bioihbjkbjnl/mcl2 huggingface dataset:
Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this research will be to perform a small randomized controlled trial (RCT) of a
      new diabetes educational intervention that teaches self-management skills that compensate for
      poor numeracy skills among a sample of primary care patients with type 2 diabetes and low
      literacy and/or numeracy.
    

Detailed description: 
      Results of the National Adult Literacy Survey (NALS) suggest that over 90 million adult
      Americans have poor quantitative skills. Numeracy, the ability to understand and use numbers
      and math skills in daily life, may be particularly important to patients with diabetes
      because caring for diabetes often requires self-management skills that rely on the daily
      application of math skills, such as counting carbohydrates, interpreting blood glucose
      monitoring, applying sliding scale insulin regimens, and calculating insulin to carbohydrate
      ratios. Presumably diabetes patients with poor numeracy have more difficulty with
      self-management and are at risk for poorer clinical outcomes, but to date, there are no
      published studies that rigorously examine the role of numeracy in diabetes. We have recently
      completed the initial development of a new scale to measure numeracy in patients with
      diabetes: the Diabetes Numeracy Test (DNT).

      The aim of this research will be to perform a small randomized controlled trial (RCT) of a
      new diabetes educational intervention that teaches self-management skills that compensate for
      poor literacy and numeracy skills among a sample of patients with type 2 diabetes and low
      numeracy or literacy skills. We hypothesize that a group of patients with poor literacy
      and/or numeracy who are taught self-management skills that accommodate their poor numeracy
      will have: (1) improved treatment satisfaction and perceived self-efficacy, (2) improved
      performance in self-management tasks, and (3) improved glycemic control compared to a control
      group that receives usual education and care.
    

Intervention name(s): Literacy/Numeracy oriented educational intervention; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Receives comprehensive literacy/num sensitive diabetes care; Receives standard diabetes disease management
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Type 2 Diabetes; Diabetes Education; Health Literacy
Caffeinated Gum Softball Performance
Condition: Caffeine
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of caffeinated chewing gum on female
      softball pitching and hitting performance. 24 trained female softball players (10 pitchers
      and 14 fielders) were divided into a caffeine chewing gum trial (CAF) or a placebo trial
      (PLA) in a single-blind, randomized, crossover experimental design. Two pieces of gum
      containing 100 mg of caffeine (CAF) or without caffeine (PLA) were chewed for 10 minutes and
      then spit out, followed by a 15-minute warm-up. The physical tests included grip strength and
      countermovement jump. The softball-specific tests included pitching (fast ball speed) or
      hitting (exit speed). The two trials were separated by seven days.
    

Detailed description: 
      This study utilized a randomized, crossover, single-blind experimental design. At least two
      familiarization tests were conducted one week before the formal trial to ensure each
      participant was familiar with the experimental procedures. Before the first formal trial,
      participants were randomly assigned to either the caffeinated chewing gum trial (CAF) with
      200 mg of caffeine or the placebo trial (PLA) without caffeine, seven days apart (Figure 1).
      The primary outcome was the pitching and hitting performance, and the secondary outcomes were
      hand grip strength and height of countermovement jump.
    

Intervention name(s): CAFFEINE GUM
Intervention type(s): Other
Intervention description(s): Observing the effect of chewing gum on the performance of female softball players.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Non-inferiority Study of a Cardiac Tele-rehabilitation in Hybrid Form Compared to a Cardiac Rehabilitation
Condition: Cardiac Tele-rehabilitation
Study type: Interventional

Summary: 
      Cardiac tele-rehabilitation in a hybrid form can be a choise for the management of
      cardiovascular diseases. The aim is to increase the participation rate of patients in cardiac
      rehabilitation.

      This new form of care can be as effective as traditional care.
    

Detailed description: 
      The Covid-19 pandemic has had indirect effects on the health system, particularly in the
      management of cardiovascular diseases. Rehabilitation centres had to adapt their operation to
      the recommendations of health authorities. The choice appeared to be unavoidable:
      tele-rehabilitation care in a hybrid form. Moreover, Many patients do not participate at this
      kind of care. Many identified factors can explain this low rate of participation : a lack of
      proximity facilities does not promote patient participation.

      The objective of this study is to demonstrate a comparable effectiveness between a cardiac
      telerehabilitation programme in hybrid form and a cardiac classic rehabilitation programme.
    

Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): Hybrid approach in cardiac telerehabilitation. Patients underwent 20 cardiac rehabilitation sessions: alternatively, patients underwent 10 classical cardiac rehabilitation sessions in the clinic and 10 cardiac telerehabilitation sessions at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization in two groups: a Hybrid Tele-pulmonary Rehabilitation group and a classic Rehabilitation group.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cardiac tele-rehabilitation, cardiac rehabilitation
The Antihypertensive Effect of Remote Ischemic Conditioning (RIC-HTN).
Condition: Hypertension,Essential; Prehypertension
MeSH terms: Hypertension; Prehypertension; Essential Hypertension
Study type: Interventional

Summary: 
      This study intends to further reveal the antihypertensive effect of LRIC and explore its
      potential mechanisms.
    

Detailed description: 
      Stroke is the second-leading cause of death in the world and the leading cause of death in
      China. The estimated lifetime risk of stroke for those aged 25 years old and above is 24.9%
      worldwide and 39.3% in China. Hypertension is one of the main independent risk factors for
      stroke. Studies have shown that the risk of stroke increase at blood pressure (BP) above
      115/75mmHg, each increase of 20mmHg in systolic blood pressure (SBP) or 10 mmHg in diastolic
      blood pressure (DBP) will double the risk of stroke. For those hypertensive patients without
      complications, each reduction of 10mmHg in SBP reduces approximately 17% risk of stroke, and
      each reduction of 5mmHg in DBP reduces 20%. Therefore, enhancing the primary prevention of
      stroke in hypertensive patients without vascular complications is important to reduce the
      burden of stroke in the future. However, these patients do not pay enough attention to their
      elevated BP and have poor compliance with antihypertensive drugs. Therefore, it is necessary
      to explore an economical, convenient and effective non-pharmacological therapy to control BP
      in order to reduce the risk of stroke.

      Limb remote ischemic conditioning (LRIC) triggers endogenous protective effect through
      transient and repeated ischemia in the limb to protect remote tissues and organs. The
      mechanisms of LRIC involve the regulation of autonomic nervous system, release of humoral
      factors, improvement of vascular endothelial function and modulation of immune/inflammatory
      responses, which can antagonize the pathogenesis of hypertension through multiple pathways to
      lead a drop in BP theoretically. This theory has been preliminarily confirmed by several
      small sample-size studies. Therefore, this study intends to conduct a randomized controlled
      trial to further reveal the antihypertensive effect of LRIC and explore its potential
      mechanisms.
    

Intervention name(s): Remote ischemic conditioning (RIC); Sham remote ischemic conditioning (Sham-RIC)
Intervention type(s): Device; Device
Intervention description(s): RIC is a non-invasive therapy which is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol include five cycles of 5-min inflation to 200mmHg and 5-min deflation.; The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Remote ischemic conditioning; Essential hypertension; Prehypertension; Blood pressure
The Effects of Jerusalem Artichoke and Fermented Soybean Powder Mixture Supplementation on Glucose Control
Condition: Prediabetes; Newly Diagnosed Type 2 Diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The purpose of this randomized, double-blind, placebo-controlled study was to determine
      whether jerusalem artichoke and fermented soybeans powder mixture is effective in the control
      of blood glucose level in subjects with prediabetes or newly diagnosed type 2 diabetes.
    

Detailed description: 
      The objective of this clinical study was to evaluate the effect of jerusalem artichoke and
      fermented soybean powder mixture supplementation on blood glucose. A randomized,
      double-blinded, placebo-controlled study was conducted on 60 subjects with impaired fasting
      glucose (IFG), impaired glucose tolerance (IGT) or newly diagnosed type 2 diabetes. The
      subjects were randomly assigned to either a group ingesting 40 g jerusalem artichoke and
      fermented soybean powder mixture supplementation daily or a placebo group for 12-week. We
      assessed fasting and postprandial levels of glucose.
    

Intervention name(s): jerusalem artichoke and fermented soybeans powder mixture; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 40 g jerusalem artichoke and fermented soybean powder mixture; 40 g powdered rice flour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Clinical Outcomes After Cataract Surgery With and Without Capsular Tension Ring
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      This study was set up to identify clinical outcomes including a refractive shift or change in
      IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes
      without zonular instability.
    


Intervention name(s): Insertion of the capsular tension ring
Intervention type(s): Device
Other intervention name(s): a pre-loaded CTR in single use injector was inserted just before IOL implantation during cataract surgery
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The patients who were planned to undergo the cataract surgery in Department of
        Ophthalmology, Yonsei University College of Medicine
Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM
      XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with
      epilepsy.
    


Intervention name(s): TPM XR
Intervention type(s): Drug
Intervention description(s): Equivalent TDD in XR form, QD, Day 1-14
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Pediatrics; Young Adults
SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study
Condition: Chronic Inflammatory Demyelinating Polyneuropathy; Peripheral Neuropathy; Charcot-Marie-Tooth Disease; Charcot-Marie-Tooth Disease Type 1A; Charcot-Marie-Tooth Disease, Type 1B; Anti-MAG Neuropathy
MeSH terms: Tooth Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional
Phase: Phase 2

Summary: 
      The single-center, open-label Phase II study has the objective of assess the effect of MD1003
      on motor and sensory conduction in patients suffering from demyelinating polyneuropathies in
      15 subjects.
    


Intervention name(s): MD1003
Intervention type(s): Drug
Other intervention name(s): High Dose Biotin
Intervention MeSH terms: Biotin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuropathy; Demyelinating polyradiculoneuropathy
EEG Diagnostic for Repetitive Sub-concussive Head Impacts
Condition: Concussion
Study type: Observational

Summary: 
      The purpose of this study is to develop a diagnostic algorithm to help with the detection,
      diagnosis, and monitoring of sub-concussive head impacts.
    

Detailed description: 
      This prospective study will investigate the potential effects of soccer ball heading on EEG
      and oculomotor measurements.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Soccer players between 18 and 38 years old.
Canola Oil, Fibre and DHA Enhanced Clinical Trial
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of consumption of a novel food supplement
      consisting of Canola Oil, Fibre and DHA, containing the most effective food bioactives,
      including n-3 fatty acid enriched dietary oil high in monounsaturated fatty acids (MUFAs) and
      soluble dietary fibre, aiming at the management of heart disease risk factors in people with
      metabolic syndrome and to test its efficacy and safety in humans.
    

Detailed description: 
      The proposed study is a randomized, single-blind, crossover trial, it will be conducted at
      the Richardson Centre for Functional Food and Nutraceuticals (RCFFN), University of Manitoba.
      The study design will consist of 4 phases with 30 days per phase, each phase will be
      separated by 4-week washout periods. Participants will consume a recommended
      weight-maintaining diet (35% energy from fat, 50% carbohydrate, 15% protein) supplemented
      with the following novel Muffin and cookies: (a) control food containing butter, sunflower
      and safflower oil comprised largely of saturated fat with substantial levels of n-6 linoleic
      acid, and refined wheat flour common to current North American intakes, (b) food containing
      high oleic canola oil and docosahexaenoic acid (HOCO-DHA) and refined wheat flour, (c) food
      containing high molecular weight barley B-glucan and a combination of sunflower, safflower
      oil and butter, (d) food containing combination of HOCO-DHA and high molecular weight barley
      β-glucan. Treatments will be isocalorically incorporated into muffin and cookies consumed in
      equal parts at breakfast and supper.
    

Intervention name(s): Butter, sunflower and safflower oil; High Oleic Canola Oil and DHA (HOCO-DHA); Barley beta-glucan; HOCO-DHA and Barley beta-glucan
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Metabolic syndrome; Cardiovascular disease; High Oleic Canola Oil; DHA; β-glucan; Barley; Cholesterol; Lipoproteins; Lipids; Inflammation; Glucose; Insulin; Satiety; Body composition; Blood pressure
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat
Condition: Subcutaneous Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      The Phase 2a component of the study will be a randomized, open-label, parallel, and multiple
      dose study to further examine the safety and efficacy profile of 3 CBL-514 dose levels based
      on the results from Phase 1 of the study.
    


Intervention name(s): CBL-514
Intervention type(s): Drug
Intervention description(s): Both sides of the abdominal region will receive CBL-514.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study
Condition: Genotype Guided(HNF4a); Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in
      healthy subject in relation to the presence of HNF-4A G60D variant.
    

Detailed description: 
      After a single oral administration of 2 mg tolterodine in 31 healthy subjects (6 with the
      heterozygous mutation of HNF-4A G60D vs 25 subjects with wild type of that whose CYP2D6
      genotype and gender were matched with variant group), blood were collected for 24hrs. Assay
      of tolterodine and the metabolite, 5-hyroxymethyl tolterodine was conducted using LC/MS/MS.
    

Intervention name(s): Tolterodine
Intervention type(s): Drug
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HNF4a; CYP2D6; Toterodine; Genetic polymorphism
Food Additives Effects on EEG Profiles in College Students With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of food additives on college students
      with ADHD. This study could potentially answer an important question which still remains
      unanswered as to whether certain food additives may be able to cause cognitive and electrical
      activity changes in college students with and without ADHD. In this context, food additives
      will be artificial food coloring.
    

Detailed description: 
      Consent will be obtained at the first visit. Baseline data will be collected on the
      participants, including height, weight, computerized cognitive functioning, and an EEG
      recording. Participants will also be taught how to keep a detailed food and symptom diary
      over the following week. One week later, the participant will return to the lab and turn in
      the food/symptom diary. All ADHD participants and a subgroup of controls (called extended
      controls or EC) will be trained on how to follow the dietary intervention. Detailed
      information on the diet will be given, including food additives to avoid, healthy foods which
      should be eaten, and shopping tips. For the next two weeks, the participant will follow the
      dietary intervention at home with access to Dr. Holton to answer any questions. The
      participant will return to the lab after following the diet for two weeks and assessments
      (cognitive testing, and EEG) will be completed again along information on dietary compliance
      will be collected. The third meeting will also mark the beginning of the first challenge
      period. For the challenges, the participant will consume chocolate cookies every Monday,
      Tuesday, and Wednesday for two weeks. The cookies may or may not contain artificial food
      coloring depending on the week. Every Wednesday repeat testing will be completed after the
      cookies are consumed. The participant will be asked not to take ADHD medication on testing
      days. After two weeks of challenges the study will be completed. The participant will receive
      information on their performance and on the study results overall.
    

Intervention name(s): Artificial Food Coloring; Placebo
Intervention type(s): Other; Other
Intervention description(s): 225mg mixed powdered Artificial Food Coloring (AFC); Placebo chocolate cookies
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All ADHD participants and a subgroup of control participants will be exposed to all challenge mixtures (artificial food coloring/placebo, placebo/artificial food coloring) with adequate washout periods between exposures.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Food Additives; Artificial Food Coloring; Diet
Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients
Condition: Sepsis
MeSH terms: Sepsis; Toxemia; Febrile Neutropenia
Study type: Observational

Summary: 
      The aim of this study is to find out whether inflammation markers including cardiac markers
      have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological
      patients.
    

Detailed description: 
      Adult AML and ASCT patients with neutropenic fever. Observation of possible progress to
      severe sepsis or septic shock. Blood sample collection on days 0-3 (from the beginning of
      neutropenic fever).
    

Intervention name(s): Severe sepsis vs. non-severe sepsis
Intervention type(s): Other
Intervention description(s): To compare these two groups
Other intervention name(s): Severe sepsis vs. non-severe sepsis adult AML patients; Severe sepsis vs. non-severe sepsis adult ASCT patients
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Neutropenic patients in haematology ward having neutropenic fever with or without severe
        sepsis
      
Keywords: Severe sepsis in neutropenic haematological patients
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers
Condition: Healthy Subjects; Drug Interactions; Pharmacokinetics of ASP015K
Study type: Interventional
Phase: Phase 1

Summary: 
      This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in
      healthy volunteers.
    

Detailed description: 
      The subjects will be confined to the unit for 13 days and have a brief follow-up visit to
      obtain hematology blood samples. Numerous blood and urine samples will be taken to determine
      the pharmacokinetics of the drugs.
    

Intervention name(s): ASP015K; Mycophenolate Mofetil
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): CellCept
Intervention MeSH terms: Mycophenolic Acid; Peficitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: transplant; ASP015K; healthy subjects