bioihbjkbjnl/mcl2 huggingface dataset:
Intellectual Enrichment to Build Cognitive Reserve in MS
Condition: Cognitive Impairment in Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Cognitive problems are a primary concern for people with multiple sclerosis. In many cases,
      people with MS report these issues to be more debilitating than the motor symptoms that are
      targeted by most treatment strategies. For people with MS, impaired memory and thinking
      skills can interfere with the ability to function efficiently in multiple professional and
      personal roles. Finding ways to decrease, slow, or reverse declines in memory and thinking
      skills is a vitally important research priority. We now know that engaging in intellectually
      enriching activities helps protect against the negative impact of MS disease-related declines
      in memory and thinking. Such activities contribute to something called 'cognitive reserve,'
      which serves as a protection against disease-related declines in memory and thinking. Thus
      far, no one has created a treatment that aims to provide a concentrated 'dose' of
      intellectual enrichment to build cognitive reserve. The present intervention aims to do
      precisely this. Here, we have developed a program of enriching activities that are delivered
      via a personal iPad. This allows for a 12-week 'treatment' that is entirely home-based, while
      also providing close personal contact between participants and our study personnel, who will
      communicate daily via emails. Week by week, participants choose from a menu of intellectually
      enriching activities such that their treatment is dynamic and customizable to fit their
      interests. The intervention is designed to be fun, as we hope the activities will be
      incorporated into people's lives beyond the period of the study itself. Given what we already
      know about the striking benefits of cognitive reserve to protect against disease-related
      declines in cognitive functioning, we expect to show that treatment with a daily, intense,
      intellectually enriching schedule of activities results in improved thinking and memory for
      people with MS. We will also investigate the positive impact of our treatment on the brains
      of people with MS through brain scans. We expect to see evidence for a shift toward more
      efficient processing in the brain, changes that translate to improved memory and thinking
      skills.
    


Intervention name(s): Intellectual Enrichment daily activities; Intellectual Enrichment documentary videos
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A daily program of intellectually enriching, iPad/tablet-based activities: games, reading/writing, hobby activities, or a documentary video (control).; Participants watch daily documentary videos.
Other intervention name(s): Placebo control condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive reserve; intellectual enrichment
Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.
Condition: Circulatory Shock; Cardiovascular Shock
MeSH terms: Shock, Cardiogenic; Shock
Study type: Observational

Summary: 
      This is an open-label, single center, trial that will enroll up to 25 participants with
      circulatory shock after cardiac surgery. Participants will be administered a topical
      sublingual nitroglycerin solution and assessed for changes microcirculatory blood flow using
      incident dark field microscopy.
    


Intervention name(s): Nitroglycerin Topical Product
Intervention type(s): Drug
Intervention description(s): Topical nitroglycerin solution
Intervention MeSH terms: Nitroglycerin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective cardiovascular surgery
Effects of CSL324 in the Lung After Segmental Challenge
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers
      to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a
      lipopolysaccharide (LPS) endotoxin challenge in a single lung segment. Saline will be
      instilled into a segment in the contralateral lung for the purpose of comparison.
    


Intervention name(s): CSL324; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intravenous (IV) dose of CSL324; IV dose of 0.9% saline
Other intervention name(s): Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody (mAb)
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Complementary Food Supplements for Reducing Childhood Undernutrition
Condition: Stunting; Wasting
MeSH terms: Wasting Syndrome; Malnutrition; Cachexia; Growth Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to test the impact on child growth of three specially formulated
      complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available
      complementary food, and vs. a control group that receives no food. All groups will receive
      nutrition education related to infant and young child feeding. This will be a
      cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in
      Bangladesh.
    

Detailed description: 
      Childhood stunting and growth faltering is highly prevalent in South Asia. Among other
      strategies, adequate complementary feeding practices and provision of complementary foods
      that are appropriate and fill the nutrient gap by providing macro and micronutrients
      essential for growth are important means to reduce the global burden of undernutrition and
      related morbidity and mortality.

      We propose to evaluate the impact of three complementary food supplement products that are
      fortified with micronutrients in a rural, remote setting in Bangladesh, where high rates of
      childhood undernutrition persist on child growth, health, and development. The three foods
      being tested are an enhanced wheat-soy blend (WSB++) developed by WFP, and locally developed
      chickpea-based and a rice-based complementary food supplements.

      We will assess the impact of feeding these daily against the non-fed controls, hypothesizing
      that the children fed these foods show increased length for age Z scores (LAZ) and weight for
      length age Z scores (WLZ) of >0.21 and decreased prevalence of stunting and wasting by >10%.
      We expect that the impact of the three foods will be equivalent/ non-inferior to that of
      Plumpy'Doz.
    

Intervention name(s): Wheat Soy Blend (WSB++); Chickpea based complementary food supplement; Rice based complementary food supplement; Plumpy Doz
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals.; A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.; Locally developed rice based complementary food with and added vitamins and minerals.; Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: complementary food supplements; stunting; wasting; growth; Bangladesh; infant feeding
NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins
Condition: Chronic Kidney Diseases; Healthy
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The objective of the pilot study is to validate the clinical use of an innovative symbiotic
      in patients with chronic kidney disease (CKD) stage 3b-4 and in healthy subjects.

      The study aims at evaluating the effects of a symbiotic, consisting of a mixture of
      probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructooligosaccharides and inulin)
      and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins), by
      achieving two objectives:

        1. Reduction of the serum levels of microbiota-derived uremic toxins, involved in a variety
           of cardiovascular complications in CKD

        2. Reduction of intestinal permeability, inflammatory markers and oxidative stress
    


Intervention name(s): Symbiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout; 2-months oral administration of the placebo (2 bags/day) + 1 month washout
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: gut microbiota dysbiosis; uremic toxins; symbiotic
Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X.
      Bleeding events related to rivaroxaban are the consequence of physiopathologic,
      pharmacokinetic issues or poisoning. A recent study, in healthy subjects, shows that
      activated charcoal can reduce significantly exposition to rivaroxaban. However, no results
      are available on the minimal dose of activated charcoal necessary in rivaroxaban poisoning.
      The objective of this study is to evaluate the effect of 4 dosing regimen activated charcoal
      on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete
      cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments
      modalities will be studied: rivaroxaban with 50g, 24g, 12g and 6g of activated charcoal
      administrated 3 hours after rivaroxaban intake.
    


Intervention name(s): Rivaroxaban; Activated charcoal
Intervention type(s): Drug; Drug
Intervention description(s): rivaroxaban 40 mg/day (1 day).; Activated charcoal 2 hours after rivaroxaban administration (1 day).
Intervention MeSH terms: Rivaroxaban; Charcoal
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Rivaroxaban,; Activated charcoal; Pharmacokinetics; Poisoning
Postural Control and Fine Motor Skills in People With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      This study evaluates the relationship between seated posture and fine motor performance in a
      drawing task in people with stroke and in healthy control subjects.
    

Detailed description: 
      Current stroke rehabilitation practice guidelines support an interprofessional approach which
      integrates discipline-specific goals into a comprehensive plan of care. However, there has
      been a failure to implement interprofessional guidelines into today's stroke rehabilitation
      clinical practice. Instead it is common that one discipline focuses on recovery of posture,
      while another discipline focuses on recovery of fine motor skills. The investigators argue
      that control of the hand is not independent from postural control. In fact, treating them
      separately ignores the kinematic and muscular linkages connecting the trunk to the hand via
      the scapula and proximal arm. It also ignores evidence that postural and hand muscles have
      overlapping cortical representations thus likely have similar neural control networks. Hence,
      the overall goal of this project is to demonstrate the relationship of posture and fine motor
      skills to advance stroke rehabilitation.

      The study will include two groups, stroke survivors and neurologically healthy controls, and
      both will perform a tracing task while seated on a backless bench. The task will be performed
      twice, at baseline and after giving participants cues to improve their posture. Both task
      repetitions will be performed in a single session on the same day. Kinetic and kinematic data
      will be collected to evaluate posture, postural stability and fine motor performance. Data
      collected at baseline will be used to examine the relationship between postural impairments
      and fine motor deficits. Additionally, we will evaluate the effects of postural cues on body
      segment alignment, stability and fine motor performance.
    

Intervention name(s): Postural counseling
Intervention type(s): Behavioral
Intervention description(s): A therapist will provide verbal/physical cues to improve the participants posture
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Stroke patients will be recruited from the MUSC Center for Rehabilitation Research in
        Neurological Conditions database (approved IRB PRO# 15991, PI Kautz) that currently
        contains contact information for ~120 stroke survivors who have agreed to be contacted for
        research participation.
      
Keywords: Stroke rehabilitation; Upper extremity; Posture
Safety Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO)
      is a safe treatment for patients who have suffered an acute ischemic stroke.
    

Detailed description: 
      Acute ischemic stroke is a major cause of death and severe disability. There is only one
      approved pharmacological treatment, Alteplase, which has to be administered within 3 hours
      from symptom onset. Consequently, only about 2-3% of patients world wide with ischemic
      strokes are treated. The naturally occurring hormone, erythropoietin (EPO), is able to
      protect various neuronal tissues from ischemic injury and is beneficial in animal models of
      acute ischemic stroke. However, treatment of stroke with EPO is undesirable due to its
      ability to stimulate production of red blood cells and to promote the blood to coagulate. Lu
      AA24493 is a modified (carbamylated) version of EPO, neuroprotective but without the
      haematopoietic side effects. Lu AA24493 is developed for treatment of patients with acute
      ischemic stroke.

      In this safety study of single doses with Lu AA24493, patients will receive Lu AA24493 within
      12-48 hours from symptom onset.
    

Intervention name(s): Lu AA24493 (CEPO); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset; Vials with solution for IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute ischemic stroke; Erythropoietin; Carbamylated; Neuroprotection
A Study of Sibutramine in Overweight Adolescents to Assess Weight Loss and Safety.
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effectiveness of sibutramine on weight loss,
      reduction in body size and improvement in metabolic risk factors and safety in obese
      adolescents.
    


Intervention name(s): sibutramine
Intervention type(s): Drug
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Meridia; Sibutramine; Obesity; Adolescent; BMI
Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The objective of this study is to compare the effect of outpatient pelvic floor muscle
      training versus home pelvic floor muscle training in the treatment of stress urinary
      incontinence. The hypothesis of this study is that home pelvic floor muscle training is as
      effective as outpatient pelvic floor muscle training for the treatment of stress urinary
      incontinence.
    

Detailed description: 
      Success with the pelvic floor muscle training (PFMT) is hampered by non-adherence, which is
      related to factors such as inability to contract the pelvic floor muscles and lack of
      motivation. Thus under supervision by a physiotherapist (outpatient training), PFMT has the
      potential of improving adherence to training and has been demonstrated to be more effective
      when compared to unsupervised PFMT (home training). The objective of this study is to compare
      the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle
      training in the treatment of stress urinary incontinence. This is a randomized controlled
      trial and which will be conducted at the Division of Urogynecology and Reconstructive Pelvic
      Surgery at the Federal University of Sao Paulo, Brazil. As a primary endpoint, the
      standardized volume test pad (250 mL) will be used. To assert that one of the groups (home
      PFMT or outpatient PFMT) is superior to the other, it will be necessary to find 38.5% more
      patients cured when the groups are compared. Secondary outcome measures will be used,
      assessment of the pelvic floor muscles function, urinary symptoms, quality of life and
      subjective cure.
    

Intervention name(s): Exercises of the pelvic floor muscle at home; Exercises of the pelvic floor muscle in the outpatient
Intervention type(s): Other; Other
Intervention description(s): Patients will perform pelvic floor exercises at home.; Patients will perform pelvic floor exercises in the outpatient.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Protocol of group I (Outpatient training): Patients will perform 24 outpatient sessions of pelvic floor muscle (PFM) strength training and home training. At the end of one month, the patients will perform PFM evaluation and training progression
Group II protocol (home training): Patients will perform strength training of the pelvic floor muscles daily at home. At the end of one month, the patients will return for consultation, in which the PFM evaluation and training progression will be performed.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary Incontinence, Stress; Pelvic Floor; Exercise; Physical Therapy Modalities
Pain Responses in Patients on Long-Term Opioid Therapy for Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      The MGH Center for Translational Pain Research is seeking patients with chronic pain for a
      research study. The study is looking at the effect of opioid (narcotic) pain medicines on
      pain sensation, threshold and tolerance.
    

Detailed description: 
      The study consists of one visit, in which an interview, physical exam, lab work (urine test)
      and sensory testing will be done. The testing (Quantitative Sensory Testing) is noninvasive
      (no needles) and involves heat and cold stimulation. Compensation and some parking
      reimbursement provided.
    

Intervention name(s): Quantitative Sensory Testing (QST)
Intervention type(s): Device
Intervention description(s): QST consists of a series of heat and cold stimulation tests.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The groups of subjects on chronic opioid and non-opioid treatment for chronic pain will be
        recruited from the MGH Pain Center's patients. We want to emphasize that our MGH Pain
        Center patient population comprehends a significant number of patients on stable dose of
        non-opioid and opioid pain medication for chronic pain. The investigators and study staff
        will search daily the MGH Pain Center clinic list and will approach the patients who might
        qualify for the study. The group of opioid naive subjects will be recruited by advertising
        in local newspapers and by using e-mail announcements through Partners HealthCare system.
      
Keywords: Pain
Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium
      Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults
      (18-45 years of age).
    


Intervention name(s): Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R; Investigational MenC-CRM adjuavnted with 25 ug of LHD153R; Investigational MenC-CRM adjuavnted with 50 ug of LHD153R; Investigational MenC-CRM adjuavnted with 100 ug of LHD153R; Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular (IM) vaccination of 1 dose of 0.5 mL; IM vaccination of 1 dose of 0.5 mL; IM vaccination of 1 dose of 0.5 mL; IM vaccination of 1 dose of 0.5 mL; IM vaccination of 1 dose of 0.5 mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention