bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult
      population suffers the disease.

      Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin
      secretion.

      The investigators hypothesis was that the the administration of resveratrol modifies the
      metabolic syndrome, insulin sensitivity and insulin secretion.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients
      with a diagnosis of metabolic syndrome in accordance with the International Diabetes
      Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were
      evaluated after a 75 g of dextrose load.

      12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months.

      The remaining 12 patients received placebo with the same prescription.

      Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion
      (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin
      sensitivity (Matsuda index).

      This protocol was approved by a local ethics committee and written informed consent was
      obtained from all volunteers.

      Results are presented as mean and standard deviation. Intra and inter group differences were
      tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was
      considered significant.
    

Intervention name(s): Banaba; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.; Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
Other intervention name(s): Lagerstroemia speciosa; calcined magnesia
Intervention MeSH terms: Magnesium Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metabolic syndrome; central obesity; Banaba; insulin secretion; insulin sensitivity
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of
      this extension study will be to explore antibody persistence at approximately 40 months of
      age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV
      NZ administered to subjects at approximately 40 months of age. Antibody persistence will be
      subsequently measured at 18-20 months after these booster doses when the subjects are 60
      months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be
      recruited in the study to serve as a baseline comparator for assessing antibody persistence
      at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ.
      Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if
      they have not already received these vaccines prior to enrollment.
    


Intervention name(s): Meningococcal (group B) multicomponent recombinant adsorbed vaccine.; Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)
Intervention type(s): Biological; Biological
Intervention description(s): Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB+OMV NZ) or two catch-up doses.; Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB).
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Pre-school; Meningococcal disease; Prevention; Vaccination
The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia
Condition: Schizophrenia
MeSH terms: Neurobehavioral Manifestations; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether minocycline are effective in the treatment
      of negative and cognitive symptoms in schizophrenia.
    

Detailed description: 
      Immune-related disorders have been hypothesized as etiological factors in
      schizophrenia.Minocycline is a second-generation tetracycline that exerts anti-inflammatory
      and antimicrobial effects while having a distinct neuroprotective profile.This study was
      performed as a double-blind, placebocontrolled,randomized evaluation of Second generation
      antipsychotics(SGA) and minocycline versus SGA and placebo.
    

Intervention name(s): minocycline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): variable dose SGA and minocycline,100mg per capsule po（take orally） bid，16 weeks；; variable dose SGA and 100mg per capsule po（take orally） bid，16 weeks；
Other intervention name(s): Minocycline Hydrochloride Capsules
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia minocycline cognition
Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes
Condition: Latent Autoimmune Diabetes in Adults
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Latent Autoimmune Diabetes in Adults
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effects of 3 intra-nodal injections of GAD-alum (Diamyd),
      together with oral vitamin D supplementation. Safety and feasibility of the treatment will be
      evaluated and also effects on the immune system and on the preservation of endogenous insulin
      production.
    


Intervention name(s): recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel; Vitamin D
Intervention type(s): Drug; Drug
Intervention description(s): 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden; 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden
Other intervention name(s): GAD-alum (Diamyd(R)); Divisun 2000 IE
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glutamic Acid Decarboxylase; Alum Compounds; Injections; Inguinal Canal; Diamyd; rhGAD65; Vitamin D
Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients
Condition: Neurophysiology; Physiology
Study type: Interventional

Summary: 
      Patients with COPD have lower capability of activating their muscles. At the cortical level,
      force production is not only controlled by contralateral primary motor cortex but also by
      ipsilateral motor cortex. The aim of this study is to determine whether ipsilateral areas are
      functionally impaired in COPD.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) patients exhibit not only respiratory symptoms
      but also a peripheral muscular weakness. This weakness is characterized by a loss in
      strength, harmful for the patients' life quality and vital prognosis (Swallow et al., 2007).
      Even if many studies have enlightened damages at a peripheral level, the muscular atrophy
      itself cannot totally explain the loss in force (Menon et al., 2012). Furthermore, the
      contractile properties of COPD muscles fibres are preserved (Debigare et al., 2003).
      Consequently, peripheral muscle weakness cannot only be explained by peripheral factors and
      central structures must be investigated.

      At the central level, it is admitted that force production is controlled by the activation of
      contralateral motor areas. In COPD, these areas were found to be less activated than in
      controls during force production (Alexandre et al., 2014). However, recent studies bring the
      evidence that ipsilateral motor areas are also mobilized to cope demand during such task. The
      activation of ipsilateral areas is possible through inter hemispheric pathways, as the corpus
      callosum. Recently, the integrity of the corpus callosum have been linked to the capability
      of activating the ipsilateral motor cortex (Chiou et al., 2014) during force production. This
      is of concern knowing that several studies reported white matter lesions in the brain of COPD
      patients (Dodd et al, 2012) and more precisely in regions containing the corpus callosum
      (Lahousse et al., 2013).

      Therefore, we hypothesize that COPD patients have a lower capability of activating their
      ipsilateral motor cortex during force production compared to controls.
    

Intervention name(s): Transcranial magnetic stimulation (TMS)
Intervention type(s): Other
Intervention description(s): Evaluations by TMS
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: COPD Patients vs. Controls
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COPD; Transcranial magnetic stimulation; Motor-evoked potentials; Muscle weakness; Interhemispheric; Inhibition
Pharmacokinetic Study for PCA Derivate Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      A comparative bioavailability study of PCA slow release versus immediate release
      formulations, after a single dose to fasting healthy subjects.
    


Intervention name(s): PCA; PCA; PCA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo tablet, once; PO, 700mg, once; PO, 1000mg, once
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Comparative; bioavailability; of PCA; formulations
Clinical Comparison of Two Silicone-Hydrogel Contact Lenses
Condition: Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the clinical performance of two silicone-hydrogel
      contact lenses.
    


Intervention name(s): galyfilcon A; comfilcon A
Intervention type(s): Device; Device
Intervention description(s): galyfilcon A; comfilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Evaluate Safety and Tolerability of FK949E in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder Patients
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to evaluate the safety and plasma concentration changes of
      quetiapine after multiple oral administration of FK949E (extended-release formulation of
      quetiapine) in patients with major depressive disorder (MDD).
    

Detailed description: 
      This is a dose-titration study. In low-dose-group, patients receive prescribed dose on Day 5
      after 3-step dose increases. In high-dose-group patients receive prescribed dose on Day 7
      after 4-step dose increases. Patients receive prescribed dose of FK949E for 7 days in each
      group. The dosage period is 12 days in low dose group and 14 days in high dose group.
    

Intervention name(s): FK949E
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): extended release formulation of quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: FK949E; Antipsychotic; Quetiapine
GCF IL-17 Levels and Oxidative Status of Smoking and Non-smoking Individuals With Periodontitis
Condition: Chronic Periodontitis; Smoking, Cigarette
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Observational

Summary: 
      This study was performed to evaluate the effects of both periodontal treatment and smoking on
      the gingival crevicular fluid(GCF) levels of interleukin (IL)-17A, IL-17E, Total oxidative
      stress(TOS) and total antioxidant capasity(TAOC) in smoking and non-smoking patients with
      severe chronic periodontitis.

      Systemically healthy 15 smoker,15 non-smoker with chronic periodontitis were attended for the
      study. Periodontal status were determined by recording periodontal clinical measurements. GCF
      samples were collected at the baseline, at the end of initial periodontal treatment and 4
      weeks after periodontal flap surgery. The data were tested statistically by the Student t and
      paired sample t tests.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic periodontitis (with an age range of 35 to 60 years) seeking dental
        treatment at the Periodontology Clinic, School of Dentistry, Ondokuz Mayis University, were
        included in the present study.
      
Keywords: chronic periodontitis; smoking,; periodontal treatment,; IL-17,; oxidative stress
Turmeric for Memory Impairment and Cognition
Condition: Cognitive Change; Mood; Stress
Study type: Interventional

Summary: 
      The objective of the study is to test the capacity of acute and chronic supplementations of
      Turmipure GOLD® to improve cognitive performance in healthy aging
    

Detailed description: 
      The aim of this clinical study is to determine whether oral administration of Turmipure GOLD®
      can contribute to the short- and long-term improvement of cognitive functions, including
      memory and attention, in subjects with age-associated memory impairment.
    

Intervention name(s): Turmipure Gold®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): TPG: Turmipure GOLD® - 1 capsule per day - as prescribed; Placebo: colored acacia gum - 1 capsule per day - as prescribed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Turmeric; Curcuminoids
Influenza Vaccination and COPD Phenotypes
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Influenza, Human; Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The aim of this study is to determine responses of the immune system to the annual flu
      vaccination in people with COPD who experience frequent or infrequent exacerbations and
      healthy participants. We will collect blood and saliva immediately before and one month after
      flu vaccination at GP surgeries in the Autumn/Winter period. By measuring how quickly
      antibodies (that provide protection against infection) develop in the blood after vaccination
      we can provide important new information to help confirm whether those prone to COPD flare
      ups have weaker immune systems.
    


Intervention name(s): Influenza Vaccination
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 65-85 years with a diagnosis of COPD (according to Global Initiative for
        Chronic Obstructive Lung Disease criteria: post bronchodilator FEV1/FVC ratio <0.70) and
        moderate to severe airflow limitation (FEV1 30-80% predicted) will be approached.

        We will also include healthy participants as a control reference group who are aged 65-85
        years without symptoms of lung disease and have normal spirometry.
      
Biospecimen description: 
      Venous blood samples will be collected in K3EDTA and serum vacutainer tubes. Saliva samples
      will be obtained while participant is seated with the head tilted slightly forward and
      passively dribbling into a pre-weighed sterile tube (keeping orofacial movement to a
      minimum).

      Whole blood samples will be used on the day of collection and analysed before being
      appropriately disposed of on the same day. Blood samples will be centrifuged with plasma and
      serum frozen at -80c for later analysis. Saliva samples will also be centrifuged with
      supernatant frozen at -80c for later analysis.
    
Keywords: Influenza; Exacerbations
Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, open-label, single center, crossover study to investigate the
      effect of formulation and food on the pharmacokinetics of GDC-0810 in female healthy
      participants of non-childbearing potential. This study is divided into three parts.
      Participants in each part will be randomized to one of three treatment sequences. Part 1
      study in 4 periods will investigate the effect of formulation on the pharmacokinetics (PK) of
      GDC-0810 administered with low-fat food. Each participant in this part will receive a single
      dose of GDC-0810 dose level A following consumption of a low fat meal (30 minutes after the
      start of the meal) in each treatment period. Part 2 is an optional Phase I study in 3 periods
      to investigate the effect of formulation on the PK of GDC-0810 administered with low-fat food
      in healthy female participants of non-childbearing potential. Part 3 study in three periods
      will compare the PK of a Phase III prototype tablet formulation selected from Parts 1 and 2
      of the study with the Phase II tablet formulation (both administered 30 minutes after the
      start of a low fat meal) at dose level B and to investigate the PK of the Phase III prototype
      formulation administered in the fasted state.
    


Intervention name(s): GDC-0810 Phase II Tablet; GDC-0810 Phase III Prototype Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.; Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level
Condition: Berberine Hydrochloride
Study type: Interventional

Summary: 
      The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine
      Hydrochloride on lowering glucose and delaying progress to diabetes in patients with
      prediabetes and to detect the potential mechanism.
    

Detailed description: 
      Gut microbiota may play an important role in patients with prediabetes. Berberine, which is
      usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in
      vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut
      microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, the aim
      of this study is to assess the beneficial effects of Bifidobacterium and Berberine
      Hydrochloride on lowering glucose and delaying progress to diabetes in patients with
      prediabetes and to detect the potential mechanism.
    

Intervention name(s): Berberine Hydrochloride group; Bifidobacterium group; Berberine Hydrochloride and Bifidobacterium group; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bifidobacterium; People With Abnormal Glucose Level
Impact of Vitamin D Therapies on Chronic Kidney Disease
Condition: Chronic Kidney Disease (CKD); End-stage Renal Disease (ESRD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      This investigation will consist of a prospective study utilizing two separate populations of
      patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one
      with normal renal function.
    

Detailed description: 
      Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D
      helps the immune system fight infection as well as helps keep muscles strong. Without enough
      vitamin D, bones can become weak, thin and brittle.

      Vitamin D is useful in people with all different types of health issues. CKD is the slow loss
      of kidney function over time. The main function of the kidneys is to remove wastes and excess
      water from the body. This loss of function usually takes months or years to occur Patients
      with CKD often have low levels of vitamin D in their blood.

      This study will have two groups of patients with CKD and one group of patients that have
      normal kidney function, but all groups will have low levels of vitamin D. The two groups with
      CKD (group 1 and group 2) will receive either cholecalciferol or calcitriol. The purpose of
      having a control group (group 3) without CKD will be to evaluate if any changes that are
      witnessed in response to vitamin D therapy are specific to patients with kidney disease or
      apply to all patients with vitamin D deficiency who receive vitamin D supplements.

      There are two different drugs in this study. One is called Calcitriol and is approved by the
      Food and Drug Administration (FDA) as a vitamin D supplement. The other drug is called
      cholecalciferol and it is approved by the FDA. Unlike calcitriol, cholecalciferol is a
      nutritional form of vitamin D that can often be found in various types of foods and its
      chemical structure must be changed by the body to become the active form of vitamin D. It is
      believed that cholecalciferol may have different effects in the body compared to calcitriol.
      It is possible that CKD patients would benefit from receiving both of these drugs, but this
      is currently unclear. While on this study you will receive either one of these study drugs,
      depending on which group you are assigned to.
    

Intervention name(s): Cholecalciferol - CKD; Calcitriol - CKD; Cholecalciferol - non-CKD
Intervention type(s): Drug; Device; Drug
Intervention description(s): Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks; Calcitriol 0.25 mcg once daily for 8 weeks; Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks
Other intervention name(s): Vitamin D3; 1,25(OH)2D; Vitamin D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Calcitriol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment