bioihbjkbjnl/mcl2 huggingface dataset:
IMUNOR® Preparation in the Prevention of COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to achieve prevention of COVID-19 disease in healthcare professionals
      with the administration of the IMUNOR® preparation, and decreasing the symptoms should the
      disease appear.
    

Detailed description: 
      This prospective study is designed to collect data for evaluation of the preventive and
      therapeutic effect of the IMUNOR® preparation, which is commonly used to treat patients with
      laboratory or clinical manifestations of immunity disorders. Administration of
      immunomodulation treatment will be based upon a willing informed consent with the
      administration of the drug and based upon random selection. The study subjects will receive
      IMUNOR® preventively; the anticipated preventive effect when using one packing (4 vials) is 6
      weeks, and 12 weeks when using two packings. Should any signs of acute illness appear
      (increased body temperature, cough, loss of smell and taste, etc.), a treatment dose of
      IMUNOR®, i.e. 1 vial/day (total of 4 vials) will be administered immediately. Monitoring of
      individual patients will take 6 weeks (1 packing) or 12 weeks (2 packings) from the beginning
      of IMUNOR® administration. The clinical condition of study subjects will be monitored on a
      daily basis. At the same time, the possible onset of symptoms will be recorded.

      The obtained data will be compared with a control group consisting of patients followed by
      the Department of Preventive Medicine, University Hospital Ostrava.
    

Intervention name(s): IMUNOR
Intervention type(s): Drug
Intervention description(s): The intervention consists of the administration of IMUNOR as prevention against COVID-19 disease
Intervention model: Single Group Assignment
Intervention model description: The study treatment (IMUNOR) will be administered to one group of study subjects only.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Covid19; prevention; pork dialyzed leukocyte extract; immunomodulation
A Study to Evaluate CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate
      the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults with Moderately
      Severe Crohn's Disease
    


Intervention name(s): CC-5013
Intervention type(s): Drug
Intervention MeSH terms: Lenalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder
Condition: Incontinence, Urinary and Urinary Bladder, Overactive; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa study to evaluate the efficacy, safety and tolerability of GW679769 vs
      placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with
      overactive bladder in women.
    

Detailed description: 
      A Twelve-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced Titration,
      Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the
      Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs Placebo in
      Women with Overactive Bladder
    

Intervention name(s): GW679769 oral tablets
Intervention type(s): Drug
Intervention MeSH terms: Casopitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Overactive Bladder
A Phase 1b Study of SMT C1100 in Subjects With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether increasing doses of SMT C1100 are safe,
      well tolerated and achieve appropriate blood levels in patients with Duchenne Muscular
      Dystrophy (DMD).
    

Detailed description: 
      Primary Objective: To determine the safety and tolerability of single and multiple oral doses
      of SMT C1100 in patients with Duchenne Muscular Dystrophy (DMD).

      Secondary Objectives: To determine the single and multiple oral dose pharmacokinetics of SMT
      C1100 and its metabolites in patients with DMD.
    

Intervention name(s): SMT C1100
Intervention type(s): Drug
Intervention description(s): Comparison of safety and pharmacokinetic of different dosages of drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanisms of Inflammation, Immunity, Islet Cell and Intestinal Hormone Changes in Youth at Risk for Diabetes
Condition: Obesity; PreDiabetes; Adolescent Obesity; Inflammation; Metabolic Problems; Insulin Resistance; Gut Microbiome; Immunity; Beta Cell Dysfunction; Gut Hormones
MeSH terms: Obesity; Insulin Resistance; Pediatric Obesity; Inflammation
Study type: Observational

Summary: 
      This study intends to assess the role of inflammation in insulin resistant conditions (i.e.,
      obesity and pre-diabetes) and the subsequent development of disease, such as type 2 diabetes
      (T2D) and cardiovascular disease (CVD), in the adolescent population.
    

Detailed description: 
      This study proposes to characterize inflammatory biomarkers, insulin resistance and fecal
      microbiome composition in obese/pre-diabetic adolescents after glucose ingestion, followed by
      an oral fat tolerance test on a separate visit. Lipoprotein abnormalities and intestinal
      biomarkers, post-lipid ingestion, will also be evaluated. The primary aim is to assess the
      role of inflammation in insulin resistant conditions (i.e., obesity and pre-diabetes) and the
      subsequent development of disease, such as type 2 diabetes (T2D) and cardiovascular disease
      (CVD), in the adolescent population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents with obesity
Impact of Bean Polyphenols and Phytic Acid on Iron Absorption
Condition: Blood Iron Isotope Enrichment
Study type: Interventional

Summary: 
      Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have
      the potential to alleviate iron bioavailability problems associated with PA. These plants
      have normal phosphate levels, but reduced PA phosphate due to various modifications of the
      biosynthetic pathway of PA. So far lpa crops are in an early stage of development, most of
      them exhibiting reduced yield and seed germination. However, the lpa bean isolated by Campion
      and co-workers 2009 by chemical mutagenesis exhibited only 10 % of the native bean PA
      concentration without any defects in terms of growth and yield.

      Crossing the lpa variety with bean varieties low in PP and high in iron might lead to the
      development of a variety which has the potential to improve the iron status of bean consuming
      populations.

      The following study will evaluate the relative impact of PA and PP on iron absorption from
      beans by comparing iron absorption from four different bean varieties. Iron absorption from a
      bean with normal PA concentration and high PP concentration will be compared to iron
      absorption from a bean with normal PA and low PP concentration as well as to two lpa
      varieties, one with high and one with low PP concentration.
    


Intervention name(s): 586/8x87 white; 586/8x87 brown; BAT 881; 586/8
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 2 x 50 g; 2 x 50 g; 2 x 50 g; 2 x 50 g
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: beans; lpa mutant; polyphenols; phytic acid; stable iron isotopes
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
Condition: Breast Cancer; Quality of Life
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Distress monitoring is an important issue in cancer survivors. However, conventional distress
      screening is very difficult to perform. This study investigates the efficacy of wearable
      device as a tool of distress monitoring in breast cancer survivors.
    


Intervention name(s): Wearable device (Fitbit Charge HR® or Fitbit Alta ®)
Intervention type(s): Device
Intervention description(s): Physical activities will be monitored by wearable device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Distress; Exercise; Wearable device; Smartphone
The Role of 5% Lidocaine Patches in the Pain Control of Hepatocellular Carcinoma Patients Receiving Radiofrequency Ablation
Condition: Liver Cancer; Post Ablation Syndrome
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      Background: This study aims to test whether 5% lidocaine patches can reduce Radiofrequency
      ablation-induced pain. Methods: The study will enroll patients with hepatocellular carcinoma
      and schedule a radiofrequency ablation procedure. 200 patients will be invited to allocate
      randomly into study or control groups: pretreatment with a 5% lidocaine patch (LidotopⓇ)
      (Group A); pretreatment with a placebo patch (Group B); The skin patch is applied before
      Radiofrequency ablation (RFA) while admission, and is changed every day till discharge. Pain
      severity is evaluated by a visual analog scale using a 10-point scale recorded by a study
      nurse before RFA and after the procedure. The demographic data, hepatocellular carcinoma
      characteristics, analgesics usage, patient satisfaction with pain control, and visual analog
      scale will be compared between the two groups. Anticipated results: Pretreatment with 5%
      lidocaine patches is an effective and straight method of reducing Radiofrequency
      ablation-induced pain to reduce analgesics usage and improve patient satisfaction with pain
      control.
    


Intervention name(s): The skin lidocaine patch.; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The skin patch is applied before RFA while admission and is changed every day till discharge. Pain severity is evaluated by visual analogue scale using a 10-point scale recorded before RFA and after the procedure.; patch without drugs
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma; Radiofrequency ablation; Lidocaine patch
Neurocognitive Assessment in Youth Initiating HAART
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      ATN 071 is a prospective cohort study comparing neurocognitive functioning in four groups of
      youth, age 18-24: Two groups with CD4+ T cells above 350 cells/mm3 and HIV RNA >1,000
      copies/ml, one initiating HAART (Group 1) and the other not initiating treatment (Group 2);
      and two groups with CD4+ T cells < 350 cells/mm3, one initiating treatment (Group 3) and the
      other not initiating treatment (Group 4). Groups 2 and 3 represent standard of care. Group 1
      and a portion of group 2 will be co-enrolled in ATN 061 and will be randomly assigned to
      group by that protocol.
    


Intervention name(s): Early Treatment with HAART; No treatment; HAART Treatment - standard care
Intervention type(s): Drug; Other; Drug
Intervention description(s): HAART with possibility of de-intensification; No treatment. For group 2, participants do not yet meet DHHS guidelines. For group 4, treatment is not initiated due to unwillingness or providers' expectation of poor adherence.; Initiation of HAART per DHHS guidelines, i.e. starting treatment and CD4+ T cells less than 350 cells/mm3 or HIV RNA >100,000 copies/ml
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        English or Spanish speaking youth, 18 years 0 days to 24 years 364 days, with HIV-1
        infection acquired after age 9 via behavioral means, in the following immunological and
        treatment categories:

          1. Early initiation of HAART and enrolled in 061 Arm A; CD4+ T cells above 350 cells/mm3
             and HIV RNA >1,000 copies/ml;

          2. Initiation of HAART per DHHS guidelines (standard of care) but not yet meeting
             criteria. There will be 25 participants from ATN 061 preferentially enrolled into this
             protocol; an additional 25 participants will be enrolled with similar biomedical
             characteristics.

          3. Initiation of HAART per DHHS guidelines (not part of ATN 061).

          4. Meeting DHHS guidelines for initiating HAART, but not initiating due to unwillingness
             or providers' expectation of poor adherence.
      
Keywords: HAART; DHHS guidelines; Treatment Naive
Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants
Condition: Infant, Premature; Ductus Arteriosus, Patent; Ventricular Function, Left
MeSH terms: Ductus Arteriosus, Patent
Study type: Observational

Summary: 
      The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings
      in VLBW infants. The investigators hypothesize that high urine NT-proBNP concentrations are
      associated with a hemodynamically significant ductus arteriosus. The investigators also
      hypothesized that new echocardiographic parameters such as isovolumic relaxation time
      (IVRT)is useful for the prediction of ductus intervention.
    

Detailed description: 
      Urine samples were collected within 24 to 48 hours of age, on day 7, on day 14 and on day 28
      of life. The samples were spun and the platelet-free urine was stored at -80°C until
      NT-proBNP analysis. The NT-proBNP assay was performed with an automated immunoassay (Roche
      Diagnostics). Color Doppler and tissue Doppler echocardiography was determined at the same
      time as the urine collection. New echo parameters such as IVRT, tissue velocity, strain and
      strain rate were measured and compared with the standard parameters for significant ductus
      arteriosus. Furthermore we compared the tissue Doppler measurements with clinical findings.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        VLBW infants
      
Biospecimen description: 
      urine
    
Keywords: NT-proBNP
Assessment of the Effect of Captopril Versus Combination of Captopril and Pentoxifylline on Reducing Proteinuria in Type 2 Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Proteinuria
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and
      morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic
      patients they can not hinder the progression of renal disease completely. Pentoxifylline as a
      TNFa blocker may hinder progression of diabetic nephropathy in combination of captopril.
    

Detailed description: 
      Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and
      morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic
      patients they can not hinder the progression of renal disease completely. TNFa is a cytokine
      that is a target for medical therapy in diabetic nephropathy. In this study the effect of
      captopril on overt diabetic nephropathy compared to effect of combination of captopril and an
      antiTNFa drug ( pentoxifylline).
    

Intervention name(s): Captopril; Captopril + Pentoxifylline
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg captopril tablet q8h; patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h
Intervention MeSH terms: Captopril; Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; proteinuria; pentoxifylline
Impact of Neck Cooling Collar on Exercise Performance in the Heat
Condition: Hyperthermia
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      During exercise in the heat, the thermoregulatory system impacts performance in an athletic
      population. Increased in core body temperature could lead to development of heat-related
      illnesses and impair physical performance. To facilitate heat loss and optimize performance
      during exercise in the heat, various cooling strategies, including cold water immersion and
      wearable cooling devices have been previously explored. Although whole body cooling by cold
      water immersion is considered to be the most effective way to reduce core body temperature,
      this cooling method would not be feasible for athletes during practice or competition.
      Therefore, previous studies strongly recommended neck cooling during exercise because of the
      rate of heat dissipation through the large blood vessel and accessibility compared to other
      body part. Furthermore, multiple studies reported that the neck cooling could improve aerobic
      performance (i.e. running distance and time). In addition to physiological changes, human
      prefer to be cool in the neck region as well as the face in hot environment. Thus, local
      cooling of the neck is efficient way to reduce thermal discomfort during heat exposure. The
      novel neck cooling collar device (NeuroRescue Inc., Lafayette, LA) used in the current study
      may be able to produce powerful effect of conductive cooling, which result in improving
      performance and also reduce thermal discomfort during exercise in the heat.

      While this neck cooling collar would assist athletes in improving sports safety and
      performance by decreasing skin temperature around the neck, the effectiveness of this neck
      cooling collar on core temperature was not examined at this point. Moreover, other
      physiological and perceptual changes are important to assess along with changes in core body
      temperature. Therefore, this study aims to examine how internal body temperature, heart rate,
      perceptual measures, and athletic performance are affected by the novel neck cooling collar
      during exercise in the heat.
    


Intervention name(s): NeuroRescue Cooling Collar; Ice Towel
Intervention type(s): Other; Other
Intervention description(s): Between bouts of exercise subjects will be provided cooling on the neck with the NeuroRescue Collar. The custom sized cooling collar has ice water (which is kept around 2 degrees celsius) that is circulated through a neoprene sleeve that is attached to their neck for the cooling period.; Between bouts of exercise subjects will be provided cooling on the neck with a towel. The towel will be kept in ice water (which is kept around 2 degrees celsius) and placed around the neck of the individual during the cooling intervention period.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
Condition: Chronic Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this trial is to show non-inferiority of a CNI-free regimen with
      respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate -
      Nankivell method - as compared to the standard CNI-based regimen in de novo renal transplant
      patients.
    


Intervention name(s): Everolimus; Tacrolimus (FK506); Basiliximab; Enteric Coated Mycophenolate Sodium (EC-MPS); Corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One tablet containing 0.25, 0.5mg or 0.75 mg. Initially 2 mg/day. Afterwards based on blood level (target 6-10 ng/mL); Capsules 0.5 mg, 1 mg. Dosing according to blood level.; One vial containing 20 mg lyophilisate. 2 x 20 mg [day 0 (2 hrs prior to Tx) and day 4 post Tx] to be applied as 10 sec. bolus injection, i.v.; One tablet containing 180 mg or 360 mg. 1440 mg/day (2x720 mg). If tolerated, dose reduction due to side effectis were possible (min. dose at BL@: 720 mg/day); Used according to Israeli standards. A minimum dose of 5mg [prednisone, or equivalent, was used throughout the study period.
Other intervention name(s): Certican; Prograf; Simulect; Myfortic
Intervention MeSH terms: Mycophenolic Acid; Everolimus; Tacrolimus; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment