bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry
Condition: End-Stage Renal Disease; Hemodialysis
MeSH terms: Kidney Failure, Chronic; Calcinosis
Study type: Interventional

Summary: 
      The high rate of cardiovascular complications in the dialysis population cannot be explained
      by traditional cardiovascular risk factors. One of such factors proposed to contribute to the
      cardiovascular mortality in dialysis patient population is vascular calcification possibly
      resulting from disturbances of calcium-phosphate metabolism.

      The aim of this study is to assess the effects of treatment with dialysate containing 1.75 or
      1.5 mmol/L to 1.25 mmol/L calcium regarding coronary artery calcification and bone
      histomorphometry in hemodialysis patients.
    

Detailed description: 
      Sample size calculations were based on previously reported changes in coronary artery
      calcification scores in hemodialysis patients during time (90% power with a two-sided, alpha
      error rate of 5%). Four hundred fifty-seven hemodialysis patients, taking drop-out rate into
      consideration, will be enrolled in this prospective-controlled study.The cases already being
      treated with calcium-based phosphate binder and dialysate containing 1.75 or 1.5 mmol/L
      calcium will be enrolled from eight hemodialysis centers.The cases will be randomized to two
      arms:

        1. Dialysate containing 1.25 mmol/L calcium + calcium-based phosphate binder group:
           Dialysate calcium will be reduced from 1.75 or 1.5 mmol/L to 1.25 mmol/L in this group.
           Patients will use calcium-based phosphate binder according to phosphate level.

        2. Dialysate containing 1.75 mmol/L calcium + calcium-based phosphate binder group (Control
           group): Dialysate calcium will remain or switched to 1.75 mmol/L and patients will be on
           calcium-based phosphate binder.

      The study will last for 18 months.Coronary artery calcification (Multi-slice CT), bone
      histomorphometry, and bone mineral density will be assessed in the beginning and at the end
      of the study. Coronary artery calcification and bone mineral density will be measured in all
      patients; bone histomorphometry will be assessed in 150 patients, 75 from each group.
    

Intervention name(s): Low dialysate calcium; high dialysate calcium
Intervention type(s): Drug; Drug
Intervention description(s): 1.25 mmol/L dialysate calcium; 1.75 mmol/L dialysate calcium
Intervention MeSH terms: Calcium, Dietary; Dialysis Solutions; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis; Coronary artery calcification; Adynamic bone disease; Dialysate calcium; Bone mineral density; Bone histomorphometry
Mindful Walking in Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a mindful walking program is effective in
      the treatment of patients with chronic low back pain.
    


Intervention name(s): Mindful walking program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Muscle Fat Compartments and Turnover as Determinant of Insulin Sensitivity
Condition: Diabetes
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Early research found that high levels of fat within muscle meant poorer control of blood
      sugar. However, more recent research has shown that athletes have similar levels of fat
      within muscle, but in contrast, they have very good control of blood sugar. The investigators
      are not sure why this is and want to find out if the fat within muscle can be changed to
      improve blood sugar control, as good blood sugar control reduces the risk of heart disease,
      diabetes and stroke.
    

Detailed description: 
      Higher levels of triglycerides (TG) and diacylglycerols (DAG) are found in skeletal muscle of
      patients with obesity/diabetes as well as in trained athletes. Despite similar metabolic
      storage, patients and athletes have opposite insulin sensitivity phenotypes and an
      explanation for this is lacking. The investigators' objective is to understand how these fat
      compartments can be beneficially modulated to improve insulin resistance and cardio-metabolic
      risk. The investigators will investigate if either structural differences (saturated versus
      unsaturated balance of TG and DAG side-chains) or different handling abilities (fast versus
      slow lipid pool turnover) will be induced by exercise capacity interventions in athletes and
      in diabetic patients. In a longitudinal study pre- and post-exercise, the investigators will
      use novel, non-invasive 1H-Magnetic Resonance Spectroscopy to benchmark the
      saturated/unsaturated compartments against skeletal muscle biopsies for the first time and
      stable isotope analysis for fat compartments' rate of turnover.
    

Intervention name(s): Training or detraining
Intervention type(s): Other
Intervention description(s): A period of detraining or a supervised exercise program.
Other intervention name(s): Detraining or training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Food Effect Study Of AG-013736 In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the effect of food on typical blood levels obtained after
      oral dosing of AG-013736. Drug levels in blood will be compared after an overnight fast and a
      high-fat, high-calorie meal.
    


Intervention name(s): AG-013736; AG-013736; AG-013736; AG-013736; AG-013736; AG-013736
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> B -> C. Each of these treatments will be separated by a 7 day washout period.; A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> C -> B. Each of these treatments will be separated by a 7 day washout period.; A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> C -> A. Each of these treatments will be separated by a 7 day washout period.; A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> A -> C. Each of these treatments will be separated by a 7 day washout period.; A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> A -> B. Each of these treatments will be separated by a 7 day washout period.; A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> B -> A. Each of these treatments will be separated by a 7 day washout period.
Intervention MeSH terms: Axitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: food-effect pharmacokinetics AG-013736 food fasting
Dalacin-T Gel Post Approval Study
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and
      safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne
      vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify
      the clinical positioning of Dalacin T Gel.
    


Intervention name(s): clindamycin; nadifloxacin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Nadifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates an investigational vaccine that is designed to protect humans against
      infection with respiratory syncytial virus (RSV) and is administered as drops in the nose.
      Specifically, the study analyzes the safety of, and the immune response to, the vaccine when
      administered to healthy children between the ages of 15 and 59 months who are seropositive to
      RSV.
    


Intervention name(s): Investigational RSV vaccine MV-012-968 (Dosage 1); Investigational RSV vaccine MV-012-968 (Dosage 2); Placebo; Investigational RSV vaccine MV-012-968 (Dosage 3)
Intervention type(s): Biological; Biological; Other; Biological
Intervention description(s): Single dose administered intranasally on Day 1; Single dose administered intranasally on Day 1; Single dose administered intranasally on Day 1; Single dose administered intranasally on Day 1
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The first 15 enrolled participants will be assigned to Dosage Group 1 and be randomly allocated to receive either investigational vaccine at Dosage 1 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 1 safety data through Day 14, to allow dosage escalation. The next 15 enrolled participants will be assigned to Dosage Group 2 and be randomly allocated to receive investigational vaccine at Dosage 2 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 2 safety data through Day 14, to allow dosage escalation. The final group (Dosage Group 3) will consist of up to 12 enrolled participants who will be allocated to receive investigational vaccine at Dosage 3.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Live attenuated vaccine; Safety; Immunogenicity; Phase 1 clinical trial; Pediatric; Seropositive
Analysis of Metabolic State in Normal-weight and Overweight-obese After Lifestyle Improvement and/or Weight Loss
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The aim of this study is to design and validate a test, METAHEALTH-TEST, based in gene
      expression analysis in blood cells, to quickly and easily analyse metabolic health. This test
      will be used to analyse metabolic improvement in overweight/obese individuals and in
      metabolically obese normal-weight (MONW) individuals after undergoing a weight loss
      intervention and/or an intervention for improvement in eating habits and lifestyle.
    


Intervention name(s): Dietary and physical activity intervention
Intervention type(s): Other
Intervention description(s): OW-OB group: 6-month program of weight loss consisting in a low-calorie food plan (30% reduction in the individual energy requirements) with dietary sessions and exercise counselling.
MONW group: 6-month program to improve eating habits (Mediterranean diet) with dietary sessions and exercise counselling.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Volunteers are assigned to three groups for the duration of the study:
Normal-weight
Overweight-Obese
Metabolically obese normal-weight
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Overweight; Obesity; Blood cells; Metabolic health; Weight loss
Induction of Migraine Aura With Cilostazol
Condition: Migraine With Aura; Stroke
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In a double blind placebo-controlled cross-over study the effect of cilostazol on aura
      induction and endothelial response is tested in patient with migraine with aura.
    

Detailed description: 
      Migraine with aura is associated to an increased risk of stroke. The mechanism behind such
      increased risk is not fully understood. Cilostazol induce headache and migraine in migraine
      patients and is used as secondary prevention of stroke. The effect on aura induction is not
      known. We investigate the aura inducing potential of cilostazol and associated changes in
      endothelial function.
    

Intervention name(s): Cilostazol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of active or placebo one week apart
Other intervention name(s): Pletal
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery
Condition: Type 2 Diabetes; Inpatient Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      High blood glucose levels in surgical patients with diabetes are associated with increased
      risk of medical complications and death. Improved glucose control with insulin injections may
      improve clinical outcome and prevent some of the hospital complications. In patients who have
      undergone surgery, high blood glucose increases the risk of wound infection, kidney failure
      and death. It is not known; however, what is the best insulin regimen in patients who will
      undergo surgery. The use of repeated injections of regular insulin is commonly used for
      glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus®
      and Apidra® insulins has been shown to improve glucose control with lower rate of
      hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted
      to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental
      glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital
      complications than treatment with regular insulin per sliding scale (SSRI). The present study
      aims to determine which insulin treatment is best for glucose control in hospitalized
      patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment
      of patients with diabetes by the FDA.

      Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial
      Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta,
      Georgia. A total of ~94 patients will be recruited at each institution.

      A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial
      will be completed in order to determine differences in hospitalization cost between basal
      bolus insulin and SSI regimen.
    


Intervention name(s): Insulin glargine; Regular insulin; Insulin glulisine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Insulin glargine once daily SQ; Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO; scheduled glulisine given SQ at mealtime TID; none given if patient NPO
Other intervention name(s): Lantus; Novolin R; Apidra
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; post-op complications; inpatient hyperglycemia
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
Condition: Irritable Bowel Syndrome; Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      Irritable bowel syndrome is a highly prevalent disorder and consumes many health resources.
      Its physiopathogenesis is multifactorial. Some of the factors involved have to do with the
      alteration of the intestinal microbiota, low-grade inflammation and the alteration of
      intestinal permeability. Specific tannins have been shown to have prebiotic effects and could
      be useful in treating this condition. This is an exploratory before-after study that aims to
      evaluate the effect of a chestnut and quebracho extract on the symptoms of IBS diarrhea
      predominant, serum cytokine levels, microbiota and intestinal permeability, as well as on
      metabolomics.
    

Detailed description: 
      In vitro studies have shown that chestnut and quebracho extract has a prebiotic effect of
      modulating the intestinal microbiota, but also, bacterial fermentation produces metabolites
      with powerful anti-inflammatory effects such as quecetin. Irritable bowel syndrome (IBS) is a
      multifactorial disorder involving factors related to the intestinal microbiota, low-grade
      inflammation, and impaired intestinal permeability.

      In this study, 30 patients with predominant IBS diarrhea and 50 healthy controls will be
      included. IBS patients will receive chestnut and quebracho extract twice a day for 8 weeks.
      They will be measured at baseline and at 8 weeks: 27 serum pro and anti-inflammatory
      cytokines and serum zonulin. Likewise, the intestinal microbiota and metabolomics will be
      evaluated.
    

Intervention name(s): ARBOX (QUEBRACHO AND CHESNUT EXTRACT)
Intervention type(s): Dietary Supplement
Intervention description(s): ARBOX TWICE A DAY FOR 60 days
Intervention model: Single Group Assignment
Intervention model description: before- after study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intestinal microbiota; intestinal permeability; intestinal inflammation
SOLIACS: Solian Solution in the Acute Setting
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      During this study the efficacy and safety profile will be evaluated of the use of amisulpride
      in the form of a solution in schizophrenic patients with an acute episode.

      The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a
      solution during the first days of an acute episode of schizophrenia.
    


Intervention name(s): amisulpride
Intervention type(s): Drug
Intervention MeSH terms: Amisulpride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in
      patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional
      electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping
      system without fluoroscopy image integration
    

Detailed description: 
      The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is
      designed for minimizing the exposure to X-ray for physician, staff and patients. This
      randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and
      dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory
      paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional
      electroanatomical mapping system, comparing with using 3-dimentional electroanatomical
      mapping system without fluoroscopic image integration. Patients with documented paroxysmal
      atrial fibrillation, who are going to receive a catheter interventional treatment to atrial
      fibrillation, will be randomized (1:1) into two groups after signing an informed consent.
      Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical
      mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system
      without fluoroscopic image integration.

      The ablation strategies in both study groups are the same, including circumferential
      isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification.
      According to the randomization, the ablation procedure will be performed with or without
      fluoroscopic image integration.

      The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels
      (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary
      endpoints include complete isolation of the pulmonary veins, completely bidirectional block
      of linear ablation lines, total procedure time, ablation-related complications.
    

Intervention name(s): Radio-frequency catheter ablation
Intervention type(s): Device
Intervention description(s): Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: fluoroscopy exposure; paroxysmal atrial fibrillation Ablation; fluoroscopy; Atrial Fibrillation Ablation
Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media
Condition: Pain; Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain
      relief associated with acute otitis media.
    


Intervention name(s): Benzocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): topical otic solution; topical otic solution
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
AM-101 in the Treatment of Post-Acute Tinnitus 1
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to test the safety and local tolerance of repeated
      treatment cycles of AM-101.
    

Detailed description: 
      This open-label extension study is assessing the safety and local tolerance of repeated
      treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study
      (NCT01803646).
    

Intervention name(s): AM-101
Intervention type(s): Drug
Intervention description(s): AM-101 gel for intratympanic injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment