bioihbjkbjnl/mcl2 huggingface dataset:
Serial Changes in sTREM-1 During Ventilator-associated Pneumonia (VAP)
Condition: Pneumonia
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Study type: Observational

Summary: 
      Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that
      plays an important role in myeloid cell-activated inflammatory responses. The aim of this
      study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in
      bronchoalveolar lavage (BAL) fluid of clinically diagnosed ventilator-associated pneumonia
      (VAP) and its correlation with response to treatment and outcome.
    

Detailed description: 
      A prospective, interventional study conducted between August 2006 and August 2007 in MICU in
      Mackay Memorial Hospital, 35 patients with clinically diagnosed VAP were investigated.
      sTREM-1 was measured in BAL samples using ELISA at the onset, 4th - 5th and 7th - 9th day of
      clinical diagnosis of VAP.Of these 35 patients, 27 had positive BAL culture. The sTREM-1
      levels in BAL fluid were measured and compared between patients with positive BAL culture and
      negative BAL culture. Serial changes in sTREM-1 levels were evaluated in relation to patient
      outcome.
    

Intervention name(s): Bronchoscopy BAL
Intervention type(s): Procedure
Intervention description(s): The bronchoscope was passed through endotracheal tube via a specific adaptor without topical anesthesia. The bronchoscope was introduced and wedged into the segmental bronchial orifice where pneumonia was suspected. Five aliquots of 20ml sterile saline were instilled and aspirated gently. The first aliquot was discarded and the last 4 aliquots were pooled for analysis. Part of the retrieved specimen in the first BAL fluid was sent to the laboratory immediately after collection for measurement of sTREM-1 level, the rest of sample was sent to microbiology lab for quantitative culture.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were clinically suspected to have VAP were enrolled in the study. VAP was
        clinically diagnosed with a new infiltrate on a chest radiograph in a patient receiving
        mechanical ventilation for more than 48 hr with at least one of the following: purulent
        tracheal secretions, a body temperature >38°C or <36°C, and leukocytosis (WBC > 10,000/mm³)
        or leukopenia (WBC < 4000/mm³)
      
Keywords: STREM-1; BAL; VAP
Comparison of Different Types of Resistant Starch
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      This study is to determine whether different types of resistant starch have different effects
      on blood glucose in healthy adults.
    

Detailed description: 
      Each volunteer will visit the laboratory in a 10-12 hour fasted state on three occasions over
      a three-week period, up to two visits/wk, with at least 48 hours between visits. Volunteers
      will be asked to refrain from vigorous physical activity and the consumption of alcohol the
      day before each testing visit. Randomization using a Latin Square design was applied to
      minimize confounding issues associated with the order of administration.

      In the morning of each test, a finger-prick capillary blood samples will be collected to
      determine fasting (baseline) blood glucose levels. The volunteers will then consume the test
      solution assigned for that trial. Ten minutes will be allowed for the test solution to be
      consumed. Over the two hours following the start of each test, finger-prick capillary blood
      samples were collected at 30, 60, 90, and 120 min. Blood glucose levels will be immediately
      measured in duplicate using an automated blood glucose analyzer (YSI 2300, Yellow Springs,
      OH). Analysis of the collected sample was repeated if the difference between duplicate
      samples was greater than 0.1 mmol/L. Once the samples were analyzed, the data was entered and
      the incremental area under the curve was calculated using the trapezoidal model (GraphPad
      v5.0, La Jolla, CA).
    

Intervention name(s): Resistant Starch
Intervention type(s): Dietary Supplement
Intervention description(s): 30 g of carbohydrate per Arm
Other intervention name(s): Hi-Maize 260; Fibersym RW
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes; Obesity; Hyperglycemia; Dietary Fiber; Wheat; Grain
Isometric Core Muscle Endurance in Healthy Active and Non-active Working Age Populations
Condition: Physical Endurance
Study type: Interventional

Summary: 
      Objectives: The purpose of this study was to investigate a possible correlation between core
      muscle endurance and participants' age in healthy adult population. Secondary purpose was to
      identify other dependent variables influencing isometric core muscle endurance (e.g. low back
      pain, physical activity, gender, body mass index).

      Methods: 48 (35 females, 13 males) healthy adults (aged 21-66 years) performed 4 isometric
      core muscle endurance tests- Biering-Sorensen, McGill V-sit, right and left side plank. A
      correlation between core endurance and age, gender, lower back pain (LBP), physical activity
      level (PAL), and body mass index (BMI) was calculated.
    

Detailed description: 
      This is the first study to investigate the core muscle endurance of different age groups and
      genders with all four endurance tests of the core.

      Since strength and endurance are key to keeping healthy as we age and National Institute for
      Health and Care Excellence (NICE) and European guidelines advocate them, this study aims to
      look at the 3 main measurements of core endurance namely flexor, extensor and lateral
      muscles, and the possible correlations with age, PAL, existence of LBP, BMI and gender. Each
      participant performed 4 isometric core endurance tests in the same order- 1.
      Biering-Sorensen, 2.-3. side plank on both sides, and 4. McGill V-sit. All participants were
      tested by the same tester to reduce potential differences in procedure and testing error. The
      four tests were each measured using a stopwatch and documented in seconds. Each participant
      was told the time they had reached during testing to improve their motivation. Pain during
      testing was documented.

      Based on the normative data of abdominal muscle endurance for young adults Null hypothesis
      (H0)- There is no significant difference in endurance tests for age, presence of LBP or PAL.
      Hypothesis (H1)- Any significant difference in endurance tests for age, presence of LBP or
      PAL are due to chance factors. This is a two-tailed hypothesis, as previous evidence shows
      conflicting results. Pearson's correlation and Independent T-test in SPSS (The Statistical
      Package for the Social Sciences) were used to confirm or reject the possible correlations
      between the core muscle endurance and age, LBP, PAL, gender, BMI, and participants' job.
    

Intervention name(s): isometric core muscle endurance testing
Intervention type(s): Other
Intervention description(s): holding previously described isometric positions until fatigue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: aging; lower back pain; physical activity level; body mass index; core muscle endurance; gender; McGill V-sit; Biering-Sorensen; sideplank
Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to
      assess the safety and tolerability of ascending single doses of REGN2009 administered to
      healthy volunteers.
    


Intervention name(s): REGN2009; placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Breast Support Intervention for Women With Breast Pain
Condition: Mastodynia
MeSH terms: Mastodynia
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether prescribing a bra to participants results in
      an improvement in the Patient Global Impression of Change (PGIC) compared to participants who
      receive standard care alone.
    


Intervention name(s): Bra prescription; Standard Care
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast Pain; Mastalgia; Bras; Breast Support
Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)
Condition: Carcinoma, Pancreatic Ductal
MeSH terms: Carcinoma, Pancreatic Ductal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic
      cancer disease by combining the new investigational medicinal product Atu027 with the
      standard chemotherapeutic gemcitabine. This combination aims at enhancing gemcitabine´s
      anti-tumor activity with Atu027.

      The objectives of this clinical trial are to evaluate safety and activity of two Atu027
      schedules in combination with standard gemcitabine treatment in patients with advanced or
      metastatic pancreatic adenocarcinoma.
    


Intervention name(s): Atu027 & gemcitabine in lead in safety period; Atu027 & gemcitabine in treatment arm 1; Atu027 & gemcitabine in treatment arm 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will be treated in a 28-day cycle with Atu027 twice weekly for 4 weeks and gemcitabine once weekly for the first three weeks.; Subjects will be treated in a 28-day cycle with Atu027 and gemcitabine once weekly for three consecutive weeks (on days 1, 8, and 15). During week four no treatment is administered.
Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs.; Subjects will be treated in a 28-day cycle with gemcitabine once weekly (on days 4, 11, and 18) and Atu027 twice weekly (on days 1, 4, 8, 11, 15, 18, 22, and 25). The 28-day combination cycle is followed by a 28-day gemcitabine monotherapy cycle.
Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs.
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adenocarcinoma; Pancreas; Gemcitabine; Atu027
A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with
      moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
    

Detailed description: 
      The study is comprised of a 35-day screening period, a 24-week double-blinded treatment
      period, and a follow-up visit 12 weeks after the last dose. Participants who complete Week 24
      have the option to enroll into an open-label study (Study M19-850; NCT04195698) of
      upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52
      weeks.

      Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive
      either upadacitinib or dupilumab. Randomization will be stratified by Baseline disease
      severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD]
      score of moderate [3] versus severe [4]) and age (<40, ≥ 40 to < 65, ≥ 65 years).
    

Intervention name(s): Upadacitinib; Dupilumab; Placebo to dupilumab; Placebo to upadacitinib
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): Extended release tablet; Dupilumab is administered as a subcutaneous (SC) injection; Placebo administered as a subcutaneous injection; Tablet
Other intervention name(s): ABT-494; RINVOQ®; Dupixent®
Intervention MeSH terms: Upadacitinib; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Upadacitinib; ABT-494; Dupilumab; Atopic Dermatitis
Development a Method to Extract Antibiotic Concentration From Interstitial Lung and Epithelial Lining Fluid.
Condition: Lung Transplantation
Study type: Observational

Summary: 
      Infections are critical factors for the survival of critically ill patients. A serious
      problem is the high variability of antibiotic concentrations in critically ill patients. This
      may result in the risk of underdosage with possible ineffective therapeutic levels as well as
      in the risk of overdosage with possible adverse and toxic effects. Essential for the
      effectiveness of antibiotic therapy is the antibiotic concentration at target site. The goal
      of this study is to establish a method to extract Interstitial Lung Fluid (ILF) and
      Epithelial Lining Fluid (ELF) for antibiotic concentration measurements in patients following
      lung Transplantation and to calculate a tissue/serum concentration ratio. Improved knowledge
      regarding tissue penetration of Antibiotics may help to optimize drug dosing and management.
    

Detailed description: 
      Informed consent will be obtained prior to inclusion. 30 patients following lung
      Transplantation at the University Hospital of Munich will be included in this study.
      Intravenous Meropenem will be administered as perioperative antibiotic prophylaxis for lung
      transplantation. Interstitial Lung Fluid and Epithelial Lining Fluid will be extracted
      immediately after explantation of the lung from explanted lung tissue. Concentrations of
      antibiotics will be determined by liquid chromatography-mass spectrometry (LC-MS/MS) in ILF
      and ELF. Serum samples will be collected according to our in clinical routine established
      therapeutic drug monitoring. Tissue/Serum concentration ratio will be calculated. ELF will be
      collected on postoperative day 1-5 when bronchoscopy is performed during clinical routine.
      Numerous clinical and laboratory parameters will be determined. The investigators expect that
      correlations between antibiotic target site and blood concentrations and clinical and
      laboratory parameters will be found.
    

Intervention name(s): extraction of ELF and ILF from explanted lung tissue; meropenem concentration in ELF and ILF; ELF on postoperative day 1-5 when bronchoscopy is performed within clinical routine.
Intervention type(s): Diagnostic Test
Intervention description(s): Interventions will only be performed on explanted lung tissue ex vivo and on supernatant of bronchoscopy and are therefore non-invasive
Intervention MeSH terms: Meropenem
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Lung transplant patients at University Hospital of Munich
      
Keywords: Interstitial lung fluid; Epithelial lining fluid; Antibiotic concentration in the lung
Simvastatin for Treating Erectile Dysfunction
Condition: Erectile Dysfunction; Vascular Disease Detected; C Reactive Protein
MeSH terms: Erectile Dysfunction; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized clinical trial, double-blind, placebo controlled, to verify if
      simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any
      cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function,
      improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in
      improvement of erection.
    


Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): simvastatin 20 daily for six months.
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: simvastatin; endothelial dysfunction; erectile dysfunction
Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura
Condition: Henoch Schönlein Purpura
MeSH terms: IgA Vasculitis; Purpura
Study type: Observational

Summary: 
      The primary objective of this study is to search for evidence of quantitative or functional
      defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein
      Purpura (HSP) as compared to a control population.
    

Detailed description: 
      The secondary questions/objectives for this study are:

      A. During an inflammatory HSP flare, is there a quantitative and / or qualitative defect in
      plasma Tregs? Are such blood anomalies real or are they due to a modification of the
      distribution of theses cells to localized sites? B. In the asymptomatic phase, are there
      quantitative or functional abnormalities among Tregs in subjects with HSP compared to healthy
      control subjects? C. Are Treg abnormalities associated with modifications in other blood cell
      lineages, including B cells secreting IgA and abnormally glycosylated IgA1, and secretion of
      cytokines during acute relapses and during the asymptomatic phase? D. Can streptococcus or
      other oral or digestive pathogens (bacterial or viral) (as suggested in other chronic
      diseases such as rheumatoid arthritis ) provoke (via stimulation Th3) isotype commutation
      towards secretion of IgA1 at the origin of HSP? Does HSP intestinal damage or imbalance of
      the intestinal microbiota allow the translocation of intestinal microorganisms that sustain
      this stimulation?
    

Intervention name(s): Blood samples; Stool samples
Intervention type(s): Biological; Biological
Intervention description(s): Compared to routine practice, 3 additional tubes of blood will be drawn for the observational needs of this study.; Stool samples will be collected for the observational needs of this study (and are not part of routine practice).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Three different populations will be included in this study: (A) patients presenting with an
        acute episode of Henoch Schönlein purpura; (B) patients who have had an episode of Henoch
        Schönlein purpura in the past, but currently present with no symptoms; (C) a group of
        control patients recruted from elective surgery candidates at the participating hospitals.
      
Biospecimen description: 
      Stool samples: DNA extractions for microbiota analysis. Blood samples: DNA extractions for
      bacterial translocation analysis Blood samples: samples remaining will be kept for further
      analysis
    
Keywords: Tregs; bacterial translocation; cytokines
Effect of Melatonin on Multiple Sclerosis Related Fatigue
Condition: Fatigue
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment
      of fatigue and Quality of Life of MS patients.
    

Detailed description: 
      Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the
      world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System
      (CNS) which affects individuals in the productive ages and causes a large burden for years to
      come. Fatigue is a common complaint and one of the least understood symptoms of MS
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): it is kind of drug; It is Placebo
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Melatonin; Fatigue; Quality of life
Polymorphic Effects of Cytochrome P450 3A5 on Pharmacokinetics of Maraviroc and Its Metabolites
Condition: Cytochrome P450 CYP3A5 Enzyme Polymorphism; Healthy Subjects; Pharmacokinetics of Maraviroc
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the influence of genetic polymorphism of cytochrome
      P450 3A5 on pharmacokinetics of maraviroc and its oxidative metabolites
    

Detailed description: 
      This study aims to evaluate the effects of CYP3A5 genotype on pharmacokinetics of maraviroc
      and its oxidative metabolites. A single oral dose of 300 mg maraviroc will be given to 24
      eligible healthy individuals who will be screened and determined to have specific CYP3A5
      genotype - 8 homozygous wild type (2 CYP3A5*1 alleles), 8 heterozygous (1 CYP3A5*1 allele and
      1 mutant allele), and 8 without wild type genotype (2 mutant alleles). Blood samples will be
      drawn and urine samples will be collected immediately before and during a 32-hr period
      following the dose. The concentrations of maraviroc and its oxidative metabolites from the
      blood and urine samples will be measured and the pharmacokinetics of maraviroc and its
      metabolites will be compared among the three groups with different CYP3A5 polymorphic status.

      --------------------------------------------------------------------------------
    

Intervention name(s): Maraviroc
Intervention type(s): Drug
Other intervention name(s): Selzentry
Intervention MeSH terms: Maraviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CYP3A5; maraviroc; polymorphism
Validation of the CPS+EG, Neo-Bioscore and Modified Neo-Bioscore Staging Systems After PST of BC in China
Condition: Breast Cancer; Neoadjuvant Therapy; Neoplasm Staging; Estrogen Receptor; Histological Grade; HER2; Prognosis; Predictive Value of Tests
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Prognostic assessment after preoperative systemic therapy (PST) plays a vital role in breast
      cancer patients. The clinical-pathologic staging system incorporating estrogen receptor
      (ER)-negative disease and nuclear grade 3 tumor pathology (CPS+EG staging system) can
      effectively predict prognosis after PST. The Neo-Bioscore has been developed by the
      incorporation of the human epidermal growth factor receptor 2 (HER2) status into the CPS+EG
      staging system. But in a real world in China, the both staging systems had limits because of
      trastuzumab administration varied a lot in China from the United States. This retrospective
      study will validate CPS+EG and Neo-Bioscore system and explored a modified Neo-Bioscore
      system in multiple centers.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Nonmetastatic primary breast cancer patients who were treated with preoperative systemic
        therapy and surgery and had complete interesting clinicopathological data will be included.