bioihbjkbjnl/mcl2 huggingface dataset:
Risk Factors of Shoulder Injuries in Youth Volleyball Players
Condition: Shoulder Injuries
MeSH terms: Wounds and Injuries; Shoulder Injuries
Study type: Observational

Summary: 
      Shoulder injuries are usual in volleyball players. Nowadays, few prospective studies assessed
      risk factors of shoulder injuries in this sport. So, the objective of this study is to assess
      the risk factors of injuries in youth volleyball players. For that purpose, the following
      factors will be taken into consideration : shoulder internal/external rotators strength,
      shoulder range of motion, scapular dyskinesis, functional tests (medicine ball throw and
      upper quarter Y balance test), training load and psychosocial factors (POMS questionnaire).
    

Detailed description: 
      About 100 youth volleyball players (13-20 years), playing at least 8 hours volleyball in a
      week will be included in the study.

      At the beginning of the 2019-2020 season, they will have to take part at the following
      evaluations :

        1. Clinical evaluation :

             -  Scapular dyskinesis assessment (normal, subtle abnormality and obvious abnormality)

             -  Scapular upward rotation at 0°, 45°,90° and 120° with an inclinometer.

             -  Rounded shoulder posture

             -  Posterior shoulder stiffness

             -  Internal/external rotation range of motion (at 90° of abduction)

        2. Medicine ball throw :

           From a cocking position, players have to throw a 800g medicine ball as far as possible
           (3 trials). Only the best result will be retained for analysis. Volunteers have 2
           minutes of rest between trials.

        3. Upper Quarter Y Balance Test :

           In a facial drop position, the purpose of this test is to bring the plastic board as far
           as possible in the 3 directions (supero-lateral, infero-lateral, medial). 3 trials are
           performed by each subject and only the best test is kept for analysis. A rest period of
           one minute is provided between tests to avoid fatigue.

        4. Strength assessment (isokinetic test) :

           Internal and external rotators strength (concentric 60°/s, eccentric 60°/s and
           concentric 240°/s) are measured with an isokinetic device (Cybex Norm) at 90° of
           abduction.

        5. Psychosocial factors assessment :

      Players will have to fill in POMS questionnaire (65 questions), that give information about
      stress and well-being.

      After that, players will be followed during all the 2019-2020 season and will have to fill in
      a form each month about the potential injuries they had during the previous month.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Youth volleyball players, playing at good level in Wallonia (Belgium) will be included in
        the study
      
Keywords: strength; risk factors; youth volleyball players
Safety and Efficacy of Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops in the Treatment of Seasonal Allergic Rhinitis (SAR) in Children and Adolescents
Condition: Seasonal Allergic Rhinitis; Seasonal Allergic Conjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis; Conjunctivitis, Allergic; Hypersensitivity
Study type: Interventional

Summary: 
      Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection
      against external agents like aeroallergens. The effects of Ectoin containing nasal spray and
      eye drops have already been demonstrated in several studies with adult Seasonal Allergic
      Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of
      allergic rhinitis without resulting in any significant adverse events.

      The aim of this clinical investigation is to demonstrate the safety, tolerability and
      efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR patients.
      It is assumed that Ectoin containing products show an excellent safety profile and very good
      tolerability together with a potent efficacy in the treatment of SAR.
    


Intervention name(s): ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01); Placebo products
Intervention type(s): Device; Device
Intervention description(s): Comparison of ANS01 and AAT01 with placebo; Nasal Spray and Eye drops without Ectoin
Other intervention name(s): ect4allergy
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Intervening With Children/Adolescents With FAS/ARND
Condition: Treatment; Control
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Children diagnosed through the FAS DPN clinic (who receive non-study services through the
      clinic/referrals) will receive baseline assessment. The baseline assessment for the child
      will include: medical issues (including medication), intellectual assessment, academic
      achievement, language, social functioning, executive functioning, neurological assessment,
      perceived self-confidence, and behavioral observation of parent-child interactions
      (videotaped and coded). For caregivers, baseline assessment will include: demographics,
      medical histories, educational history, current services, satisfaction with services,
      knowledge of FAS, stress, parenting competence, and family functioning.
    

Detailed description: 
      Functional analysis of challenging behaviors will be conducted. Intervention will be an
      individualized, multimodal, behavioral consultation. The consultation will include: FAS
      education, emotional/practical support, and teaching child management strategies specific to
      children with FAS/ARND, advocacy assistance, and school consultation. Specific procedure will
      be based on previous findings and experience. In particular, specialized "Behavior Support
      Plans" will be developed for each child with input from parents, teachers, and clinicians.

      Team consultations at the child's home during weekly visits. Instruction will include
      information on FAS, behavioral strategies, and information for advocating with service
      systems.

      Evaluation Plan: Both interventions: Treatment and control groups will be compared using pre-
      and post-tests measures. Post-tests will be at the conclusion of the intervention and at a
      9-month follow-up (end of school year).
    

Intervention name(s): Positive Behavior Support
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Educational/Counseling/Training
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objective of the study is to compare the bioavailability and characterise the
      pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India
      and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA
      in normal, healthy, adult human subjects under fasting conditions, and to assess the
      bioequivalence.
    

Detailed description: 
      48 +8 (stand-by) normal healthy adult subjects will be enrolled in the study. Subjects will
      be administered either the Test or the Reference Product with 240 mL of water in each period
      as per the randomization schedule. Subjects will fast for at least 10 hours prior to dose
      administration and for at least 4 hours post dose. Standardized meals will be provided in
      each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours
      Post dose in each period. A total of 28 blood samples will be withdrawn for pharmacokinetic
      profiling. The concentration of mycophenolate mofetil and mycophenolic acid will be
      quantitated using validated LC-MS / MS method.ANOVA, two one-sided tests for bioequivalence,
      power and ratio analysis for un-transformed and ln-transformed pharmacokinetic parameters
      Cmax, AUC0-t AUC0-inf will be computed and reported for Mycophenolic acid. Bioequivalence of
      the test product with that of the reference product under fasting conditions will be
      concluded if the 90% confidence interval falls within the acceptance range of 80.00-125.00%
      for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Mycophenolic
      acid.
    

Intervention name(s): Mycophenolate Mofetil Capsule 250 mg
Intervention type(s): Drug
Intervention description(s): Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
Other intervention name(s): Mycophenolate Mofetil Capsule
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study in healthy volunteers
RAte Control Efficacy in Permanent Atrial Fibrillation
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The investigators hypothesis is that in patients with permanent AF lenient rate control is
      not inferior to strict rate control in terms of cardiovascular mortality, morbidity,
      neurohormonal activation, NYHA class for heart failure, left ventricular function, left
      atrial size, quality of life and costs. Lenient rate control is defined as a resting heart
      rate <110 bpm.Strict rate control is defined as a mean resting heart rate < 80 beats per
      minute (bpm) and heart rate during minor exercise < 110 bpm. Patients will be seen after 1,
      2, 3 months (for titration of rate control drugs) and thereafter yearly.
    

Detailed description: 
      Study objectives:

        1. To show that lenient rate control is not inferior to strict rate control in terms of
           cardiovascular mortality and morbidity

        2. To show that lenient rate control is not inferior to strict rate control in terms of all
           cause mortality, cardiovascular hospitalizations, NYHA class for exercise tolerance,
           left ventricular function and left atrial size, quality of life, neurohormonal
           activation as measured by NT-proBNP, hospitalization for heart failure, syncope,
           sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD
           for ventricular arrhythmias, cardiac arrest, and pacemaker implantations, stroke,
           systemic emboli, and bleeding, unstable angina pectoris and myocardial infarction, costs
           and renal function
    

Intervention name(s): Strict versus lenient rate control
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers
Condition: Hepatitis C; HIV
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      The investigators believe that boceprevir's drug concentrations will be reduced when
      administered in combination with etravirine. The investigators believe that etravirine's drug
      concentrations will be increased when administered in combination with boceprevir.
      Additionally, the investigators believe that boceprevir and etravirine are safe when
      administered alone or in combination.
    

Detailed description: 
      To investigate the potential for drug interactions between boceprevir and etravirine,
      participants will receive each drug alone and the drugs in combination for 11-14 days. The
      pharmacokinetics of boceprevir and etravirine when given in combination vs. alone will be
      compared.
    

Intervention name(s): boceprevir; etravirine
Intervention type(s): Drug
Intervention description(s): boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
Intervention MeSH terms: Etravirine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: HCV; HIV
Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to demonstrate bioequivalence of a fixed dose
      combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg (Test) and
      RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg and
      pseudoephedrine-HCl 30 mg following orally administration.
    


Intervention name(s): Ibuprofen; Ibuprofen; Pseudoephedrine-HCl; Pseudoephedrine-HCl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mg oral administration (RhinAdvil(R)); 200 mg oral administration (BI product); 30 mg oral administration (BI product); 30 mg oral administration (RhinAdvil(R))
Intervention MeSH terms: Ibuprofen; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of the Kidneys and Liver in the Elimination of Glucagon
Condition: Chronic Kidney Diseases; Liver Cirrhosis; Hyperglucagonemia
MeSH terms: Liver Cirrhosis; Kidney Diseases; Renal Insufficiency, Chronic; Fibrosis
Study type: Interventional

Summary: 
      The study aims to evaluate the kinetics and effect of glucagon in patients with chronic
      kidney disease and liver cirrhosis and matched healthy subjects, respectively.
    

Detailed description: 
      In the present project the investigators wish to identify whether the effect, elimination and
      degradation of glucagon differ between healthy control subjects and patients with Chronic
      Kidney Disease (CKD) and liver cirrhosis, respectively. By performing glucagon infusions on
      healthy control subjects and matched subjects with either limited renal and hepatic function,
      the contribution of both organs to the metabolic clearance rate (MCR) of glucagon can be
      tested. A primed infusion of stable isotopic labelled tracers will allow the researchers to
      investigate the effects of the glucagon infusion on the glucose, lipid and amino acid
      metabolism.

      The quantification of the MCR of glucagon will be accompanied by a range of pharmacodynamic
      measures in order to substantiate whether a potentially altered glucagon MCR inflicts
      pharmacodynamic changes of glucagon, which could contribute to the pathophysiology of CKD and
      liver cirrhosis.
    

Intervention name(s): Glucagon infusion; Primed tracer infusion
Intervention type(s): Biological; Biological
Intervention description(s): One hour glucagon-clamp followed by one hour of blood sampling; Infusion of primed isotopically labelled glucose, amino acids and lipids. From 2 hours prior to glucagon infusion and throughout the test day,
Intervention MeSH terms: Glucagon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Metabolic clearance rate; Glucagon pharmacodynamics; Glucagon pharmacokinetics
SET-Recovery/Healthy Home
Condition: Substance-Related Disorders; Mental Health
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The study conducts a community-based randomized trial comparing an adaptation of Structural
      Ecosystems Therapy (SET), "Healthy Home", as an enhancement of substance abuse or mental
      health outpatient treatment, to outpatient treatment as usual (TAU) among approximately 172
      Black, Hispanic and White nonHispanic mothers enrolled in outpatient substance abuse or
      mental health services. The study is conducted with a community partner, Banyan Health
      Systems, that delivers substance abuse/mental health treatment and primary care. Data is
      collected at baseline and 4, 8, and 12 months postrandomization. The Specific Aims of the
      proposed study are to: 1) test the effectiveness of Healthy Home for improving physical and
      mental health and reducing relapse of mothers in substance abuse/mental health recovery; 2)
      test the effectiveness of Healthy Home for improving health and mental health outcomes of
      children of mothers in recovery; 3) test mechanisms of action of Healthy Home (self care,
      environmental risk, family functioning and stigma); 4) assess implementation and
      sustainability factors and the relationship between fidelity and outcomes; and 5) examine the
      interactions of ethnicity and ethnicity related factors on outcomes. Healthy Home is a
      manualized, strength-based, directive and process oriented family ecosystemic home health
      intervention developed to address the needs of mothers and their children affected by
      substance abuse and other mental health disorders.
    


Intervention name(s): SET-R/Healthy Home
Intervention type(s): Behavioral
Intervention description(s): SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Easy Stretch Toolkit: A Pilot Study
Condition: Facial Injuries
MeSH terms: Facial Injuries
Study type: Interventional

Summary: 
      To research the use of a novel set of intraoral tools called the Easy Stretch Toolkit for the
      therapeutic management of facial burns and other facial disorders.
    

Detailed description: 
      In this initial pilot study, we plan to recruit 20 adult or pediatric patients who have
      sustained facial burns or who have sustained a facial injury resulting in scarring,
      tightness, limited range of motion of facial skin or musculature, or fibrosis to complete the
      8 week treatment. Participants will need to be able to attend a weekly telehealth or in
      person session with the investigators and complete the entire 8 week prescriptive program.
      Participants will be outpatient. A facial injury can be any disorder that results in
      scarring, tightness, limited range of motion of facial skin or musculature or fibrosis.
      Facial burn injury or facial injury is defined as an injury to the midface or lower half of
      the face and may be unilateral or bilateral. Participants must be in the chronic phase of
      recovery. Chronic burns are defined as those burns that are not in the acute healing phase,
      ie., there are no concerns for injury to new or healing skin or wound dehiscence.
    

Intervention name(s): Easy Stretch Toolkit
Intervention type(s): Device
Intervention description(s): Study the use of novel intraoral tools for management of facial burns and other facial disorders
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physiological Brain Atlas Development
Condition: Parkinson Disease; Dystonia; Tremors; Obsessive Compulsive Disorder; Depression
MeSH terms: Parkinson Disease; Dystonia; Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.
    

Detailed description: 
      The study proposes the enrollment of candidates undergoing a deep brain stimulator (DBS)
      implant. Data will be collected before, during and after surgery and will be electronically
      entered into the Atlas database where it will be stored indefinitely.

      The purpose of the study is to create an Atlas to store physiological information utilizing
      non-rigid MRI normalization algorithms. In addition to collating and analyzing the
      physiological atlas in a statistical manner that allows the surgeon to predict optimal
      targeting locations for DBS implants based on multiple physiological variables, including
      pre-operative severity of disease, intraoperative neurophysiological observations, and
      post-operative response to DBS stimulation therapy.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Other intervention name(s): Single Arm Group
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who are undergoing DBS implantation surgery at the Ohio State University.
Air Pollution, Inflammation and Acute Coronary Syndrome
Condition: Patients With Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome; Inflammation
Study type: Observational [Patient Registry]

Summary: 
      The objectives of this study are: 1) To determine whether patients with acute coronary
      syndrome, the level of environmental exposure to particulate air pollutants in the week prior
      to admission, are related to concentrations of inflammatory molecules and oxidative stress.
      2) To investigate whether the level of environmental exposure is an independent prognostic
      factor in terms of overall and cardiovascular mortality, myocardial infarction or unstable
      angina at 30 days, 6 and 12 months.
    


Intervention name(s): Particulate air pollutants
Intervention type(s): Other
Intervention description(s): We will determined the average concentrations of different sizes of particulate matter from 1 day or up to 7 days prior to admission in patients with acute coronary syndrome.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cohort of consecutive patients admitted with diagnosis of aucte coronary, which will
        quantify the exposure of particulate air pollutants 24 hours a day 7 days earlier prior to
        admission. Also be determined inflammatory molecules and oxidative stress in admission.
        During the evolution of these patients, after 30 days, 6 and 12 months will recorded major
        adverse cardiovascular events. It also will quantify the exposure of air pollutant
        particles, in all patients included at 30 days, 6 and 12 months.
      
Keywords: Acute coronary syndrome; Air pollution.; Inflammation.; Oxidative Stress.; Prognosis
S90652 in Paediatric Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the long-term safety and effects on blood pressure of a
      paediatric formulation of perindopril in hypertensive children
    


Intervention name(s): Perindopril
Intervention type(s): Drug
Intervention MeSH terms: Perindopril
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)