bioihbjkbjnl/mcl2 huggingface dataset:
Early Nutrition Impact on Post Abdominal Surgery Outcome
Condition: Postoperative Nutrition
Study type: Observational [Patient Registry]

Summary: 
      Introduction: Nutritional support is a vital therapy of most surgical patients. Early
      initiation via the enteral route has a significant effect on postoperative recovery. The
      prognostic role of CRP and albumin can be explained by their abilities to reflect
      inflammation in the acute phase in critical settings and assess the nutritional status of
      critically ill patients, respectively. This indicates the prognostic value of the CRP/ALB
      ratio in postoperative patients admitted to the ICU.

      Aim of work: Determine the effect of early enteral & parenteral nutrition on ICU outcome &
      nutritional status in postoperative abdominal surgical patients and investigate the effect of
      enteral & parenteral nutrition on CRP/albumin ratio as an inflammatory marker & its
      correlation with SOFA score.

      Methods: A prospective cohort non randomized study included 80 postoperative abdominal
      surgical patients at Critical Care Department, Cairo University over one year duration. Forty
      patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients
      (50%) received parenteral nutrition 6 hours after surgical procedures. Nutritional status and
      inflammatory markers were screened. All patients were followed up during the ICU stay & up to
      3 months. SOFA scoring was done every 48 hours.
    


Intervention name(s): postoperative nutrition
Intervention type(s): Dietary Supplement
Intervention description(s): Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study included patients with age more than 18 years underwent major abdominal
        surgeries.

        Pre-operative nutrition screening was done using Nutritional risk screening (NRS 2000).

        Patients were divided into two groups: Group A: 40 patients (50%) received enteral
        nutrition 6 hours after surgical procedure & Group B: 40 patients (50%) received parenteral
        nutrition 6 hours after surgical procedure according to the surgeons preference.

        Enteral feeding in group (A) was started 6 hours postoperatively via ryle tube or feeding
        jejunostomy including proteins (1.5 gm/kg/day) with a caloric value (4.1 kcal/gm), fat
        (caloric value = 9 kcal/gm) & carbohydrates.

        Parenteral feeding in group (B) was started 6 hours postoperatively using SmofKabiven
        Peripheral [FRESENIUS KABI] : 1200 ml , 38 gm amino acids, 34 gm lipids, 85 gm glucose,
        osmolarity 850 mosmol/L with total energy approximately 800Kcal.
REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      Impaired contractile function after a heart attack of the heart is a major cause of "heart
      failure" limiting quality of life and prognosis, which cannot be prevented even with optimal
      standard therapy, including immediate balloon/stent dilation of the infarct vessel.

      The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into
      the infarct vessel (after successful reperfusion therapy) may improve left ventricular
      contractile function compared to placebo therapy. After bone marrow aspiration progenitor
      cells are enriched via a centrifugation method.
    

Detailed description: 
      -  The study is a double-blind, placebo-controlled, randomized, multicenter trial.

        -  Patients after an acute myocardial infarction, undergoing successful reperfusion therapy
           are included.

        -  All patients undergo bone marrow aspiration 3 to 6 days after the infarction.

        -  After cell processing, enriched bone marrow-derived progenitor cells or placebo medium
           is infused direct into the infarct related artery during stop-flow. In addition, a left
           ventricular angiography is performed.

        -  After 4 months left ventricular angiography is repeated. The primary endpoint is the
           difference in change of left ventricular ejection fraction between the two groups.
    

Intervention name(s): Intracoronary infusion of enriched bone marrow-derived progenitor cells; Placebo medium supplemented with autologous serum
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute myocardial infarction
Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      In this study the investigators compare three stimulants to each other. The effects of these
      agents on cognitive performance (eg, attention and memory) and on the brain are being
      measured. The hypothesis is that stimulants will have a positive effect on cognitive
      performance.

      Each study participant will receive once a placebo and once methylphenidate or modafinil or
      caffeine. Methylphenidate (also known as Ritalin ®) is a drug that is used in the treatment
      of attention deficit / hyperactivity disorder (ADHD) in children, adolescents and adults.
      Modafinil ( Vigil ®) is a drug used in the treatment of narcolepsy (sleeping sickness). In
      the study. These substances are given in the study only once and in the dosages in which is
      also used for the treatment of the above diseases. In the case of caffeine , the dosage
      corresponds to two cups of coffee.
    


Intervention name(s): Methylphenidate 20 mg tablet given once by mouth; modafinil 200mg tablet given once by mouth; caffein 200mg tablet given once by mouth; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3-arm, single-drug dosage comparison study; 3-arm, single-drug dosage comparison study; 3-arm, single-drug dosage comparison study
Other intervention name(s): Ritalin; Provigil; Coffeinum
Intervention MeSH terms: Caffeine; Methylphenidate; Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Brain Activity
Sorbent Therapy of the Cutaneous Porphyrias
Condition: Erythropoietic Protoporphyria
MeSH terms: Protoporphyria, Erythropoietic; Porphyria, Erythropoietic; Porphyrias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators demonstrated that cholestyramine is an effective binding agent in vitro for
      porphyrins. A few isolated case reports of treatment of individuals with a cutaneous
      porphyria suggest that cholestyramine and colestipol effectively remove porphyrins.
      Hypothesis: orally administered colestipol will effectively reduce sun sensitivity and lower
      erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).
    

Detailed description: 
      Four adults with proven EPP volunteered as subjects for this study. First period: Subjects
      received 1 gm colestipol twice daily for ~45 days, then 2 gm twice daily for ~45 days. Labs
      included CBC; liver chemistries including cholesterol; serum iron, TIBC and ferritin;
      erythrocyte and plasma protoporphyrin concentrations; and completion of sun exposure
      questionnaire focused on cutaneous manifestations every 2-4 weeks. Second period: Subjects
      received colestipol tablets, 2 grams twice daily, completing the sun exposure questionnaire
      and protoporphyrin determinations ~monthly for 5-6 months.
    

Intervention name(s): Colestipol
Intervention type(s): Drug
Intervention description(s): 2 grams morning and bedtime for 90 days.
Intervention MeSH terms: Colestipol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sorbent; Resin; EPP; Cutaneous porphyria; Adult; over age 21; without intercurrent illness; not pregnant; willing to participate
Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing
Condition: Wheezing
MeSH terms: Respiratory Sounds
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone
      dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg
      nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in
      children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of
      symptoms and exacerbations, will be assessed.
    


Intervention name(s): Nebulized beclomethasone dipropionate
Intervention type(s): Drug
Intervention description(s): Nebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg)
Other intervention name(s): BDP
Intervention MeSH terms: Beclomethasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wheezing; Children
Effects of a Gum Gel Intended to Treat Signs and Symptoms of Teething
Condition: Tooth Eruption Disorder
MeSH terms: Exanthema
Study type: Observational

Summary: 
      Teething discomfort is a widespread disorder affecting a very high percentage of infants. The
      use of hyaluronic acid gels has been shown in the last 20 years to be an effective tool,
      generally devoid of side effects, in reducing oral mucosal inflammation in adults. Its
      effectiveness in infants is affected by the strength of hyaluronic acid retention over the
      oral mucosa. This is in turn affected by formulation and may vary between different products
      due to the different ingredients used. In this study, the results collected by monitoring the
      paediatric experience regarding a newly developed HA-based medical device, intended to
      counteract teething discomfort in infants, will be reported.
    


Intervention name(s): Teething Gel; Teething Ring
Intervention type(s): Device; Device
Intervention description(s): Dosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks; The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants, without ethnic limitations, of both sexes and between the ages of 2 and 12 months,
        affected by teething discomfort but considered otherwise healthy.
      
Keywords: gums; redness; fever; paediatric; inappetence; sleep disturbance
Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke
Condition: Stroke; Dysphagia
MeSH terms: Deglutition Disorders; Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether pharyngeal electrical stimulation in
      addition to standard care can enhance swallowing recovery in severely dysphagic stroke
      patients post extubation compared to sham treatment plus standard care.
    


Intervention name(s): Phagenyx-Catheter, Phagenesis Limited, UK.; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Pharyngeal electrical stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual patients. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.; The intraluminal catheter (Phagenesis Ltd.) for pharyngeal electrical stimulation is placed. In the sham group the optimisation procedure was imitated as closely as possible to mitigate any bias or effect of time spent interacting with the patient during PES, but no current was applied. After this procedure 10 min of sham stimulation were delivered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: extubation
A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®)
Condition: Polyarticular Juvenile Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Observational

Summary: 
      The objective of this study is to assess persistence, adherence and changes in disease
      activity in the children population of juvenile arthritis patients treated with adalimumab
      (HUMIRA®) in the routine clinical settings in the Russian Federation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with diagnosed polyarticular juvenile arthritis according to ILAR criteria treated
        with HUMIRA (adalimumab) in routine clinical settings in the Russian Federation.
      
Keywords: Humira®; polyarticular juvenile arthritis; Adalimumab
To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients
Condition: Mucopolysaccharidosis II
MeSH terms: Mucopolysaccharidosis II; Mucopolysaccharidoses
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human
      iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients
    


Intervention name(s): GC1111_0.5mg/kg; GC1111_1.0mg/kg; Elaprase_0.5mg/kg
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hunter syndrome; MPS II; Idursulfase
Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry
      eye subjects following 90 days of QID (4 times/day) dosing.
    


Intervention name(s): Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops
Intervention type(s): Other
Other intervention name(s): Systane® Gel Drops
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.
Condition: Osteopenia; Bone Turnover Markers; Quality of Life
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      The aim of our research was to define both in vivo and in vitro whether and to what extent an
      high-impact exercise program would affect bone cell turnover and improve the QoL in
      osteopenic postmenopausal women.
    

Detailed description: 
      Subjects were selected among those attending the "Bone and Mineral Metabolism Disorders"
      Clinic of Perugia University, Italy, since May 2nd 2015 and January 31st 2016. A total of 33
      post-menopausal women volunteered to participate in the study.
    

Intervention name(s): Physical exercise
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This was an interventional, single group assignment study in which the subjects were first assigned to the control group and, after 1-month interval with no physical training, were shifted into the 3-months exercise intervention group. Thus, the subjects acted as their own control at the end of the study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteopenia; Physical activity; Bone turnover markers; Osteoprogenitor cells; Quality of life
Influenza Immunization of Children in India
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      Influenza viruses are significant causes of human illness and death in developed and
      developing countries. This study will measure the ability of influenza vaccine given to
      children in India to protect both the children and unimmunized persons around them from
      influenza. It will also determine whether the best time to immunize in a country like India
      that has both summer and winter outbreaks of influenza is in the fall, as is done now, or
      whether immunization should be in the spring to protect against influenza infections in the
      summer.
    

Detailed description: 
      Although influenza vaccines are used routinely in the United States, including in young
      children, influenza vaccines have not seen widespread use in India. This is likely
      contributed to by the lack of information from India about disease burden due to influenza
      and because influenza vaccines have not been tested for efficacy in India. In addition,
      because young children are thought to be important in the spread of influenza in families, it
      is possible immunization of children against influenza will reduce influenza infections among
      older children and adults in the home. The study described here is an extension of an earlier
      study (ClinicalTrials.gov NCT00934245) that tested the use of immunization against influenza
      in the fall. The current study will administer influenza vaccine in the spring prior to the
      summer monsoon rains that are associated with peaks of influenza activity in parts of India.
      Reduction of influenza infections among the influenza immunized children and their household
      members will be compared to the children and household members in the control vaccine group.
    

Intervention name(s): Inactivated Trivalent Influenza Vaccine (TIV); Inactivated poliovirus vaccine (IPV), trivalent
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; India; Children; Trivalent Influenza Vaccine (TIV); Inactivated poliovirus vaccine (IPV); Direct influenza vaccine effectiveness; Total influenza vaccine effectiveness; Indirect influenza vaccine effectiveness
Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome
Condition: Dysbiosis; Endotoxemia; Metabolic Syndrome; Inflammation
MeSH terms: Endotoxemia; Metabolic Syndrome; Syndrome; Inflammation; Dysbiosis
Study type: Interventional

Summary: 
      This study evaluates dietary green tea extract to improve gut health and inflammation in
      persons with metabolic syndrome and healthy adults. Participants will complete two phases of
      intervention in random order in which they will consume green tea extract or placebo for one
      month and then switch to the opposite treatment for an additional month.
    

Detailed description: 
      Tea is the most abundantly consumed prepared beverage in the world. Green tea, containing
      catechins, exerts antiinflammatory activities. However, a fundamental gap exists concerning
      its intestinal-level targets that can prevent metabolic syndrome (MetS) development and
      progression. Studies in obese rodents indicate that green tea inhibits nuclear factor
      kappa-light-chain-enhancer of activated B cells (NFκB) activation by limiting gut-derived
      endotoxin translocation to the portal circulation and decreasing hepatic Toll-like receptor-4
      (TLR4) pro-inflammatory signaling. The objective of this clinical investigation is to
      establish evidence-based recommendations for green tea, based on improvements in endotoxemia
      and restored gut barrier function, that promote optimal health. The hypothesis is that green
      tea catechins function to limit metabolic endotoxemia by ameliorating gut dysbiosis-mediated
      inflammation that otherwise provokes intestinal permeability. This will be tested by
      conducting a double-blind, placebo-controlled, randomized-order, crossover trial in MetS and
      healthy persons to examine the efficacy of green tea on metabolic endotoxemia. Each treatment
      will be one-month in duration and separated by a washout period. The anticipated outcomes are
      expected to be of significance, because they will advance a dietary strategy to help avert
      MetS complications attributed to metabolic endotoxemia by establishing antiinflammatory
      prebiotic and antimicrobial bioactivities of catechins that promote intestinal health.
    

Intervention name(s): Green Tea Extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A gummy confection with catechin-rich green tea extract (1 g/d); A matched gummy confection formulated without green tea extract
Other intervention name(s): Camellia sinesis plant extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Green tea; Gut barrier function; Gut dysbiosis; Inflammation; Metabolic endotoxemia; Metabolic syndrome; Microbiome
Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5)
      after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase
      chronic myeloid leukemia (CML) using EUTOS (European Treatment and Outcome Study for
      CML)-standardized laboratories. All participants received nilotinib 300 mg twice daily (BID).
    

Detailed description: 
      This was a Phase IV open-label, multi-center, single-arm study in participants with newly
      diagnosed Philadelphia chromosome positive (Ph+) CML in chronic phase for who nilotinib is
      the appropriate treatment at the discretion of the investigator.

      A screening period of 2 weeks was used to assess eligibility and to taper participants off
      disallowed medications. Participants whose eligibility was confirmed entered a 24 months
      treatment phase with nilotinib 300mg BID. Nilotinib was prescribed by the investigator
      according to the individual needs of the participants.
    

Intervention name(s): Nilotinib
Intervention type(s): Drug
Intervention description(s): A daily dose of 300 mg was given to all participants as two 150 mg capsules BID. The prescription of study drug was not study dependent and followed medical needs of the participant only. The study treatment was administered for 24 months.
Other intervention name(s): AMN107
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Myeloid Leukemia; Nilotinib; Molecular Response; MR4.5