bioihbjkbjnl/mcl2 huggingface dataset:
Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional

Summary: 
      Oscillatory positive expiratory pressure (OPEP) devices such as Flutter®, Aerobika® or Shaker
      ® are commonly prescribed in the clinical practice for airway clearance in children with
      chronic lung diseases including bronchiectasis, cystic fibrosis, and primary ciliary
      dyskinesia. Health insurance companies may cover these devices in some countries; but this is
      not a common practice around the world. Therefore, many families have to purchase these
      devices themselves. Unfortunately, these devices are rather expensive especially in the
      developing countries and consequently, families become financially burdened. Aim of this
      study is to investigate whether the addition of OPEP devices to a comprehensive chest
      physiotherapy program provide additional benefits on pulmonary function and exercise capacity
      in children with bronchiectasis. Results of this study may help better interpreting the
      cost-effectiveness of these devices.
    


Intervention name(s): Chest physiotherapy; Oscillatory Positive Expiratory Pressure (OPEP) device
Intervention type(s): Other; Device
Intervention description(s): Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.; Shaker® device will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bronchiectasis; children; oscillatory positive expiratory pressure device; chest physiotherapy; pulmonary function; exercise capacity
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        -  To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in
           patients with moderate chronic kidney disease (CKD) on stable angiotensin converting
           enzyme-inhibitor (ACE-I)

      Secondary Objectives:

        -  To assess in patients with moderate CKD the effect of concomitant multiple dose of
           SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate

        -  The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to
           ACE-Is (AcSDKP)

        -  The pharmacokinetic profile of repeated oral administration of SAR407899A during
           co-administration of ACE-Is
    

Detailed description: 
      The total duration for this study will be around 8 weeks.
    

Intervention name(s): SAR407899A
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:capsule
Route of administration: oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to analyse the effect of a probiotic supplement on functional
      intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).
    

Detailed description: 
      The aim of the intervention is to analyse the effect of a probiotic supplement in a
      dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS
      according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life,
      anxiety and depression and adequate relief will be assessed as with questionnaires as outcome
      measures. The intestinal microbiota will be analysed from faecal samples.
    

Intervention name(s): Probiotic (Active high); Probiotic (Active low); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Higher dose of probiotic supplement; Lower dose of probiotic supplement; Placebo
Other intervention name(s): Lactobacillus; Lactobacillus; Maltodextrin as placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: irritable bowel syndrome; probiotic; pain; bloating; diarrhoea; constipation
Haemostasis and Tranexamic Acid in Caesarean Delivery
Condition: Postpartum Hemorrhage; Hyperfibrinolysis
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean
      delivery and the effect of tranexamic acid (TXA) given in prevention of post-partum
      haemorrhage (PPH).
    

Detailed description: 
      Post-partum haemorrhage (PPH) remains a leading cause of maternal morbidity and mortality.
      Haemostasis and fibrinolysis are activated in peripartum. Fibrinolysis is decreased during
      pregnancy, is quickly activated after childbirth and can be overactivated in case of PPH.
      Tranexamic acid (TXA), an antifibrinolytic drug, has been proven to efficiently decrease
      bleeding and death in PPH. Its place in prevention of PPH after caesarean section remains to
      be established. The aim of the study protocol TRAAP2 is to conduct a large multicentre
      randomized, double blind placebo-controlled trial to adequately assess the impact of TXA for
      preventing PPH following a caesarean section. Peripartum is also a period of increased
      thrombo-embolic risk. TXA has never been proven to increase thromboembolic events.
      Nevertheless, it seems important to reserve TXA for women with activated fibrinolysis.

      The aim of the ancillary biologic study BIO-TRAAP is thus to explore haemostasis and
      fibrinolysis in peripartum, to determine which women will in the future benefit from TXA.
      Fibrinolysis will be studied by clot lysis time by Global Fibrinolytic Capacity test on the
      Lysis Timer (GFC/LT), t-PA, PAI-1, PAI-2, euglobulin clot lysis time, plasminogen,
      plasmin-anti-plasmin complex, thrombin-anti-thrombin complex, fibrin degradation products
      (FDP).
    

Intervention name(s): peripartum haemostasis
Intervention type(s): Diagnostic Test
Intervention description(s): Three blood samples of 20 ml each at T0 after the anaesthesia for the caesarean section and before the administration of the product (TXA or placebo), T15 fifteen minutes after the administration of the product and T120, 2 hours after the administration of the product.
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three blood samples of 20 ml each at T0 after the anesthesia for the caesarean section and before the administration of the product (TXA or placebo), T15 fifteen minutes after the administration of the product and T120, 2 hours after the administration of TRAAP2 study IMP (tranexamic acid or placebo).
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: ancillary biologic study; fibrinolysis; tranexamic acid; post-partum haemorrhage
Walk With Me: a Mobile Application to Improve Walking in Persons With MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      During 10 weeks the subjects will use a mobile application (Walk with Me). The aim of this
      study is to investigate the usability of the mobile application, as well as investigating if
      the mobile application effects walking.
    


Intervention name(s): Walk with Me app
Intervention type(s): Device
Intervention description(s): For 10 weeks the subjects will use a mobile application (Walk with Me). The aim of this study is to investigate the usability of the mobile application, as well as investigating if the mobile application effects walking
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer
Condition: Kidney Cancer; Long-term Effects Secondary to Cancer Therapy in Adults; Perioperative/Postoperative Complications; Urinary Complications
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell; Ischemia; Postoperative Complications
Study type: Interventional

Summary: 
      RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold
      ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether
      warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage I
      kidney cancer.

      PURPOSE: This randomized phase III trial is studying warm ischemia to see how well it works
      compared with cold ischemia during surgery in treating patients with stage I kidney cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the effect of warm ischemia during partial nephrectomy on long-term renal
           function in patients with solitary stage I renal cortical tumor and normal contralateral
           kidney.

      Secondary

        -  Determine to what degree the contralateral kidney compensates for the damage inflicted
           on the operated kidney during surgery.

        -  Determine the 1-year disease-specific and overall survival of these patients.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo warm ischemia followed by partial nephrectomy.

        -  Arm II: Patients undergo cold ischemia followed by partial nephrectomy. Blood and urine
           samples are collected periodically after nephrectomy to assess renal function.

      Patients are followed at 1, 3, 6, 9 , and 12 months after nephrectomy.
    

Intervention name(s): cold ischemia procedure; warm ischemia procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): Cold ischemia followed by partial nephrectomy; Warm ischemia followed by partial nephrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: perioperative/postoperative complications; urinary complications; long-term effects secondary to cancer therapy in adults; stage I renal cell cancer
Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This project will evaluate an after-school substance abuse prevention intervention, compared
      to a standard substance abuse education program, targeting 6th grade AI youth in three AI
      communities: Ojibwe/Chippewa in Minnesota, Choctaw in Oklahoma, and Lumbee in North Carolina.

      A community-based participatory research approach will be used to culturally and
      technologically adapt the intervention. A two-condition controlled study will evaluate the
      efficacy of the intervention to increase AI youth Native self-reliance while decreasing AI
      youth substance use involvement. An adult training program second level intervention study
      will also be implemented to train tribal personnel from the three regional tribes on how to
      implement the intervention as a tribal program beyond the study period.

      Effectiveness will be determined by a small partial cross-over randomized trial comparing the
      intervention to a wait-list control condition. Process evaluations will focus on the future
      adoption and implementation of the intervention, and recommendations for sustainable
      adaptations.
    

Detailed description: 
      The proposed study will consist of a 5-year plan: Year 1 has been completed and consisted of
      strengthening and extending community partnerships in each community and collecting data that
      will inform the cultural adaptation and tailoring of the intervention; Years 2, 3, and 4 will
      entail implementation by using a two-condition controlled study in which the culturally
      competent intervention is compared to standard care; and Year 5 will consist of final data
      collection, analysis of results, dissemination of results to local communities, and
      finalization of a sustainability plan for each Tribe.

      Participants in the proposed study will consist of 540 male and female American Indian 6th
      grade students who represent at least three different Tribes - Choctaw, Ojibwe/ Chippewa, and
      Lumbee, in three different regions of the U.S. Participants will also include 70 tribal
      personnel (adults 18 and over) who be trained to implement the intervention in Years 3 & 4 of
      the project. Finally, 15-20 stakeholders and community partnership members will be
      interviewed at various stages of this project.
    

Intervention name(s): Culturally Tailored Intervention; Standard Substance Abuse Education
Intervention type(s): Other; Other
Intervention description(s): School-based substance use prevention; Class room program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Culturally tailored intervention; American Indian early adolescents; Prevention of substance use
Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis
Condition: Polycythemia Vera; Essential Thrombocytosis
MeSH terms: Polycythemia Vera; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of
      CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with
      Essential Thrombocytosis (ET).
    

Detailed description: 
      This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of
      CEP-701 (lestaurtinib) treatment at a dosage of 80 mg bid for 18 weeks (126 days) in patients
      with Polycythemia Vera (PV) who have abnormal baseline neutrophil counts or require
      hydroxyurea therapy and patients with Essential Thrombocytosis (ET) who require hydroxyurea
      therapy for disease control.
    

Intervention name(s): lestaurtinib
Intervention type(s): Drug
Intervention description(s): 60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Intravenous Ketamine Infusion for Hemodynamic Stability in Patients Undergoing Caesarean Delivery.
Condition: Hemodynamic Instability
Study type: Interventional

Summary: 
      Hypotension is the most frequent side effect of intrathecal anesthesia, with a found
      incidence of more than 80%. With a frequency of between 40% and 60% in patients undergoing
      surgery, Perioperative shivering is a serious consequence that frequently follows neuraxial
      anesthesia. This study aimed to determine the multiple advantages of intravenous minimal dose
      ketamine for intrathecal anesthesia in patients undergoing cesarean delivery
    

Detailed description: 
      126 female patients undergoing cesarean deliveries, ASA-(II and III) and 21-40 ys old
      selected from an attendee of outpatient clinics of the Anesthesia Department. Two groups of
      patients were random to group K (63 patients): Received 0.3 mg/kg of ketamine IV diluted to
      10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution, group C (Controlled) (63
      patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml
      solution.
    

Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution before spinal anesthesia; Normal saline
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: spinal anesthesia; obstetric anesthesia
Fundus Changes in the Microphthalmy Eyes
Condition: Eye Diseases, Hereditary
MeSH terms: Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn
Study type: Observational

Summary: 
      The goal is to describe the fundamental aspects of fundoscopic eye in patients with
      microphthalmia
    

Detailed description: 
      Microphthalmos is a developmental ocular disorder defined as a small eyeball. The condition
      can be associated with abnormalities of anterior and posterior segments. The most common
      anterior characteristics include corneal opacities, angle-closure and a shallow anterior
      chamber and cataract. The main findings of posterior segment are uveal effusion, retinal
      folds, abnormalities of macular capillary vascularization, absence of foveal depression and
      peripheral retinoschisis. We performed on 3 patients with microphthalmos and their OCT
      features of posterior segment.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        the study is the description of three cases of microphthalmy with changes to fund of the
        eye, all documented with optical coherence tomography and clinical characteristics.
      
Keywords: retina; fold; fovea
Residual Gastric Area and Weight Loss After Sleeve Gastrectomy
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Observational

Summary: 
      BACKGROUND: The aim of this study is to evaluate the impact of the actual size and area of
      the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss
      after LSG.

      MATERIALS AND METHODS: From May 2017 to December 2019, 56 patients with morbid obesity were
      admitted to the Department of Medical and Surgical Sciences, University of Foggia and
      underwent laparoscopic sleeve gastrectomy.

      UGI tract radiography was performed on day two after the operation to rule out leakage.
    

Detailed description: 
      Study design and setting

      From May 2017 to December 2019, 56 patients with morbid obesity were admitted to the
      Department of Medical and Surgical Sciences, University of Foggia and underwent laparoscopic
      sleeve gastrectomy. UGI tract radiography with water-soluble contrast medium was performed on
      the second day after the operation to rule out leakage. The radiographic images were
      collected through a software program called "PACS" which combined with a viewer for image
      processing, allows for the calculation of the residual stomach area (RSA). RSA was correlated
      with postoperative weight (EWL) at 1, 6, and 12 months.

      Eligibility criteria

      Adult patients of both genders with morbid obesity defined as BMI>40 kg/m2 or BMI>35 kg/m2
      with at least one associated major comorbidity were included. We excluded patients with
      secondary obesity due to endocrine and psychological disorders, patients with previous
      bariatric procedures and patients unwilling to comply with postoperative diet and exercise
      program.

      Statistical analysis

      Continuous data were expressed as mean and standard deviation (SD) and they were analyzed
      using Student's T test. The correlation between gastric volume before and after LSG and BMI
      and weight loss was measured using Pearson correlation coefficient test. Correlation
      coefficients were classified as strong (-1.0 to -0.5 or 0.5 to 1.0), moderate (-0.5 to -0.3
      or 0.3 to 0.5), and weak (-0.3 to -0.1 or 0.1 to 0.3). P<0.05 was considered statistically
      significant. This work is fully compliant with the STROCSS criteria
    

Intervention name(s): The radiographic images were collected through a software called "PACS" which combined with a viewer for image processing, that allows the calculation of the residual stomach area (RSA).
Intervention type(s): Diagnostic Test
Intervention description(s): Upper gastrointestinal radiographie
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        56 patients underwent sleeve gastrectomy with a mean age of 43,5± 11 years of which 40 were
        female.
Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new
      formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with placebo.

      Primary Objectives:

      Safety:

        -  To obtain safety and tolerability data for a single subcutaneous vaccination with
           ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old).

      Immunogenicity:

        -  To obtain data on the antibody response to a single subcutaneous vaccination with
           ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior Japanese
           encephalitis immunity.

        -  To assess the durability of immune response up to 12 months following a single
           subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.
    

Detailed description: 
      All participants will received a single dose of study vaccine, ChimeriVax™-JE or placebo on
      Day 0. The double-blind treatment phase will last 30 days, with follow-up visits at 6 and 12
      months.
    

Intervention name(s): Live attenuated Japanese encephalitis virus; Live attenuated Japanese encephalitis virus; Live attenuated Japanese encephalitis virus; ChimeriVax™ diluent (Placebo)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL,Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Other intervention name(s): ChimeriVax™-JE; ChimeriVax™-JE; ChimeriVax™-JE; Paricipants received a dose of ChimeriVax™ diluent at Day 0.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Japanese Encephalitis; ChimeriVax™-JE Vaccine; Adult