Kornimate/medical-research-clean huggingface dataset:
proximally extended resection for rectal cancer after neoadjuvant chemoradiotherapy

Conditions: Rectal Cancer

Summary: neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for locally advanced rectal cancer. however, preoperative radiotherapy increases the risk of bowel dysfunction after sphincter-preserving surgery, for which patients suffer from incontinence, urgency, and unpredictability defecation problems. furthermore, preoperative chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal cancer surgery. unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a major concern. when conventional surgical procedures would retain part of sigmoid colon that has been included in the radiation target, sphincter-preserving surgery with proximally extended resection margin could provide an intact proximal colon limb for the anastomosis. it is not known yet whether proximally extended resection improves postoperative bowel function or anastomotic integrity for patients with rectal cancer after neoadjuvant chemoradiotherapy. the proposed study will compare sphincter-preserving surgery with and without proximally extended resection margin, to observe the postoperative bowel function, as well as the incidence of anastomotic complication. this study will examine a new surgical strategy, which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.


Eligibility criteria:
inclusion criteria: * age: 18-75 years old * ecog performance status: 0-2 * histologically confirmed adenocarcinoma of the rectum * distal border of the tumor located ≤ 12 cm from the anal verge * primary stage t3-4 or any node-positive disease * undergoing long-course 5-fluorouracil based neoadjuvant chemoradiotherapy * conventional fractionated radiotherapy of at least 45 gy * resectable disease after neoadjuvant chemoradiotherapy * no evidence of distant metastasis * amenable to sphincter-preserving surgery * tolerable to general anesthesia * provision of written informed consent exclusion criteria: * prior or concurrent malignancies within the past 5 years except for effectively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix * synchronous colon cancer * history of colorectal resection except appendectomy * acute intestinal obstruction or perforation * multiple visceral resection * abdominoperineal resection * american society of anesthesiologists (asa) class ⅳ or ⅴ * pregnant or nursing, fertile patients do not use effective contraception * serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease * psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Keywords: rectal cancer neoadjuvant therapy chemoradiotherapy resection margin bowel function anastomosis
percutaneous transhepatic cholangiography (pthc) in acute cholecystitis and clinical outcomes

Conditions: Cholecystitis, Acute; Elderly Infection; Drain Abscess

Summary: in a setting of acute cholecystitis (ac) one of the treatment option is percutaneous transhepatic cholangiography (pthc) drainage. the goal of current study is to evaluate some radiology aspects and correlate with clinical patient outcomes in patients with acute cholecystitis severity grade iii (presented as acute cholecystitis with organ dysfunction).


Eligibility criteria:
inclusion criteria: * clinical markers of acute cholecystitis * diagnosis confirmed with some imaging technique: computed tomography (ct), ultrasound (us). exclusion criteria: * clinical diagnosis was not confirmed with imaging.
iccac-tonf & tinnitus

Conditions: Tinnitus, Subjective

Summary: prevalence of chronic subjective tinnitus is rising with age and associated with maladaptive oscillatory changes in auditory as well as non-auditory regions of the brain such as the insula and the anterior cingulate cortex which are known to be key points within the salience and distress networks of the brain.thus, we are conducting a clinical trial by implementing those auditory as well as non-auditory regions into a tomographical neurofeedback training (tonf) -protocol. prior to 12 electroencephalography (eeg) -based tonf-trainings with 36 older participants using standardized low resolution electromagnetic tomography software (sloreta, pascual-marqui 2002), participants' brains will be measured using structural magnet resonance imaging (smri) in order to identify potential structural markers for training success (e.g. cortical thickness). training success will be measured by oscillatory change via eeg before and after the training period as well as by means of follow-up measures. furthermore, a comprehensive battery of behavioral and psychometric standardized self-report questionnaires will be applied. based on this multifocal (insula, dorsal anterior cingulate cortex \& auditory cortex) tonf we expect oscillatory changes resulting in decreased tinnitus symptoms such as perceived loudness and distress.


Eligibility criteria:
inclusion criteria: * chronic tinnitus (\>6 months) * age 40 to 80 * informed consent * fluent in german language * mentally \& physically fit exclusion criteria: * ferromagnetic implants * cochlear implants * average hearing loss over 50 db * claustrophoby * addiction to alcohol or drugs * intake of anesthetics, tranquilizers, neuroleptics or antiepileptics * acute suicidal
use of sv40 vectors to treat chronic myeloid leukemia (cml)

Conditions: Chronic Myeloid Leukemia

Summary: chronic myeloid leukemia is a serious disease which is characterized by progression from relatively quiescent stages of the disease to an aggressive phase. although now there is highly successful medical therapy known as gleevec (imatinib), the treatment is not always successful and patients do develop resistance. those patients have limited treatment options. we are developing a gene therapy model of treatment for this disease using pseudoviral particles to insert molecules of genetic material which would not allow the harmful genes causing the leukemia to function.

a novel methodology that facilitates specific silencing of genes has recently been developed. the method is based on the property of small molecules of nucleic acids (rna) to specifically repress expression of targeted genes. these small interfering rna (sirna) molecules were recently demonstrated to repress, in tissue culture cells, one of the two types of the common fusion genes present in cml patients. those studies showed that treatment with synthetic sirna inhibited cell growth and increased the sensitivity to imatinib. these findings offer hope that a novel form of gene therapy based on this strategy may improve the treatment outcome of cml patients, particularly when used in combination with other approaches such as the tyrosine kinase inhibitor imatinib that was mentioned above. our group has developed an innovative vector that is most suitable to deliver sirna molecules into human hematopoietic cells with sufficient efficacy. the vector is based on a monkey virus called simian virus 40 (sv40). the viral coat, or capsid, is produced biosynthetically. it was engineered to self-assemble in the test tube around the nucleic acids of choice, and to deliver this dna or rna into target cells. this vector is safer than other available viral vectors since all the viral genetic material is excluded from the final product. the vector does not elicit immune response, thus allowing repeated administration.we will start the project by testing the recently published sirna molecules against one of the fusion genes, and several alternative sirna molecules that we will design against the other fusion genes. the molecules will be tested for efficacy in tissue culture cell-lines, by measuring repression of the respective fusion gene, reduction in the level of the tyrosine kinase and inhibition of cell growth. the most effective sirna molecules will be selected for further studies. the vectors will be tested on cell-lines for gene silencing and cell death as before. at the final stage we will test the best vectors for their efficacy in white blood cells obtained from cml patients.

Eligibility criteria:
inclusion criteria: * diagnosis of cml exclusion criteria: * under 18 years old * pregnant
reducing work-related screen time in health care workers during leisure time

Conditions: Stress; Burnout, Caregiver

Summary: the purpose of this study is to determine the effect that uninstalling work email applications from mobile devices during leisure time has on health care worker stress levels.

burnout is more common in physicians than in the general population. the recent covid-19 pandemic has increased burnout and stress levels among health care workers, leading to a peak of 34% of health care workers experiencing burnout symptoms. but even before the covid-19 pandemic, the prevalence of burnout symptoms among health care workers was trending upwards. in fact, most health care workers experience burnout to some degree. managing email inboxes and working with electronic health records (ehr) can increase screen time levels for health care workers who use them. high amounts of screen time have been linked to depression and stress in teenagers and adults. ehr digital work is a noted burden on physicians, and inbox management has been linked to physician stress and burnout. a study that measured physician stress during electronic health record inbox work found that accessing and responding to ehr inbox outside of work hours increased stress levels in physicians. the effect of an intervention that lowers screen time usage in health care workers during leisure time has not been measured. determining this effect can influence new protocols on inbox and work email management during leisure time for health care workers. this can benefit organizations by improving employee performance, employees by reducing stress and burnout levels, and patients by providing more refreshed patient care. this study aims to determine the effect that uninstalling email from mobile devices during leisure time has on health care worker stress levels.

Eligibility criteria:
inclusion criteria: * 1) be an active health care worker * 2) be ≥ 19 years old * 3) routinely use a smartphone * 4) have a work email application (e.g., outlook) installed on their smartphone. exclusion criteria: * none

Keywords: screen time
repair of articular osteochondral defect

Conditions: Osteochondritis Dissecans

Summary: background: matrix-associated autologous chondrocyte implantation (maci) has been recently used to treat cartilage defects. the investigators had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. the investigators further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.

methods: ten patients with symptomatic isolated osteochondritis at the femoral condyle were treated by replacing the pathological tissue with autologous chondrocyte-laden biphasic cylindrical plug of dl-poly-lactide-co-glycolide, with its lower body impregnated with -tricalcium phosphate as the osseous phase. the osteochondral lesion was drilled to fashion a pit of identical size and shape as the plug. the chondrocyte-laden plug was press-fit to fill the pit. outcome of repair was examined by koos scale at 3, 6 and 12 months postoperatively, and tissue sample was collected with second-look arthroscopic needle-biopsy at 12 months. the primary outcome parameter was the postoperative change of koos; and the secondary outcome parameter was the regeneration of cancellous bone and hyaline cartilage at the repair site.

Eligibility criteria:
inclusion criteria: * age: 18 \~ 60 years * articular cartilage defect of the knee * diagnosis by x-ray and/or mri, arthroscopy * confined area: diameter \< 3 cm * full layer cartilage damage exclusion criteria: * pregnancy * nonunion of fracture around the knee * diffuse degenerative arthropathy of the knee * diffuse cartilage pathology due to * rheumatism: rheumatoid, psoriatic, ... * metabolic disorder: gouty, hemorrhagic, ... * stiff knee from any reason * flexion \< 130˚ * extension loss \> 20˚
meropenem vs cefotaxime as empirical treatment of sbp

Conditions: Spontaneous Bacterial Peritonitis

Summary: we aimed to evaluate whether meropenem is superior to cefotaxime for treatment of sbp empirically.

ascites is the most frequent complication of cirrhosis and represents a significant change for the patient because the impact on mortality and quality of life is important. spontaneous bacterial peritonitis (sbp) is a dreaded complication in patients with decompensated cirrhosis. spontaneous bacterial peritonitis (sbp) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. it is defined by the presence of \>250 polymorphonuclear cells (pmn)/mm3 in ascites in the absence of an intra-abdominal source of infection or malignancy. spontaneous bacterial peritonitis carries a mortality rate of 30 to 70% in patients with end-stage liver and kidney disease. choice of antibiotic is dependent on type of microbes responsible for infection. gram negative enteric bacteria are considered the most common pathogens responsible for sbp. this is the reason, 3rd generation cephalosporins are the recommended drugs of choice for treating sbp empirically. but recent studies have shown that cephalosporins are effective only in 70% of community acquired and 56% of hospital acquired sbp.it is most likely due to changing bacterial pathogens of sbp over last two decades as now gram positive bacteria and multi drug resistance organism (mdro) are increasingly being isolated in sbp. it is the consequence of undue, over the counter misuse of cephalosporins in community and frequent exposure of cirrhosis patients to these drugs during recurrent hospital admissions.

Eligibility criteria:
inclusion criteria: * liver cirrhosis patients with ascites ascitic fluid pmn cell count \>250/mm3 age: 18:80 exclusion criteria: * : history of abdominal surgery within 4 weeks, secondary peritonitis, tuberculous peritonitis, malignant tumor, patients who use hormones or immunosuppressants, aids patients.
urinary tract infections in older persons admitted to a psychogeriatric ward

Conditions: Urinary Tract Infections

Summary: urinary tract infections are one of the most common types of infections in older persons. the general aim of this study is to improve the epidemiological knowledge and develop a better diagnostic algorithm for urinary tract infections in older institutionalized individuals in order to reduce excessive prescribing of antibiotics and prevent antimicrobial resistance.


Eligibility criteria:
inclusion criteria: * older (65+ years) persons admitted to a gerontopsychiatric ward exclusion criteria: * patients not understanding dutch or not willing to participate (no informed consent)

Keywords: aged psychiatric hospitals
treatment of chronic low back and lower extremity pain

Conditions: Low Back Pain

Summary: 1. to demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. improvement will be assessed in relation to the clinical outcome measures of pain and function. 2. to evaluate and compare the adverse event profile in all patients.


Eligibility criteria:
inclusion criteria: * subjects of at least 18 years of age * subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration * subjects who are able to give voluntary, written informed consent to participate in this investigation * subjects who, in the opinion of the pi, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups * subjects have not had recent surgical procedures within the last 3 months. exclusion criteria: * cauda equina symptoms and/or compressive radiculopathy * narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent * uncontrolled major depression or uncontrolled psychiatric disorders * uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease. * chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function * women who are pregnant or lactating * subjects who have participated in a clinical study with an investigational product within 30 days of enrollment * patients with multiple complaints involving concomitant hip osteoarthritis, due to the overlap of pain complaints * inability to achieve appropriate positioning and inability to understand informed consent and protocol * history of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers * previous surgery.

Keywords: lumbar disc herniation discogenic pain lumbar interlaminar epidural injections
fecal microbiota alterations in steroid refractory active colitis ulcerosa

Conditions: Colitis, Ulcerative

Summary: alterations in the intestinal microbiota have been associated to disease pathogenesis in ulcerative colitis. refractory disease to standard medical therapy as corticosteroids often leads to an unfavourable course in patients suffering from this disorder. this study proposal aims at investigating changes in the intestinal microbiota that can predict a therapy refractory course of ulcerative colitis (uc) and may be used to identify high risk patients in an early phase of their disease.

the investigators suggest that certain alterations in the intestinal microbiota are at least in part responsible for the inability of some patients to response to steroid therapy and probably also for the failure to other immunosuppressive therapies. certain pathobionts have the capability to stimulate the mucosal immune system, thereby leading to chronic inflammation. on the other hand, commensals are necessary for repair processes in the mucosa and are providing metabolites that are used as an energy source for the colonic epithelium. an increase in pathobionts in combination with a lack of certain commensals might therefore maintain colonic inflammation despite immunosuppressive therapy with systemic steroids in patients with uc. the investigators therefore plan to investigate the intestinal microbiota in uc patients before and 4 weeks after a systemic corticosteroid therapy and correlate potential alterations of the microbiota to the therapeutic response. other factors like concomitant uc treatment, disease severity, disease extent and environmental factors will also be correlated to changes in the microbiota. in the subgroup of patients not responding to steroids and requiring a rescue therapy with infliximab or a calcineurin inhibitor, the predictive value of microbiota alterations will also be investigated. if certain bacterial taxa can predict a steroid refractory and an unfavorable disease course, the results of this study will help in identifying possible microbiota based biomarkers for an individualized treatment approach in uc patients in the future.

Eligibility criteria:
inclusion criteria: * active ulcerative colitis with a lichtiger score ≥4 * patient scheduled for steroid therapy with systemic steroids (prednisolone or methylprednisolone) at standard dosing and patients who started steroid therapy not longer than 48 hours prior to the study inclusion. * written informed consent * established or suspected diagnosis of ulcerative colitis or indeterminate colitis exclusion criteria: * no follow up possible * bacterial intestinal infections (c. difficile, salmonella, ehec, campylobacter, shigella, yersinia), parasitic or viral infection causing acute infectious diarrhea at baseline. * diagnosis of crohn´s disease * planned initiation or discontinuation of probiotic therapy between baseline and follow up visit
does a nasal instillation of miglustat normalize the nasal potential difference in cystic fibrosis patients ?

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to investigate within a short delay the effect of nasal instillation of miglustat on nasal potential difference in cystic fibrosis patients homozygous for the f508del mutation.

miglustat is an inhibitor of α-glucosidases and other enzymes. oral miglustat is currently marketed in europa and us for the treatment of gaucher type 1 patients for whom enzyme replacement treatment is not an option. gastro-intestinal side effects are common with this formulation. this medication has been shown to have a beneficial effect both on cl- an na+ transports in cystic fibrosis epithelial cells. in addition, a single airway delivery of low-dose miglustat normalizes nasal potential difference (npd) in f508del cystic fibrosis mice. npd abnormalities specific of cf patients are considered to reflect the primary defect of cftr protein so that any curative treatment is expected to correct them at least partially. in the field of respiratory pharmacology, it is a general rule that the inhaled route is to be favoured whenever possible : it is usually more effective despite much lower doses and systemic absorption (which also implies lower costs and improved tolerance). the aim of this study is to investigate the effect of a single local administration of miglustat on npd measurements in cf patients homozygous for the f508del mutation.

Eligibility criteria:
inclusion criteria: * cystic fibrosis patients homozygous for the f508del mutation as confirmed by genetic test * aged 14 years and older * male or female (non-pregnant women who are to remain non-pregnant for 3 months after the end of the study) * fev1 \> 50% of predicted normal exclusion criteria: * acute respiratory tract infection or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of visit 1 * any condition prohibiting the correct measurement of the npd such as respiratory tract infection * active or passive smoking * allergic chronic rhinitis * history of significant lactose intolerance * history of neuropathy * history of cataracts or known increased risk of cataract formation * hypersensitivity to miglustat or any excipients * planned treatment or treatment with another investigational drug or therapy within 1 month prior to randomisation

Keywords: cystic fibrosis miglustat nasal instillation nasal potential difference
bioavailability and bioequivalence of ezetimibe tablets in healthy subjects

Conditions: Hyperlipidemias

Summary: this study was conducted to assess the bioequivalence of the ezetimibe tablet to ezetrol ® in healthy chinese volunteers and estimate the pharmacokinetic proﬁles of ezetimibe tablet.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects ≥18 years of age * the body mass index is in the range of 18.0-26.0 kg/m2 (including the critical value). * the weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg. * serum total cholesterol was between 2.9 and 5.0mmol/l (not including critical value). exclusion criteria: * any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseases * hepatic/renal impairment * abnormal vital signs * drug or alcohol abuse * smoking ≥5 cigarettes per day , * donation(≥300ml) o * enrollment in other clinical trials during the 3 months prior to screening * allergic to ezetimibe or its excipients * any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication * lactating or pregnant women

Keywords: ezetimibe tablet, bioequivalence, pharmacokinetics