bioihbjkbjnl/mcl2 huggingface dataset:
Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients?
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Increased intestinal permeability is one of the main pathophysiological mechanisms involved
      in irritable bowel syndrome. The expression of some intestinal tight junction proteins is
      decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased
      intestinal permeability. Currently, no test used in clinical practice could assess intestinal
      permeability.

      We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.
    

Detailed description: 
      The goal of our study is to look for a correlation between plasmatic zonulin and increased
      colonic permeability (assessed by the expression of intestinal tight junction proteins by
      western blot) in IBS patients and to look for a role of intestinal low-grade inflammation and
      microbiota.

      Population :

      IBS patients with diarrhoea or IBS with constipation or mixed with worsening of symptoms

      Outcomes measures :

      Plasmatic zonulin (ELISA kit) Occludin expression in colonic biopsies (western blot)
    

Intervention name(s): colonoscopy with biopsies in the left colon to assess intestinal permeability
Intervention type(s): Procedure
Intervention description(s): Eleven colonic biopsies are taken in the left colon during colonoscopy. Intestinal permeability is assessed by western blot, qPCR and immunofluorescence for claudin; occludin and ZO-1.
One blood sample is taken to assess plasmatic zonulin (ELISA kit).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Plasmatic zonulin; Irritable Bowel Syndrome; Intestinal permeability
Determination of the Levels of Lipocalin-2 and Semaphorin3A
Condition: Gingivitis; Periodontitis; Periodontal Diseases
MeSH terms: Gingivitis; Periodontitis; Periodontal Diseases
Study type: Interventional

Summary: 
      The aim of this clinical trial is to investigate the concentrations of Lipocalin-2 and
      Semaphorin 3A levels in gingival crevicular fluid in subjects with different periodontal
      diseases. At the same time for the periodontitis group; the purpose of this study is to
      analyze the correlation of these proteins with clinical parameters at the first and third
      months after the nonsurgical periodontal treatment.
    

Detailed description: 
      In our study, gingival crevicular fluid samples will be taken along with the measurement of
      all oral clinical parameters from sixty systemically healthy volunteers (20 periodontally
      healthy, 20 gingivitis, and 20 periodontitis). Gingival crevicular fluid samples will be
      taken again after the nonsurgical periodontal treatment for the periodontitis group in the
      first and third months. Lipocalin-2 and Semaphorin 3A levels will be determined by an
      enzyme-linked immunosorbent assay test (ELISA). Subsequent statistical analyses will be used
      to interpret protein levels among different groups and peridontitis group after the
      nonsurgical periodontal treatment.

      Possible significant differences may illuminate the future work with Lipocalin-2 and
      Semaphorin 3A. Also, these glycoproteins may help to develop different diagnostic methods or
      treatment strategies for future periodontal treatments.
    

Intervention name(s): Non-surgical Periodontal Treatment
Intervention type(s): Procedure
Intervention description(s): Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Periodontal Disease, Non-surgical Periodontal Treatment, GCF
The Equivalency of the Imp SFB7+ (L-Dex U400) With the Imp XCA Device
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Observational

Summary: 
      The purpose of this project is to prove that the Imp™SFB7+ (L-Dex U400) is equivalent to the
      Imp™ XCA device in assessing Lymphoedema. The Imp™ XCA device is a simple device capable of
      assessing Lymphoedema of a single arm. The Imp™SFB7+ (L-Dex U400) is a more complex device
      capable of assessing Lymphoedema in a larger population of Lymphoedema sufferers. The
      Imp™SFB7+ (L-Dex U400) will be developed to assess patients with Lymphoedema in their arms or
      their legs. The Imp™ XCA and Imp™ SFB7 are both TGA approved devices. The Imp™ SFB7+ (L-Dex
      U400) is similar to the Imp™ SFB7 the changes are to the software and user interface.
    

Detailed description: 
      When Lymphoedema is present, lymph and other fluids build up in the interstitial spaces of
      the tissues. This results in an overall increase in the total amount of extracellular fluid
      (ECF) in the limb, causing swelling. This can be documented by measuring the impedance
      (opposition) to a low frequency current that has been passed into the limb. Low frequency
      current travels predominantly through the ECF, where the Lymphoedema manifests. As the fluid
      builds up in the limb, the impedance to the current decreases and it is in this way that low
      frequency bioimpedance is able to assess Lymphoedema.

      Multi-frequency bio-impedance analysis otherwise known as Bioimpedance Spectroscopy (BIS) has
      been reported to be effective for the measurement of ECF and sub clinical changes in ECF to
      predict the onset of Lymphoedema in the arms in studies conducted by Cornish et al. It has
      been reported by Warren et al that BIS can be used as a reliable and accurate tool for
      documenting presence of lymphoedema in patients with wither upper- or lower-extremity
      swelling.

      The Imp™ XCA device uses an "impedance ratio" methodology to assess unilateral Lymphoedema of
      the arm. By this method the unaffected arm acts as an internal and subject specific control.
      The Imp SFB7+ (L-Dex U400) uses the same principles but at a lower frequency. This study is
      designed to show the equivalence of the 2 devices in assessing unilateral Lymphoedema of the
      arm.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Group 1 - Primary care clinic Group 2 - Community sample
      
Keywords: Lymphedema; Bioimpedance
Phase II Clinical Study of Pegylated Liposomal Doxorubicin Hydrochloride Injection as 2nd-line or Later Therapy in Patients With Mullerian Carcinoma (Epithelial Ovarian Carcinoma, Primary Carcinoma of Fallopian Tube, Peritoneal Carcinoma) Having Prior Platinum-Based Chemotherapy
Condition: Ovarian Neoplasms
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effectiveness and safety of pegylated liposomal
      doxorubicin hydrochloride injection in Japanese patients with Mullerian carcinoma. This
      clinical study is a multi-center, non-randomized, open-label study in Japanese patients with
      Mullerian carcinoma (including epithelial ovarian carcinoma, primary carcinoma of fallopian
      tube, peritoneal carcinoma) with a prior history of platinum-based chemotherapy. Eighty
      patients will be administered intravenously at least two cycles of 50 mg/m2 of pegylated
      liposomal doxorubicin hydrochloride every 4 weeks to investigate the effectiveness and safety
      of the treatment.
    

Detailed description: 
      Pegylated liposomal Doxorubicin hydrochloride is intended to change the pharmacokinetics of
      conventional doxorubicin in the blood and to improve the safety and effectiveness of the
      drug. Pegylated liposomal doxorubicin hydrochloride has been approved in many countries
      including US and EU, becoming a standard drug for 2nd-line therapy in ovarian cancer and
      AIDS-related Kaposi's Sarcoma. This clinical study was planned to assess effectiveness and
      safety for Japanese patients with Müllerian carcinoma (including epithelial ovarian
      carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma), who had a prior
      history of receiving platinum-based chemotherapy such as Cisplatin (which is considered to be
      the standard chemotherapy for ovarian carcinoma). In this study, at least two cycles of
      pegylated liposomal doxorubicin hydrochloride 50 mg/m2 will be intravenously administered to
      80 patients every 4 weeks. These patients include twenty 2nd-line "platinum-sensitive" and
      sixty "platinum-resistant" 2nd-line or 3rd-line patients. Pegylated liposomal doxorubicin
      hydrochloride 50 mg/m2 will be given by intravenous drip infusion on day 1. After this, a
      27-day drug-free period will be followed as one cycle. At least two cycles will be given as
      long as the patient does not meet the discontinuation criteria.
    

Intervention name(s): doxorubicin hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Müllerian Carcinoma; Doxil; Japanese Patients
Orphenadrine and Methocarbamol for LBP
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Low back pain is a common cause of visit to emergency department. It is not clear if skeletal
      muscle relaxants are of benefit for patients with acute low back pain. This is a randomized
      study to determine if skeletal muscle relaxants, when combined with naproxen, improve
      outcomes more than naproxen alone
    

Detailed description: 
      Patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time
      of discharge from the emergency department. Participants will be followed by telephone one
      week and 3 months after the ED visit
    

Intervention name(s): Orphenadrine; Methocarbamol; Naproxen; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Orphenadrine 100mg PO BID x 7 days; Methocarbamol 750mg 1-2 tabs po TID x 7 days; Naproxen 500mg PO BID x 7 days; 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days
Other intervention name(s): anticholinergic drug; Muscle relaxant; nonsteroidal anti-inflammatory drug
Intervention MeSH terms: Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Orphenadrine; Methocarbamol; Cholinergic Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Specialize Dysphagia Training and Knowledge/Competency of Nurses
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      The aim of this research is to determine the effect of specialized dysphagia training on
      knowledge and competency of nurses.
    


Intervention name(s): Dysphagia training; Reading material
Intervention type(s): Other; Other
Intervention description(s): Training using PowerPoint and simulation. Training includes anatomy physiology, screening and management sections. Simulation will be used for practice. Reading material will also be provided; Reading material provided to nurses covering knowledge related to nursing evaluation and caring for dysphagia patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dysphagia; Swallowing disorder; Dysphagia screening; Nurses role; Assessment
Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)
Condition: Head Cancer; Neck Cancer; Pain
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      The overall goal of this study is to examine the effect of a single dose of TENS on mucositis
      pain and function secondary to head and neck radiation therapies. Oral mucositis is an
      extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth,
      nose, and throat) that causes significant pain, functional impairment, and diminished quality
      of life. Head and neck cancers pose specific challenges to effective pain management and past
      studies suggest the use of effective non-pharmacologic strategies such as TENS may be
      particularly beneficial for avoiding sources of acute and chronic pain, thereby improving
      quality of life. The investigators hypothesize that a single dose of TENS will decrease pain
      and improve function and quality of life in head and neck cancer patients. This project is
      particularly innovative because it is the first known study to examine the efficacy of TENS,
      an established safe, inexpensive and easy-to-use non-pharmacologic pain management
      intervention, for treating acute oral mucositis pain. The investigators research translates
      bench (animal model) science to human subjects using an interdisciplinary approach to pain
      management. Establishing whether TENS is effective for reducing mucositis pain is a critical
      first step toward establishing an effective, non-pharmacologic pain relief intervention for
      mucositis.
    


Intervention name(s): Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention type(s): Device
Intervention description(s): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).
Other intervention name(s): EMPI Select
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Head and Neck Cancer; Oral Cancer; Laryngeal Cancer; Oropharyngeal Cancer; Transcutaneous Electrical Nerve Stimulation (TENS); Oral Mucositis; Pain; Function; TENS; Functional Pain; Non-pharamcologic; Quality of Life
Validation and Comparison of the Appendicitis Inflammatory Response Score and Adult Appendicitis Score
Condition: Acute Appendicitis; Acute Appendicitis With Rupture
MeSH terms: Appendicitis; Acute Disease; Rupture
Study type: Observational

Summary: 
      Acute appendicitis is one of the most frequent reasons of emergency laparotomy in adults.
      Symptoms of acute appendicitis overlap with other clinical conditions and might present as a
      challenge, especially in the early phases. Despite the advances and widespread use of imaging
      modalities, still negative laparotomies are performed with the initial diagnosis of acute
      appendicitis. Several scoring systems are developed by using various clinical and laboratory
      parameters in order to improve the diagnostic accuracy and prevent unnecessary laparotomies.
    

Detailed description: 
      In the recent guideline of World Society of Emergency Surgeons (WSES) recommendations
      regarding the clinical scoring systems for acute appendicitis are remarkable. It is stated
      that clinical scoring systems, on their own, can be used to exclude acute appendicitis and
      decrease negative laparotomy rates. Currently Appendicitis Inflammatory Response Score (AIR)
      and Adult Appendicitis Score (AAS) are the best clinically performing scoring systems. As a
      result, based on strong evidence the use of these two systems are recommended. Both scoring
      systems are developed on the basis of clinical findings and laboratory parameters.

      The aim of this study is to validate both systems as well as to compare the efficiency of
      both systems on excluding negative laparotomies and on the determination of severity of acute
      appendicitis.
    

Intervention name(s): Appendicitis Inflammatory Response; Adult Appendicitis Score
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters; A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients between 18-65 years old, presenting to ER with right lower quadrant pain.
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
Condition: Menopause; Dyspareunia
MeSH terms: Dyspareunia
Study type: Interventional

Summary: 
      The main objective of this study is to measure changes in the thickness of the vaginal lining
      (epithelium + underlying stroma) between 0 and 8 weeks after injection.
    

Detailed description: 
      The secondary objectives of this study are to measure changes in the following between 0 and
      8 weeks after injection:

      A. vaginal flora and Nugent score.

      B. vaginal pH.

      C. functional evolution via the VHI index by Gloria Bachman (state of the vaginal mucosa),
      pain / dyspareunia (visual analog scale) and the satisfaction concerning care viay the PGI-I
      questionnaire (Patient Global Impression and Improvement).

      D. Procollagen I and III gene expression (by PCR) and mitotic activity of the mucosa (Ki67
      proliferation marker) based on biopsies.
    

Intervention name(s): DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
Intervention type(s): Device
Intervention description(s): Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
The intervention is Intended for intra-mucosal injection in women for biostimulation / rehydration of the surface layers of the lining of the genital areas, vaginal hypotrophies and / or treatment of female sexual dysfunction related to subsidence G "spot or area of Gräfenberg ".
Following disinfection and topical anesthesia (lidocaine gel), the vesitbule is injected using a multi-point technique. The optimal volume of DESIRIAL® to be used for injection into the vestibule is approximately 0.3 ml in total.
Other intervention name(s): Cross-linked Hyaluronic Acid; DESIRIAL®
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaginal discomfort; Vaginal dryness
Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients
Condition: HCV Infection; Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Response to a second-line anti-HCV treatment in non responder patients to a first-line dual
      therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be
      potentially effective to treat hepatitis C.
    

Detailed description: 
      Background : Response to a second-line anti-HCV treatment in non responder patients to a
      first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that
      this drug could be potentially effective to treat hepatitis C.

      Design : randomized, double-blind, multicenter trial.

      Interventions compared : Peg-interferon alfa 2A + ribavirin + amantadine versus
      Peg-interferon alfa 2A + ribavirin + Placebo

      Eligibility criteria : Chronic hepatitis C, previously treated with combination of interferon
      plus ribavirin for at least 24 weeks,detectable HCV RNA.

      primary outcome : sustained virological response, defined as an undetectable HCV RNA level 24
      weeks after the end of anti HCV treatment.
    

Intervention name(s): Peginterferon alfa-2a; ribavirin; amantadine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hepatitis C, chronic; HCV infection; Treatment failure; PEG Interferon; (Interferons/therapeutic use; Interferon Alfa-2a/adverse effects); ribavirin; (Ribavirin/therapeutic use; Ribavirin/adverse effects); Amantadine; Drug Therapy, Combination
Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the effect of PF-06305591 on capsaicin and
      capsaicin/heat-induced neurogenic flare.
    


Intervention name(s): PF-06305591; Capsaicin challenge; Placebo; Capsaicin challenge
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): 150 mg PF 06305591 will be administered to subjects as a 100 mL extemporaneous prepared oral solution once.; 110 mg capsaicin cream (Axsain®) will be applied topically at each visit.; Placebo will be administered to subjects as a 100 mL extemporaneous prepared oral solution once.; 110 mg capsaicin cream (Axsain®) will be applied topically at each visit.
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science