bioihbjkbjnl/mcl2 huggingface dataset:
Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
Condition: Peritoneal Dialysis (PD); Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration
      (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered
      intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
      It is an open label, dose escalation study.
    

Detailed description: 
      This is a phase 1, open-label, dose escalation study assessing the pharmacokinetic (PK)
      profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of
      Triferic iron administered intraperitoneally in chronic kidney disease patients on peritoneal
      dialysis (Continuous Cycling Peritoneal Dialysis (CCPD) or Continuous Ambulatory Peritoneal
      Dialysis (CAPD)).

      Screening can be up to 4 weeks, and the enrollment period is approximately one week. There
      are two treatment (dosing) visits and one follow-up visit during the enrollment period.

      At each treatment visit, the patients will be randomly assigned to receive either a single
      ascending dose of Triferic administered intraperitoneal (IP) during a long (12 hour)
      peritoneal dialysis dwell or a single 6.6 mg dose of Triferic administered IV over 4 hours.
      Blood samples will be obtained at defined times over 12 hours to establish the total serum
      iron PK of IP Triferic as well as the clinical serum iron profile.

      The IP dose of the first Cohort will be 5 mg Triferic iron/liter IP. Subsequent Cohort IP
      doses will be 12.5 mg Triferic iron/liter, and 20 mg Triferic iron/liter, with the final
      Cohort dose to be determined (TBD). The IV dose will be 6.6. mg for all Cohorts. Six patients
      will be enrolled in each Cohort, with enrollment in the subsequent (higher dose) Cohort not
      being initiated until the completion and evaluation of the previous (lower dose) Cohort.
    

Intervention name(s): Triferic
Intervention type(s): Drug
Intervention description(s): Triferic is an iron salt that is approved by the FDA for the maintenance of hemoglobin in patients with end stage kidney disease on hemodialysis. It is experimental in this study because it has not yet been approved for patients on chronic peritoneal dialysis.
Other intervention name(s): ferric pyrophosphate citrate; FPC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Triferic; ferric pyrophosphate citrate (FPC); peritoneal dialysis; anemia; chronic kidney disease
Costimulatory Molecules as Biomarkers in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to investigate the expression of a certain class of molecules,
      called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic
      disorder which renders the lung susceptible to persistent inflammation which, at times, can
      worsen, resulting in accelerated decline in lung function and eventually death or transplant.
      Our goal is to determine if the levels of costimulatory markers can be used to predict
      exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with Cystic Fibrosis
      
Biospecimen description: 
      Plasma, Serum, urine
    
Keywords: Costimulatory molecules; Cystic Fibrosis; Biomarkers
Preoperative Pain Control in Gastric Bypass Surgery Patients
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will
      alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly
      obese patients undergoing laparoscopic gastric bypass surgery.
    

Detailed description: 
      Pregabalin is a popular adjunct for relieving neuropathic pain in diabetics. There have been
      multiple studies evaluating its use in pre and post-operative pain control in various
      surgeries. Post-operative pain control is a challenging problem in bariatric patients due to
      the high doses of narcotic required, related to the high body mass, and the danger of
      concomitant respiratory depression. In the obese patient, the goal of postoperative pain
      management is provision of comfort, early mobilization and improved respiratory function,
      without causing inadequate pain control, respiratory compromise or increased nausea.

      Methods: A Randomized Controlled Trial, whereby patients undergoing Laparoscopic Roux-en-Y
      gastric bypass will be administered a single pre-operative dose of Pregabalin or a placebo.
      We plan to follow their immediate post-operative course in the hospital, with regard to the
      following primary endpoints:

        -  Post-operative analgesic requirements

        -  Post-operative pain scale (rated 0-10)

        -  Episodes of vomiting

        -  Post-operative antiemetic requirement

        -  Length of stay
    

Intervention name(s): Pregabalin; Placebo (for Pregabalin)
Intervention type(s): Drug; Drug
Intervention description(s): One 300 mg oral dose of Pregabalin given before surgery.; One oral dose of placebo given before surgery.
Other intervention name(s): Lyrica; Sugar pill manufactured to mimic Pregabalin 300 mg tablet
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention
Condition: Anterior Cruciate Ligament Injuries; Post-traumatic Osteoarthritis; Knee Osteoarthritis; Knee Injuries; Cartilage, Articular; Gait
MeSH terms: Osteoarthritis; Wounds and Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to report the feasibility and determine the initial effects of
      18 sessions of real-time gait biofeedback delivered over a 6-week period on retention and
      transfer of normalized gait biomechanics and improvements in indicators of early
      post-traumatic osteoarthritis development in those with an anterior cruciate ligament
      reconstruction (ACLR) at 6 and 8-week posttests.
    


Intervention name(s): Real-time gait biofeedback; Sham real-time gait biofeedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 9th and 10th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.; The Sham RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 9th and 10th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Biofeedback
MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial
Condition: Dialysis Access Malfunction; End Stage Renal Failure on Dialysis; End Stage Renal Disease; Fistulas Arteriovenous; Stenosis
MeSH terms: Kidney Failure, Chronic; Arteriovenous Fistula; Fistula
Study type: Observational [Patient Registry]

Summary: 
      For patients with End Stage Renal Failure (ESRF), the surgical creation of an Autogenous
      Arteriovenous Fistula (AVF) or Autogenous Arteriovenous Graft (AVG) is the recognised
      standard for providing vascular access. A functioning dialysis vascular access is essential
      to facilitate hemodialysis (HD) treatment. Advantages include improved hemodialysis
      initiation time, improved dialysis quality, better maintenance of accesses and generally,
      better outcomes in patients. Unfortunately almost 50% of AVF and AVG fail after a median
      lifetime of 3 to 7 years and 12 to 18 months respectively. Vascular access dysfunction is a
      major cause of morbidity and hospitalisation for ESRF patients, costing the healthcare system
      USD 18 million globally. Venous stenosis and scarring are caused by trauma from surgical
      access creation when the circuit comes arterialized and from repeated percutaneous punctures
      from subsequent hemodialysis. This study is performed to evaluate Sirolimus-coated balloon
      efficacy and safety using MagicTouch™ Drug coated balloon catheter (Concept Medical Inc,
      Tampa, FL, US) on AVF patency with de novo and recurrent stenosis.
    


Intervention name(s): AVFistuloplasty with Sirolimus coated balloon
Intervention type(s): Device
Intervention description(s): After an initial fistulogram, the lesion will first be predicated with standard high pressure balloon, followed by MagicTouch™ Sirolimus drug coated balloon
Intervention MeSH terms: Sirolimus
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have received inpatient treatment (i.e. fistuloplasty) for their failing
        dialysis access at Singapore General Hospital
      
Keywords: Sirolimus coated balloon; Target lesion primary patency; Arterio-venous fistula; Outcome; Safety
Study Investigating Efficacy of an Occluding Dentifrice for Dentine Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This study will investigate the efficacy of an experimental dentifrice containing 0.454%
      weight/weight (w/w) stannous fluoride in relieving dentine hypersensitivity (DH) after twice
      daily brushing, over a 2 week treatment period compared with a standard fluoride dentifrice.
    


Intervention name(s): 0.454% w/w stannous fluoride (1100ppm fluoride); 0.76% sodium monofluorophosphate (1000ppm fluoride)
Intervention type(s): Other; Other
Intervention description(s): Dentifrice containing 0.454% w/w stannous fluoride (1100ppm fluoride); Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Pharmacokinetics of New HepBQuin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Sanquin Plasma Products BV developed a new manufacturing process for the Quin plasma products
      in order to improve viral safety and to remove procoagulant activity. Since the new
      manufacturing process will be the same for all Quin products, a clinical study with one of
      the Quin products is sufficient for marketing authorisation of all new Quin products.
      HepBQuin will serve as model for all other Quin products. Pharmacokinetic (PK) data are
      considered as a surrogate indicator of efficacy.
    


Intervention name(s): a human hepatitis B immunoglobulin solution for injection for intramuscular administration
Intervention type(s): Biological
Intervention description(s): intramuscular administration
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Neural Mechanisms of Sevoflurane Induced Anesthesia: an EEG fMRI Study in Healthy Volunteers
Condition: Anesthesia; Drug Effects
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In imaging functional connectivity (FC) analyses of the resting brain, alterations of FC
      during unconsciousness have been reported. These results are in accordance to recent
      electroencephalographic studies observing impaired top-down processing during anesthesia. In
      this study, simultaneous records of functional magnetic resonance imaging (fMRI) and
      electroencephalogram (EEG) were performed to investigate the causality of neural mechanisms
      during sevoflurane anesthesia by correlating FC in fMRI and directional connectivity (DC) in
      electroencephalogram.
    


Intervention name(s): Sevoflurane
Intervention type(s): Drug
Intervention MeSH terms: Sevoflurane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: EEG; fMRI; connectivity; sevoflurane
Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
Condition: Cognitive Ability, General
Study type: Observational

Summary: 
      This is a follow-up study of a multi-center, double-blind, randomized, controlled,
      parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5
      years of age and health outcomes through 5.5 years of age in participants who received one of
      two staged study formulas through one year of age.
    


Intervention name(s): Enriched Protein Fractions; Protein Fraction
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Enriched protein fractions; Protein fractions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants who previously consumed study formula through one year of age in MJN Project
        6027.
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
Condition: Narcolepsy; Excessive Sleepiness
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the
      effect of JZP-110 on driving performance in subjects with excessive sleepiness due to
      narcolepsy.
    


Intervention name(s): JZP-110; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): solriamfetol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Driving
Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
Condition: Acute Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is:

        -  to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper
           respiratory tract infections in children;

        -  to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute
           upper respiratory tract infections in children.
    

Detailed description: 
      The overall duration of a patient's participation in the trial is 6 days
      (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up
      period-1 day).
    

Intervention name(s): Ergoferon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Safety and Efficiency of liquid dosage form; Safety and Efficiency of liquid dosage form
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619
      in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects
      with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and
      tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to
      receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.
    


Intervention name(s): TC-5619; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Group 1: 25 mg TC-5619 administered once daily for 28 days. Group 2: 50-150 mg TC-5619 administered once daily for 10 days.; Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Alzheimer's Disease
Effects of Sensomotoric Training on Neck/Scapular Pain in People With Visual Disability
Condition: Neck/Scapular Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether sensomotoric training can reduce
      neck/scapular pain in people with visual disability.
    

Detailed description: 
      People with prolonged musculoskeletal disorders have impaired quality of life, physical
      function, work conditions and work ability and consume substantial public resources. An often
      overlooked fact in this context is the relationship between musculoskeletal disorders and the
      importance of a normally functioning visual system. People who have a visual impairment in
      adulthood often experience reduced health and life satisfaction. Many people lose their faith
      in order to continue with the activities previously carried out as to cope with their life,
      their work, and in some cases,personal care. Rehabilitative efforts to reduce the negative
      effects often involve the prescription of various visual aids which, in turn, often leads to
      unfavourable ergonomic and static postures with further increased risk of musculoskeletal
      problems. A prevention of such disorders is likely to allow them to continue their work,
      which is important from both an individual and a society perspective. The overall objective
      of the project is to evaluate the effects of an intervention program and develop a
      theoretical model for the relationship between near work, eye disorders and musculoskeletal
      disorders. The intervention is to be evaluated in a randomized trial on people with impaired
      vision and pain in the neck and scapular area. An intervention based on development and
      adaptation of an established physiotherapy practice in order to increase body awareness, body
      control and movement patterns will be evaluated. The effects of the intervention will be
      measured by a variety of outcome measures derived from WHO's ICF-model. An innovative
      solution for establishing proprioception and eye-hand coordination in everyday activities,
      the Clinical Kinematic Assessment Tool, will be used.
    

Intervention name(s): Sensomotoric training
Intervention type(s): Behavioral
Intervention description(s): The intervention will be given once a week (2h per occasion) for twelve weeks.
Each occasion is planned to have the following structure:
10 min initial conversation about how participants are feeling today and how it felt after the last time.
70 min guided sensory motor learning. 10 min final talks, reflections on how it felt today.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal and Neural Physiological Phenomena; Postural Balance; Eye/hand coordination
Pictorial Warning Labels & Memory for Relative & Absolute Cigarette Health-risk Information Over Time in Adult Smokers
Condition: Smoking Cessation; Smoking, Cigarette
Study type: Interventional

Summary: 
      Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but
      experimental research has not examined PWLs' longer term effects on memory for health risks.
      In this study, adult smokers are repeatedly exposed to text-only vs. low arousal graphic vs.
      high arousal graphic warning labels paired with numeric risk information. This study will
      allow the investigators to assess the extent to which reactions to warnings remain consistent
      over time and influence smoking risk perceptions and quit intentions. The investigators will
      also assess the impact of graphic images on memory for smoking risk information presented in
      absolute (a smoker's lifetime risk of getting a smoking related disease) versus relative (a
      smoker's risk of getting a smoking related disease, compared to the risk of non-smokers)
      formats.
    


Intervention name(s): text-only PWL; low arousal graphic PWL; high arousal graphic PWL; absolute risk; relative risk
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): control condition (no image); pictorial warning; pictorial warning; Percentage risk information for smoking-related diseases for smokers; Percentage risk information for smoking-related diseases for smokers and non-smokers
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pictorial warning labels; risk knowledge; emotion; memory; risk perceptions; quit intentions
Impact of CRISP on Self-Efficacy, Loneliness, and Depression
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of an innovative program, entitled CRISP
      (Community Integration for Socially Isolated Patients), on improving self-efficacy and
      assessing whether improved self-efficacy helps to reduce depression and loneliness of people
      with MS.
    

Detailed description: 
      Whether CRISP increases self-efficacy while decreasing loneliness and depression
    

Intervention name(s): CRISP Program; Control Group
Intervention type(s): Behavioral; Other
Intervention description(s): Educational program to improve self-efficacy, loneliness and depression; no treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment