bioihbjkbjnl/mcl2 huggingface dataset:
Mothers Understand And Can do it - Mid Upper Arm Circumference Screening for Malnutrition Performed by Mothers
Condition: Marasmus; Kwashiorkor; Malnutrition; Degree, Moderate; Malnutrition
MeSH terms: Malnutrition; Kwashiorkor; Protein-Energy Malnutrition
Study type: Observational

Summary: 
      PRIMARY OBJECTIVE :

      To determine whether mothers, given minimal group training, are capable of using a MUAC
      (mid-upper arm circumference) bracelet to screen their children for malnutrition and
      categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow'
      (MAM ; moderate acute malnutrition) or 'green' (normal nutritional status)

      SECONDARY OBJECTIVES :

      To establish whether there is a difference in the MUAC value if measured on the right arm as
      opposed to the left, in young children

      To determine whether there is a difference in the MUAC value if the mid upper arm position is
      determined visually as opposed to being measured in the 'classical' fashion
    

Detailed description: 
      Severe Acute Malnutrition (SAM) and its complications are major causes of death in under 5s
      in the developing world. A simple, reproducible, scalable way to recognise acute malnutrition
      and target early intervention would be a huge advance. Can mothers with limited training
      reliably measure and interpret the results of Mid Upper Arm Circumference (MUAC), a
      measurement performed with a MUAC measuring tape costing $0.06? MUAC contrasts with Z-score
      (WHZ), which requires both scales and a height gauge, both health worker interventions
      susceptible to considerable error, sensitive to non-nutritional factors, requiring
      calculations and growth curves, yet much less accurate in predicting risk of death compared
      with MUAC.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children present in the inpatient malnutrition treatment unit and paediatric service of the
        Mirriah district hospital aged between 6-59 months old

        Children aged between 6-59 months old in the two villages of the Mirriah district, Niger;
        where the community phase of the study was conducted
      
Keywords: Acute Malnutrition; Mid Upper Arm Circumference; Screening
Efficacy of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Breast Cancer
Condition: Breast Cancer Metastatic
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: Endocrine therapy is an effective and safe treatment for hormone receptor
      positive breast cancer. Unfortunately , endocrine treatment resistance occurs and there is an
      urgent need for treatment alternative. Laboratory researches and clinical case reports
      indicate that hormone receptor-high expressed breast cancer patients may potentially benefit
      from high-dose Tamoxifen or high-dose Tamoxifen plus chemotherapy , providing a new option
      for treatment strategy.

      Aim: To explore the efficacy and safety of high-dose Tamoxifen to standard hormone
      receptor-high expressed endocrine therapy resisted breast cancer.

      Methods: Eligible patients will be treated with tamoxifen 100 mg/d or high-dose Tamoxifen(100
      mg/d ) plus chemotherapy. Blood and tumor samples will be obtained from the patients.Evaluate
      curative effect every 3 months.

      Primary endpoint: progression-free survival (PFS). Secondary endpoints: objective response
      rate (ORR), clinical benefit rate (CBR), overall survival (OS) and safety.

      Exploratory endpointsincluded the efficacy predictive value of the 18F-FES SUVmax.
    


Intervention name(s): Tamoxifen Oral Product
Intervention type(s): Drug
Intervention description(s): Tamoxifen 100 mg/d or high-dose Tamoxifen(100 mg/d ) plus chemotherapy
Intervention MeSH terms: Tamoxifen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; high dose Tamoxifen; endocrine therapy; Hormone Receptor Positive Malignant Neoplasm of Breast; Tamoxifen; Breast Cancer Metastatic
House Dust Mite Observational Study
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Observational

Summary: 
      A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a
      History of House Dust Mite-Induced Rhinoconjunctivitis
    

Detailed description: 
      House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and
      fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with
      poorer lung function, greater medication requirements and more asthma symptoms as well as
      chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA
      leads to the development of asthma, in addition to exacerbating pre-existing asthma in
      HDM-sensitised patients.

      The proposed observational study is designed to gather information on subjects with
      HDM-related rhinoconjunctivitis.
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis
      
Keywords: HDM Allergy; Rhinoconjunctivitis
Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study investigated the feasibility of the novel modular mobile health (mHealth) for
      personalized rehabilitation and explored the participants' satisfaction and app data during
      treatment of breast cancer.
    

Detailed description: 
      This is prospective, feasible, parallel study in post-operative patients with breast cancer
      and during treatment. Disability of Arm, Shoulder, Hands (DASH), Physical activity data
      (IPAQ-SF), Physical measurement such as hand grip strength, body mass index (BMI), muscle
      mass, and differences in arm circumference, PRO-CTCAE, Distress Thermometer, needs and
      satisfaction in app, personal health record of app (exercise, daily step count, etc.) Measure
      will be evaluated on 1-month, 2-month, 4-month, 6-month, 9-month, and 12-month after POD.
    

Intervention name(s): Modular mHealth for Tailored Rehabilitation
Intervention type(s): Behavioral
Intervention description(s): an individually tailored self-management through the mHealth app with a smart band worn on the wrist
Other intervention name(s): mHealth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
Condition: Sickle Cell Disease; Acute Chest Syndrome
MeSH terms: Acute Chest Syndrome; Anemia, Sickle Cell; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety of defibrotide in subjects with sickle cell disease
      (SCD)-associated acute chest syndrome (ACS).
    


Intervention name(s): Defibrotide
Intervention type(s): Drug
Intervention description(s): Defibrotide 6.25 mg/kg IV q6h up to 7 days
Other intervention name(s): Defitelio®
Intervention MeSH terms: Defibrotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Beating Versus Arrested Heart for Mitral Valve Replacement
Condition: Mitral Stenosis; Mitral Insufficiency
MeSH terms: Mitral Valve Stenosis; Mitral Valve Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immediately clinic and ultramicroscopic
      myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested
      heart versus on-pump empty beating heart surgical techniques.
    

Detailed description: 
      During open-heart surgery prevention of ischemia and reperfusion following cardioplegic
      arrest are essential for myocardial protection. Beating heart surgery on normothermic bypass
      simulates physiologic cardiac status and is good method for myocardial protection. A
      comparison of both available techniques for valve replacement arrested heart versus on-pump
      empty beating heart of the clinical and ultramicroscopic myocardial alterations will allowed
      to better understand myocardial protection because eliminated the use of cardioplegia and the
      corollary risk of ischemic reperfusion injury.
    

Intervention name(s): Mitral valve replacement; mitral valve replacement
Intervention type(s): Procedure; Procedure
Intervention description(s): Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups; Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mitral valve; valve replacement; arrested heart; beating heart
Effects of Rosuvastatin on the, in Vivo, Kinetic of apoB and apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      Statins have been shown to reduce significantly the risk for cardiovascular events in
      patients with type 2 diabetes and statin therapy is largely recommended in this high
      cardiovascular risk population. However, a residual cardiovascular risk is observed in
      patients with type 2 diabetes treated by statins. This may be due to the fact that statins do
      not correct all lipid abnormalities associated with diabetic dyslipidaemia, such as hyperTG
      and low HDL-cholesterol.

      Rosuvastatin is a statin which, in addition to its efficacy to reduce LDL-cholesterol, has
      been show to decrease significantly plasma triglycerides. However, the effects of
      rosuvastatin on triglyceride rich lipoproteins and HDL remains unknown. The purpose of this
      study is to analyze the effect rosuvastatin 20 mg on the metabolism of triglyceride rich
      lipoproteins and HDL in patients with Type 2 diabetes using and in vivo kinetic study of
      VLDL1-apoB,VLDL2-apoB,IDL-apoB and HDL-apoA1.
    

Detailed description: 
      This is a randomized, double blinded, placebo-controlled, monocentric, cross-over study with
      two 6-week periods of placebo or rosuvastatin. Subjects will enter a one month placebo
      lead-in period after which they will be eligible for rosuvastatin 20 mg or placebo for two
      6-week periods.

      An in vivo kinetic study will be performed with stable isotopes (13C leucine) in type 2
      diabetic patients (n=8) before and after a 6-week period of rosuvastatin (20mg) therapy. The
      study is design with a one-month steady state period with placebo then on a cross-over design
      with two 6-week periods of placebo or rosuvastatin (20 mg. An in vivo kinetic study will be
      performed at the end of each 6-week period.

      The kinetic studies performed, in each patient, will assess the production rates and
      fractional rates of VLDL1-apoB, VLDL2-apoB, IDL-apoB, LDL-apoB and HDL-apoA-I.
    

Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): rosuvastatin 20 mg/day during 6 weeks versus placebo during 6 weeks in a cross-over design; Placebo
Other intervention name(s): CRESTOR (brand name for rosuvastatin)
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Triglycerides; HDL-cholesterol; kinetic; rosuvastatin
Safety of Cat-PAD in Cat Allergic Subjects
Condition: Cat Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with
      allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived
      peptide desensitising vaccine, currently being developed for the treatment of cat allergy.
      This study will investigate the safety of Cat-PAD administered as increasing single doses.
    

Detailed description: 
      This study is designed as a two centre, randomised, placebo-controlled, escalating single
      dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each
      cohort will undergo screening 14-28 days before treatment and a baseline challenge for EPSR
      and LPSR to cat allergen injected into the arm 7 days before treatment. On the treatment day,
      subjects will be injected either intradermally (into the skin) or subcutaneously (under the
      skin) with a single dose of Cat-PAD or placebo and safety observations made for 8 h. After 21
      days, subjects will again have cat allergen injected into the arm and the EPSR and LPSR will
      be recorded. The dose of Cat-PAD will be increased in successive cohorts, provided that the
      previous dose tested was well tolerated.
    

Intervention name(s): Cat-PAD
Intervention type(s): Biological
Intervention description(s): single, escalating dose intradermal and subcutaneous injections of Cat-PAD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cat allergy; Immunotherapy; Cat-PAD
Maggot Therapy for Wound Debridement
Condition: Pressure Ulcers
MeSH terms: Pressure Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the trial was to study the efficacy of bagged larvae on wound
      debridement in comparison to classical treatments. The secondary outcome was to assess wound
      healing, treatment related pain, microbiological modifications, adverse events, comfort of
      the dressing and duration of wound care. We performed a randomized, double-blind,
      multicenter, controlled, prospective phase III trial in three referral institutional centers
      of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a
      non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index
      (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´
      hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged
      larvae twice a week) or classical treatments (mechanical debridement and classical dressings
      performed three times a week). At discharge, classical dressings were applied and a follow-up
      visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin
      percentage on wounds treated with MDT and classical treatments at D15. The percentages of
      fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems,
      British Columbia, Canada), which enables the quantification of color surface variations in a
      wound after manual delimitation (using a mouse) on a series of photographic images.
    


Intervention name(s): application of wound dressing made of bio-bags (vitapads) containing maggots; application of classical hydrogel/alginate wound dressing
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in
      patients undergoing open upper abdominal surgery; when compared with thoracic epidural
      analgesia. Half of participants will receive intravenous lidocaine infusion, while the other
      half will receive thoracic epidural bupivacaine infusion.
    

Detailed description: 
      Postoperative pain is one of the commonest problems encountered by anaesthesiologists,
      especially after open abdominal surgeries, in which post-operative pain would cause a
      restrictive respiratory dysfunction, which is associated with poor postoperative outcomes.
      Despite the fact that epidural blocks provide superior analgesia; it is not often an ideal
      option as it frequently causes hypotension that may require excessive intravenous fluid
      administration, which is particularly deleterious after bowel surgery. Other complications
      include epidural hematoma and higher failure rate. Furthermore epidural analgesia may be
      contraindicated in some patients e.g. patients on certain anti-platelet therapy and patients
      refusing the technique.

      Other modalities to control postoperative pain are used e.g. intravenous analgesics and
      continuous wound infiltration, but none of which was proven to be as effective as epidural
      block.

      Whether perioperative lidocaine infusion is as effective as epidural block in reducing
      post-operative pain, is this study's concern.

      Some researches studied the efficacy of lidocaine infusion in controlling neuropathic as well
      as acute postoperative pain with encouraging results. Lidocaine infusion was found to reduce
      postoperative pain, opioid consumption and the length of hospital stay. Although risks of
      neurological and cardiac toxicity exist, these were not substantiated in the trials.

      Lidocaine has been described to have both analgesic, and anti-hyperalgesic effects6, as well
      as anti-inflammatory properties. It also accelerates the return of post-operative
      gastrointestinal function, which is of particular importance after major abdominal surgery.
      Opposite to opioids, which increase the incidence of nausea and vomiting, lidocaine decreases
      their incidence.
    

Intervention name(s): Bupivacaine; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): Thoracic epidural bupivacaine infusion; Intravenous lidocaine infusion
Other intervention name(s): Marcaine; Xylocaine; Lidocaine Hydrochloride
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
OHRQoL Evaluation After Functional Therapy in JIA Patients
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      The aim of the study was to determine the changes in Oral Health-Related Quality of Life
      (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint
      (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex
      group in which the functional therapy was most effective.
    

Detailed description: 
      This prospective interventional study included 93 patients with JIA and TMJ disorders at the
      start of functional orthodontic therapy. Children were prospectively followed in the 24
      months of treatment and completed the Oral Health Impact Profile (OHIP-14) before treatment
      (T0), and at 6 months (T1), 12 months (T2), and 24 months (T3) after the start of therapy.
    

Intervention name(s): Andresen functional removable orthodontic appliance
Intervention type(s): Device
Intervention description(s): Included patients were treated for 24 months with a Functional removable orthodontic appliance, the Andresen activator. The initial checks were performed after 6 weeks with subsequent checks being carried out every 8th week, with the final follow-up at 24 months. The patient underwent functional treatment using the activator described in the protocol with midlines coincidence.
Other intervention name(s): Andresen Activator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Is There a Relationship Between the Risk of Injury and Posture in Wrestlers?
Condition: Sport Injury; Posture; Wrestling; Risk Reduction
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Observational

Summary: 
      This study was planned to investigate the relationship between the risk of injury and posture
      in wrestlers. The study will be included male wrestlers. The spine posture and flexibility of
      the athletes will be measured during standing position with the Idiag M360® brand Spinal
      Mouse (SM), while the overall body posture will be measured from the anterior and lateral
      sides using the New York Posture Analysis Method (NYPAM). Injury risks of the athletes will
      be evaluated by Functional Movement Screen (FMS) which was consisting of seven basic movement
      patterns.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In this cross-sectional study, 18- to 40-year-old elite wrestler who have won medals in
        their championships from four different clubs will be tested
      
Keywords: Wrestling; Functional movement screen; Injury risk; Posture
Resveratrol, Cardiovascular Risk Markers And Cognitive Performance In Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters
      in patients with schizophrenia taking antipsychotics?
    

Detailed description: 
      Randomized, double-blind, placebo-controlled trial comparing supplementation with resveratrol
      or placebo in patients diagnosed with schizophrenia.
    

Intervention name(s): resveratrol
Intervention type(s): Drug
Intervention description(s): 100mg 2x/day
1 month
Other intervention name(s): Resveratrol (10 patients); Placebo (10 patients)
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination in Healthy Volunteers
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is performed to evaluate the total systemic exposure and lung bioavailability of
      CHF 5993 pMDI combination, in healthy volunteers subjects.
    


Intervention name(s): CHF 5993 HS 200/6/25 pMDI; CHF 5993 MS 100/6/25 pMDI; CHF 5993 HS 200/6/25 pMDI + Charcoal Block; CHF 5993 MS 100/6/25 pMDI + Charcoal Block; Placebo pMDI
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment