bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Seaweed Derived Polyphenols on Inflammation and Oxidative Stress in Vivo - The SWAFAX Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is currently the leading cause of death worldwide. Epidemiologic
      studies have shown a diet rich in plant food protects against chronic degenerative diseases
      especially cardiovascular disease. Many of these studies have highlighted a potential role
      for phenolic compounds, which are abundant secondary plant metabolites, and which provide
      antioxidant and anti-inflammatory properties and are increasingly being shown to have an
      important role in influencing critical cell signalling pathways. A less well known, but
      nevertheless rich source of polyphenolic compounds is seaweed. In Ascophyllum nodosum, a
      common brown alga in the British Isles, polyphenols have been reported to comprise up to 14%
      of the dry weight of the plant. Some studies suggest that the potential antioxidant and
      anti-inflammatory benefits of seaweed-derived polyphenols may yield highly bioactive
      components with commercial potential for food and pharma applications. Preliminary work in
      our laboratory has revealed potent antioxidant activity of Ascophyllum nodosum extracts.

      Therefore, the aim of this randomised, double-blind, placebo controlled, crossover design
      study is to investigate the biological activity of a food grade seaweed polyphenol extract in
      terms of reducing oxidative damage to DNA, modulation of inflammatory responses and reduction
      on chronic, low level inflammation in vivo. Apparently healthy volunteers (aged 30-65 years)
      will be randomised to receive either a capsule containing 100mg seaweed extract or a matched
      placebo daily for an 8 week period, with an 8 week washout period between each treatment.
      Fasting blood and urine samples will be taken from each volunteer at 4 time-points during the
      study, at baseline and completion of the 2 treatment phases.
    


Intervention name(s): Treatment capsule containing seaweed extract (treatment); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400mg capsule containing seaweed extract (treatment)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
An Observational Study for the Assessment of Compliance and Persistence to Rebif® Therapy of Patients With Relapsing-remitting Multiple Sclerosis (MS) and Evaluation of Potential Factors Influencing These Parameters
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The present study aims to assess the adherence to therapy with interferon beta-1a (Rebif®)
      and at investigating potential factors that are involved in its outcome, in a representative
      sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life
      conditions.
    

Detailed description: 
      In the relapsing-remitting type of the disease the objective of the therapy is the reduction
      of relapse rate, duration and severity, as well as the delay of transition to the progressive
      form of the disease. Subjects' adherence to long-term therapy of MS plays a pivotal role in
      the optimization of therapeutic outcome and maximization of the derived clinical benefit for
      the treated subjects. Rebif current formulation has been developed by assessing and refining
      the physicochemical characteristics of existing formulations aiming at further improving
      product's tolerability profile. Studies performed for the assessment of Rebif have
      demonstrated a 3-fold reduction in injection site reactions as well as improved overall
      tolerability and safety profile.

      This is a multicentre, prospective, non interventional, non randomized, open label study for
      the assessment of the adherence to therapy with Rebif of subjects with RRMS. The
      participating subjects shall be already on treatment with (Rebif) prior to their enrolment
      into the study, according to the approved Summary of Product Characteristics (SPC) and the
      clinical, imaging and laboratory findings of the disease, as evaluated by their treating
      physician, in real life clinical practice. Data will be collected retrospectively from a
      sample of 150 subjects' medical files and through questions that will be posed to the
      subjects, and prospectively during the course of the study. The total duration of the study
      is estimated to be 18 months.

      OBJECTIVES

      Primary objective:

        -  To assess the compliance and persistence with Rebif therapy in MS subjects, after six
           months of therapy, in "real life" clinical settings in Greece

      Secondary objective:

        -  To investigate the potential factors influencing compliance and persistence to Rebif
           therapy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with documented diagnosis of RRMS according to the McDonald criteria (2005)
      
Keywords: Multiple Sclerosis, Relapsing-Remitting; Interferon-beta
Surgery for Pancreatic Cancer With Oligo-Metastasis
Condition: Pancreatic Cancer; Pancreatic Surgery
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      Pancreatic cancer is increasing in incidence and will be the second leading cause of
      cancer-related deaths in 2030 in the West. Only 10 to 15% of patients are eligible for
      curative resection with long-term survival rarely exceeding 20% at 5 years. The management of
      metastatic or recurrent diseases can not, unfortunately, be recommended to date because of
      limited data available (INCA 2019).

      However, recent, low-strength publications have reported encouraging results on the long-term
      survival of stage IV or recurrent patients.

      The aim of the present retrospective cohort study is to analyze results of
      surgery/destruction of metastatic synchronous or metachronous disease or local recurrence in
      patients with stage IV pancreatic cancer
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had resection or destruction of one or more synchronous or metachronous
        metastases or local recurrence of pancreatic adenocarcinoma
      
Keywords: Surgery; Metastasis surgery; Survival; Multimodal treatment; Stage IV
Investigations of New Markers in Patients With Shock
Condition: Shock State
MeSH terms: Shock
Study type: Interventional

Summary: 
      Shock is a severe deficiency in oxygen at the cell level which could lead to the death.The
      study was aimed at finding markers of treatment response in patients with shock, with a
      better accuracy than that of lactate actually used : hypoxia-inducible factor (HIF),
      circulating DNA (cDNA), and plasma from cells (MPs).
    

Detailed description: 
      Shock is a severe deficiency in oxygen at the cell level which could lead to the death. The
      treatment strategy relies on the profile of plasma lactate level, which the kinetics and
      metabolism are inadequate for evaluating the treatment efficiency without delay. Hence, it is
      now critical to identify adequate markers of dysoxia.

      The study was aimed at finding markers of treatment response in patients with shock, with a
      better accuracy than that of lactate.To this purpose, a multiple approach is undertaken with
      the analysis of 3 independent markers of cellular ischemia : hypoxia-inducible factor (HIF),
      circulating DNA (cDNA), and plasma from cells (MPs). Indeed, the characteristics of HIF as
      marker of cell dysoxia, and MPs as markers of cell apoptosis, combined with cDNA seem
      providing complementary information in order to describe the consequences of shock as well as
      the response to treatment.

      Samples of patients will be collected (from rest of blood sample collected for other
      measurements) at each step of the management of these patients. The evolution of these
      markers will be compared with that of lactate plasma levels (standard of care). Subgroup
      analysis will be undertaken in relation with the cause of shock state (septic, cardiogenic,
      hemorrhagic).
    

Intervention name(s): blood sample
Intervention type(s): Biological
Intervention description(s): from rest of blood sample collected for other measurements
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Genetics of Kidneys in Diabetes (GoKinD) Study
Condition: Diabetic Nephropathy
MeSH terms: Diabetic Nephropathies
Study type: Observational

Summary: 
      Kidney disease in diabetes (diabetic nephropathy) tends to run in families. It is likely,
      therefore, that there are genes that predict or are associated with either getting or not
      getting diabetic nephropathy. The GoKinD Study will provide clinical information and DNA for
      investigators to look for these genes. Evaluation will be performed and DNA obtained from
      approximately 1100 diabetic persons with kidney disease and 1000 diabetic persons without
      kidney disease. In some cases, samples for DNA will also be obtained from the parents of
      these subjects. Clinical information and DNA will be coded so that individuals cannot be
      identified, but the DNA can be linked to the clinical data from the individual. Multiple
      investigators will be able to use this genetic material to test hypotheses about the genetics
      of kidney disease in diabetes.
Human Dopamine Transported Imaging in Cocaine Abuse: 1 - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the density of DA transporters during prolonged
      cocaine abuse and during withdrawal from cocaine use. This aim will test the hypothesis that
      DA transporters are altered by cocaine abuse and reestablished during withdrawal.
    


Intervention name(s): Cocaine
Intervention type(s): Drug
Intervention MeSH terms: Cocaine
Primary purpose: Treatment
Keywords: cocaine dependence
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Condition: Body Dysmorphic Disorders
MeSH terms: Body Dysmorphic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded
      to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with
      a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will
      be conducted over a 3 month period.
    

Detailed description: 
      In this pilot study, up to 12 adult outpatients with body dysmorphic disorder that has not
      responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated
      openly with a single oral dose of psilocybin. Procedures will follow those previously
      established in depression studies of psilocybin. Patients will receive intensive preparation
      and support from two therapists, including 8-9 hours accompanying the patient on the day of
      medication administration in the Biological Studies Unit of New York State Psychiatric
      Institute. Followup visits to monitor safety and clinical outcome will be conducted at day 1,
      week1, and months 1,2, and 3 post-administration. Resting state function magnetic resonance
      imaging will be conducted prior to and one day after psilocybin administration to assess the
      effect of medication on brain circuits.
    

Intervention name(s): Psilocybin
Intervention type(s): Drug
Intervention description(s): A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Intervention MeSH terms: Psilocybin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Deep Brain Stimulation in Treatment Resistant Schizophrenia
Condition: Refractory Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional

Summary: 
      This study aims at assessing efficacy and safety of Deep Brain Stimulation (DBS) for
      treatment of patients with treatment resistant schizophrenia, by means of a random,
      controlled and crossed study.
    

Detailed description: 
      The first phase of the study will consist of implanting electrodes. Recruited patients will
      be random to 2 targets: (1) medial prefrontal cortex (mPFC); (2) nucleus accumbens (NAcc).
      Continuous stimulation will be applied until the patients stabilise clinically. This period
      is anticipated between 6 and 9 months.

      After this stage, the next phase will consist of the crossover study. Those patients who
      respond to DBS will be randomly distributed in two groups, for a period of 3 months: on
      stimulation group and off stimulation group. Patients will then be crossed over to the other
      group for a further 3 months.

      Weekly visits during first month after, and fortnightly visits will be made during the entire
      study to evaluate treatment efficacy and patient tolerance.

      Patients who complete the study and respond to treatment with DBS will be provided continuing
      with treatment, and keeping control visits to assess the long-term effectiveness.
    

Intervention name(s): On-Stimulation; Off-Stimulation
Intervention type(s): Device; Device
Intervention description(s): The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "on"; The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "off"
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment-Resistant Schizophrenia; Deep Brain Stimulation
Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation
Condition: Leukemia; Graft-Versus-Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether orale budesonide is effective in the
      prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic
      stem cell transplantation.
    

Detailed description: 
      The purpose of this study is to determine whether orale budesonide is effective in the
      prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic
      stem cell transplantation.
    

Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: graft-versus-host disease; budesonide; stem cell transplantation
The Effects of Pilates on Functional Capacity and Blood Glucose Levels in Adults With Diabetes Type 2
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of the Pilates training on Functional
      Capacity among adults with type 2 diabetes The aim of this study is to investigate the
      effects of the Pilates training on blood glucose response among adults with type 2 diabetes
    

Detailed description: 
      A Randomized Control Trial study of 3 month period will be arranged, at Riphah International
      University Faisalabad after the approval of synopsis. The convenience sampling technique will
      be selected for registration of patients. According to specified inclusion, exclusion
      criteria, patients will be chosen. Calculation of Sample size for the study tells need of
      both males and females (45 yrs-65 yrs) that will fulfill the certain criteria. The
      participants of group A will receive Pilates exercise and standard care and participants of
      group B will receive a brisk walk on treadmill and standard care. The evaluation of patients
      will be done at baseline, at 6th week, 12th week and at follow up after one month of
      discontinuation of treatment. The patient's outcome will be measured by 6-Minute Walk Test
      (distance), hemoglobin A1c level and Blood Glucose level and the recording of the patient's
      data will be at pre-treatment and post-treatment. The data of before treatment and after
      treatment will be compared at follow up after one month of discontinuation of treatment. For
      each patient informed consent will be taken. Through Statistical Package of Social Sciences
      20 software, data entry and analysis will be done
    

Intervention name(s): pilates exercise; brisk walk
Intervention type(s): Other; Other
Intervention description(s): Pilates exercise for 40 minutes (5 minutes for warm-up and 30 minutes of pilates and 5 minutes for cool down). These participants will continue their standard care.
Patients in Group-A will get 40 minutes of session, Alternative three days/ week for 12 weeks.; Brisk walk on treadmill for 40 minutes (5 minutes for warm-up and 30 minutes of brisk walk on treadmill and 5 minutes for cool down). These participants will continue their standard care.
Patients in Group-B of 40 minutes of session, Alternative three days/ week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: glycemic control; hyperglycemia; functionality; Pilates exercises
A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS
Condition: Restless Legs Syndrome
MeSH terms: Dyssomnias; Parasomnias; Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to investigate the effects on RLS symptoms and sleep
      disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks,
      compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome
    


Intervention name(s): Pramipexole
Intervention type(s): Drug
Intervention MeSH terms: Pramipexole
Intervention model: Parallel Assignment
Primary purpose: Treatment
Safety And Efficacy Of Solifenacin In Men With Overactive Bladder (OAB) And Detrusor Underactivity
Condition: Overactive Bladder; Detrusor Underactivity
MeSH terms: Hypokinesia; Urinary Bladder, Overactive; Urinary Bladder, Underactive
Study type: Observational

Summary: 
      Detrusor underactivity (DUA) in men is responsible for LUTS in a significant minority, the
      symptoms being indistinguishable from those seen in BOO. The International Continence Society
      (ICS) defines DUA as 'a detrusor contraction of inadequate magnitude and/or duration to
      effect complete bladder emptying in the absence of urethral obstruction. Whilst a reduced
      maximum urinary flow rate (Qmax) is indicative of voiding dysfunction, flow studies cannot
      distinguish between DUA and BOO, which are the two principal causes of low flow rates. DUA is
      diagnosed from a pressure-flow study (PFS)and is characterized by a low-pressure, poorly
      sustained, or wave-like detrusor contraction with an associated poor flow rate.

      Overactive bladder (OAB) is the most common term currently used in clinical medicine to
      describe a complex of lower urinary tract symptoms (LUTS) with or without incontinence but
      most commonly consisting of urgency, frequency, nocturia, troublesome or incomplete
      emptying,and, occasionally, pain. With the exception of pain and incontinence, these symptoms
      are often found together; thus, the term LUTS has come to replace previous terms, such as
      urgency-frequency syndrome,urethral syndrome, and prostatism.

      Drug treatment is frequently used as the initial management approach for LUTS in older
      men.Among men who desire treatment, general practice prescribing data have shown that
      antimuscarinics are not often given to elderly men. There is theoretical concern that the
      inhibitory effect of antimuscarinics on detrusor contraction could aggravate voiding
      difficulties or cause urinary retention in patients with BOO. There are virtually no data
      evaluating the safety and efficacy of solifenacin treatment in men with DUA and OAB.
    


Intervention name(s): solifenacin
Intervention type(s): Drug
Intervention MeSH terms: Solifenacin Succinate
The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the
      breathing effort required to briefly wake people with obstructive sleep apnea from sleep
      (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the
      severity of obstructive sleep apnea in some people (those that have a low respiratory arousal
      threshold; i.e. wake up easily to respiratory stimuli).
    

Detailed description: 
      Obstructive sleep apnea is an exceedingly common disease with major neurocognitive and
      cardiovascular consequences. The current primary treatment e.g. Continuous positive airway
      pressure (CPAP) is effective but poorly tolerated by many patients particularly those with
      mild-moderate disease. Secondary treatments such as oral appliances to advance the mandible
      or surgical procedures to enlarge the airway are commonly appealing to the patient. However,
      these approaches have only modest success in reducing apnea frequency to an acceptable level.
      Thus, finding tolerable and effective therapy for sleep apnea remains an important objective.

      The causes of sleep apnea vary between patients. Targeted therapy according to the underlying
      causes of sleep apnea in individual patients is likely to be most effective. However, current
      therapeutic options for sleep apnea are quite limited. The purpose of this physiological
      research study is to determine if taking eszopiclone (Lunesta)changes the breathing effort
      required to briefly wake people with obstructive sleep apnea from sleep (the arousal
      threshold) and if administration of the sedative medication eszopiclone (Lunesta) to certain
      sleep apnea patients (those with a low arousal threshold ie wake up easily) would be
      beneficial.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3mg tablet once prior to sleep; 1 placebo capsule prior to sleep
Other intervention name(s): Lunesta; sugar pill
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Obstructive sleep apnea; Arousal threshold; Sedative medication; upper airway