Kornimate/medical-research-clean huggingface dataset:
kinetic oscillation stimulation (kos) of nasal mucosa in non-allergic rhinitis: investigation of treatment procedure

Conditions: Non-allergic Rhinitis.

Summary: the purpose of the study is to evaluate how treatment with kinetic oscillation stimulation (kos) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize any patient reported discomfort during treatment procedure.


Eligibility criteria:
inclusion criteria: * patients with persistent (\>12w) symptoms of idiopathic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days * having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3) * male or female 18 - 65 years * judged by the investigator as suitable for participation in the study without safety concerns based on medical history and physical examination * willing and able to provide written informed consent prior to participation in the clinical investigation * willing and able to comply with all study related procedure exclusion criteria: * patients with allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or rast(radioallergosorbent test) * ongoing respiratory tract infection including nasal cavity at inclusion (treatment visit 1) * systemic steroid treatment less than 4 weeks before the inclusion in the study * patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture * history of frequent nose bleeds or a condition that increases the risk of excessive bleeding * pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination * current malignancy of any kind * known allergy to polyvinylchloride or medicinal liquid paraffin * any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk * any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region * previous treated with radiation on the face, head or neck regions * female patients who are pregnant or nursing, or become pregnant at any time from first visit at ent(ear, nose and throat) - clinic until treatment day (second visit) * female patients: unwilling to use adequate contraceptive between first and last visit * received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer
endoscopic injection of dextranomer/hyaluronic acid versus ureteral reimplantation in treatment of vesicoureteral reflux

Conditions: Vesico-Ureteral Reflux

Summary: in this study, the investigators aim to compare the outcomes of dextranomer/hyaluronic acid (dexell®) and extravesical reimplantation (lich- gregoir) procedures for primary vesicoureteral reflux (vur) grades iii and iv in children.

a total of 60 patients with 93 renal unites were prospectively enrolled in a comparative intervention study. patients were randomly allocated by simple randomization at a 1: 1 ratio into 2 groups, where dextranomer/hyaluronic acid (dexell) injection was used in group a (30 patients with 45 renal units) and lich-gregoir in group b (30 patients with 48 renal units). children over 1 year with primary vur grade iii \& iv based on recent vcug included in the study. this study and method of attaining consent were approved by clinical research and ethical committee of our department. written consents were taken from patients' guardians involved in the study. the investigators offered all of patients with symptomatic vur entry into a prospective protocol between june 2015 and february 2018 at the urology department, al hussein university hospital, al-azhar university. surgical technique: 1. dextranomer/hyaluronic acid injection: the endoscopic procedure was done under general anesthesia, and all patients received antibiotic prophylaxis. the investigators used the subureteral injection technique (sting), as described by o'donnell and puri . the volume of dextranomer/hyaluronic acid was injected until ureteral orifice collapse in all patients. the needle was held for 30 s. 2. ureteral reimplantation (lich-gregoir): the juxtavesical ureter is dissected and a submucosal groove is created extending laterally from the ureteral hiatus along the course of the ureter. the ureter is placed in the groove and the detrusor is closed over the ureter with ureteric stent fixation for 21 days. urethral catheter for bladder drainage for 3-5 days. postoperative care all children were maintained on prophylaxis until resolution of reflux documented on the vcug. patients were assessed by general examination, serial urinalysis and urine c.s. renal ultrasound at 1,3 months and at 1 year after the procedure and a vcug at 3-6 months. mru at 1 year. dmsa scintigraphy were done at 6 months after the procedure. the investigators analyzed the outcome in these 2 surgical groups in terms of success rate at short-term follow-up, contralateral reflux, de novo hydronephrosis, urinary tract infections and complications. the investigators considered that a patient was cured from reflux when there was no vur on vcug.

Eligibility criteria:
inclusion criteria: • children over one year with primary vesico-ureteral reflux grade iii and iv. exclusion criteria: * secondary vesico-ureteral reflux. * active urinary tract infection * untreated voiding dysfunction.

Keywords: extravesical reimplantation subureteral injection vesico-ureteral reflux endoscopic dexell
barotrauma in adults with critical covid-19

Conditions: COVID-19; Barotrauma

Summary: during the pandemic of covid-19, studies reporting a high incidence of barotrauma, both pneumothorax but also pneumomediastinum, in patients with critical covid-19. if this is complications of the respiratory support used to treat patients hypoxemia or if it is a direct consequence of covid-19 damaging the lung tissue is not known. the aim of this study is to investigate the incidence and type barotrauma, if there is an association between barotrauma and level of respiratory support used in the intensive care unit, and if barotrauma is associated with worse outcome compared to patients without barotrauma.


Eligibility criteria:
inclusion criteria: * positive polymerase chain reaction for sars-cov-2 * admitted to icu due to respiratory failure exclusion criteria: * transferred to or from an icu in other hospital/region making data collection regarding baseline data/outcomes not possible
clinical profiles and outcomes of acute aortic dissection in the chinese patients

Conditions: Aorta Thoracic Ascending Dissection; Dissection of Descending Aorta

Summary: clinical profiles and outcomes of patients with acute aortic dissection have not yet been evaluated in china. the aim of this study is to establish clinical registry of acute aortic dissection in china and to analyze clinical features, managements and outcomes of chinese patients with acute aortic dissection.

in 1996, the internation registry of acute aortic dissection(irad) was established to improve clinical diagnosis and treatment of acute aortic dissection. however, most patients from the irad are caucasian. these data were not sufficient to reflect clinical profiles and outcomes of chinese patients with acute aortic dissection. in china, little is known about clinical features, managements and outcomes of acute aortic dissection involving a large number of patients. the investigators established clinical multicenter registry of acute aortic dissection. between january 2009 and february 2012, about 2000 were enrolled in the chinese registry of acute aortic dissection(crad) database. the aim of this study is to analyze clinical profiles and outcomes of chinese patients with acute aortic dissection.

Eligibility criteria:
inclusion criteria: * stanford type a dissection * stanford type b dissection * retrograde stanford type b dissection * unclassified dissection with primary tear located in the aortic dissection exclusion criteria: * aortic aneurysm * active infection or active vasculitides * myocardial infarction or cerebral accident within 2 months * unwillingness to cooperate wiht study procedures or follow-up visits

Keywords: aortic dissection risk factor feature management outcome
a first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of hm12470

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to investigate safety, tolerability, pharmacokinetics (pk) ad pharmacodynamics (pd) of hm12470 after single injection in t1dm and t2dm patients.

this study is designed to evaluate safety, tolerability, pk and pd of hm12470 after single administration in subjects with t1dm and t2dm. in some cohorts for this study, the safety, tolerability, pk and pd of hm12470 will be compared with that of commercially available insulin.

Eligibility criteria:
inclusion criteria for t1dm: * t2dm more than 12 monthm * age ≥18 and ≤70 years * body mass index between 18.0 and 35.0 kg/m2 inclusive. * considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator. * females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug. * signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject). inclusion criteria for t2dm: * t1dm more than 12 monthm * age ≥18 and ≤70 years * body mass index between 18.0 and 30.0 kg/m2 inclusive. * considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator. * females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug. * signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject). exclusion criteria * a subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator * recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis * pregnant or lactating women * participation in an investigational study within 30 days prior to dosing * clinically significant abnormal ecg at screening, as judged by the investigator
neuroendocrine mechanisms of developmental massage therapy (dmt) in preterm infants: clinical study

Conditions: Premature Birth of Newborn

Summary: the purpose of this study is to see if daily massage therapy will help premature infants respond to stress better, as well as improve their growth and neurobehavioral development.

optimal postnatal growth and development is essential for the survival and long-term health of infants born premature, however, growth and developmental delays are common. many factors contribute to poor postnatal growth and development including immature organ systems, stress due to illness and even routine care in the neonatal intensive care unit environment. massage therapy is associated with decreased cortisol levels during stress in a variety of populations including premature infants. massage has also been reported to improve postnatal weight gain in premature infants. concerns about methodological quality, however, weaken the credibility of previous studies and prevent the integration of massage therapy into conventional medical practice. therefore, we plan to study the interrelationship of the ans and hpa axis in preterm infants to assess how developmental massage therapy (dmt) modulates physiologic stability and promotes postnatal growth by the following specific aims: specific aim 1: we will determine ans balance, measured by heart period variability, before, during, and after dmt. specific aim 2: we will compare the relationships between ans balance and hpa response before and after dmt. specific aim 3: we will evaluate somatotrophic response in premature infants who receive dmt. infants will be stratified by gender and randomized to receive developmental massage therapy or sham control. this study will also allow for post-discharge assessment of development. infants will return to the hospital at term, 3months and 6 months for multiple measurements and developmental testing.

Eligibility criteria:
inclusion criteria: * premature infants born between 29 4/7 and 32 3/7 weeks gestation by physical exam at birth, and with birth weight, length and head circumference between the 5th and 95th percentiles for gestational age. exclusion criteria: * intrauterine growth less than the 5th or greater than the 95th percentiles for gestational age, congenital anomalies, complex cardiac defects, severe cns injury, hypothyroidism, inborn errors of metabolism, or inability to establish full enteral feeds by day of life 14.

Keywords: infant premature message therapy nicu neonatal intensive care unit cortisol level stress postnatal weight gain dmt development message therapy growth
study to evaluate pharmacokinetic and bioavailability of envarsus® vs. advagraf® in liver transplant recipients

Conditions: Liver Transplantation

Summary: single centre, open-label, randomized, controlled, cross over study to evaluate the pharmacokinetic and bioavailability of envarsus® in comparison to advagraf® in de novo liver transplant recipients

using an open-label, randomized, controlled, 2-period cross-over design, two treatments (envarsus® and advagraf®) will be compared (with regard to pk profile and bioavailability) after administration of imp to 20 de novo transplanted recipients. the patients will be randomly assigned to one of the two treatments as treatment period 1 and afterwards switched to treatment period 2 (group 1: envarsus® - advagraf®; group 2: advagraf® - envarsus®).

Eligibility criteria:
inclusion criteria: 1. ability to understand the patient information and to personally sign and date the informed consent to participate in the clinical trial, before completing any clinical trial related procedures. 2. male or female recipients ≥ 18 years of a liver graft from a deceased or living donor 3. the patient must receive a twice daily tacrolimus based immunosuppression treatment. 4. females of child-bearing potential who agree to comply with any applicable contraceptive requirements of the protocol or females who are permanently sterilized (at least 6 weeks post sterilization). 5. non-pregnant, non-lactating female. 6. recipients of a first or re-liver transplant in the last 30 days 7. the patient is co-operative and available for the entire clinical trial. exclusion criteria: 1. patients with a known hypersensitivity to any of the drugs used in the study. 2. patients who are not able to take oral medication at the time point of randomization. 3. recipients of combined organ transplants. 4. patients who are recipients of ab0 incompatible transplant grafts. 5. currently participation in a clinical trial and any imp intake within the last four weeks. 6. patients who use drugs known to strongly interact with the cytochrome p-450 3a4 pathway and therefore influence the tacrolimus blood level are not allowed during envarsus®/advagraf® treatment period. 7. patient with renal impairment with need of dialysis treatment at the time point of randomization. 8. patient with a quick value \< 30 % 9. patient with a thrombocytopenia \<20 mrd./l 10. patients with a leukopenia \< 1.0 mrd. / l 11. patients with inability of oral food intake.

Keywords: pharmacokinetic study comparing envarsus versus advagraf
exercise therapy in cancer patients who are recovering from covid-19

Conditions: Covid19; Coronavirus; Cancer

Summary: the purpose of the study is to evaluate the safety and tolerability of a 30-week aerobic exercise therapy program in cancer patients recovering from covid-19. the study will look at whether the aerobic exercise therapy causes few or mild side effects in participants. aerobic exercise is physical activity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for several minutes at a time. the aerobic exercise therapy being used in this study will be a walking program that will be adjusted so it matches participant fitness levels (how much exercise you can handle).


Eligibility criteria:
inclusion criteria: * age ≥ 18 * previously admitted to a hospital for covid-19 * discharged from hospital for at least 30 days * previously treated for cancer at msk * interval of ≥ 12 months but ≤ 10 years following completion of primary non-hormonal anti-cancer therapy (current endocrine therapy and maintenance therapy allowed) * space to house a treadmill at personal residence * cleared for exercise participation as per screening clearance via the physical activity readiness questionnaire (par-q+) * performing less than 90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self-report * if a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study. * women \<50 years old who are of child-bearing potential must have a negative pregnancy test within 14 days of enrollment. exclusion criteria: * currently receiving home oxygen after discharge * enrollment onto any other interventional investigational study * current treatment for any other diagnosis of invasive cancer of any kind * distant metastatic malignancy of any kind * receiving non-hormonal anticancer therapy * any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Keywords: covid19 coronavirus cancer exercise 21-101 memorial sloan kettering cancer center
continuous supraglottic ph monitoring in prolonged intubated intensive care patients and high risk aspiration intraoperative patients

Conditions: Aspiration, Respiratory

Summary: this is a pilot prospective cohort study of the incidence of supraglottic ph readings.

aspiration is a serious morbidity that leads to an increase in both patient mortality and duration of hospital stays. many practices exist within the hospital setting whose goal is to help prevent clinically significant aspiration including preoperative starvation, pharmaceutically reducing gastric acidity, facilitating gastric drainage, postural changes, cricoid pressure, endotracheal cuff pressure modification, and maintenance of a competent lower esophageal sphincter. however, to date, no monitoring system exists to help a clinician identify active aspiration. at present, video fluoroscopy, is the gold standard for detecting aspiration. this pilot prospective cohort study will examine the incidence of supraglottic ph readings. a continuous ph/impedence sensor will be placed immediately above the glottic opening in four high risk populations: burn patients who are intubated, intubated post-stroke patients, patients undergoing robotic prostectomy, and in patients undergoing peritoneal tumor debulking and chemotherapy. the presence of acidic fluid above the glottic opening will be measured using a supraglottic impendence/ph probe attached to an endotracheal tube.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo robotic prostatectomy. * patients undergoing peritoneal tumor debulking and chemotherapy * mechanically ventilated burn intensive care unit (bicu) patients * mechanically ventilated neuro care unit (ncu) patients who have suffered a stroke exclusion criteria: * icu patients who are not receiving enteral feeds * patients who present for tumor debulking or robotic prostatectomy who receive preoperative h2 blockers, proton pump inhibitors, antacids or metoclopramide.

Keywords: supraglottic ph
effectiveness of various electrotherapy methods in treating people with cervical spine pain syndrome.

Conditions: Cervical Spine Syndrome

Summary: volunteers will take part in the study; students of the university in the area of rzeszow reporting chronic spinal ailments participation in remote learning. applicant participants will be randomised into 3 groups of subjected to various electrotherapy procedures.

study participants will be tested: 1. before a series of electrotherapy treatments. 2. 7 to 10 days after the end of electrotherapy. 3. 3 months after the end of electrotherapy. the study will use 1. a self-authored survey taking into account: basic personal data (age, gender, value and bmi, lifestyle and degree of load on the cervical spine), information on the nature, intensity and frequency of the presence of pain in the spine cervical system, taking into account possible adverse reactions 2. a questionnaire for subcjective assessment of the state of the spine neck disability index, 3. measuring the tone of the vertebral muscles in the cervical (myotonometer), 4. a visual analog scale used to assess the severity of symptoms (visual analog scale -vas) intervention; 1. irradiation of the neck area with a sollux lamp with a blue filter 2. individual exercises conducted according to the prepared author's mobility improvement program 3. electrotherapy treatments: * trabert currents * tens currents (conventional) * tens currents (pseudo-acupuncture)

Eligibility criteria:
inclusion criteria: * informed written consent of the patient to participate in the study * no contraindications to electrotherapy in the area of the cervical spine; exclusion criteria: * poor tolerance of electrotherapy treatments; * breaks between consecutive treatments longer than 3 days; * failure to complete a series of kinesiotherapy and electrotherapy treatments; * use of any stimulants during the observation period.

Keywords: cervical spine pain syndrome electrotherapy tens träbert ultrastimulation