Kornimate/medical-research-clean huggingface dataset:
the physiologic effect of the flow generated by high flow nasal cannula in mild respiratory failure

Conditions: Respiratory Failure

Summary: high flow nasal cannula (hfnc) oxygen therapy is increasingly used for hypoxemic respiratory failure and is proving useful in avoiding or delaying intubation and mechanical ventilation. however, basic information regarding the physiologic effects of this method is missing. in this study, the effects of oxygen delivery by hfnc on oxygenation, ventilation and cardiovascular vital signs in patients with mild hypoxemic respiratory failure were evaluated.

oxygen (o2) therapy delivered by means of high flow nasal cannula (hfnc) is being increasingly used. this device, capable of delivering high flow, oxygen enriched gas, has been shown to reduce intubation rates in patients with hypoxemic respiratory failure. the primary components of hfnc are "nasal prongs" (or cannulae) that are inserted into the nostrils, a device which provides a warmed and humidified air / oxygen mixture and regulators that control oxygen concentration, temperature and total gas flow. commercially available systems can deliver up to 40 - 60 liters per minute (lpm) of oxygen flow. this method of non-invasive oxygen delivery has several presumed important working principals. firstly, the high flow rate may meet the patient's own inspiratory flow rate. this enables accurate delivery of a high fractional inspired concentration of oxygen (fio2). second, the high gas flow might also produce a certain degree of continuous positive airway pressure (cpap). in addition, the heated and humidified gas might also wash out/reduce the physiological airway dead space of the patient. furthermore, hfnc is more comfortable and might be better tolerated than other non-invasive ventilation (niv) devices, such as bi-level positive airway pressure (bipap). this, in turn, can prolong the time the patient is comfortably connected to the hfnc device. information regarding the basic physiologic influence of hfnc on oxygenation, ventilation and vital signs is missing in the literature. patients with mild respiratory failure provide an opportunity to examine this topic. on one hand, these patients suffer from respiratory failure manifested by hypoxemia, on the other hand the respiratory failure is mild to the extent that removal of the conventional oxygen therapy (cot) will not lead to immediate respiratory collapse. this prospective study evaluates the physiologic effects of hfnc in 28 patients with mild respiratory failure.

Eligibility criteria:
inclusion criteria: * minimal age 18 * the patient had invasive blood pressure monitoring via an arterial line in situ * the patient had a mild respiratory failure manifested by the need for oxygen support via nasal prongs in order to maintain oxygen saturation (spo2) above 90% for at least one hour prior to the start of the intervention exclusion criteria: * shortness of breath * patients regularly using o2 at home * no patient consent for participation

Keywords: high flow nasal cannula oxygenation ventilation conventional oxygen therapy arterial blood gasses
the application value of 68ga-grazytracer pet in immunotherapy for stage iii non-small-cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung; PET / CT; Neoadjuvant Immunotherapy

Summary: neoadjuvant immunotherapy can significantly improve the pathological complete response (pcr) and major pathological response (mpr) rates in resectable stage iii non-small cell lung cancer (nsclc), and extend the event-free survival (efs). however, the current means for evaluating its efficacy are limited. this study aims to utilize the convenient and non-invasive 68ga-grazytracer pet imaging to detect the aggregation of cd8+ t cells in target lesions after neoadjuvant immunotherapy for stage iii nsclc, and to assess its value in efficacy monitoring, providing valuable information for clinical treatment decisions.


Eligibility criteria:
inclusion criteria: 1. patients with stage iii nsclc, after assessment according to clinical guidelines, require neoadjuvant immunotherapy; 2. fully-informed written consent obtained from patients; 3. patient ability to comply with protocol requirements; 4. age 18-75 years; 5. life expectancy of at least 6 months. exclusion criteria: 1. patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc; 2. intestinal perforation, complete intestinal obstruction; 3. patients with uncontrolled diabetes mellitus or a fasting blood glucose value of ≥11 mmol/l on the day of the test; 4. pregnant women and women who are potentially pregnant, as well as nursing mothers; 5. patients with poor compliance.
reliability, validity of the turkish version of craniofacial pain and disability inventory

Conditions: Temporomandibular Joint Disorders

Summary: this study, we are aim to make the turkish version validity and reliability of the cranifacial pain and disability inventory, jaw functional limitation scale-20, and jaw functional limitation scale-8.

approximately 60% of individuals with temporomandibular disorders (tmd) reported increased pain intensity from midlevel to severe. this was seen at the end of the intervention or work related activities in the quarter of individuals. therefore, the correct diagnosis of tmd is very important to reduce the economic cost. craniofacial pain and disability inventory (cf-pdi) is designed based on a biopsychosocial approach. evidence has shown that cf-pdi is an well-structured, internal consistency, repeatable and valid, and that an objective outcome for the evaluation of pain and discomfort in patients with craniofacial pain. there is no turkish version and validity study of cf-pdi. each item is scored between 0-3. the total score ranged from 0 to 63, and a high score indicate a high level of discomfort. the aim of this study was to evaluate the validity and reliability of the turkish version of cf-pdi. the study of validity and reliability is planned with 105 individuals with tmd. the sociodemographic characteristics of the individuals will be questioned by the investigators and then the patients will be evaluated with cf-pdi, neck disability index (ndi), tampa scale for kinesiophobia (tsk), pain catastrophizing scale (pcs), headache impact test-6 (hit-6), jaw functional limitation scale (jfls) (turkish version) and visual analogue scale (vas). the test-retest will be re-administered by face-to-face interview technique after 1 week. the results will be analyzed using the spss version 22.0 computer package program.

Eligibility criteria:
inclusion criteria: * having a temporomandibular disorder * individuals who suited temporomandibular disorders/ research diagnostic criteria classification exclusion criteria: * pregnant, * canser, * trauma, * neurologic disorder, * infection, * trigeminal or postherpatic neuralgia

Keywords: validity reliability temporomandibular joint disorders
secondary care - continuous glucose monitoring

Conditions: Diabetes Mellitus, Type 2

Summary: introduction and objective: the current state of glucose monitoring includes the use of a1c, self-monitoring of blood glucose (smbg), and continuous glucose monitoring (cgm). cgm technology has got the potential to revolutionize diabetes care in the near future striving to optimal diabetes management and tight glucose control. until very recently, this determination could only be achieved by the attainment of multiple capillary blood glucose determinations each day and/or measuring hemoglobin a1c. those methods are not accurate in cases of unrecognized hypoglycemia, unrecognized nighttime events or in cases of large swings in blood glucose. our aim is to analyze the benefit of tracking patterns of glucose values by using professional cgm technology used for "blinded" collection of glucose data retrospectively in patients with t2dm in secondary care- diabetologist clinic.

study design: an observational, multicenter, cross-sectional study. a total of 20 diabetologist from four croatian regions will recruit up to ten subjects of both sexes from may 2018 till the end of may 2019, diagnosed with type 2 diabetes mellitus at least one year prior to study entry, aged ≥40 years, with only basal insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycaemia and hemoglobin a1c findings. sociodemographic, laboratory (hba1c, fasting and postprandial glucose, total cholesterol, and high density cholesterol, and low density cholesterol, triglyceride and serum creatinine) and habits data will be collected. setting: totally 100 of patients will be included. at diabetologist office each patient wear the device (ipro™2 medtronic) subcutaneously for up to 7-days and return it to the office for download. patients only see the cgm data after it's been analyzed by the healthcare professional. a cgm device is to be set and take off by the diabetologist. before the study start all diabetologist who are not familiar to the method will have a short education. study period is seven days and includes screening before study entry and two visits. on day 1, after screening and signing the informed consent, the cgm device is applied. patient is instructed to keep a 7 day diary with four daily standard smbg along with the data on eating, physical exercise, drugs. on day 7, cgm device is taken off and the data from ipro2 is uploaded to pc. at the end, each patient fills a short query on satisfaction while wearing cgm.

Eligibility criteria:
inclusion criteria: * t2dm diagnosed at least one year prior to study entry * only basal insulin in therapy * patients' ability to understand and answer the questionnaire by themselves * signed informed consent exclusion criteria: * known coagulopathy * oral anticoagulants in therapy * skin disease that enables continuous glucose monitor device application * febrile illness * patient's inability to physically visit a general practitioners office * patient's inability to answer the questionnaire by themselves

Keywords: continuous glucose monitoring glycemic variability hypoglycemia
the study to evaluate efficacy and safety of imotun capsule in osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to evaluate efficacy and safety of imotun capsule in osteoarthritis of the knee

this is a six-month, multicenter, randomized, double blind, parallel-group,placebo controlled study. patients take imotun capsules or placebo once a day, between the meals. patients are allowed to take study drugs during the meal in the case of intolerant reflux of oil smell from gi. if patients do not tolerate the pain, they are able to take celecoxib as a rescue medication during 6 months.

Eligibility criteria:
inclusion criteria: * female and male patients who aged 40 or more and agreement with written informed consent * patients with osteoarthritis according to acr criteria lasted for the past 3 months or more * patients with kellgren \& lawrence grade ⅱ\~ⅲ on radiographs * patients with 40mm or higher 100mm pain vas on screening and baseline visit (based on more painful knee) * patients with lequesne's index 5 or more on screening and baseline visit exclusion criteria: * patients who had taken sysadoa within the past 3 months (imotun, diacerein, s-adenosyl-methionone, joins, glucosamine, chondroitin and any other cartilage protective agents determined by investigator) * patients who experienced cartilage surgery within the past 5 years or arthroscope surgery within a year(one side or both) * patients who were treated with joint space injection within the past 3 months * patients who had taken nsaids including pain killers within 7 days (except, it is acceptable to enroll the study if the patients have wash out periods at least 7 days before randomization) * patients with hypersensitivity or allergy to the study or rescue medicine or those who have medical history. * patients with severe liver, kidney or cardiac diseases who are not acceptable for the study determined by investigator * patients with active peptic ulcer or gi bleeding. * pregnancy, nursing women or women of reproductive age who do not agree to the contraception. * patients with abuse of alcohol, illegal drugs or drug dependency * patients who were treated with another investigational product within the past 4 weeks * all other patients who are not acceptable for the study determined by investigator

Keywords: osteoarthritis of the knee
the impact of mobile technology on clinical outcomes in children and adolescents with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to determine whether a simple text message reminder sent to the parent of an child/adolescent with type 1 diabetes(or parent and adolescent) is effective in helping the individual(or parent) become more compliant with self-managing the type 1 diabetes (t1d). there will be 5 arms: text message sent to parents of children age 8-12 years old with t1d, text messages sent to parents of adolescents ,age 13-18 years old, with t1d,text messages sent to parents of adolescents with t1d as well as the adolescent with t1d,no text message sent to parents of children age 8-12 years, and no text message sent to adolescents or parents of adolescents age 13-18 years old.

managing type 1 diabetes requires daily checks of blood glucose and medication adjustments. children and adolescents are known to have more difficulty with this than adults. parents/legal guardians also face the task of helping with this self-management. a weekly text message regarding type 1 diabetes, sent to the parent or the parent and adolescent, may help to remind and motivate an individual to perform the daily tasks needed to manage their type 1 diabetes.

Eligibility criteria:
inclusion criteria: 1. be willing to agree to participate(assent) in the study and have the permission of the parent to do so. 2. have a diagnosis of type 1 diabetes for ≥ one year. 3. be aged 8 to 18 years old. 4. be on insulin therapy for ≥ one year. 5. have a parent/legal guardian with access to a working cell phone or have a parent/legal guardian with access to a working cell phone and have a working cell phone (if 13 years of age or older). 6. utilize one of the following mobile carriers: t-mobile, sprint, verizon, at\&t, or virgin mobile. 7. the parent/legal guardian must express intent to maintain a carrier plan for the duration of the study. 8. the parent/legal guardian must be able to read english or the parent/legal guardian and the adolescent must be able to read english. exclusion criteria: 1. participants, who in the opinion of the investigator, have any contraindication to tight glycemic control. 2. individuals who are unable to undertake blood glucose testing during the study period 3. individuals who are deemed unable or unlikely to comply with the protocol.
a study to evaluate the integrated dose counter on an albuterol hydrofluoroalkane (hfa) metered dose inhaler (mdi)

Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Chronic Bronchitis

Summary: this study is evaluating the effectiveness of a dose counter for an inhaler device used to deliver medication to people diagnosed with asthma or copd.


Eligibility criteria:
inclusion criteria: * written informed consent/assent * general good health * asthma or copd * capable of understanding the requirements, risks, and benefits of study participation. * able to demonstrate proper metered-dose inhaler use and technique. * other inclusion criteria apply exclusion criteria: * history of life-threatening asthma or copd that is defined for this protocol as an asthma or copd episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures. * culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of screening visit. * is being treated with a long-acting β2-agonist alone. * is currently being treated with ventolin hfa. * any asthma or copd exacerbation requiring oral corticosteroids within 2 months of screening visit. a subject must not have had any hospitalization for asthma or copd within 4 months prior to screening visit. * historical or current evidence of a clinically significant non-asthmatic acute or chronic condition. * uncontrolled hypertension * history of any adverse reaction to any component of the hfa-mdi formulation. * participation in any investigational drug study within the 30 days preceding the screening visit. * other exclusion criteria apply.
effect of oral preparation on bacterial colonization of the pharyngeal mucosa in surgery of head and neck cancer

Conditions: Bacterial Infection

Summary: surgical site infections are an important health indicator for hospitals and a significant medico-economic issue. the aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa.

the main objective is to reduce the number of patients with significant pathogenic bacterial colonization for pharyngeal mucosa at the end of the surgery. oral flora is the same as the pharyngeal flora, so this suggests that the action of the oral mouthwash may also act in pharyngeal mucosa by buccopharyngeal communication. patients will be randomized into two groups : * preoperative oral preparation with sodium chloride (nacl) 0.9% (control group) * preoperative oral preparation with chlorhexidine (experimental group) a quantitative and qualitative analysis will be performed from samples collected during the surgery : before mouthwash (t0), after mouthwash (t1), before intubation in the operating room (t2), after intubation (t3), before incision (t4) and just before the end of the intervention on the mucosal scar (t5)

Eligibility criteria:
inclusion criteria: * histological evidence of cancer regardless of histological type * surgical treatment requiring mucosal effraction regardless of the surgical approach; * patient over 18 years old; * oral cancer, oropharyngeal cancer, hypopharyngeal cancer or laryngeal cancer; * written and informed patient consent exclusion criteria: * concomitant vascular interventions; * interventional radiology; * needing of second surgery at a same location during the 30 postoperative days); * cancer of the paranasal sinus, nasal cavity, skull base, salivary glands, skin, * neck dissection without mucosal effraction * thyroid or parathyroid surgery * size tumor forbidden tumor surgery * allergy to any tested product; * concurrent infection the day before or day of surgery * protected adults (guardianship) and persons deprived of liberty

Keywords: mouthwash head and neck cancer chlorhexidine pathogens germs
identification of predictive markers for testis cancer in a population of men with high risk

Conditions: Testicular Cancer

Summary: testis cancer with germ cells is the most frequent cancer of young men and its incidence is in constant increase in many industrialized countries, as in france. an increased risk of developing testis cancer has been described in patients with testicular ectopia history and testicular cancer history (controlateral testicular cancer) and more recently suggested in a population of hypofertile men with altered spermatogenesis. to a better understanding of this risk, an attempt of characterization of this group of patients has been proposed in the present work. the general objective of this project is to characterize morphological and molecular markers of hypofertility which could serve as predictive markers of testis malignant transformation. in this project conducted in 3 establishments, the investigators propose: * to select a population of hypofertile patients exhibiting compatible clinical and morphological characters with a high risk of testis tumoral transformation (secretory azoospermia and/or a history of testicular ectopia. to determine the spermatogenic arrests on histological criteria (score of jonhsen). * to study the expression of four proteins or family of proteins suspected of being involved in testis tumorogenesis such as: the placenta alkaline phosphatase (plape), cyclin a1, vasa and connexin (cx) by immunohistochemistry and by real-time quantitative rt-pcr analysis real-time analyses. * to establish a possible correlation between the clinical data, spermatogenesis arrest and the expression of these biomarkers. these approaches would allow to identify, in this population of hypofertile patients, subgroups of men who could develop tumours with germ cells, and subsequently to propose potential biomarkers for testis cancer. a more clinical observation of these subgroups will be also proposed.


Eligibility criteria:
inclusion criteria: * patients with infertility azoospermia * age 18 to 35 years * definition of clinical and biological character of azoospermia: testicular volume less than 10 ml and fsh more than 10 iu / l * normal karyotype * surgical exploration included in a standardized medical aid to procreation * testicular biopsy performed by traditional surgery * patient informed about the research protocol and having signed consent to conduct a further testicular biopsy included in this study. exclusion criteria: * adults protected by law, minors * individuals who are not affiliated to a social security * subjects hospitalized for any reason other than research. * patients will be used to support reproductive techniques: * positive serology (hiv, hepatitis ...). * patients with karyotype anomalies and unfavourable genetic counselling

Keywords: testicular cancer incidence young men
a novel serological risk model for early non-invasive diagnosis of cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: this is a prospective, observational and exploratory clinical study. the object of this study is to evaluate the accuracy of a novel serological risk model on blood samples in early diagnosis of cholangiocarcinoma patients.

a reliable and accurate preoperative tool capable of early diagnosing malignant cholangiocarcinoma is lacking and urgently needed for clinical practice. this study proposes to establish and evaluate a novel serological risk model on blood samples for non-invasively diagnosing cholangiocarcinoma. the study includes the construction of capable novel serological risk model and the validation of the diagnosis model.

Eligibility criteria:
inclusion criteria: * 1. the patient must sign an informed consent form; * 2. age 18-75 years old, both male and female; * 3. ecog performance status score (ps score) 0-2; * 4. cholangiocarcinoma with resectable tumor lesions; * 5. complete the blood collection before treatment; exclusion criteria: * 1. accompanied with other primary malignant tumors; * 2. patients who have neoadjuvant chemotherapy or other tumor-targeted therapies; * 3. incomplete serological examinations or medical history data.

Keywords: hilar cholangiocarcinoma intrahepatic cholangiocarcinoma extrahepatic cholangiocarcinoma early diagnosis non-invasive diagnosis serological prognosis chemotherapeutic benefits