bioihbjkbjnl/mcl2 huggingface dataset:
The Absorption and Metabolism of Seaweed Polyphenols in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Brown seaweeds are a rich source of phlorotannins, a characteristic class of polyphenols
      which are unique to seaweeds of this type and can comprise 5 to 15 % of the dried weight.
      Unlike other classes of polyphenols, there is a lack of knowledge regarding phlorotannins and
      their bioavailability and bioactivity. The purpose of this study is to investigate the
      absorption and metabolism of seaweed polyphenols in humans. As part of an EC project
      (SWAFAX), an acute clinical intervention will be conducted to investigate the metabolism/
      bioavailability of brown seaweed phlorotannins. Urine and plasma samples from 24 healthy
      volunteers that consumed a seaweed capsule containing polyphenols will be collected before
      and after the intervention. Data emanating from this project will provide strong scientific
      evidence for bioavailability and health promoting activity of a seaweed polyphenol extract in
      human volunteers.
    


Intervention name(s): Seaweed extract
Intervention type(s): Dietary Supplement
Intervention description(s): Treatment capsule containing seaweed extract (treatment)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Polyphenols; Absorption; Metabolism; Phlorotannins; Seaweeds
Compare the Scapular Muscular Endurance, Stabilization and Dyskinesis Parameters of Sedentary Individuals
Condition: Scapular Dyskinesis; Sedentary Behavior
MeSH terms: Dyskinesias
Study type: Observational

Summary: 
      The aim of this study was to compare the parameters of scapular muscular endurance, scapular
      stabilization, scapular dyskinesia, upper extremity functional status and postural alignment
      of adult women aged between 40-65 years old who were performing clinical pilates exercises
      regularly compared with sedentary adult women in the same age group and to determine whether
      regular exercise had an effect on these parameters.
    

Detailed description: 
      The aim of this study was to compare the parameters of scapular muscular endurance, scapular
      stabilization, scapular dyskinesia, upper extremity functional status and postural alignment
      of adult women aged between 40-65 years old who were performing clinical pilates exercises
      regularly compared with sedentary adult women in the same age group and to determine whether
      regular exercise had an effect on these parameters. A total of 70 individuals were included
      in the study, including 35 individuals performing regular clinical pilates exercises and 35
      individuals with sedentary lifestyles. Clinical pilates group was selected from the
      individuals who participated in the exercise program under the control of a physiotherapist
      regularly for 1 hour, 2-3 days a week for at least 6 months. Socio-demographic
      characteristics, health status and exercise habits of the participants were recorded. For
      scapular muscle strength assessment, digital hand dynamometer; for scapular muscular
      endurance assessment, Scapular Muscular Endurance Test (SMET) and Shoulder External Rotation
      Fatigue Protocol; for the assessment of scapular dyskinesia, Lateral Scapular Slide Test
      (LSST) and Lennie test; for assessment of upper extremity functional status, Disabilities of
      the Arm, Shoulder and Hand Questionnaire (DASH); for the assessment of postural alignment,
      the New York Posture Assessment Test were used.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        70 Women, 35 Sedentary and 35 Doing Regular Clinical Pilates Exercise
      
Keywords: Scapular Dyskinesis; Muscle Strength; Muscle Endurance; Pilates Exercises
TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis
Condition: Dentofacial Functional Disorder
Study type: Interventional

Summary: 
      The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate
      mandibular growth or in interception / contention.

      The proposed research project will focus initially on assessing the comfort and safety of
      TwiCare® device. The orthopedic efficiency therefore not part of this study.

      The comfort and safety of the brace will be evaluated firstly by the practitioner during the
      visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and
      with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after
      the start of the port of the device, and during the control visit at 11 weeks.
    


Intervention name(s): TwiCare®.
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using the Xbox Kinect for Chronic TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      This study will evaluate the potential for improving balance for a single individual with a
      history of traumatic brain injury (TBI). The participant will engage in supervised therapy
      using commercial games on the Xbox Kinect. This study will also evaluate the viability of
      improving cardiovascular fitness using this intervention as well. The investigators
      hypothesize that balance improvements will occur and that using the Xbox Kinect is a viable
      way of improving cardiovascular fitness.
    

Detailed description: 
      Various forms of virtual reality (VR) training have been recently used for rehabilitation of
      neurological impairments including postural stability and coordination. Virtual reality
      training has also been shown to increase motivation and attention through its use of novel
      goal-directed challenges. The Xbox Kinect gaming system allows the Veteran to perform
      challenging full-body and goal-oriented activities. Balance improvements using laboratory
      developed games have been demonstrated in those with a history of TBI. However, the
      investigators are specifically interested if improvements can be made using commercial games
      which can be utilized in physical therapy clinics more readily. Exercise gaming has been
      shown to provide adequate intensity exercise to improve heart health in the healthy
      population. However, such benefits have not yet been investigated using the Xbox Kinect for
      individuals with a history of TBI.
    

Intervention name(s): Xbox One Kinect Gaming
Intervention type(s): Other
Intervention description(s): The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called "Shape Up" and "Kinect Sports: Rivals" to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant's abilities.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: traumatic brain injury; virtual reality; Xbox kinect; balance
Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck Cancer
Condition: Larynx; Lip; Oral Cavity; Pharynx
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This pilot clinical trial studies how well metformin hydrochloride works in affecting
      cytokines and exosomes in patients with head and neck cancer. Metformin hydrochloride may
      reduce the metabolic activity of cancer cells and of surrounding supportive tissues.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the capacity of metformin hydrochloride (metformin) to alter the cytokine and
      exosome profiles.

      II. To assess the capacity of metformin to mitigate known side effects of external beam
      radiation therapy including inflammation, mucositis, dysphagia, xerostomia, and fatigue.

      SECONDARY OBJECTIVES:

      I. Assess safety and tolerability of metformin treatment in subjects undergoing external beam
      radiation treatment for head and neck cancer.

      II. To determine the effect of metformin treatment on symptoms of xerostomia as assessed by
      the Xerostomia Questionnaire (XQ).

      III. To determine the effect of metformin treatment on symptoms of mucositis as assessed by
      World Health Organization (WHO) classification.

      IV. To determine the effect of metformin treatment on symptoms of dysphagia as assessed by
      the MD Anderson Dysphagia Inventory.

      V. To determine the effect of metformin treatment on symptoms of fatigue as assess by the
      Multidimensional Fatigue Inventory (MFI).
    

Intervention name(s): External Beam Radiation Therapy; Metformin Hydrochloride; Placebo
Intervention type(s): Radiation; Drug; Other
Intervention description(s): Undergo External Beam Radiation Therapy; Given orally; Given orally
Other intervention name(s): Definitive Radiation Therapy; EBRT; External Beam RT; 1,1-Dimethylbiguanide Hydrochloride; 1115-70-4; 91485; Cidophage; Glucoformin; Glucophage ER; Dimefor
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Multicenter Neonatal Eye Disease Screening in China
Condition: Eye Disease
MeSH terms: Eye Diseases
Study type: Observational

Summary: 
      These exams are vital to protect healthy neonates from blindness. The purpose of this study
      is to better screen ocular disease in otherwise healthy neonates using wide-field digital
      imaging system (RetCam III) in a multi-center network in China leaded by Xinhua Hospital
      Affiliated to Shanghai Jiao Tong University School of Medicine. The multi-center network will
      be built with the collaboration of eight hospitals from different parts of China.
    

Detailed description: 
      Studies reveal that ocular anomalies may also be found in healthy full-term babies. These
      abnormal ocular findings included subconjunctival haemorrhage, congenital microphthalmos,
      congenital corneal leukoma, posterior synechia, persistent pupillary membrane, congenital
      cataract, enlarged C/D ratio, retinal hamartoma versus retinoblastoma, optic nerve defects,
      macular pigment disorder and non-specific peripheral retinopathy. The highest proportion of
      these abnormal findings is retinal haemorrhages, accounting for 92% of abnormalities. Most
      retinal hemorrhages are benign and will finally self-resolve. However, sometimes it takes a
      long time for the hemorrhage to resolve. Some slow-resolving hemorrhages could obstruct the
      visual axis and may do great harm to visual development in critical period. Some neonatal eye
      diseases are time sensitive, such as retinoblastoma, and if found late, the best opportunity
      for effective treatment is missed, leading to irreversible visual impairment. Newborns are
      unable to express their discomforts or visual disorders as adults do and only through an
      examination, the neonatal eye diseases can be detected. Therefore, this screening protocol is
      designed to screen the otherwise healthy neonates in a multi-center network on neonatal
      ophthalmopathy and to achieve early diagnosis and timely treatment. All the neonates will
      undergo eye examination by using RetCam III. The external eye, pupillary light reflex, red
      reflex, opacity of refractive media, anterior chamber and posterior segments will be
      examined. The outcomes will be analyzed by a blinded specialist in order to discover serious
      congenital, hereditary and acquired diseases in the neonatal period of healthy newborns and
      to improve epidemiological information of neonatal ophthalmopathy. Neonatal ocular
      examination may play a positive role in promoting paediatric eye health to paediatricians and
      parents.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Otherwise healthy neonates in a multicenter network in China
      
Keywords: eye disease; neonatal eye disease; newborn; screening; multicenter
Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children
Condition: Cognition
Study type: Interventional

Summary: 
      The aim of the current study is to investigate the beneficial impact of 4 month consumption
      of a beverage powder fortified with Brahmi (Bacopa monnieri) extract and multiple vitamins
      and minerals on short term memory as assessed using standardised cognitive test battery.
    

Detailed description: 
      Bacopa monnieri (Brahmi) from Scrophulariaceae family has been traditionally used in India as
      'memory tonic'. Brahmi's use as a cognitive enhancer has led to recent research to
      investigate a broad spectrum of cognitive domains. Additionally, micronutrient deficiency in
      children can impair cognitive functions, and micronutrient supplementation can help
      reduce/prevent deficiencies in those at risk. Several studies have been conducted so far
      which establish the cognition enahncing abilities of Brahmi, with no major side effects. The
      aim of the current study is to investigate the beneficial impact of 4 month consumption of a
      beverage powder fortified with Brahmi extract and multiple vitamins and minerals on short
      term memory as assessed using standardised cognitive test battery.
    

Intervention name(s): Beverage powder fortified with micronutrients and Bacopa monnieri extract; Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Test beverage powder is fortified with micronutrients and Bacopa monnieri extract. Each sachet contains 32g of treatmemt product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily; Control beverage powder is the non-fortified isocaloric powder i.e. without micronutrients and Bacopa Monnieri extract. Each sachet contains 32g of placebo product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes
Condition: Platelet-rich Fibrin; Simvastatin
Study type: Interventional
Phase: Phase 1

Summary: 
      ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been
      found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier
      may decrease bone loss around implants.

      PURPOSE: To compare the long term effects of autologous PRF alone, and PRF loaded with SIM on
      peri-implant bone changes and implant stability in patients undergoing implant
      rehabilitation.

      MATERIALS AND METHODS: A randomized controlled split-mouth studyincluding 8 males between the
      ages of 45-60 years. Each patient received two implants, one on each side of the arch. One
      side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of
      Osteotomy. A cone-beam CT was used to evaluate bone changes around the insertion of implant
      sites atthree, six, and twelve months postoperatively. The secondary outcome included
      measuring implant stability using Ostell device at baseline and 3 months post insertion. To
      compare groups at different time periods, data was examined using a two-way (ANOVA) analysis.
    


Intervention name(s): Simvastatin
Intervention type(s): Drug
Intervention description(s): Simvastatin with PRF at site of osteotome
Intervention MeSH terms: Simvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy.
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Platelet-rich fibrin; Simvastatin; Bone loss; Peri-implant Bone Changes
EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
Condition: Mitral Valve Insufficiency
MeSH terms: Mitral Valve Insufficiency
Study type: Observational

Summary: 
      The goal of the study is to identify the patients suffering from a mitral valve condition who
      benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and
      long-term relief of mitral valve regurgitation.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population includes all patients suffering from mitral valve disease, indicated
        for a mitral valve repair procedure, either as a stand-alone procedure or concomitant to a
        coronary artery bypass grafting, an aortic replacement or tricuspid valve repair and/or the
        treatment of atrial fibrillation, and for which the surgeon considers the implantation of a
        Profile 3D annuloplasty product most appropriate to reconstruct the regurgitant valve.
A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open label, non-randomized metabolism, excretion, and mass balance
      study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.
    


Intervention name(s): [14C]-plazomicin
Intervention type(s): Drug
Intervention description(s): single intravenous dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed
      type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS
      (continuous glucose monitoring system) and to further realize the safety and effect of
      Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.
    

Detailed description: 
      Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic
      response. About 24% of the total energy provided by Glucerna SR is due to monounsaturated
      fatty acids, which can help keep good metabolic state in accordance with the recommendations
      of the American Heart Association. The aim of the study is to evaluate the effect of Glucerna
      SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the
      application of CGMS (continuous glucose monitoring system) and to further realize the safety
      and effect of Glucerna SR consumed as a meal replacement at breakfast meal on daily and
      day-to-day amplitude of blood glucose fluctuation.
    

Intervention name(s): Glucerna SR
Intervention type(s): Dietary Supplement
Intervention description(s): Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention
Condition: Myocardial Infarction; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The investigators aim to evaluate circulating irisin levels alterations in patients with
      acute myocardial infraction and in patients with coronary artery disease subjected to
      percutaneous coronary intervention.
    

Detailed description: 
      Irisin is a newly discovered myokine induced in exercise. There is evidence that cardiac
      muscle produces more irisin than skeletal muscle in response to exercise. Furthermore, irisin
      has been associated with isoproterenol-induced myocardial infarction (MI) in rats while it
      has been reported to decrease after acute myocardial infarction in humans.

      The investigators aim 1) to investigate circulating irisin levels in patients at the time of
      acute myocardial infarction and after reprefusion [primary percutaneous coronary intervention
      (PCI)] 2) to compare irisin' s diagnostic and prognostic value and specificity value in
      myocardial infarction with known markers of cardiac injury such as creatine kinase-MB
      isoenzyme (CK-MB) and troponin 3) to evaluate irisin as an early necrosis biomarker 4) To
      evaluate irisin's sensitivity as a biomarker to detect minor myocardial necrosis after
      elective percutaneous coronary intervention
    

Intervention name(s): percutaneous coronary intervention; coronary angiography; Stent, Medronic Resolute Integrity
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease; is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels; A stent is placed in an artery as part of a procedure called percutaneous coronary intervention (PCI) to restore blood flow through narrow or blocked arteries. A stent helps support the inner wall of the artery in the months or years after PCI.
Other intervention name(s): coronary angioplasty
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: irisin; myocardial infarction; coronary
EVP-6124 Hepatic Impairment Study
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after
      a single oral dose in subjects with mild, moderate and severe hepatic impairment compared
      with subjects with normal hepatic function.
    


Intervention name(s): Experimental: EVP-6124
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; Safety