Kornimate/medical-research-clean huggingface dataset:
eosinophil-guided reduction of inhaled corticosteroids

Conditions: COPD; Inhaled Corticosteroid; Azithromycin; COPD Exacerbation; Pneumonia

Summary: clinical trial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid (ics) therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (copd) receiving long-acting b-agonist (laba) / long-acting muscarinic receptor antagonists (lama) / ics treatment.

inhaled corticosteroid (ics) treatment is recommended by global initiative for obstructive lung disease (gold) for patients with frequent and/or servere exacerbations and blood eosinophils \> 0.3 x 10\^9 cells/l and in those with ≥ 0,1 x 109 cells blood-eosinophils and recurrent exacerbations while on bronchodilators. ics treatment, however, is associated with side effects such as diabetes, osteoporosis and pneumonia which is costly for both patients and society. by studying the effects of a personalized, eoseosinophil-guided approach to direct ics in copd patients with frequent aecopds through a randomized clinical trial this study will examine the possibilities of reducing ics overtreatment and thus ics-related adverse events. long term ics treatment is known for affecting the bacterial load in stable copd patients. azithromycin exerts multiple effects on the structure and composition of the lower airway microbiota and has anti-inflammatory effects. this study will, moreover, investigate whether an oral low-dose prophylactic treatment with azithromycin 250 mg three times weekly can reduce the number of moderate-severe aecopd and improves time alive and out of hospital. this study is a randomized, double-blinded, multicentre, four-arm intervention clinical trial and is conducted based on the principles of good clinical practise (gcp).

Eligibility criteria:
inclusion criteria: * copd (verified by a specialist in respiratory medicine + spirometry) * gold class e anytime within the last 2 years (corresponding to 2 ≥ aecopd and/or ≥1 aecopd leading to hospitalization during a 12 months period within the last 2 years) and/or fev1\<30%. * treatment for last 4 weeks including lama, laba and ics * informed consent exclusion criteria: * known asthma. * male \< 40 years. * female \<40 years, if non-menopausal (had menstruation within the last 12 months) conditioned by a negative urine hcg test * severe mental illness which considerably complicates co-operation. * language problems that considerably complicate co-operation. * current treatment with systemic corticosteroids corresponding to \> 5 mg prednisolone per day. * systemic antibiotic treatment (if to participate in microbiota sub-study) or systemic corticosteroid treatment within 14 days (also prophylactic azithromycin). * contra-indication to treat with azithromycin (as listed by the producer). * non-bacterial exacerbation per investigator judgement in the last 3 months.
phase i clinical study of hrs-9815 for pet/ct imaging in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry of hrs-9815 for pet/ct imaging in adult patients with prostate cancer.


Eligibility criteria:
inclusion criteria: 1. voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing; 2. male, age ≥18 years; 3. ecog score 0 - 1; 4. histologically confirmed adenocarcinoma of the prostate; exclusion criteria: 1. severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. note: subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study. 2. active syphilis infection. 3. known allergy, hypersensitivity, or contraindication to the trial product or any component of its formulation.。 4. active in other clinical studies or less than 4 weeks after the last dose in the previous clinical study at the time of the first dose.
local collagen-gentamicin and extra fixation of the sternum for prevention of sternal wound infection in cardiac surgery

Conditions: Drug Resistance, Bacterial; Postoperative Wound Infection

Summary: the aim of the present study is to evaluate a new technique for prevention of sternal wound infection consisting of local application of collagen-gentamicin in addition to routine i.v. antibiotic prophylaxis. the technique has been evaluated in a previous randomised study. the aim of the present study is to evaluate the technique after it has been introduced in clinical practise to monitor the bacterial antibiotic susceptibility and to verify that the suggested reduction in sternal wound infection still exits.

a new technique for prevention of sternal wound infections after cardiac surgery is studied. local application directly in the surgical wound of aminoglycoside antibiotics (gentamicin) bound to collagen reduced the incidence of wound infection with more than 50 % in a previous prospective randomised trial. as the technique has been introduced in clinical practise two questions need to be monitored: * are there signs of change in the bacteria that cause the wound infections with a shift over time towards more gentamicin resistant agents? * is the effect of the prophylaxis still comparable to that which was seen in the previous study? furthermore, results from the previous study indicated that the effect of the local antibiotic was better when combined with an extra rigid sternal wound infection, defined as at least one extra steel wire for sternal fixation. the study is conducted at those two swedish cardiothoracic surgery centers where it was first studied. there are thus two objectives of the study: first to analyze the microbiologic findings of the sternal wound infections that occur, and secondly to monitor the incidence of sternal wound infection (especially deep infections) when the local collagen-gentamicin prophylaxis is used in daily routine in combination with a specific surgical technique for optimization of the strength of sternal fixation.

Eligibility criteria:
inclusion criteria: * all consecutive cardiac surgery patients operated via median sternotomy exclusion criteria: * existing inclusion of the patient in another study of treatment aimed at reducing postoperative swi. * known allergy or other contraindication to gentamicin or bovine collagen. * pregnancy or breast feeding * treatment with aminoglycosides during the last week

Keywords: antibiotic prophylaxis
optimuscle - improving respiration by optimising muscle function

Conditions: Dysfunctional Breathing; Breathing Pattern Disorder

Summary: the primary aim will be to understand whether a digital breathing biofeedback system can improve the outcomes of physiotherapist guided breathing retraining.

approximately 10% of people in the united kindom exhibit some form of dysfunctional breathing. this term describes a range of conditions which are characterised by an impairment in the muscular control of breathing and which can result in breathlessness, hyperventilation and, in some cases, dizziness. current clinical assessment techniques and treatments for dysfunctional breathing are low-tech. the investigators propose that patients would get more benefit from a system which uses biofeedback on muscle patterns to guide breathing re-education. the investigators have developed a new digital health system for the clinical management of dysfunctional breathing. the system uses an avatar to provide biofeedback to communicate abnormal muscle function in real-time, guiding patients through a process in which they gradually learn the correct muscular control of breathing. the proposed intervention seeks to understand if the addition of a digital breathing biofeedback system improves the outcomes of physiotherapy guided breathing retraining. patients awaiting respiratory physiotherapy for dysfunctional breathing will be recruited to receive 4 sessions of breathing retraining with the assistance of the digital breathing biofeedback system. all patients will complete lung function tests and quality of life questionnaires pre- and post- treatment. patients will also be offered an interview to understand their experiences of using the system.

Eligibility criteria:
inclusion criteria: * ability to stand and walk independently * history of breathing difficulties, such as breathlessness and difficult or laboured breathing for at least previous 6 months. * clinical diagnosis of dysfunctional breathing, sometimes referred to as breathing pattern disorder. * if participants have co-existing respiratory problems, e.g. asthma, these should not be felt (in the opinion of the referring clinician) to be the cause of the current symptoms of breathlessness. exclusion criteria: * inability to speak and understand english sufficient to read and understand the information sheet and sign the consent form. * bmi \>34 * currently receiving active treatment for dysfunctional breathing * received treatment for acute lower respiratory tract infection or asthma exacerbation with last 4 weeks * significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not asthma)
study of cmab009 to treat kras wild type metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the primary purpose of this study is to evaluate the clinical response and safety of cmab009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in kras wild-type metastatic colorectal cancer patients

cmab009 is a recombinant, human/mouse chimeric monoclonal antibody (mab) that binds specifically to the extracellular domain of egfr. it is composed of the fv regions of a murine anti-egfr antibody with human igg1 heavy and k light chain constant regions and it is expressed by chinese hamster ovary cells. it has the same amino acid sequence as cetuximab (c225, erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by shanghai zhangjiang biotechnology limited company and produced by biomabs. phase i study results suggest that cmab009 showed well-tolerated safety profile and primary efficacy. this multicenter, open-label study was to determine whether adding cmab009 to irinotecan increased the response rate and prolongs survival in patients with kras wild-type metastatic colorectal cancer (mcrc) previously treated with fluoropyrimidine and oxaliplatin.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic colorectal adenocarcinoma * kras wild-type tumors, egfr-expressing or egfr-nonexpressing by immunohistochemistry; * has measurable lesion, at least 1cm in diametre by ct or mri, at least 2cm diametre by physical examination or other iconography * ecog performance status 0 to 1 * failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve exclusion criteria: * previous irinotecan or anti-egfr therapies * hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter * liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not * renal function: serum creatinine, more than 1.5 times the upper limit of normal * patients with symptomatic central nervous system metastases

Keywords: kras wild-type metastatic colorectal cancer cmab009 plus irinotecan phase ii/iii
biliary limb as a percentage from the small intestine rather than fixed length in loop bypass surgery for morbid obesity

Conditions: Obesity, Morbid

Summary: in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length. we do it as a percentage from total small intestine length rather than fixed length

in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length we count the length of small intestine and do it as a percentage from total small intestine length rather than fixed length

Eligibility criteria:
inclusion criteria: * obese patients with bmi more than 40 or more than 35 with comorbidity * patients fit for laparoscopic surgery * give approval to share in the study exclusion criteria: * patients refused to share in the study * patients unfit for surgery * patients aged less than 18 and older than 50 * patients with bmi less than 35 * patient with previous upper abdominal surgery either for obesity or other diseases

Keywords: biliary limb length in bypass bariatric surgery
patient-reported outcomes in philadelphia-negative cytogenetic myeloproliferative neoplasms (prophecy).

Conditions: Myeloproliferative Neoplasm

Summary: this study will ultimately aim at developing a gimema platform for collecting hrqol and symptom burden information on italian patients with philadelphia chromosome negative mpn. the main objective of the protocol is to improve our understanding of the impact of the disease and various treatments on patients-wellbeing, symptom burden and daily functioning.


Eligibility criteria:
inclusion criteria: * patients diagnosed with polycythemia vera (pv), essential thrombocythemia (et) and primary myelofibrosis (pre-pmf, overt-pmf) and post-et/post-pv myelofibrosis (mf), (i.e. philadelphia chromosome negative myeloproliferative neoplasm (mpn)) according to 2016 who classification. * known ipss/ipset/dipss risk score category at time of initial diagnosis of pv, et and pmf, respectively. * initial diagnosis of mpn within one year before date of registration. * having a full baseline pro evaluation completed. * adult patients (≥ 18 years old). * written informed consent provided. exclusion criteria: * having any kind of psychiatric disorder or major cognitive dysfunction problems hampering a self-reported evaluation. * not able to read and understand local language (i.e. italian).
increasing autonomous motivation in esrd to enhance phosphate binder adherence

Conditions: End Stage Renal Disease

Summary: hyperphosphatemia in end-stage renal disease (esrd) patients is a non-traditional risk factor for all-cause and cardiovascular mortality. non-adherence to phosphate binders is as high as 74% in esrd patients and has been shown to be most related to psychosocial factors including attitudes. there is limited data on the influence of attitudes and perceived autonomy support on phosphate binder adherence and these two psychosocial constructs can be positively influenced through the use of motivational interviewing skills to increase autonomous motivation. furthermore, racial disparities are known to exist in esrd however and there are still gaps, which exist in understanding the determinants of disparities in adherence in vulnerable patients with esrd. in this study, the investigators seek to determine the impact of motivational interviewing on phosphate binder adherence in diverse esrd patients. the investigators will ask all the subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy support and phosphate binder adherence. the investigators will administer motivational counseling to subjects in the intervention arm of the study, at baseline and 1 month after recruitment. the investigators will ask all the subjects to fill out the same surveys 2 months after recruitment and the investigators will compare subjects who underwent motivational interviewing to those who did not.


Eligibility criteria:
inclusion criteria: * adults age 18 years or older * receiving phosphate binder therapy currently * english speaking exclusion criteria: * non- english speaking * known diagnosis of psychosis or dementia, limiting ability to provide informed consent * any medical condition that precludes participation in the study including deafness, dying etc. * initial morisky medication adherence score greater than 6

Keywords: phosphate binder adherence autonomous motivation
wild 5 wellness: a 30-day intervention

Conditions: Wellness; Anxiety; Depression; Cognitive and Executive Dysfunction

Summary: the purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in first year beloit college students self-selected into a wellness focused first year initiative.

the purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in first year beloit college students self-selected into a wellness focused first year initiative. this program is called "wild 5 wellness: a 30-day intervention". results for this study will be quantified through the use of standardized self-report questionnaires administered prior to and after students complete the wild 5 program. data will be collected to evaluate participants' adherence and response to each element of wild 5, a 5-pronged 30-day wellness intervention. it is expected that this 30-day integrated, prescriptive, and trackable program will be found to be an efficacious wellness intervention for first year beloit college students.

Eligibility criteria:
inclusion criteria: * students 18 years of age or older * students enrolled in first year initiative course titled, "habits of mind, habits of body." exclusion criteria: * individuals who are pregnant or plan to get pregnant during the next 30 days * students who are not enrolled in the first year initiative course titled, "habits of mind, habits of body".
actual human use of methotrexate (mtx) subcutaneously administered via the vibex™ mtx auto-injector device

Conditions: Rheumatoid Arthritis (RA)

Summary: the purpose of this study is to assess the usability of the vibex mtx device for sc self-injection of methotrexate.

primary objective: - to assess the safe usability of the vibex mtx device for subcutaneous (sc) self-injection of methotrexate (mtx) in adult patients with rheumatoid arthritis (ra) after standardized training by site personnel and review of written instructions secondary objectives: * to evaluate the reliability and robustness of the vibex mtx device * to evaluate the safety and local tolerance of an sc self-injection of mtx using the vibex mtx device * to evaluate the effectiveness and ease of use of the vibex mtx device patient education tools for sc self-injection

Eligibility criteria:
inclusion criteria: * male or female patients \>18 years of age, diagnosed with rheumatoid arthritis exclusion criteria: * pregnant females * any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk
ai for colorectal polyp detection in endoscopy

Conditions: Focus of the Study is to Evaluate a New Developed Deep-learning Computer-aided Detection System in Combination With LCI for Colorectal Polyp Detection

Summary: linked color imaging (lci) has shown its effectiveness in multiple randomized controlled trials for enhanced colorectal polyp detection. most recently, artificial intelligence (ai) with deep learning through convolutional neural networks has dramatically improved and is increasingly recognized as a promising new technique enhancing colorectal polyp detection. study aim was to evaluate a new developed deep-learning computer-aided detection (cad) system in combination with lci for colorectal polyp detection.


Eligibility criteria:
inclusion criteria: * full endoscopy withdrawal videos with lci of patients ondergoing screening or surveillance endoscopy exclusion criteria: * non adequate bowel preparation * no full length withdrawal in lci mode
efficacy of topical treatment with clobetasol in symptomatic oral lichen planus.

Conditions: Oral Lichen Planus

Summary: the investigators want to study the effect of clobetasol in symptomatic oral lichen planus. the investigators will include 90 patients and randomly allocate them in three groups. the first group will receive active treatment both in the morning an evening. group two receives placebo in the morning and active treatment in the evening. group three will get placebo both in the morning and in the evening. all groups will follow the same protocol with rinsing twice daily with test substance in conjunction with antifungal treatment. the patients will be controlled after two weeks and and again after another two weeks. a biopsy will be performed at inclusion and another biopsy will be taken at the end of the test period. smears for candida will also be evaluated. the patients will be examined for changes in clinical appearance and will answer questions to note changes in symptoms. our hypotheses: #patients receiving clobetasol will have a better resolution af symptoms than those who got placebo. #patients treated with clobetasol twice daily will have a faster relief of symptoms than patients just treated once daily. #the clinical signs of oral lichen planus will diminish more pronounced in the two groups given active treatment. #a majority of the olp lesions were infected by candida. #specific histological changes can be seen in the biopsies taken after clobetasol treatment compared to those taken before treatment.


Eligibility criteria:
inclusion criteria: * symptomatic oral lichen planus * age above 40 years exclusion criteria: * lichenoid contact lesions * graft versus host disease * bacteria related lichenoid reaction * intraoral vesiculobullous diseases * active antibiotic treatment * active treatment with steroids or other immunomodulating substance * allergy to clobetasol * severe periodontitis * bad oral hygiene * biopsy not supporting olp * allergy to nystatin * not in menopause * previous or actual oral malignancy * participation in other medical study

Keywords: oral lichen planus treatment candida
high intensity interval versus focused ultrasound on insulin resistance in diabetics with abdominal obesity

Conditions: Insulin Resistance; Abdominal Obesity; Diabetes

Summary: obesity and diabetes share a common insulin resistance pathway and contribute to chronic hyperglycemia. both high-intensity interval exercise (hiie) and focused ultrasound (fus) have been explored in the context of managing insulin resistance in diabetic individuals with abdominal obesity, though they operate through different mechanisms and have different implications.

forty diabetic females aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. they will be assigned into two equal groups, group a will receive high intensity interval exercise 2 times per week for 4 months in addition to intermitted fasting diet. group b will receive focused ultrasound 2 times per week for 4 months in addition to intermitted fasting diet. assessment of abdominal obesity will be applied pre and post treatment through measuring body mass index (bmi), waist circumference (wc) in addition to value of hba1c and homa-ir hormone will be measured to determine effect of treatment on insulin resistance.

Eligibility criteria:
inclusion criteria: they will be recruited from el_shinnawy physical therapy centre. * all are suffering from abdominal obesity * their age between 25-35 years old * their body mass index more than 30 kg/m2, * their waist circumference ranged from 88 cm * the fat thickness at the treatment area was at least 2.5 cm exclusion criteria: * females having any skin diseases in the abdomen. * female suffering from any physical or mental disorders. * females suffering from abdominal scars or hernia * females didn´t take any medication that might affect their weight all over the study period. * females complaining from any cardiovascular disorders.