bioihbjkbjnl/mcl2 huggingface dataset:
Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits.
Condition: Respiratory and Allergic Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, non-randomized, controlled, interventional study aiming to assess, in
      a primary school in the city of Palermo, the health effects of a maintenance and care
      intervention of the school's green areas.

      All children of the third, fourth and fifth classes of two school complexes of the same
      primary school will be selected. One complex will undergo maintenance and care of the green
      areas and gardens inside the school. The other complex will serve as a control group and will
      not undergo any intervention.

      The study will involve three phases.

        1. During the first phase (prior to the intervention) respiratory and allergic symptoms
           will be assessed through a standardized questionnaire to be administered to students,
           parents and teachers in both the school complexes.

        2. During the second phase, the maintenance and care intervention plan will be implemented
           in the experimental complex.

        3. During the third phase, 1 week after the maintenance intervention, respiratory and
           allergic symptoms will be re-assessed through a standardized questionnaire to be
           administered to the same students, parents and teachers in both the school complexes.
    


Intervention name(s): Manteinance and care intervention on the green areas.
Intervention type(s): Other
Intervention description(s): Manteinance and care intervention on the green areas.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Infections; Communicable Diseases; Pneumonia, Pneumococcal; Pneumococcal Infections; Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of GSK
      Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having
      asplenia, splenic dysfunction or complement deficiencies.

      In addition, this study will include an age-matched control group of healthy children aged
      24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in
      the at-risk population to that of the general, healthy population one month after each
      pneumococcal vaccination.
    

Detailed description: 
      The protocol has been amended to clarify the definition of priming status to consider for
      inclusion of subjects in the primed groups.
    

Intervention name(s): Synflorix™
Intervention type(s): Biological
Intervention description(s): 1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal infection; Synflorix; Children; Immunogenicity; Safety
Ultrasound for Neuraxial Anesthesia
Condition: Lumbar Ultrasound
Study type: Interventional

Summary: 
      The patients will be allocated to 2 groups: the ultrasound group and the palpation group.
      Ultrasound detection of the puncture site will be performed to the patients of the one group
      (group U). The puncture site will be determined by palpation of the landmarks at the patients
      of the other group (group L). The main purpose of the study is to determine if the ultrasound
      scan of the lumbar spine can facilitate spinal, epidural and combined spinal-epidural
      anesthesia, increase the success and decrease the complication rate of these techniques. The
      secondary purpose of the study is to evaluate if the lumbar ultrasound scan can be used to
      determine accurately the depth of the epidural space.
    


Intervention name(s): Detection of the puncture site by ultrasound scan of the lumbar spine.; Detection of the puncture site by identification of the landmarks.
Intervention type(s): Device; Procedure
Intervention description(s): Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The scanning will be performed as described by Arzola et al. The L3-L4 space will be identified by palpation and identification of the landmarks (Tuffier's line). The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified (bright signal followed by dark triangular area). The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site. The distance from the skin to the ligamentum flavum will be measured by the ultrasound caliper.; Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ultrasound; Spinal anesthesia; Epidural anesthesia
Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus
Condition: Ebola Hemorrhagic Fever
MeSH terms: Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and pharmacology of single
      administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.
    

Detailed description: 
      Ebola hemorrhagic fever (EHF) is a rare human disease caused by Ebola Virus (EBOV), a
      filamentous single-stranded, negative-sense RNA virus. Since 1976 several Ebolavirus
      outbreaks have occurred with fatality rates ranging from 57% to 90%, with most of these
      outbreaks traced to single EBOV species; EBOV-Z. No effective therapy is currently available
      for Ebolavirus.

      AVI-6002 is an experimental combination of 2 phosphorodiamidate morpholino antisense
      oligomers with positive charges on selected subunits (PMOplus™). These oligomers specifically
      target viral messenger RNA encoding 2 Ebolavirus proteins thought to be important in viral
      replication and host immune suppression. The present study is designed to characterize the
      safety, tolerability and pharmacokinetics of escalating single-administration doses of
      AVI-6002 in healthy human subjects.
    

Intervention name(s): Placebo; AVI-6002
Intervention type(s): Drug; Drug
Intervention description(s): Normal saline; Single intravenous administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Motor Imaginary Training on Upper Limb Functions in Stroke
Condition: Stroke, Cardiovascular
MeSH terms: Stroke; Myocardial Infarction
Study type: Interventional

Summary: 
      This study will provide knowledge about effectiveness of motor imaginary training in upper
      limb performance in chronic stroke patients. Very little data is available about the use in
      Motor Imaginary in post stroke upper limb rehabilitation in Pakistan. Moreover, studies done
      previously did not specified population of stroke; This study will include MCA stroke
      patients only, whom upper limb weakness is more prevalent.
    

Detailed description: 
      Motor imagery is a technique for inducing motor activity in response to a certain motor
      output by producing a mental image of the action without intending to conduct it. It is a
      cognitive technique that, rather than making a patient to pick up new procedures, promotes
      neural alterations in order enable the patient to re-acquire motor skills mastered before the
      CVA or copy the actions of others. Motor imaging training is a sort of therapy in which the
      patient imagines a gesture or movement in order to learn, reinforce, or improve the
      movement's performance. A study done in South Korea, published in 2015, revealed that Motor
      imagery training has a good impact on UL performance by refining functional mobility during
      stroke rehabilitation. The results suggest that motor imagery training is viable and helpful
      for improving UL function in CVA patients.

      Meta-analysis done in Australia in the year 2013, was supportive of Motor imaginary
      techniques further convincing that Mental imagery can be a possible intervention for stroke
      patients given that it being, safe cost-effective & unlimited practice opportunities. Study
      done in China in 2017, suggested that clinicians should consider the use of MI in addition to
      treatment currently used to improve upper extremity functions after stroke as no evidence of
      side effects or harm was noted . RCT done in year 2006 in USA indicated that for patients
      with chronic, moderate upper limb impairment after CVA, program of CIMT with mental practice
      only resulted in decrease impairment, with functional enhancement.
    

Intervention name(s): Motor Imaginary Training Group; Task oriented Training Group
Intervention type(s): Other; Other
Intervention description(s): After the baseline assessment, the participant will receive Motor Imaginary Program; After the baseline assessment, the participant will receive MRP and CIMT training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Motor imaginary technique
The HEP-OKS Study - Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
Condition: Spatial Neglect; Cerebral Stroke
MeSH terms: Stroke; Perceptual Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Spatial neglect represents one of the major cognitive disorders following stroke. Patients
      patients fail to be aware of objects or people to their left and orientate instead to their
      right side. Enduring neglect has been found to be a poor prognostic indicator for functional
      independence following stroke. Despite some promising experimental accounts there are no
      established treatments for this condition.

      The aim of this study is to test whether a combined treatment with hemifield eye patching
      (HEP) and optokinetic stimulation (OKS) can permanently reduce neglect behaviour and improve
      functional outcome in patients with hemispatial neglect following stroke.

      The investigators hypothesise that the treatment with HEP and OKS will lead to a greater
      reduction of neglect scoring in the neglect test battery as well as a greater improvement in
      functional independence scores as compared to the spontaneous clinical course of the
      usual-care control group.
    

Detailed description: 
      To specify, this study should answer the following main question: Does the daily wearing of
      hemifield eye patches over a period of 1 week in combination with daily sessions of
      optokinetic stimulation lead to a significant reduction of neglect behaviour as measured by
      total scores in a paper-and-pencil neglect test battery and/or an improvement in functional
      independence scores (Catherine-Bergego-Scale, Barthel Index) in a cohort of stroke patients
      with acute hemispatial neglect as compared to the spontaneous course of the disease in a
      control patient group without a neglect-specific treatment?
    

Intervention name(s): hemifield eye patching (HEP) + optokinetic stimulation (OKS)
Intervention type(s): Behavioral
Intervention description(s): Patients in this arm will wear standard spectacle frames containing noncorrective lenses to which right half-field patches are attached (hemifield eye patching, HEP). In case of patients already wearing prescribed glasses, the patches will be attached to their own glasses. The glasses will be worn all-day for the duration of the treatment phase (seven days) and only be removed for sleeping and face cleaning as well as for the duration of the daily OKS treatment sessions.
Furthermore these patients will receive daily sessions (20 minutes) of optokinetic stimulation (OKS). Therefore patients will be seated in front of a widescreen monitor, watching a black background with a pattern of various objects (size 1°), which coherently and continuously move to the left at a velocity of 10 °/s.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of Anlotinib in Patients With Small Cell Lung Cancer (ALTER1202)
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the effects and safety of Anlotinib with placebo in patients with small cell lung
      cancer(SCLC).
    


Intervention name(s): Anlotinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle; Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Gastric banding has been shown to significantly reduce weight and has been approved as a
      treatment of morbid obesity. The standard laparoscopic operation requires five small
      incisions for the introduction of instruments and the band into the patient's abdomen. We
      have developed a technique for performing this operation through a single incision at the
      belly button. This study compares this method to the conventional 5-incision approach.
    


Intervention name(s): Laparoscopic gastric banding
Intervention type(s): Procedure
Intervention description(s): Laparoscopic gastric banding for the treatment of morbid obesity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether FDG-PET is capable of detecting
      atherosclerotic plaque inflammation and monitoring the effects of statins on plaque
      inflammation. The usefulness of FDG-PET in risk stratification is also investigated.
    

Detailed description: 
      There is increasing evidence that inflammation plays a role in progression and
      destabilization of atherosclerotic plaque. However, currently, no non-invasive method is
      available for detecting plaque inflammation in clinical practice. FDG-PET can visualize
      activated metabolic levels of not only tumor cells but also inflammatory cells. Thus, it is
      possible that FDG-PET can detect atherosclerotic plaque inflammation and that, if so, FDG-PET
      can monitor the direct effect of statins on plaque inflammation. Additionally, monitoring the
      plaque inflammation by FDG-PET may be useful for determining the risk stratification of
      atherosclerotic patients.

      Originally, we sought to compare patients with FDG-positive plaque with patients with plaque
      but not with FDG uptake, patients with FDG-positive plaque receiving statin therapy, and
      patients with FDG-positive plaque receiving diet management therapy. However, because patient
      number enrolled in the study was too small, the comparison was performed between FDG-positive
      patients with and without any statin therapy.
    

Intervention name(s): simvastatin
Intervention type(s): Drug
Intervention description(s): simvastatin 5-10 mg/day
Other intervention name(s): control
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atherosclerosis; inflammation; statins; PET; carotid ultrasonography
Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily
      premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction
      from baseline to end of study. The test for superiority can be done if noninferiority is
      achieved.

      Secondary Objectives:

        -  To assess efficacy in terms of percentage of patients achieving HbA1c <7% and HbA1c <7%
           without hypoglycemia.

        -  To assess efficacy in terms of percentage of patients achieving fasting plasma glucose
           (FPG) <7 mmol/L and FPG <7 mmol/L without hypoglycemia.

        -  To assess safety in term of occurrence of moderate/severe hypoglycemia.

        -  To assess daily blood glucose (BG) variation.

        -  To assess patient satisfaction.
    

Detailed description: 
      The duration of study is approximately 21 months. Each patient will be followed for
      approximately 27 weeks from screening visit to end-of-study
    

Intervention name(s): INSULIN GLARGINE (HOE901); Insulin Glulisine; Biphasic insulin aspart 30; Repaglinide; Acarbose; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: subcutaneous injection; Pharmaceutical form: solution for injection
Route of administration: subcutaneous injection; Pharmaceutical form: solution for injection
Route of administration: subcutaneous injection; Pharmaceutical form: tablet
Route of administration: oral administration; Pharmaceutical form: tablet
Route of administration: oral administration; Pharmaceutical form: tablet or capsule
Route of administration: oral administration
Other intervention name(s): Lantus; Apidra; Novolog Mix70/30; NovoNorm; Glucobay
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Aspart; Biphasic Insulins; Acarbose; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin glulisine; Repaglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients
Condition: End Stage Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to study the effect of zinc supplementation in end stage renal
      failure on hemocystein level.
    

Detailed description: 
      hemocystein increased in end stage renal failure and zinc involved in hemocystein metabolism
      thus zinc supplementation may be effective on hemocystein level.
    

Intervention name(s): Zinc Supplement; placebo
Intervention type(s): Drug; Drug
Intervention description(s): in 50 patients zinc sulfate 220 mg per day orally for 6 weeks; placebo daily for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hemocystein zinc renal failure
A Study of Different Endoscopic Surgery Procedures in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Condition: Chronic Rhinosinusitis (Diagnosis); Surgery
MeSH terms: Sinusitis; Nasal Polyps
Study type: Interventional

Summary: 
      CRS remains a common challenging clinical entity due to variable phenotypes with different
      underlying mechanisms that lead to persistence or recurrence polyps. The eosinophils dominant
      inflammation was considered as a major pathological hallmark and challenges of CRS with nasal
      polyps (CRSwNP). Differentiate surgical approaches towards eosinophilic CRSwNP (eCRSwNP)
      should be addressed on the basis of the inflammatory endotypes. eCRSwNP has been recognized
      as the most easily relapsed type of CRS, and the combination of asthma increases the
      difficulty of treatment. Till now there is no recognized surgical strategy for eCRSwNP with
      asthma.
    


Intervention name(s): radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.; radical endoscopic sinus surgery (RESS); functional endoscopic sinus surgery (FESS)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The procedure of RESS was completed as described in "full-house FESS (FHF)" approach, involving complete removal of all nasal polyps along with a full maxillary antrostomy, total ethmoidectomy, wide sphenoidotomy, and a Draf 2A frontal sinusotomy. Moreover the bilateral inferior two-thirds of MTs were meanwhile resected. The technique for the Draf 3 frontal drillout procedure was described in detail in previous publications with resection of the superior nasal septum, central frontal sinus floor, and frontal beak region, resulting in a widely patent, oval-shaped, common frontal sinus neo-ostium; The procedure of RESS was completed as described in "full-house FESS (FHF)" approach, involving complete removal of all nasal polyps along with a full maxillary antrostomy, total ethmoidectomy, wide sphenoidotomy, and a Draf 2A frontal sinusotomy. Moreover the bilateral inferior two-thirds of MTs were meanwhile resected; FESS was performed by Messerklinger technique with middle turbinate preservation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomly assigned 1:1:1 to receive FESS, RESS and RESS plus Draf 3 surgery.
Masking: None (Open Label)
Primary purpose: Treatment
Post-mortem Genetic Testing
Condition: Cardiac Ion Channelopathy
MeSH terms: Channelopathies
Study type: Observational

Summary: 
      This is a prospective observational study to examine the incidence of cardiac ion
      channelopathies in unexplained still births.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Unexplained still births
      
Biospecimen description: 
      Skin and muscle
    
Keywords: Ion channelopathy,; Still birth; Sudden death