Intervention type(s): Drug; Drug
Intervention description(s): Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary.; 'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs
Other intervention name(s): Diovan; Conventional anti-hypertensive treatment
Intervention MeSH terms: Valsartan; Antihypertensive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: High risk hypertension; Ischemic heart disease; Angiotensin receptor blockers; Cardiovascular mortality- morbidity; KYOTO HEART Study
Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
Condition: Aphakia; Cataract
MeSH terms: Cataract; Aphakia
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate, for the visual correction of aphakia, the
      safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device
      (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity
      in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes
      implanted with a commercially available IOL will be used to compare the safety and
      effectiveness of the LAL.
    


Intervention name(s): Light Adjustable lens (LAL) and Light Delivery Device (LDD); Control IOL
Intervention type(s): Device; Device
Intervention description(s): Primary eye will receive Light adjustable lens with Light delivery Device treatments; Fellow eye will receive control IOL
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Light Adjustable Lens; Intraocular lens; LAL
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
Condition: Hepatic Failure
MeSH terms: Liver Failure; Hepatic Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effect of hepatic impairment on the
      systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with
      varying degrees of hepatic impairment.
    

Detailed description: 
      This is a Phase 1, multi-center study with parallel groups. The study employs a single-dose,
      open-label design in subjects with mild, moderate, or severe hepatic impairment along with
      matched healthy control subjects with normal hepatic function. Subjects with normal hepatic
      function will be matched with subjects with hepatic impairment for gender, age (± 10 years),
      body weight (± 15%), and smoking status (smoker or non-smoker).

      Up to a total of 48 participants will be enrolled in this study (approximately 8 in each mild
      [Child-Pugh A], moderate [Child-Pugh B], severe hepatic impairment [Child-Pugh C] groups),
      and up to 24 healthy control subjects). Each participant will receive a single oral dose of
      300 mg of icenticaftor (QBW251) on Day 1 under fasting conditions.

      The study is comprised of an up to 28-day screening period (Days -28 to -1), a baseline
      evaluation (Day -1) prior to treatment on Day 1, and a follow-up period of 7 days for
      pharmacokinetics (PK) sample collection (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48,
      72, 96, 120, 144 and 168 hours post-dose). A safety follow-up contact will be done 30 days
      after administration of the study drug.

      The primary purpose of this study is to evaluate the effect of hepatic impairment on the
      systemic PK, safety, and tolerability of icenticaftor in participants with varying degrees of
      hepatic impairment.
    

Intervention name(s): Icenticaftor
Intervention type(s): Drug
Intervention description(s): Single oral dose of 300 mg of icenticaftor (QBW251)
Other intervention name(s): QBW251
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic impairment; Child-Pugh classification; Icenticaftor; QBW251
A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to assess the bioequivalence of the oral suspension
      formulation, the oral solution formulation, and the marketed tablet formulation of
      levofloxacin, with the marketed tablet as the reference.
    

Detailed description: 
      In this single-dose study conducted at at single center, 3 oral formulations of levofloxacin
      (tablet, suspension, and solution) were assessed for their bioequivalence in healthy men and
      women aged 18 to 55 years old. Subjects were assigned different treatments based on chance;
      both the researcher and the study participant knew the treatment being administered. The
      study consisted of a screening period, 3 open-label treatment periods separated by washout
      periods of at least 4 days between doses, and a post-treatment period. Subjects received a
      single dose of all 3 study formulations, administered as a single dose of each formulation on
      Day 1 of each treatment period. Blood samples were collected on Days 1, 2, and 3 of each
      treatment period immediately before dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 10, 14,
      24, 30, 36, and 48 hours after dosing for measurement of levofloxacin concentration. Subjects
      were admitted to the study site prior to dosing and remained through the 48-hour measurements
      on Day 3. The post-treatment period included physical examination and clinical laboratory
      testing to ensure subject safety before being discharged from the study. Safety evaluations,
      including adverse event monitoring, standard clinical laboratory evaluations (hematology,
      serum chemistry, and urinalysis), vital sign monitoring, and physical examinations, were
      monitored throughout the study.

      Two cohorts of 36 subjects each were enrolled in the study. The first cohort received a
      single dose of study drug and completed Period 1; the study was then stopped and reinitiated.
      Subjects from the first cohort completed early termination procedures; their data were
      included in safety analyses, however, no blood samples for levofloxacin concentrations were
      analyzed or included in pharmacokinetic analysis. Thirty-four subjects in the second cohort
      completed all study procedures. Levofloxacin oral suspension (125 mg/5 mL), levofloxacin oral
      solution (125 mg/5 mL), and levofloxacin tablet (500 mg) administered on Day 1 of each
      treatment period.
    

Intervention name(s): Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulations
Intervention type(s): Drug
Intervention MeSH terms: Levofloxacin; Ofloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open-label; randomized; crossover; bioequivalence
Use of Lapis Judaicus to Dissolve Kidney Stones
Condition: Kidney Calculi
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators will investigate the safety and effectiveness of an Iranian traditional
      medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will
      be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in
      random order. End points are changes in urinary chemistries and stone burden by Ultra
      sonography / CT scan.

      It will be used in proven calcium stone forming adults who are not pregnant. This phase is a
      double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine
      supersaturations, pH and sodium determinations will be collected. Entry and final stone
      quantification Ultra sonography / CT scan will be performed. End points will be changes in
      urine chemistry/supersaturation and stone quantitative stone volume.
    


Intervention name(s): Lapis Judaicus; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 g capsule per day.; 2 g capsule per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kidney Calculi; Iranian traditional medicine; Lapis judaicus
Effect of Hip and Core Muscle Strengthening for Patellofemoral Osteoarthritis: A Feasibility Study
Condition: Patellofemoral Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this research is to develop and test the feasibility of an exercise
      intervention for persons with painful knee osteoarthritis involving the patella (kneecap).
      Participants in the patellofemoral osteoarthritis (PFOA) group will be treated with a 6-week
      supervised exercise program that targets strengthening the hip and trunk core muscles.
      Painfree control participants will attend one session to gather biomechanical, strength, and
      function data for use in comparison to the patellofemoral osteoarthritis group. Feasibility
      outcomes include adherence to the treatment program, recruitment, and retention. It is
      hypothesized that PFOA group participants will change score on a knee pain and function
      questionnaire by the minimum clinically important difference score for positive improvement
      at the end of the 6-week intervention program.
    

Detailed description: 
      The investigators propose to develop and test the feasibility of a 6-week supervised hip and
      core muscle exercise intervention for persons with painful patellofemoral osteoarthritis
      (PFOA), a common condition for middle-aged and older adults. Currently there is limited
      evidence regarding effective conservative interventions for PFOA, a chronic condition that is
      painful and limits function and quality of life. Exercise is recommended as a first-line
      treatment for knee osteoarthritis, but the optimal type of exercise for PFOA is unknown. This
      intervention is based upon similar programs shown to improve pain and function in younger
      persons with patellofemoral pain, a condition that may lead to PFOA. Feasibility outcomes
      include adherence to the treatment program, recruitment, retention, and the impact of the
      intervention on participants' pain and function at 6-weeks and 6 months after finishing the
      program. The investigators will also compare PFOA participants to a matched pain-free
      volunteer control group to explore the differences in their biomechanics, muscle strength,
      pain report, and function at baseline. Data from this feasibility study will be used to
      design a future randomized controlled trial investigating the efficacy of conservative
      exercise interventions for PFOA. The investigators' overarching goal is to develop a
      conservative exercise intervention that improves the symptoms, function, and quality of life
      of persons with PFOA.
    

Intervention name(s): Supervised exercise program
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; osteoarthritis; knee; patellofemoral pain
Strain-Encoded Magnetic Resonance Imaging in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The aim of the study was therefore to evaluate whether myocardial deformation imaging
      performed by SENC allows for quantification of regional left ventricular function and is
      related to transmurality states of infarcted tissue in patients with acute myocardial
      infarction (AMI).
    

Detailed description: 
      CMR was performed in 38 consecutive patients with AMI 3±1 days after successful reperfusion
      using a clinical 1.5 Tesla MR-scanner. Ten healthy volunteers served as controls. SENC is a
      technique that directly measures peak circumferential strain from long-axis views and peak
      longitudinal strain from short axis views. Measurements were obtained for each segment in a
      modified 17 segment model. Wall motion and infarcted tissue were evaluated
      semi-quantitatively from SSFP cine sequences and contrast-enhanced-MR-images and were then
      related to myocardial strain. Comparison of peak circumferential strain assessed by SENC and
      MR-tagging was performed.
    

Intervention name(s): cardiac MRI
Intervention type(s): Procedure
Intervention description(s): cardiac MRI at one time point for group 1 after intervention for group 2 at any time point
Other intervention name(s): cardiac resonance magnetic imaging
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Consecutive Patients with AMI 3+/-1 days after successful reperfusion

          -  Ten healthy volunteers serving as control group
      
Keywords: AMI,; Reperfusion; successful
Effect of Daily Doses of Rice or Whey Protein on Resistance Training Adaptations
Condition: Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      The purpose of this study is to compare the ability of isocaloric and isonitrogenous (2 x
      15-gram) doses of rice protein or whey protein to stimulate resistance training adaptations
      in young, healthy, resistance-trained men.
    

Detailed description: 
      The study will be conducted using a randomized, double-blind approach with individuals being
      provided two doses of either 15 grams of rice or 15 grams of whey protein over an 8-week
      supplementation period while completing a heavy resistance training. One dose will be
      ingested within one hour of completing each workout and the other dose will be ingested
      within an hour of going to bed. On non-workout days, one dose of 30 grams will be ingested
      within 60 minutes of going to bed. The resistance training protocol will follow a linear
      periodization, split-body resistance training design consisting of two upper body and two
      lower body workouts each week resulting in each muscle group being trained twice each week.
      To minimize the influence of training experience and any learning effect, individuals with at
      least 12 months of resistance training history will be recruited. Participants will also be
      required to complete a two-week lead-in period (8 total workouts) before beginning the
      supplementation regimen to become accustomed to the training program and to account for any
      early neurological adaptations. Participants will then continue to follow the resistance
      training program for an additional 8 weeks. To assess the efficacy of the two different forms
      of protein supplementation on resistance training adaptations, changes in fat-free, lean, and
      fat mass will be determined using DEXA. Maximal strength and endurance of both upper and
      lower-body muscle groups will be determined while anaerobic capacity markers will be measured
      with the completion of a Wingate anaerobic capacity test. Participants will also be provided
      nutritional recommendations in order to ensure adequate energy and macronutrient consumption
      to facilitate positive training adaptations and eliminate any potential influence of
      differing dietary intakes.
    

Intervention name(s): Whey Protein
Intervention type(s): Dietary Supplement
Intervention description(s): Each condition (both rice and whey protein) match in color, flavor, and serving size.
Other intervention name(s): Rice Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Morbimortality in Older Patients Undergoing Urgent Abdominal Surgery
Condition: Surgery--Complications
Study type: Observational [Patient Registry]

Summary: 
      Morbimortality in older patients undergoing abdominal surgery.
    

Detailed description: 
      The aim of this study is to validate the modified CriSTAL tool for 30 mortality in elderly
      patients undergoing urgent abdominal surgery. To provide a new tool that could be used in
      conjunction with clinical judgment to aid in decision-making.

      The second objective of our study was to assess the quality of life, frailty, functional
      status and nutritional status in elderly patients that survive six months after an urgent
      abdominal surgery.
    

Intervention name(s): surgery
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patiens>65 years old
      
Keywords: Urgent abdominal surgery. Quality of life, functional status, frailty, nutritional status