bioihbjkbjnl/mcl2 huggingface dataset:
Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain
Condition: Recurrent Low Back Pain
MeSH terms: Recurrence; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      1. Specific aim 1:Identify factors that influence muscle performance by use of ultrasound
           imaging.

           Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles.

        2. Specific aim 2. To compare the performance of trunk deep muscles (transversus abdominis
           and multifidus) and the sensation and pain thresholds of patients with recurrent low
           back pain with asymptomatic subjects.

           Hypothesis: patients with recurrent low back pain have:

           (A) less activation of the transversus abdominis and multifidus, (B) peripheral and
           central sensitization, with decreased sensation and pain thresholds in the lumbar and
           foot areas.

        3. Specific aim 3. To determine the performance of the transversus abdominis and
           multifidus, and the sensation and pain thresholds by use of ultrasound feedback training
           in asymptomatic adults, and to compare these results with the traditional training
           protocols for trunk stabilization.

           Hypothesis: Specific stabilization exercise using ultrasound feedback training is more
           effective in activating deep trunk muscles and increasing sensation and pain thresholds
           than the traditional stabilization training protocol in asymptomatic adults.

        4. Specific aim 4. To determine the performance of the transversus abdominis and
           multifidus, and the sensation and pain thresholds by using the ultrasound feedback
           training in adults with low back pain, and to compare these results with the traditional
           training protocols for trunk stabilization.

      Hypothesis: Specific stabilization exercise using ultrasound feedback training is more
      effective in activating deep trunk muscles and increasing sensation and pain thresholds than
      the traditional stabilization training protocol in adults with low back pain.
    


Intervention name(s): specific stabilization exercise
Intervention type(s): Other
Intervention description(s): The specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: specific stabilization exercise; ultrasound; low back pain
Physical Activity Level of Norwegian Boys With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      The aim of this population based study is to examine, quantify and describe physical activity
      level in Norwegian boys with DMD, and to compare the level of physical activity level between
      boys with DMD and age matched healthy boys. A co-project will validate ActiGraph
      accelerometry to measure physical activity in boys with DMD.
    

Detailed description: 
      International guidelines recommend regular physical activity for boys with DMD, and
      participation in physical activity plays a key role in the management. Paradoxically,
      patients with severe neuromuscular disease like DMD, have considerable limitations to
      participate in such activities. Limitation may be muscle weakness, pain, fatigue, reduced
      mobility and overall function, and also limited knowledge of physical activity benefits among
      health care personnel. Limited participation leads to a sedentary lifestyle, and gradual
      under-use of still functioning muscles may cause secondary deterioration in DMD.

      The current physical activity level amongst Norwegian DMD's are unknown, and physical
      activity registration and self-reported questionnaire will be examined in this study.
    

Intervention name(s): Physical activity registration
Intervention type(s): Behavioral
Intervention description(s): At start, participants and parents fills out a Self-report questionnaire and the UngKan-3 Questionnaire, before a seven day physical activity registration takes place by use og ActiGraph. A physical activity diary are filled out every evening while the physical activity registration takes places.
Other intervention name(s): Self-report Questionnaire; Physical activity diary; UngKan-3 Questionnaire
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Study population will be requited from all the Norwegian regional pediatric rehabilitation
        centre's out patient clinics. Verbal and written information about the study will be
        provided if inclution criteria to be met.
      
Keywords: Physical activity level
The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain
Condition: Acute Ankle Distortion
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis
      in the treatment of an acute ankle sprain. These treatments will be compared to a placebo
      group.
    

Detailed description: 
      Ankle sprain is the most occurring sport related injury. In spite of the high prevalence of
      this injury and the often residual symptoms, there is a large variety in diagnostic approach
      and therapeutic protocols. Concerning the treatment of an acute ankle sprain, it remains a
      challenge to minimize injury consequences on short and long term.

      In this study we investigate the immediate effect of two therapeutic techniques: fascia
      therapy and transcutaneous fibrolysis. They will be compared to a third group, who receives a
      placebo treatment. Muscle strength, muscle vascularisation, muscle tenderness and joint
      position sense are measured before and after treatment.

      The purpose of this study is to contribute to the knowledge of treating acute ankle sprains.
    

Intervention name(s): fascia therapy or transcutaneous fibrolysis
Intervention type(s): Other
Intervention description(s): fascia therapy or transcutaneous fibrolysis as treatment for an acute ankle distortion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fascia therapy; transcutaneous fibrolysis; acute ankle distortion
Comparing Different Ways of Delivering Humidity to Children With Croup
Condition: Croup
MeSH terms: Laryngitis; Croup
Study type: Interventional
Phase: Phase 2

Summary: 
      Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency
      Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered
      is humidification which can liquify airway secretions and decrease airway swelling. This
      study will compare the effectivenesss of 40% and 100% humidity through a specially designed
      machine called a nebulizer, with the usual humidity set-up (blown into the patient's face
      from a hose).
    


Intervention name(s): nebulized humidity
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: croup; humidity therapy; pediatrics
Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children
Condition: Acellular Pertussis; Diphtheria; Tetanus
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals'
      DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to
      24 months of age, in terms of safety and immunogenicity.
    


Intervention name(s): Infanrix™; Hiberix™
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, one dose; Intramuscular injection, one dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infanrix/Hib; Chinese children
Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors
Condition: Liver Tumor
MeSH terms: Liver Neoplasms
Study type: Interventional

Summary: 
      Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the
      periooperative setting. In order to facilitate tumor access, patient should collaborate with
      a surgeon during the procedurę, therefore should be conscious.

      This study aims to assess the impact of a single shot thoracic paravertebral block (TPVB) on
      a patient's haemodynamic stability, patient's and operator's comfort and satisfaction during
      the operation and analgesia in the post-operative period.
    

Detailed description: 
      High temperatures used during the percutaneus radiofrequency ablation (PRFA) of liver tumors
      can cause acute pain in the perioperative setting. In order to facilitate tumor exposure and
      access, patient should collaborate with a surgeon during the procedurę, therefore should be
      conscious. It is mandatory to provide an adequate acute postoperative pain control for our
      patients.

      This prospective randomized, single center study was approved by the Bioethics Committee at
      the University of Warmia and Mazury in Olsztyn, (Poland) under the resolution No. 46/2017.
    

Intervention name(s): thoracic paravertebral blockade; local anaesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Anesthesia was performed under the ultrasound guidance: the Th8 spinous process was identified, then a probe was moved lateral to medial until two adjacent transverse processes and the pleura were visible. After anaesthetising the skin with 2ml of 1% lignocaine (Lignocainum hydrochlorici, WZF 1%), the Touhy needle 22G (Smith Medical)was introduced under the real time guidance. Once in the paravertebral space, 20ml of 0,25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa Warsaw SA) was injected with an end point of a characteristic pleural displacement.; Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 patients scheduled for an elective Percutaneus Radiofrequency Ablation (PRFA) of a hepatocellular carcinoma were enrolled in the study. Patients were divided in 2 groups:
group PVB - 15 patients under paravertebral block anaesthesia
group BB - 15 patients under local anesthesia, without paravertebral block.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Paravertebral block; Anaesthesia; Analgesia; regional anaesthesia; pain; patient satisfaction; patient comfort; operator satisfaction
A Naturalistic Study of Adolescents and Young Adults in Treatment for Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      Many buprenorphine treatment programs do not have services dedicated to adolescents and young
      adults. As a precursor to developing and evaluating an adolescent and young adult
      buprenorphine treatment program at APT Foundation Inc, we propose to conduct a 1 year
      prospective study of 16 to 25 year old treatment-seeking individuals enrolled in the APT
      Adolescent and Young Adult Suboxone Program
    

Detailed description: 
      Participants will consent to in-person assessments and monthly chart reviews. We anticipate
      that the results from this study will inform the development of future services targeted
      towards adolescents and young adults with opioid dependence.
    

Intervention name(s): Naturalistic Prospective Cohort
Intervention type(s): Other
Intervention description(s): Follow subjects through 1 year of naturalistic buprenorphine treatment
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Fifty16 to 25 year old opioid treatment-seeking individuals enrolled in the APT Adolescent
        and Young Adult Suboxone Program.
European Study in Bone Sarcoma Patients Over 40 Years
Condition: Spindle Cell Sarcoma of Bone; Osteosarcoma
MeSH terms: Sarcoma; Osteosarcoma
Study type: Observational

Summary: 
      The study is a first step of a process to establish the standard chemotherapy treatment with
      the aim to improve outcome for patients with these rare tumours. For this reason the study
      will be non-controlled clinical trial.

      In this regard, the study aims to determine the feasibility of intensive chemotherapy in this
      age group, and/or separate efficacy analyses according to the different histologic categories
      and whether the number of patients recruited by the co-operating groups permits future
      randomised studies.
    

Detailed description: 
      Wide surgical removal of the tumor with the addition of a systemic treatment based on the
      antineoplastic drugs active against osteosarcoma (Adriamycin, Cisplatin, Ifosfamide,
      Methotrexate). The use of radiation therapy will be given to patients with unresectable
      tumors. It is recommended in patients who underwent inadequate surgical removal of the tumor.
      The addition of radiation therapy can not compensate for an adequate surgical treatment.

      All the patients eligible for the study will receive the planned systemic treatment.
      Depending on clinical features, and feasibility of adequate surgical removal of the tumor,
      patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment
      or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an
      adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).
    

Intervention name(s): Doxorubicin+cisplatin+ifosfamide; Doxorubicin+cisplatin+ifosfamide+methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Chemotherapy for Good responder high grade osteosarcoma; Chemotherapy for Poor responder high grade osteosarcoma
Other intervention name(s): Doxorubicin,cisplatin,ifosfamide; Doxorubicin,cisplatin,ifosfamide,methotrexate
Intervention MeSH terms: Cisplatin; Doxorubicin; Liposomal doxorubicin; Methotrexate; Ifosfamide; Isophosphamide mustard
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients older than 40 years with highly malignant spindle cell sarcoma of bone
Feasibility Study: Ulthera Treatment of the Buttocks and Thighs
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to
      one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90
      and 180 days post-treatment. Study images will be obtained pre-treatment, immediately
      post-treatment, and at each follow-up visit.
    

Detailed description: 
      This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the
      Ulthera® System to improve buttock and thigh skin laxity. Global Aesthetic Improvement Scale
      scores and patient satisfaction questionnaires will be obtained.
    

Intervention name(s): Ulthera System Treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin.
Other intervention name(s): Ultherapy™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
Condition: Dysfunction of the Prosthetic Conduct; Lesions of the Right Ventricular Outflow Tract
Study type: Interventional

Summary: 
      This prospective interventional study is designed to evaluate the cost/advantage ratio in the
      treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary
      valved stent (Melody).
    

Detailed description: 
      Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of
      the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent
      implantation and surgery of the RVOT remains unknown.

      Main objective : evaluate the cost of the procedure as compared with conventional technique.

      Design : multicenter intervention prospective study. Population : 180 patients in three arms
      (3*60).

      End point criteria :

        -  Primary : cost

        -  Secondary : rate of reoperation
    

Intervention name(s): Melody; bare stent; Surgery
Intervention type(s): Device; Device; Procedure
Intervention description(s): insertion of a pulmonic valved stent; insertion of a bare metal stent; conventional surgery methode
Other intervention name(s): insertion of a pulmonic valved stent; insertion of a bare metal stent; conventional surgery methode
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: right ventricular outflow tract; endovascular valve insertion; economic evaluation; valved stent
Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate
      extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and
      escitalopram at 2 months.
    


Intervention name(s): zolpidem tartrate
Intervention type(s): Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation
Condition: Insulin Resistance
MeSH terms: Insulin Resistance; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to study the effects of Vitamin D supplementation on the
      body's response to insulin (a hormone that controls blood sugar), on inflammation, and on
      specific cells and processes in fat tissue.
    

Detailed description: 
      Over the last several years, studies have shown that low vitamin D levels may increase risk
      of developing Type 2 Diabetes. The investigators will administer vitamin D3 (cholecalciferol)
      to non-diabetic, insulin resistant subjects with vitamin D deficiency (total vitamin D levels
      <20 ng/ml) to increase the level of vitamin D3. The investigators will study the effects of
      increased Vitamin D on insulin action, adipose tissue inflammation, and on certain cells and
      processes in fat tissue.

      Investigators will study participants with a procedure called a "pancreatic clamp" study.
      During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas
      that regulates the amount of glucose in the blood) are infused with an intravenous catheter,
      and blood samples are collected periodically throughout the procedure to measure blood sugar
      levels and the levels of several hormones that are found in the body and are related to
      glucose metabolism. Adipose tissue inflammation will be measured using the following
      inflammatory markers: IL-6, PAI-1, TNF-alpha, and iNOS.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Vitamin D3 (cholecalciferol)
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorders; Insulin Resistance; Endocrine System; Vitamin D
Comparison of Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position
Condition: Thoracic Epidural Injection
MeSH terms: Aortic Dissection; Pressure Ulcer
Study type: Interventional

Summary: 
      It is reported that the distribution of contrast medium had an obvious correlation with the
      extent of sensory analgesia after injection of LA. Our previous study showed that different
      posture (prone vs. lateral decubitus) resulted in different degree of contrast medium spread.
      We supposed that differences of epidural pressure between diverse postures might be one
      factor contributing those differences of epidurography.

      This study was designed to compare the epidural pressure and extent of spread of
      epidurography between prone and lateral decubitus position
    

Detailed description: 
      It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore,
      intraoperative or postoperative pain management using continuous thoracic epidural
      catheterization is suggested good option to prevent this potential complication.

      The spread of local anesthetics is influenced by various factors including volume, location
      of needle insertion, speed of injection, patient position, age, weight and height. However,
      there are few studies about the effect of different patient position affeting the epidural
      pressure and the extent of spread of contrast medium during thoracic epidural
      catheterization.

      Studies of lumbar epidural blockade have shown that lateral position can produce 0-3 segment
      more to the dependent position compared to the supine position. When the same amount of local
      anesthetic was injected in supine of sitting position, the most cephalad level of spread was
      indifferent. Recent studies showed that neck flexion demonstrated significant cephalad spread
      of contrast dye in high thoracic epidural blockade. The purpose of this study was to compare
      and evaluate the changes of epidural pressure with extent of spread of contrast medium
      between different posture
    

Intervention name(s): thoracic epidural catheterization
Intervention type(s): Procedure
Intervention description(s): thoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: epidurography epidural pressure patient posture