Kornimate/medical-research-clean huggingface dataset:
clinical study on monitoring the plasma concentration of ceftazidime-avibactam in critically ill patients

Conditions: Severe Sepsis

Summary: a observational study is conducting at the first affiliated hospital of the medical college of zhejiang university from january 1, 2022 to january 1, 2024. patients with severe sepsis and treatment with ceftazidime-avibactam will be enrolled. blood samples at different time points: 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time and the steady state concentration(more than 4 times drug administration) of drug administration will be collected to detect plasma drug concentrations of ceftazidim-avibactam.

the investigators will collect the blood samples at different time points: 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time and the steady state concentration(more than 4 times drug administration) of drug administration from the patients receive treatment with ceftazidime-avibactam to detect plasma drug concentrations of ceftazidime-avibactam. the collected specimens will be stored in a refrigerator at 0-8 °c, centrifuges within 24 hours (4 °c, 4000 r/min, 10 min), and the supernatant will be collected in an ep tube and stored at -80°c until subsequent analysis. ultra-high performance liquid chromatography-mass spectrometry (uplc-ms/ms) will be used to detect plasma drug concentrations of ceftazidime-avibactam. according to the outcomes ,the investigators will analyze the following items,(1)t\>mic,(2)cmax/mic,(3)auc/mic,(4)population pharmacokinetics.

Eligibility criteria:
inclusion criteria: * patients with severe sepsis and treated with ceftazidime avibactam * age ≥ 18 years * the patient or authorized persons agree and sign the informed consent * the patient's hemoglobin is greater than 70g/l during blood collection exclusion criteria: * the expected length of icu stay less than 48 hours, * pregnant woman, * the blood sample is hemolysis.

Keywords: severe sepsis ceftazidime-avibactam plasma drug concentration
effectiveness of nutritional counselling and "improved atta" supplementation in cachexic adult indian cancer patients

Conditions: Cachexia; Cancer

Summary: investigators are evaluating the nutritional role of iatta supplementation along with nutritional counselling in delaying the progression of cachexia to refractory cachexia in adult cancer indian patients. patients will receive iatta (100 g) or whole wheat flour (100 g) for daily consumption for 6 months. dietary and physical activity counseling will be imparted every fortnight to patients. nutritional, biochemical, quality of life and anthropometric estimations will be assessed at baseline, after 3 months and at 6 months of intervention for all patients. investigators hypothesize that intake of nutrient rich bread mix iatta (along with dietary and physical activity counselling) for six months will improve the health status and quality of life in free-living patients suffering from cancer cachexia.

patients will be randomly distributed into two groups i.e. control and intervention group. 75 patients will be allocated in intervention group and receive nutrient rich flour mix i.e. iatta (100 g) along with dietary and physical activity counseling and 75 patients will be allocated in the control group who will receive whole wheat flour with dietary and physical activity counseling. intervention group patients will collect 14 packets of 100 g of iatta every fortnight during their clinician appointments while the control patients will collect 14 packets of 100 g of whole wheat flour at every clinician visit for 6 months. dietary counseling for 30 minutes will be imparted to all patients on each visit by the nutritionist. depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions. nutritional, biochemical, quality of life and anthropometric estimations would be assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Eligibility criteria:
inclusion criteria: * female, age 18 years and above. * diagnosed with cancer. * weight loss \>5% from pre-treatment weight or bmi\<20kg/m2. * hemoglobin level \<12 g/dl. * energy intake \< 1500 kcal/d (to be assessed on consultation) exclusion criteria: * incapable to provide written consent. * patient diagnosed with refractory cachexia. * life expectancy \< 3 months. * unresponsive to anti-cancer therapy. * patient is a pregnant woman or a nursing mother. * suffering from secondary illnesses. * gastrointestinal tract defects which affect nutrient absorption.

Keywords: cachexia nutrition supplementation iatta palliative care quality of life
timing of damage control orthopedic surgery

Conditions: The Precision Personal Timeline in Definitive Surgery Associated With Outcome

Summary: the decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis. we hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.

the decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis. the aim of our study is to analyze if serum lactate a predictive factor of optimal surgical timing in multi-trauma patients. in order to obtain more accurate data, we choose to utilize ili database and trauma database instead of national health insurance research database. multi-trauma patients from 2002 through 2022 were included to our study. we hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.

Eligibility criteria:
inclusion criteria: * (1) injury severity score(iss) \> 16 with pelvicfracture or long bone fracture requiring surgical fixation (2) patient age ≥ 20. pathologic fracture was excluded. our primary endpoint si mortality rate, secondary endpoints include icu stay, icu complications (sepsis, pneumonia, multiple organ failure) exclusion criteria: * death before into undergoing surgery

Keywords: multi-trauma lactate definitive orthopedic operation
aromatase inhibitor host factors study

Conditions: Breast Neoplasms

Summary: the purpose of this study is to examine how key patient factors, including body size affect how well letrozole suppresses circulating estrogen levels. this study has two components: (1) part a - an observational phase to evaluate the impact of vitamin d and obesity on estrogen suppression in post-menopausal women already receiving letrozole treatment, and (2) part b - an interventional phase for women with body mass index (bmi) \> 25 kg/m2 to assess the effect of double ai dose on estrogen levels. if bmi or other patient factors reduce the effectiveness of letrozole, modifications to treatment recommendations and studies to test higher dosing of letrozole may be needed to maximize the benefit of this treatment and minimize the risk of the breast cancer coming back.

the available evidence suggests that circulating estradiol levels play a critical role in determining effectiveness of aromatase inhibitor therapy, and that maximal suppression of aromatase activity and estrogen production is essential for optimal disease control. host factors such as high 25-hydroxy vitamin d (25-oh d) levels and obesity, which might increase residual estrogen levels, could adversely impact outcome and lead to an increased risk of recurrence or death. the primary objective of part a (which includes women regardless of bmi) is to directly evaluate the relationship between (i) 25-oh d levels and serum estrogen levels and (ii) bmi and serum estrogen levels in a cohort of postmenopausal women on standard dose letrozole therapy (2.5 mg/day). part b (which includes only women with bmi \> 25 kg/m2) will determine whether an increased dose of letrozole (5 mg/day), which had no dose limiting side effects in a phase i study improves suppression of estrogen in overweight/obese women.

Eligibility criteria:
inclusion criteria: * postmenopausal female patients * histological confirmed diagnosis of estrogen receptor and/or progesterone receptor positive breast cancer (stage i-iii) who have completed local therapy * currently prescribed and taking letrozole 2.5 mg daily for a minimum of 3 months * willing to provide written informed consent to participate * for the experimental arm: all of the above and body mass index (bmi) \> 25 kg/m2 exclusion criteria: * known abnormal liver or renal function defined by: 1. serum creatinine \> 1.25 times institutional upper limit of normal (uln) or calculated creatinine clearance \< 40 ml/min 2. serum bilirubin, aspartate transaminase (ast) or alanine transaminase (alt) \> 1.5 times uln * presence of persistent local or known metastatic cancer

Keywords: aromatase inhibitors
a study to evaluate changes in nasal airflow of loratadine/pseudoephedrine tablet and fluticasone propionate nasal spray in subjects following allergen exposure

Conditions: Rhinitis, Allergic

Summary: the purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (claritin d) tablet and fluticasone propionate 50 mcg per spray nasal spray (flonase) in subjects suffering from nasal congestion and other allergy symptoms.


Eligibility criteria:
inclusion criteria: * healthy, ambulatory male and female subjects between 18 to 65 years of age * self-reported seasonal allergic rhinitis to ragweed pollen for at least 2 years prior to screening * documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen at screening or within the previous 12 months conducted at research site (prick with wheal diameter \>= 5 mm larger than the diluent response) * in order to qualify to continue to treatment phase, at the end of priming phase (which is 3 hours), total symptom score (tss) has to be ≥ 7, with nasal congestion score alone ≥ 2 and change in peak nasal inspiratory flow (pnif) has to be ≥ 15% from pre-prime baseline; * subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to priming and during the trial * at the discretion of the investigators, subjects may be considered with self-reported mild intermittent asthma (using \<=2 doses of saba (short-acting beta agonists) per week) or exercise-induced asthma * subject is free of any clinically significant disease that required a physician´s care and/or would interfere with trial evaluations, procedures or participation * subject is able to repeatedly and reliably perform pnif measurements and must achieve pnif value of \>=60l/min at screening * subject must be capable of reading english and willing to participate in all aspects of the study exclusion criteria: - any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, pseudoephedrine and fluticasone propionate, or might interfere with the trial. these may include subjects with injury or surgery to the nose that is not fully healed, fungal infections, immunocompromised conditions (hiv, tuberculosis), severe nosebleeds, narrow-angle glaucoma, chickenpox measles..., severe facial pain or thick nasal discharge, sinusitis, constant whistling sound from the nose, structured abnormality of the nose, uncontrolled thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease ischemic heart disease, uncontrolled high blood pressure, symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, renal disease
transversus abdominis plane catheter: a study of method

Conditions: Postoperative Pain

Summary: major abdominal surgery is associated with postoperative pain. transversus abdominis plane(tap) block has been shown to reduce pain and opioid-requirements after abdominal surgery. however a single block has a short effect of up to 12 hours depending on the type local-anesthetics used. with this study we wish to investigate the possibilities to place a tap-catheter in order to prolong the the effect of the tap-block by giving repeatedly bolus-injections in the tap catheter and to study the pain and the opioid requirements of patients undergoing elective colon-resection when given a tap-catheter preoperatively. our hypothesis is that it is practical and technical possible to place bilateral tap-catheters pre-operatively and that pain and opioid-requirements will be low.

postoperative pain is a major challenge in the work of anesthesia. epidural catheter is the golden standard for postoperative pain management after major abdominal surgery. however a number of patient have absolute or relative contraindication to the placement of an epidural catheter. it is therefore necessary to find a good alternative to epidural catheter. transversus abdominis plane(tap) block has been shown to provide analgesia of the abdominal wall and reduce opioid-requirements and pain after abdominal surgery. however the effect of a tap block is limited to the time of efficacy of the local analgesic used. placing a tap-catheter in order to prolong the effect of the tap-block by repeatedly bolus-injections in the tap-catheters has only been sporadically described and so far never investigated in a systematic way. we will investigate the practical and technical possibility to place bilateral ultrasound-guided tap-catheters pre-operatively on patients undergoing elective colon-resection. further more we will evaluate the pain and opioid-requirement postoperatively.

Eligibility criteria:
inclusion criteria: * elective open colon-resection * adult * written and informed consent exclusion criteria: * re-operation within the first 48 hours * need for sedation and ventilator-support postoperatively * accidental removal of catheter within the first 24 hours

Keywords: transversus abdominis plane catheter tap catheter
the use of 5-aminolevulinic acid (ala) as an intraoperative tumor marker for resection of pediatric central nervous system (cns) tumors

Conditions: Central Nervous System Tumor, Pediatric

Summary: surgery is the cornerstone treatment of most pediatric cns tumors, including astrocytomas, ependymomas, medulloblastomas, and many other pathologies. in most pediatric cns tumors, the aim of surgery is maximal tumor resection, while preserving neurological function. extent of tumor residual has been shown to be a major prognostic factor for progression free survival (pfs), and survival in several malignant and low-grade tumors such as medulloblastomas, ependymomas, and astrocytic tumors. 5-aminolevulinic acid (5-ala) has been shown to be valuable in intraoperative marking of various cancers. following oral admission, during surgery, the tumor tissue is illuminated by blue light. tumor cells tend to metabolize 5-ala to a porphyrin named protoporhyrin ix (ppix). ppix reacts with the blue light and emits a pinky color (- fluorescence). this enables the surgeon to better identify tumor cells and perform a more extensive resection. over recent years, many studies have proven the efficacy using 5-ala for resecting various intracranial and spinal tumors, thus achieving a better tumor control. in the suggested study, we propose using the same technique for various pediatric central nervous system tumors. we will focus on the correlation between various pathologies and the fluorescence, trying to deduce the role of 5-ala in resection of specific pathologies. also, we will study the safety of 5-ala use in the pediatric population.

following the above general description, eligible children will receive 5-aminolevulinic acid (5ala) prior to surgery. during surgery, careful attention will be payed to the fluorescence from the tumor, as well as the ability to differentiate between tumor and non tumorous tissue. comparisons between fluorescence and pathologies will be performed. additionally, careful documentation of side effects will be done, to increase the safety of 5ala use.

Eligibility criteria:
inclusion criteria: * age 3 -18 years old * any cns related pathology (including intraaxial and extraaxial tumors, intracranial or spinal intradural) that is planned for either open (microscopic) resection (or biopsy), or lesions undergoing stereotactic biopsies. * parental consent * no personal or familial (1st degree) history of porphyria * liver function test within normal limits (alanine aminotransferase (alt), aspartate aminotransferase (ast)\<2 \* upper normal limit) * normal renal function (cr \<2) exclusion criteria: * surgery with no microscopic use (i.e. purely endoscopic surgeries) * history of hepatic disease within last 12 months * history of cutaneous photosensitivity, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis, or porphyria * inability to comply with photosensitivity precautions

Keywords: pediatrics brain tumor cns fluorescence 5ala
effects of htea on heart failure secondary to idiopathic dilated cardiomyopathy or post-myocardial infarction

Conditions: Congestive Heart Failure

Summary: the investigators would evaluate the effects of the novel method, htea on cardiac function in the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial infarction.

the investigators would evaluate the effects of the novel method, htea on cardiac function in the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial infarction. the specific index is 6 miniutes walk distance, echocardiography, nyha, ntprobnp level, peripherial wbc, rbc, plt, cre, ua, k+, na+ upon entrance to hospital and 4 weeks after htea treatment, and 3 months after discharge. the morbidity and re-hospitalization would also calculated 3 months after discharge.

Eligibility criteria:
inclusion criteria: * 90 chronic cardiac failure patients in our hospital were selected and divided into two groups. exclusion criteria: * vavular diseases
preference of women with fibromyalgia undergoing a three different volumes of resistance training

Conditions: Fibromyalgia, Primary; Chronic Pain; Exercise Addiction

Summary: fibromyalgia is a painful syndrome of unknown etiology, which affects 2% of world population, with symptoms such as: pain, unrefreshing sleep, fatigue and mood disorders. it is already established in the literature that resistance training is part of the non- pharmacological treatment for patients with fibromyalgia. the big gap is about the quantity adequate and/or recommended exercise volume, despite some studies with exercise volumes different resistance trainings show improvements, we do not have a direction, besides we still do not know whether there is a preference for these patients in different resistance training volumes.

objective: assess training volume preference resisted in women with fibromyalgia. method: crossover randomized clinical trial, randomized and blind. 36 women with fibromyalgia will be evaluated, who will undergo three resistance training programs with different training volumes. the primary outcome will be patient preference in relation to training volumes, and the secondary ones will be the patient expectation, pain intensity, affect and subjective perception of exertion. analysis statistics: for the primary outcome preference, the number of choices will be counted of the 3 types of training in percentage form. regarding the analysis of the primary outcome we will summarize the patient's preference in a contingency table, we will compare the proportions using the chi-square test, and finally we will check the effect size of the observed differences. for secondary outcomes, statistical analyzes will be performed by a blind statistician using commercial software. the kolmogorov-smirnov test will be applied to verify the distribution of data and levene's test will be used to analyze the homogeneity of variance. the bonferroni test will be used in post hoc analyzes to determine whether there are differences between the groups at different intervention times. one 5% significance level and 95% ci will be adopted for all statistical analyses. ethic and dissemination: the results of the study will be disseminated to participants and subjected to a peer-reviewed journal and scientific meetings.

Eligibility criteria:
inclusion criteria: * women aged 18 to 65 * have a diagnosis of fibromyalgia according to the acr 2016 criteria exclusion criteria: * have performed resistance training in the last 6 months * having another associated rheumatic condition * have a trip or appointment scheduled that requires absence for the next 4 (four) weeks from the start of the survey; * women with musculoskeletal injuries in the upper and/or lower limbs * have heart problems that prevent maximal efforts and submaximums
validation of simplified electrophysiological examination in the diagnosis of critical illness myopathy or neuropathy

Conditions: Critical Illness Polyneuropathy; Critical Illness Myopathy

Summary: evaluate the accuracy, in the diagnosis of critical illness myopathy and / or neuropathy, of the simplified peroneal nerve test performed by a neurophysiopathology technician or by a neurophysiopathology doctor (as the gold standard) compared to the exam performed by an intensivist.


Eligibility criteria:
inclusion criteria: - adult patients admitted to intensive care unit exclusion criteria: * patients in terminal conditions * patients with peroneal nerve exam not feasible ( for example with presence of prostheses, wounds, plaster casts, edema of the limbs)
evaluation of the efficiency of eswt and custom i̇nsoles produced with podometric measurement in the treatment of painful heel spurs (eswt: extracorporeal shock wave therapy)

Conditions: Heel Spur; Heel Spur Syndrome; Heel Pain Syndrome

Summary: the aim of the study; to determine the effectiveness customized insoles produced by podpmetric analysis and eswt in patients with painfull heel spur and to determine the superiority of the treatments to each other.

heel spurs are the most common cause of heel pain in adults. pain that occurs in heel spur and radiates to the soles of the feet is characteristic of this disease. the pain is most severe in the first steps after rest. patients typically complain of severe pain on the first steps after getting out of bed in the morning. the pain is partially relieved after a few steps, but may increase again after intense activities. typical pain history and examination findings are important to diagnose heel spur, and the diagnosis is confirmed by lateral x-ray. generally, most patients with heel spurs benefit from conservative and medical treatment, and only a few need surgery. these treatment methods include many options such as activity and shoes modifications, topical and oral nsaids, insoles, stretching and strengthening exercises, various injections. tens, ultrasound, electrotherapy modalities that can be used in therapy to relieve pain and promote healing. although many studies have been done for eswt and insoles, there is not any study that comperes these two modalities. in this study, our aim is to investigate the effects of using eswt and customized insoles alone or together on pain and foot functions in patients with heel spurs.

Eligibility criteria:
inclusion criteria: * aged between 18-65 years * pain in the heel for at least 3 weeks * confirmation of the diagnosis with lateral foot radiography exclusion criteria: * be younger than 18 and older than 65 * patients with systemic rheumatological disease (rheumatoid arthritis, ankylosing spondylitis etc.) * entrapment neuropathy in the lower extremities * systemic active infection * malignancy * pregnancy * coagulopathy * patients who have had a previous heel injection of steroids * patients who received physical therapy from the heel area in the last 6 weeks (tens, ultrasound, hotpack, etc.) * inserted cardiac pacemaker * underweight, obese, and morbidly obese according to bmi * patients using nsaids and myorelaxants continuously

Keywords: heel spur extracorporeal shock wave therapy insole customized insole