bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the Laser Assisted New Attachment Procedure (LANAP
      protocol) using the Free-running (FR) Pulsed Neodimium: Yttrium aluminium garnet (Nd:YAG)
      laser to Scaling and Root Planing (SRP) alone, Modified Widman Flap (MFF) surgery, and
      Coronal Debridement (CD) alone with respect to periodontal clinical attachment level gain.
    

Detailed description: 
      This multi-center study of the Laser Assisted New Attachment Procedure (LANAP protocol) using
      the FR Pulsed Nd:YAG laser compared to Scaling and Root Planing alone, Modified Widman Flap
      (MWF) surgery, and Coronal Debridement (CD) alone will utilize a single-blind, four-quadrant
      split-mouth design with MWF as the positive control, CD as a weak positive control and SRP as
      the standard treatment control. The study will be conducted at three (3) to five (5)
      investigational centers. Subjects will receive the Laser Assisted New Attachment Procedure
      (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified
      Widman Flap surgery, and Coronal Debridement alone each in one quadrant of their mouth at
      Baseline. Treatment modalities are randomly assigned to quadrants at the time of treatment.

      Efficacy evaluations, including clinical attachment level (CAL), probing depth (PD), and
      bleeding on probing (BOP) will be performed at Baseline, month 6, and month 12 using a
      Florida Electronic Probe. Radiographs will be taken at Screening/Baseline and at month 6 and
      month 12.
    

Intervention name(s): LANAP
Intervention type(s): Device
Intervention description(s): Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
Other intervention name(s): Periolase MVP 7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LANAP, Laser dentistry
A Methodology Study in Healthy Subjects to Evaluate the Effect of AZD8309 After Nasal Administration of Lipopolysaccharide (LPS)
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this methodology study is to evaluate the effect of AZD8309 on cells and
      inflammatory biomarkers in nasal lavage and blood after nasal challenge with
      lipopolysaccharide (LPS)
    


Intervention name(s): AZD8309; AZD8309
Intervention type(s): Drug; Drug
Intervention description(s): oral solution 30 mg/g, dose: 300mg bid for 3 days; oral solution 30 mg/g, dose: 300mg bid for 3 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy subjects; LPS; Effect; Intranasally
Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to provide an initial assessment of the gastrointestinal safety
      of a 7-day regimen of PLA-695 compared to placebo or naproxen.
    


Intervention name(s): PLA-695; Naproxen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Health
Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To estimate the pharmacokinetics of apixaban when administered as three different modified
      release formulation tablets relative to that when apixaban is administered as an immediate
      release tablet
    


Intervention name(s): Apixaban IR; Apixaban MR1; Apixaban MR2; Apixaban MR3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): immediate release tablet, 10 mg, single dose; modified release tablet 1, 10 mg, single dose; modified release tablet 2, 10 mg, single dose; modified release tablet 3, 10 mg, single dose
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: formulation; sustained release; modified release; extended release
Myomectomy During Cesarean Section
Condition: Myomectomy
Study type: Interventional
Phase: Phase 1

Summary: 
      Cesarean Myomectomy, safety and effect on uterine cavity.
    

Detailed description: 
      this study aims to compare between women who underwent Cesarean Myomectomy and those who
      underwent Cesarean section only regarding the procedure safety and whether uterine cavity was
      affected later on.
    

Intervention name(s): Cesarean Myomectomy; Cesarean section
Intervention type(s): Procedure; Procedure
Intervention description(s): Myomectomy was done during Cesarean section; Cesarean delivery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Cesarean Myomectomy
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of a Propionate Colon Release Form on ad Libitum Eating and Appetite Perception
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The present study aims to investigate the effect of a standardized liquid breakfast
      containing a food grade propionate colon release form on ad libitum eating and appetite
      perception in healthy overweight humans using a double-blinded, randomized, cross-over study
      design
    

Detailed description: 
      To determine, in healthy overweight subjects, the acute effect of a standardized liquid
      breakfast containing a propionate colon release form compared with placebo on appetite and GI
      comfort, food intake, serum glucose and insulin, plasma ghrelin, total GLP-1 and serum PYY
      concentrations, and plasma propionate concentrations
    

Intervention name(s): Ca-propionate 1 g; Ca-propionate 3 g; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast; 3 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast; 2.6 g of cellulose will be mixed in 203 mL of a standardized liquid breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination.
Condition: Ovarian Stimulation Preceding Intrauterine Insemination
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study aims to elucidate if the FSH and LH activity contained in hMG preparations
      is comparable to the recombinant FSH and LH administration in a 1:1 ratio. The mean outcome
      is the corresponding ovarian response in terms of oestradiol increase during stimulation and
      number of mature follicles the day of hCG administration. The patients will be included and
      randomized into two groups and stimulated either by HMG injections started on day 3 at a dose
      of 75 IU every day and fixed for the first 5 days, and in the second group, rFSH and rLH
      injections be started on day 3 at a dose of 75 UI/day of rFSH + 75UI/day of rLH. Serum
      estradiol levels will be measured on stimulation day 1, day 6 and the day of hCG injection.
      All follicles greater than 14 mm of diameter will be recorded on hCG day Intrauterine
      insemination is performed during two consecutive days starting the day after the human
      chorionic gonadotrophin (Ovitrelle) injection. Secondary outcomes are Days of stimulation,
      Total doses of gonadotrophins administrated, Clinical pregnancy , Ongoing pregnancy and
      Miscarriage rate, and Cancellation rate.
    


Intervention name(s): Menopur®, Ferring; rFSH (Gonal®,
Intervention type(s): Drug; Drug
Intervention description(s): 75 UI/day of Hp-hMG (Menopur®); 75UI/day of rFSH (Gonal®, Serono) + 75UI/day of rLH (Luveris®, Serono)
Intervention MeSH terms: Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction
Condition: Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly
      related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion
      time has not been fully studied for SETMI patients undergoing primary percutaneous coronary
      intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety
      of left radial approach for primary PCI in STEMI patients compared with right radial
      approach.
    

Detailed description: 
      The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary
      PCI.

      Patients will be included within 12 hours of symptom onset for primary PCI. Patients will be
      excluded if they are in cardiogenic shock.
    

Intervention name(s): Left radial approach; Right radial approach
Intervention type(s): Procedure; Procedure
Intervention description(s): Primary PCI performed through left radial approach.; Primary PCI performed through right radial approach.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transradial Approach, Primary PCI, ST-segment elevation myocardial infarction
The Effects of Type of Exercise in Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The type of physical activity such as, aerobic or resistant exercise required to reduce liver
      fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear. The
      purpose of this study is to determine whether aerobic exercise should provide improvement of
      hepatic fat content and inflammation as well as metabolic profiles and anthropometric
      parameters better than resistant exercise.
    

Detailed description: 
      Increasing prevalence of overweight and obese worldwide, non-alcoholic fatty liver disease
      (NAFLD) is commonly diagnosed in daily clinical practice. Weight reduction has been the only
      strategy established thus far to reduce hepatic lipid levels. Thus, dietary restriction and
      exercise focusing on weight reduction is recommended as the cornerstone for managing NAFLD.
      Recent reports have indicated that increased exercise greatly reduces hepatic fat
      accumulation and inflammation and the related oxidative stress levels outweigh those achieved
      by dietary restriction alone. Clear guidelines for such a "lifestyle physical activity" for
      NAFLD management are currently lacking. The type of physical activity such as, aerobic or
      resistant exercise required to reduce liver fat content remains unclear.The purpose of this
      study is to determine whether aerobic exercise should provide improvement of hepatic fat
      content and inflammation as well as metabolic profiles and anthropometric parameters better
      than resistant exercise.
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): 12 weeks of aerobic or resistant exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aminotransferase; Fibrosis, liver; Anthropometry; Exercise
Cardiac Outcome Measures in Children With Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Limb Girdle Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Dystrophies, Limb-Girdle
Study type: Observational

Summary: 
      The purpose of the research study is to evaluate different cardiac measures that are obtained
      by echocardiographic tests in patients with muscular dystrophy.
    

Detailed description: 
      The research study will include 50 participants aged 8 to 18 years old (before 18th birthday)
      with Duchenne, Becker, or autosomal recessive limb-girdle (specifically: LGMD 2C-2F and 2I)
      muscular dystrophies.

      Participants will be seen in one of five Cooperative International Neuromuscular Research
      Group (CINRG) centers located in the United States.

      All study assessments will be completed in the same day and include reviewing past medical
      and surgical history, collecting vital signs, collecting cardiac measures through
      echocardiographic tests.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        8 to 18 years old Confirmed diagnosis of Duchenne, Becker, or autosomal recessive
        limb-girdle muscular dystrophy (LGMD: 2C-2F and 2I)
      
Biospecimen description: 
      Prospective collection of blood sample for BNP measurements.
    
Keywords: Cardiac; Muscular Dystrophy; Prospective; Pediatric; Echocardiogram
Midfacial Product Selection
Condition: Facial Volume Loss
MeSH terms: Facies
Study type: Interventional
Phase: Phase 4

Summary: 
      This study seeks to determine whether patients pursuing injectable treatments for facial
      volume loss and/or contour deficiency can be separated into strata based on characteristics
      such as skin envelope and subcutaneous tissue quantity in the zygomatic, submalar and
      anteromedial cheek regions in order to guide the clinician in making the ideal product choice
      (i.e., Restylane Volyme vs Lyft)?
    

Detailed description: 
      With age, loss of facial fat and hollowing of the cheeks can result in a "sinking" appearance
      in the mid-face. Augmentation and contouring of the area can be corrected using dermal
      fillers such as Restylane.

      Currently, product choice and amount of volume used for injectable procedures varies between
      physicians as there is no standard for treatment. Individual assessment based on the
      attending physician's preference and experience determines final product selection and
      technique. An algorithm is needed to standardize best practices between physicians and
      clinics and to better regulate the use of dermal fillers in facial plastic surgery.

      Therefore, the purpose of this study is to is to develop an algorithm to decide on which
      product (i.e., Restylane Volyme or Lyft) to use in the cheek area based on subject
      characteristics such as age, skin quality, subcutaneous fat quantity and positioning, and
      bony structure.
    

Intervention name(s): Restylane Lyft; Restylane Volyme
Intervention type(s): Device; Device
Intervention description(s): Restylane® Lyft is a sterile gel of hyaluronic acid with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation. It is recommended that the product be used for shaping the contours of the face and the correction of folds using the co-packed needles. Given the very high lift capacity of Lyft, it is often used when the skin envelope is normal or thicker than normal, as the contours of the product may be palpable in the presence of thin skin.; Restylane® Volyme is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, and homogeneous soft hyaluronic acid gel with a high lifting capacity. Volyme is intended for injection into the supraperiostic zone or subcutis to augment the volume of the cheeks.
Given Volyme's viscoelastic and lifting capacities, it is best used when there is significant loss of volume and a thin skin envelope.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Preliminary Outcomes of Sacral Neuromodulation Applications; Tertiary-Center Experience in Turkey
Condition: Sacral Neuromodulation
Study type: Observational [Patient Registry]

Summary: 
      to report our patients' outcomes of SNM in tertiary health centres in Turkey
    

Detailed description: 
      We retrospectively analyzed 18 patients who underwent SNM for urinary or bowel dysfunction
      between 2017 and 2022 in our clinic. We excluded 2 patients due to non-effective responses
      after the test period. After local ethics committee approval was obtained from our institute
      (Number and date: 21-12.1T/14). Patient characteristics and demographic data including age,
      gender, indications to the SNM, age at diagnosis, and comorbidities were collected from our
      Hospital patients' record system. Urinary functions were evaluated by the ICIQ-SF
      questionnaire form. Patients' diagnosis, implantation duration, complications, and
      improvement of symptoms were recorded.
    

Intervention name(s): sacral neuromodulation
Intervention type(s): Device
Intervention description(s): sacra neuromodulator implantation outcomes
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with urinary or faecal incontinence and interstitial cystitis who are
        unresponsible for medical therapy between the age of 18-85.
      
Keywords: Sacral neuromodulation; Overactive bladder; Urinary incontinence; Fecal incontinence; Lower urinary tract dysfunction
Analysis of Incidence and Risk Factors of Severe Cardiovascular Events in Patients With Diastolic Dysfunction
Condition: Diastolic Dysfunction
Study type: Observational

Summary: 
      This retrospective cohort study was intended to analyze the incidence and risk factors of
      perioperative severe cardiovascular events in patients with diastolic dysfunction.
    

Detailed description: 
      The investigators retrospected patients underwent noncardiac surgery with pre-operative
      echocardiography and was diagnosed with diastolic dysfunction in 2015 in Peking University
      First Hospital. Patients' perioperative data were collected. Major adverse cardiovascular
      events(MACE), other complication incidence, and post-operative hospital stay were reviewed.
      propotional harzad ratio cox survival model was established. Risk and protective factors
      relative to MACE were analysed.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with diastolic dysfunction
      
Keywords: non-cardiac surgery; major adverse cardiac event
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, single-center study will be conducted in an open-label, randomized, parallel
      design. Healthy male and female participants aged 18 to 65 years will receive a single dose
      of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an
      autoinjector (AI). Itepekimab will be administered by a trained healthcare professional
      (HCP).

      Female and male participants will have a body weight between 50.0 and 100.0 kg and body mass
      index (BMI) >18.5 and ≤30 kg/m2.

      Participants who satisfy the inclusion criteria will be randomized to one of the 2 study
      intervention groups:

        -  Itepekimab administered via AI (test)

        -  Itepekimab administered via PFS (reference) The randomization will be stratified by
           weight category (<70 kg, ≥70 to <80 kg and ≥80 kg) and injection site (abdomen, thigh,
           and arm).

      Study duration for each participant is up to approximately 162 days, including:

        -  Screening period: up to 21 days

        -  Institutionalization: 2 days including 1 treatment day (Day 1)

        -  Follow-up period: 140 days (±5 days)

        -  End of study (EOS): Day 141 (± 5 days)
    


Intervention name(s): Itepekimab AI; Itepekimab PFS
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous AI; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous PFS
Other intervention name(s): SAR440340; SAR440340
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
THE EFFECT OF ACUPUNCTURE ON THE BLOOD LACTIC ACID LEVELS
Condition: Post-exercise Sport Students
Study type: Interventional

Summary: 
      Background: In sports, recovery after exercise is a very important process for athletes.
      Several studies have shown that the rate of disease associated with athlete's recovery can be
      increased by several modalities, one of which is acupuncture.

      Objectives: The purpose of this study was to see how the effect of press tack needle
      acupuncture in reducing blood lactic acid levels after exercise in sports students.

      Methods: The study design was a randomized controlled clinical trial. Twenty-four sport
      students were divided into two groups: the acupuncture group (n = 12) and the normal group (n
      = 12). Press tack needle was attached on PC6 Neiguan and ST36 Zusanli 30 minutes before doing
      high-intensity exercise. Measurement of lactic acid levels was carried out at 5 minutes and
      30 minutes after exercise.
    


Intervention name(s): Press tack needle acupuncture
Intervention type(s): Device
Intervention description(s): Pyonex press tack needle sized 0.20x1.2mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; lactic acid levels; post-exercise recovery; press tack needle