Kornimate/medical-research-clean huggingface dataset:
sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer

Conditions: Breast Cancer; Invasive Breast Cancer

Summary: title of study: sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. objectives of the study: primary objective 1. evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy. secondary objectives 1. evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy. 2. evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients. number of patients: n = 300 population: patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that present with biopsy proven positive axillary nodes. study duration: from february 2009 to february 2012 - 3 years


Eligibility criteria:
conditions for patient eligibility inclusion criteria: * patients must be female. * patients must be 18 years of age or older. * patients with stage iia, iib, iiia (t1-3 and n1-2) breast cancer. clinical n0 accepted if biopsy proven node disease. * patients that have biopsy proven positive axillary disease made by core needle biopsy or fine needle aspiration . * patients that accept to undergo neoadjuvant chemotherapy; patients are eligible until the day of surgery. * patients with bilateral breast cancer are eligible. sentinel node biopsy is allowed on the contralateral breast if there is no disease in the axilla prior to chemotherapy. * patients that understand, accept and have signed the approved consent form. exclusion criteria: * patients with inflammatory breast cancer. * patient with stage iiib, iiic or iv breast cancer (t4 and n3) patients with clinical n3 disease are excluded. * patients that have had previous axillary dissection or an axillary sentinel node biopsy; (patients that have had excisional biopsy or ipsilateral tumorectomy are eligible). * patients that have had previous radiotherapy to the axillary nodes * patients that have had mammary reduction * patients that are medically unfit to receive chemotherapy, as evaluated by the treating physician. * if the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue or methylene blue or radiocolloid dye are ineligible. * patients who are pregnant or breast feeding . * psychiatric or addictive disorders or other conditions that preclude the patient from meeting the study requirements.

Keywords: breast cancer node positive breast cancer sentinel lymph node biopsy breast surgery axillary lymph node dissection neoadjuvant chemotherapy
fiberlocker® system augmentation of rotator cuff repairs

Conditions: Rotator Cuff Tear; Rotator Cuff Tears; Rotator Cuff Tears of the Shoulder

Summary: the purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the fiberlocker® system (encompassing the speedpatch® pet and the fiberlocker® instrument sn). the primary outcome measure is healing evaluation based on magnetic resonance imaging (mri) at a minimum of 6 months post-operatively. the secondary outcome measures are the sugaya classification, goutallier stage and tendon quality based on mri as well as objective scores and patient-reported outcome measures (proms) from validated outcome scoring systems.


Eligibility criteria:
inclusion criteria: 1. the subject is between the ages of 30 and 70 years. 2. subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (rct) 3. tear size ≥ 2 cm 4. primary rotator cuff repair 5. subject preoperative mri obtained within 1 year prior to surgery exclusion criteria: 1. the subject is unable or unwilling to sign the patient informed consent, approved by the institutional review board. 2. the subject objects to the use of the fiberlocker® system 3. history or known allergy or intolerance to polyester 4. complete full-thickness subscapularis tears of \> than the superior 1/3 of the tendon (lafosse grade 3 and above) 5. hamada grade iii and above 6. less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph 7. recurrent shoulder instability 8. corticosteroid injection in the operative shoulder within three months before surgery 9. subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) 10. subjects with current acute infection in the area surrounding the surgical site 11. revision rotator cuff repair 12. pregnant or planning to become pregnant during the study period 13. subject is breastfeeding during the study period 14. subject has conditions or circumstances that would interfere with study requirements intraoperative exclusion criteria: 1. partial rotator cuff repairs 2. lafosse grade 3 or higher subscapularis tears 3. limited space for implant delivery 4. fiberlocker® system cannot be used as indicated

Keywords: rotator cuff tears rotator cuff repair augmentation reinforcement mechanical augmentation rotator cuff degeneration
analysis t cells response for identification of aspergillus bronchitis with cystic fibrosis patients

Conditions: Cystic Fibrosis Patient; Patient Without Treatment Against A.Fumigatus

Summary: the study aims to asses the ability of cell tests based on the analysis of the anti-aspergillus cell responses and identify aspergillus bronchitis with patients with cystic fibrosis. in addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by baxter et al. compared to the classification used in clinical practice in the hospital of montpellier.


Eligibility criteria:
inclusion criteria: * patient with cystic fibrosis followed at resource centers and cystic fibrosis skills (crcm) montpellier * patient aged 15 or over * patient able to understand the nature, purpose and methodology of the study. * patient and his legal representative for minors who have given their free and informed consent * affiliate or beneficiary of a social security scheme. exclusion criteria: * patients on antifungal treatment at the time of sampling * pregnant or breastfeeding * major protected by law (guardianship, curator or under backup justice) * inability to understand the nature and goals of the study and / or communication difficulties with the investigator * subject attending another search including a period of exclusion still going to run-in

Keywords: bronchitis aspergillus cystic fibrosis
evaluation of the possible relationship between periodontal disease and preterm labor

Conditions: Preterm Labor; Periodontal Disease

Summary: the primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preterm labor. the secondary objective of the study is to analyze the relationship between preterm labor and periodontal infection, using clinical, biochemical and microbiological methods.

preterm infants are born prior to completion of 37 weeks of gestation. periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preterm labor. it is believed that the results will set light to the etiology of preterm labor and will help to develop strategies to prevent the disease.

Eligibility criteria:
inclusion criteria: * pregnant women with preterm labor * 37. weeks of pregnant women with no history of preterm labor exclusion criteria: * genitourinary infection * pregnancy or pre-pregnancy hypertension * hiv infection * diabetes mellitus * multiple pregnancy, preterm labor / low birth weight * smoker and alcohol use history * ivf pregnancy * placental, cervical and uterine anomalies * pregnancy with intrauterine growth retardation * pregnancies with congenital or chromosomal fetal anomalies * significant vaginal bleeding * infertility stories * drug addicts * poor socioeconomic level
impact of comprehensive rehabilitation nursing combined with refined airway management and nutritional support on prognosis and care delivery models in critically ill patients

Conditions: Critically Ill Patients; Nutritional Support; Pulmonary Infections; Gastrointestinal Bleeding; Acute Kidney Injury (AKI)

Summary: this combined intervention protocol effectively improves the prognosis of critically ill patients and optimizes nursing management models

to investigate the impact of comprehensive rehabilitation nursing combined with refined airway management and nutritional support on the prognosis of critically ill patients and nursing management models, and to develop a new care management protocol. critically ill patients were divided into a control group (routine nursing) and an intervention group (comprehensive rehabilitation nursing combined with refined airway management and nutritional support). complications such as pulmonary infection and gastrointestinal bleeding, as well as clinical indicators including oxygen saturation (spo₂), mechanical ventilation time (mvt), and length of stay (los), were compared between the two groups. logistic regression and xgboost models were constructed to analyze key influencing factors.

Eligibility criteria:
inclusion criteria: * fulfillment of icu admission standards with critical illness confirmed by attending physicians or senior specialists * age ≥ 18 years * stable vital signs: systolic blood pressure ≥ 90 mmhg and ≤ 180 mmhg heart rate ≤ 120 beats/min oxygen saturation (spo₂) ≥ 85% under ≤ 60% fraction of inspired oxygen (fio₂) * intact or tolerable gastrointestinal (gi) function for enteral nutrition * informed consent from both patients and families exclusion criteria:(1) * terminal malignancies * brain death * irreversible organ failure (e.g., end-stage cirrhosis, advanced heart failure) * comorbidities potentially confounding study outcomes * contraindications to interventions (e.g., laryngeal edema, complete intestinal obstruction) * pregnancy or lactation
effect of age on the median effective concentration(ec50) for motor block with spinal plain bupivacaine

Conditions: Mononeuropathy of the Median Nerve, Mild

Summary: this study was performed in 131 adult patients undergoing transurethral, urological or lower limb surgery under combined spinal and epidural anesthesia. patients were stratified according to age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years. the spinal component of the anesthetic was established by bolus administration of up-and-down doses of 0.75% plain bupivacaine, determined by dixon's method. the degree of motor block after intrathecal administration of each concentration was evaluated by the modified bromage and hip motor function score. the ec50 were estimated from the up-and-down sequences using the method of dixon and massey and logistic regression. other endpoints were included on the basis of sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.


Eligibility criteria:
inclusion criteria: - asa physical status i-ii adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal component of established combined epidural-spinal anesthesia, with the epidural component to be used if there was a need for intra-operative analgesic supplementation or for postoperative analgesia. exclusion criteria: * patients with diabetes, obesity, neuromuscular diseases, bleeding diathesis, hypersensitivity to amide local anesthetics, lumbar vertebrae abnormality, chronic back pain, or who were pregnant were excluded from this study

Keywords: intrathecal; bupivacaine; concentration;
risk factors of perforated hscr in neonates

Conditions: Hirschsprung Disease; Bowel; Perforation, Fetus or Newborn

Summary: hirschsprung's disease (hscr) is a common digestive malformation with radiographic evidence of distal bowel obstruction and clinical signs of abdominal distension, vomiting, constipation, and failure to pass meconium. bowel perforation (perforated hscr) is a very serious complication of hscr, but if this occurs it is most often in the neonatal period. the current study collected information on all cases diagnosed with perforated hscr from multi-centers in china over 10 years, the aim was to evaluate the clinical features of perforated hscr, and investigate possible risk factors for perforated hscr in neonates.


Eligibility criteria:
inclusion criteria: * neonates (≤1 month age) * diagnosed with hscr * suffered with bowel perforation exclusion criteria: * patients complicated with suspected necrotizing enterocolitis (nec), imperforate anus (ia), intestinal atresia, and meconium plug syndrome * neonates who transferred from outside participating hospitals.
sonazoid contrast-enhanced ultrasound in assessing effectiveness of neoadjuvant chemotherapy in breast cancer patients.

Conditions: Ultrasound

Summary: sonazoid as a new generation of ultrasound contrast agent.this study based on the features of sonazoid specific angiography and high mechanical index,the role of sonazoid in assessing effectiveness of neoadjuvant chemotherapy in breast cancer patients was explored.

this is a prospective, multicenter study.more than 1000 participants will enrolled.most of them with ceus,mri and pathological follow up.when enhanced mri is needed in the neoadjuvant cycle of patients, sonazoid-ceus examination is added at this time point, and postoperative pathology will be used as the gold standard, so as to compare the ability of the two imaging examinations in judging the effect of neoadjuvant chemotherapy. investigators will also record the parameter information of imaging examination, pathological type of pathological examination and immunohistochemical index, etc.contrast-enhanced ultrasound includes lesion location, initial peak tumor volume, 1-minute tumor volume, 2-minute tumor volume, and 5-minute tumor volume, as well as the time for contrast enhancement, contrast agent clearance, and contrast agent clearance.whether there is no enhancement area in the lesion after contrast enhancement, shape after contrast enhancement, edge after contrast enhancement, order of enhancement, uniformity of enhancement, intensity enhancement, pattern of enhancement, clear boundary after contrast enhancement, aspect ratio after contrast enhancement, etc.the magnetic field strength of the equipment is planned to be recorded in the enhanced mri information, the name of the mri contrast agent, the lesion location, the size of the lesion, and the scanning performance are enhanced (lump-like enhancement, non-lump-like enhancement, point-like enhancement), time-signal intensity enhancement curve, dwi signal, adc value, etc.

Eligibility criteria:
inclusion criteria: * (1) refer to the guidelines and specifications for diagnosis and treatment of breast cancer, and it is clearly identified as breast cancer by pathological biopsy. * (2) plan to implement nac therapy; * (3) all patients and their family members signed informed consent forms, which were approved by the hospital medical ethics committee exclusion criteria: * (1) those who are known to be allergic to ultrasound contrast agents; * (2)the subject has a history of allergy to eggs or egg products (i.e. skin rash, dyspnea, swelling of the mouth or throat, hypotension or shock, etc.) * (3) intolerance to neoadjuvant chemotherapy; * (4) poor compliance with chemotherapy treatment; * (5) patients who cannot receive contrast agent mri examination * (6) arteriovenous (left and right) shunt patients in the heart and lungs; * (7) mental disorders or mental disorders; * (8)patients with serious heart disease or lung disease; * (9)pet-pregnant, possibly pregnant or lactating; * (10)in addition, the researcher or the researcher thinks that the patient is not suitable to participate in this study.

Keywords: breast
a phase ii multi-centre, extension study to investigate the long term safety of ono-2506po in patients diagnosed with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: the objective of this study is to investigate the long term safety of als patients taking ono-2506po.

this is an extension study which consists of two phases: double-blind phase; patients will continue to take blinded study medication, as allocated in study ono-2506poe014 by the central randomization system, in the presence of stable standard riluzole therapy, until un-blinding of the study results. open label phase; patients who were allocated to ono-2506po in the ono-2506poe014 study will be offered entry into the open label phase of ono-2506poe015 study and will continue to take 1200 mg of ono-2506po for the duration of their participation in the study, in the presence of stable standard riluzole therapy. patients who were allocated to placebo in ono-2506poe014 study will be withdrawn from ono-2506poe015 study, but will continue to be followed up by their site with standard care.

Eligibility criteria:
inclusion criteria: * adult male and female patients with diagnosis of als over the age of 18 years. * previous randomization and completion of the last visits in ono-2506poe014 study. * patients whom the investigator has no concern and judges tolerable for the continued treatment with ono-2506po and riluzole from a risk and benefit point of view. exclusion criteria: * a clinically relevant medical history or presence of cardiovascular, gastrointestinal, renal, hepatic, endocrine/metabolic, neurologic, lymphatic, haematologic, immunologic, musculoskeletal, connective tissue, dermatologic, genito/urinary, psychiatric diseases or disorders that, in the opinion of the investigator may pose an unwarranted risk to the patient

Keywords: ono-2506po amyotrophic lateral sclerosis als
impact of mandibular canal trajectory on paresthesia after inferior alveolar nerve lateralization

Conditions: Alveolar Bone Loss; Neurosensory Disorder

Summary: this prospective cohort study aims to investigate the relationship between mandibular canal trajectory and the duration of postoperative paresthesia in patients undergoing inferior alveolar nerve lateralization. the study will assess mandibular canal trajectory using anatomic factors and evaluate nerve sensory function using subjective and objective tests. implant success criteria will also be assessed. the study will be conducted on patients who underwent ianl due to mandibular atrophy and were unable to receive standard or short implant placement. data will be collected at regular follow-up visits up to 1-year post-surgery.


Eligibility criteria:
inclusion criteria: * patients with atrophied posterior mandible with less than or equal to 6 mm of bone over the inferior alveolar canal * no previous grafting or implant surgery at the site where nerve lateralization is planned * no neurosensory impairment * no contra-indications for implant surgery exclusion criteria: * patients who have undergone radiotherapy in the associated area * patients using bone-modifying agents * smokers with daily consumption of more than ten cigarettes * patients with neurosensory impairment due to trauma, tumor, or cancer

Keywords: mandibular canal paresthesia dental implants survival analysis inferior alveolar nerve lateralization
setmelanotide in pediatric participants with rare genetic diseases of obesity

Conditions: Bardet-Biedl Syndrome; POMC Deficiency Obesity; PCSK1 Deficiency Obesity; LEPR Deficiency Obesity

Summary: this is a phase 3 open-label, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric participants aged 2 to \<6 years with obesity due to either biallelic variants of the pro-opiomelanocortin (pomc), proprotein convertase subtilisin/kexin type 1 (pcsk1) or leptin receptor (lepr) genes or bardet-biedl syndrome (bbs).

pediatric participants aged 2 to \<6 years with obesity due to either biallelic variants of the pomc, pcsk1 or lepr genes or bbs will be enrolled into this phase 3 open-label clinical trial at one of approximately 8 clinical centers in north america, europe, or australia. all participants will be assigned to receive setmelanotide via daily subcutaneous (sc) injection for 1 year.

Eligibility criteria:
key inclusion criteria: 1. participants must have obesity due to either: 1. pomc, pcsk1, or lepr deficiency, confirmed by genetic testing demonstrating biallelic variants that are interpreted as pathogenic, likely pathogenic, or of undetermined significance (vus) by the american college of medical genetics and genomics criteria (acmg), or 2. bbs confirmed clinical and genetic diagnosis 2. age between 2 to \<6 years at the time of informed consent 3. obesity, defined as body mass index (bmi) ≥97th percentile for age and gender and body weight of at least 15 kilograms (kg) at the time of enrollment. 4. symptoms or behaviors of hyperphagia 5. parent or guardian of study participant is able to understand and comply with the requirements of the study (including qd injection regimen and all other study procedures) and is able to understand and sign the written consent/assent. key exclusion criteria 1. glycated hemoglobin (hba1c) \>9.0% at screening 2. history of significant liver disease 3. glomerular filtration rate (gfr) \<60 milliliter per minute per 1.73 meter square (ml/min/1.73 m\^2) 4. history or close family history of melanoma, or participant history of oculocutaneous albinism. 5. significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion) 6. participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing. 7. previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide. 8. significant hypersensitivity to any excipient in the study drug. 9. inadequate hepatic function 10. any other uncontrolled endocrine, metabolic or medical condition(s) known to impact body weight other protocol defined inclusion/exclusion criteria may apply.

Keywords: bardet biedl syndrome pomc deficiency pcsk1 lepr obesity pediatric obesity
a network intervention for reducing sexual risk for hiv with african american men who have sex with men (aa msm)

Conditions: HIV Infections

Summary: the purpose of the study is to examine the efficacy of a network-oriented "outreach intervention" to reduce hiv and sexually transmitted infection (sti) related risk behaviors among african american men who have sex with men (aa msm)and their social network. the hypothesis is to determine whether the new intervention is more efficacious at reducing high risk sexual behaviors than the standard normal of care provided to the public (a single session of individual hiv counseling and testing.

the intervention increases participants' personal level of knowledge and skills concerning hiv prevention and inspires participants to diffuse the information to their social network.

Eligibility criteria:
inclusion criteria: * identify as a black / african american male * report sex with at least 2 people in past 3 months/ 1 being male * willingness to take hiv test or provide documentation if hiv+ * willingness to identify and recruit friend/relative to study exclusion criteria: * under age 18 * identify as female or transgender * not identify as black / african american

Keywords: hiv prevention men who have sex with men african american unprotected sex hiv seronegativity