bioihbjkbjnl/mcl2 huggingface dataset:
ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have
      anti-inflammatory effects and to change the composition of the faecal micro flora in the
      colon.

      In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome
      are randomized to two types of diet intervention: a low and a high fiber diet. The
      participants are subjected to endoscopy before and in the end of each intervention.
    

Detailed description: 
      Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have
      anti-inflammatory effects and to change the composition of the faecal micro flora in the
      colon.

      In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome
      are subjected to two types of diet intervention:

        1. a western style diet, WSD, with a low fiber content and

        2. a healthy carbohydrate diet, HCD, a high fiber diet. Between the two 4-weeks diet is a
           wash-out period of four to eight weeks. The participants are subjected to endoscopy with
           tissue samples before and in the end of each intervention. Fecal and blood samples will
           be collected at the same time.

      We hypothesize that a high content of resistent starch and arabinoxylans increases colonic
      butyrate concentration, changes colon's mucosal immune system and the microbiota.

      A small pilot study will be carried out on 12 healthy volunteers in order to obtain a
      reference to participants with metabolic syndrome. The healthy volunteers will be subjected
      to an endoscopy but no dietary intervention.
    

Intervention name(s): Western Style Diet; Healthy Carbohydrate Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers (Arabinoxylans and Resist Starch) compared with a Western Style Diet with a low content of dietary fibers.; Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers ( Arabinoxylans and Resistent Starch) compared with Western Style Diet with low content of dietary fibers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Dietary fibers; Butyrate; Short Chain Fatty Acids; Colon; Metabolic Syndrome
Chewed Versus Integral Pill of Ticagrelor
Condition: Percutaneous Coronary Intervention
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis The primary question the investigators propose to answer is whether all patients
      undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed
      ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as
      compared to integral pill form 1 hour after drug administration.
    

Detailed description: 
      Hypothesis The primary question the investigators propose to answer is whether all patients
      undergoing PCI with stent deployment who receive chewed ticagrelor will demonstrate more
      rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1
      hour after drug administration.

      Secondary Hypotheses:

        1. Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year.

             1. Death

             2. Repeat myocardial infarction

             3. Need for urgent revascularization

             4. Cerebrovascular accident

        2. Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year.

        3. Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in
           myocardial infarction (TIMI) criteria.
    

Intervention name(s): Ticagrelor; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Chewed; Integral
Other intervention name(s): Brilinta; Brilique; Possia; Brilinta; Brilique; Possia
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ticagrelor; Stent
A Study to Evaluate the Effects of Dietary Fiber on Blood Lipids in Men and Women
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      There is a need to assess the LDL-C-lowering abilities of a dietary fiber ingredient, in
      order to confirm the product's efficacy. Thus, the objective of this study is to assess the
      effect of 3g dietary fiber on lowering serum LDL-C in otherwise healthy men and women.
    

Detailed description: 
      This study will assess the effect of 3g/d dietary fiber ingredient on lowering serum LDL-C in
      otherwise healthy men and women. Subjects will be generally healthy men and women
      (approximately equal number of men and women) 21-79 years of age, inclusive, each with a
      fasting LDL-C level ≥130 mg/dL and <190 mg/dL.

      This randomized, controlled, 28-day parallel study will include one screening Visit (Visit 1,
      Day -14), two baseline visits (Visits 2 and 3; Days -3 and 0) and three test visits (Visits
      4, 5, and 6; Days 14, 25, and 28), and two contact reminders (Days 7 and 21).

      Study ingredients will be provided in three servings of study products each day. During the
      study, subjects will be instructed to consume one serving of study product at each mealtime.

      The primary outcome variable will be the percent change in LDL-C concentration from baseline
      (average of Days -3 and 0) to the end of each intervention condition (average of Days 25 and
      28).
    

Intervention name(s): dietary fiber
Intervention type(s): Other
Intervention description(s): Fiber containing drink mixes and crackers to be consumed with meals (1g fiber/serving) three times per day for a total of 3 g fiber.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: fiber; cholesterol
Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children
Condition: Fatty Liver; Obesity
MeSH terms: Fatty Liver
Study type: Observational

Summary: 
      In the past decades, obesity in children is much more prevalent in the world. Given the
      increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.

      Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat
      content in adults.

      The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP)
      influence fatty liver in obese children and adolescent.
    

Detailed description: 
      The primary aim of this study is to assess the associations between to investigate the
      association of rs2854117 C > T and rs2854116 T > C SNPs of the APOC3 gene with liver
      steatosis, as measured by liver ultrasound.

      As a secondary aim, the investigators will examine the associations between APOC3 rs2854117 C
      > T and rs2854116 T > C SNPs and serum alanine aminotransferase (ALT) and aspartate
      aminotransferase (AST) levels. In addition, the investigators will further analyze the
      association with other biomarkers, such as body mass index, adiponectin and insulin
      resistance.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese children and adolescents in Taiwan
      
Biospecimen description: 
      serum, WBC DNA
Raynaud's Treatment Study (RTS)
Condition: Cardiovascular Diseases; Heart Diseases; Raynaud's Disease; Vascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Raynaud Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the relative efficacy of usual medical care and a course of treatment by thermal
      biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to
      confirm the frequency and severity of attacks, examine the role of psychophysiological
      factors in precipitating attacks, and assess the influence of treatment on health quality of
      life.
    

Detailed description: 
      BACKGROUND:

      Primary Raynaud's phenomenon is a peripheral vascular disorder resulting in vasospastic
      attacks provoked by cold and/or emotional stress. Attacks most often occur in the fingers,
      but may occur in other extremities as well.

      DESIGN NARRATIVE:

      Randomized. Patients were assigned to one of four treatment groups: slow release Nifedipine,
      a calcium channel blocker; pill placebo; temperature biofeedback; or electromyograph
      biofeedback from the frontalis muscle. The primary endpoint was reduction in number of
      vasospastic attacks. Other endpoints included: other measures of Raynaud's attacks including
      frequency, severity, duration, response to laboratory-based cold challenge, and quality of
      life.
    

Intervention name(s): nifedipine; biofeedback (psychology); electromyography
Intervention type(s): Drug; Behavioral; Procedure
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Primary purpose: Treatment
Intraoperative Norepinephrine Versus Fresh Frozen Plasma in Patients Undergoing HIPEC to Reduce Renal Insult
Condition: Anesthesia
Study type: Interventional

Summary: 
      comparing the effect of low dose norepinephrine infusion versus fresh frozen plasma in
      patients undergoing HIPEC to reduce renal insult
    

Detailed description: 
      To compare the efficacy of maintaining intraoperative hemodynamic stability through infusing
      low dose norepinephrine versus fresh frozen plasma in patients undergoing cytoreductive
      surgery and heated intraperitoneal chemotherapy in cancer patients undergoing cytoreductive
      surgery and heated intraperitoneal chemotherapy
    

Intervention name(s): Norepinephrine; Fresh frozen plasma
Intervention type(s): Drug; Biological
Intervention description(s): 5 mic/kg/hr norepinephrine; early administration of fresh frozen plasma
Other intervention name(s): low dose norepinephrine; Blood products
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Effects of CPAP on Visceral Fat Thickness
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and
      increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and
      liver fat, plasma lipids, carotid artery thickness.
    

Detailed description: 
      This proposed randomized control trial (RCT) will compare the effects of therapeutic CPAP
      versus subtherapeutic CPAP in patients newly diagnosed with OSA with reference to visceral
      fat especially mesenteric fat thickness, liver fat, carotid artery intima media thickness
      (IMT), lateral pharyngeal wall (LPW) thickness, plasma lipids and adipokines over a treatment
      period of 3 months. The results of this study will advance our understanding of the relative
      role of OSA and obesity in the pathogenesis of metabolic syndrome (MetS) and whether CPAP
      therapy can improve these metabolic dysregulation.
    

Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): All subjects will undergo ultrasound examination of the abdomen the day after overnight polysomnography (PSG) and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by
      using soluble dietary fibres) may reduce the glycemic or insulinemic response. This may in
      turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma
      triacylglycerol concentration A higher postprandial fat oxidation may result in less lipid
      accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic
      profile in the longer term.
    


Intervention name(s): Polydextrose and soluble gluco fibre
Intervention type(s): Other
Intervention description(s): Polydextrose and soluble gluco fibre
Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      This study is designed as a prospective, randomized, multi-center trial to demonstrate an
      inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting
      stents(EES) at long lesions(> 28 mm) in clinical outcomes at 12 months as a primary objective
      and safety of 6- month dual antiplatelet therapy following EES implantation in comparison
      with a 12-month dual antiplatelet therapy.
    

Detailed description: 
      The primary purpose of this study is to investigate the impact of IVUS guidance on the
      clinical outcomes after implantation of DES at long lesions > 28 mm.
    

Intervention name(s): PCI with IVUS guidance; PCI without IVUS guidance
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.; Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
Other intervention name(s): PCI with IVUS guidance group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Beetroot Juice Ingestion on Female Rugby Performance
Condition: Nitric Oxide; Placebo
Study type: Interventional

Summary: 
      Rugby is a team sport characterized by high-intermittent efforts, due to the importance of
      realizing intermittent and explosive efforts in rugby the use of nutritional strategies such
      as beetroot ingestion should be explored with the aim to enhance the capacity for repeating
      high-intensity actions in female players.
    

Detailed description: 
      Rugby is a team sport characterized by high-intermittent efforts, thus, to the importance of
      realizing intermittent and explosive efforts in field hockey is crucial. For this reason, the
      use of nutritional strategies in field hockey should be explored with the aim to enhance the
      capacity for repeating high-intensity actions. However, scientific evidence supports only a
      few numbers of dietary supplements that have reported good evidence for improving sports
      performance, between we can mention beetroot juice supplementation with doses > 5 mmol of
      NO3-. Beetroot juice is a NO3- precursor with recognized effectiveness to elicit performance
      due to different physiological mechanisms associated with its ingestion such as increment in
      vasodilatation, skeletal muscle contractility, or delaying fatigue development that could be
      linked with an enhance or performance in team-sports athletes. However, the majority of the
      studies has been realized in male athletes being female athletes underrepresented in beetroot
      juice supplementation research. Thus, the aim of this study was to analyze the effects of
      beetroot juice ingestion on neuromuscular performance in female rugby players.
    

Intervention name(s): Beetroot juice
Intervention type(s): Dietary Supplement
Intervention description(s): Acute effects of beetroot juice ingestion on neuromuscular performance in female rugby players
Other intervention name(s): Nitrate precursors
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dietary supplements; nitrate; sports performance
The Effects of Bindarit in Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether bindarit is effective to reduce
      albuminuria, compared to placebo, in nephropathic patients treated with irbesartan, as a
      background therapy.
    

Detailed description: 
      This is a pilot phase II, double-blind, multicentre, randomized, placebo-controlled, parallel
      groups study in patients with DN undergoing irbesartan therapy.

      According to screening urinary albumin excretion, at baseline and before randomization, all
      patients will be categorized into 2 strata:

      Stratum 1: microalbuminuria (20 to 200 μg/min, in at least 2 of 3 consecutive overnight urine
      samples collected at the screening) Stratum 2: macroalbuminuria (>200 μg/min, in at least 2
      of 3 consecutive overnight urine samples collected at the screening).

      Within each stratum, patients will be randomly allocated on a 1:1 basis to the 2 treatment
      arms (after one month induction period):

        -  bindarit 600MG twice a day

        -  placebo All patients will be treated with irbesartan 300 mg/day as background therapy.
           After 12 months of treatment albuminuria will be evaluated as primary endopoint.
    

Intervention name(s): Bindarit; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks; dosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks
Other intervention name(s): AF2838
Intervention MeSH terms: Bindarit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2-Diabetic Nephrophaty; bindarit; albuminuria; MCP-1
IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker
Condition: Insulin Resistance
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Previous studies have demonstrated defects in the trafficking and translocation of GLUT4
      glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin
      resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which
      collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin.
      The extracellular domain of IRAP is cleaved and released in the bloodstream.

      Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.

      In this study the investigators seek to confirm this hypothesis by using the gold standard of
      insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.

      It is a multicenter descriptive study.
    


Intervention name(s): It is a hyperinsulinemic-euglycemic clamp.
Intervention type(s): Other
Intervention description(s): The hyperinsulinemic-euglycemic clamp includes three periods:
A basal period (from T-30 to T0)
The infusion of insulin at a constant rate (first level at 1 mUI.kg-1.min-1 and a second level at 2 mUI.kg-1.min-1) during 4 hours ( to obtain stable hyperinsulinemia)
The infusion of glucose at variable rate (so as to maintain euglycemia)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: IRAP; insulin sensitivity marker
Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the concentrated
      autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia
      patients.
    

Detailed description: 
      A total of 15 patients suffering from end stage IV and V Rutherford /CLI in whom all previous
      therapeutic strategies failed (e.g. surgical revascularization) will be selected and undergo
      local transplantation of autologous BMMNCs. Conventional treatments include angioplasty and
      /or bypass to remove blood vessel blockage for restoring blood supply, along with prescribed
      medicines that aid in ulcer recovery and wound healing and debridement of damaged/infected
      tissue. Amputation is inevitable in many cases because some blood capillaries cannot be
      corrected and restenosis of vessels is very common. Cell therapies with mononuclear cells
      from patients own bone marrow is promising because these stem cells are capable of
      stimulating and regenerating capillaries and blood vessels (neovascularization).

      This is a Phase Ib (feasibility study), prospective, non randomized and open labeled study
      aimed to find out the safety and efficacy of intramuscular autologous bone marrow mononuclear
      cells implantation in patients with chronic critical limb ischemia.

      The efficacy/safety of this therapy will be assessed by using several endpoints such as (a)
      prevention of amputation, (b) wound healing and (c) degree of angiogenesis. In order to
      assess the limb ischemia, the measurements will be performed at pre- and post transplantation
      at a variety of time intervals. The measurements include: ABI-ankle brachial index,
      Transcutaneous partial pressure of Oxygen (TcPO2), 6 min walk test, Rest pain and
      intermittent Claudication assessment, Healing of ulcers/ wounds and angiography of the
      affected limb.
    

Intervention name(s): Autologous Bone Marrow Mononuclear cells (BMMNCs)
Intervention type(s): Other
Intervention description(s): Multiple intramuscular injections of concentrated bone marrow derived mononuclear cells (0.5 cc/injection) into the ischemic muscle of the affected limb.
Other intervention name(s): Autologous bone marrow mononuclear cell concentrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CLI; Peripheral arterial disease