bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Nilotinib in Cerebellar Ataxia Patients
Condition: Ataxia, Cerebellar; Ataxia, Progressive
MeSH terms: Ataxia; Cerebellar Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an institutional cohort study. Patients confirmed with spinocerebellar ataxia (SCA)
      and taking or planning to take Nilotinib (Tasigna®) are enrolled in this study. The daily
      dose of Nilotinib is 150mg-300mg and the patients will be followed up at 1, 3, 6, and 12
      months. Rating scale for Friedreich's ataxia I and II and Barthel index are used as general
      function and daily living performance index. Scale for assessment and rating of ataxia (SARA)
      are used as an objective measure of cerebellar function. Adverse drug reactions are evaluated
      based on CTCAE version 4.0.
    

Detailed description: 
      1. Patients taking Nilotinib 1-1.Baseline information: demographics, genetic type of SCA,
           brain MRI, electrocardiography, routine blood evaluations 1-2. Time point of evaluation:
           At initiation of taking Nilotinib, 1, 3, 6, and 12 months 1-3. Evaluation items (at each
           time point) Routine check-up: electrocardiography, routine blood evaluations Adverse
           events: CTCAE version 4.0 Daily living performance: Barthel index General function:
           Friedreich's ataxia I and II 1-4. Change of drug dose Based on the attending physician's
           decision

        2. Patients planning to take Nilotinib 2-1.Baseline information: demographics, genetic type
           of SCA, brain MRI, electrocardiography, routine blood evaluations 2-2. Time point of
           evaluation: Baseline, 1, 3, 6, and 12 months 2-3. Evaluation items (at each time point)
           Routine check-up: electrocardiography, routine blood evaluations Adverse events: CTCAE
           version 4.0 Cerebellar function: Scale for assessment and rating of ataxia (SARA) Daily
           living performance: Barthel index General function: Friedreich's ataxia I and II 2-4.
           Change of drug dose Based on the attending physician's decision
    

Intervention name(s): Nilotinib
Intervention type(s): Drug
Intervention description(s): 150-300mg daily dose of nilotinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinocerebellar ataxia; treatment; nilotinib; bcr-abl; receptor-tyrosine-kinase-inhibitor
Biological Effects of Treatment With Resveratrol in ART Patients
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      To evaluate the effects of a new nutraceutical formulation containing resveratrol (trademark
      GENANTE) on gamete quality in order to improve the reproductive process during ART.
    

Detailed description: 
      The purpose of the study is to evaluate the effect of a new nutraceutical formulation
      containing resveratrol (trademark Genante) on gamete quality in order to improve the
      reproductive protocols during Assisted reproductive technology (ART) protocols.

      The study is a randomized, single blind, parallel, comparative, experimental study during the
      pre-treatment before in vitro fertilization-embryo transfer (IVF-ET). A total number of 100
      patients will be enrolled: 50 patients with a pretreatment control group (control group) and
      50 patients with experimental pretreatment study group (resveratrol group). Patients will be
      assigned to groups during the recruitment phase in a randomized manner. In the control group,
      the treatment will consist of taking 400 microg once a day of folic acid commonly suggested
      as part of clinical practice, while in the Resveratrol Group, patients will receive one
      tablet twice a day (two tablets/day) of Genante. It is specified that the pretreatment with
      Genante includes folic acid in accordance with the clinical practice, 400 total microg per
      day. Both treatments will last for 3 months before the IVF procedure.
    

Intervention name(s): Resveratrol; Folic acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6; 400 mcg of folic acid
Other intervention name(s): Genante (S&R Farmaceutici S.p.A, Italy)
Intervention MeSH terms: Folic Acid; Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel, single blind, grouped randomised, interventional clinical study
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Continuous Quantified EEG in NeuroIntensive Care
Condition: Coma; Traumatic Brain Injury; Subarachnoid Hemorrhage; Ischemic Stroke
MeSH terms: Brain Injuries; Ischemic Stroke; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      To evaluate the ability of NICU staff to interpret, before and after a training period,
      symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG tracings.
    

Detailed description: 
      Using a web based tool, the clinicians of the two study centers will review 24 hours of
      recording (raw EEG data + derived qEEG variables).

      The intensivists will evaluate:

        -  symmetry,

        -  sedation level,

        -  seizures activities and

        -  artefact on continuous cEEG/qEEG tracings. The same tracings will be blindly reviewed by
           a certified neurophysiologist (using the app). The neurophysiologist evaluation will be
           considered as "reference".

      The results of the evaluation will be compared (intensivists vs. neurophysiologist) in order
      to understand if the intensivists are able to adequately identify the pathological findings.

      The study period will be:

        -  before a formal training

        -  after a formal training by neurophysiologist in order to understand if the training is
           able to improve the intensivists performance.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Intensivists will evaluate tracing from patients in coma after a traumatic/vascular event
        admitted to neurointensive care and recorded with continuous EEG for clinical reasons
      
Keywords: continuous EEG
Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.
Condition: Squamous Cell Head and Neck Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that induction chemotherapy followed by radiation
      therapy plus Cetuximab will give better results than the validated treatment
      (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.
    

Detailed description: 
      Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for
      patients with locoregional advanced head and neck cancers.

      This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU)
      followed by radiation therapy + Erbitux for patients with head and neck carcinoma with almost
      one measurable lesion by RMI or CT scan.

      We hope we can improve the progression free survival of 14% at two years .
    

Intervention name(s): carboplatin; 5 fluorouracil; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 70 mg per m2 and per day for four days. day 1; day 22; day 43; 600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43; total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks
Intervention MeSH terms: Carboplatin; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: induction chemotherapy; followed by irradiation and concurrent Erbitux, or radiochemotherapy
Testosterone and Weight Loss
Condition: Obesity in Men
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesise that testosterone therapy will synergize with dietary
      intervention to achieve weight loss. Obese men will receive diet, and be randomised to either
      testosterone therapy or placebo. Primary outcomes will be weight and body composition.
    


Intervention name(s): Testosterone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): TU im; placebo im
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To evaluate and compare plaque removal efficacy and safety of a novel dentifrice formulation
      immediately after the first supervised use and following one week of twice, daily use at
      home.
    

Detailed description: 
      Study participants brushed their teeth for one minute, two times daily, for seven days.

      Participants who met study entry criteria were randomized to either the test (Protegera™) or
      control (Crest™ Cavity Protection) toothpaste, and each were given the same straight, soft
      bristled toothbrush to use throughout the study.

      On Day 1, participants were given an oral exam, and a pre-brushing plaque score was recorded.
      Participants then brushed their teeth for one minute under supervision, and a post-brushing
      plaque score was recorded.

      On Day 7, participants were given an oral exam, and a pre-brushing plaque score was recorded.
      Participants then brushed their teeth for one minute under supervision, and a post-brushing
      plaque score was recorded.
    

Intervention name(s): Protegera™ toothpaste (NaF); Crest™ Cavity Protection toothpaste (NaF)
Intervention type(s): Drug; Drug
Intervention description(s): Plaque Reduction; Plaque Reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, single-center, examiner-blinded, parallel design clinical trial.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Orange Juice and Cardiovascular Disease Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study aims to compare the effect of an anthocyanin-rich blood orange juice with a
      standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD).

      Participants aged between 25 and 84 years of age will be recruited into a single arm, two way
      cross-over study based on their waist measurement, with 42 individuals required to complete
      the study. Participants will each receive two interventions in a randomised order: 500mL
      blood orange juice daily for 28 days, and 500ml standard (blonde) orange juice daily for 28
      days.

      Prior to each intervention there will be a 2 week "run in period" where participants will be
      asked to avoid consuming foods rich in anthocyanins. After the first 28 day intervention
      period, there will be a 3 week wash out period after which the participants will be asked to
      then drink the other juice for 28 days. The 500 mL of blood orange juice contains
      approximately 50mg of anthocyanins, whereas the standard juice contains none.

      Blood samples will be collected for the preparation of plasma and peripheral blood
      mononuclear cells (PBMCs) for the analysis of anthocyanin metabolite concentrations,
      transcriptomics and CVD risk markers. Urine samples will be collected and urinary excretion
      of anthocyanin metabolites will be quantified. Other measurements will include pulse wave
      analysis, pulse wave velocity, central blood pressure, waist and hip circumference, blood
      glucose, glycated haemoglobin (HbA1C) and insulin concentrations, and various measurements
      using the TANITA machine which include weight, fat mass, muscle mass, fat percentage,
      fat-free mass, total body water, bone mass, metabolic age, basal metabolic rate, visceral fat
      rating, and degree of obesity. All measurements and samples will be taken at baseline and
      post intervention for each phase of the study.
    


Intervention name(s): Standard (blonde) orange juice; Blood orange juice
Intervention type(s): Other; Other
Intervention description(s): Consumption of 500ml standard (blonde) orange juice daily for 28 days; Consumption of 500ml blood orange juice daily for 28 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular disease, blood orange juice, anthocyanins
Bicarbonate Administration in CKD
Condition: Chronic Kidney Disease; Metabolic Acidosis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acidosis
Study type: Interventional

Summary: 
      Low serum bicarbonate levels, even within the normal laboratory range, are strongly
      associated with increased risks of hypertension, endothelial dysfunction, cardiovascular
      disease and death. The current proposal will investigate whether bicarbonate administration
      in patients with chronic kidney disease (CKD) will improve the health and function of
      arteries and reduce the size of the left ventricle of the heart. Overall, the proposed
      research will provide important new scientific evidence upon which physicians can base
      recommendations to patients with CKD to decrease the risk of developing cardiovascular
      diseases.
    


Intervention name(s): Sodium bicarbonate; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating Single Ascending Doses of MR1817
Condition: Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study of MR1817. This study will provide an initial assessment of
      the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after
      administration of ascending single oral doses to healthy adult subjects.
    


Intervention name(s): MR1817; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Milk Warming on the Very Low Birth Weight Infant
Condition: Very Low Birth Weight Infant; Weight Gain; Feeding Disorder Neonatal
MeSH terms: Body Weight; Birth Weight; Weight Gain; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      This study will compare if using a continuous milk warmer to warm breast milk compared to the
      standard method of warming breast milk in a hot water bath improves weight gain and feeding
      tolerance in infants born at 32 weeks gestation or less over a ten-day period. The standard
      method does not keep the breast milk at a consistent temperature during the feeding. A
      continuous milk warmer maintains the breast milk at body temperature throughout the feeding.
      It is unknown which method improves weight gain and feeding tolerance in very low birth
      weight infants.
    

Detailed description: 
      The aim of this randomized prospective quasi-experimental study is to determine if providing
      body temperature breast milk feedings to very low birth weight infants through use of
      continuous milk warmer improves feeding tolerance and weight gain compared to a standard milk
      warming technique.

      Warming breast milk in a hot water bath just prior to feeding prior to feeding in the
      neonatal intensive care unit is a common practice. However, little evidence is available to
      support a standard warming method. This method allows inconsistent temperatures at time of
      feeding and progressive cooling of the milk during the feeding. No published study used a
      continuous warming device that delivered milk at a consistent physiological temperature
      throughout the feeding. The continuous warmer externally heats milk in the tubing just
      posterior to the feeding tube to provide body temperature milk to the infant.

      A convenience sample from the Children's Hospital at OU Medical Center of 50 very low birth
      weight infants will be randomly assigned to either the experimental or control group for ten
      days. The experimental group will receive warmed feedings through the duration of the feeding
      through the use of the Guardian Warmer™, a continuous milk warming device. A control group
      will receive breast milk feedings warmed using the standard milk warming methods. Feeding
      tolerance and weight gain over the ten-day period will be used to evaluate the effectiveness
      of continuous milk warming.
    

Intervention name(s): Treatment Guardian Milk Warmer (Medela TM); Control
Intervention type(s): Other; Other
Intervention description(s): Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm); Standard warming procedure of breast milk in syringe prior to feeding.
Other intervention name(s): Continuous milk warmer (Guardian Warmer, Medela™)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized prospective quasi-experimental controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast milk; milk warming
Nitric Oxide (NO) Activity and Diabetic Nephropathy
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Experimental data suggest that oxidative stress and endothelial dysfunction are key players
      in the pathogenesis of diabetic nephropathy. In the last few years the investigators were
      able to establish a method to assess endothelial function of the renal vasculature in humans
      and started to systematically study a variety of cardiovascular disorders known to be
      associated with endothelial dysfunction in other vascular beds, including hypertension,
      hypercholesterolemia and type-2 diabetes. In patients with type-2 diabetes the investigators
      could demonstrate that despite unaltered basal and stimulated NO-activity, the renal response
      to the antioxidant vitamin C was more pronounced compared to control subjects. These data
      suggest that oxidative stress is increased in the renal vasculature of diabetic patients.
      Furthermore, NO-activity in diabetic patients appears to be upregulated to compensate for the
      increase in oxidative stress. This hypothesis is supported by the demonstration of increased
      endothelial nitric oxide synthase (eNOS) expression in kidney biopsies of diabetic patients.

      The major focus of the investigators' current research activities is to assess the role of
      endothelial dysfunction in the very early stages of diabetic nephropathy. To this end,
      patients with increased fasting glucose or metabolic syndrome will be studied in comparison
      with an age-matched control group. Endothelial function and the role of oxidative stress will
      be assessed in the renal vasculature in all groups. In parallel, the investigators will study
      endothelial function in the forearm by venous occlusion plethysmography and in the retinal
      vasculature by scanning laser doppler flowmetry to dissect regional differences in the
      regulation of endothelial function. Further aspects include the role of microalbuminuria,
      glomerular hyperfiltration, and endogenous inhibitors of NO synthase such as
      NG,NG-Dimethyl-L-Arginine (ADMA). In a therapeutic approach, the investigators will determine
      the effects of various antioxidant treatment strategies on endothelial function and their
      potential role in the prevention of diabetic nephropathy.
    


Intervention name(s): Folic Acid
Intervention type(s): Drug
Intervention description(s): oral administration of folic acid 5mg /d for 4 weeks
Intervention MeSH terms: Folic Acid
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Prediabetes; Metabolic Syndrome; Healthy Controls; Endothelial function
Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
Condition: Asthma; Obesity
MeSH terms: Asthma; Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This project will assess the effectiveness of omega-3 fatty acid supplementation in
      controlling asthma symptoms among obese asthmatics, and will assess if a person's genes
      influence response to treatment (personalized medicine). This project may improve our ability
      to treat asthma and our understanding of the link between obesity and asthma.
    

Detailed description: 
      Obesity increases the risk for asthma diagnosis in children and adults. With obesity on the
      rise, a better understanding of this association may become critically important to public
      health. We will determine the impact of fish oil-derived Eicosapentaenoic acid (EPA) and
      Docosahexaenoic acid (DHA) on asthma control among obese asthmatics. These omega-3 fatty
      acids have been shown to: reduce inflammation important to asthma and improve asthma outcomes
      in an inconsistent manner across previous smaller studies - results that are consistent with
      a pharmacogenetic influence. There exists evidence that omega-3 fatty acid response displays
      a pharmacogenetic response related to ALOX5 genotype. Preliminary data suggests that obese
      individuals are at greater risk for possessing this same ALOX5 variant and thus obese
      asthmatics may be more responsive to fish oil. We will determine (in a sub-aim) if there
      exists an ALOX5 genotype-related response effect with fish oil. This will be the largest
      clinical trial of omega-3 fatty acid for the treatment of asthma, and the first applying
      pharmacogenetic/nutrigenetic analysis.
    

Intervention name(s): omega-3 polyunsaturated fatty acids; Omega-3 Fatty Acid
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): ProEPA Xtra 1000mg softgels: 3 softgels twice daily; Soybean oil: 3(age 12-25) matched softgel caps twice daily
Other intervention name(s): ProEPA Xtra 1000mg softgels; Placebo Soybean oil 1000mg soft gels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Obesity; Pharmacogenetics; Nutrigenetics