bioihbjkbjnl/mcl2 huggingface dataset:
Study of Botulinum Toxin and Recovery of Hand Function After Stroke
Condition: Stroke With Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether injections of botulinum toxin (commonly
      known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles
      controlling the hand, will lead to improved use of the hand when compared to injections of
      placebo (a substance that looks similar to the study drug but contains no active study
      medication).
    

Detailed description: 
      Hemiparesis is the most common motor impairment after stroke that frequently leads to
      persistent deficits in hand function. This study investigates whether the application of
      botulinum toxin to a set of synergistically-acting hand muscles, in conjunction with
      task-specific therapy, will lead to reorganization and improved motor function in the
      stroke-involved hand. The investigators will use objective psychophysical measures of hand
      function and hand function rating scales to investigate if Botox in conjunction with
      task-specific therapy will lead to:

        -  improved motor execution,

        -  improved motor planning during a psychophysical two-finger grasping and lifting task
           with varying object weight, and

        -  increased hand function as assessed by the time taken to complete fine motor tasks.
    

Intervention name(s): Botulinum Toxin commonly known as BOTOX®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
There will be 1 treatment cycle during the 9 week study.; The control group will receive a placebo injection.
Other intervention name(s): BOTOX®; Saline
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Rehabilitation; Fingers; Grasp; Hand; Strength; Brain Infraction; Pathology; Physiopathology; Functional Laterality; Neuronal Plasticity; Psychomotor Performance; Biomechanics; Touch; Weight-Bearing
A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3%
      (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)
      in the treatment of the actinic keratosis
    


Intervention name(s): Diclofenac sodium; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.; Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Other intervention name(s): Solaraze; Vehicle base
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery
Condition: Intraoperative Blood Loss; Thoracolumbar Spine Surgery
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Observational

Summary: 
      This is a single-center, prospective, observational study that will compare the blood
      transfusion rate between intraoperative bleeding severity characterized using the Validated
      Intraoperative Bleeding Scale (VIBe).
    

Detailed description: 
      Primary Aim: Assess the association between the VIBe scale and intraoperative and
      postoperative blood transfusion rates for posterior thoracolumbar spine surgery.

      Primary Hypothesis: Patients with higher recorded VIBe grades during the five stages of spine
      surgery (exposure, decompression, instrumentation, fusion, and closing) will have a higher
      rate of receiving blood transfusions.

      Secondary Aims: Determine the association between the VIBe scale and other postoperative
      outcomes and complications.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective open, posterior thoracolumbar surgery
      
Keywords: Blood Loss; Thoracolumbar Spine Surgery; VIBe; Blood Transfusion
Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health
Condition: Chronic Gingivitis; Chronic Gingivitis, Plaque Induced
MeSH terms: Gingivitis; Chronic Disease
Study type: Interventional

Summary: 
      This study evaluates the addition of a mouth rinse containing sea salt, xylitol and lysozyme
      to standardized oral health practices on biofilm formation and gingival health in a group of
      young adults.
    

Detailed description: 
      The purpose of this study is to evaluate a new sea salt mouth rinse containing xylitol and
      the antibacterial enzyme, lysozyme on biofilm formation and gingival health in a group of
      young adults. Xylitol is a well-established non-sugar sweetener and an anti-caries agent. The
      use of this polyol results in loosely adherent biofilms by reducing the amount of
      extracellular lipopolysaccharides and lipoteichoic acids, facilitating its easy removal by
      mechanical means. Lysozymes are antibacterial proteins that hydrolyze the linkage between
      N-acetylmuramic acid and N-acetylglucosamine of peptidoglycan in the cell wall of Gram +
      bacteria effectively limiting growth.
    

Intervention name(s): Sea Salt Mouth Rinse; Standardized Oral Health Practices
Intervention type(s): Other; Other
Intervention description(s): Rinsing mouth with a tablespoon of sea salt mouth rinse without any dilution, for 30 seconds, once in the morning and once before bed, in addition to Standardized Oral Health Practices.; Brushing teeth for two minutes using the modified Bass technique, twice per day with the provided dentifrice, and flossing once daily using the spool method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gingival Health; Biofilm Formation
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to
      treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive
      assessment.

      The secondary objectives of the study are to evaluate the safety of T-817MA and the
      activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to
      evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the
      ADCS-CGIC.
    


Intervention name(s): T-817MA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 224 mg T-817 MA once daily; Placebo once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Alzheimer's
Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome
Condition: Turner's Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional

Summary: 
      RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X
      chromosome and do not produce estrogen. Giving estrogen is standard treatment for girls who
      have Turner's syndrome. Estrogen may be effective treatment for mental and social functioning
      problems experienced by girls with Turner's syndrome.

      PURPOSE: Clinical trial to study the effectiveness of long term estrogen therapy on mental
      and social functioning in girls who have Turner's syndrome.
    

Detailed description: 
      PROTOCOL OUTLINE: Participants are evaluated for cognitive and social function at entry and 4
      years following entry. Assessments include the Wechsler Intelligence Scale for
      Children-Revised, a child behavior checklist, the Children's Self-Concept Scale, and
      visual-spatial, visual-motor, attention, memory, language, and facial recognition tasks.

      Patients (and parents) undergo X-chromosome analysis; brain magnetic imaging is optional.

      Controls are matched using school selection and telephone interviews.

      A study duration of 12 years is estimated.
    

Intervention name(s): Estrogen
Intervention type(s): Drug
Intervention MeSH terms: Estrogens
Primary purpose: Treatment
Keywords: Turner's syndrome; genetic diseases and dysmorphic syndromes; rare disease
Whey Protein, Resistance Training, and Changes in Body Composition
Condition: Obesity
Study type: Interventional

Summary: 
      The objective of this project is to determine the effect of 9 months of progressive
      resistance training with daily whey protein supplements on the body composition (changes in
      muscle and fat) in young adults. The investigators hypothesize that those individuals who
      receive whey protein supplements will have larger gains in muscle and larger losses of fat
      tissue in response to resistance training compared to those who receive supplements of soy or
      carbohydrate.
    

Detailed description: 
      Healthy men and women will be recruited to participate in 9 months of supervised resistance
      training (3 days/wk) and will be randomized to one of three daily supplement groups: Whey
      protein, soy protein, or carbohydrate control. Body weight, muscular strength and endurance,
      and resting blood pressure will be assessed at baseline, 3, 6 and 9 months. Body composition
      will be assessed at baseline, 3, 5, 7, and 9 months. A sub-sample (N = 17 per group, assessed
      at baseline and 9 months) will be randomly selected for muscle samples of the upper leg to
      determine changes in the size of muscle fibers, and chemical factors associated with muscle
      growth. Blood samples will be obtained from sub-sample participants to assess changes in
      glucose and fat metabolism, as well as other chemicals likely to promote or inhibit muscle
      growth. We will also assess changes in daily energy expenditure and the use of fuel to
      produce energy (carbohydrate, fat, protein) that may result from the intervention. We
      hypothesize that those individuals who receive whey protein supplements will have larger
      gains in muscle and larger losses of fat tissue in response to resistance training compared
      to those who receive supplements of soy or carbohydrate.
    

Intervention name(s): Whey Protein supplement; Soy Protein Supplement; Carbohydrate supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 40 g/day of whey protein will be consumed in 2 doses for 9 months (Study duration); 40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration); 40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Whey Protein; Soy Protein; Resistance training; Weight Management
Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: A computer-aided detection program may help doctors find breast cancer sooner,
      when it may be easier to treat, in women undergoing screening mammography.

      PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer
      detection works in women undergoing screening mammography.
    

Detailed description: 
      OBJECTIVES:

        -  Compare, prospectively, the breast cancer detection rate and recall rate of single
           reading using computer-aided detection vs standard double reading in women undergoing
           screening mammography.

      OUTLINE: This is a prospective, randomized, multicenter study. Participants are randomized to
      1 of 3 screening arms.

        -  Arm I (double reading): Screening mammograms are independently reviewed by two readers
           (i.e., radiologist or radiographer), each of whom reports on any abnormalities and
           decides whether a participant is recalled for further assessment or returned home to
           routine screening. In the event there is disagreement between the readers' findings, a
           third reader acts as an arbitrator by rendering an interpretation of the mammogram and
           making the final decision to recall the participant or return to routine screening.

        -  Arm II (single reading with computer-aided detection [CAD]): Screening mammograms are
           reviewed initially by a single reader who reports on any abnormalities. The reader then
           re-examines the mammogram with the aid of CAD, a system that uses computer prompts to
           recall suspicious features or abnormalities that may have been overlooked or previously
           dismissed as being normal. Based on these evaluations, a recommendation is made by the
           reader to either recall the participant for further assessment or return home to routine
           screening. If there is a discrepancy between the reader's interpretation and the CAD
           findings, another reader may be consulted to review the mammogram.

        -  Arm III (double reading followed by single reading with CAD): Screening mammograms are
           reviewed by double reading as in arm I followed by single reading with CAD as in arm II.

      Peer Reviewed and Funded or Endorsed by Cancer Research UK

      PROJECTED ACCRUAL: A total of 30,000 participants will be accrued for this study.
    

Intervention name(s): breast imaging study; comparison of screening methods; radiomammography
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Primary purpose: Screening
Keywords: breast cancer
Examination of Virtual Supermarket (Vmall) as an Assessment of Executive Functions in Children and Adolescents With Acquired Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries
Study type: Observational

Summary: 
      The purpose of this research is to find whether or not there are differences in the executive
      functions during "shopping" in a "virtual mall", between children with Acquired Brain Injury
      (ABI) vs healthy children.

      The hypothesis is that there will be differences in time (more time to shop) and mistakes
      (more mistakes during shopping), in the ABI group.
    


Time perspective: Other
Keywords: year and more after TBI; good vision; at least one functinal hand; cap[able od doing shopping during everyday life
Assessing the Bite Counter
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to test the usability of the Bite Counter in an attempt to reduce
      participants' daily bites while also increasing their daily steps.
    

Detailed description: 
      Self-monitoring is an important component of behavioral management of obesity. The Bite
      Counter is a wrist-worn device which detects the motions characteristic of taking a bite of
      food or a drink of liquid, to provide the wearer with a cumulative count of bites and sips
      over the day. In earlier studies the method was shown to accurately count bites across a wide
      variety of foods, utensils and subject demographics, and to provide an unbiased intake
      measurement. The proposed work will continue to improve the bite counting method by adapting
      to varying eating rates, develop a self-managed bite count-based weight loss protocol, and
      perform an independent test of the protocol. An improved Bite Counter device will also
      measure activity (steps).
    

Intervention name(s): Bite Counter
Intervention type(s): Device
Intervention description(s): This study is a 15-week assessment of the possible utility of a wrist-worn device, the Bite Counter, in assisting the weight loss behavior change efforts of overweight and obese individuals. The Bite Counter tracks and analyzes wrist motions to identify those associated with taking bites of food and drinking beverages. It also has a step-counter feature. This study is designed to determine if using the Bite Counter with specific goals to reduce the numbers of bites and increase the numbers of steps will result in those changes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: obesity; weight loss
A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin,
      itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with
      ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with
      ivacaftor on lung function.
    


Intervention name(s): Lumacaftor; Ivacaftor; Ciprofloxacin; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet, 200mg taken every 12 hours; tablet, 250mg taken every 12 hours; 750 mg taken every 12 hours; 200mg taken once daily; 600mg taken once daily
Other intervention name(s): VX-809; VX-770
Intervention MeSH terms: Itraconazole; Ciprofloxacin; Rifampin; Ivacaftor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, open-label, active controlled, Phase 2 study designed to assess the
      safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and
      semi-monthly doses of GX-H9 in the treatment of Paediatric Growth Hormone Deficiency (PGHD)
      as compared to the standard of care daily rhGH treatment.
    

Detailed description: 
      GX-H9 is a new hGH product fused to hybrid Fc in studies as a once-a-week and every other
      week dosing regimen designed to overcome the inconvenience of daily rhGH injections and is
      under the studies designed to determine if the safety profile is comparable to currently
      approved daily rhGH products. Obviating the need for daily injections may increase compliance
      and therefore efficacy, which would be of great benefit to both paediatric and adult patients
      with GHD and other disorders with associated growth impairment and need for hGH substitution.
    

Intervention name(s): GX-H9; Genotropin
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection (weekly or twice-monthly); subcutaneous injection (daily)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Phase 2, randomized, open-label, active controlled, dose finding study
Masking: None (Open Label)
Primary purpose: Treatment
Relationship Between Diabetes and Cognitive Impairment Based on Olfactory Function Assessment and Functional MRI
Condition: Diabetes Mellitus; Cognitive Impairment; Obesity
MeSH terms: Diabetes Mellitus; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to explore the relationship between diabetes and cognitive
      impairment by olfactory function assessment and functional MRI.
    

Detailed description: 
      Previous research has shown both obesity and diabetes are associated with an increased risk
      of cognitive impairment. Meanwhile, olfactory impairment is associated with incident
      (amnestic mild cognitive impairment) aMCI and progression from aMCI to (Alzheimer disease) AD
      dementia. On one hand, in the cross-sectional study, biometric measurements, cognitive
      assessment, olfactory function and fMRI results are analysed to explore the differences among
      T1DM patients, T2DM patients and non-diabetic people . One the other hand, in the
      longitudinal study, changes in olfactory function and fMRI results in diabetic and
      non-diabetic obese patients both at baseline and 6 months after their bariatric surgery are
      collected to investigate whether better glucose and weight control benefit brain function.
    

Intervention name(s): Cognitive assessment; functional magnetic resonance imaging; olfactory function measurement; bariatric surgery
Intervention type(s): Behavioral; Other; Other; Procedure
Intervention description(s): Only a subgroup of the subjects will have the bariatric surgery.
Other intervention name(s): fMRI
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        T1DM(latent autoimmune diabetes in adult,LADA) and T2DM patients.
      
Keywords: functional MRI; olfactory function; bariatric surgery
Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers
Condition: VOLUNTEERS
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects of the probiotic Lactobacillus plantarum
      3547 over different inflammation and immune system markers on a healthy middle-aged group.
    

Detailed description: 
      In this randomized double blind controlled trial, a group of healthy middle-aged people (45
      to 65 years old) had a nutritional intervention to evaluate the Lactobacillus plantarum 3547
      probiotic effects over different inflammation and immune system markers, the experimental
      group took the experimental supplement (Lactobacillus plantarum 3547) during one period of
      parallel study (12 weeks), the volunteers consumed 1 capsule/daily with Lactobacillus
      plantarum 3547 (10x109 cfu/d) immediately after finishing their meal, the capsule contains:
      77 mg probiotic Lp3547 and 390 mg maltodextrins. The control group took the control
      supplement (Maltodextrin) during one period of parallel study (12 weeks), volunteers consumed
      1 daily capsule of maltodextrin without Lactobacillus plantarum 3547 (Placebo) immediately
      after finishing their meal. (The capsule contains 425 mg of maltodextrin)
    

Intervention name(s): Lactobacillus plantarum 3547; Maltodextrin
Intervention type(s): Other; Dietary Supplement
Intervention description(s): During one period of parallel study (12 weeks) volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 immediately after finishing their meal.; During one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lactobacillus plantarum; Maltodextrin; Probiotics; Randomized Controlled Trial