bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Fluids Consumption on Balance and Gait Function in Old Adults
Condition: Aging; Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      Experimental design overview The proposed project is a prospective experimental RCT study
      design. Independent old adults(age 65 years old and older) who do not suffer from balance
      problems willing to participate in the study will be tested before and after water
      consumption to explore whether there are differences in balance control as a result of
      dehydration.
    

Detailed description: 
      Experimental design overview The proposed project is a prospective experimental study design.
      independent old adults(age 65 years old and older) who do not suffer from balance problems
      willing to participate in the study will be tested with well-established measuring techniques
      of Balance control before and 2 hours after mineral water consumption (1 liter) in the
      movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract
      standardized stabilogram-diffusion parameters from each of the COP data sets collected during
      quiet standing. These parameters include diffusion coefficients, critical displacement,
      critical time and scaling exponents for both lateral and anterior-posterior sway directions
      (Collins & De Luca, 1993). For each of the conditions (before and 1 hour after the use of
      Ritalin) in three task conditions single task; dual task (concentrating and identifying
      specific music); and just Listening to a relaxing music. Participants will be required to
      stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as
      little as possible.
    

Intervention name(s): water consumption
Intervention type(s): Dietary Supplement
Intervention description(s): The effect of water consumption on postural stability of old adults (65 years old and over) will be measured using RCT study design
Other intervention name(s): balance in older adults
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ageing; Balance control; Falls; dehydration
An Exercise Intervention to Improve the Eating Patterns of Preadolescent Children at High Risk for Obesity
Condition: Eating Behavior; Self-Regulation
Study type: Interventional

Summary: 
      Children in rural communities experience significant obesity-related health disparities; they
      are 26%-55% more likely to be obese and less likely to have health insurance and access to
      weight management specialists than are their urban peers. Geographic-specific disparities in
      obesity may be due, in part, to variations in eating behaviors. Children in rural communities
      describe purchasing and consuming significantly more energy-dense, low-nutrient food items
      relative to their urban peers. Existing behavioral strategies for improving children's EI
      patterns have largely been ineffective in reducing risk for excess weight gain. The primary
      aim of the proposed study is to test the effects of a brief, novel strategy for improving
      rural children's eating behaviors. Specifically, the study aims to harness the
      well-documented benefits of an acute bout (20 min) of moderate physical exercise on
      children's executive functioning, and to see if these cognitive changes lead to better
      self-regulation of eating. If 20 min of moderate physical exercise is associated with
      observed improvements in preadolescent children's eating secondary to increases in executive
      functioning, these data may offer explicit targets for an obesity prevention trial in rural
      Oregon elementary schools.
    


Intervention name(s): Acute moderate physical activity
Intervention type(s): Behavioral
Intervention description(s): For 20 minutes, participants will walk on a treadmill at a moderate intensity based on a combination of evidence-based and pre-determined parameters, including ratings of perceived exertion and heart rate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover design
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Tolerability Study of Drug to Treat Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with
      schizophrenia.
    


Intervention name(s): Lurasidone 20 mg; Lurasidone 40 mg; Lurasidone 80mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lurasidone 20mg oral tablet taken once daily for 6-months; Lurasidone 40mg oral tablets taken once daily; Lurasidone 80mg oral tablet taken once daily
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Latuda; Lurasidone
Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to perform biopsies of one of the glands that make saliva. The
      biopsied tissue will then be analyzed to see if it has changes that occur in Parkinson's
      disease. This study will determine whether it is possible to do a second biopsy a few years
      after a previous biopsy and determine whether there are changes in the biopsy that would
      allow for analysis of disease progression.
    

Detailed description: 
      Tissue biopsies documenting the presence and density of Lewy type synucleinopathy (LTS) in
      living patients with probable Parkinsons disease (PD) would be extremely valuable as a
      diagnostic test, as a marker of molecular therapeutic target engagement and as a progression
      marker. Based on recent data from our group with both early and advanced PD patients, we
      propose to perform a second transcutaneous submandibular gland (SMG) needle core biopsy in 12
      patients who have previously been biopsied and had LTS present in their SMG tissue.
    

Intervention name(s): Submandibular gland biopsy
Intervention type(s): Procedure
Intervention description(s): Needle biopsies of the right and left submandibular glands
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Fraction of Oxygen on Induction of Anesthesia in Infants
Condition: Apnea
MeSH terms: Apnea
Study type: Interventional

Summary: 
      Invesetigators evaluated the effect of positive end-expiratory pressure during anaesthesia
      induction on nonhypoxic apnoea time in infants. Invesetigators assigned infants to a 7 cmH2O
      positive end expiratory pressure (PEEP) with fraction of inspired oxygen 80% or 0 cmH2O PEEP
      with fraction of oxygen 80% group. Anaesthesia was induced with 0.02 mg kg atropine, 5 mg kg
      thiopental sodium and 3 to 5% sevoflurane, and neuromuscular blockade with 0.6 mg kg
      rocuronium. Thereafter, 80% oxygen was provided via face mask with volume-controlled
      ventilation of 6 ml kg tidal volume, and either 7 cmH2O or no positive end-expiratory
      pressure. After 3 min of ventilation, the infants' trachea was intubated but disconnected
      from the breathing circuit, and ventilation resumed when pulse oximetry reached 95%.
    


Intervention name(s): positive end expiratory pressure; fraction of inspired oxygen 80%
Intervention type(s): Other; Other
Intervention description(s): 7cmH2O of positive end expiratory pressure with fraction of inspired oxygen 80% applied during induction of anesthesia; fraction of inspired oxygen 80% applied during induction of anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Total Body Albumin Measurement Utilizing a Modification of the BVA 100 Blood Volume Analyzer
Condition: Hypoalbuminemia; Heart Failure; Nephrosis; Cirrhosis; Shock
MeSH terms: Nephrosis; Hypoalbuminemia
Study type: Observational

Summary: 
      The DAXOR Corporation manufactures and distributes a blood volume analyzer. The analysis is
      based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. In
      addition to calculating human blood volume it is hypothesized that measurement of the
      dilution of the tracer can also yield an accurate measurement of total body albumin.
    

Detailed description: 
      Twenty adult individuals underwent a standard blood volume measurement. The specimens for
      this determination are normally collected over a period of approximately 40 minutes. For the
      determination of total body albumin, additional specimens were collect over a three to four
      day period until the counts in the blood specimens were stable. Calculation of the degree of
      dilution over this time interval is thought to represent dilution of the tracer in albumin in
      both the intra and extravascular space. The ratio of albumin in the intravascular to the
      extravascular space is available in the medical literature. The total volume in which the
      tracer is distributed can be determined from the dilution determined. A calculation of total
      body albumin is therefore possible. Computation of the total body albumin for the test
      subjects (all normal individuals) was consistent with values for total body albumin in the
      literature. The purpose of the development of this method is to permit clinicians to
      determine albumin status in patients with disturbances in albumin such as burn patients,
      cirrhotic patients, nephrotic patients as well as patients with protein losing
      gastroenteropathies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult male and female volunteers
      
Keywords: BVA-100 Blood volume analyzer; Human serum albumin labeled with Iodine 131
Ondansetron for the Treatment of Cocaine Dependence - 1
Condition: Cocaine-Related Disorders; Drug Administration Schedule
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of ondansetron to reduce
      cocaine use in subjects with cocaine dependence.
    

Detailed description: 
      Double-blind, placebo-controlled, 4-parallel group design to assess the efficacy and safety
      of 3 wide range doses of ondansetron to reduce cocaine use in subjects with cocaine
      dependence and to determine the optimal dose of ondansetron.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Condition: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will utilize Erwinaze via intravenous administration in patients between the ages
      of 1 and 30 who have experienced an allergy to their frontline therapy. The study will
      determine the proportion of patients with 2 day nadir serum asparaginase activity levels that
      are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
    


Intervention name(s): asparaginase Erwinia chrysanthemi
Intervention type(s): Drug
Intervention MeSH terms: Asparaginase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Erwinaze; asparaginase; Eusa Pharma; Pharmacokinetic study; NSAA
Safety, Tolerability, and Pharmacokinetics Study of NDX-1017
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will
      evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of
      NDX-1017 in healthy young and elderly subjects, and elderly subjects with amnestic mild
      cognitive impairment (MCI), Alzheimer's disease (mild, mild-to-moderate, or moderate), or
      mixed dementia with Alzheimer's and vascular components (mild, mild-to-moderate, or
      moderate).
    

Detailed description: 
      NDX-1017 is being developed for the treatment of Alzheimer's disease (AD).

      This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will
      evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of
      NDX-1017 in healthy young and elderly subjects, and elderly subjects with mild AD. The study
      contains the following two parts:

      Part A:

      A single-ascending dose (SAD) study conducted in an inpatient setting for 3 days in healthy
      young male and healthy elderly male and female volunteers evaluated in up to 7 dose cohorts
      to identify the maximum tolerated dose (MTD) within the single dose range studied. Up to 56
      subjects (aged 18 to 45 years for young and 60 to 85 years for elderly) may be enrolled in
      Part A.

      Part B:

      A multiple ascending dose (MAD) study conducted in an inpatient setting for 10 days in male
      or female healthy elderly volunteers (aged 60 to 85 years) or subjects with amnestic mild
      cognitive impairment (MCI), Alzheimer's disease (mild, mild-to-moderate, or moderate), or
      mixed dementia with Alzheimer's and vascular components (mild, mild-to-moderate, or moderate)
      (aged 40 to 85 years) in up to 6 dose cohorts that were proven tolerable in the SAD part of
      the study to identify the MTD within the multiple dose range studied. Up to 44 subjects (aged
      40 to 85 years) may be enrolled in Part B.

      Subjects will be screened for eligibility within 28 days (or 90 days for amnestic MCI,
      Alzheimer's Disease, or mixed dementia with Alzheimer's and vascular components) prior to
      enrollment. Those eligible will be admitted to an inpatient facility for investigational
      product administration, safety monitoring, and collection of blood or urine for
      pharmacokinetic evaluations.
    

Intervention name(s): NDX-1017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution of NDX-1017 for subcutaneous injection; Placebo solution for subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Cognition; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders
A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose
      study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels
      of ANS-6637 and EtOH in healthy male moderate alcohol drinkers. The study will include a
      screening visit, a qualification visit, a Treatment Phase and follow-up.
    


Intervention name(s): ANS-6637 Oral Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single doses administered orally.; Placebo administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Substance abuse disorder
Tobacco Zero: Interactive Tobacco Education for Teens
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      There have been a number of tobacco prevention programs developed and tested in the past few
      years, and some of the comprehensive programs have been promoted by the Office on Smoking and
      Health at the Centers for Disease Control (CDC). However, the use of these programs and
      integration into school-based curriculum has been lacking due to a number of factors. We are
      proposing to develop an interactive computer-based program for tobacco prevention aimed at
      middle school students. The CD-ROM is designed to be an adjunct to the existing health
      education curriculum provided for 6th through 8th grade students.
    

Detailed description: 
      The CD-ROM is based upon our Phase I prototype program entitled Tobacco World in which
      students are presented with a video arcade interface that offers them random access to
      several game-like activities in which they learn about tobacco and the negative health
      effects associated with tobacco use. We will expand the menu of options to include more
      complex activities and entertaining games.

      The Phase II program will deliver engaging media to educate students about the risks of
      tobacco and peer and industry influences on their decisions regarding tobacco. Games and
      activities will be designed to act on mechanisms shown to be effective in decreasing
      intentions to use tobacco through changing attitudes, social images, beliefs about short and
      long term physical consequences, perceptions of peers' social images, subjective norms, and
      perceived behavioral control. We will test individual components of the program with middle
      school students for effectiveness in changing mediating variables related to initiation and
      use of tobacco.

      The final program will be evaluated in a randomized trial where middle schools in Oregon and
      New York will be assigned to either an established tobacco prevention curriculum, or to the
      usual tobacco curriculum plus the Tobacco World program. Students will be assessed at pre-,
      post- and 6-month follow-up to evaluate the impact of program use on intentions, and actual
      tobacco use.
    

Intervention name(s): Interactive Tobacco Education
Intervention type(s): Behavioral
Intervention description(s): Increase perceived behavioral control (self-efficacy) Decrease willingness to use tobacco Decrease intentions to use tobacco
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Tobacco use among middle and junior high school students remains a concern among health educators.; The use of tobacco prevention programs and their integration into school-based curricula has been lacking due to a number of factors.
Safety of Fluconazole Treatment of Premature and Full-term Newborn Infants
Condition: Ductus Arteriosis, Patent; Bacterial Infections and Mycoses
MeSH terms: Mycoses; Bacterial Infections; Bacterial Infections and Mycoses
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate pharmacological interventions between fluconazole and ibuprofen
      when they are given to premature newborn babys. This in order to find out if the drugs are
      influencing each other when they are given at the same time. The study is meant to find out
      if there are reasons to adjust the dose when fluconazole and ibuprofen are given together.
    

Detailed description: 
      To evaluate the effect of fluconazole and/or ibuprofen on the urinary excretion of two
      vasoactive arachidonic acid products, thromboxane A2 (TXA2) and prostacycline (PGI2), in
      newborn infants treated with one or both of these drugs because of fungal infection
      prophylaxis and/or patent ductus arteriosis (PDA), respectively, as measurement of the
      possible interactions between these drugs.
    

Intervention name(s): Treatment with fluconazole.; 2. Treatment with both fluconazole and Ibuprofen.; 3. Treatment with ibuprofen.; 4. No treatment with either fluconazole nor ibuprofen.
Intervention type(s): Drug; Drug; Drug; Other
Intervention MeSH terms: Fluconazole; Ibuprofen
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Airway Inflammation in Children With Allergic Rhinitis and Intervention
Condition: Allergic Rhinitis; Inflammation; Respiratory Tract Diseases; Hypersensitivity
MeSH terms: Rhinitis; Rhinitis, Allergic; Respiratory Tract Diseases; Hypersensitivity; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether treating upper airway with intranasal
      corticosteroids in children with allergic rhinitis and no asthma may bring favors in reducing
      lower airway inflammation and improving small airway function.
    

Detailed description: 
      Type of study :

      This is a prospective randomized,double-blind, placebo-controlled study , to clarity whether
      treating upper airway with intranasal corticosteroids in children with allergic rhinitis may
      bring favors in reducing elevated lower airway inflammation，improving airway reactivity and
      airway resistance.

      Methods :

      The children with allergic rhinitis accompanied lower airway inflammation such as elevated
      percentage of eosinophil in induced sputums and/or higher level of fractional exhaled nitric
      oxide(FeNO) are recruited.By using a random digit table, eligible subjects were randomized
      into one of two groups,to receive budesonide nasal spray (BUD group) or nasal placebo(placebo
      group), 1 spray/nostril, 2 times/day, for three consecutive months observation. The following
      measurements were performed: skin prick test (SPT), peripheral blood cells
      five-classification test, serum total immunoglobulin E (IgE) and specific IgE of common
      inhalant allergens testing, nasal lavage and inflammatory cells classification ，pulmonary
      function test, bronchial provocation test，airway resistance measured by impulse oscillation
      technique. Meanwhile,history of all subjects were collected, visual analogue scale，rhinitis
      symptoms scores and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores were
      evaluated. Symptom scores and laboratory examinations are performed at baseline,4 w,8w and 12
      w after treatment.
    

Intervention name(s): Budesonide nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 64mcg/1putt, 1 putt/nostril,b.i.d; 1 putt/nostril,b.i.d
Other intervention name(s): intanasal corticosteroids; Placebo nasal spray
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: allergic rhinitis；airway inflammation；hyperreactivity