bioihbjkbjnl/mcl2 huggingface dataset:
Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months
Condition: Fever; Bacterial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Observational

Summary: 
      The primary objective is to study the value of serum procalcitonin as a predictive marker for
      severe bacterial infection in febrile infants.

      2200 febrile infants aged less than 3 months will prospectively be included. All infants will
      have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin
      concentration in infants with and without serious Bacterial infection.

      Evaluation of the area under the ROC for Procalcitonin concentration.
    

Detailed description: 
      Serious bacterial infections are often difficult to detect in infant with fever without
      source. Procalcitonin is a better blood marker of infection than White blood cell count and
      possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription.
      Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in
      children 1 to 3 month old with fever without source and our hypothesis is that it will lower
      the antibiotic prescription rate.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children 7 days older to 3 month older with fever
      
Keywords: Fever; Infant; Procalcitonin; Serious Bacterial Infection
Pharmacokinetics of Apixaban in Nephrotic Syndrome
Condition: Nephrotic Syndrome; Proteinuria
MeSH terms: Proteinuria; Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to investigate the pharmacokinetics and pharmacodynamics of apixaban in
      nephrotic syndrome.
    

Detailed description: 
      Nephrotic syndrome (NS) is characterized by proteinuria and hypoalbuminemia, and patients
      with nephrotic syndrome are known to be hypercoaguable with increased incidence of venous
      thromboembolism necessitating anticoagulation. While classically warfarin has been used as an
      anticoagulant in NS, newer oral anticoagulants, such as apixaban, are increasingly used to
      treat venous thromboembolism (VTE) in the general population. It is unknown how
      hypoalbuminemia and proteinuria affect the pharmacokinetics and pharmacodynamics of apixaban.

      This will be a parallel arm, single-dose pilot study of the pharmacokinetics of apixaban in
      adults with nephrotic syndrome. Goal enrollment of twenty subjects with non-diabetic
      nephropathy who have nephrotic-range proteinuria, defined as >3.5g/24 hours or UPC >3.5 and
      ten healthy control subjects without nephrotic syndrome. Each subject will be administered a
      single dose of apixaban 10 mg. Plasma drug concentration level and plasma anti-Xa activity
      levels will be measured at 0, 0.5, 1, 3, 4, 6, 8, 24 hours after drug administration in order
      to determine the maximum plasma concentration of apixaban, area under the curve, and
      half-life of apixaban in the setting of hypoalbuminemia and proteinuria due to nephrotic
      syndrome. Apixaban levels will be measured via liquid-chromatography spectrometry mass.
      Additionally, thrombin generation will be measured at 0, 3, 6, and 24 hours.
    

Intervention name(s): apixaban
Intervention type(s): Drug
Intervention description(s): Study subjects will be given a single-dose of apixaban 10 mg.
Other intervention name(s): Eliquis
Intervention MeSH terms: Apixaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Apixaban; Pharmacokinetics; Pharmacodynamics
The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of Ischemic Stroke
Condition: Periodontal Diseases; Saliva Altered; Stroke
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Methods: 100 consecutive patients with their first ever ischemic stroke were enrolled in the
      study. 56 randomly selected patients were subjected to stimulation of salivation, the
      remaining patients were not stimulated. The severity of the neurological condition was
      assessed using the NIHSS scale on days 1, 3 and 7 of stroke. The incidence of periodontal
      diseases was classified using the Hall's scale in the 1st day of stroke. On days 1 and 7 of
      stroke, the concentration of IL-1beta, MMP8, OPG and RANKL in the patients' saliva was
      assessed using the Elisa technique. At the same time, the level of CRP and the number of
      leukocytes in the peripheral blood were tested on days 1, 3 and 7 of the stroke, and the
      incidence of upper respiratory and urinary tract infections was assessed.
    

Detailed description: 
      The course of an ischemic stroke varies by many factors. The influence of periodontal
      diseases and the stimulation of salivation on the course and difficulty of stroke remains
      unresolved.

      Methods: 100 consecutive patients with their first ever ischemic stroke were enrolled in the
      study. 56 randomly selected patients were subjected to stimulation of salivation, the
      remaining patients were not stimulated. The severity of the neurological condition was
      assessed using the NIHSS scale on days 1, 3 and 7 of stroke. The incidence of periodontal
      diseases was classified using the Hall's scale in the 1st day of stroke. On days 1 and 7 of
      stroke, the concentration of IL-1beta, MMP8, OPG and RANKL in the patients' saliva was
      assessed using the Elisa technique. At the same time, the level of CRP and the number of
      leukocytes in the peripheral blood were tested on days 1, 3 and 7 of the stroke, and the
      incidence of upper respiratory and urinary tract infections was assessed.
    

Intervention name(s): saliva stimulation
Intervention type(s): Diagnostic Test
Intervention description(s): In 50 patients with ischemic stroke, saliva was the option of a neurologopedic massage of choice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in
      subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a
      sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon
      (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®,
      each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.

      Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD)
      assessments will be carried until 4 hours. Safety will be assessed during all the trial
      period.

      The total trial maximum duration for the individual subject will be up to 10 weeks.
    


Intervention name(s): BioChaperone® glucagon formulation 1; BioChaperone® glucagon formulation 2; GlucaGen® HypoKit®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg; Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg; Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence of Telmisartan/g Ramipril Fixed Dose Combination Compared With the Monocomponents Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to demonstrate the bioequivalence of 80 mg telmisartan/10 mg ramipril fixed dose
      combination versus its monocomponents given concurrently
    


Intervention name(s): Telmisartan/Ramipril; Telmisartan; Ramipril capsule; Ramipril tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fixed dose combination tablet
Other intervention name(s): Micardis®; Altace®; Delix®
Intervention MeSH terms: Telmisartan; Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The prevalence of diabetes is up to 11.6% according to the data released in 2013 by the China
      Noncommunicable Disease Surveillance Group.Less than 40% of all diagnosed-diabetes were well
      controlled.Among all kinds of antidiabetic medications, metformin is recommended as the
      first-line antihyperglycemic management for type 2 diabetes. Insulin secretagogue,repaglinide
      is still one of the most widely used antidiabetic medications in China. However, there were
      few studies comparing the effects of these two medications on glycaemic control in Chinese
      patients with type 2 diabetes.
    


Intervention name(s): Repaglinide; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose of repaglinide 0.5 mg once daily. During the dose titration period of 1 week, the dose of repaglinide could be titrated up to 1 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 0.5 mg three times daily.; Initial dose of metformin 250mg once daily. During the dose titration period of 1 week, the dose could be titrated up to metformin 500 mg three times daily, according to fasting glucose values.
Intervention MeSH terms: Metformin; Repaglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of SHR-1905 in Healthy Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.
      The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and
      immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.
    

Detailed description: 
      The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects
      will be randomized to receive SHR-1905 as reflected by the guiding principle for the dose
      esclation/expansion phase. Each dose group includes a screening period, a baseline period, an
      observational period, and a safety follow-up period.
    

Intervention name(s): SHR-1905; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SHR-1905 will be injected subcutaneously; Placebo will be injected subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study will:

        -  Explore whether GA decreases inflammation more on the 3T optimized protocol when
           compared to the 1.5T standard protocol.

             -  Compare whether the decrease in the cumulative number of Gd-enhancing lesions
                significantly differs between pre-treatment (day 0) and post-treatment (12 months)
                using 1.5T standard and 3T optimized protocols.

        -  Investigate the correlation between MTR and the cumulative number and volume of Gd
           enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with
           GA.

      This study suggests that GA may favorably affect early events in lesion formation, in
      addition to exerting more transient beneficial effects on established areas of inflammation
      and demyelination, and that this effect may be observed only with the 3T optimized protocol.
    

Detailed description: 
      Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in
      the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central
      nervous system (CNS) inflammation, they do so by very different mechanisms. Therefore, use of
      1.5T MRI, triple dose of Gd, delay of scanning time for 20-30 min after Gd injection, and
      application of off-resonance saturated MT pulse may increase the ability to detect Gd lesions
      by approximately 120% when compared to 1.5T single dose MRI protocol. The 3T standard
      protocol may increase the ability to detect Gd enhancing lesions by 40-50% when compared to
      the 1.5T standard protocol. This may indicate that the 3T optimized protocol may increase the
      ability for Gd lesion detection by approximately 150-180%, when compared to the 1.5T standard
      protocol.
    

Intervention name(s): Copaxone
Intervention type(s): Drug
Intervention description(s): 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
Other intervention name(s): Glatiramer acetate
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Inflammation; Multiple Sclerosis; Glatiramer Acetate; Gd enhancing lesions; 1.5T protocol; 3T protocol; Magnetization transfer imaging (MTI); Lesion activity analysis; Copaxone
Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate
      safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult
      subjects.
    

Detailed description: 
      Subjects will be screened up to 14 days (Day -14 to Day 0) before randomization.

      On the planned day of vaccination (Day 1), subjects will be randomized in a 1:1:1:1 ratio (N
      = 30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection.

      Approximately 5 subjects per group (N = 20) will be enrolled in parallel initially, and
      safety data through Day 8 will be collected. An Independent Data Monitoring Committee (IDMC)
      will convene to review Day 8 safety data before any additional subjects will be enrolled. If
      there are no safety concerns in the IDMC meeting, study enrollment will continue.

      Blood and serum samples for safety laboratory tests and HAI titers will be obtained at
      baseline on Day 1 before administration of vaccine dose and after vaccination.
    

Intervention name(s): Low dose; Intermediate dose; High dose; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Low dose of KBP-V001; Intermediate dose of KBP-V001; High dose of KBP-V001; Buffered Saline Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Vaccine; Influenza Vaccine
High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER) and Weight Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study evaluates the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet
      (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian
      Indians subjects living in north India.
    

Detailed description: 
      Increasing the protein consumption promotes weight loss through several mechanisms. Diets
      high in protein promote energy expenditure through increased postprandial thermogenesis,
      increase total daily expenditure and increase satiety as compared to carbohydrate. The
      present study aims to evaluate the effects "High Protein Atkin's Complete (lacto) VEgetaRian
      Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese
      Asian Indians subjects living in north India.
    

Intervention name(s): PACER Diet; Standard weight reducing diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Pacer diet to be followed for 8 weeks; Standard weight reducing diet to be followed for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Abdominal adiposity; High protein diet
Skin Surface's Temperature Changes When Auricular Acupressure at Cervical Vertebra Acupoints in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Auricular acupressure is one of the acupuncture techniques on the ear, which is a method of
      impacting on acupoints with force and without using needles to help diagnose and treat
      physical and psychosomatic dysfunctions. Some studies prove that the acupoints on the pinna
      have a corresponding relationship with the areas of the body, and when acting on the
      acupoints can change the temperature of the corresponding area. Chronic neck pain is closely
      related to the decline in subcutaneous microcirculation, where heat transfer from deep within
      the body to the surface of the skin is carried out by the dermal vascular system. When blood
      flow through the venous network is high, heat is carried from the deep to the skin and vice
      versa. Therefore, to understand the role of cervical vertebra acupoints in neck pain, the
      study wants to demonstrate the correlation when auricular acupressure at cervical vertebra
      acupoints and the skin surface temperature of the neck area.
    

Detailed description: 
      Participants and Methods: A randomized controlled trial is conducted by surveying the change
      in temperature in the neck area respectively when auricular acupressure is applied to the
      left and right cervical vertebra acupoints compared with the sham auricular acupressure group
      in each side of the ear in healthy volunteers. A total of 60 participants were randomly
      assigned to 2 groups (A and B) and the allocation was 1:1. In group A: participants received
      sham auricular acupressure at the left AH13 acupoint (left cervical vertebra) of the ear and
      auricular acupressure after 1 week. In group B: participants received sham auricular
      acupressure at the right AH13 acupoint (right cervical vertebra) of the ear and auricular
      acupressure after 1 week. The primary outcome was change in temperature in the neck area
      respectively when auricular acupressure is applied to the left and right cervical vertebra
      acupoints compared with the sham auricular acupressure group. This trial will be performed as
      randomized, controlled, and single blinded.
    

Intervention name(s): Auricular acupressure
Intervention type(s): Procedure
Intervention description(s): To conduct this intervention, we used adhesive patches without Vaccaria seed to sham auricular acupressure at the cervical vertebra acupoint in the first trial phase and auricular acupressure at the cervical vertebra acupoint in the other two trial phases in 2 groups of auricular acupressure acupoints of the left and right cervical vertebra.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized controlled and single blinded trial
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Auricular Acupressure
A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      The objective of this study is to obtain preliminary efficacy and safety data on the use of
      the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.
    


Intervention name(s): vaginal bowel control system (LivSure)
Intervention type(s): Device
Other intervention name(s): LivSure System; Eclipse™ System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fecal incontinence; bowel control
Black Education and Treatment of Hypertension (BEAT HTN)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Clinical trials have yet to test the adequacy of HTN control in African Americans (AA) when
      both control and intervention groups are given free antihypertensive medications and are
      involved in usual versus intensive intervention strategies. Because of this, it has not yet
      been determined whether the method of prescribing antihypertensive medications according to
      JNC 7 guidelines is more, less, or equally as effective as prescribing antihypertensive
      medications and providing intensive behavioral and clinical interventions. Knowledge in this
      area of HTN treatment should better able medical and health practitioners to help their AA
      subjects control HTN. The BEAT Hypertension Clinic will evaluate this method of HTN control
      by proposing a program that will evaluate the difference in HTN control among subjects
      receiving usual care and free medications and subjects also receiving free medications, but
      additionally being treated in a clinic that operates in a more intensive manner in
      relationship to patient behavior modification, patient-clinician interactions, and physical
      and social environments. At the conclusion of the study, the BEAT Hypertension Clinic
      investigators will report findings and help to answer the question of whether medication
      alone or medication combined with intensive behavioral and clinical treatment is more
      effective in HTN control in the AA population.
    


Intervention name(s): Hydrochlorothiazide; Lisinopril; Lisinopril and Hydrochlorothiazide; Nifedipine XL; Metoprolol tartrate; Atenolol; Valsartan; Doxazosin; Clonidine; Hydralazine; Metoprolol succinate; Amlodipine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Hydrochlorothiazide 25 mg tablets; Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet; L 10 mg and H 12.5 mg tablets, L 20 mg and H 12.5 mg tablets, L 20 mg and H 25 mg tablets; 30 mg extended release tablets, 60 mg extended release tablets; 50 mg tablets & 100 mg tablets; 50 mg tablet; 80 mg tablets & 160 mg tablet; 4 mg tablets; 0.2 mg tablets; 50 mg tablets; 50 mg tablet & 100 mg tablet; 5 mg tablets & 10 mg tablets
Other intervention name(s): Lopressor; Toprol XL; Norvasc
Intervention MeSH terms: Metoprolol; Atenolol; Amlodipine; Valsartan; Hydrochlorothiazide; Clonidine; Lisinopril; Doxazosin; Hydralazine; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: African American