bioihbjkbjnl/mcl2 huggingface dataset:
Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
Condition: Gastroesophageal Reflux; Dental Erosion
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Tooth Erosion
Study type: Observational

Summary: 
      This study investigates the prevalence and pathophysiology of dental and periodontal
      involvement in pediatric patients with symptomatic or asymptomatic gastroesophageal reflux
      (GER) or gastroesophageal reflux disease (GERD). Primary objectives are to compare the
      prevalence of oral disease in children with and without a diagnosis or symptoms/signs of GERD
      in a cross-sectional study. Secondary objectives are to examine factors that might lead to
      the pathogenesis of the dental and periodontal lesions observed in this group of subjects.

      The primary hypothesis is to prove that children aged 10-18 years diagnosed with or having
      symptoms or signs of GERD have a significantly higher amount of dental erosions in comparison
      to a matched control group.

      Secondary hypotheses are that children aged 10 - 18 years diagnosed with or having signs of
      GER have higher DMFS (Decayed, Missing, Filled permanent tooth Surfaces) rates, higher SBI
      (Sulcus Bleeding Index) rates, worse Periodontal status, and lower saliva buffering capacity.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pediatric Specialty Clinics and General Pediatric Clinics at the University of California,
        San Francisco
Stress Hyperglycemia and Acute Ischemic Stroke
Condition: Stress Hyperglycemia
MeSH terms: Ischemic Stroke; Hyperglycemia
Study type: Observational

Summary: 
      Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its
      poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in
      stroke patients.Therefore, the objective of this work was to study the glycemic status of
      acute ischemic stroke patients and to assess its impact on stroke outcome.
    

Detailed description: 
      Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was
      estimated to be 80 cases.

      The NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary
      outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation,
      need for vasopressors, and 30-days mortality.
    

Intervention name(s): standard protocol for stroke patients
Intervention type(s): Other
Intervention description(s): Standard protocol for stroke patients
Other intervention name(s): no specific intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study included eighty acute ischemic stroke patients who presented within 24 hours of
        onset of symptoms. They were equally divided into two groups; group A included patients
        with normal (70-150 mg/dl) RBS on ICU admission and controlled blood sugar within 24 h,
        while group B included those with high RBS on ICU admission and uncontrolled blood sugar
        during first 24 h.
fMRI and Ghlrein in Obesity and Binge Eating Disorder
Condition: Obesity; Binge Eating Disorder
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      Binge Eating Disorder (BED) may be associated with he development of obesity. However, the
      pathogenesis of BED is currently unclear, thus making the development of treatment and
      prevention strategies for BED difficult. Differences in the mechanisms regulating food intake
      may go some way to reveal potential mechanisms for BED.The purpose of this study is to
      investigate the responses of key gut-derived hormones that are associated with the regulation
      of food intake and functional brain activity to food cues using fMRI in BED patients and
      weight matched controls.
    

Detailed description: 
      Participants will attend the laboratory on two separate occasions following an overnight
      fast. Following baseline measures they will be provided wither with a 600mL (600kcal) liquid
      meal (Fed condition) or a volume matched amount of plain water (Fasted condition) to consume
      within 15 min in a randomized crossover design. Blood samples will be collected for during
      the subsequent 120min to measure the glucose, insulin and gut hormone responses, and
      subjective appetite ratings will be collected. 1500mg of acetaminophen will be added to each
      of the test drinks so that the appearance in the blood can be used as a proxy measure of
      gastric emptying. Participants will then undergo a 45min brain scan to assess the responses
      to visual and auditory food cues.
    

Intervention name(s): Fed Condition; Fasted condition; Blood samples; Subjective appetite ratings; fMRI scan
Intervention type(s): Dietary Supplement; Dietary Supplement; Procedure; Behavioral; Procedure
Intervention description(s): Subjects will consume a 600mL 600kcal liquid test meal; Subjects will consume 600mL plain water.; Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min; Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.; Blood Oxygen Dependent (BOLD) signal response to pictures and words of food and non-food items will be measured using functional magnetic resonance imaging (fMRI).
Other intervention name(s): Boost (Novartis Nutrition)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; Binge eating disorder; fMRI; gut hormones
Effects of Ketone Bodies on Cognition in Type 2 Diabetes
Condition: Type2 Diabetes; Ketonemia; Cognitive Change
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Ketosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Diabetes negatively affects cognition and increases the risk of developing overt dementia.
      Decreased cerebral glucose metabolism may be contributing to this effect, thus providing a
      glucose substitute using ketone bodies might improve neuronal function.

      In this study the investigators propose to provide quantitative results on cognitive
      performance during acute hyperketonemia in patients with type 2 diabetes.
    

Detailed description: 
      It has been proposed that hypometabolism in the brain contributes to the neuropathology that
      leads to Alzheimer's disease (AD). Additionally cognitive disturbances in patients with AD
      are associated with and paralleled by a decrease in cerebral glucose metabolism. This AD-like
      reduction in cerebral metabolism has also been associated with insulin-resistance, and may
      contribute to one of the links between diabetes and AD. Therefore manipulating
      neuro-energetics by providing a glucose substitute seems to be a means of improving neuronal
      function.

      Here the investigators will examine the effect of ketone bodies on cognitive performance in
      patients with type 2 diabetes by a randomized cross-over trial. Each subject will meet for
      two experimental visits separated by 2-6 weeks. During the two visit days subjects will, in a
      randomized order, receive ketone bodies (β-hydroxybutyrate) or placebo (saline)
      intravenously. On both test days plasma glucose levels will be clamped. After glucose levels
      have been stabilized cognitive performance will be assessed by a battery of validated
      cognitive tests.
    

Intervention name(s): Ketone infusion; Saline infusion
Intervention type(s): Drug; Drug
Intervention description(s): β-hydroxybutyrate is infused intravenously.; saline is infused intravenously.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
An Optional Investigation of Biomarkers of Efficacy
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Observational

Summary: 
      House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and
      fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with
      poorer lung function, greater medication requirements and more asthma symptoms as well as
      chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA
      leads to the development of asthma, in addition to exacerbating pre-existing asthma in
      HDM-sensitised patients.

      ToleroMune House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy.

      Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will
      identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002
      study participants
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of subjects who completed TH002 and have been dosed with
        either placebo or the 12 nmol dose in the TH002 study.
      
Keywords: House Dust Mite; Rhinoconjunctivitis; ToleroMune
Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough
Condition: Respiratory Tract Diseases
MeSH terms: Respiratory Tract Diseases
Study type: Interventional

Summary: 
      This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub®
      (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for
      control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as
      rated by both parents and children.
    


Intervention name(s): Ointment containing camphor, eucalyptus oil, and menthol; Petroleum jelly
Intervention type(s): Other; Other
Intervention description(s): One time use; One time use
Intervention MeSH terms: Camphor; Menthol; Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cough symptoms; Cold symptoms; Congestion; Children; URI; Alternative cough symptom treatment
4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective: safety and tolerability of BI 10773 in male and female patients with type
      2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773
    


Intervention name(s): BI 10773 low dose; placebo to BI 10773; BI 10773 medium dose; BI 10773 high dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective
Condition: Diagnostic Self Evaluation
Study type: Observational

Summary: 
      In the present study, we propose objective diagnostic criteria for dry nose (DN) and
      investigate its characteristics. Questionnaires were completed by each participant during
      recruitment to record demographic data. DN test strips were used to evaluate the severity of
      DN at five time points and allergic status was assessed based on serum sIgE levels. Nasal
      secretions were collected and vasomotor rhinitis was diagnosed using the cold dry air test.
      The diagnosis of allergic rhinitis (AR) was based on the criteria of the Allergic Rhinitis
      and its Impact on Asthma consensus statement. Data are expressed as median and interquartile
      range, unless otherwise specified. Statistical significance was set at P < 0.05. The
      reference range (RR) of the 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were
      determined for each test strip length at each time point. This study aimed to investigate the
      characteristics of and propose objective diagnostic criteria for DN.
    


Intervention name(s): test strips,sponges and cold dry air test
Intervention type(s): Diagnostic Test
Intervention description(s): Test strips were used to evaluated the degree of dry nose, sponges were used to obtain the nasal secretion and cold dry air test was used to making diagnosis of vasomotor rihinitis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Overall, 20 patients (13 men and seven women) with dry nose and 100 controls (47 men and 53
        women) were recruited for the study. The ages of the participants ranged from 23 to 73
        years (mean = 47.7 years).
Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
Condition: Cryptosporidiosis; HIV Infections
MeSH terms: Cryptosporidiosis
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of diclazuril capsules compared with placebo capsules as
      treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be
      based on the drug's clinical results and on its anti-protozoan effects. Safety will be
      assessed by the occurrence of side effects as reported by patients at their visits and by
      frequent monitoring of hematology, biochemistries, and urinalysis.
    


Intervention name(s): Diclazuril
Intervention type(s): Drug
Intervention MeSH terms: Diclazuril
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Cryptosporidiosis; Diarrhea; diclazuril; Coccidiostats; Acquired Immunodeficiency Syndrome
Remote Ischemic Conditioning for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose is to evaluate feasibility and efficacy of Remote Ischemic Conditioning(RIC) as
      adjuvant therapy for Parkinson's Disease(PD). Sixty patients will be randomized into 2groups:
      RIC group receiving Remote Ischemic Conditioning except conventional therapy（n=30）and control
      group with conventional therapy (n=30).
    

Detailed description: 
      Remote ischaemic conditioning (RIC) is a procedure whereby ischaemia is induced to a limb for
      short periods of time by inflating pressure cuffs around arms to above systolic pressures
      (mmHg). This procedure induce neurohormonal, systemic or vascular changes in the body. Such
      changes often result in improved collateralisation of blood supply to various areas of the
      body, as well as improved efficiencies of cellular metabolism. RIC has been shown to improve
      outcomes in patients with heart attacks, strokes, but is not investigated for PD. We argue
      that RIC may exert neuroprotective effect on PD due to its multiple mechanisms. The aim of
      the study is to evaluate the impact of RIC on long term outcomes in patients with PD.
    

Intervention name(s): Remote ischaemic conditioning; conventional therapy
Intervention type(s): Device; Other
Intervention description(s): 5 cycles of 5 minutes of upper limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual sphygmomanometer applied to the upper arm and activated to go through 5 such cycles automatically. The blood pressure cuff in the active treatment arm will inflate to 200 mmHg. RIC will be completed 1-2 times per day for six months.; conventional therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Remote ischaemic conditioning
Pharmacokinetics of Meropenem During High-dose CRRT
Condition: Infection; Renal Failure
MeSH terms: Renal Insufficiency
Study type: Observational

Summary: 
      Assessment of meropenem plasma concentration in critically ill patients who require CRRT
      (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1
      gram every 8 hours.
    

Detailed description: 
      This is a prospective observational study performed on critically ill patients. Inclusion
      criteria are a severe infection on admission requiring the use of meropenem and CRRT.

      Both medical and surgical patients will be included. Any type of infections can be included
      (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes one-hour infusion of
      meropenem (1.0 gram) intravenously every 8 hours.

      Blood samples (2 mL) will be collected at the 15, 30, 45, 60, 75, 90, 120, 180, 240, and 480
      minutes after each dose of meropenem for 3 consecutive days. The standard arterial canula
      will be used to obtain samples.

      30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000
      rpms. Subsequently, supernatant will be collected and frozen.

      Serum meropenem concentration will be measured by high-performance liquid chromatography.

      Each patient's hemodynamic parameters will be recorded with the use of transpulmonary
      thermodilution technique (PICCO). Other therapies, i.e. ventilatory support, sedation, an
      antifungal agent will be given as required.
    

Intervention name(s): Meropenem; CRRT
Intervention type(s): Drug; Device
Intervention description(s): 1.0 gram of meropenem given intravenously every 8 hours; Continuous renal replacement therapy for three days
Intervention MeSH terms: Meropenem
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Severely ill patients treated in ICU
      
Biospecimen description: 
      Blood samples for obtaining meropenem concentrations
Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study will investigate the effects of methylphenidate on sleep in adults with Attention
      Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.
    

Detailed description: 
      Previous studies in children with Attention Deficit/ Hyperactivity Disorder (ADHD) have
      described the effect of stimulants on sleep patterns. However the data on adults with ADHD is
      sparse.

      The aim of this study is to investigate the effects of methylphenidate on sleep in adults
      with ADHD using polysomnographic parameters.
    

Intervention name(s): One-night polysomnographic recordings
Intervention type(s): Device
Intervention description(s): One-night polysomnographic recordings before and during methylphenidate treatment.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ADHD; Adult
Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans
Condition: Muscle Injury
Study type: Interventional

Summary: 
      Successful skeletal muscle regeneration depends on a functional pool of muscle stem cells,
      termed satellite cells (SC). SC are in a quiescent state throughout adulthood, but undergo
      multiple cycles of proliferation and self-renewal in response to muscle damage. During aging,
      there is a loss of SC quiescence, and SC more readily enter an ageing-state impairing their
      function.

      Animal studies have revealed a common denominator for increasing SC function and activity,
      namely Sirtuin activation. Natural stimulators of Sirtuins includes Nicotinamide Riboside
      (NR) (a Nicotinamide adenine dinucleotide (NAD+) precursor) and the polyphenol Pterostilbene
      (PT). In this study, we aim to investigate if NR+PT supplementation will promote skeletal
      muscle regeneration after muscle damage in elderly humans by enhanced recruitment of SC.
    

Detailed description: 
      14 days after start of placebo or NR/PT (500/100 mg twice daily) supplementation a muscle
      damage will induced in the m. vastus lat. by electric stimulation combined with eccentric
      work in a dynamometer. Muscle biopsies will be collected at 2 hours, 2, 8 and 30 days post
      damage and placebo or NR/PT supplementation will continue for the whole study period (45
      days).
    

Intervention name(s): Placebo (twice daily); Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)
Intervention type(s): Other; Other
Intervention description(s): Matching placebo; Elysium Basis TM, Elysium Health, Inc., NY, USA
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates NP001 in patients with amyotrophic lateral sclerosis (ALS) and evidence
      of systemic inflammation. Half of participants will receive NP001 and the other half will
      receive placebo.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS
      and evidence of elevated systemic inflammation. Subjects will be allocated (1:1) to NP001 and
      placebo. Drug or placebo will be given intravenously.
    

Intervention name(s): NP001; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ALS; Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Diseases; Inflammation; C-Reactive Protein
Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy
Condition: Cerebral Palsy Spastic Hemiplegic
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study evaluates the therapeutic effects of constraint-induced movement therapy on
      infants and children with hemiplegic cerebral palsy. Half of the participants will receive
      CIMT (constraint-induced movement therapy) and others will not.
    

Detailed description: 
      This study evaluates the therapeutic effects of constraint-induced movement therapy on
      infants and children with hemiplegic cerebral palsy. Half of the participants will receive
      CIMT (constraint-induced movement therapy) and others will not.

      Participants will be randomly assigned to either CIMT group or control group. Children of the
      CIMT group will wear forearm splint 24 hours for 3 weeks to inhibit use of the unaffected
      arm.
    

Intervention name(s): Constraint-induced movement therapy
Intervention type(s): Other
Intervention description(s): The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: constraint-induced movement therapy; hemiplegia; hand function; gross motor