bioihbjkbjnl/mcl2 huggingface dataset:
PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Observational

Summary: 
      The primary aim of the present study is to investigate the vaginal microbiota of infertile
      women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and
      a PCR method supported with conventional Gram staining.

      We hypothesize that the molecular based tests will prove more efficient than conventional
      Gram staining and that they have a place in future IVF diagnostics.
    

Detailed description: 
      Our first aim is to investigate the prevalence of altered vaginal microbiotas among women
      seeking fertility treatment in Denmark. Secondly we want to establish whether there are
      correlations between altered vaginal microbiotas and self-measurements of both the vaginal pH
      performed with the Saling pH glove™ and a self-collected swab with Copan Eswab™ because these
      would be useful for an easy-access longitudinal screening option. Finally, the third aim was
      to explore how the species composition of vaginal microbiotas measured by a multiplex qPCR
      assay was reflected in Nugent scores.

      A possible 4th aim is to identify patterns in the relative abundances of different species
      with 16sRNA primers among fertile women compared with infertile women because these
      differences could be indicative of a vaginal microbiota associated with bad fertility
      outcome.
    

Intervention name(s): pH glove
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        IVF patients
      
Biospecimen description: 
      Vaginal flora swabs
The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to determine if embryo culture under a single CO2 setting
      improves blastocyst formation rate.
    

Detailed description: 
      Following enrollment, patients will undergo ovarian stimulation and oocyte retrieval per
      routine as previously consented to at the clinic. IVF stimulation protocol will be at the
      discretion of the patient's individual provider, per routine. Intracytoplasmic Sperm
      Injection (ICSI) will be performed and embryos will be cultured to the blastocyst stage per
      routine. There are no changes to the embryology care itself, the only difference within the
      study is the CO2 level within the incubator pending the patient's randomization.
    

Intervention name(s): Continuous CO2 Level
Intervention type(s): Other
Intervention description(s): Embryos will be cultured in a single, continuous CO2 setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
L-arginine Concentrations and CPS Polymorphisms in VLBW Infants
Condition: Infant, Very Low Birth Weight
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      Plasma L-arginine concentrations are decreased in premature infants with necrotizing
      enterocolitis (NEC). A carbamoyl-phosphate synthetase 1 (CPS1) polymorphism has been
      correlated with low plasma concentrations of L-arginine in neonates (> 35 weeks of
      gestation). Recently Moonen et al (Pediatr Res 2007; 62(2):188-90) described a correlation
      between this CPS1 T1405N single nucleotide polymorphism (SNP) and the presence of NEC in VLBW
      infants. However there is no data about the correlation between the plasma arginine
      concentrations and the T1405N SNP in the CPS-1 gene in VLBW infants. In the present project
      we postulate that T1405N SNP in the CPS-1 gene is associated with lower plasma arginine
      concentrations and is also a risk factor for the development of NEC.
    

Detailed description: 
      Plasma L-arginine concentrations are decreased in premature infants with necrotizing
      enterocolitis (NEC). A C-to-A nucleotide transversion (T1405N) in the gene that encodes
      carbamoyl-phosphate synthetase 1 (CPS1), the rate-limiting enzyme in the urea cycle, has been
      correlated with low plasma concentrations of L-arginine in neonates (> 35 weeks of
      gestation). Recently Moonen et al (Pediatr Res 2007; 62(2):188-90) described a correlation
      between this CPS1 T1405N single nucleotide polymorphism (SNP) and the presence of NEC in VLBW
      infants. However there is no data about the correlation between the plasma arginine
      concentrations and the T1405N SNP in the CPS-1 gene in VLBW infants. In the present project
      we postulate that T1405N SNP in the CPS-1 gene is associated with lower plasma arginine
      concentrations and is also a risk factor for the development of NEC.
    

Intervention name(s): blood sample and buccal swab sample
Intervention type(s): Other
Intervention description(s): one blood sample (500 mL) will be obtained from each VLBW infant between 6 and12 hours after birth from an umbilical-artery or peripheral artery catheter.
Additional DNA collection buccal cell samples were obtained with a sterile OmniSwab.
Other intervention name(s): OmniSwab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
Condition: Digestive Fistulae
MeSH terms: Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the
      treatment of patients with digestive fistulae.
    

Detailed description: 
      The purpose of this study is to determine whether lanreotide 30mg compared to placebo is
      effective on the evolution of drainage volume of digestive fistulae in the 72 hours following
      the beginning of treatment and on the spontaneous closure time of digestive fistulae.
    

Intervention name(s): Lanreotide microparticles; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lanreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment
Blueberries for Improving Vascular Endothelial Function in Postmenopausal Women With Elevated Blood Pressure
Condition: Menopause; Elevated Blood Pressure; Hypertension; Endothelial Dysfunction
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Postmenopausal women are at an increased risk of developing cardiovascular disease (CVD)
      largely due to accelerated aging-related modifications to vascular health following
      menopause. The vascular endothelium is responsible for producing chemicals that are essential
      for proper vasodilation and blood flow and therefore is involved in maintaining normal blood
      pressure. A major modification that occurs during aging and is accelerated during menopause
      is termed vascular endothelial dysfunction which is characterized by impaired
      endothelium-dependent dilation. This can lead to increased blood pressure, atherosclerosis,
      and increased risk of CVD and death. Nitric oxide (NO) is a chemical produced by the
      endothelium and is essential for normal endothelial function and cardiovascular health.
      Vascular endothelial dysfunction is primarily caused by reduced NO bioavailability secondary
      to excessive oxidative stress. Approximately 3/4 of postmenopausal women have elevated blood
      pressure or hypertension which further worsens endothelial function and increases CVD risk
      through increased oxidative stress and inflammation. Blueberries are rich in phytochemicals
      including anthocyanins, phenolic acids, and pterostilbene. These phytochemicals and their
      metabolites are known to attenuate oxidative stress and inflammation. The overall goal of the
      current study is to assess the efficacy of blueberries to improve vascular endothelial
      dysfunction in this high-risk population and to gain insight into underlying mechanisms. 58
      postmenopausal women with elevated blood pressure and stage 1-HTN will be asked to consume 22
      grams freeze-dried blueberry powder or placebo powder per day for 12 weeks. Vascular
      endothelial function will be assessed at baseline and 12 weeks. Measurements indicative of
      vascular nitric oxide production, oxidative stress, inflammation, cardiometabolic health,
      cognitive function, and blueberry phytochemical metabolism will be measured at baseline and
      12 weeks. Blood pressure will be assessed at baseline and 4, 8, and 12 weeks.
    


Intervention name(s): Blueberry Powder; Placebo Powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 22 g/day freeze-dried blueberry powder for 12 weeks; 22 g/day placebo powder for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blueberries; Polyphenols; Cardiovascular Disease; Atherosclerosis; Oxidative Stress; Inflammmation; Endothelium; Vasodilation; Blood Pressure; Menopause; Women's Health; Functional Food; Bioactive Compounds; Dietary Supplements; Aging
Aurinia Early Urinary Protein Reduction Predicts Response
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict
      clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily
      (BID) in combination with standard of care in patients with active lupus nephritis
    

Detailed description: 
      Voclosporin is a novel calcineurin inhibitor (CNI) intended for use in the prevention of
      organ graft rejection and for the treatment of autoimmune diseases. The aim of the current
      development program is to investigate whether voclosporin added to the standard of care
      treatment in active Lupus Nephritis (LN) is able to reduce disease activity, as measured by a
      reduction in proteinuria. The background therapy will be mycophenolate mofetil (MMF) 2 g
      daily, initial treatment with IV methylprednisolone followed by a reducing course of oral
      corticosteroids. Patients with active, flaring LN will be eligible to enter the study. They
      are required to have a diagnosis of LN according to established diagnostic criteria (American
      College of Rheumatology) and clinical and biopsy features suggestive of active nephritis.
      Efficacy will be assessed by the ability of the drug combination to reduce the level of
      proteinuria while demonstrating an acceptable safety profile.
    

Intervention name(s): voclosporin
Intervention type(s): Drug
Other intervention name(s): ISA247
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lupus nephritis; calcineurin inhibitors; voclosporin
Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet
Condition: HIV
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, single arm, 48-week open-label study of FDC ELV/COBI/FTC/TDF
      [Stribild] in acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV
      Infection Study Consortium. Participants will be enrolled for 96 weeks. Clinical care and
      study drug (ELV/COBI/FTC/TDF) will be provided for the first 48 weeks. After week 48,
      clinical care but not study drug will be provided through week 96. A study participant
      suppressed at week 48 can continue on FDC ELV/COBI/FTC/TDF.

      The primary hypothesis is that once daily fixed-dose combination elvitegravir (ELV),
      cobicistat (COBI), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) will rapidly
      reduce viral replication to <50 copies RNA/ml in participants with acute HIV infection. The
      secondary hypotheses to be considered are 1) virologic response rates as measured by plasma
      HIV RNA levels will be non-inferior or superior to a historical group of participants from
      the PHI cohort treated with EFV/FTC/TDF, 2) compared to historical controls treated with
      EFV/FTC/TDF, plasma HIV RNA will decrease more rapidly in PHI participants treated with
      ELV/COBI/FTC/TDF, 3) compared to historical controls treated with EFV/FTC/TDF, immune
      activation as measured by the proportion CD4+ and CD8+ cells expressing HLA-DR and CD38+ will
      decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 4)in a subset of
      participants samples will be obtained from compartments such as the gastrointestinal tract,
      and lymphoid tissues to assess changes over time in parameters such as HIV-1 RNA, immunologic
      responses to HIV, and tissue and anatomic reservoirs. We hypothesize that treatment with the
      ELV/COBI/FTC/TDF will demonstrate improved viral clearance in these compartments as compared
      to historical controls treated with EFV/FTC/TDF. 5) in a subset of participants who remain
      suppressed on therapy, resting CD4 cells with replication-competent HIV-1 (latent reservoir)
      will be quantitated and compared to similar measurements in PHI participants treated with
      EFV/FTC/TDF. In addition, we will compare these results to those measured in HIV-1 infected
      participants treated and 6) ELV/COBI/FTC/TDF will be well tolerated, and the proportion of
      participants who require treatment modification will be less than that observed in
      participants treated with EFV/FTC/TDF.
    

Detailed description: 
      None desired
    

Intervention name(s): (FDC) ELV/COBI/FTC/TDF
Intervention type(s): Drug
Intervention description(s): Antiretroviral treatment
Other intervention name(s): STRIBILD
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337
      combination
    


Intervention name(s): T; R
Intervention type(s): Drug; Drug
Intervention description(s): CKD-391 40/10mg; D086 and D337 co-administration
Other intervention name(s): Test Drug; Reference drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the
      major birch allergen bet v 1, in subjects allergic to birch pollen.
    

Detailed description: 
      The study tested - all by skin tests - in the same group of 20 trial subjects, one positive
      control (histamine solution), one negative control (placebo saline) and five experimental
      peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as
      negative (no reaction) or positive (wheal diameter > 4 mm with erythema)
    

Intervention name(s): placebo; Histamine; AllerT1; AllerT2; AllerT3; AllerT4; AllerT5; mix of AllerT1-T2-T3; mix of AllerT4-T5
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): saline solution; positive control; synthetic peptide T1; synthetic peptide T2; synthetic peptide T3; synthetic peptide T4; synthetic peptide T5; mix of peptides T1, T2 and T3; mix T4-T5
Other intervention name(s): saline; Histamine solution; AllerT; mix T4-T5
Intervention MeSH terms: Histamine; Histamine phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: allergy; birch
Potassium and Sodium to Control Blood Pressure in Hypertensives
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine the role of dietary sodium reduction with and without potassium supplementation in
      controlling blood pressure in hypertensive men.
    

Detailed description: 
      BACKGROUND:

      Appropriately increased interest and concern about high blood pressure as a major public
      health problem coincided with the indication that the risks of hypertension-related morbidity
      and mortality could be reduced by reduction of blood pressure. Consensus suggestions that
      individualized approaches be used in treating patients with mild hypertension stimulated
      further investigations of non-pharmacological methods. Such investigations were also of
      considerable interest in relation to understanding the physiology of blood pressure control
      as well as the development of less costly non-drug therapies. Interest was heightened by
      information suggesting that there might be distinctly harmful side effects related to
      antihypertensive drug therapy, particularly thiazide diuretics, in some settings. Studies of
      non-drug therapies included dietary modifications primarily involving weight reduction and
      sodium restriction with increasing recent concern about other factors such as alcohol intake,
      dietary fat, calcium, magnesium, and potassium intake.

      DESIGN NARRATIVE:

      Randomized, double-blind. One hundred forty-five subjects were randomized into a low sodium
      placebo group in which sodium intake was restricted to no more than 80 mEq/day, 142 subjects
      into a potassium supplementation (96 mEq/day) group whose sodium intake was also restricted
      to no more than 80 mEq/day. After 12 weeks of intervention, antihypertensive drugs were
      withdrawn. Follow-up of each participant was for at least two years. The primary endpoint was
      the proportion of subjects requiring antihypertensive medication at various points following
      randomization.
    

Intervention name(s): diet, sodium-restricted; diet, potassium-supplementation
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Effects of Breast Milk Simulated Infant Formula
Condition: Infant Formula; Breast Milk
Study type: Interventional

Summary: 
      Objective：The aim of this trial is to assess effects of Kieember and Yashili infant formula
      on body growth, behavior development, intestinal comfort, infectious diseases, allergic
      diseases, the absorption of nutrients and gut microbiota as compared to breast-milk in term
      infants aged 0-3 months.

      Participants：195 healthy term infants at the age of 0-14 days at entry to study.

      Study Design: A open-label, quasi-randomized, controlled trial. Random allocation is
      performed between the two infant formula groups.

      Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2)
      Breast Milk Simulated Formula Group：fed with breast milk simulated infant formula
      (Ruibuen®Kieember, Phase I); (3) Traditional Formula Group: fed with traditional infant
      formula (Ruibuen®Yashili, Phase I). Random allocation is performed between the two formula
      groups.

      Intervention Duration: 12 weeks.

      Visits: 2 (baseline), 6 and 12 weeks old.

      Outcome measures: (1)Biochemical detection of feces (total fat, fatty acids, calcium,
      nitrogen);(2)Stool characteristics (frequency, color, volume, and stool
      consistency);(3)Anthropometric parameters (body length, body weight, and head
      circumferences);(4)Temperament and adaptive behavior;(5)Gut microbiota;(6)General health and
      wellbeing;(7)concomitant medications and adverse events.
    


Intervention name(s): Breast milk; Kieember Infant formula, Ruibuen®; Yashili Infant formula, Ruibuen®
Intervention type(s): Other; Other; Other
Intervention description(s): Breast milk: Human breast milk, provided and fed by the corresponding infant's mother; Kieember Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by (1) OPO structured lipid of the third generation; and (2) Breast Milk Simulated complete structured lipid UPU. It was produced by Yashili New Zealand Dairy Co., Limited; Yashili Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by(1) lactoferrin and(2) lutein . It was produced by Yashili International Holdings Ltd.,China
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: gut microbiota; temperament; body growth; fecal residual nutrient
Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall aim of this study is to evaluate the safety and immunogenicity of Butantan
      Institute Trivalent Seasonal Influenza Vaccine in comparison with the Sanofi Trivalent
      Seasonal Influenza Vaccine.
    

Detailed description: 
      To detemine whether immunogenicity elicited by a single-dose Butantan Institute Trivalent
      Seasonal Influenza Vaccine is not inferior to that elicited by a single dose of Sanofi
      Trivalent Seasonal Influenza Vaccine in adult and elderly populations measured by HI GMT for
      the three vaccine components 21 days post-immunization.

      To describe the safety profile of Butantan Institute Trivalent Seasonal Influenza Vaccine and
      Sanofi Trivalent Seasonal Influenza Vaccine after a single dose in adult and elderly
      populations.
    

Intervention name(s): Butantan Institute Trivalent Seasonal Influenza Vaccine; Sanofi Trivalent Seasonal Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Butantan Institute and Pasteur-Mérieux (present, Sanofi Pasteur) established a technology transfer in 1999 for the production of a trivalent influenza vaccine of inactivated split-virion using embryonated eggs. The technology transfer followed a progressive approach from importing the finished product, to packaging and quality control test for release (1999), and, finally, to the first batch of influenza vaccine entirely produced by Butantan (2011). In 2013, the Butantan vaccine was registered by the Brazilian National Agency of Sanitary Surveillance (ANVISA).; VAXIGRIP® was launched in 1968 and since then has been licensed in more than 100 countries and prequalified by WHO in 2011. Several clinical studies by Sanofi Pasteur have examined the safety and immunogenicity of Vaxigrip® in older children (8-10 years), adults (18-59 years), elderly (> 60 years),11,12 children (six months to three years) 13 and pregnant women.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Immunization; Safety; Immunogenicity