bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI
Condition: Patients With Atherosclerotic Plaques in the Coronary Arteries That Require Excision
MeSH terms: Plaque, Atherosclerotic
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the safety and efficacy of intravascular
      high-pressure cut balloon catheter compared to cut balloon catheter during PCI, and to
      support product registration and clinical application.
    


Intervention name(s): PCI
Intervention type(s): Procedure
Intervention description(s): The subjects underwent immediate coronary angiography after Percutaneous transluminal coronary angioplasty to evaluate the success rate of instruments, and immediate coronary angiography after PCI to evaluate the success rate of clinical treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
Condition: Tonsillitis; Pain
MeSH terms: Tonsillitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Tonsillectomy is the most common pediatric surgical procedure performed in the US. The
      postoperative period can be particularly painful. Codeine (usually in mixed formulation with
      acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data
      questions its ability to provide optimal pain relief, while avoiding side effects, especially
      in the postoperative setting. Tramadol may be a better option for children in the
      postoperative setting due to its well-documented analgesic properties, low potential for side
      effects, and excellent safety profile. Seventy-two children scheduled to undergo
      tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate in
      a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of
      codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers will
      be asked to record daily information about their child's postoperative pain and other core
      outcomes and domains as recommended in the recent consensus statement put forth by the
      Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials
      (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the
      efficacy and side effects associated with tramadol as compared with codeine/acetaminophen
      (the current practice standard) in a pediatric population.

      Hypotheses

      H1: Children who receive scheduled tramadol following tonsillectomy will report better pain
      control than children who receive scheduled codeine/acetaminophen.

      H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side
      effects than children who receive scheduled codeine/acetaminophen.
    


Intervention name(s): Codeine with acetaminophen; Tramadol suspension
Intervention type(s): Drug; Drug
Intervention description(s): Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day); Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
Other intervention name(s): Capital® with Codeine Suspension; Acetaminophen and Codeine phosphate suspension; tramadol hydrochloride; Ultram
Intervention MeSH terms: Acetaminophen; Tramadol; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tonsillectomy; Pain; Pediatric; Opioids; Tramadol; Codeine
Assesment of Muscular Unloading in Chronic Obstructive Pulmonary Disease (COPD) Patients With NIV
Condition: COPD
Study type: Interventional

Summary: 
      Evaluation of high intensity NIMV in terms of physiological parameters has been performed in
      short-term studies in COPD patients. However, the support pressure levels used in exacerbated
      patients seem contradictory and the muscular unloading levels are uncertain. The objective of
      study is to determine the discharge level of the inspiratory musculature reached at the same
      pressure support (PS) values in a group of hospital and domiciliary ventilators. Patients
      with COPD in at least 6 months of treatment with home NIMV and in stable phase of their
      disease will be included. Eight commercial ventilators will be used, each patient will use 2
      different ventilators. A 5 minute record will be taken at baseline (without NIMV).
      Subsequently, 5 minutes in NIMV in 3 levels of PS (15/10/20) for each ventilator (15/10/20)
      and patient with expiratory positive airway pressure (EPAP) of 5 centimeters of water (cmH2O)
      will be recorded. The results will be compared between the different ventilators and PS
      values using a general linear model for repeated variables to determine the differences
      between ventilators and PS levels of respiratory muscular unloading in COPD patients
    


Intervention name(s): Basal record; PS 10 record; PS 15 record; PS 20 record
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.; PS 10 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record; PS 15 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record; PS 20 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Monitoring NIV, inspiratory muscular unloading, EMG
A Phase 3 Pharmacokinetic Study of TAK-536 (Azilsartan) in Pediatric Patients 6 to Less Than 16 Years With Hypertension
Condition: Pediatric Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of
      TAK-536 (azilsartan) in pediatric patients aged 6 to less than 16 years with hypertension.
    

Detailed description: 
      The drug being tested in this study is called azilsartan. Azilsartan was being tested to
      evaluate how it is processed by the body (pharmacokinetics). This study looked at lab results
      in pediatric participants who took azilsartan.

      The study enrolled 6 patients. Participants were assigned to study medication dose by body
      weight as follows:

        -  Body Weight <50 kg: azilsartan 5 mg

        -  Body Weight ≥50 kg: azilsartan 10 mg

      All participants took a single oral dose of azilsartan on Day 1 of the study.

      This multi-center trial was conducted in Japan. The overall time to participate in this study
      was 17 days. Participants made multiple visits to the clinic, and were contacted by telephone
      on Day 6 and Day 15 after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Azilsartan
Intervention type(s): Drug
Intervention description(s): Azilsartan tablets
Other intervention name(s): TAK-536
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Condition: Tendonitis
MeSH terms: Tendinopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II
      block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on
      postoperative pain control and opioid utilization in participants who undergo open
      subpectoral tenodesis.
    


Intervention name(s): Pecs II block; Surgical infiltration
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive an interscalene nerve block with 15 mL 0.5% bupivacaine + a Pecs II fascial plane block with 20 mL 0.25% bupivacaine; Patients will receive an interscalene nerve block with 20 mL 0.5% bupivacaine + local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Release of Cytokines by Stimulated Peripheral Blood Mononuclear Cells (PBMC) From Chronic Periodontitis Subjects
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Observational

Summary: 
      Background and Objective: It has been reported that peripheral blood mononuclear cells (PBMC)
      from periodontal patients have a different profile of cytokine release when compared to the
      ones of healthy patients. Cigarette smoking is a recognized risk factor for periodontitis and
      is known to affect the systemic and local immune responses. Thus, the aim of the present
      study was to obtain preliminary data about the interaction of periodontal condition and
      smoking in the secretion of some cytokines by PBMC.

      Material and Methods: PBMC samples were isolated from 19 donors, divided into generalized
      chronic periodontitis (P; n=10) and periodontal health (H; n=9) groups. In addition, the
      smokers and non-smokers of each group were separately evaluated: SP- smokers with severe
      generalized chronic periodontitis (n=5); SH- periodontally healthy smokers (n=5); NSP-
      non-smokers with severe generalized chronic periodontitis (n=5) and NSH- periodontally
      healthy non-smokers (n=4). Cells were incubated for 24-48 hours in 500 µL wells containing
      RPMI 1640 and stimulated with 1.0 ng/mL of E. coli LPS. Supernatants were used to quantify
      the amounts of TNF-α, IL-6, IL-8 and IL-10 released using ELISA kits.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy humans
      
Keywords: periodontitis; find cytokines in blood of periodontal patients
Dry Needling for Treating Spasticity in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the efficacy of dry needling (DN) in the treatment of
      spasticity in patients with multiple sclerosis (MS). [Participants and Methods] participants
      with MS, with no evidence of a relapse in the last four weeks and with an EDSS (Expanded
      Disability Sta- tus Scale) greater than 2.5 points (related with pyramidal score) were
      recruited. DN was performed in lower limbs for 12 consecutive sessions and evaluated with:
      EDSS (Pyramidal item), Time up and go (TUG), 25 foot, 9hold peg test (9HPT) and the
      improvement or not in the quality of life (MSQol54) was verified before and after treatment.
      A follow up visit was carried out to assess improvement.
    


Intervention name(s): Dry needling
Intervention type(s): Procedure
Intervention description(s): Only dry needling of the lower limbs will performed in all patients with acupunture needling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dry needling, multiple sclerosis, physiotherapy
The Effect of Progressive Relaxation and Breathing Exercise on Sleep Quality and Exercise Self-Efficacy in Patients With COPD
Condition: COPD Asthma
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Aim: This study was conducted to determine the effect of progressive muscle relaxation and
      breathing exercise on sleep quality and exercise self-efficacy in chronic obstructive
      pulmonary patients.

      Methods: This study was conducted as a randomized controlled experimental study. The study
      was conducted with 64 chronic obstructive pulmonary patients, where 36 of them were in the
      intervention group and 34 in the control group. Data of the study were collected using the
      descriptive information form, the Pittsburgh Sleep Quality Index, and the Exercise
      Self-Regulatory Efficacy Scale (Ex-SRES) for patients with COPD.

      Results: When the total scores pertaining to the sleep quality index and exercise
      self-efficacy of the individuals in the intervention and control groups were compared, it was
      found that there were statistically significant differences in the intervention group
      compared to the control group (p < 0.05).

      Keywords: Exercise Self-Regulatory Efficacy, sleep quality in patients with COPD, PGE along
      with breathing exercises, pulmonary rehabilitation
    


Intervention name(s): progressive muscle relaxation+breathe exercises; breathe exercises
Intervention type(s): Other; Other
Intervention description(s): progressive muscle relaxation+breathe exercises; breathe exercises
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Exercise Self-Regulatory Efficacy,; sleep quality; PGE with breathing exercises; pulmonary rehabilitation
A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Osteoarthritis (OA) is the most common joint disease affecting millions of people around the
      world, for which there is unfortunately no cure. Among existing therapies,
      viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an
      established place in the symptomatic treatment of knee OA.

      The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized in
      two phases. With results obtained in the first phase the best dose of JTA-004 is determined,
      and the efficacy of the selected dose will then be confirmed in the second phase.
    


Intervention name(s): JTA-004 intra-articular injection; Reference product intra-articular injection
Intervention type(s): Drug; Device
Intervention description(s): Each patient will undergo a single injection of JTA-004 into the knee joint; Each patient will undergo a single injection of Reference product into the knee joint
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: viscosupplement; osteoarthritis; knee; intra-articular injection; arthritis; degenerative
Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage
Condition: Brain Damage; Cerebral Palsy; Traumatic Brain Damage
MeSH terms: Cerebral Palsy; Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      This research centers on the comparison of the immediate efficacy (right after therapy) and
      the maintained efficacy (3 months and 6 months) between "Modified Constraint-Induced Movement
      Therapy" (mCIMT) group and control group at different age.
    

Detailed description: 
      "Modified Constraint-Induced Movement Therapy" is one of the most recent treatments for
      children with Brain damage.

      This well-designed and follow-up RCT study compared home-based CIT with a control
      intervention (traditional rehabilitation, TR) by combining kinematic analysis and clinical
      evaluation, which is possible to examine whether functional improvement is accompanied by a
      change in motor control. We hypothesized that home-based CIT would induce better motor
      control strategies (shorter RT, MT, lesser MUs, MGA, and PMGA, and larger peak velocity (PV))
      for greater functional gains than TR. Furthermore, the beneficial effects would be maintained
      at 3 and 6 months of follow-up. Findings of this study allow clinicians to understand the
      underlying motor control changes for functional improvement after home-based CIT.
    

Intervention name(s): Modified Constraint-induced Movement Therapy
Intervention type(s): Behavioral
Intervention description(s): Home based CIT
Restriction of the less affected limb
Intensive practice using affected limb
Positive experience
Functional task (task)
Other intervention name(s): Constraint-Induced Therapy; Forced-use Therapy; Immobilization Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: brain damage; constraint induced movement therapy; kinematic; function; outcome; Quality of life
Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia (Allena-Mente).
Condition: Mild Cognitive Impairment; Healthy Subjects With Family History for Dementia
MeSH terms: Dementia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The Allena-Mente study is a randomized, controlled, single-blind trial assessing the efficacy
      of cognitive stimulation (CS) compared to an active control group, participating to sanitary
      education lessons (AC). This non-pharmacological intervention is delivered to Mild Cognitive
      Impairment (MCI) and cognitively healthy individuals with first-degree relative with dementia
      (NDFAM).
    

Detailed description: 
      The experimental protocol was set up with a pilot study on healthy elderly individuals. Data
      from this pilot study will be excluded from the statistical analysis.

      Sample size: a priori power analysis was performed to evaluate the sample size required for
      the study. MCI and NDFAM were considered separately for sample size calculation. For power
      calculation a two-tailed test was used and a significance level (α) and test power (1-β) were
      set at 0.05 and 0.8/0.9, respectively.

      Randomization: The individuals belonging to MCI and NDFAM subgroup were randomly assigned to
      CS or AC group. The randomization was performed by a statistician blind to participants
      characteristics using the Random Allocation Software. Allocation ratio was set at 1:1,
      stratification was performed for birth cohort (≤1937 and ≥1938), education level (years of
      education ≤5 years and >5 years).

      Participants provided written informed consent before study participation.
    

Intervention name(s): Cognitive stimulation; Sanitary education
Intervention type(s): Other; Other
Intervention description(s): Participants are pooled in small groups (6-8 individuals). Each group participates to ten twice weekly meetings. Each CS session is run by one trained operator. One observer participates to the sessions to guarantee homogeneity between different operators. Exercises are structured with an increasing cognitive complexity and are tailored to the characteristics of the group.
Meetings (each lasting about 2 hours) have a common structure:
body awakening (10 minutes)
cognitive stimulation (1 hour and a half) scheduled as follow:
temporospatial orientation
attentional abilities
one of the following cognitive areas: language, executive functions, verbal and visual memory (encoding, consolidation, retrieval); Participants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild Cognitive Impairment; Cognitive Stimulation; Aging; Elderly; Randomized Controlled Trial
Food Supplementation With Eufortyn Colesterolo Plus for LDL Modulation in Subjects With Polygenic Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups
      clinical study conducted in Italy.

      The objective of this study is to evaluate the effect of dietary supplementation of a
      combined supplement containing bergamot (Vazguard®) phytosomal polyphenolic fraction
      associated with standardized artichoke extract (Pycrinil®, Cynara cardunculus) and Cynara
      scolimus, associated with high coenzyme Q10 bioavailability (Q10 phytosome® Ubiqsome) and
      zinc, on the glycometabolic structure of subjects with suboptimal levels of LDL
      cholesterolemia compared with placebo.
    


Intervention name(s): Eufortyn Colesterolo Plus; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Food supplement combination containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara Cardunculus L) and Cynara scolimus, associated with high coenzyme Q10 bioavailability(Q10 phytosome® Ubiqsome) and zinc.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
Condition: Tooth Decay
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate

        1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal
           carious lesions on permanent teeth in children compared fluoride varnish alone

        2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride
           varnish
    

Detailed description: 
      Objectives: The purpose of this study is to evaluate

        1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal
           carious lesions on permanent teeth in children compared fluoride varnish alone

        2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride
           varnish

      Methods: 90 patients with early occlusal lesions (ICDAS-II:2-3) on permanent molars and
      pre-molars will be allocated in this randomized, controlled, single blinded study to one of
      the two test groups (Test1: Curodont™ Repair+Fluoride Varnish; Test2: Curodont
      Repair+Curodont Protect) or control (Fluoride Varnish) group.

      Lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries
      activity (Nyvad), clinical status (ICDAS-II) and with Diagnodent®. Visual Analog Scale (VAS)
      in addition to the Global Impression of Change Questionnaire will also be used for the
      evaluation of the outcome.
    

Intervention name(s): Fluoride Varnish; Curodont Repair; Curodont Protect
Intervention type(s): Device; Device; Device
Intervention description(s): Fluor Protector S (Ivoclar, 7'700 ppm F-); P11-4 (monomeric peptide) - for professional use; Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment