Kornimate/medical-research-clean huggingface dataset:
local cecal cancer - optimization of surgical treatment

Conditions: Colonic Neoplasms Malignant; Cecal Neoplasms

Summary: the purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (icr) with d3 lymphadenectomy compared to standard right hemicolectomy(rhc) for cecal cancer.

the design involves random allocation of eligible patients to icr or rhc group in 1:1 ratio. requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience. regular quality control includes the requirement to photograph the surgical specimen with a mark to determine the extent of lymphadenectomy performed and the number of the lymph node group. after surgery patients are treated according to local standards, regardless of whether icr or rhc was performed. short-term and long-term outcomes are recorded according to the protocol. intervention. in all cases the tumor is localized in the area of the cecum; the border of the transition to the ascending colon is the upper lip of the ileocecal valve. the patient is not included in the study if the preoperative stage of examination reveals: synchronous cancer, distant metastasis (m1), locally advanced nature of the primary tumor (ct \> 3). all patients will be randomly divided into two groups in a 1:1 ratio. 1. research group (icr) - laparoscopy ileocecal resection with extended d3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). the minimum distance from the tumor is 10 cm, along the line of adequate blood supply. next step - formation of a manual double-row ileo-ascendo-anastomosis. 2. control group (rhc) - laparoscopy right hemicolectomy with d3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). next step - formation of a manual double-row ileo-transverse-anastomosis. expected results. the icr will improve the short-term results of treatment of patients with cecal cancer compared with the standard rhc technique without affecting long-term results.

Eligibility criteria:
inclusion criteria: * at least 18 years of age. * ecog status 0-2. * histologically confirmed adenocarcinoma of the colon. * clinical stage t1-3; n+; m0. * the physical status from asa classification i, ii, iii or iv. * written informed consent. exclusion criteria: * synchronous or metachronous malignancy. * locally-advanced tumor (t\>3). * presence of distant metastases (m1). * complicated tumor: obstruction, perforation. * neoadjuvant chemotherapy. * medical contraindications for surgical treatment. * pregnancy or breast feeding. * medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol.

Keywords: colorectal cancer segmental colonic resection ileocecal resection cecal cancer right hemicolectomy
safety and efficacy of mometasone furoate (sch 032088) vs beclomethasone dipropionate or placebo in seasonal allergic rhinitis (c93-013)

Conditions: Seasonal Allergic Rhinitis

Summary: the objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.


Eligibility criteria:
inclusion criteria: * nonpregnant women of childbearing potential must be using a medically acceptable form of birth control for at least 3 months prior to screening, and must continue its use for the duration of the study. women not of childbearing potential must be surgically sterilized or at least one year post menopausal, or be otherwise incapable of bearing children * 2-year history of seasonal allergic rhinitis * positive skin test response to a local seasonal allergen within last 2 years * good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis exclusion criteria: * women who are pregnant or breastfeeding * women of childbearing potential who are not using an acceptable form of birth control * pre-menarchal females * asthma requiring therapy with inhaled or systemic corticosteroids * significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, may interfere with the study, or require treatment which might interfere with the study * on immunotherapy (unless maintenance therapy) * upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks * use of any investigational drug within the previous 90 days unless the investigational drug is a nasal corticosteroid or has a short (12 hours or less) duration of action, in which case the washout period will be 30 days * large nasal polyps, marked septal deviations or any other nasal structural abnormality that significantly interferes with nasal air flow * allergy to corticosteroids, or a history of multiple drug allergies * history of posterior subcapsular cataracts * dependence upon nasal, oral or ocular decongestants or who are diagnosed with rhinitis medicamentosa * chronic use of any medication which could affect the course of seasonal allergic rhinitis * clinically significant abnormal electrocardiogram (ecg)
effects of transcutaneous electrical nerve stimulation (tens) to improve the cognitive functions in older adults

Conditions: Mild Cognitive Impairment

Summary: recent evidence has shown that transcutaneous electrical nerve stimulation (tens) was effective in improving the cognitive function in healthy adult and people with dementia. however, lacking of evidence investigated the effect of tens in improving the cognitive function and reversing the occurrence of dementia during the period of mild cognitive impairment (mci), which is the crucial period to prevent the significant loss of cognition function. therefore, the main objective of this study is to investigate the optimal tens treatment protocol in improving the cognitive function in older adults with mci.

this study aims to investigate the effectiveness of 3 intervention protocols (1) in the t1 tens group, the subject will receive tens on t1 spine. (2) in the vagus nerve tens group, the subject will receive tens on the concha of left outer ear. (3) in the sham stimulation group, the subject will receive sham stimulation on the t1 spine, in improving the cognitive function in older adults with mci.

Eligibility criteria:
inclusion criteria: should fulfil the diagnosis criteria of mci (albert et al., 2011): 1. concern regarding a change in cognition 2. impairment in one or more cognitive domains 3. preservation of independence in functional abilities 4. no signs of dementia were to be present and confirmed by the medical staff and medical records. exclusion criteria: 1. if their medical records reported a history of either psychiatric disorder, alcoholism, cerebral trauma, cerebrovascular disease, hydrocephalus, neoplasm, epilepsy, disturbances of consciousness, insulin-dependent diabetes mellitus or focal brain disorders; 2. having active implants, such as cochlear implants, pacemaker; 3. having wounds and diseased skin on the electrode position.

Keywords: cognitive function transcutaneous electrical nerve stimulation
effects of pulsed dye and co2 laser in treatment of hypertrophic burn scars.

Conditions: Hypertrophic Scar

Summary: a prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the usaisr burn clinic. laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmx6cm total, in one contiguous region. the study sites, will consist of four equally sized treatment areas (3cm x 3cm), will be randomized to be treated with pdl, co2, a combination of co2+pdl, and an untreated control for 6 treatments. the areas will be photographed prior to each treatment and at the final visit 4-6 months after the last treatment. color, pliability and thickness will be measured using a colorimeter, cutometer and high frequency ultrasound respectively at each appointment. additionally, the patient observer scar assessment scale (posas) will be used to score the quality of the scar, using two trained, blinded observers. the patients will also be asked on a voluntary basis for a pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological changes.


Eligibility criteria:
inclusion criteria: 1. must have at least four areas of burn scar located on the trunk or extremities measuring 3cm x 3cm and not previously treated with laser. 2. timing: there has been a minimum of 1 month after burn closure 3. the subject is at least 18 years of age and not older than 65. 4. able and willing to provide verbal and written consent. exclusion criteria: 1. active infection in experimental area 2. use of isotretinoin (accutane) in last six months 3. life or limb-threatening injury/disease 4. prior history of non-compliance with medical regimes 5. active drug use/abuse 6. active psychiatric illness except depression (unless being treated for suicidal intentions) 7. pregnancy 8. active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell carcinoma, melanoma and squamous cell carcinoma, as long as the subject is disease free at the time of enrollment. 9. prior pdl or other laser treatment of the study area. 10. patient unable to tolerate laser procedure.
macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy

Conditions: Fluid Removal; Critically Ill; Continuous Renal Replacement Therapy; Fluid Overload

Summary: macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. a monocentric ancillary study of the earlydry randomized controlled trial.


Eligibility criteria:
inclusion criteria: * acute kidney injury treated by continuous renal replacement therapy in icu less than 7 days, * at least 1 organ failure during icu in addition to aki (mechanical ventilation or vasopressors administration\>12 hours), * cumulative uf net less than 1000ml before inclusion, * norepinephrine \< 0,5 µg/kg/min, * absence of hypoperfusion signs, * fluid overload defined as follows: fluid overload \> 5% of base weight (based on cumulative fluid balance or a weight gain) and/or peripheral edema (akiki edema scale \> 2). exclusion criteria: * chronic renal failure hemodialyzed before admission to the icu, * mechanical circulatory support (ecmo, lvad), * pregnant, child -bearing age or lactating women, * stroke less than 30 days, * intestinal ischemia less than 7 days documented non-operated, * interventional study participation or exclusion period on going, * guardianship, curatorship or safeguard of justice, * absence of signature of free and informed consent by the patient and/or relative, * patients not affiliated to a social security scheme or beneficiaries of a similar scheme * absence of transpulmonary thermodilution monitoring

Keywords: fluid removal hemodynamic net ultrafiltration continuous renal replacement therapy
nurse-led educational intervention on patients with glaucoma with low health literacy

Conditions: Glaucoma; Health Literacy; Patient Activation

Summary: introduction: chronic diseases are a major cause of ill health, disability and death worldwide and are potentially preventable and treatable. glaucoma is among the main causes of morbidity and blindness; its early detection can reduce the risk of poor patient outcomes. the existence of health illiteracy among these patients and the absence of self-management of these diseases are a barrier to their effective management worldwide. aim: the investigation of effect of a nurse-led patient education on both the incidence of negative outcomes and the activation levels of glaucoma patients with low health literacy status. secondary objectives of the present study are the assessment of patient activation and health literacy prior to (baseline) and after (follow-up period)patient education at predefined times, as well as the association of patient socio-demographic and clinical parameters with the patient activation and health literacy levels. methodology: a quasi experimental study will be conducted with follow-up in a population of patients with diagnosed glaucoma, who will attend the outpatient ophthalmological clinic of the heraklion university general hospital. the research tools that will be used for the assessment of health literacy will be the greek version of the european health literacy survey questionnaire 16 (hls-eu-16) and for the assessment of the patients' activation level the patient activation measure - 13 (pam-13) questionnaire will be used, which will be translated . the data will be analyzed using the statistical package for social sciences (spss) (ibm statistics) software program, version 24.0, and ethical and moral rules will be followed. expected results: the proposed study is expected to underline both the level of health literacy of glaucoma patients in greece and the importance of self-management of chronic diseases carried by patients. additionally, the present study is expected to highlight the significance of the nurse-led education process of patients with low health literacy status on reducing the poor patient outcomes incidence and the improvement of their activation levels, leading to the optimal self-management and self-care.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * informed written consent to participate in the study * adequate knowledge of the greek language (writing and reading) * diagnosis of the condition for at least six months exclusion criteria: * patients with incomplete health records * patients who provided incomplete information * patients who wished to stop participating were excluded

Keywords: health literacy glaucoma patient activation nurse-led training intervention
in-office bleaching with a 2-day interval between sessions: tooth sensitivity

Conditions: Dentin Sensitivity

Summary: the calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2 days after the first bleaching session without increasing the bleaching-induced tooth sensitivity

the in-office bleaching uses 35% hydrogen peroxide gel which is applied in 2 to 3 sessions usually with one week interval between sessions, without a scientific and plausible reason for this recommendation (. the aim of this study was to evaluate the tooth sensitivity (ts) risk using a shorter interval between clinical sessions. methods: in this randomized, single-blind study, 40 young patients with color c2 or darker were selected and randomly divided in two groups. in the 7-day group, two bleaching sessions with a 35% hydrogen peroxide gel (whiteness hp blue calcium - fgm) were performed with a one-week interval and in the 2-day group, the same protocol was performed but with a 2-day interval. ts was recorded on a 0-10 visual analog scale up to 48 h after bleaching. the color evaluation was performed at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. the absolute risk of ts (%) was evaluated by fisher´s exact. the ts intensity was evaluated by two-way repeated measured anova and color changes (δsgu and δe) were evaluated by student´s t-test (alpha = 5%).

Eligibility criteria:
inclusion criteria: the participants should have: at least six maxillary and mandibular anterior teeth caries-free. without restorations on the labial surfaces. the central incisors should be c2 or darker according to a value-oriented shade guide (vita lumin). - exclusion criteria: pre-existing anterior restorations. pregnant/lactating. severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth). taking any drug with anti-inflammatory and antioxidant action. bruxism habits or any other pathology that could cause tooth sensbility (such as recession, dentine exposure). -

Keywords: randomized controlled clinical trial tooth bleaching
a study to compare sb11 (proposed ranibizumab biosimilar) to lucentis in subjects with neovascular age-related macular degeneration (amd)

Conditions: Age-Related Macular Degeneration

Summary: this is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of sb11 compared to lucentis® in subjects with neovascular amd.

subjects will be randomised in a 1:1 ratio to receive either sb11 or lucentis® (administered via intravitreal (itv) 0.5 mg every 4 weeks). investigational products (ip) (sb11 or lucentis®) will be administered up to week 48, and the last assessment will be done at week 52.

Eligibility criteria:
inclusion criteria: 1. age ≥ 50 years 2. newly diagnosed, active subfoveal choroid neovascularisation (cnv) lesion secondary to amd in the study eye 3. bcva of 20/40 to 20/200 in the study eye 4. written informed consent form exclusion criteria: 1. any previous itv anti-vascular endothelial growth factor (anti-vegf) treatment to treat neovascular amd in either eye 2. presence of cnv in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia 3. any concurrent macular abnormality other than amd in the study eye
comparison of patient comfort after two anesthetic protocols for injections into the eye

Conditions: Pain

Summary: patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.

the primary goal of this investigation is to determine the relative comfort of an intravitreal injection (same day and the next day) after a preparation utilizing three cotton swabs soaked in 4% lidocaine versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel. based on the available data, the researchers contend that a preparation based on viscous 3.5% ophthalmic lidocaine gel, which coats the surface and remains in contact with the eye longer, may provide greater anesthesia and result in greater patient comfort than the topical 4% lidocaine, which is part of the standard preparation routinely utilized in the ophthalmology department currently. secondary outcome measure is the intraocular pressure rise after the injection, and the authors will generate prospective data to study whether softening the eye with cotton swabs prior to the injection lowers post-injection pressure spike.

Eligibility criteria:
inclusion criteria: * has required repeat ranibizumab injections and has had at least 3 injections prior to recruitment * informed consent * age ≥ 18 years * clinical need for a therapeutic ranibizumab intravitreal injection regardless of the medical indication * able to understand and read english exclusion criteria: * pregnancy (positive pregnancy test) * mental disability * prisoners * patients with fluctuating or impaired decision-making capacity * inability to comply with study or follow-up procedures * previous reaction to the same drug class

Keywords: pain discomfort anesthetic drugs topical drug administration injections, intraocular lidocaine intraocular pressure keratopathy
qualitative study on osteoporosis representation and management in the general population and in general practitioners.

Conditions: Osteoporosis

Summary: osteoporosis (op) and subsequent fractures (op fractures) are a source of morbidity and high mortality in the elderly. despite numerous programs aiming at improving op care, the prevention, diagnostic and treatment remain suboptimal. barriers to a better care are multiple, both in the general and at-risk population, and in medical practitioners. since they do not perceive their susceptibility to op, people do not see the benefit of prevention. in addition, physicians do not give sufficient importance to op prevention and care, despite the existence of guidelines. the investigators implemented a qualitative study to explore the knowledge and representations regarding osteoporosis in the general and at-risk population and in doctors in rhône-alpes region, france, using focus groups with women and men and semi-structured face-to-face interviews with general practitioners. understanding barriers to osteoporosis care in patients and general practitioners will help to set up effective strategies to improve prevention and treatment.


Eligibility criteria:
inclusion criteria: * group 1: women aged 50 to 85 years with a history of fragility fracture or an osteoporosis diagnostic * group 2: women aged 50 to 85 years without a history of fragility fracture or an osteoporosis diagnostic * group 3: men aged 60 to 85 years with a history of fragility fracture or an osteoporosis diagnostic * group 4: men aged 60 to 85 years without a history of fragility fracture or an osteoporosis diagnostic * group 5: general practitioners in region rhône-alpes, france * who signed the consent form exclusion criteria: * no signed consent * legal disability * difficulty in understanding french * psychiatric disorder

Keywords: osteoporosis prevention care management focus groups