bioihbjkbjnl/mcl2 huggingface dataset:
Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene
Condition: Healthy Elderly People
Study type: Interventional

Summary: 
      Ageing of the population is a major event in the world. Gerontological/geriatric literature
      unanimously indicate that physical exercise and diet are at present the two available
      fundamental approaches to contrast/prevent most of the age associated alterations. In the
      elderly the inflammageing, the oxidative stress and the alteration of the intestinal
      microbiota can be influenced by nutritional status and possibly corrected by an appropriate
      dietetic intervention:

      Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve
      the quality of individual diet for specific needs This study will focus on the development of
      a specific dietary approach through an E-Health dietary service, associated or not to
      nutraceutical food supplements intake, to modulate the oxidative stress, inflammageing and
      gut microflora in the elderly people.
    

Detailed description: 
      Ageing of the population is a major event in the world. Gerontological/geriatric literature
      unanimously indicate that physical exercise and diet are at present the two available
      fundamental approaches to contrast/prevent most of the age associated alterations. In the
      elderly the inflammageing, the oxidative stress and the alteration of the intestinal
      microbiota can be influenced by nutritional status and possibly corrected by an appropriate
      dietetic intervention:

      Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve
      the quality of individual diet for specific needs
    

Intervention name(s): VSL#3® probiotic blend; AISA-5203-L fruit extracted terpene; Argan oil; Optimal Diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Behavioral
Intervention description(s): Product should be administrated orally, 2 capsules b.i.d. on an empty stomach (at least 30 min. before lunch and dinner) with a glass of water; Product should be administrated orally, the dosage depending from the body weight of the subject enrolled in the study as already stated : 1-2 pills three times a day with a meal and a large glass of water; Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water; a dietician will train each subject (or the caregiver) to use the personalized diet on web platform.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diet; probiotics; inflammaging; oxidative stress; gut microbiota; food complements
Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics
Condition: Dexmedetomidine; Midazolam; MRI; Pediatrics
Study type: Interventional
Phase: Phase 4

Summary: 
      An increasing number of studies have reported the use of dexmedetomidine in clinical
      practice. However, few studies have reported on the intranasal use of dexmedetomidine in
      radiological procedures The aim of this work is to compare the efficacy and safety of
      intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.
    

Detailed description: 
      This prospective randomized double-blind clinical trial will be carried out on 60 children
      undergoing elective MRI in Tanta University Hospitals.

      Sixty children will be randomly allocated into two equal groups by computer-generated
      sequence through sealed opaque envelopes:

      Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will
      be sedated with 0.3 mg/kg intranasal midazolam.
    

Intervention name(s): Dexmedetomidine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): 30 children will be sedated with 2 μg/kg intranasal DEX.; 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty children will be randomly allocated into two equal groups by computer generated sequence through sealed opaque envelopes:
Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
Masking: Double (Participant, Investigator)
Primary purpose: Other
School-Based Telemedicine Enhanced Asthma Management
Condition: Pediatric Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This project aims to improve guideline-based asthma care using enhanced communication and
      screening tools, telemedicine and directly observed therapy of preventive medications in city
      schools. Web-based screening will be used to identify children with persistent or poorly
      controlled asthma and to send reports to the child's primary care doctor. Children in the
      SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed a
      daily preventive asthma medication to be taken through school-based directly observed
      therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention for
      improving guideline based care, enhancing adherence to effective preventive medications and
      at reducing morbidity among young urban children with asthma.
    


Intervention name(s): School-Based Telemedicine Enhanced Asthma Management; Enhanced Usual Care
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling
Condition: Aging
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Elderly are supplemented with either Omega-3 (3 x 1.1g per day) or placebo (corn oil) during
      14 weeks. The last 12 weeks, supplementation is combined with resistance exercise training
      (3x per week) focusing on upper leg strength. In the present project, the investigators study
      whether differences in muscle strength and/or muscle mass between conditions can be explained
      by omega-3-induced effects on systemic or muscle inflammatory signaling, or differences in
      muscle molecular signaling.
    

Detailed description: 
      Elderly are supplemented with either Omega-3 (3 x 1.1g per day) or placebo (corn oil) during
      14 weeks. The last 12 weeks, supplementation is combined with resistance exercise training
      (3x per week) focusing on upper leg strength. In the present project, the investigators study
      whether differences in muscle strength and/or muscle mass between conditions can be explained
      by omega-3-induced effects on systemic or muscle inflammatory signaling, or differences in
      muscle molecular signaling.
    

Intervention name(s): Omega-3 polyunsaturated fatty acid supplementation; Resistance exercise; Placebo - appearance-matched oil supplementation
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): Daily supplementation with omega-3 capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g; Resistance exercise training in both supplementation conditions (3 times per week for 12 weeks).; Daily supplementation with placebo capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Elderly humans (>65y) are randomized to a placebo or omega-3 group (interventions, tests, analyses etc. are executed in parallel).
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: muscle metabolism; inflammation; muscle molecular signaling; muscle functioning
Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare the PK parameters of multiple doses and applications of K-285 with a
      single dose of indomethacin capsule.
    


Intervention name(s): K-285; Indomethacin
Intervention type(s): Drug; Drug
Intervention description(s): Topical; Capsule
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Remote SMBG Combined With the Application of APP on the Improvement of T2DM Management in the Community
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To investigate whether strengthen community diabetes patients self-monitoring of blood
      glucose can improve the patient's blood glucose control under Chinese guidelines for the
      prevention and treatment of diabetes (CDS 2017) and whether this intervention produces health
      and economic benefits.
    

Detailed description: 
      This project is a cohort intervention study for randomized controlled trials. Community
      health service centers are the main body of implementing treatment and community diabetes
      patients are the objects of intervention. 498 T2DM patients with poor blood glucose control
      (7%<HbA1c≤9.5%) from 4 different community health service centers will be randomized into two
      groups (strengthen group and control group). Strengthen self-monitoring of blood glucose by
      APP is the intervention and its duration is 12 months. Follow-up time of this study is 24
      months (12 months after the intervention stopped). The diabetes treatment of patients from
      both groups follows Chinese guidelines (CDS 2017).
    

Intervention name(s): Strengthen self-monitoring of blood glucose
Intervention type(s): Other
Intervention description(s): Strengthen self-monitoring of blood glucose by Internet mobile terminal（APP）.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Condition: Venous Thromboembolism; Thromboembolism; Thrombosis; Embolism and Thrombosis; Deep Vein Thrombosis; Arthroplasty, Replacement, Hip
MeSH terms: Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Embolism and Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b
      15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after
      elective total hip arthroplasty.
    


Intervention name(s): DU-176b 15mg; DU-176b 30mg; Enoxaparin sodium 20 mg (=2000IU)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.; DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.; Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
Other intervention name(s): edoxaban; edoxaban
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; venous thromboembolism; edoxaban; anticoagulants
Prospective Cohort Study of Association of Insulin Resistance/Steatosis With Hepatic Fibrosis in CHB and NAFLD
Condition: Chronic Hepatitis B; Hepatic Fibrosis; Fatty Liver
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic; Fatty Liver; Liver Cirrhosis; Insulin Resistance; Fibrosis
Study type: Observational [Patient Registry]

Summary: 
      Hepatic steatosis and insulin resistance are associated with severity of fibrosis in
      non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical
      significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is
      not well established. The aim was to investigate the relationship between insulin resistance,
      hepatic steatosis, and fibrosis in patients with CHB.
    

Detailed description: 
      acoustic radiation force impulse elastography
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic hepatitis B patients who showed evidences of hepatic steatosis on ultrasonography
      
Biospecimen description: 
      We intended to collect sera from registered subjects, but no biospecimens are to be retained
      yet.
    
Keywords: Chronic hepatitis B; Hepatic fibrosis; Steatosis
Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      Aim:

      To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in
      Pakistan.

      Design:

      Randomized Control Trial

      Setting:

      Psychiatry Departments of General Hospitals in Karachi.

      Participants:

      A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a
      psychological intervention or treatment as usual arm.

      Intervention:

      Culturally Adapted Cognitive Behavioral Therapy (CBT)

      Outcome measure:

      Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)
    

Detailed description: 
      The purpose of the study is to test the feasibility of culturally adaptive CBT for Psychosis
      in Pakistan

      Primary :

      -To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in
      Pakistan.

      Secondary:

        -  To assess fidelity of culturally-adapted CBT for psychosis.

        -  To further modify CaCBTp in accordance with findings of feasibility study

      The Participants will be recruited from psychiatric department of different hospitals.They
      will be randomly divided into two groups; intervention group and treatment-as-usual group. A
      total of thirtysix participants will be recruited in the feasibility study and divided
      equally into two arms. This will ensure that, even after loss to follow-up, the investigators
      will have at least 12 subjects per group for analysis (FDA guidance
      http://www.fda.gov/cder/guidance/5356fnl.pdf. Randomization will be carried out by the on
      offsite statistician . This will provide a reliable geographically remote service. For
      intervention group twelve sessions of CaCBTp will be delivered by trained research clinician
      for a period of three months. Participants in the treatment as usual (TAU) group will be
      given details of intervention at the end of the study and interested Participants will be
      offered CaCBTp.
    

Intervention name(s): Culturally Adapted Cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
Other intervention name(s): Psychosocial intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CBT, Psychosis, cultural adaptation, Pakistan
Nutritional Metabolomics: the Search for Dietary Exposure Variables
Condition: Nutrition Disorders; Metabolic Disorders
MeSH terms: Nutrition Disorders; Metabolic Diseases
Study type: Interventional

Summary: 
      In the post-genomic era, a major challenge for health research is to understand the complex
      interactions among genetic, environmental and lifestyle factors including dietary intake.
      Unfortunately, such initiatives are hampered by the lack of accurate dietary intake
      assessment methods for large studies. The newly emerging field of metabolomics offers unique
      possibilities to characterize individual food intake, dietary patterns and effects of dietary
      intervention in large studies. The investigators propose to develop a platform to detect
      broad metabolomic responses to food intake in controlled trials as well as to use targeted
      metabolomics approaches to characterize dietary intake in longitudinal studies. Our
      laboratory has a long history of developing methodology for assessing nutritional status and
      effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy
      Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern
      metabolomics equipment and competence in bioinformatics, and use this in the context of
      nutrition research. To their knowledge, the investigators are among the first groups in the
      country to develop skills in metabolomics to assess dietary intake and effects of nutrition
      on metabolism, and probably the first to use two complementary platforms with both
      mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should
      be useful to nutritional scientists nationally as well as internationally.
    


Intervention name(s): Diet
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Interest of the Use of the Web Platform LICORNE (LIaison and COoRdination With a NumériquE Health Reseau) Concerning Coordination of Care for Dependant Elderly Patients
Condition: Polypathology
Study type: Observational

Summary: 
      This project is associating partners from the public area (university hospital of Nice, Nice
      university) and the private area (Agfa Health Care, Radhuis, Domicalis) to create a unique
      medico-psycho-social shared record.

      The purpose of this project is to significantly improve coordination of care, especially
      between hospital and home. We can expect a significant improvement in the patient's living
      conditions, improving its management, its security and ultimately, lower health care costs.
    

Detailed description: 
      The LICORNE project was created to give the possibility for the medical establishments to
      share there medico-psycho-social informations with all actors taking part of the patient
      care. Indeed, current informatique systems in medical establishments have an isolated
      functionning, without transmission of information outsite the wall of the hospital. The idea
      of this project is to bring together all actors involved in the care of a patient around a
      single shared patient record, regardless of the structures where professionnals work. This
      project is associating partners from the public area (university hospital of Nice, Nice
      university) and the private area (Agfa Health Care, Radhuis, Domicalis) to create a unique
      medico-psycho-social shared record. The informations will be share between all the
      professionnal taking car of the patient.

      The main objective of this protocol will be to determine the impact of using the LICORNE
      platform on the coordination of care of elderly patients with multiple diseases. We will
      assess the impact of using the LICORNE platform on the implementation of electronic health
      record (Dossier Médical Partagé, public health insurance of the social security), and the
      benefit of using the LICORNE platform to reduce patient's hospital readmissions.

      The purpose of this project is to significantly improve coordination of care, especially
      between hospital and home. We can expect a significant improvement in the patient's living
      conditions, improving its management, its security and ultimately, lower health care costs.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        old patient with polypathologies and loss of autonomy
Is Carotid Intima-media Thickness Affected by A1C Variability?
Condition: Type 2 Diabetes; A1C Variability
Study type: Observational

Summary: 
      This study was conducted to evaluate the effect of A1C variability on the progression of
      carotid artery intima-media thickness in type 2 diabetic patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        typeII, Fluroscopy in carotid once a year during 2 years.
The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device
Condition: Normal Hearing (76 Subjects); Subjects With Hearing Loss (15 Subjects)
MeSH terms: Hearing Loss; Deafness
Study type: Observational

Summary: 
      There are no differences between the exams made with the new device,that evaluates the
      hearing, and the device gold standard, that is widely used in clinics and hospitals.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults Normal hearing subjects and hearing loss Subjects
      
Keywords: Evoked Potentials, Adult, Hearing Loss