bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery
Condition: Erector Spinae Plane Block; Pain Control; Post-Operative Pain, Chronic
MeSH terms: Pain, Postoperative; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Interfascial plane blocks have been developed for analgesia, among which the erector spinae
      plane (ESP) has gained popularity. The ESP block has been hypothesized to provide truncal
      analgesia by spread of local anesthetic into the paravertebral space. Recent studies have
      contested this idea showing unreliability in the spread of the local anesthetic into the
      paravertebral space.
    

Detailed description: 
      Post-operative pain is a significant issue following open heart surgeries and poorly
      controlled pain can result in significant cardiorespiratory morbidity. Many patients suffer
      pain both at rest (49%) and on movement (62%) following open heart surgeries via sternotomy
      and adequate pain management requires closer re-assessment and treatment. The intensity of
      pain is noted to be higher in the first 48 hours post surgery and hence modalities to control
      pain may make the greatest difference in the first 2 days after surgery.

      Enhanced recovery pathways utilizing multimodal analgesia have shown significant analgesic
      and opioid sparing benefit while minimizing ICU and length of hospital stays. Some multimodal
      regimens have also incorporated regional blocks but the optimal analgesic regimen remains
      elusive. The ESP block has been hypothesized to provide truncal anesthesia by spread of local
      anesthetic into the paravertebral space, but recent studies contest this idea. Bilateral
      paravertebral blocks can result in higher than acceptable levels of local anesthetic in both
      cardiac and non-cardiac surgical patients and this may be true following bilateral erector
      spinae plane (ESP) as well. Hence, the pharmacokinetic profile of administered local
      anesthetics is necessary given the lack of information about the local anesthetic systemic
      levels following bilateral ESP.
    

Intervention name(s): Intravenous Administration of Lidocaine Post Cardiac Surgery; Administration of Lidocaine Post Cardiac Surgery via ESP Catheter
Intervention type(s): Drug; Drug
Intervention description(s): Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours; Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
Other intervention name(s): Pain control post cardiac surgery; Pain control post cardiac surgery
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound
Condition: Breast Diseases
MeSH terms: Breast Diseases
Study type: Interventional

Summary: 
      Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional
      handheld (HH) breast ultrasound (US) exam.
    

Detailed description: 
      This is a research study to test a FDA-approved automated breast ultrasound (ABVS) machine in
      subjects recommended for an ultrasound of the breast. The main purpose of the study is to
      compare images obtained from the automated breast ultrasound exam with the standard physician
      performed handheld breast ultrasound exam for lesion detection equivalence.

      Each subject will have a bilateral hand-held breast ultrasound and a bilateral automated
      breast ultrasound, both exams preferably done on the same day. The hand-held ultrasound will
      be performed by a breast imaging physician participating in the study and the automated
      ultrasound exam will be performed by a sonographer.

      There is no radiation risk from ultrasound. The physician performing the handheld breast
      ultrasound is blinded to the study, will not know the subject's history, but only the reason
      for the breast ultrasound exam.

      The automated scan requires gentle pressure on the breast during a scan. Three basic views
      will be acquired for each breast, each scan lasting approximately one minute. Once all
      necessary views are acquired, the images will be sent to a remote workstation, where a second
      radiologist, also blinded to the results of the handheld study, will interpret the automated
      ultrasound.

      Once all images and patient information are gathered, the study radiologists will review the
      previous images, if available, to provide the final result that will determine clinical
      management. Therefore, it is possible that the hand-held or automated ultrasound scan will
      lead to further evaluation of the breast and possibly a biopsy.
    

Intervention name(s): Supine automated breast ultrasound scanner; High-resolution handheld breast ultrasound
Intervention type(s): Device; Device
Intervention description(s): Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Percutaneous Microelectrolysis (MEP) Versus Ischemic Compression in Miofascial Trigger Points
Condition: Myofascial Trigger Point Pain
MeSH terms: Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The Percutaneous Microelectrolysis ® (MEP®) is a technique that employs a galvanic current up
      to 990 uA, which is applied percutaneously with an acupuncture needle connected to the
      cathode. Although it is used in tendinopathies, trigger points and muscle injuries, among
      other conditions, its bases are mostly empirical and there is lack of evidence.

      Ischemic compression is a manual therapy that is usually applied in muscle pain.

      Myofascial Pain Syndrome (MPS) usually presents painful myofascial trigger points (MTrPs).
      One methodology used to quantify the pain in MPS is the algometry, which measures the
      pressure pain threshold (PPT).

      The aim of this study was to compare the effects of MEP® with ischemic compression on MTrPs
      with algometry.
    


Intervention name(s): MEP; Ischemic compression
Intervention type(s): Device; Other
Intervention description(s): MEP® will be applied with an acupuncture needle (0,30 x 25 mm). The needle will be introduced perpendicularly to the MTrP with 100 uA and then increased up to 600 uA. The current will be paused if the patient feels a burning sensation, pain or oppression, waiting up to the patient feels no discomfort. The procedure will be repeated as many times is necessary until the patient do not feel any discomfort for more than 1 minute.; Ischemic compression will be applied perpendicularly to the MTrP, increasing gradually the pression until the patient refers the maximum tolerable pain. This pressure will be applied for 1 minute.
Other intervention name(s): Percutaneous microelectrolysis; Percutaneous galvanic microcurrent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: galvanic current; electrolysis; myofascial trigger point; percutaneous microelectrolysis; dry needling; ischemic compression
Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients
      with severe atopic dermatitis.
    


Intervention name(s): Prednisolone; Ciclosporine A
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclosporine; Prednisolone; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis; prednisolone; ciclosporine; SCORAD; DLQI; QALY; WLQ
Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and
      pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers,
      in fed and fasted states, in a single-dose crossover study.

      Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses
      of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple
      ascending-dose study with optional up-titration of dose level within cohort.
    


Intervention name(s): IW-1973; Matching Placebo Tablet
Intervention type(s): Drug; Drug
Intervention description(s): IW-1973 Tablet; Matching placebo tablet
Intervention MeSH terms: Praliciguat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PEP Breathing Versus Incentive Spirometry on Dyspnea and Sputum Profile in Bronchiolectasis Patients
Condition: Bronchiolectasis
MeSH terms: Dyspnea
Study type: Interventional

Summary: 
      Bronchiolectasis is the manifestation of chronic bronchitis characterized by saccular
      dilatation of the terminal bronchioles & bronchiectasis refers to abnormal dilatation of the
      bronchi. In bronchiolectasis more proximal bronchi may or may not show radiological changes.
      Airway dilatation can lead to failure of mucus clearance and increased risk of infection.
      Pathophysiological mechanism of bronchiectasis/bronchiolectasis include persistent bacterial
      infections, deregulated immune responses, impaired mucociliary clearance and airway
      obstruction. Treatment is directed at reducing the frequency of exacerbations, improving
      quality of life. Although no therapy is licensed for bronchiectasis by regulatory agencies,
      evidence supports the effectiveness of airway clearance techniques, antibiotics and mucolytic
      agents. Enhancing effective expectoration of stagnated bronchopulmonary secretions, usually
      with physiotherapy support, is key to management. There are different methods for delivering
      chest physiotherapy, such as the active cycle of breathing technique, postural drainage,
      (PEP) and oscillating PEP devices. The objective of the study is to compare the effects of
      PEP & Incentive spirometry techniques on bronchiolectasis patients.

      The study will be a randomized clinical trial. Total 24 subjects will be assigned randomly
      into two groups by using convenient sampling technique. Baseline treatment will be same
      (chest physiotherapy) in both groups. Group A will use PEP and Group B will use incentive
      spirometry technique for total 60 repetitions (15 repetitions 2 sets, two times per a day) 5
      sessions per week and total 4 weeks. Dyspnea severity index and cough & sputum assessment
      questionnaire (CASA-Q) would be used as an outcome measurement tools. Measurements will be
      taken at Baseline, and at the end of the 4 weeks treatment session. After assessing the
      normality, data will be analyzed by using parametric and non-parametric tests.
    


Intervention name(s): PEP (Positive Expiratory Pressure); IS (Incentive spirometry)
Intervention type(s): Other; Other
Intervention description(s): Group A containing 12 participants, will perform Positive expiratory pressure (PEP) technique for total 60 repetitions (15 repetitions 2 sets, twice) per a day (5 sessions/week and total 4 weeks).; Group B containing 12 participants, will perform Incentive spirometry technique for total 60 repetitions (15 repetitions 2 sets, twice) per a day (5 sessions/week and total 4 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bronchiolectasis; Dyspnea Severity Index; Incentive Spirometry; Positive Expiratory Pressure (PEP); Saccular Dilation
An Eight-Week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)
      in patients with depression.

      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to
      placebo in patients with depression.

      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy
      of saredutant on disability and quality of life in patients with depression, and to evaluate
      blood levels of saredutant.
    

Detailed description: 
      The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo
      and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a
      1-week, placebo, single-blind period and Segment B is an 8-week, double blind period.
      Patients completing Segment B may be eligible for enrollment into Segment C, a 44-week,
      double blind extension. All randomized patients must complete a post-study visit 1 week after
      intake of the last dose of study medication.
    

Intervention name(s): Saredutant succinate (SR48968C)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: depression; antidepressive agents; controlled clinical trial
Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care
Condition: ADHD
Study type: Interventional
Phase: Phase 4

Summary: 
      ADHD is the most prevalent mental health disorder of childhood. The majority of children with
      ADHD receive their care in primary care settings. While the American Academy of Pediatrics
      (AAP) issued evidence-based guidelines and recommendations for pediatricians, most
      pediatricians have difficulty adhering to these guidelines. Given observed deficiencies in
      evidence-based ADHD care and the likely effects on child outcomes, the development and
      testing of interventions aimed at improving ADHD care in primary care settings is necessary.
      Cincinnati Children's Hospital Medical Center has developed a model intervention, termed the
      ADHD Collaborative, to comprehensively address this issue. The ADHD Collaborative
      intervention model includes academic detailing, quality improvement methods, and innovative
      tools (e.g., web portal) designed to promote and support the systematic use of the AAP
      guidelines. This intervention model has been used to train over 200 physicians at 55
      practices in the Greater Cincinnati area. The intervention appears to produce 2- to 4-fold
      increases in the use of evidence-based ADHD-related practice behaviors in participating
      physicians. To date, the intervention has been implemented as a quality improvement project
      with few experimental controls. The primary goal of the proposed study is to conduct an
      experimentally-controlled cluster randomized trial of the ADHD Collaborative intervention.
      Thirty-two pediatric practices will be randomly assigned to receive the ADHD Collaborative
      intervention or to provide usual care. Approximately 96 physicians and 576 of their ADHD
      patients will be included in the study. Chart reviews, parental interviews, and parent and
      teacher rating scales will be collected. Between- and within-group hierarchical linear
      modeling analyses will examine whether the intervention produces significant improvements in
      pediatrician practice behaviors, patient satisfaction with ADHD care, and child outcomes over
      and above typical ADHD care. Also, the relative cost effectiveness of the ADHD Collaborative
      intervention over typical care will be established by computing incremental
      cost-effectiveness ratios using cost and effect size estimates.
    


Intervention name(s): ADHD Collaborative
Intervention type(s): Other
Intervention description(s): The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)
Condition: Childhood Obesity; Pediatric Obesity; Quality of Life; Cardiovascular Risk Factor
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The investigators propose a randomized controlled effectiveness trial to evaluate the
      integrated clinic-community model of child obesity treatment as compared with routine primary
      care.
    

Detailed description: 
      The purpose of this study is to evaluate how different types of physical activity and
      nutrition education and support (in addition to normal clinical care) affect children's
      health. The investigators will be looking at changes in child BMI, physical activity,
      nutrition, and overall health. The investigators also hope to better understand biological
      differences in metabolism and the microbiome (the bacteria that grows normally on and in the
      body) in children with high BMI who are making lifestyle changes.
    

Intervention name(s): Hearts & Parks
Intervention type(s): Behavioral
Intervention description(s): The Hearts & Parks intervention will be looking to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) through attendance and participation in the Duke Healthy Lifestyles/Bull City Fit clinic/community program, affect children's health. The investigators will be looking at changes in BMI, physical activity, nutrition and overall health.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The investigators will use a two-arm, randomized crossover controlled trial to compare routine primary care management of childhood obesity versus a novel clinic/family/community partnership program to treat childhood obesity. This design will allow for a randomized comparison of Group 1 (6-month standard control) to Group 2 (immediate 6-month intervention program) and to Group 3 (delayed crossover intervention on the standard control group). The design will also allow the investigators to observe intervention effects at 3 months in both intervention groups (Groups 2 and 3), and to track Group 2 for 6 additional months after active intervention to assess whether health benefits seen at 6 months were sustained to 12 months.
Masking: None (Open Label)
Primary purpose: Treatment
Footwear Minimalism Study
Condition: Healthy Runners
Study type: Interventional
Phase: Phase 2

Summary: 
      The following study proposes to investigate the injury risk associated with the use of a new
      category of running footwear: the minimalist shoe. A group of experienced adult male and
      female runners with neutral foot types will take part in this study. All participants will be
      randomized to receive one of three different shoes: a full minimalist shoe (Vibram
      5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive
      running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes
      to be investigated are pain, footwear perception, and number of injury events.

      The hypothesizes is that participants using the minimalist footwear during their running
      program will experience a reduction in running related pain. A greater degree of footwear
      minimalism will result in a greater reduction in pain (compared to the partial minimalist
      shoe, Nike Free).
    


Intervention name(s): Nike Pegasus; Nike Free 3.0; Vibram Five Fingers Shoe
Intervention type(s): Other; Other; Other
Intervention description(s): Conventional neutral supportive running footwear. Non minimalist.; Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility.; Full minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Running; Footwear; Injury incidence; injury risk; pain
Protein Requirements for Active Adolescent Males (IAAO-AM)
Condition: Healthy
Study type: Interventional

Summary: 
      Protein requirements in active individuals have been suggested to be greater than the current
      recommended dietary allowance (RDA).

      Nutritional requirements for dietary amino acids in adolescents have traditionally been
      determined utilizing the nitrogen balance technique, which is prone to underestimating
      protein requirements. As a result, there is a need to re-evaluate recommendations in order to
      characterize how dietary amino acid needs may be modulated by physical activity.

      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique
      have suggested that protein requirements in young men are at least 50% higher than the RDA
      based on nitrogen balance data.

      The purpose of this study is to measure the protein requirement in adolescent, males using
      the IAAO technique in the presence of a variable intensity exercise stimulus.
    


Intervention name(s): Amino Acid Intake
Intervention type(s): Dietary Supplement
Intervention description(s): Amino acid intakes will be varied at 0.2-2.67 g/kg/d
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Increased Metabolic Requirement
Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up?
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to clarify cost effectiveness and quality of life issues among
      colon cancer patients followed up in a hospital setting or by their GP's.Statement of study
      hypothesis:Postoperative follow up of colon cancer patients (according to national
      guidelines) by general practitioners will not have any influence on patients' quality of
      life. There will not be observed any increase in serious clinical events and cost
      effectiveness will be improved.
    


Intervention name(s): ca coli follow-up by GP
Intervention type(s): Other
Intervention description(s): patients randomized to follow up by GP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Colonic Neoplasms/surgery*; Continuity of Patient Care*; Follow-Up Studies; Quality of Life; Patient Satisfaction