bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants
Condition: Nosocomial Infection; Necrotizing Enterocolitis
MeSH terms: Infections; Communicable Diseases; Cross Infection; Enterocolitis; Enterocolitis, Necrotizing; Birth Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether oral probiotic supplementation could reduce
      the incidence of nosocomial infections in preterm infants.
    

Detailed description: 
      There are growing numbers of evidence indicating the beneficial effects of normal enteric
      flora (probiotics) with regard to the host defense against infection. In vitro and in vivo
      studies have shown that probiotics such as lactobacilli and bifidobacteria have inhibitory
      effects on other pathogenic bacteria.This evidence, along with the results of recent clinical
      studies, has demonstrated the beneficial effects of probiotics in the prevention of NEC in
      VLBW infants.However, most of the studies reported nosocomial infection as a secondary
      outcome and the findings were controversial regarding probiotics efficacy in preventing
      nosocomial infections. There is only one study that was aimed to investigate effects of
      probiotic on the incidence of nosocomial infection.

      Given the potential benefit of probiotics against infection and the lack of clinical studies
      in this regard, we conducted a randomized clinical trial to determine whether probiotic
      supplementation (in the form of Lactobacillus acidophilus and Bifidobacterium infantis) could
      reduce nosocomial infection rate among preterm VLBW infants in a intensive care nursery
      setting.
    

Intervention name(s): probiotics
Intervention type(s): Biological
Intervention description(s): Daily enteral probiotic supplementation (live Lactobacillus acidophilus and Bifidobacterium infantis) at a dose of 2.5 x 108 CFU of each strain once a day.The supplementation was started on the first day of enteral feeding and continued for at least 28 days or until discharge. The study drug was in liquid form and mixed with breast milk or formula before given to the infants. The preparation was made on a daily basis by one person who was not involved in the care of the infants.
Other intervention name(s): Infloran (Swiss Berna)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: nosocomial infections; necrotizing enterocolitis; preterm infants; ver low birth weight; probiotics
Functional Testing and Performance in Tennis
Condition: Tennis
Study type: Observational

Summary: 
      The aim of this study was to correlate functional tests, clinical tests and rotator cuff
      strength with the speed of serve.

      For that purpose, tennis players (ITN 2-4) will be recruted among tennis players in the
      Province of Liege. They will be assessed 2 times.

      During the first assessment, lateral medicine ball throw, 2 ball throws, upper extremity y
      balance test and shoulder rotation range of motion will be assessed.

      During the second assessment, lateral medicine ball throw, the 2 ball throws and rotator cuff
      strength will be assessed.
    

Detailed description: 
      Forty healthy tennis players (ITN 2-4) will be recruted among players in the club of the
      Province of Liege.

      First session :

        -  Clinical testing

             1. Upper extremity Y Balance Test

             2. Range of motion (internal/external rotation)

        -  Functional tests

           a. Lateral Medecine Ball throw (5 repetitions) b. Single arm ball throw (1,5kg) d. Core
           endurance test

        -  Assessment of serve speed (radar) during 15 serves

      Second session :

        -  Clinical testing

           a. Assessment of rotator cuff muscles strength

        -  Functional tests

             1. Lateral Medecine Ball throw (5 repetitions)

             2. Single arm ball throw (1,5kg)
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Forty healthy tennis players (aged 14-30) and ITN 2-4 will be recruted in the clubs of the
        Province of Liege.
      
Keywords: tennis serve, performance, functional testing
Recombinant Human Leptin Therapy Effects on Insulin Action
Condition: Type Two Diabetes Mellitus
Study type: Interventional

Summary: 
      Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not
      known whether it improves insulin action in persons who are not leptin deficient. The purpose
      of the present study was to determine whether leptin therapy has effects on insulin action in
      obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial
      was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to
      treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.
    

Detailed description: 
      Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not
      known whether it improves insulin action in persons who are not leptin deficient. The purpose
      of the present study was to determine whether leptin therapy has weight loss-independent
      effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A
      randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed
      T2DM. Subjects were randomized to treatment with placebo (saline), low-dose (30 mg/d), or
      high-dose (80 mg/d) recombinant methionyl human (r-met hu) leptin for 14 days. Multi-organ
      insulin sensitivity before and after treatment was evaluated by using the
      hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labelled
      tracer infusions to measure glucose, glycerol and fatty acid kinetics.
    

Intervention name(s): placebo; low-dose leptin; high-dose leptin
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention description(s): saline placebo; 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days; 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: diabetes; obesity
The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to verify the efficacy and safety of Qizhiweitong granule on Chinese patients
      with functional dyspepsia diagnosed by the Rome III criteria. It includes two subtypes of
      functional dyspepsia, postprandial distress syndrome or abdominal pain syndrome.
    


Intervention name(s): Qizhiweitong granule
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dairy Product Consumption and Impact on Nutritional Adequacy, Environment and Diet Cost
Condition: Diet Pattern Analysis; Environmental Impact; Nutrient Intakes; Cardio-metabolic Health; Dietary Cost
Study type: Observational

Summary: 
      This is a secondary analysis of dietary, demographic and health parameter data collected in
      the 2008/09-2011/12 National Diet and Nutrition Survey (NDNS), UK to determine the roles of
      dairy products in sustainable diets by modelling nutritional adequacy, financial cost and
      environmental impact of UK diets containing varying amounts of dairy products.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The data included food consumption and nutritional data for 1655 adults (males: n=710 and
        females: n=945) aged 19-64 years old, in 2008/09-2011/12 National Diet and Nutrition Survey
        (NDNS).
Saving Life and Limb: FES for the Elderly With PAD
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will take the first step to improve public health for millions of Americans with
      Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The
      investigators will assess a proof of concept, home administered, functional electrical
      stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.
    

Detailed description: 
      This study will evaluate an innovative approach to reduce the debilitating symptoms of
      peripheral arterial disease (PAD) and ischemic pain during walking (intermittent
      claudication) by using a new Functional Electrical Stimulation (FES) system. The
      investigators hypothesize that combining the FES and walking one hour/day (FES+Walk) will
      significantly reduce pain during walking, improve locomotion, and enhance quality of life
      when compared to walking one hour/day (Walk) alone after 8 weeks of intervention.
    

Intervention name(s): FES (Gait MyoElectric Stimulator)
Intervention type(s): Device
Intervention description(s): Functional Electrical Stimulation (FES) will be tested in a group of peripheral arterial disease patients using the Gait MyoElectric Stimulator. The FES device will be applied to the calf and shin muscles on both of the patients legs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intermittent Claudication; Functional Electrical Stimulation
Acute Effects of Kinesiology Taping in Handball Players
Condition: Kinesiology Taping
Study type: Interventional

Summary: 
      The aim of this randomised placebo-controlled study was to investigate the acute effect of
      kinesiology taping in the gastro-soleus muscle group of handball players.

      Researchers compared the placebo and the kinesiology taping groups to see if there were any
      effects on foot plantar and dorsiflexion muscle strength, balance, proprioception, horizontal
      jumping and injury proneness.
    

Detailed description: 
      This randomised placebo-controlled and double blinded study aimed to investigate the acute
      effect of kinesiology taping in the gastro-soleus muscle group, which has the key role in
      jumping, of handball players on foot plantar and dorsiflexion muscle strength, balance,
      proprioception, horizontal jumping and injury proneness. There were two groups in the study:
      the experimental group was applied 'Y shaped' kinesiology taping on gastro-soleus muscle
      group, based on facilitation technique with 25-50% stretching. The control (placebo) group
      was applied kinesiology taping on gastro-soleus muscle group without any stretching.
      Participants' muscle strength, proprioception, balance, horizontal jumping and injury
      proneness was measured before and two hours after taping.
    

Intervention name(s): Kinesiology Taping; Placebo Taping
Intervention type(s): Procedure; Procedure
Intervention description(s): The experimental group was applied 'Y shaped' kinesiology taping on gastro-soleus muscle group, based on facilitation technique with 25-50% stretching.; The placebo group was applied kinesiology taping on gastro-soleus muscle group without any stretching.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised placebo-controlled with pretest-posttest both groups.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: muscle strength; proprioception; handball players
Nattokinase Supplementation and Hemostatic Factors
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to examine the effects of nattokinase supplementation on hemostatic
      factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time,
      prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid
      profiles were measured at baseline and at 8-week follow-up.
    


Intervention name(s): Nattokinase; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Renew NCP-5 for the Treatment of Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild Dementia of the Alzheimer's Type
Condition: Alzheimer Disease; Cognitive Dysfunction; Mild Cognitive Impairment; Mild Dementia; Cognitive Decline; Dementia, Alzheimer Type
MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized Pivotal Study of RenewTM NCP-5 for the Treatment of Mild Cognitive Impairment
      due to Alzheimer's Disease or Mild Dementia of the Alzheimer's Type is a pivotal, single
      blind, parallel design, multi-site study intends to examine the efficacy and safety of
      RenewTM NCP-5 therapy in the treatment of Cognitive Impairment due to Alzheimer's Disease or
      Mild Dementia of the Alzheimer's Type. Subjects will be prospectively randomized to treatment
      or sham (in a 1:1 ratio) using stratification for Cognitive Impairment due to Alzheimer's
      Disease or Mild Dementia of the Alzheimer's Type, and Cardiovascular Risk (CVR) score at
      multiple sites. Subjects, ages 55-85, will be consented for 13 months and will receive
      thirty-five 60-minute RenewTM NCP-5 treatment sessions during a 7-to-12-week initial
      treatment period, and then transition to a lower frequency maintenance period (twice a week)
      for a total treatment period of 24 weeks.
    


Intervention name(s): Renew NCP-5
Intervention type(s): Device
Intervention description(s): Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to either the treatment group or the sham group.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Exercise Effects on Insulin, Gut Peptides, and Appetite
Condition: Endocrine and Metabolic Responses to Exercise and Diets
Study type: Interventional

Summary: 
      Determine whether the mid-day suppression of hunger and amplified increase in the release of
      glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) following
      morning exercise is due to increased fat content of the diet per se or a combination of high
      fat diet after morning exercise. The action of gut peptides, particularly GLP-1, on gastric
      emptying is likely to be important in mediating its effects on postprandial appetite and
      glycemia (Nauck et al. 1997). Our hypothesis is that exercise amplifies gut peptide secretion
      when diet is enriched with fat, and that this stimulus suppresses the hunger sensation.
    

Detailed description: 
      Specific aim: Determine whether a change in macronutrient composition from 60% carbohydrate
      and 25% fat to 30% carbohydrate and 45% fat is responsible by itself for suppression of
      hunger and increased secretory response of glucose-dependent insulinotropic hormone (GIP) and
      glucagon-like peptide-1 (GLP-1), or whether these changes depend on preceding exercise. We
      will measure (a) concentrations of plasma GIP and GLP-1 by chemiluminescent multiplex assay,
      (b) concentrations of plasma ancetaminophen to assess the gastric emptying rate, (c)
      concentrations of plasma insulin, and glucagon by radioimmunoassay, and glucose, ketone
      bodies, and free fatty acids with appropriate spectrophotometric methods, (d) hourly appetite
      responses with visual analog scale under two conditions: sedentary (SED) and exercise (EX).

      Hypothesis: Hunger suppression and secretion of GIP and GLP-1 after the morning meal will be
      greater with slower gastric emptying rate when a meal consisting of 45% fat and 30%
      carbohydrate follows three hours after a 2-hour bout of moderate-intensity exercise than in
      the absence of exercise.
    

Intervention name(s): Exercise and diets
Intervention type(s): Other
Intervention description(s): Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise; high carbohydrate and high fat diets; insulin; gut peptides; appetite; metabolism; glucose
Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of 3 different approaches to exercise
      training in women with early stage breast cancer who have completed all primary treatments
      (except hormone therapy, if appropriate). Prior research in women with early stage breast
      cancer has shown that some treatments may have an adverse impact on physical fitness levels
      leading to feelings of fatigue and poor quality of life. Supervised exercise training has
      been shown to reduce some of these side-effects. However, all the exercise programs have
      followed essentially the same approach. This study is designed to see if a different approach
      to exercise training is more effective than the conventional approach currently in use.
    


Intervention name(s): Linear Aerobic Training; Nonlinear Aerobic Training; Progressive Stretching; Cardiopulmonary exercise test (CPET); Blood draws
Intervention type(s): Behavioral; Behavioral; Behavioral; Other; Other
Intervention description(s): The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).; The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).; All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.; Complete blood count
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: breast cancer; Linear Versus Nonlinear Aerobic Training; 15-147
Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the feasibility and potential efficacy of augmenting SRIs with
      minocycline. The study will assess whether the addition of minocycline leads to measurable
      changes in striatal glutamate (Glu) levels. This study will recruit up to 45 youth ages 8-20
      diagnosed with clinically significant OCD who have demonstrated no more than minimal response
      to SRI treatment and are currently on a stable dose of SRI medication for at least 12 weeks.
      Participants will be randomized to receive either 12 weeks of minocycline treatment or pill
      placebo. Randomization will be 2:1 so that 2 of 3 participants receive minocycline. Screening
      for eligibility will take place for 1-4 weeks. Participants will undergo magnetic resonance
      spectroscopy (MRS) scans to measure striatal Glu levels prior to randomization, and again
      immediately following the treatment period. During the treatment period, participants will
      meet initially weekly and then every other week with the study psychiatrist. All participants
      will be offered three months of open medication treatment following participation. The
      clinical trial will only be conducted at the New York State Psychiatric Institute (NYSPI) and
      the MRS scans may be conducted at Weill Cornell Medical Center or NYSPI.
    

Detailed description: 
      Please see the brief summary for study description.
    

Intervention name(s): Minocycline; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.; A placebo pill will be administered twice a day (BID) for 12 weeks.
Other intervention name(s): Minomycin, Minocin, Arestin, Aknemin, Solodyn and Dynacin
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obsessive compulsive disorder
Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation
Condition: Obesity; Overfeeding; Muscle Mass; Body Composition; Ectopic Fat
MeSH terms: Cardiac Complexes, Premature
Study type: Interventional

Summary: 
      To investigate metabolic and molecular response to fatty acid-specific overfeeding in
      overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin
      sensitivity
    


Intervention name(s): PUFA-group; SFA-group
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Overfeeding; Weight gain; Liver fat; Pancreatic fat; Ectopic fat; Skeletal muscle; Adipose tissue; Gene expression; DNA methylation; Palmitate; Linoleic acid; Saturated fat; Polyunsaturated fat; Metabolism; Insulin sensitivity
A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients
Condition: Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      This study is a methodology study designed to discover whether a brain imaging technology is
      a better way of compare the relative sensitivities of fMRI and subjective psychometric
      assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical
      study design.
    


Intervention name(s): Placebo; Pregabalin; Tramadol SR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BID; Dose 75 mg titrated to 150 mg, bid; Dose 50mg titrated to 200 mg, bid
Intervention MeSH terms: Pregabalin; Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment