bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Pre-exercise Beta-hydroxy-beta-methylbutyrate Free Acid (HMB-FA) and Cold Water Therapy for the Attenuation of Muscle Damage and Soreness
Condition: Muscle Damage
Study type: Interventional

Summary: 
      Study Objectives

        1. Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on
           performance recovery from an acute bout of high intensity resistance exercise.

        2. Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion.

        3. Examine the effect of these recovery modalities on markers of muscle damage,
           inflammation and immune function.

      Subjects

      Subjects (men and women, 18 - 35 y) with at least one year of resistance training experience
      will be recruited. Subjects will be randomly divided into one of four groups: a cold water
      immersion group (CW), HMB-FA, CW+HMB-FA and a control group (CT).

      Study Protocol

      Subjects will report to the Human Performance Laboratory (HPL) on four separate occasions. On
      the first visit (T1) subjects will be tested for maximal strength [one repetition-maximum
      (1-RM)] on the squat, dead lift and barbell lunge exercises.] On their second visit (T2)
      subjects will perform a lower body resistance exercise session consisting of four sets of the
      squat, dead lift and barbell lunge exercises. All subjects will then report back to the HPL
      at 24- (T3) and 48-hours (T4) post-exercise. During T3 and T4, subjects will perform four
      sets of the squat exercise only using the same loading pattern and rest interval length as
      T2. Following the T2 and T3 workouts subjects in CT will undergo no treatment; subjects in CW
      will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water at 50° F
      - 54° F (10° C - 12° C); subjects in HMB-FA will be provided the supplement 30 min prior each
      workout and CW+HMB-FA will be administered together at time points describe above.

      Statistical Analysis

      Statistical evaluation of performance and biochemical changes will be accomplished using a
      repeated measures analysis of variance (ANOVA).
    


Intervention name(s): cold water immersion; beta-hydroxy-beta-methylbutyrate free acid (HMB-FA); Placebo
Intervention type(s): Procedure; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Diabetes Care Management Trial of Telemetric Monitoring
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and
      will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa
      Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be
      randomly assigned to one of two treatment arms. The telemedicine group or the group receiving
      usual care (the control group).

      This study hopes to show the usefulness of this telemonitoring technology and more
      specifically, to assess whether this device improves markers of control of diabetes, glycemic
      control, and cardiovascular risk factors
    


Intervention name(s): Telemonitoring Device
Intervention type(s): Device
Intervention description(s): Telemonitoring device was installed in patients' homes
Other intervention name(s): Samsung Health Diary
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; HbA1c; Fructosamine; Blood Pressure; Telemonitoring
Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis
Condition: End Stage Renal Disease; Thrombosis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety and efficacy of AB023 (xisomab 3G3) in patients with end
      stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two
      cohorts. Within each cohort the patients will be randomized to receive either AB023 (xisomab
      3G3) or placebo (at a ratio of 2:1 active: placebo).
    


Intervention name(s): AB023- Dose 1; AB023-Dose 2; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single dose of 0.25 mg/kg AB023.; Participants will receive a single dose of 0.5 mg/kg AB023.; Participants will receive a single dose of placebo.
Other intervention name(s): xisomab 3G3- Dose 1; xisomab 3G3- Dose 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hemodialysis
Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study will perform UC-MSCs and CM transplantation. The first group will be injected by
      UCMSC+NaCl. the 2nd group will be injected by UC-MSC+CM. the 3rd group will be injected by
      CM. Each group consists of 6 subjects. all groups will be transplanted via peribulbar route.
      the dosage of UC-MSC is 1 million cells for each subject. All groups will be observed until 6
      months.
    

Detailed description: 
      The eyes which will give the transplant should be given an aseptic and antiseptic technique
      to prevent the contamination from the inside and outside. Sterile cover attached to other
      parts of the face except for the eyes. 1.8 ml cell preparations are suspended in
      physiological NaCl until it reaches a total of 2 ml volume of cell suspension (for UC-MSC +
      NaCl group). Stem cell suspension will be injected by peribulbar and if the injection was
      done, patients will be given a quinolone antibiotic. On day 1st and day 7th after therapy,
      patients will be observed the presence of infection, inflammation, and increasing of eye
      pressure. On day 7th, day 30th, and day 90th after therapy, patients will do a visual field
      test, visual acuity test, electroretinography, funduscopy, and Optical Coherence Tomography
      examination. The observation results will be written in the observation table and analyzed by
      a statistic. After the data was completed, then make a discussion, conclusion, and suggestion
      of the study.
    

Intervention name(s): Umbilical Cord Mesenchymal Stem Cell (UC-MSC); Conditioned Medium (CM)
Intervention type(s): Biological; Biological
Intervention description(s): Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar; Conditioned Medium (CM) injected by peribulbar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allogeneic Mesenchymal Stem Cell; Umbilical Cord Mesenchymal Stem Cell; Conditioned Medium; Allogeneic Umbilical Cord Mesenchymal Stem Cell
Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma
Condition: Diffuse Intrinsic Brainstem Gliomas
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study consists in only one treatment group, which will receive the first-line therapy for
      the disease - standard radiotherapy and a 150 mg/m2 dose of the investigational product
      (nimotuzumab)
    

Detailed description: 
      General Purpose

      1. To determine the therapeutic efficacy of the treatment with nimotuzumab in combination
      with radiotherapy in pediatric patients with diffuse intrinsic astrocytic of the brainstem
      glioma

      Specific Purposes

        1. To determine the efficacy regarding the event-free survival (EFS) rate by 6 months of
           treatment.

        2. To determine the overall survival time of the patients with diffuse intrinsic astrocytic
           tumors of the cerebral trunk treated with combined radiotherapy and nimotuzumab.

        3. To determine the antitumoral objective response of the patients treated with combined
           radiotherapy and nimotuzumab.

        4. To determine the duration time of the response in the cases of objective response
           reached (CR or PR) or disease stabilization.

        5. To assess the toxicity of the combination AcM h-R3-nimotuzumab and radiotherapy in the
           patients enrolled in the clinical study.
    

Intervention name(s): Radiotherapy; Nimotuzumab
Intervention type(s): Radiation; Biological
Intervention description(s): Radiotherapy will be given at the standard dose between 54 and 60 Gy for irradiation of tumors of the central nervous system.; The patients will receive the induction therapy for 12 weeks. If the patient reaches a complete, partial response (CR, PR) to the treatment or is at least evaluated as stable disease (SD) on week 12, the consolidation therapy should be initiated. The consolidation therapy will consist of the nimotuzumab administration, every 2 weeks.
Intervention MeSH terms: Nimotuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brainstem gliomas; pediatric patients
Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts
Condition: Femur Fracture
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Interventional

Summary: 
      Prospective randomized controlled trial comparing use of single leg spica with double leg
      spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years
      old.
    

Detailed description: 
      Introduction

        -  double-leg spica casting is the treatment of choice at many centers for the treatment of
           diaphyseal femur fractures in children 2 to 6 years old.

        -  Investigators hypothesize that these patients can be effectively treated with single-leg
           spica casting and that such treatment will result in easier care and better patient
           function during treatment.

      Methods

        -  Prospective randomized controlled study of patients between 2 and 6 years old with
           diaphyseal femur fractures

        -  patients randomly assigned to either immediate single or double-leg spica casting groups
           after consent was obtained

        -  Radiographs serially evaluated for maintenance of reduction with respect to length,
           varus/valgus angulation and procurvatum/recurvatum angulation

        -  After casts removal, the Activity Scale for Kids (Performance Version) questionnaire and
           a custom written survey were given to parents evaluating ease of care and function of
           children during treatment.
    

Intervention name(s): Spica casting
Intervention type(s): Other
Intervention description(s): single versus double leg spica casting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; femur; femoral; fracture; spica; cast; diaphyseal; single; double; patient age 2 to 6 years old
Efficacy of Sublingual Immunotherapy in Polysensitized Allergic Rhinitis Patients
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic
      rhinitis. It is often suggested that polysensitized patients might not benefit from specific
      immunotherapy as much as monosensitized patients, although further research on this subject
      is needed. This study compared the efficacy of SLIT with standardized house dust mite extract
      in mono- and polysensitized allergic rhinitis patients.

      Patients who were sensitized to house dust mites and treated with SLIT for house dust mites
      for at least 1 year between November 2007 and March 2010 were included. The mono-allergen
      sensitized group (Mgr) was defined as the patients who were sensitized to Dermatophagoides
      pteronyssinus (Dp) or D. farinae (Df; n = 70). The poly-allergen sensitized group (Pgr) was
      defined as the patients who were simultaneously sensitized to house dust mites and other
      allergens (n = 64). A standardized extract of house dust mites was used for immunotherapy.
      Anti-allergic medication and the total nasal symptom score (TNSS), including rhinorrhea,
      sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after SLIT.

      This study enrolled 134 patients. The TNSS improved significantly after SLIT in both groups,
      while the change in the TNSS did not differ significantly between the groups. The
      anti-allergic medication scores also decreased significantly in both groups, but there was no
      significant difference between the groups.

      In polysensitized allergic rhinitis patients, SLIT for Dp/Df gave comparable improvements in
      both nasal symptoms and rescue medication scores to those in monosensitized patients,
      regardless of other positive allergens. SLIT for Dp/Df might be considered in polysensitized
      allergic rhinitis patients.
    


Intervention name(s): Pangramin®
Intervention type(s): Drug
Intervention description(s): During a 4-week increasing-dose phase, the patients increased the daily dose from 1 to 5 drops of 1.6 STU/mL solution from day 1 to 10, 1 to 5 drops of 8 STU/mL solution from day 11 to 15, 1 to 5 drops of 40 STU/mL solution from day 16 to 20, 1 to 5 drops of 200 STU/mL solution from day 21 to 25, and 1 to 5 drops of 1000 STU/mL solution from day 26 to 30. After reaching the maintenance dose, 5 drops of 1000 STU/mL solution, the patients took the allergen three times per week during the maintenance phase.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allergic rhinitis; immunotherapy; sublingual
Dysphagia in Thoracic Surgical Patients
Condition: Thoracic Diseases
MeSH terms: Deglutition Disorders; Thoracic Diseases
Study type: Observational

Summary: 
      The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility
      impairment (VFMI) in individuals undergoing throacic surgical procedures. It also seeks to
      determine the impact of postoperative swallowing impairment on health-related outcomes.
    

Detailed description: 
      Swallowing impairment and VFMI are common, yet often overlooked, complications of thoracic
      surgical procedures. The true incidence of both dysphagia and VFMI in this patient population
      is unclear due to a lack of rigorous study using instrumental assessment techniques and
      validated outcomes in all patents undergoing thoracic surgery. The study is therefore aimed
      to determine the incidence of dysphagia and VFMI in this patient population and to
      characterize impairment profiles related to swallowing safety and efficiency. In addition,
      the study is also aimed to assess the relative impact of VFMI and dysphagia on health-related
      outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge
      status
    

Intervention name(s): Fiberoptic Endoscopic Evaluation of Swallowing
Intervention type(s): Procedure
Intervention description(s): This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
Other intervention name(s): FEES
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        240 individuals undergoing thoracic surgery will be enrolled in this study.
      
Keywords: Dysphagia; Extubation; Vocal Fold Mobility Impairment; Peak Cough Flow (PCF)
Establish Finite Element Mesh of the Numerical Models of the Thoracic Aorta
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      This study will be using finite element meshes and averaged algorithms to create the
      numerical thoracic aorta at different ages.
    

Detailed description: 
      This study will be using finite element meshes and averaged algorithms to create the
      numerical thoracic aorta at different ages.
    

Intervention name(s): computed tomography
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: thoracic aorta; finite element mesh
Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations
      that could be, in part, due to a central modification of nociception mechanisms. Previous
      studies have shown that pain perception was altered in Parkinson's disease (subjective and
      objective pain thresholds and pain-induced cerebral activity) and that administration of
      L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in
      dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain
      threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be
      involved in pain alteration in PD.

      To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine
      (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that
      duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients
      with PD.

      36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine
      increase the pain perception level compare to the placebo. This increase would be the same
      than those observed with L-Dopa.
    


Intervention name(s): duloxetine; placebo of duloxetine; injection of apomorphine; injection of placebo of apomorphine; L-Dopa; injection of placebo of L-Dopa
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): administration during 28 days; administration during 28 days; injection performed at D28; performed at D28; performed at D28; performed at D28
Other intervention name(s): injection of L-dopa
Intervention MeSH terms: Duloxetine Hydrochloride; Levodopa; Apomorphine; Dihydroxyphenylalanine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Noradrenergic system and pain in Parkinson's disease
Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a double-masked, randomized, bilateral, 2-Arm parallel group study. Subjects are
      scheduled for 3 study visits (screening/baseline, 7-Day and 30-Day follow-up visits) over a
      period of one month.
    


Intervention name(s): 9618X investigational lipid eye drops; Blink® Tears
Intervention type(s): Device; Device
Intervention description(s): Test Eye Drops; Control Eye Drops
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
3D Imaging of Neonatal Faces
Condition: Nose Deformities, Acquired
MeSH terms: Nose Deformities, Acquired
Study type: Observational

Summary: 
      Facial scans of newborns will be performed before and after implementation of respiratory
      support devices such as nasal CPAP. 3D scanned images will be processed by Fisher & Paykel
      Healthcare Limited. Images will be analyzed for changes or distortion in nasal structure.
    

Detailed description: 
      Any newborns admitted to the neonatal intensive care unit at Sharp Mary Birch Hospital for
      Women and Newborns between 24-42 weeks CGA with parental informed consent are eligible. 3D
      scanned image will be obtained prior to implementation of nasal support devices and after
      nasal support devices. Fisher & Paykel Healthcare Limited will analyze the 3D images and
      observations will be made for changes in nasal structure or distortion.
    

Intervention name(s): 3D Scan of nares
Intervention type(s): Other
Intervention description(s): 3D scan of subjects nose prior to implementation of ncpap and upon discontinuation of ncpap.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants between 24 and 42 weeks corrected gestational age and admitted to Sharp Mary Birch
        NICU.
      
Keywords: 3-Dimensional; continuous positive airway pressure; nasal changes
Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus
      also receiving metformin.

      Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma
      Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose
      (fasting and post-prandial), and also the safety and tolerability of AVE2268.
    


Intervention name(s): AVE2268
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus
Study on Musculoskeletal Disorders in Spanish Pianist
Condition: Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      Background: musculoskeletal disorders related to instrumental practice (TMRPI) affect many
      pianists.

      Objectives: to know the prevalence of TMRPI in the population of Spanish pianists and its
      relationship with gender, age, physical activity, number of years playing the piano and the
      number of hours per week.

      Design: transversal study based on a survey that included 30 volunteers of both genders, aged
      between 17 and 65, who played the piano for at least 2 years.

      Method. due to the absence of specific questionnaires for pianist populations on MMRPI, a
      questionnaire was conducted combining a validated questionnaire on MMR, the Nordic
      Musculoskeletal Questionnaire (NMQ) with an "ad hoc" questionnaire created specifically for
      this study
    


Intervention name(s): SURVEY
Intervention type(s): Other
Intervention description(s): Pain survey on pianists
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        professional pianists with musculoskeletal disorders
      
Keywords: assessments; pain; physical therapy specialty; musics