Kornimate/medical-research-clean huggingface dataset:
web-based oncofertility support tool for reproductive-age women with breast cancer

Conditions: Breast Neoplasm Female; Fertility Preservation

Summary: the aim of this study was to develop electronic systems (e-systems) for oncofertility support, and to examine the comprehensibility, feasibility, usability, and effects on social support and preparation for decision-making.

background: when reproductive-aged women with breast cancer lack support in making decisions about fertility, this results in conflicts in decision-making with negative effects on their mental health. objective: the aim of this study was to develop electronic systems (e-systems) for oncofertility support, and to examine the comprehensibility, feasibility, usability, and effects on social support and preparation for decision-making. methods: the study steps were guided, tested, and utilized to (a) identify the requirements of a patient, (b) guide the development of support interventions, and (c) evaluate the quality of web-based oncofertility support. both qualitative and quantitative data were collected to explore supportive requirements related to oncofertility care, and an initial website concerning oncofertility was developed based on the resulting requirements and system review regarding social support. alpha testing and beta testing were used to ensure the quality of the web-based oncofertility support tool. the effectiveness was evaluated using the preparation for decision-making scale and social support questionnaire.

Eligibility criteria:
inclusion criteria: * health provider who ever cared the patients with breast cancer. * patients with breast cancer aged between 20 and 45. exclusion criteria: * patients of severe psychiatric disorders. * patients under 20 years old.

Keywords: breast cancer fertility preservation social support ottawa decision support framework website
pd-improved dialysis efficiency with adapted apd

Conditions: Chronic Renal Failure

Summary: the aim of this study is to observe the effect of adapted apd (aapd) on maintenance and/or improvement of the hydration status of more than 250 pd patients, and to observe the tolerability of the therapy over a long period.

in some studies it has been observed that the use of a combination of short dwell/small volume and long dwell/large volume can improve the effectiveness of apd. however, these studies have been performed in a small number of patients during a short observation period. the aim of this study is to assess the hydration status of pd patients treated with aapd and observe its development during one year using the bcm-body composition monitor (bcm), a bioimpedance spectroscopy (bis) device. in addition, it is intended to observe the variability of aapd prescriptions and their influence on the hydration status of the patients. this is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.

Eligibility criteria:
inclusion criteria: * ckd patients with indication for renal replacement therapy * patient treated or to be treated with aapd * fluid status regularly monitored with bcm exclusion criteria: * patients who have any condition prohibiting the use of bcm like patients with major amputations (e.g. lower leg) * participation in an interventional study which could have an effect on the study objectives hydration status and dialysis adequacy (e.g. studies on pd solutions, studies on diuretics)

Keywords: automated peritoneal dialysis adapted apd (aapd) hydration status residual renal function ultrafiltration
istent inject new enrollment post-approval study

Conditions: Glaucoma, Open-Angle; Glaucoma

Summary: study to evaluate the rate of clinically relevant complications associated with istent inject placement in the post-market setting.

to evaluate the rate of clinically relevant complications associated with istent inject placement and stability, as determined at 36 months in the postmarket setting.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 22 years of age 2. mild to moderate primary open-angle glaucoma 3. scheduled to undergo cataract surgery 4. able and willing to attend scheduled follow-up exams for three years postoperatively 5. able and willing to provide written informed consent on the irb approved informed consent form operative inclusion criterion: 6. successful, uncomplicated cataract surgery exclusion criteria: 1. angle closure glaucoma 2. traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle 3. retrobulbar tumor, thyroid eye disease, sturge-weber syndrome or any other type of condition that may cause elevated episcleral venous pressure
to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after anterior talofibular ligament repair surgery

Conditions: Anterior Talofibular Ligament Injury

Summary: the goal of this clinical trial is to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after anterior talofibular ligament repair surgery. with applying crosslinking hyaluronan hydrogel, the range of motion (rom) of the ankle is expected to be better than sham group.


Eligibility criteria:
inclusion criteria: 1.1 voluntarily participate and sign an informed consent form; 1.2 age 18 to 60 years of male or female; 1.3 patients experiencing lateral ankle pain discomfort, confirmed by mri to have anterior talofibular ligament (atfl) injury; 1.4 history of recurrent ankle inversion sprains three times or more, with no improvement after six months of conservative treatment, and scheduled for atfl repair surgery; 1.5 willing to comply with all follow-up requirements of the trial protocol. exclusion criteria: 2.1 severe ankle osteoarthritis; 2.2 patients with a history of ankle fracture or surgery; 2.3 undergoing foot- or ankle-related treatments that may affect the trial results; 2.4 presence of skin infection, skin defects, or need for skin grafting at the surgical site; 2.5 uncontrolled chronic diseases, such as diabetes mellitus; 2.6 presence of autoimmune diseases (such as autoimmune collagenopathy, rheumatoid arthritis), malignancies, coagulation disorders, heart diseases, psychiatric illnesses, or other conditions that may pose higher risks to patients in the trial; 2.7 use of corticosteroids within the past 6 months, systemic corticosteroids within the past month, immunosuppressive drugs within the past 3 months, or daily use of non-steroidal anti-inflammatory drugs (nsaids) within the past week, or occasional use within 8 hours (patients using nasal/inhaled corticosteroids may be considered for inclusion) ; 2.8 clinically significant coagulation abnormalities or undergoing anticoagulant therapy within 10 days before surgery or currently taking anticoagulant drugs; 2.9 known allergy to sodium hyaluronate or any components of medical devices;allergy to gram-positive bacterial protein or streptococcal protein；or other severe allergic history deemed unsuitable for participation by the investigators; 2.10 pregnant, lactating women, or women planning to become pregnant during the trial period; 2.11 other conditions deemed unsuitable for participation by the investigators.
cd64 and antibiotics in human sepsis

Conditions: Antibiotic Resistant Infection; Critical Illness; SIRS; Sepsis

Summary: the purpose of the study is to find out whether cd64 expression on neutrophils measured by a new bedside test (leukodx) within 30 minutes is associated with effective antibiotic therapy in critically ill adult patients at risk of sepsis.

in the present study, in critically ill patients with suspected infection undergoing application of antibiotics, cd64 and inflammatory plasma markers will be determined on days 1 to 4. cd64 expression on the surface of neutrophils will be determined by fluorescence activated cell sorter (facs) and with a new bedside test (leukodx). the purpose of the study is to clarify: 1. is cd64 expression on neutrophils associated with effective antibiotic therapy in critically ill adult patients at risk of sepsis? 2. is cd64 expression associated with distinct plasma parameters of inflammation? 3. do the results of the gold standard cd64 determination by facs correlate with those of a new bedside test (leukodx)?

Eligibility criteria:
inclusion criteria: * age \> 18 years * critically ill adult patients * sepsis * sirs * initiation of antibiotic treatment * patients \< 48 hours after admission on icu exclusion criteria: * multiple admissions on icu, (\>1 in last 2 weeks period) * leukopenia \< 1 g/l * and thrombocytopenia * rhg-csf or ifn-gamma therapy up to 1 week before inclusion * participation in another study receiving drugs or biological within the preceeding 30 days * recent longterm corticosteroid treatment * hiv * patients after organ transplantation treated with immunomodulating drugs * pregnant patients or after delivery * life expectancy \< 24 hours * polytraumatized patients with reanimation on scene, or infest prognosis * patients under high dose corticosteroids or chemotherapy

Keywords: cd64 antigens biomarkers granulocyte colony-stimulating factor interleukin-4 interferon-gamma c-reactive protein lipopolysaccharide-binding protein procalcitonin cytokines patients human systemic inflammatory response syndrome sepsis infection antibiotics intensive care units point-of-care systems bedside testing
person-centered, occupation based therapy for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Occupational Therapy

Summary: this study was conducted to investigate the effect of a person-centered, occupation-based intervention program supported with problem-solving strategy in individuals with type 2 diabetes (t2d). method: the study was a randomized controlled trial, that included intervention (n=33) and control group (n=34), between the ages of 18 and 65 years.

it was planned as a single-blind, randomized controlled study with 3-month follow-up in adults. a total of 67 subjects were randomly allocated to the intervention (n=33) or the control group (n=34). this program prepared with consider to meaningful activities for individual and overcome to barriers via problem solving. that was designed as 6 modules including evaluations, diabetes education and problem-solving therapy. each module was implemented at least 1 session per week, about 60 minutes, and was arranged according to individual needs.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * able to read and write turkish exclusion criteria: * cancer * mental disorder

Keywords: diabetes mellitus problem solving occupational therapy healthy lifestyle occupational performance person-centered occupation based
ampicillin and ceftriaxone for the treatment of enterococcus faecalis infective endocarditis.

Conditions: Endocarditis, Infective

Summary: phase iv, open-label, randomized and multicenter clinical trial to prove that patients with enterococcus faecalis infective endocarditis treated with an antibiotic treatment as a continuous infusion is non-inferior to the standard intermittent infusion regimen, usually administered in hospitalized patients.

the aim of the study is to prove that the continuous infusion of antibiotic treatment for the patients with enterococcus faecalis infective endocarditis is as effective and safe as the traditional intermittent infusion. the continuous infusion modality of treatment is expected to provide numerous benefits for individual patients, global health, and for the national health care system by reducing to hospital stays from 4-6 weeks to approximately 2-3 weeks and hospital-driven complications. the mortality, rate of serious adverse events, total number of days of antibiotic treatment and days of hospitalization, among others, are included as secondary objectives. this is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. final contact and final visit for the study will be performed at 365 days after the 42 days of treatment.

Eligibility criteria:
inclusion criteria: * adult patients * possible or definitive diagnosis of infective endocarditis due to enterococcus faecalis * signed informed consent of patients exclusion criteria: * allergy to penicillins or cephalosporins * pregnancy and lactation * polymicrobial infection including microorganisms different to e. faecalis

Keywords: endocarditis, infective enterococcus faecalis antibiotics outpatient infusion therapies outpatient care
prevention of post-polypectomy colorectal bleeding by clips in patients on anticoagulants

Conditions: Polyp of Colon

Summary: this observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry. the main question it aims to answer is: can clips prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy? researchers will compare adults who received preventive clipping after a polypectomy with those who did not, regarding colorectal bleeding after receiving restarted anticoagulants. participants have undergone a colorectal polypectomy and received restarted anticoagulants (acetylsalicylic acid excluded) after the procedure.

screening colonoscopy allows early detection of cancer and removal of adenomas before they become malignant. unresected polyps larger than 1 cm have a 24% risk of invasive adenocarcinoma. post-polypectomy bleeding is influenced by factors such as polyp size, location, tumor type, anticoagulants and concomitant diseases. prophylactic measures such as clipping show mixed results; selective clipping is cost-effective, but universal clipping is not. the updated esge guideline on colorectal polypectomy and endoscopic mucosal resection from 2024 recommends prophylactic endoscopic clip of the mucosal defect after endoscopic mucosal resection of large non-pedunculated polyps in the right colon to reduce the risk of delayed bleeding. however, there is no clear recommendation for patients on anticoagulants whether to use or not to use prophylactic clipping. therefore, this observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry (\> 10.000 colonoscopies).

Eligibility criteria:
inclusion criteria: * adult who has received a colonoscopy with endoscopic colorectal polypectomy * patient who has received at least one anticoagulant after polypectomy exclusion criteria: * endoscopic polypectomy was combined with closure of the mucosal defect by a suturing device or full thickness resection device

Keywords: polyps hemorrhage anticoagulants
lifestyle intervention and physical capacity in patients with morbid obesity

Conditions: Physical Capacity

Summary: lifestyle intervention and physical capacity in patients with morbid obesity (leico)

it is still uncertainty about which is the most effective lifestyle treatment to reducing body weight and increased quality of life. increased physical capacity and muscle mass lead to increased energy expenditure, thus explaining parts of the difference in weight loss achieved after lifestyle treatment. however, literature in this area is limited and need better documentation of how, and to what extent increased physical capacity can affect the effect of lifestyle treatment offered to patients in the health service.

Eligibility criteria:
inclusion criteria: * treatment morbidly obese patients (bmi ≥ 40 kg/m2 or bmi 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the vestfold hospital trust. exclusion criteria: * uncompensated heart failure * recent myocardial infarction or stroke (\<½ years) * severe arrhythmia or heart failure * unstable angina pectoris * renal failure * severe eating disorders * active substance abuse
eovist vs. dotarem healthy volunteer mri

Conditions: Transient Severe Arterial Phase Motion

Summary: the purpose of this study is to evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (eovist) administration, compared with saline, and gadoterate dimeglumine (dotarem). healthy volunteers will be recruited from three study sites. these subjects will be given three, blinded, randomized injections while undergoing an mri of their liver and holding their breath. during the scan, the subjects' oxygen saturation and heart rate will be closely monitored. following the scan, the subjects will complete a questionnaire regarding the breath hold.


Eligibility criteria:
inclusion criteria: - normal renal function (serum egfr \>60) exclusion criteria: * renal impairment * allergy to gadolinium-based contrast * metallic implanted devices * claustrophobia * pregnant and lactating females
multi-center clinical evaluation of pc 1-day vs 1-day acuvue moist

Conditions: Myopia

Summary: the objective of this study is to compare the clinical performance of proclear 1-day versus 1-day acuvue moist each for one week of daily disposable wear.

the purpose of this cross-over study is to evaluate the clinical performance of the proclear-1 day in comparison with 1-day acuvue® moist®. in particular, the study will focus on lens wearing comfort.

Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study if he/she: * is between 18 and 40 years of age (inclusive) * have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study. * has had a self-reported visual exam in the last two years * is an adapted soft cl (contact lens) wearer * must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so * has a cl spherical prescription between - 1.00 and - 6.00 (inclusive) * has less than 0.75d (diopters) spectacle cylinder in each eye. * is correctable to a visual acuity of 20/25 or better in both eyes * has clear corneas and no active ocular disease * has read, understood and signed the information consent letter. * is willing to comply with the wear schedule (at least 40 hrs per week) * is willing to comply with the visit schedule exclusion criteria: a person will be excluded from the study if he/she: * has never worn contact lenses before. * currently wears rigid gas permeable contact lenses. * has a history of not achieving comfortable cl wear (5 days per week; \> 8 hours/day) * has a cl prescription outside the range of - 1.00 to -6.00d * has a spectacle cylinder greater than -0.50d of cylinder in either eye. * has best corrected spectacle distance vision worse then 20/25 in either eye. * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion * has persistent, clinically significant corneal or conjunctival staining * has active neovascularization or any central corneal scars. * is aphakic. * is presbyopic. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
early detection of cognitive dysfunction in diabetes

Conditions: Dementia; DM; MCI

Summary: the rate of cognitive decline due to ageing is increased 1.5-fold to 2.0-fold in individuals with type 2 diabetes.there are no established specific treatment measures to prevent or ameliorate cognitive impairments in patients with diabetes. we want to detecte early clinical dementia in diabete.

clinically relevant cognitive decrements in relation to diabetes mainly occur during two crucial periods in life: the period of brain development in childhood, and the period when the brain undergoes neurodegenerative changes associated with ageing.potential leads for treatment are to optimise glycaemic control and avoid and treat vascular risk factors.we want to detecte early clinical dementia in diabete by mmse and olfactory function.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes(age\>50 years) exclusion criteria: * with stroke or other complications.

Keywords: dementia olfactory
study of tl117 in patients with recurrent or metastatic head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to assess the safety, pharmacokinetic and efficacy of tl117 plus paclitaxel in patients with recurrent or metastatic head and neck cancer.

this is a phase 1/2 open label, single arm study, and is divided into three phases: the single-agent dose-escalation phase ia trial, the tl117 plus paclitaxel dose-escalation phase ib trial, and the open label, multicenter phase 2 trial of tl117 plus paclitaxel. adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 28. when the maximum tolerated dose (mtd) of tl117 plus paclitaxel is determined, additional patients will be treated at the defined rp2d dose until occurrence of unacceptable toxicity, disease progression or withdrawal of consent or death.

Eligibility criteria:
inclusion criteria: 1. 18-70 years old for phase 1a, 18-75 years old for phase 1b and 2; 2. histologically and/or cytologically confirmation of recurrent/metastatic squamous cell carcinoma of the head and neck; 3. at least one evaluable or measurable tumor lesion; 4. adequate performance status; 5. a minimum life expectancy of \> 3 months; 6. adequate cardiac, kidney, and liver function; 7. willingness of all subjects of childbearing potential to use acceptable methods of birth control; exclusion criteria: 1. any chemotherapy, radiotherapy, targeted therapy, immunotherapy, endocrine therapy and other systematic anti-tumor therapies within 4 weeks prior to the first dose of the study drug (some exceptions apply) 2. prior or current pi3k inhibitor therapy; 3. type 1 or type 2 diabetes requiring antihyperglycemic medication; 4. major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose, or required elective surgery during the study period; 5. any unresolved toxicities from prior therapy greater than grade 1; 6. inability to swallow, or serious gastrointestinal absorption conditions; 7. history of immunodeficiency; 8. active central nervous system metastases; 9. active hepatitis b or c virus infection; 10. uncontrolled active infection; 11. serious cardiovascular disease； 12. clinically uncontrollable effusion in the third space; 13. known allergy and/or contraindications to paclitaxel; 14. known alcohol or drug dependence; 15. mental disorders or poor compliance; 16. pregnant or lactating women;