Kornimate/medical-research-clean huggingface dataset:
study of subcutaneous injection of low-dose rhgm-csf +/- wll in pap.

Conditions: Pulmonary Alveolar Proteinosis

Summary: the purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhgm-csf, or of similar injection after whole lung lavage , in patients with pap.

the purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhgm-csf, or of similar injection after whole lung lavage , in patients with pap. during the observation, study visits will occur at the end of each month. during the 1-year follow-up period which is lasting 6 months after the treatment, all participants will be required to check the various efficacy indicators.

Eligibility criteria:
inclusion criteria: * diagnosed pap patients * aged 17-80 * signed informed consent exclusion criteria: * secondary pap * received whole lung lavage therapy within 4 weeks before enrollment * received previous gm-csf therapy within 6 months before enrollment * wbc≥12,000/ul * fever≥38℃ * severe edema, severe liver, kidney, lung and cardiovascular disease. * pregnant，planning to get pregnant or nursing * inability to express the subjective discomfort * serious drug allergy history, e.coli preparation or rhgm-csf serious allergy history

Keywords: pulmonary pulmonary alveolar proteinosis pap
the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia

Conditions: Remimazolam; Spinal Anesthesia

Summary: the goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.

sedation during spinal anesthesia can reduce the patient's anxiety and increase satisfaction, but sedatives such as dexmedetomidine and midazolam may cause hemodynamic instability such as hypotension and bradycardia. in previous studies , hypotension occurred in about 33% and bradycardia in about 13% during spinal anesthesia, which is related to reduced cardiac output due to sympathetic blockade and relative activation of the parasympathetic nerve. in the study comparing remimazolam and dexmedetomidine in patients with delirium after orthopedic surgery, the incidence of hypotension was lower in the remimazolam group (10.8%) than in the dexmedetomidine group (39.5%) (p=0.007) and there was no significant difference between the remimazolam group (2.7%) and the dexmedetomidine group (13.2%) in the incidence of bradycardia (p=0.200). however, the effect of remimazolam on the incidence of hypotension during spinal anesthesia has not been revealed. therefore, this study is designed to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adults patients.

Eligibility criteria:
inclusion criteria: - patient scheduled for surgery under spinal anesthesia, aged 19-79, of asa class i, ii, or iii exclusion criteria: * patient refusal * contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis) * contraindications or allergy to dexmedetomidine or remimazolam administration * emergency surgery * pregnancy
social workers of elderly care in hungary

Conditions: Stress; COVID-19; Burnout, Professional

Summary: in our research the goal is to examine the level of stress and burnout among social care workers and their causes and effects after covid-19 pandemic. we would like to examine the migration from work trend and its socio-demographic causes in the light of covid-19 pandemic among social care workers in hungary. we would like to analyze the extent of stress and burnout at work after covid-19 pandemic, as well as the resulting turnover intentions in hungary among social care workers. our goal is to validate on hungarian population the turnover intention scale (tis-6), to measure fluctuation and migration.

a number of stress factors have been identified that affect nurses' burnout and job change, but there is little domestic research on the topic among social workers in connection with the covid-19 epidemic. as a result of our research, we expect that higher fear of covid-19 is associated with lower job satisfaction, increased workplace anxiety, burnout, and increased turnover intentions.

Eligibility criteria:
inclusion criteria: * social workers in hungary, who are actively employed, * 18 years of age or older * working in the field of elderly care. exclusion criteria: * people, who do not have an active employment * currently have no job * working online * non-professional staff working in social care (eg. cleaning, maintenance)

Keywords: social workers stress turnover covid-19 burnout hungarian social sector validation of tis
investigation of the clinical performance of biatain fiber ag on venous leg ulcers

Conditions: Venous Leg Ulcer

Summary: the goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study visits, and will have the dressing changed once pr. week at the research facility. the wound will be cleaned, assessed and photos will be uploaded to a digital software system.

: the clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study the test product, biatain fiber ag is a non-ce-marked gelling fiber wound dressing, containing silver. the product is intended for moist wound healing and exudate management of moderate to high exuding wounds. the overall purpose of this investigation is to obtain clinical data supporting effectiveness of biatain fiber ag to obtain the ce-mark in eu. the total study duration for the subject will be approximately four weeks, consisting of a four-week test period and 6 study visits (v0/v1, v2, v3, v4 and v5). v5 will also terminate the 4-week study period. the primary endpoint is mean area wound reduction. the endpoint is used to evaluate clinical performance in terms of relative wound area reduction as an indication of total wound healing.

Eligibility criteria:
inclusion criteria: 1. has signed informed consent 2. is 18 years or above 3. is capable of following study procedure (assessed by the investigator). 4. has a venous leg ulcer that has failed to progress along the expected wound healing trajectory within 4 weeks 5. the shape of the wound should be possible to fit under a 10x10 cm dressing 6. the shape and location of the wound should be suitable for photo capture (assessed by the investigator). 7. has at least three of five pre-defined clinical signs of infection; pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour, or heavy exudate (assessed by the investigator). 8. has a wound that has medium to high level of exudate (assessed by the investigator). 9. has an ankle to brachial pressure index (abpi) of 0.8 -1.3 10. agrees to wear compression therapy daily in combination with the test dressing 11. is suitable to use the test product for wound treatment (assessed by the investigator). exclusion criteria: 1. is pregnant/breastfeeding 2. wound is older than 12 months 3. wound with exposed tendons or bones or has fistulas 4. wound which is undermined or tunneling 5. is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area) 6. known history of skin sensitivity to any components of the treatment dressings 7. intake of antibiotics within one week before the start of the enrolment 8. participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).

Keywords: wound healing
investigation of fol-005 on clinical safety and effect on hair growth

Conditions: Hypertrichosis; Alopecia; Hirsutism

Summary: a study to investigate clinical safety and effect on hair growth of fol-005 in healthy volunteers. the study is divided in two parts, a single ascending dose (sad) part and a multiple dose (md) part.

sad part: a total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3. md part: in total 12 weeks of dosing where group a will be dosed twice weekly and group b three times weekly each injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. one area will be completely untreated.

Eligibility criteria:
inclusion criteria: * healthy male, aged 18-45 years * clinically visible terminal hair growth on thighs exclusion criteria: * damaged skin in or around test sites * history of any acute (e.g. acute infections) or chronic illness or known skin cancer that might confound the results of the trial * history or clinical signs of keloids or hypertrophic scars * immunological disorders such as alopecia areata, and systemic lupus erythematosus * current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. pentoxifyllin, nitroglycerine) or anticoagulating drugs (e.g. heparine, cumarines, new oral anticoagulants) * current or within 3 months prior to first dosing use of anti-inflammatory medication, corticosteroids or immunosuppressive drugs taken for more than 2 consecutive weeks * current or within 3 months prior to first dosing use of medication with hair growth modifying properties like minoxidil, diazoxid, cyclosporine, antiandrogens * current or within 12 months prior to first dosing intake of anabolics or 5-alpha reductase inhibitors * current or within one week prior to first dosing use of any topical drugs on the legs
thulium vs. hol:yag laser

Conditions: Nephrolithiasis

Summary: this is a randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease: 1. a superpulsed thulium fiber laser (thulium) 2. a pulse modulated high power holmium laser (holmium)

this is a randomized prospective study. the purpose is to compare the stone free rate and operative efficiency of two leading contemporary laser systems used during retrograde intrarenal surgery for kidney stone disease. the researchers will compare the following two systems: 1. a superpulsed thulium fiber laser (thulium) 2. a pulse modulated high power holmium laser (holmium) the researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between \>5mm to \< 20 mm. subjects will be randomized to undergo lithotripsy with either ho:yag or thulium lasers. all subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care. the primary outcome is stone free rate evaluated by postoperative ct scans done 6-12 weeks after surgery.

Eligibility criteria:
inclusion criteria: * undergoing single stage unilateral rirs for total stone burden volume \>5mm to \< 20 mm * preoperative ct scan for baseline measurements exclusion criteria: * anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture * ureteral stent * uric acid component \>50% on stone analysis * prior ureteroscopy within 6 weeks of current surgery * irreversible coagulopathy * urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope.
efficacy and safety of linperlisib in relapsed/refractory large granular t lymphocytic leukemia

Conditions: Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Summary: this is a prospective, multicenter, single-arm, phase 2 study. this study aims to evaluate the efficacy and safety of linperlisib, the pi3k delta inhibitor for patients with relapsed/refractory large granular t lymphocytic leukemia.


Eligibility criteria:
inclusion criteria: * male or female age ≥ 18 years * diagnosis of t-cell large granular lymphocytic leukemia (t-lgll) * meet any of the following indications for treatment： 1. hemoglobin \< 100g/l or rbc transfusion dependence 2. neutrophil count \<0.5×10\^9/l or neutrophil count decreased with recurrent infection 3. progressive splenomegaly and/or massive splenomegaly 4. combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc. 5. severe b symptoms * failure or intolerance to a first-line therapy * ecog performance status ≤2 * expected survival ≥ 6 months * willing and able to comply with the requirements for this study and written informed consent exclusion criteria: * history of other lymphoproliferative neoplasms * had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors * previously received organ or stem cell transplantation * patients with active infection within 2 weeks before giving the first dose of medication * patients with hbv, hcv, hiv or other infections that require treatment * history of immunodeficiency, or congenital immunodeficiency disorders * any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract. * abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that alt and ast are 2.5 times higher than the upper limit of normal values * renal impairment: creatinine clearance \<30ml/min * history of mental illness * history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc. * received attenuated vaccine 4 in weeks before enrollment * participation in another clinical trial within 4 weeks before the start of this trial * have an allergy to linperlisib or any other part of this medicine. * pregnant or breast-feeding patients * patients considered to be ineligible for the study by the investigator for reasons other than the above
precog pilot project

Conditions: Cognition; Affect (Mental Function); Gut Microbiome

Summary: this pilot study aims to investigate the chronic effects of a prebiotic blend on cognitive, affective and gut microbiome outcomes in healthy adults aged 60-75 years.

this pilot study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 12-week-long prebiotic blend consumption on cognitive, affective, gut microbiome, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. fifty participants will be randomised to intervention or placebo groups where they will be consuming 10g of prebiotic fibre blend or 10g of placebo (matched placebo powder) per day for 12-weeks. outcome measures will be acquired before and after a 12-week chronic supplementation. these will include cognitive measures of overall cognitive functioning, and domain-specific cognitive performance, affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. in addition, stool samples will be collected at all timepoints to assess microbiome diversity and composition.

Eligibility criteria:
inclusion criteria: * aging between 60-75 years old * having normal vision and hearing * having a normal body mass index (bmi\<30) exclusion criteria: * having mild to moderate subjective cognitive complaints * smoking * having food allergies * following restrictive and/or unbalanced diets * changing dietary intake majorly in past month * being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders * being diagnosed with any cardiometabolic diseases (including type ii diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease * currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors * currently consuming prebiotic or probiotic supplements * continuous antibiotic use for \> 3 days within 1 month prior to enrolment * continuous use of weight-loss drug for \> 1 month before screening * having a significant gastrointestinal (gi) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years * having a high fibre intake defined as \> 20g of fibre/day * wheat and/or gluten intolerance and having coeliac disease

Keywords: prebiotics cognition depression anxiety gut microbiome diversity relative abundance
phenylephrine for spinal induced hypotension

Conditions: Hypotension

Summary: this study is designed to determine the ed90 for a single dose of phenylephrine for the treatment of spinal induced hypotension in parturients presenting for an elective cd. the ed90 is the effective dose at which 90% of subjects will have a "positive" response to phenylephrine. the primary outcome measure is the ed90 for bolus phenylephrine. secondary outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia, and the presence of hypertension following administration of phenylephrine.


Eligibility criteria:
inclusion criteria: 1. non-emergent cesarean delivery with planned regional anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery) 2. american society of anesthesia physical status class i \& ii (asa i - healthy, asa ii - mild and controlled systemic disease, eg. controlled essential hypertension) 3. age ≥ 18 years (standard within the obstetrical literature) 4. term gestational age 5. english-speaking exclusion criteria: 1. morbid obesity (body mass index ≥ 45 kg/m2) (morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study, typically have an exaggerated response to vasopressors, and the blood pressure cuff occasionally needs to be replaced by an intraarterial catheter due to limitations in size) 2. height \< 5'0" (women \< 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study) 3. laboring women 4. urgent or emergency cesarean delivery 5. severe hypertensive disease of pregnancy defined as systolic blood pressure (sbp) \> 160mmhg, diastolic blood pressure (dbp) \> 110mmhg and/or requiring antihypertensive treatment or associated with significant proteinuria 6. severe maternal cardiac disease 7. diabetes type i 8. subjects on monoamine oxidase inhibitors (maoi's) or tricyclic antidepressants 9. fetal anomalies 10. failed spinal anesthesia 11. subject enrollment in another study involving a study medication within 30 days of cd 12. any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

Keywords: spinal induced hypotension in cesarean delivery
the application of soluble triggering receptor expressed on myeloid cells-1 in sepsis & relevant acute kidney injuries

Conditions: SIRS; Sepsis

Summary: triggering receptor expressed on myeloid cells-1 is a member of the immunoglobulin superfamily of receptors that is specifically expressed on the surfaces of monocytes and neutrophils.trem-1 expression is increased in infectious diseases and is associated with the release of soluble trem-1 (strem-1).there has been demonstrated that the value of plasma strem-1 levels as an indicator of sepsis was superior, although other studies reported that the value of strem-1 for diagnosing sepsis was inferior.an increasing number of studies indicate that there are increased levels of strem-1 in body fluid samples for the following diseases and conditions: sepsis, pneumonia, pleural effusion, septic arthritis, meningitis, peritonitis, and uterine cavity infection. inflammation is now believed to play a major role in the pathophysiology of aki. it is hypothesized that the initial insult results in morphological and/or functional changes in vascular endothelial cells and/or in tubular epithelium in sepsis models. then, leukocytes including neutrophils, macrophages, natural killer cells, and lymphocytes infiltrate into the injured kidneys and induce the generation of inflammatory mediators. whether urine strem-1 could also be detected and its significance in sepsis and aki has not been reported yet. the present study focused on the value of serum \& urine strem-1 for sepsis identification, severity and prognosis assessments, and potential sepsis-related aki. we also made comparisons between strem-1 and wbc counts, serum crp, serum pct, urine output,cc scr, and bun among sepsis patients.


Eligibility criteria:
inclusion criteria: 1. male and female aged 18 years old and over; 2. clinically suspected infection; 3. fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °c or lower than 36 °c (b)respiratory rate above 20/min, or pco2 below 32 mmhg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands. exclusion criteria: those who fulfilled one below: * neutropenia (≤ 500 neutrophils/mm3) * hiv infection, and * patients or their relatives refused

Keywords: strem-1 sepsis sirs blood urine diagnosis prognosis