bioihbjkbjnl/mcl2 huggingface dataset:
External DCR Versus Canalicular SI With MMC in NLDO
Condition: Primary Acquired Nasolacrimal Duct Obstruction
MeSH terms: Lacrimal Duct Obstruction
Study type: Interventional

Summary: 
      While external DCR is the gold standard procedure for primary NLDO as well as complicated
      cases, SI with MMC could achieve comparable success rates in primary acquired NLDO, hence
      should be considered as an alternative as a safe and minimally invasive procedure.
    

Detailed description: 
      Purpose: To compare external dacryocystorhinostomy versus canalicular silicone intubation
      with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).

      Methods: the study was carried out at the department of Ophthalmology, Menoufia university
      Hospital, Egypt, between June 2012 to July 2014. Fifty-six patients who were diagnosed with
      primary acquired NLDO. Patients were randomly allocated into two groups: thirty cases
      underwent external DCR and twenty-six cases underwent silicone intubation with MMC.
    

Intervention name(s): external dacryocystorhinostomy; canalicular silicone intubation with MMC
Intervention type(s): Procedure; Procedure
Intervention description(s): external DCR under general anesthesia with standard sterilization procedures.; canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: External DCR, canalicular silicone intubation, Mitomycin C
Safety and Immunogenicity of Candidate HIV Vaccines Given Sequentially
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary object of the study is to assess the safety profile of candidate vaccines
      ChAdOx1.HTI and MVA.HTI administered sequentially in healthy HIV-1/2 negative adult
      volunteers.

      In addition, the study will assess the immune responses generated of the candidate vaccines
      ChAdOx1.HTI and MVA.HTI administered sequentially in healthy HIV-1/2 negative adult
      volunteers.

      10 healthy, HIV-negative adult volunteers will receive one vaccination of CHAdOx1.HTI
      followed by a one vaccination of MVA.HTI 8 weeks later.
    


Intervention name(s): ChAdOx1.HTI and MVA.HTI
Intervention type(s): Biological
Intervention description(s): ChAdOx1. HTI dose 5 x 10^10 vp MVA.HTI dose 2 x 10^8 pfu
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Pharmacokinetics of GEH200486 in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, prospective, dose escalation study (4 different dose levels) for a
      novel magnetic resonance imaging (MRI) contrast agent, in male and female healthy volunteers
      . The study is primarily designed to collect safety data. In addition, researchers want to
      learn more about how the novel contrast agent, GEH200486 circulates and is eliminated from
      the body (pharmacokinetics) after injection in healthy volunteers. Up to 24 healthy
      volunteers will be enrolled and will each receive a single administration of one of the 4
      doses of GEH200486. Each healthy volunteer will stay at the clinical unit for the first 24
      hours post injection and return for up to 3 follow-up visits with 1 additional follow-up
      phone call.

      Dose escalation from one dose group to the next dose group will be sequential and only be
      allowed if the clinical safety of all healthy volunteers from the tested dose group is
      acceptable, as assessed by an independent safety committee, members of GEHC team and the
      principal investigator.
    


Intervention name(s): GE200486 0.5M Injection
Intervention type(s): Drug
Intervention description(s): Single administration by intravenous (IV) hand injection without dilution, followed by a 5mL saline flush
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF)
Condition: Chronic Kidney Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The low-level laser therapy (LLLT) has been used in many inflammatory disorders. More
      recently the LLLT was associated with an improvement in the muscle strength and endurance.
      But, these effects were described only in health or athletic individuals. In this randomized
      and controlled clinical trails, the investigators will study the effects of LLLT on muscle
      strength of the patients with kidneys failure on long time hemodialysis treatment.
      Additionally, investigators will explore three different intensities up the muscle strength.
    

Detailed description: 
      This study will be conducing in a large hospital that is reference in kidneys disorders
      treatments. 16 patients will be randomized for placebo, 4J, 6J, or 8J low-level laser therapy
      (LLLT). The maximal voluntary contraction (MVC) will be test by handgrip test before and
      after de LLLT. One-week interval between the LLLT will gave to reduce the influence between
      the treatments. Moreover the endurance test will be use to evaluate the muscle oxidation
      impact of the LLLT.
    

Intervention name(s): 0J LLLT; 4J LLLT; 6J LLLT; 8J LLLT
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Sham Low-Level Laser Therapy (Sham LLLT): perform with the machine off.; 4J Low-Level Laser Therapy (4J LLLT) irradiation will be perform with 4J.; 6J Low-Level Laser Therapy (6J LLLT) irradiation will be perform with 6J.; 8J Low-Level Laser Therapy (8J LLLT) irradiation will be perform with 8J.
Other intervention name(s): Sham LLLT; 4J; 6J; 8J
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CoolSculpting of the Distal Thigh Study
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area
      applicator for non-invasive subcutaneous fat reduction in the distal thigh.
    

Detailed description: 
      This study will investigate the use of a Small Area Applicator with the CoolSculpting device
      for reducing subcutaneous fat in the distal thigh. The study will evaluate the safety and
      effectiveness of treatments.
    

Intervention name(s): The ZELTIQ System
Intervention type(s): Device
Intervention description(s): The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.
Other intervention name(s): CoolSculpting System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional

Summary: 
      This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow
      Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system
      using an endovascular, minimally invasive approach for the treatment of Critical Limb
      Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage
      procedures.
    


Intervention name(s): LimFlow Stent Graft System
Intervention type(s): Device
Intervention description(s): Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
Intervention model: Single Group Assignment
Intervention model description: Prospective, multi-center pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with
      ipilimumab with or without sargramostim may help doctors learn more about the effects of
      ipilimumab and sargramostim on cells. It may also help doctors understand how well patients
      respond to treatment.

      PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III
      melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.
    

Detailed description: 
      OBJECTIVES:

        -  To compare the pathology of primary melanomas, melanoma metastases, and post-treatment
           melanoma metastases in relation to clinical outcomes for patients receiving ipilimumab
           plus sargramostim (GM-CSF) and patients receiving ipilimumab alone.

        -  To determine the effects of the addition of systemic GM-CSF to ipilimumab on effector
           immune function in patients with metastatic melanoma.

        -  To determine the effects of the addition of systemic GM-CSF to ipilimumab on regulatory
           immune function in patients with metastatic melanoma.

        -  To determine the effects of the addition of systemic GM-CSF to ipilimumab on anti-tumor
           humoral immunity in patients with metastatic melanoma.

      OUTLINE: Serum, peripheral blood mononuclear cells, and tumor tissue (from primary tumor and
      post-treatment biopsies) samples are analyzed for biomarkers predictive of clinical outcomes,
      immune function, and anti-tumor humoral immunity by IHC, RT-PCR, flow cytometry, ELISPOT
      assays, and ELISA.
    

Intervention name(s): RNA analysis; in situ hybridization; polymerase chain reaction; enzyme-linked immunosorbent assay; flow cytometry; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Other; Other; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients who participated in E1608 and provided samples for research.
      
Keywords: stage IIIC melanoma; stage IV melanoma; recurrent melanoma
A Study Evaluating the Efficacy and Safety of HSK21542 Injection for Analgesia in Subjects Undergoing Colonoscopy
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, two-stage, phase II clinical study .The main objective is
      to evaluate the safety and tolerability of HSK21542 injection for analgesia in patients
      undergoing colonoscopy, and, combining the pharmacodynamic (PD) and pharmacokinetic (PK)
      characteristics
    


Intervention name(s): Stage I: HSK21542 0.5 μg/kg; Stage I: HSK21542 1 μg/kg; HSK21542 0.5 μg/kg; HSK21542 1 μg/kg; HSK21542 2 μg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): intravenous injection; intravenous injection; intravenous injection; intravenous injection; intravenous injection; intravenous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Training Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This study aims to conduct a single-blind randomized controlled trial with sixty children
      with Cerebral Palsy (CP) to explore if a home-based computerized multi-modal executive
      training is effective improving infants' executive functions (EF), as the primary outcome. As
      secondary outcomes, it will be tested if the intervention exerts a positive effect on other
      cognitive functions, social relationships, and quality of life (QOL) in children with CP. It
      is expected to observe changes in brain structure and functioning associated to clinical
      improvements.

      The primary hypothesis to be tested is that a computerized multi-modal cognitive training
      will be more effective at improving EF than usual care alone.

      Secondary hypotheses are that the computerized therapy will be more effective than usual care
      alone at improving specific cognitive functions such as visuoperception, memory, social
      relationships and QOL. In addition, we also hypothesize there will be changes on brain
      structure and function. We further hypothesise that these changes will be maintained over
      time (9 months). Finally, sociodemographic and clinical factors are expected to be related
      with the level of efficacy of the computerized multi-modal cognitive training.
    


Intervention name(s): Computerized Executive Functions training; Care as usual
Intervention type(s): Behavioral; Other
Intervention description(s): Home-based executive function training with adaptive difficulty, through NeuronUp (https://www.neuronup.com) over 12 weeks (30 min/day, 5 days per week, 30h in total).; Care as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Executive Functions; Cognitive Training; Computerized Therapy; Quality of Life; Neuroimaging; Participation
The Segmental Distribution of Hypersensitivity in Patients With Chronic Subacromial Pain Syndrome
Condition: Subacromial Pain Syndrome; Central Sensitisation
MeSH terms: Hypersensitivity; Syndrome; Somatoform Disorders
Study type: Observational [Patient Registry]

Summary: 
      This study aimed to determine the distribution of pain sensitivity according to body segments
      in patients with central sensitization associated with chronic subacromial pain syndrome
      (SPS).This cross-sectional study included patients with chronic SPS and central sensitization
      (patient group) and the same number of healthy participants as controls. The presence of
      central sensitization was determined using the Central Sensitization Inventory. To determine
      the segmental distribution of pain sensitivity, pressure pain threshold measurements were
      performed bilaterally from the shoulder, forearm, and leg.
    

Detailed description: 
      Shoulder pain is a common musculoskeletal pain condition in the general population, with a
      prevalence that has doubled in all age groups over the past 40 years, reaching 22%-30%.
      Despite treatment, at least 40% of patients report incomplete improvement in pain severity
      and duration of symptoms, which are the two main determinants of treatment response. There is
      convincing evidence that the persistence of pain in these patients is due to peripheral or
      central sensitization mechanisms. Central sensitization refers to pain hypersensitivity
      mainly resulting from amplifying central nervous system signals and reduced activity of
      central inhibitory pathways. The clinical presence of central sensitization is determined by
      examining specific pain characteristics or evaluating changes in pain threshold. The
      objective manifestation of central sensitization is a decreased pressure-pain threshold (PPT)
      (hypersensitivity). In previous studies using PPT measurement, pain sensitivity was detected
      in the shoulder and remote joints in patients with subacromial pain syndrome (SPS), which was
      considered as evidence of central sensitization. However, these studies did not show how pain
      sensitivity differs according to body segment in patients with SPS. Hypersensitivity that
      develops due to chronic shoulder pain would exacerbate the perception of pain caused by other
      musculoskeletal diseases or trauma. Therefore, it may be important for clinicians to
      determine how pain sensitivity varies by body segment in patients with SPS
    

Intervention name(s): Assessment of hypersensitivity
Intervention type(s): Diagnostic Test
Intervention description(s): Assessment of pain hypersensitivity in body segments was performed using pressure pain measurement
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Physical medicine and rehabilitation clinic
      
Keywords: shoulder pain; hypersensitivity; pressure pain threshold
A Food Effects Study and Optional Multi Dose Study to Assess PK of BTD-001
Condition: Food Effect; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating
      females. The study will consist of up to 2 parts; the decision to proceed to the optional
      second part will be made following review of Part 1 data.

      Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001.

      Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK
      profile of BTD-001
    


Intervention name(s): BTD-001
Intervention type(s): Drug
Intervention description(s): BTD-001 in fed vs fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food Effect; Pharmacokinetics
A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study is to demonstrate bioequivalence (comparable safety and
      efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic
      rhinitis.
    


Intervention name(s): Mometasone furoate; Nasonex Nasal Spray; Placebo nasal spray
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
AKI Management Using Electronic Alerts
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      Acute kidney injury (AKI) is a common clinical event with severe consequences. In the United
      States alone, greater than one million hospitalized patients per year are diagnosed with AKI.
      It has been independently associated with prolonged hospital stays, 25-80% risk of
      in-hospital death, and future progression to chronic kidney disease. While there has been an
      increase in awareness about the prevalence and significance of AKI, studies have uncovered
      systematic failure in the management of AKI, largely relating to the failure of clinicians to
      recognize and manage the condition appropriately. This is where we can use electronic health
      records (EHRs) and electronic alerts (e-alerts) to our advantage. In this study, the
      investigators plan to use e-alerts integrated into a clinical decision support (CDS) system
      to improve the care of and outcomes of patients with AKI. The aims are to study the
      prevalence of AKI and its progression among hospitalized patients using an 'AKI sniffer' (an
      EHR based automated system) and to prospectively study if introducing a complex intervention
      (an e-alert combined with a clinical decision support system) will reduce progression of AKI
      in children. The investigators have developed an AKI care bundle which provides simple
      guidelines for management of AKI along with specific discharge instructions to improve follow
      up care. The primary outcome is AKI progression. Secondary outcomes include morbidity,
      mortality, length of hospital stay, need for renal replacement therapy, and recovery of renal
      function by time of hospital discharge. The investigators will also look at documentation of
      AKI and if these participants get appropriate follow up.
    


Intervention name(s): electronic alert and clinical decision support system
Intervention type(s): Other
Intervention description(s): Providers taking care of patients will receive an electronic alert and will be guided to use a clinical decision support system
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Background:

      Low back pain is the leading cause of disability, affecting the quality of life and work
      productivity.

      It is the most common reason for seek medical help and advice. Low back pain creates huge
      economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically
      defined with no preferred medical treatment

        1. Study objectives:

           To prove that consulting using the "Stage of change" model for daily physical activity
           will lead to long term improvement of pain, disability and well-being parameters of
           those suffering from chronic low back pain, people age 25-55, when compared to
           conventional Physical Therapy.

        2. Study hypotheses:

           The intervention groups vs. Physical Therapy group will demonstrate that the following
           parameters will improve after: 3 months, one, two and five years.

             1. Pain reduction.

             2. Less disability - improvement in daily activities.

             3. Better feeling of health and well-being.

             4. Increased and better compliance to daily sport activities.

             5. BMI reduction.

             6. Reduction of cigarette smoking.

             7. Reduction of usage of anti-analgesics and anti-inflammatory medications.

             8. Reduction in number of visits to Physical Therapy clinics due to low back pain.

        3. Methods:

      The present Randomized intervention study that will include 220 healthy individuals, males
      and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or
      without radiation to the legs that were referred to Maccabi Healthcare Services Physical
      Therapy clinics in the Sharon district in Israel.

      These individuals will be randomized to one of the following two groups:

        1. Conventional Physical Therapy.

        2. Physical Therapy focused on healthy lifestyle using the "Stage of Change" model.

      Non-dependent observer will follow-up on the outcome parameters via phone calls and filling
      the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5
      years.
    


Intervention name(s): Daily physical activity consultation, Using the "Stage of change" model
Intervention type(s): Other
Intervention description(s): Consultation of daily physical activity is provided, including selection of up to four pain relief exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment