bioihbjkbjnl/mcl2 huggingface dataset:
Upper Airways Cephalometric Measures Compared to Skeletal Class and Divergence
Condition: Skeletal Malocclusion
MeSH terms: Malocclusion
Study type: Observational

Summary: 
      The aim of the present study is to investigate the baseline upper airways dimensions in adult
      patients belonging to all skeletal classes
    

Detailed description: 
      Lateral cephalometric radiographs of adult orthodontic patients referring for orthodontic
      consultation at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry,
      Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia,
      27100 Pavia, Italy, will be collected for the study according to the inclusion criteria.

      For each lateral cephalometric radiograph, a cephalometric tracing will be performed with
      DeltaDent software (version 2.2.1, Outside Format, Spino d'Adda, Italy). Riedel's ANB angle
      [Riedel 1952] has been adopted to determine patients' skeletal class. Steiner's SN^GoGn angle
      [Steiner 1953] will be used to evaluate skeletal divergence. Biprotrusion will be assessed
      for SNA > 84° and SNB > 82°, while biretrusion for SNA < 80° and SNB < 78°.

      Sample size calculation was performed with "soft palate length" as primary outcome.
      Considering alpha = 0.05 and power = 95%, an expected mean value of 31.05 with a standard
      deviation of 4.16 was hypothesized, with an expected mean difference of 3.34 [Sprenger et al.
      2017], therefore 40 patients per group were required.

      Statistical analysis will be conducted with R® software (version 3.1.3 R Development Core
      Team, R Foundation for Statistical Computing, Wein, Austria). For each cephalometric measure
      belonging to the three skeletal classes, descriptive statistics (mean and standard deviation)
      will be calculated. Appropriate statistical tests will be used to assess data normality and
      multiple comparisons. Linear regressions will be performed between upper airways diameters
      and SNA, SNB, ANB, SN^GoGn, ANSPNS^GoGn, PT, PL, sex and age.
    

Intervention name(s): Cephalometric analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Cephalometric analysis will be performed evaluating upper airways landmarks.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients referring to the Unit of Orthodontics and Pediatric Dentistry for orthodontic
        consultation.
      
Keywords: Upper airways dimensions; Skeletal Class; Skeletal Divergency
A Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and
      safety of MXP22 on liver health
    


Intervention name(s): MXP22 (Probiotic and antioxidant capsule); Placebo (Microcrystalline Cellulose)
Intervention type(s): Other; Other
Intervention description(s): Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days; Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Parallel Group, Placebo Controlled Trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Chronic Mechanical Low Back Pain (CMLBP) is a common disabling health problem among the
      general population. Multifidus muscle inhibition accompanying CMLBP plays a major role in
      perpetuating the pain and functional disability. Lumbar stabilisation and treadmill exercises
      are established treatments for CMLBP. However, it is not known which of the two techniques is
      more effective. This study was conducted to compare the effects of lumbar stabilisation and
      treadmill walk on multifidus activation, pain and functional disability in individuals with
      CMLBP.
    

Detailed description: 
      Fifty-three individuals (23 females and 30 males) with CMLBP participated in this single
      blind randomised clinical trial. Consecutive participants were recruited from the outpatient
      Physiotherapy clinic of the Aminu Kano Teaching Hospital, Kano, Nigeria and were randomly
      assigned to one of two exercise groups: Lumbar Stabilisation Group (LSG; n = 27) or Treadmill
      Walk Group (TWG; n = 26). However, 50 participants, (LSG: n = 25; and TWG: n = 25) completed
      the eight week study. Participants in the LSG had lumbar stabilisation exercises using McGill
      protocol while those in the TWG had walking exercise on a treadmill using the Bruce protocol.
      Treatment was applied three times weekly for eight weeks. Outcomes assessed at baseline and
      end of eighth week of study were: Pain Intensity (PI) using Visual Analogue scale, Functional
      Disability (FD) using Oswestry Disability Index Questionnaire; and Multifidus Muscle
      Activation (MMA) level using a surface electromyography machine. Data were analysed using
      descriptive statistics, paired and independent t-tests at α0.05.
    

Intervention name(s): Lumbar Stabilisation Exercise; treadmill walk exercise
Intervention type(s): Procedure; Procedure
Intervention description(s): McGill protocol starting with:
'cat-camel' exercise exercise 10 repetitions with 7 seconds hold each
'curl-up' exercise 10 repetitions with 7 seconds hold each
'side-bridge' exercise 10 repetitions with 7 seconds hold each
'cat-camel' exercise 10 repetitions with 7 seconds hold each progression was based on subjects' tolerance and endurance.; Bruce protocol
This include:
'5 minutes warm up' at zero degree inclination.
'20 minutes active exercise with increasing speed and inclination'
'5 minutes cool down'
Other intervention name(s): Core Exercise; Aerobic Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lumbar Stabilisation Exercise; Treadmill Walk; Multifidus Muscle Activation; Pain Intensity; Functional Disability
Safety and Bioavailability of IV and SC LBR-101
Condition: Bioavailability and Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101
      when administered intravenously or subcutaneously to healthy volunteers.
    


Intervention name(s): LBR-101 IV; LBR-101 SC
Intervention type(s): Biological; Biological
Intervention description(s): LBR-101 Administered Intravenously; LBR-101 Administered Subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Tobacco Cessation in Postmenopausal Women (Part I) - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects of ERT on appetitive behavior and
      withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal
      female smokers.
    

Detailed description: 
      Female subjects were screened and randomized. Following two weeks of medication monitoring,
      all participants continued smoking as usual for one week, at which time baseline measurements
      were taken. For the remaining two weeks (the experimental period), participants were
      randomized to a continued smoking or smoking abstinence condition. The abstinent group was
      provided with cessation counseling and monitored for abstinence. For all participants, data
      were collected during five clinic visits on all dependent measures: MNWS, QSU, Beck
      Depression Inventory (BDI), Profile of Mood States, Motor Speed Tasks and Reaction Time
      Tests. Question of interest was whether hormone replacement therapy would improve these
      dependent measures as manifested during short-term smoking cessation.
    

Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Tobacco Cessation; Postmenopausal Women
Efficacy in Ablative Fractional Laser Assisted Photodynamic Therapy According to Ablative Depth for Actinic Keratosis
Condition: Actinic Dermatosis
MeSH terms: Keratosis, Actinic; Keratosis; Skin Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Er:YAG ablative fractional laser-assisted photodynamic therapy (AFL-PDT) has shown
      significant benefit for the treatment of actinic keratosis(AK). Er:YAG ablative fractional
      laser ablates the epidermis and dermis without significant thermal injury, creating
      microscopic ablation zones (MAZ) in the portion of the skin that the laser is applied to. The
      formed MAZ depends on the laser parameters such as laser depth, laser density and laser
      passes, which affect the treatment outcome.
    

Detailed description: 
      The investigators aimed to investigate whether the use of increased laser ablative depth
      affects the efficacy, side effects, cosmetic outcomes, and PPIX accumulation of AFL-PDT for
      facial AK in a randomized clinical trial.
    

Intervention name(s): lidocaine/prilocaine (5%) application; 2940-nm Er:YAG AFL pretreatment; MAL application; Measurements of the fluorescence intensity; irradiation with red light-emitting diode lamp
Intervention type(s): Drug; Device; Drug; Other; Device
Intervention description(s): For AFL pre-treatment, lidocaine/prilocaine (5%) cream (EMLA; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area under occlusion for 30 min; After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 150 µm ablation depth, level 1 coagulation, 22% treatment density and a single pulse; Immediately after AFL treatment, an approximately 1- mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. Incubation time is 3 hours; After 3 hours of application with MAL, saline wash was performed and fluorescence imaging analysis was performed with ultraviolet examination light (model 31602,356 nm; Burton Medical Products Crop.) at 10 cm height above the base of each lesion. The red fluorescence (610 nm-700 nm) was separated and extracted by Matlab program and then used to measure the amount of 633 nm fluorescence of protoporphyrin IX.; After incubation for 3 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface, and a total light dose of 37 J/cm-2. All patients wore protective goggles during illumination.
Intervention MeSH terms: Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: actinic keratosis; ablative fractional laser; photodynamic therapy; ablative depth; protoporphyrin IX
Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      This observational study will document to what extent in daily clinical practice Humira
      (adalimumab) therapy is continued, interrupted or permanently discontinued during a follow-up
      period of 2 years. Reasons for interrupting or permanently discontinuing Humira therapy and
      reasons for restarting Humira therapy will be noted. An evaluation will be performed of the
      effect of the disease on quality of life and work productivity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with psoriasis followed in university or peripheral hospitals or peripheral
        private practices with experience in psoriasis patient care.
      
Keywords: Multicenter study
Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
Condition: Breast Neoplasms; Osteoporosis
MeSH terms: Breast Neoplasms; Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6
      months when given upfront versus delayed start (based on a post-baseline BMD T- Score below
      -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to
      trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage
      I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive
      Letrozole 2.5 mg daily as an adjuvant therapy.
    


Intervention name(s): Zoledronic Acid; Letrozole
Intervention type(s): Drug; Drug
Intervention description(s): Participants received Zoledronate 4 mg IV 15-minute infusion every 6 months.; Participants received Letrozole 2.5 mg daily.
Other intervention name(s): ZOL446; Zoledronate; Femara
Intervention MeSH terms: Zoledronic Acid; Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cancer-treatment related bone loss; postmenopausal women; breast cancer; hormone receptor positive breast cancer; adjuvant therapy; hormonal therapy; bone loss; bisphosphonates; ZFAST; Letrozole; Zoledronic Acid; US32
14 Weeks Exercise Training on Lean Women With and Without PCOS
Condition: Polycystic Ovary Syndrome (PCOS)
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      The aim of this project is to investigate the pathophysiology of PCOS in regards to the
      metabolic profile including defects in insulin sensitivity in skeletal muscle and adipose
      tissue, and to investigate the effects of exercise training on these parameters.
    


Intervention name(s): 14 weeks exercise training
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Polycystic Ovary Syndrome (PCOS)
The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is evidence that inhibition of FFA-release by acipimox is associated with a significant
      decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of
      systolic left ventricular function) in healthy subjects, indicating, that the heart is
      dependent on a constant supply of free fatty acids in order to guarantee normal cardiac
      function, and it further indicates, that the heart is not able to cover its energy demand by
      switching to glucose oxidation.

      Since that phenomenon, better known as "metabolic inflexibility" has been mainly described in
      patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and
      cardiac function in patients with overt type 2 diabetes.
    


Intervention name(s): acipimox; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia
Condition: Alzheimer's Disease; Dementia
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of acupuncture for
      patients with BPSD & healthy volunteers.
    

Detailed description: 
      This open label study is designed to evaluate the safety and tolerability of acupuncture as a
      intervention for patients with Behavioral and Psychological Symptoms of Dementia (BPSD)&
      healthy volunteers,and this study will enroll a total of 30(15 patients,15healthy volunteers)
      patients who are suffered from BPSD or healthy volunteers.The patients who have to be
      suitable for the standard of inclusion criteria will be included,and who have one condition
      of the exclusion criteria will be excluded,and so do the healthy volunteers.For each enrolled
      participant will obtain a baseline psychiatric and medical assessment, results of the
      Mini-Mental Status-Evaluation (MMSE),Behavioral Pathology in Alzheimer's Disease Rating
      Scale(BEHAVE-AD),Activity of Daily Living Scale(ADL)and other basic information prior to
      beginning acupuncture.For each participant will get acupuncture which once a day for 7 days
      running. During the trial the Questionnaire of Acupuncture-related Events have to be
      evaluated every day, and at the end of the intervention,all of the MMSE,BEHAV-AD,ADL and
      Treatment Emergent Symptom Scale (TESS)will be investigated.
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Participators will be stimulated at specific acupuncture points as determined for the disease by the professional acupuncturists, and acupuncture once a day,last for one week.
Other intervention name(s): Complementary and Alternative Medicine; Traditional Chinese Medicine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupuncture; Behavioral and Psychological Symptoms of Dementia; BPSD; MMSE; BEHAVE-AD; The Questionnaire of Acupuncture Events; healthy volunteers
A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0003)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 1839100 in healthy male subjects following oral administration of
      single rising doses.
    


Intervention name(s): BI 1839100; Placebo matching BI 1839100
Intervention type(s): Drug; Drug
Intervention description(s): BI 1839100; Placebo matching BI 1839100
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td
Condition: Diphtheria; Tetanus
MeSH terms: Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus
      and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to
      the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to
      subjects ≥ 60 years of age.

      To compare the post-vaccination geometric mean titers of antibody (GMTs) to Canadian
      manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the post-vaccination GMTs to
      the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to
      subjects ≥ 60 years of age.
    

Detailed description: 
      This is a multi-center, partially open-label, partially randomized double blind trial for
      immunogenicity and safety in the United States. Participants will be enrolled to one of three
      treatment groups:

        -  Subjects ages 11-59 years will receive Canadian manufactured Td vaccine on Day 0

        -  Subjects 60 years or older will be randomized to receive either US manufactured Td on
           Day 0, or,

        -  Subjects 60 years or older randomized to receive Canadian manufactured Td on Day 0

      The trial is designed to assess the safety of Canadian Manufactured Tetanus and Diphtheria
      Toxoids Adsorbed vaccine in all trial participants 11 to 59 years of age and to describe the
      immune responses in subsets of adolescents (11-14, and 15-18 years of age) and in a subset of
      adults 19-59 years of age. The trial will also compare the immune responses and safety in
      subjects ≥ 60 years of age receiving Canadian Manufactured Tetanus and Diphtheria Toxoids
      Adsorbed vaccine to an equal number of subjects ≥ 60 years of age receiving US Manufactured
      Tetanus and Diphtheria Toxoids Adsorbed vaccine.
    

Intervention name(s): Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine; Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular, single dose; 0.5 mL, Intramuscular, Single dose
Other intervention name(s): TENIVAC™; DECAVAC®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus
The Use of Pedometers as an Adjunctive Tool in a School-based Pediatric Weight Management Program
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is:

        -  To validate the use of pedometers in assessing the level of physical activity in middle
           school children.

        -  To evaluate whether setting a step goal through the use of pedometers could increase
           physical activity and prevent weight gain in middle school children.
    


Intervention name(s): Goal-setting group; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention group will be advised to increase their daily steps by at least 20% gradually over 3 months; The control group will be advised to continue to be physically active and record daily steps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Physical activity; pedometers; children
Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      The purpose of this non-interventional, retrospective study of existing data is to evaluate
      clinical outcomes related to Methicillin-resistant Staphylococcus aureus hospital based
      pneumonia by treatment and among subpopulations.
    

Detailed description: 
      All patients meeting inclusion/exclusion criteria from inpatient database from
      1/1/02-9/30/10.
    

Intervention name(s): linezolid (Zyvox); vancomycin
Intervention type(s): Drug; Drug
Intervention description(s): As prescribed-this is retrospective cohort of existing clinical data.; As prescribed-this is retrospective cohort of existing clinical data.
Intervention MeSH terms: Vancomycin; Linezolid
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010
      
Keywords: MRSA. pneumonia; outcomes