bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Cardiac Output Measurements in Critically Ill Children Using USCOM and Transthoracic ECHO
Condition: Critical Illness; Pediatrics
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      The purpose of this study is to compare the accuracy and precision of two non-invasive
      methods of measuring cardiac output in critically ill children (<18 yrs). The participants
      will include any patient admitted to Pediatric intensive care unit (PICU) requiring a
      trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent
      cardiac output will be obtained and compared on participants using standard 2-D TTE and
      Ultrasound Cardiac Output Monitor (USCOM).
    


Intervention name(s): Ultrasonic Cardiac Output Monitor (USCOM).
Intervention type(s): Device
Intervention description(s): This device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output.
Other intervention name(s): USCOM
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects for this study can be either male or female and not limited by race or
        ethnicity. They will include critically ill pediatric patients, less than 18 yrs of age,
        being treated in the Pediatric intensive care unit.
      
Keywords: intensive care units; pediatric; cardiac index; Doppler Ultrasonography
Correct Gastric Tube Placement in Very Low Birth Weight Neonates
Condition: Gastric Tube Placement
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding
      impairment correlated with low birth weight.

      Correct GT depth is mandatory to ensure an appropriate and safe enteral feeding: X-ray is the
      gold standard in order to check GT position, but this cannot be routinely performed due to
      x-ray exposure risk. Feeding a neonate through a misplaced GT is potentially harmful and may
      increase morbidity, mortality and hospitalization length.

      Nurses estimate GT depth through external measurements. This study aims to identify the most
      appropriate insertion length predictor for orogastric tube placement in VLBW infants by
      comparing two different methods.
    

Detailed description: 
      Several methods have been suggested to estimate orogastric tube insertion length, but none of
      them has been validated in VLBW infants. The most commonly used methods are NEX
      (Nose-Ear-Xyphoid) and NEMU (Nose-Ear-Mid-Umbilicus) as predictors of nasogastric tube
      insertion. For the purpose of the present study NEX and NEMU methods were adjusted for
      orogastric tube placement.

      Hence, primary aim of this study is:

      To identify the most appropriate insertion length predictor for orogastric tube placement in
      VLBW infants by comparing NEX and NEMU methods.

      Secondary aim is:

      - To develop a new mathematical formula, based on the neonate's weight or length, to predict
      the insertion length of orogastric tube in VLBW infants
    

Intervention name(s): oro gastric tube
Intervention type(s): Device
Intervention description(s): According to clinical need, an orogastric tube will be inserted at birth using the group method in VLBW infants in whom an umbilical catheter has been placed. An X-ray chest will be performed according to routine clinical practice to assess the position of the umbilical catheter. On the same X-ray the position of the gastric tube will be assessed by a radiologist blinded to the method used for orogastric tube placement.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        VLBW infants
      
Keywords: VLBW - Very Low Birth Weight Infant; Gastric tube; Enteral nutrition; Prematurity; Nursing
A Phase I Study of Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)
      analogue that created on the basis of the Exenatide and modified by polyethylene glycol
      (PEG).

      This study aims to evaluate whether the titration mode of administration could reduce the
      incidence of adverse reactions of PEX168, also decided to observe long-term continuous
      administration of PK/PD correlation.
    


Intervention name(s): PEX168
Intervention type(s): Drug
Intervention description(s): A injection administered subcutaneously
Other intervention name(s): Polyethylene Glycol Loxenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PEX168; Phase I; titration
BIRB 796 BS Versus Placebo in Patients With Moderate to Severs Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical objective of this study was to determine the effect of BIRB 796 BS on
      pharmacodynamic markers of psoriasis as a measure of efficacy, to determine the population
      pharmacokinetics of BIRB 796 BS and to determine the safety of BIRB 796 BS over 4 weeks of
      treatment in patients with moderate to severe plaque-type psoriasis.
    


Intervention name(s): BIRB 796 BS, low dose; BIRB 796 BS, medium dose 1; BIRB 796 BS, medium dose 2; BIRB 796 BS, high dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy (Craniopharyngioma)
Condition: Craniopharyngioma
MeSH terms: Craniopharyngioma; Adamantinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection
      and protontherapy to management paediatric craniopharyngioma.
    

Detailed description: 
      This study is phase II prospective, open labelled, phase ii, monocenter. The main objective
      is to evaluate the fractionated high precision radiotherapy with a dose of 59,5 Gy (1,7 Gy
      daily, 5 fractions per week).
    

Intervention name(s): Protontherapy
Intervention type(s): Radiation
Intervention description(s): 59,5 Gy (1,7 Gy daily, 5 fractions per week).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: craniopharyngioma; protontherapy
Clinical and Genetic Testing of Patients With Usher Syndrome
Condition: Usher Syndrome; Congenital Deafness; Retinitis Pigmentosa
MeSH terms: Deafness; Usher Syndromes; Retinitis; Retinitis Pigmentosa; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      This study is aimed to characterize Russian population of Usher patients.
    

Detailed description: 
      This study is aimed to characterize Russian population of Usher patients.

      Tasks:

      Stage 1. Formation of the primary cohort of patients. Patients pre-recruiting will be
      performed based on Deaf-Blind Support Foundation "Con-nection" patient database analysis.
      Patients with clinically confirmed Usher syndrome will be evaluated according to available
      data of the clinical examination.

      Stage 2. Clinical examination of patients.

      Each patient will undergo the following diagnostic procedures according to the unified
      protocol:

        -  Visometry (with correction and without correction)

        -  Ophthalmoscopy

        -  Perimetry

        -  Optical coherence tomography

        -  Electroretinography

        -  Visually evoked potentials

        -  Refractometry

        -  Pneumotonometry

        -  Biomicroscopy

        -  Tonal audiometry

        -  Electronic audiometry (ASSR test)

        -  Acoustic impedance measurement

        -  Vestibulometry

        -  Electronystagmography

        -  Any additional examinations and consultations if necessary

      Medical record will be developed and maintained for each patient consisting results of
      extended clinical examination.

      Stage 3. Genetic study of patients. All enrolled patients will undergo single 4 ml peripheral
      venous blood sampling. DNA will be extracted from leucocytes. DNA samples will be analyzed
      and placed for long-term storage in liquid nitrogen. Statistical and bioinformatic analysis
      of detected genetic mutations in the study cohort will be performed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        It is assumed that at least 28 patients of the Russian population of men and women aged 18
        to 65 years, with verified diagnosis of Usher syndrome (type I, II or III as defined by the
        Usher syndrome consortium), will take part in this research study.
Obesity, Sleep Apnea, and Insulin Resistance
Condition: Insulin Sensitivity; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and
      public health burdens in the United States. That these diseases appear to co-exist and
      together increase one's risk of cardiovascular disease renders investigation into their
      shared pathophysiology even more urgent. Investigators will assess prevalence of insulin
      resistance, a precursor to diabetes, among overweight patients with OSA. Among those at
      highest risk of diabetes, investigators will randomize participants to pioglitazone or
      placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or
      insulin secretion. In a separate intervention, investigators will evaluate the
      cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in
      patients with OSA. Investigators will also study subjects from the community without known
      sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea
      using clinical screening questionnaires.
    


Intervention name(s): Pioglitazone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 45 mg daily Insulin sensitizing; Compare with pioglitazone
Other intervention name(s): actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: obstructive sleep apnea; insulin sensitivity; cardiovascular risk; positive airway pressure therapy
Dispensing Overnight Study in Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the fit and performance of an investigational soft
      contact lens in comparison with a currently marketed lens. Both lenses will be worn on a
      continuous wear basis, which means the lenses will be worn while sleeping.
    

Detailed description: 
      The purpose of the study is to evaluate the fit and performance of an investigational soft
      contact lens in comparison with a currently marketed lens. Both lenses will be worn on a
      continuous wear basis, which means the lenses will be worn while sleeping. Physiological
      changes will be monitored and subjective ratings collected.
    

Intervention name(s): Biofinity
Intervention type(s): Device
Intervention description(s): Soft contact lens
Other intervention name(s): Purevision
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the safety of the gynaecological formulation in
      normal and usual usage condition.
    


Intervention name(s): lactoserum
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study
Condition: End Stage Kidney Disease; Chronic Kidney Disease Requiring Chronic Dialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      This clinical study is designed to evaluate the theoretical prediction of a lower glucose
      absorption in optimized automated peritoneal dialysis regimes. Patients will receive both a
      standard 6 x 2L 1.36% glucose regime or an optimized 7 x 2 L 2.27% glucose + 5 x 2 L 0.1%
      glucose regime in a crossover fashion.
    

Detailed description: 
      Automated peritoneal dialysis (APD) is a rapidly growing, home-based kidney replacement
      therapy promoting patient autonomy, and is associated with lower societal costs compared to
      hemodialysis. However, in light of the growing number of diabetic patients on PD, the
      unwanted glucose absorption during APD is problematic. Recent results (Öberg CM, Rippe B,
      2017, see references), using a theoretical model of APD, indicate that large reductions in
      glucose absorption are possible by using specialized so-called optimized bi-modal treatment
      regimes having "UF cycles" using a higher glucose concentration (e.g. 2.27% glucose) and
      "Clearance cycles" using a low glucose concentration (e.g. 0.1% glucose).
    

Intervention name(s): Automated peritoneal dialysis (APD)
Intervention type(s): Procedure
Intervention description(s): Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dialysis; peritoneal dialysis
VRP-Clinic Software Evaluation - in Support of Rehabilitation (VRP02)
Condition: Rehabilitation
Study type: Interventional

Summary: 
      The current study is designed to evaluate neck movements performed according to the
      VRP-Clinic software, and to verify that they promote physical activities that correspond with
      physical rehabilitation.
    

Detailed description: 
      The study will take place at Shaare Zedek Medical Center (SZMC). The study will include a
      single visit.

      Each subject will put on the VR headset and perform a series of neck movements guided by
      graphic instructions appearing in the VR environment. The session will be recorded with a
      video camera which will subsequently be viewed and evaluated by clinicians. The clinicians
      will identify each movement seen on the video from a predefined list and determine if such a
      movement is recommended as part of a rehabilitation training program.
    

Intervention name(s): VRP-Clinic
Intervention type(s): Other
Intervention description(s): Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
Condition: Hashimoto Thyroiditis
MeSH terms: Thyroiditis; Hashimoto Disease
Study type: Interventional

Summary: 
      Hashimoto's thyroiditis is an autoimmune thyroid disease, which induced chronic inflammation
      of thyroid gland and destroys thyroid tissue.

      Hydroxychloroquine is used as disease modifying anti-rheumatic drug (DMARD) for treatment of
      several autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid
      arthritis(RA) for more than one century.

      The purpose of this study is to evaluate whether hydroxychloroquine is effective in treatment
      of Hashimoto's thyroiditis.
    

Detailed description: 
      Hashimoto's thyroiditis is an autoimmune thyroid disease, and when the disease progresses,
      thyroid function finally declined to hypothyroidism.

      There was no medical treatment recommended for patients with Hashimoto's thyroiditis, but
      currently at euthyroid state. Levothyroxine replacement therapy starts if patients become
      hypothyroid state.

      Hashimoto's thyroiditis is a T-cell mediated autoimmune thyroid disease. The major
      auto-antigens include thyroid peroxidase (TPO) and thyroglobulin. Anti-TPO antibodies induce
      antibody-dependent cell-mediated cytotoxicity (ADCC) and cause destruction of thyroid
      tissues.

      Antimalarial agents like hydroxychloroquine have several pharmacologic effects which may be
      involved in the treatment of rheumatic diseases, but the role of each is not known. These
      include interaction with sulphydryl groups, interference with enzyme activity (including
      phospholipase, nicotinamide adenine dinucleotide hydrogen-cytochrome C reductase,
      cholinesterase, proteases and hydrolases), DNA binding, stabilisation of lysosome membranes,
      inhibition of prostaglandin formation, inhibition of polymorphonuclear cell chemotaxis and
      phagocytosis.

      This study is to investigate the treatment effect of hydroxychloroquine on autoantibodies and
      disease progression of Hashimoto's thyroiditis.
    

Intervention name(s): Hydroxychloroquine
Intervention type(s): Drug
Intervention description(s): Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months
Other intervention name(s): Plaquenil
Intervention MeSH terms: Hydroxychloroquine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kinematic Parameters of Running in Individuals With Pronated Foot
Condition: Pronation; Ankle
Study type: Interventional

Summary: 
      The aim of the study is to examine the kinematic parameters of individuals with pronated foot
      compared with individuals with normal foot
    

Detailed description: 
      Individual with and without pronated foot will be recruited. Pronation will be defined
      according to navicular drop test. Inclusion criteria : individual who run on a regular basis
      at least 3 times per week for one hour, can run 5 Km in less then 40 minutes, without past
      injuries during the last year of Achilles tendon or other lower extremities pain.

      Individuals will be asked to run for 5 Km in self selected velocity. The Milestone pod device
      will be used to monitor kinematic parameters.

      functional test will be conducted before and after the running as follows: heel raise test
      and one leg hop for distance test.
    

Intervention name(s): running
Intervention type(s): Diagnostic Test
Intervention description(s): individuals will be asked to run for 5 km in self selected speed
Other intervention name(s): kinematic parameters of running
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups. Individuals with and without pronated foot.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: foot posture; running; foot index
The Effects of Sports Drinks on Urinary Lithogenicity
Condition: Urolithiasis
MeSH terms: Urolithiasis
Study type: Interventional

Summary: 
      The effect of sports drinks on the tendency to form kidney stones has not been assessed.
      Patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes
      in urine chemistry that may decrease the risk of forming stones.
    

Detailed description: 
      Participants will drink 1 liter of water each day for one week in the control period, then 1
      liter of sports drink each day for one week during the experimental period. Urine collections
      will be performed during both periods. Diet will be chosen by participants and a food diary
      will be kept so that participants can replicate diet during the urine collections.
    

Intervention name(s): Gatorade; Performance
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: nephrolithiasis; citrate; oxalate
Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study will determine the efficacy of cognitive behavioral therapy in treating adults
      with attention deficit hyperactivity disorder.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD), previously believed to be a disorder of
      childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for
      academic and occupational underachievement, relationship difficulties, and reduced quality of
      life. This study will determine whether cognitive behavioral therapy (CBT) is more effective
      than ADHD education and relaxation techniques in treating adults with ADHD.

      Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or
      training in which they will learn relaxation techniques and receive detailed information
      about ADHD. Questionnaires will be used to assess participants' ADHD symptoms at study entry
      and at study completion.

      The study is being conducted at Massachusetts General Hospital in Boston and requires 5
      assessment visits and 12 weekly therapy visits. Participants must be able to travel to Boston
      on a weekly basis in order to participate in the study.

      Study hypothesis: CBT is a more efficacious treatment for adult ADHD than education and
      relaxation techniques.
    

Intervention name(s): Cognitive behavioral therapy (CBT); Relaxation techniques and education about ADHD
Intervention type(s): Behavioral; Other
Intervention description(s): Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.; Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms.
Other intervention name(s): Mastering Your Adult ADHD manual (Safren, et al., 2005); Unpublished treatment manual (Sprich, et al., 2003)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult; ADHD; ADD; CBT; Relaxation Techniques; Education