bioihbjkbjnl/mcl2 huggingface dataset:
Nasal Obstruction in Sleep Apnea Patients Compared to the General Population
Condition: Obstructive Sleep Apnoea Syndrome; Nasal Obstruction
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Nasal Obstruction
Study type: Observational

Summary: 
      Recent clinical findings of research at Trondheim University Hospital suggest that surgical
      correction of the nose septum in addition to volume reduction of the nose cavity may be
      beneficial in patients who suffer from both nose obstruction and obstructive sleep apnea
      syndrome(data not yet published).

      This study aims to compare nose obstruction prevalence in sleep apnea patients and the
      general population
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients: St Olavs Hospital, Trondheim, Norway Controls: Community sample, residents of
        Trøndelag, Norway
      
Keywords: general population; prevalence; Norway
Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      Neoadjuvant treatments (nCRT) are becoming the standard treatment for patients with stage II
      or stage III mid-low rectal cancer. In fact, with the introduction of total mesorectal
      excision, the local recurrence has been reduced significantly. Recently few studies have
      shown that surgery alone is enough for patients with T3 rectal cancer. These issues raised
      the question of whether nCRT is needed for all T3 rectal cancer patients. Therefore, this
      study was designed to compare the long-term oncological outcomes between surgery and surgery
      following nCRT among patients with MRI-defined T3, clear MRF mid-low rectal cancer.
    


Intervention name(s): total mesorectal excision
Intervention type(s): Procedure
Other intervention name(s): neoadjuvant treatment
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        T3 mid-low rectal cancer patients with clear MRF
Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      Treatment of patients with diabetic neuropathy by intraarterial progenitor cell
      transplantation.
    

Detailed description: 
      Goal is:

      Stimulation of angiogenesis and induction of vasa nervorum in order to improve nerve function
    

Intervention name(s): Intraarterial bone marrow progenitor cell transplantation
Intervention type(s): Procedure
Intervention description(s): catheter delivery of stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patients with symmetric peripheral diabetic neuropathy
Newborn Screening for Spinal Muscular Atrophy
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Observational

Summary: 
      To test if the routine newborn screening dried blood spots can be used to test if missing 2
      copies of SMN1 gene, a status indicating spinal muscular atrophy
    

Detailed description: 
      Parents of newborns will be invited to test if their newborns are affected with SMA. The
      routine newborn screening dried blood spots sample will be used to test if missing 2 copies
      of SMN1 gene. If positive of screening test, further confirmation tests including physical
      examination and other methology for SMN1 gene copies quantification will be provided. Genetic
      counseling and treatment option will be provided, too.
    

Intervention name(s): newborn screening test for SMA
Intervention type(s): Other
Intervention description(s): Routine newborn screening dried blood spots sample is used to test if missing 2 copies of SMN1 gene.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        newborns whose parents agree to be tested
      
Keywords: Newborn Screening , spinal muscular atrophy
Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The purpose of this 12-month double blind, placebo controlled randomized trial is to evaluate
      the effects of daily treatments with low magnitude mechanical stimuli on bone in 160 children
      with Crohn disease.
    

Detailed description: 
      Skeletal growth is characterized by increases in the size of the hard outer layer of bone
      (cortical bone), and the density of the inner layer of bone (trabecular or "spongy" bone).
      Children with Crohn disease (CD) have numerous risk factors for impaired bone accumulation,
      including poor growth, delayed puberty, malnutrition, glucocorticoid therapy and
      inflammation. We reported that children with CD had significant deficits in trabecular bone
      mineral density (BMD), cortical dimensions, and muscle mass; bone deficits were strongly
      associated with muscle deficits. No trials of therapies that build bone or prevent bone
      breakdown have been conducted in chronic pediatric inflammatory diseases. The capacity to
      increase bone mass and dimensions in response to mechanical loading is greatest during
      growth. Recent studies demonstrate that brief daily exposure to low magnitude mechanical
      stimuli (LMMS) enhances bone mass and quality. This 12-month double blind, placebo controlled
      randomized trial will evaluate daily 10-minute treatments with LMMS in 160 children with CD.
      Trabecular BMD, cortical dimensions, and muscle area will be measured by quantitative
      computed tomography (QCT). The LMMS device monitors adherence; these data will be transmitted
      by modem to the psychologist who will work closely with subjects to optimize adherence. All
      subjects will be provided with calcium and vitamin D supplements. The primary aims are to
      determine if treatment with LMMS results in increased trabecular BMD in the lower leg and
      spine and increased cortical dimensions in the lower leg in children with CD, compared with
      placebo controls.
    

Intervention name(s): Low magnitude mechanical stimulus; Placebo (inactive) low magnitude mechanical stimulus
Intervention type(s): Device; Device
Intervention description(s): 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device; 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
Other intervention name(s): Whole body vibration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A,
      prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when
      administered up to 5 years following production.
    


Intervention name(s): Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Intervention type(s): Biological
Intervention description(s): Intramuscular (IM), two doses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H5N1; Influenza vaccine; influenza infection; GSK1557484A
A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of
      VIB4920 (formerly MEDI4920) in adult participants with rheumatoid arthritis (RA).
    

Detailed description: 
      The overall study period will be approximately 337 days. After a screening period of up to 28
      days, the participants will be randomized in a 1:1:1:1:1 ratio to receive intravenous dose of
      VIB4920 and/or placebo in 5 cohorts. Participants are to be followed on their stable
      background anti-RA therapy at least through 12 weeks (Day 85), at which time rescue therapy
      may be instituted. All participants will be followed at least through the primary (interim)
      analysis (Day 113), and those who have not instituted rescue therapy will be followed through
      Day 309 to determine the duration of clinical response. The primary analysis will be after
      all participants have completed Day 113, and the final analysis will be after all
      participants have completed follow-up.
    

Intervention name(s): VIB4920; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): liquid for IV infusion following dilution in normal saline; 0.9% saline for IV infusion
Other intervention name(s): MEDI4920; dazodalibep
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; RA; VIB4920; MEDI4920
Switch From U-100 Insulin Analog to U-500 Regular Insulin in Pumps for Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The aim of the study was to perform a 3-year retrospective analysis from a cohort of patients
      with type 2 diabetes that were treated by a pump device and were uncontrolled despite high
      U-100 insulin requirements. The study reports outcomes after the switch from U-100 U/ml
      Rapid-Acting Analog to U-500 U/ml Regular Insulin, both administered by Continuous
      Subcutaneous Infusion.
    

Detailed description: 
      This study is a retrospective evaluation of a cohort of patients with Type 2 Diabetes from
      six French centers, who were previously treated by insulin pump therapy, and then switched
      from U-100 Rapid Acting Insulin analog to 500 U/mL Regular Insulin (Eli Lilly Inc, France)
      between June 2011 and September 2017. All participants had been previously treated by
      Multiple Daily Insulin injections and then had been treated by Continuous Subcutaneous
      Insulin Infusion with U-100 Rapid Acting Insulin analog administered by an insulin pump.
      Patient's selection criteria included an insulin-resistant state defined by a Total Daily
      insulin Dose greater than 100 U per day, and a switch from U-100 Rapid Acting Insulin analog
      to 500 U/mL Regular Insulin during the study period. Data collection from patient medical
      records included HbA1c, lipid levels, weight, Total Daily insulin Dose, and the recordings of
      hypoglycemia episodes. Outcomes were recorded at different timelines including baseline and
      6, 12, 24 and 36-months after the switch from U-100 to U-500 insulin. Blinded continuous
      glucose monitoring (CGM) (ipro2, Medtronic Inc., USA) was analyzed in a subgroup of patients
      having CGM data available at baseline on U-100 insulin and after 6-months on U-500 insulin.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Type 2 Diabetes, treated by pump therapy with U-100 U/ml rapid-acting analog,
        with a Total daily Insulin dose > 100 U per day, willing to switch to U-500 U/ml insulin
        administered by Pump
      
Keywords: Type 2 Diabetes; Insulin Resistance; Continuous Subcutaneous Insulin Infusion; Insulin Pump; Concentrated Insulin
A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
Condition: Constipation Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of
      RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition
      of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery
      of screening procedures to determine eligibility for the trial.

      The study will consist of a 2-week treatment-free screening period, a 4-week blinded
      treatment period, and a 2-week treatment-free follow-up period.
    


Intervention name(s): RDX5791
Intervention type(s): Drug
Intervention description(s): Capsule, QD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Acai Berry Consumption on Blood Glucose Levels in Healthy Adults
Condition: Post-prandial Glycaemia
Study type: Interventional

Summary: 
      Type 2 Diabetes Mellitus is a chronic disease that results in hyperglycaemia. This study
      aimed to identify whether the anthocyanins contained in acai berries can mitigate
      postprandial glycaemia in healthy adults when consumed in conjunction with carbohydrate.
      Study design was double blind randomised crossover with glycaemic levels assessed via
      capillary blood samples taken at baseline and over a 2 hour post-prandial period.
    

Detailed description: 
      Type 2 Diabetes Mellitus (T2DM) is a group of chronic metabolic disorders, characterised by
      insulin resistance and relative insulin deficiency, that results in hyperglycaemia. In the UK
      an estimated 4.3m people live with T2DM, and it is a major cause of kidney failure, heart
      attacks, stroke, blindness and lower limb amputation. The primary digestive enzymes that
      affect carbohydrate digestion and hence postprandial glycaemic levels have been identified as
      α-amylase and α-glucosidase. Inhibition of these enzymes therefore reduces the rate of
      glucose absorption and is the principle behind T2DM medications such as acarbose, miglitol
      and voglibose. Whilst acai berries have been found to be rich in α-amylase and α-glucosidase,
      no research has been conducted on healthy adults to ascertain whether the consumption of acai
      berries in conjunction with carbohydrate mitigates the rise in postprandial glycaemia.

      10 participants were recruited for a double blind randomised crossover study where
      participants consumed smoothies containing either acai or placebo after 10 hours of fasting.
      Capillary blood samples were taken at baseline then at 30 minutes intervals until 2 hours
      after consumption. The study included data for sex (female/male), age (years), weight (kg),
      height (cm), body mass index (kg/m2) and blood glucose (mmol/l). All data collection,
      smoothies preparation, smoothies consumption and blood sampling procedures were completed at
      St Mary's University during the period November-December 2020. Statistical analysis was
      conducted on the data for postprandial glycaemic response to ascertain whether the
      consumption of acai mitigated the glycaemic response relative to the placebo.
    

Intervention name(s): Acai smoothie; Placebo smoothie
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Smoothie containing 150g acai pulp; Control smoothie matched nutritionally (macronutrients) and sensorially to the acai smoothie.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised double-blind crossover
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Acai (Euterpe oleracea), acute
A Study of ALS-4 in Healthy Adults Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I trial to evaluate the safety, tolerability and Pharmacokinetics of ALS-4 (IM032) in
      a single ascending dose (SAD) and multiple ascending dose (MAD) in healthy adult subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, first-in-human (FIH) study of ALS-4
      (IM032) in healthy male and non-pregnant, non-lactating female volunteers. The study will
      consist of two phases: SAD and MAD. The study will evaluate the safety, tolerability and
      pharmacokinetic (PK) in 6 planned SAD cohorts (5 dose levels, and 1 cohort to evaluate for a
      potential food or circadian effect) with sentinel design (n=8 per cohort, total randomized 6
      active: 2 placebo; sentinel design not applicable when a cohort with the same or a higher
      drug exposure has already been evaluated) and 3 planned MAD cohorts with sentinel design (n=8
      per cohort, total randomized 6 active: 2 placebo).
    

Intervention name(s): ALS-4; Placebo; ALS-4; ALS-4; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of ALS-4 before Breakfast; Single dose of placebo before Breakfast; Dose three separate times in crossover fashion: (1) fasted morning dose; (2) fed morning dose; (3) fasted evening dose; Multiple dose of ALS-4 up to two times daily; Multiple dose of placebo up to two times daily
Other intervention name(s): IM032; IM032; IM032
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Role of 12-lipoxygenase in Platelet Reactivity and Type 2 Diabetes Mellitus
Condition: Thrombosis; Type 2 Diabetes Mellitus
MeSH terms: Thrombosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study investigates the potential protective effects of fatty acid supplementation
      through inhibition of platelet activation. fatty acids (omega-3 and omega-6) will be
      evaluated for protection from agonist-mediated platelet activation in platelets from type 2
      diabetics and healthy controls. Post-menopausal women with type 2 diabetes mellitus and
      healthy post-menopausal women will be treated with omega-3 and omega-6 fatty acid supplements
      to determine protection from platelet activation and thrombosis in this high risk population.
    

Detailed description: 
      Essential fatty acids such as omega-3 and omega-6 have been shown to play important roles in
      regulating platelet activation, but the underlying mechanisms have not been fully elucidated
      as well as their true protection from thrombosis.

      12-lipoxygenase oxidized fatty acids are known to play both a pro- and anti-thrombotic effect
      on platelets depending on the fatty acid. oxidation of arachidonic acid by 12-lipoxygenase
      resuts in a pro-thrombotic bioactive lipid whereas oxidation of the omega-6 fatty acid DGLA
      found in plant oil results in formation of a potent anti-thrombotic bioactive lipid.
      Determining the extent of protection from this and other bioactive lipids produced through
      oxygenase activity will allow for a better understanding of which fatty acid supplementation
      may best protect from thrombosis.

      Essential fatty acids such as omega-3 (DHA/EPA) and omega-6 (DGLA) appear to be protective.
      However the underlying mechanism for this potential protection is not well understood.
      Identifying the mechanism by which these supplements protect from platelet activation may
      identify new approaches to preventing thrombotic events in this high risk population.
    

Intervention name(s): Primrose oil; Fish Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): T2DM patients and matched controls subjects will be given Primrose oil for 2 months, followed by 2-week washout. Blood will be drawn at the beginning, during, and following treatments and platelet function will be assessed.; T2DM patients and matched controls subjects will be given Fish oil for 2 months, followed by 2-week washout. Blood will be drawn at the beginning, during, and following treatments and platelet function will be assessed.
Other intervention name(s): DHA/EPA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: platelets; 12-lipoxygenase; fatty acids; DGLA; DHA; EPA; 12-LOX
Prevention of Self-care Deterioration in Early Adolescents With Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Establish the efficacy of a brief, clinic-based prevention program of teamwork coping skills
      for youth and their parents during in a high risk period of early adolescence (11-14 yrs)
      when parental involvement and self-care deterioration occurs.
    

Detailed description: 
      Promotion of optimal disease care and metabolic control in youth with Type 1 diabetes is an
      important goal of disease management during early adolescence. Typically youth assume
      increasing responsibility for these goals along with parental involvement and guidance.
      However, as youth progress through adolescence, parents often become less involved in
      diabetes management and poorer self-care and metabolic control often results.

      The goal of the prevention program is to encourage parents to remain involved in their
      child's diabetes care throughout adolescence and to provide tools to help make that
      involvement a positive experience. To minimize parent/child conflict that may accompany
      sustained parental involvement, sessions of the active treatment review the following coping
      skills: communication, problem solving, conflict resolution, attitude and behavior change.
      Meetings occur in-clinic in conjunction with four consecutive medical appointments.

      The educational comparison group also meets with study researchers for in-clinic sessions
      that occur in conjunction with four consecutive medical appointments. Families discuss a
      variety of helpful educational diabetes topics and resources.

      The overarching project goal is to demonstrate the efficacy of a brief, prevention focused
      coping skills program for youth with type 1 diabetes and their parents with the ultimate goal
      of translation into routine pediatric care.
    

Intervention name(s): TeamWork CS Sessions; Diabetes Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention focuses on an authoritative parenting approach that emphasizes continued parental involvement in daily disease care. Dyadic coping skills of communication, problem solving, conflict resolution, along with attitude and behavior change are highlighted. Families meet with a study interventionist in conjunction with four consecutive medical appointments.; Diabetes Education The education comparison group meets with an educational interventionist in conjunction with four consecutive medical appointments. This group focuses on diabetes educational and resource support for parents and their youth with type 1 diabetes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention