Kornimate/medical-research-clean huggingface dataset:
lymph node staging system with a novel concept for gastric cancer: a hybrid type of topographic and numeric ones

Conditions: Gastrectomy for Gastric Cancer

Summary: for staging the status of lymph node metastasis in gastric cancer, typographic based staging system was applied until last decade, especially in eastern countries. however the old typographic lymph node staging system in gastric cancer was too complicated and less accurate for predicting the prognosis. now the numeric based lymph node staging system is used in both east and west, but it include problems: no information on the anatomical extent of the disease, preoperative lymph node staging is nearly impossible, failure to provide an appropriate treatment plan, cannot represent the extent of lymph node dissection. we designed simple and specifically representing the anatomic extent of the disease for staging the status of lymph node in gastric cancer. thus we compared its prognostic performance of this new staging system with those of the current tnm 7th edition of ajcc/uicc.


Eligibility criteria:
inclusion criteria: * patients were pathologically confirmed as primary gastric cancer * patients underwent gastrectomy with curative intent. exclusion criteria: * patients underwent minimally invasive surgery * patients with any distant metastases including peritoneal seeding and para-aortic lns metastasis) * when the location of lymph nodes were not divided * patients underwent chemotherapy preoperatively * patients had metastatic lymph nodes with unclear location

Keywords: gastric cancer, staging system, prognosis
focused spinal stenosis rehabilitation program for lumbar spinal stenosis

Conditions: Spinal Stenosis Lumbar

Summary: lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain, as well as by weakness precipitated by walking and prolonged standing. self-management options include physical therapy, which includes exercise as a core component for improving the flexibility and mobility of the spine and hips. a williams flexion protocol has historically been used to treat low-back pain following degenerative changes to the posterior elements of the lumbar spine. however, few studies have been done to validate the efficacy of this protocol. a more focused treatment protocol may be more efficacious. patients in this study will be randomized to receive either the generic physical therapy protocol (15 sessions) or the focused rehabilitation program (5 sessions). the sessions will take place over the course of 6 months. outcomes will be assessed using validated questionnaires and physical function tests.


Eligibility criteria:
inclusion criteria: * lumbar spinal stenosis with neurogenic claudication * symptoms present for at least 3 months * moderate to severe acquired or congenital lss based on radiological evaluation * lumbar mri obtained within the past 12 months prior to initial physical therapy visit * 40 years of age or older * body mass index less than or equal to 35 * can tolerate a 6-min treadmill test * willing to comply with home exercises as prescribed exclusion criteria: * acute disc herniation * grade 3 or greater spondylolisthesis * rheumatoid or autoimmune conditions (e.g., ankylosing spondylitis) * active spinal compression fractures * knee surgery in the previous 6 months (e.g., total knee arthroplasty) * previous spinal fusion * absence of pedal pulses * inflammation/infectious process * myelopathy * psychiatric disorder preventing informed consent or participation in assigned physical therapy sessions * patients with pending litigation or workers compensation
xylitol for the prevention of acute otitis media episodes in children

Conditions: Acute Otitis Media; URTI; Dental Caries in Children

Summary: this is a randomized controlled trial of regular daily use of xylitol (or "birch sugar"), a natural sweetener that has antimicrobial properties, for the prevention of acute otitis media (aom, primary outcome) as well as upper respiratory tract infections and dental caries (the two secondary outcomes) in preschool aged children. this trial will be conducted through the target kids! research network.

this is an rct of regular daily use of xylitol (or "birch sugar"), a natural sweetener that has antimicrobial properties, for the prevention of acute otitis media (aom, primary outcome) as well as upper respiratory tract infections and dental caries (the two secondary outcomes) in preschool aged children. clinical equipoise over the efficacy of xylitol in preventing aom - a common and costly condition in early childhood - persists even after the completion of three rcts by a single research group in finland and one in the united states. several clinical trials of xylitol for the prevention of dental caries and other studies have demonstrated that the intervention in this trial (3-5 doses of xylitol per day) is safe, well tolerated and feasible for the study period. this trial will be conducted through the target kids! research network which is undertaking several cihr funded rcts and will leverage existing cihr funded infrastructure and important collaborations. the nominated principal applicant's salary is supported by a cihr rct training grant to develop this rct under the mentorship of a co-principal applicant who is an experienced trialist. this trial has the potential to transform the management of three common conditions during early childhood from treatment to prevention using a currently underutilized antimicrobial substance.

Eligibility criteria:
inclusion criteria: * children already enrolled in the target kids! network, age 2 - 4 years at start of intervention, parents or care provider able to give consent, able to understand the information in english. exclusion criteria: * craniofacial malformations, structural middle ear abnormalities, sibling or any other child living at the same address already enrolled in the trial, insertion of ventilation tubes prior to study period, current use of a xylitol product or reported xylitol sensitivity.
nutritional status and intake in patients with non-cystic fibrosis bronchiectasis (ncfb)

Conditions: Non Cystic Fibrosis Bronchiectasis

Summary: the aim of this study was to characterise nutritional status and dietary intake in a population of individuals living with bronchiectasis from a regional clinic. participants underwent usual assessment as per their standard pathway of care and in addition, body composition through skinfold measures, handgrip strength and information on dietary intake over 3 days via 24 hour multiple pass recalls was also collected. this was to establish baseline measures and knowledge in support of understanding the impact of nutritional status within this group.


Eligibility criteria:
inclusion criteria: * people who have a confirmed diagnosis of ncfb * people with ncfb who are clinically stable (not requiring acute admission to hospital) * people who attend the regional clinic exclusion criteria: * people who are pregnant * people with existing comorbidities such as malignancy

Keywords: nutritional status dietary intake ncfb
sexual functıon in young women after breast cancer surgery

Conditions: Breast Cancer Surgery; Young Adult Females

Summary: the aim of this observational study was to analyse sexual function in young women after breast cancer surgery. the main question it aims to answer is sexual function in young women after breast cancer surgery changes during the one-year follow-up period. participants will answer demographic information, female sexual function scale, breast-q and body perception scale about their sexual function, quality of life and body perception. these will be recorded before surgery and repeated 6 weeks, 6 months and 1 year after surgery.

as a result of the power analysis of the preliminary study conducted with the participation of 9 cases; it was calculated that 80% power could be obtained at 95% confidence level when at least 47 people were included in the study. however, considering that the results of the preliminary study will not be conclusive, it is planned to complete the study with at least 52 people by taking 10% more participants. the data will be analysed with spss 25.0 package programme. continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. repeated measures anova test, kruskal-wallis test or friedman test will be used according to the parametric test assumptions.

Eligibility criteria:
inclusion criteria: * individuals scheduled for surgery for breast cancer * accepting to participate in the study * being sexually active in the last 1 year * continuation of menstruation exclusion criteria: * previous breast cancer surgery * previous history of breast cancer * history of any other cancer * refusal to participate in the study * refusal to continue working * problems in her relationship with her partner

Keywords: sexual functions breast cancer surgery young adult females breast cancer treatment quality of life breast cancer survival body perception mastectomy mastectomy, modified radical mastectomy, segmental breast conserving surgery
mechanisms of anaphylaxis

Conditions: Anaphylaxis; Allergy; Transfusion Reaction; Febrile Transfusion Reaction

Summary: the purpose of this study is to explore different mechanisms for anaphylaxis and find novel biomarkers for this hypersensitivity syndrome. the study participants are patients with anaphylaxis, patients with mild allergic reactions, and patients with febrile transfusion reactions. the investigators will also include a group of healthy controls.


Eligibility criteria:
inclusion criteria: according to the specific cohort: 1. diagnosis of anaphylaxis 2. mild allergic reaction 3. febrile transfusion reaction 4. healthy, no known allergic disease exclusion criteria: suspicion or diagnosed sepsis children

Keywords: platelet activating factor basophil activation test anaphylatoxins
effect of perioperative sleep quality on chronic post-surgical pain

Conditions: Chronic Post-Surgical Pain

Summary: the goal of this prospective observational cohort study is to assess the impact of perioperative sleep quality on the development of chronic post-surgical pain (cpsp) in adult patients (aged 18-80 years, asa i-iii) undergoing elective video-assisted thoracic surgery (vats), modified radical mastectomy (mrm), or coronary artery bypass grafting (cabg). the main questions it aims to answer are: does poor perioperative sleep quality increase the risk of cpsp at 3 months post-surgery? how do subjective and objective sleep parameters (e.g., total sleep duration, deep sleep time) correlate with cpsp and recovery outcomes? researchers will compare patients with varying perioperative sleep quality levels (assessed via the richards-campbell sleep questionnaire \[rcsq\] and wearable device data) to evaluate differences in cpsp incidence, pain and quality of life. participants will: wear a huawei wearable device to collect objective sleep data (e.g., sleep duration, deep sleep time) during hospitalization. complete questionnaires preoperatively and postoperatively, including rcsq, pittsburgh sleep quality index (psqi), hospital anxiety and depression scale (hads), and brief pain inventory (bpi). undergo follow-up assessments at 1, 3, and 6 months post-surgery to evaluate pain scores , cpsp status, and quality of life (sf-36).


Eligibility criteria:
inclusion criteria: 1. aged 18-80 years. 2. scheduled for elective video-assisted thoracic surgery (vats). 3. scheduled for elective modified radical mastectomy (mrm). 4. scheduled for elective coronary artery bypass grafting (cabg). 5. american society of anesthesiologists (asa) physical status classification i-iii. 6. willing to sign the informed consent form, participate in the study, and complete all follow-up assessments. exclusion criteria: 1. history of surgery within the past 3 months. 2. chronic use of opioids or sedatives (defined as use for 3 months or longer). 3. expected completion time of surgery after 16:00 on the day of operation. 4. planned transfer to the intensive care unit (icu) postoperatively. 5. anticipated hospital stay \<24 hours. 6. contraindications to wearable device use (e.g., infection at the wrist site, allergy to the wristband material).
national screening in denmark with mr versus mammography and ultrasound of women with brca1 or brca2 mutations

Conditions: Breast Cancer

Summary: the purpose of the study is to determine whether mr of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with brca1 or brca2 gene mutations.

study type : interventional study design: diagnostic,prospective,non randomised,blinded,efficacy study further study details as provided by dbcg ( danish breast cancer cooperative group): primary outcome measures: diagnostic outcome of a yearly screening with mr versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values. secondary outcome measures: comparison of diagnostic outcome of mr versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue. comparison of the cancers found in women with brca gene mutations compared with the cancers found in the background population in respect of morphology, size, histological type, axillary lymph node status and grade. study start : january 2007. expected completion 2010. women with brca gene mutations are more likely than others to develop the disease at a young age when breast density is higher than at older age.the tumours often are more rapidly developing with a short presymptomatic phase. these factors are known to reduce the effectiveness of screening with mammography and mammography seems to have a low sensitivity in women with brca gene mutations. other studies have shown that more than 50% of the cancers appears as interval cancers between two mammography screening examinations and many have positive axillary nodes at the time of diagnosis. around 610 women are tested brca gene positive in denmark in year 2006. these women are offered a yearly screening with mammography combined with ultrasound and a clinical examination. the trial will test whether this screening offer should be combined with or replaced by mr mammography.

Eligibility criteria:
inclusion criteria: * women tested positive of brca1 or brca2 gene mutations * referred for screening * aged 25 - 70 years exclusion criteria: * general contraindications for mr * pregnant or lactating * men * bilateral mastectomy * ongoing treatment with chemotherapy * metastatic breast cancer * previous breast surgery less than 6 months before mr * previous radiation therapy of the breast less than 1 year before * incapable of managing her own affairs

Keywords: breast cancer brca1 gene brca2 gene magnetic resonance imaging mammography ultrasonography
capecitabine associated with weekly paclitaxel in metastatic breast cancer.

Conditions: Breast Cancer; Neoplasm Metastasis

Summary: tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.

the purpose of this study is to know if we can optimize in term of tolerance even of efficacy the plan of administration of weekly paclitaxel associated with capecitabine.

Eligibility criteria:
inclusion criteria: * femal patient aged \> 18 years * histologically proven breast adenocarcinoma * her2 negative receptors * previously received first or second line chemotherapy for metastatic disease * previously treated with anthracycline and/or docetaxel in adjuvant and/or as first or second line therapy * presence of one or several evaluable metastatic lesion(s) * presence of at least one target lesion not previously irradiated * previously treated with hormonotherapy in adjuvant or in metastatic line (treatment will be ceased upon patient registration in the study) * ecog performance status \< 2 * adequate biological values * patient who has clearly given her consent by signing on informed consent form prior to participation exclusion criteria: * patient previously treated with paclitaxel or capecitabine for metastatic breast cancer * patient with only local metastatic disease (with the exception of axillary lymph nodes) * active symptomatic brain metastasis * patient with an history of significant cardiovascular impairment (congestive heart failure\> nyha grade ii, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia) * peripheric neuropathy grade ≥ 2 * history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin) * patient with any medical or psychiatric condition that, in the opinion of the principal investigator, would preclude her from participating in this study * patient with a known allergy to one or several of the study compounds * patients who may not be regularly available due to geographical, social or family reasons * history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product * deficiencies of the upper intestinal tract, malabsorption syndrome * patient who is pregnant, breast-feeding or using inadequate contraception
comparison between volatile anesthetic-desflurane and total intravenous anesthesia with propofol and remifentanil on early recovery quality and long term prognosis of patients undergoing pancreatic cancer and common bile duct cancer surgery

Conditions: Pancreatic Cancer or Distal CBD Cancer

Summary: investigators asses whether there is any difference in short term recovery and long term prognosis according to the anesthetic method in patients who undergoing pancreatic cancer and bile duct cancer and undergoing surgery for pppd or distal pancreatectomy.


Eligibility criteria:
inclusion criteria: * patients with asa class i-iii who are scheduled to undergo general anesthesia and who are diagnosed with pancreatic cancer or common bile duct cancer and who are scheduled for pppd or distal pancreatectomy * patients who voluntarily agree to participate the clinical study after fully informed and understood about the study exclusion criteria: * there was distant metastasis at the time of diagnosis * history of drug adverse reaction or use of opioid or sedative drugs before the surgery * patients who can not communicate enough to answer the survey * obesity patients over bmi 30 * patient who are expected to maintain ventilator care on the first day of post operation due to the difficult to extubation right after the surgery * patients who have inappropriate reasons to participate in clinical research
removal of the evolution® esophageal stent - fully covered

Conditions: Esophageal Fistula; Esophageal Neoplasms; Esophageal Perforation; Esophageal Stenosis; Stents

Summary: the clarity study is a clinical trial approved by us fda to study the removal of the evolution® esophageal stent-fully covered in malignant and benign indications.


Eligibility criteria:
inclusion criteria: * patient is diagnosed with benign or malignant stricture, fistula, perforation, or leak * physician plans to remove the stent within the duration of study follow-up exclusion criteria: * patient is \< 18 years of age * patient is unable or unwilling to provide written informed consent or comply with follow-up schedule * patient is pregnant, lactating, or planning on being pregnant within the next 6 months * patient is simultaneously participating in another investigational drug or device study * patient that is contraindicated to upper gi endoscopy and/or any procedure to be performed in conjunction with esophageal stent placement * patient has a known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated

Keywords: esophageal fistula esophageal neoplasms esophageal perforation esophageal stenosis stents
a study of ly2127399 in participants with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus; Connective Tissue Disease; Autoimmune Disease

Summary: the purpose of this sle study is to evaluate the efficacy, safety and tolerability of two different doses of ly2127399 administered in participants with active sle.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of sle by american college of rheumatology (acr) criteria * have positive antinuclear antibodies (ana) * agree not to become pregnant throughout the course of the trial * have a screening selena-sledai score ≥6. (the participant must be actively exhibiting all the symptoms scored on the screening selena-sledai on the day of screening.) exclusion criteria: * have active severe lupus kidney disease * have active central nervous system or peripheral neurologic disease * have received intravenous immunoglobulin (ivig) within 180 days of randomization * have active or recent infection within 30 days of screening * have had a serious infection within 90 days of randomization * have evidence or test positive for hepatitis b * have hepatitis c * are human immunodeficiency virus (hiv) positive * have evidence of active or latent tuberculosis (tb) * presence of significant laboratory abnormalities at screening * have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization * have received greater than 40 mgs of prednisone or equivalent in the past 30 days * have changed your dose of antimalarial drug in the past 30 days * have changed your dose of immunosuppressive drug in the past 90 days * have previously received rituximab

Keywords: lupus sle systemic lupus erythematosis autoimmune disease ly2127399 immune system disease