bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Neck Pain in Adults With a Back School-Based Intervention.
Condition: Neck Pain; Exercise Therapy; Health Education; Primary Prevention
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The study consists of a theoretical and practical intervention based on the Back School. This
      intervention will be carried out over 8 weeks with a frequency of two sessions per week, for
      a total of 16 sessions of 45 minutes duration. Of all the sessions, 14 had a practical focus
      (strength and stretching exercises) and the other two had a theoretical focus
      (self-management techniques and pain neuroscience education).

      The clinical practice guidelines highlight the importance of neck pain prevention through
      exercise an education. There are previous studies of the effects of theoretical and practical
      programmes based on back school on the lumbar region but not on the cervical
      region.Therefore, the main aim of this innovative study is to to investigate the effects of a
      Back School based intervention on the prevention of neck pain and as secondary objectives to
      investigate the effects on neck flexor and extensor strength as well as scapular stability.
      The hypothesis is that this BS-based intervention would have positive effects on neck pain
      prevention, neck strength and scapular stability.
    


Intervention name(s): Back School
Intervention type(s): Behavioral
Intervention description(s): Intervention was carried out for 8 weeks with a frequency of two sessions per week, with a total of 16 sessions lasting 45 min. Of all the sessions, 14 had a practical focus and the other two had a theoretical focus. In the practical part, strengthening and stretching exercises were performed. In the theoretical part, self-management and pain neuroscience education were performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
Condition: Cis-Platinum Nephropathy; Mannitol Adverse Reaction
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study include cancer patients who had received chemotherapy that include cisplatin.
      Patients were randomly assigned to either a mannitol 20 g intravenous single dose after
      cisplatin or a placebo (saline). The primary outcome was to compare acute kidney injury
      (AKI), which was defined as increase creatinine 0.3 mg/dl in 48 hours by KDIGO criteria using
      serum creatinine and 24 hour urine creatinine to calculated.
    


Intervention name(s): Mannitol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin; 0.9% normal saline 100 ml
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
Condition: Trophic Ulcers; Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency; Leg Ulcer; Ulcer
Study type: Interventional

Summary: 
      The aim of this study was to evaluate comparatively the efficiency of traditional treatment
      methods in patients with chronic venous diseases of C6 class, and a new combined low level
      laser therapy (LLLT) by LASMIK device.

      The results of outpatient examination and treatment of patients with venous trophic ulcers,
      observed in the City Polyclinic of "Tula Municipal Clinical Hospital №2" were analyzed.
    

Detailed description: 
      During a longitudinal study, a group of patients was followed up in the period of complete or
      partial recovery. International classification of lower extremity chronic venous disorders
      СЕАР was used as a clinical classification of chronic venous insufficiency (CVI).

      Depending on the applied treatment method, patients were divided into 2 groups:

        1. (n=34) Conventional treatment

        2. (n=34) Conventional treatment + combined LLLT, including external exposure with 635nm
           wavelength + intravenous laser blood illumination (ILBI) with 365-405nm (UV-spectrum)
           and 520-525nm (green spectrum) wavelength alternately, according to the special scheme
    

Intervention name(s): LASMIK; Conventional therapy
Intervention type(s): Device; Other
Intervention description(s): the physiotherapeutic device LASMIK (Registration Certificate in Russia № RZN 2015/2687 dated 25.05.2015).; An elastic compression of lower extremities,
Pharmacotherapy,
Topical treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency
Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to determine the recovery time of moderate neuromuscular blockade
      with sugammadex in adults pretreated with magnesium sulfate.
    

Detailed description: 
      Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the
      encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role
      of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma,
      antinociceptive action and neuroprotective effects. However, its use is limited because
      magnesium potentiates non-depolarizing neuromuscular blocking agents.

      Primary outcome: evaluate the effect of pretreatment with magnesium sulfate on the time
      reversal with sugammadex (recovery of the T4/T1 ratio = 0.9) of moderate neuromuscular
      blockade (two answers to a train-of-four TOF) induced by rocuronium.

      Secondary outcome: evaluate severe respiratory events, the incidence of residual
      neuromuscular blockade in the post anesthesia recovery room and postoperative pain.
    

Intervention name(s): Magnesium Sulfate; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Magnesium sulfate + rocuronium + sugammadex; Saline + rocuronium + sugammadex
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physiological Effects of Drugs; Rocuronium; Sugammadex sodium; Magnesium; Molecular Mechanisms of Pharmacological Action; Neuromuscular block, antagonism; Pharmacologic Actions
Microalbuminuria in Children With and Without Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of the study is to learn more about Microalbuminuria in children with and without
      diabetes. Albumin is a protein that may be excreted in the urine. In some conditions, like
      kidney problems or diabetes, the amount of albumin in the urine increases. The purpose of
      this study is to measure concentration of albumin in the urine of diabetic children and
      compare to healthy children.
    

Detailed description: 
      Diabetic nephropathy is a known cause of significant morbidity and mortality in adult
      patients with diabetes. Microalbuminuria (MA) is predictive of future diabetic nephropathy
      (DN) in adult patients with diabetes mellitus (DM). This link between MA levels and DN allows
      patients to receive timely interventions. The predictive value of MA for DN in children with
      DM, however, is not well established. Most studies looking at this association in children
      have only been forced to use adult MA values. Children, particularly adolescents, are known
      to have different normal values for 24-hour total protein excretion compared to adults and it
      may be that they also have different normal levels of MA. Little literature exists on normal
      levels of 24 hr MA in healthy children and in children with diabetes.

      In this study, we seek to define the range of MA levels that falls between the 2.5 and 97.5
      percentiles for children with and without DM. Once these values are established, we will have
      a foundation for further studies to define which, if any, MA values are predictive of DN in
      children. If we can establish a MA level which is predictive of DN in children, it will allow
      physicians to direct medical intervention at those most likely to benefit while protecting
      others from unnecessary medications, procedures, and risks.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care/specialty clinincs and community
Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it
      has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute
      inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an
      internal control for the study.
    

Detailed description: 
      Proof of Mechanism
    

Intervention name(s): PF-03715455; PH-797804; Placebo for PF-03715455; Placebo for PH-797804
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20mg, Inhaled, single dose; 30mg, Oral, single dose; Single dose, inhaled, Placebo for PF-03715455; Single Dose, Oral, Placebo for PH-797804
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy
Biomakers in Tissue Samples From Patients With Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck Previously Treated With Cisplatin With or Without Cetuximab
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

      PURPOSE: This research study is studying biomarkers in tissue samples from patients with
      recurrent and/or metastatic squamous cell cancer of the head and neck previously treated with
      cisplatin with or without cetuximab.
    

Detailed description: 
      OBJECTIVES:

        -  To investigate the association between ERCC1 expression and clinical outcomes (response
           rate, progression-free survival, and overall survival) in patients with recurrent and/or
           metastatic squamous cell carcinoma of the head and neck who received cisplatin with
           versus without cetuximab on clinical trial ECOG-E5397.

      OUTLINE: Archived tumor tissue samples are analyzed for ERCC1 expression by IHC. ERCC1 levels
      (low or high) are assessed by an H-score and AQUA, a quantitative IHC analysis. Each
      patient's ERCC1 level result is then compared with the patient's clinical outcome.
    

Intervention name(s): immunohistochemistry staining method; laboratory biomarker analysis; medical chart review
Intervention type(s): Other; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E5397 from whom samples were submitted for research
      
Keywords: recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent verrucous carcinoma of the larynx; recurrent verrucous carcinoma of the oral cavity; stage IV verrucous carcinoma of the larynx; stage IV verrucous carcinoma of the oral cavity; recurrent salivary gland cancer; salivary gland squamous cell carcinoma
A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings
Condition: Male Circumcision; HIV Prevention; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the
      safety and efficacy of the circumcision device for applying it to the national scale up of
      adult male circumcision in Rwanda
    

Detailed description: 
      Multiple randomized and controlled studies (WHO, USAID, UNAIDS) have proven that circumcised
      men in high risk areas reduce their risk of HIV infection by 60%.

      The Government of Rwanda has ranked HIV prevention as a top priority item, and wishes to
      decrease the HIV incidence in the country by 50%. As part of a holistic HIV prevention
      approach, we decided to embark upon a process of national scale up of adult male
      circumcision. The national HIV prevention plan calls for voluntary MC of 2 million adults by
      the end of 2012.

      The PrePex System was designed to enable safe, effective, painless and bloodless male
      circumcision programs, to support global public health efforts to stop the spread of HIV.

      The PrePex System includes a simple, disposable device that is easy to use and can be
      deployed by minimally trained healthcare professionals, in urban or rural settings, without
      the need for sterile, hospital settings. As such, The PrePex System places minimal burden on
      the existing health care infrastructure to accomplish national circumcision programs.

      The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the
      safety and efficacy of the circumcision device for applying it to the national scale up of
      adult male circumcision in Rwanda.
    

Intervention name(s): The PrePex a novel device for adult male circumcision
Intervention type(s): Device
Intervention description(s): The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs. The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, without the need for sterile, hospital settings.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: male circumcision; HIV; Rwanda; HIV Seronegativity
Evaluation of Sun Protection Education for Kidney Transplant Recipients
Condition: Unspecified Complications of Kidney Transplant; Disorder Related to Renal Transplantation
Study type: Interventional

Summary: 
      This study is being done to evaluate the effectiveness of a Sun Protection Strategies
      workbook for kidney transplant recipients. Since the medication taken to preserve the kidney
      transplant puts kidney transplant recipients at an increased risk of developing skin cancer.
      The program will help people learn about how to practice effective sun protection after the
      transplant.
    

Detailed description: 
      Cognitive interview about the Sun Protection Strategies workbook will be performed with up to
      25 kidney transplant recipients (KTR) who have participated in past surveys. A second phase
      of the study involves 156 KTRs that will be asked to take part in a randomized controlled
      trial evaluating the fully developed sun protective strategies workbook.

      Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun
      protection after transplantation can reduce the risk of developing skin cancer. In 2006, the
      National Kidney Foundation (NKF) found that sun protection education delivery and content
      varied among transplantation centers. Clinicians rarely knew when to initiate education about
      skin cancer risks and prevention including timing and scope, and rarely demonstrated
      understanding of the importance of reminders for and repeated education of patients (National
      Kidney Foundation 2006).

      Aims:

        1. To explore culturally sensitive use of terms describing ethnic cultural perceptions of
           sun burning, pigment darkening after sun exposure and description of skin color by the
           amount of photo-protective pigment in the skin.

        2. To pilot test the sun protection workbook with English speaking KTRs representing the 3
           ethnic groups: White, Black and Hispanic.

        3. To assess the effectiveness of an education intervention encouraging the use of sun
           protection strategies.

        4. To explore understanding of the importance of sun protection and the KTRs confidence in
           their being able to practice sun protection.
    

Intervention name(s): Workbook
Intervention type(s): Behavioral
Intervention description(s): Subjects will read a workbook about sun protection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Kidney transplant; Renal transplant; Sun protection; Skin cancer
Exeantide in Type 2 Diabetes on Insulin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Exenatide has been shown to result in better glycemic control in type II diabetes patients.
      Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to
      decreased inflammation by virtue of better glycemic control and weight loss.

      The purpose of this study is to determine if the addition of Exenatide to diabetic patients
      will reduce the requirements of insulin particularly the short acting insulin. Exenatide may
      also lead to decreased inflammation by virtue of better glycemic control and weight loss, or
      an independent effect.
    


Intervention name(s): exenatide 5 mcg; exenatide 10 mcg; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): exenatide 5 mcg; exenatide 10 mcg; saline sq
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: type 2 diabetes; obesity
Functional Capacity of Exercise and Lung Function in Patients Submitted Early Rehabilitation
Condition: Funnel Chest
MeSH terms: Funnel Chest
Study type: Interventional

Summary: 
      The aim of this study was to compare the functional capacity of exercise by six-minute walk
      test and lung function by spirometry, before and after Nuss procedure in subjects who have
      undergone the early rehabiliation program with those who were under conventional care.
      Researchers want to find out if early rehabilitation is a strategy to enhance recovery after
      Nuss procedure.
    

Detailed description: 
      The replacement of some traditional approaches in surgical care has demonstrated that
      surgical recovery can be accelerated and convalescence decreased. These multimodal approaches
      focuses on enhancing recovery and reducing morbidity by reduction of surgical stress,minimal
      invasive surgery, optimized pain relief, early nutrition and ambulation.

      In postoperative, the bed rest leads to the increase in muscle loss and weakness, impairs
      pulmonary function, predisposes to venous stasis and thromboembolism, increases infection
      complications and reduces functional capacity even in patients who are not restricted to bed.

      However, few studies have focused on when start the mobilization and which effects on
      functional capacity of exercise and lung function during hospital stay.

      In this trial the investigators will consider early rehabilitation to be safe and feasible in
      Nuss procedure.
    

Intervention name(s): Early rehabilitation
Intervention type(s): Other
Intervention description(s): The physical exercises and breathing exercises are started as soon as after the Nuss procedure
Other intervention name(s): Physical exercises and breathing exercises after surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Nuss procedure; postoperative care; early ambulation
The BSHAPE Intervention Program for Safety and Health of Survivors of Cumulative Trauma
Condition: Violence; Cumulative Trauma; HIV Risk; Stress; Mental Health; Reproductive Health; Empowerment
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The goal of the BSHAPE study is to test a trauma informed, culturally tailored,
      multicomponent program entitled BSHAPE (Being Safe, Healthy, And Positively Empowered) for
      immigrant survivors of cumulative trauma.
    

Detailed description: 
      The central hypothesis is that the BSHAPE intervention will promote immigrant women's safety
      and health (e.g..,improved mental health, reduced physiological impact of stress and health
      inequities (especially reproductive-sexual health and HIV)), thus leading to overall
      empowerment.

      The study will:

        1. Conduct a feasibility and acceptability evaluation of the BSHAPE intervention.

        2. Test the BSHAPE intervention for large scale implementation in community-based clinics
           and programs serving immigrant women.

      The impact of BSHAPE will be evaluated in comparison to usual care in promoting safety and
      health outcomes among immigrant women with cumulative trauma experiences at post-intervention
      and at 6 and 12 months follow up.
    

Intervention name(s): The BSHAPE Intervention
Intervention type(s): Behavioral
Intervention description(s): The BSHAPE intervention program key elements include strengths based assessments, individualized plans and support based on priorities and needs, motivational interviewing strategies, psychoeducation (education with skill building exercises), mindfulness activities, danger assessment, safety planning, behavioral activation and linkage to community resources
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other