bioihbjkbjnl/mcl2 huggingface dataset:
Nutrition, Health and Quality of Life: Development of New Formulations of Traditional Products of the "Made in Italy" Diet Optimized for Consumers With an Age Over 50 Years (MIAO 50)
Condition: Aging
Study type: Interventional

Summary: 
      The study ""Nutritional trial with fortified milk in 65+ years old subjects" is a part of a
      complex research project and multi-sectoral development (MIAO 50) with the participation of
      University Research Institutes and small and medium Italian enterprises.

      The general objective of the call is to promote the collaboration between the best scientific
      knowledge, both epidemiological and experimental, and the most advanced technologies to
      develop foods with a nutritional profile adequate to the needs of consumers with an age over
      50 years old, which are easy to use and make it possible to eat in a healthy manner, complete
      and balanced and also meets the quality and flavors of traditional Italian.
    

Detailed description: 
      Aging is associated with a functional decline of most physiological systems including the
      immune system. It could be hypothesized that an inadequate nutritional status may amplify the
      effects of a low-grade chronic inflammation associated with age influencing the functionality
      of the immune systems, the resistance to infections, the cognitive function and contributing
      to an increased morbidity and mortality. Indeed experimental evidence indicate that improving
      the nutritional status attenuates the decline in immune and cognitive functions, in physical
      performance associated with age by helping to improve the level of Quality of Life.

      Therefore, the present study focus on nutrients and micronutrient which have a role in
      fighting oxidative stress, in the regulation of inflammatory responses and the immune system.
    

Intervention name(s): fortified milk
Intervention type(s): Dietary Supplement
Intervention description(s): "Fortified"Ultra-high temperature (UHT), partly-skimmed milk (1.6% fat), highly digestible (lactose <0.5%) produced by Granarolo s.p.a. supplemented with long chain unsaturated fatty acids DHA (Docosahexaenoic acid) +EPA (Eicosapentaenoic acid), vitamin D, B12, B6, B9, E,C, Zinc and Selenium versus "placebo" Ultra-high temperature (UHT), partly-skimmed milk (1.6% fat), highly digestible (lactose <0.5%) of the same manufacturer.
The nutrients added are: DHA + EPA 1.4 mg/ml; vitamin D3 0.068 mcg/ml; B6 6.4 mcg/ml; B12 0.01 mcg/ml; B9 (folic acid) 0.80 mcg/ml; vitamin E 0.05 mg/ml; vitamin C 0.19 mg/ml; Zinc 0.04 mg/ml; Selenium 0.22 mcg/ml. The protein content of the milk is 0.04 g/ml.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: fortified milk, aging, health status
Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug
      interaction study.
    

Detailed description: 
      This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction
      study.

      Each subject will qualify for entry into the study not more than 30 days before admission
      into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline
      assessments. There will be 1 treatment period, with each subject receiving a once daily dose
      of pitavastatin 4 mg on Days 1 through 5 and Days 12 through 16 and a once daily dose of
      darunavir/ritonavir 800 mg/100 mg on Days 6 through 16. On Days 1 through 4, 6 through 10,
      and 12 through 15, study drug will be administered 30 minutes before a standard breakfast. On
      Days 5, 11, and 16, subjects will fast at least 8 hours before receiving study drug and
      remain fasted for 4 hours after dosing.
    

Intervention name(s): Pitavastatin (NK-104); Darunavir/Ritonavir (Prezista)
Intervention type(s): Drug; Drug
Intervention description(s): Pitavastatin (NK-104) 4mg once daily (QD); Darunavir/Ritonavir (Prezista) 800 mg/100 mg
Intervention MeSH terms: Ritonavir; Darunavir; Pitavastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers
Effects of Direct Laryngoscopic and Fiberoptic Intubation on Intraocular Pressure
Condition: Intraocular Pressure; Intubation Complication
Study type: Interventional

Summary: 
      In this study, the investigators aimed to compare the effects of direct laryngoscopic and
      fiberoptic endotracheal intubation on intraocular pressure.
    

Detailed description: 
      Material and Method: Total of 54 American Society of Anesthesiologist Grade 1-2, Mallampati
      score 1 or 2, age between 18 to 65 patient planned to undergo nonopthalmic surgery will be
      included to study. Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary
      diseases, American Society of Anesthesiologist Grade III and IV, body mass index more than
      35, difficult intubation, undergo obstetrical surgery and propofol, fentanyl, rocuronium
      contraindicated will be excluded from the study. Patients will be divided randomly into 2
      groups as direct laryngoscopic and fiberoptic intubation group. Patients will be
      preoxygenated with %100 O2 for 3 minutes then anesthesia will be induced using propofol 2 mg
      / kg, fentanyl 1 mcg/kg, and rocuronium 0,5 mg / kg in both groups. After 3 minutes mask
      ventilation, patients will be intubated (women with No:7-7,5, men with No:8-8,5 intubation
      tube). Systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral
      oxygen saturation,perfusion index will be recorded and intraocular pressure measured by
      ophthalmologist by tonopen device will be recorded pre-induction (basal), after induction,
      1,2,3,5 minutes after intubation, respectively. Period between handling of laryngoscope or
      fiberoptic device after termination of mask ventilation and obtain end tidal CO2 will be
      accepted as application time and recorded. Study will be terminated after 5th minute values
      taken.
    

Intervention name(s): Direct laryngoscope; Fiberoptic bronchoscope
Intervention type(s): Other; Other
Intervention description(s): This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.; This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: intraocular pressure; direct laryngoscopy; fiberoptic bronchoscopy
Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block
Condition: Posterior Lumbosacral Spine Fixation Surgeries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      As the posterior lumbosacral spine fixation surgeries are common spine procedures done
      nowadays due to different causes and as this spine procedure is mostly accompanied with
      moderate to severe postoperative pain, so it is necessary to find an effective and efficient
      postoperative analgesia for patients with this surgery.
    


Intervention name(s): Dexmedetomidine injection; Bupivacaine 0.25% Injectable Solution; normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%; 20 ml of bupivacaine 0.25%,; 20 ml of normal saline 0.9%.
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects
Condition: Smallpox
MeSH terms: Vaccinia; Smallpox
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the take rate (formation of a typical postvaccinal
      lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.
    


Intervention name(s): Elstree-BN
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the lot-to-lot consistency of three production lots
      of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged
      2 months at the time of first vaccination.
    


Intervention name(s): Rotarix; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Two oral doses.; Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Gastroenteritis
Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence
Condition: Hypotrichosis
MeSH terms: Hypotrichosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine patient satisfaction with LATISSE® treatment for
      increasing eyelash prominence.
    


Intervention name(s): bimatoprost ophthalmic solution 0.03%; bimatoprost vehicle solution
Intervention type(s): Drug; Drug
Intervention description(s): One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.; One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Other intervention name(s): LATISSE®
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Nordic Walking and Exercise on Glucose Metabolism in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Condition: Type 2 Diabetes; Exercise
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this randomized controlled trial was to evaluate the effects of two
      different physical exercise programs aimed at long-term lifestyle changes in physical
      activity in patients with Type 2 Diabetes, with glucose metabolism evaluated by HbA1c as the
      primary outcome.
    

Detailed description: 
      Physical training and exercise is considered a cornerstone in the treatment of Type 2
      Diabetes Mellitus.

      Programs which include physical activity as a component in the treatment of Type 2 Diabetes
      as well as other chronic diseases have in Denmark and other countries been based on "Exercise
      on Prescription schemes". In Denmark, these schemes have focused on individual behavioral
      change and an exercise program for 16 weeks. No studies have documented whether "Exercise on
      Prescription" helps patients with Type 2 Diabetes to change their lifestyle behavior or
      whether it has a positive impact on measurements for physical capacity and glucose
      metabolism.

      Nordic Walking is a fitness type of walking; incorporating the use of specially designed
      walking sticks. Nordic Walking focuses on aerobic training where the additional activity of
      the arms increases a person's oxygen uptake and energy expenditure.

      In Denmark, many activity programs and concepts such as Exercise on Prescription and Nordic
      Walking are recommended to patients with Type 2 Diabetes but their efficacy has not been
      demonstrated.

      It is unknown whether one specific type of physical training program is more suitable than
      another, when comparing the physical effects as well as the ability to induce good compliance
      and change in lifestyle.

      The aim of this randomized, controlled trial was to evaluate the effect of two different
      physical exercise programs lasting 4 months aiming at introducing long term life style
      changes in physical activity with a follow-up period of 8 months in patients with type 2
      diabetes.
    

Intervention name(s): Exercise on Prescription; Nordic Walking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The physical training consisted of both aerobic and strength training and took place in supervised groups.; Nordic Walking is a fitness type of walking; incorporating the use of specially designed walking sticks. Nordic Walking focuses on aerobic training where the additional activity of the arms increases a person's oxygen uptake and energy expenditure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: HbA1c; Type 2 Diabetes; Lifestyle changes; Exercise
Neurobehavioral Model of HIV in Injection Drug Users
Condition: Drug Abuse; HIV Infections
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      The purpose of this R01 study is to evaluate the association between neuropsychological
      executive dysfunction and HIV infection among young injection and non-injection drug users. A
      longitudinal study will be conducted in which the cohort of seronegative drug users
      completing a baseline neuropsychological battery are re-assessed on three subsequent
      occasions, roughly six months apart. The primary aim of the longitudinal study is to estimate
      the magnitude of the suspected causal relationship between executive dysfunction and HIV-risk
      behaviors while adjusting for time-invariant (e.g. sex, ethnicity) and time-varying (e.g.
      degree of drug abuse) covariates. We also seek to evaluate: (1) the degree to which specific
      executive dysfunctions predispose heroin and cocaine users to high-risk injection practices
      or sex behaviors, and (2) whether observed relationship between executive dysfunction and
      HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or
      whether the observed data are more consistent with complex patterns of interdependency
      between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors. If successful,
      this project will shed new light on significant and potentially malleable HIV-risk factors in
      injection and non-injection drug users. This will be important evidence because injection
      drug abuse continues to account for a large proportion of HIV seroconversions particularly
      among young women and minorities. As such, this RO1 research project serves as an important
      initial step in a line of innovative investigations about suspected causal associations
      between neuropsychological deficits and HIV-risk behaviors in drug users. Ultimately, this
      line of investigation should lead to changes in public and clinical practices designed to
      prevent HIV infection.
    


Intervention name(s): Injection and Non-Injection Drug Users
Intervention type(s): Other
Intervention description(s): (1) the degree to which specific executive dysfunctions predispose heroin and cocaine users to high-risk injection practices or sex behaviors, and (2) whether observed relationship between executive dysfunction and HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or whether the observed data are more consistent with complex patterns of interdependency between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In total, we seek to recruit 150 HIV positive and 800 HIV negative drug users who are
        between the ages of 15 and 50 years and who have used illicit drugs within the previous
        five years of enrollment.
      
Keywords: HIV Epidemiology; Neurology; Neuropsychological; HIV Risk Factors; Cognitive Risk Factors; HIV
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare
      the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after
      administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and
      Amoxicillin in healthy male subjects
    


Intervention name(s): DWP14012 Amg; DWP14012 Bmg; Clarithromycin; Amoxicillin; Lansoprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): DWP14012 Amg; DWP14012 Bmg; Clarithromycin 500 mg; Amoxicillin 1 g; Lansoprazole 30 mg
Intervention MeSH terms: Amoxicillin; Clarithromycin; Lansoprazole; Dexlansoprazole; Fexuprazan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This study is designed to find the optimal dosage of home-based treadmill training needed to
      accelerate walking onset and to examine the long-term effects on the child's walking
      activity.
    

Detailed description: 
      The purpose of this study is to determine optimal parameters for dosing home-based treadmill
      training by comparing high-intensity (5 days/week, twice daily for 10-20 min for 6 weeks) to
      low-intensity (2 days/week, once daily for 10-20 minutes for 6 weeks) treadmill training; and
      to compare the effects of high- versus low-intensity treadmill training on walking attainment
      and overall walking activity in young children with cerebral palsy.

      Hypotheses

        -  A more intensive protocol of treadmill training will increase walking onset in young
           children with CP.

        -  A more intensive protocol of treadmill training will increase overall walking activity
           in young children with CP.

      Specific Aims

        -  To determine optimal parameters for dosing home-based treadmill training by comparing
           high-intensity to low-intensity home-based treadmill training.

        -  To compare the effects of high- versus low-intensity treadmill training on walking onset
           and overall walking activity.

      Study design •Prospective randomized controlled trial

      Study population

      •Two groups of 12 children with CP under the age of 3 years and are not walking yet will
      receive either home-based high-intensity treadmill training or low-intensity treadmill
      training. The children will be assessed before, immediately after, at 1-month and at 4-months
      following the intervention via standardized outcome measures.
    

Intervention name(s): home-based treadmill training; Treadmill
Intervention type(s): Other; Device
Intervention description(s): the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; treadmill training; walking
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the effect of grass pollen extract SLIT tablets on
      the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in
      response to grass pollen challenge after one week, one, two and four months of treatment in
      patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.
    

Detailed description: 
      The purpose of this study is to determine whether SLIT tablets are effective on symptoms of
      allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass
      pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT
      tablets on allergic rhinitis symptoms.
    

Intervention name(s): 300 IR grass pollen allergen extract tablet; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): 300 IR grass pollen allergen extract tablet once daily during four months; Placebo tablet once daily during four months
Other intervention name(s): Sublingual immunotherapy tablet; Sublingual placebo tablet
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sublingual immunotherapy; Rhinitis; Conjunctivitis; Allergen challenge; Allergen exposition chamber; Grass pollen tablet; Allergic rhinoconjunctivitis
Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate,
      valsartan and rosuvastatin in healthy male volunteers.
    


Intervention name(s): administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine, Valsartan Drug Combination; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics; Safety; Tolerability
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter
      in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours
      prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and
      potentially reduce the damage caused by stroke.
    

Detailed description: 
      The study is a prospective, single arm treatment feasibility trial to determine the baseline
      safety and feasibility of the NeuroFlo device in acute ischemic stroke patients whose last
      known time symptom-free is between 8-24 hours.

      A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian & European sites may be
      enrolled in this initial study phase. An independent data safety and monitoring board will
      assess the safety of the treatment on a routine basis.
    

Intervention name(s): NeuroFlo™ Catheter
Intervention type(s): Device
Intervention description(s): 45 minute Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute; ischemic; stroke; device; treatment