Kornimate/medical-research-clean huggingface dataset:
clinical assessment of an in-patient glucose monitoring system (accu-chek inform cobas it 1000)

Conditions: Diabetes Mellitus; Blood Glucose; Hospital Information Systems; Medical Device

Summary: the principal objective of this single-center 2-period study is to evaluate the glycemic control of in-patients in 3 hospital departments (diabetology, cardiology and pulmonary care) as the rate of capillary blood glucose measurements within a pre-define target range, and to compare results during the period i (warning of the accu-check inform glucose meter on glucose levels not activated) and period ii (warning activated).

the study is a 6-month large scale assessment of an information system consisting in a glucose meter with multiple alerts (accu-chek inform) associated with a data base (cobas it 1000) in order to share the results of glucose monitoring using the hospital information network. the appraisal of the glycemic control was based on the rate of capillary blood glucose measurements within a pre-defined target range (3.9-8.5 mmol/l) during each study period. whether the system implementation can improve the outcome related to the management of in-patients with diabetes is assessed in 3 hospital departments (diabetology, cardiology and pulmonary care) as follows: * principal objective, glycemic control of in-patients (cardiology and pulmonary care) as the rate of capillary blood glucose (cbg) values within the pre-defined target range, and comparison of results observed during period i (meter warning not activated) and period ii (warning of the meter on out-of-target glucose level activated). * the impact on the performance of quality controls of cbg measurements with (period ii) or without (period i) activation of a warning on the meter related to inappropriate quality control frequency (all departments). * evaluate the traceability of cbg results and compare it with (period ii) or without (period i) the activation of the automatic record of data ensured by the accu-chek inform meter and cobas it 1000 data base (all departments). * during a sub-period of period ii, the impact on patient glycemic control of the intervention of a diabetologist, determined by the activation of a warning sent to the physician in case of out of target cbg results via the cobas it 1000 data base (cardiology and pulmonary care). * the impact of the above warning activation plus diabetologist intervention on the incidence of low cbg.

Eligibility criteria:
inclusion criteria: * in-patients, * age \> 18 years, * requiring a monitoring of capillary blood glucose levels exclusion criteria: * no glucose monitoring needed

Keywords: glucose monitoring diabetes management information system in-patient glycemic control
chronic thromboembolic pulmonary hypertension after pulmonary embolism

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: to detect the incidence of cteph patients. primary outcome to predict cethp in symptomatic patients after pulmonary embolism episode. secondary outcome: on echocardiography revealed rv dysfunction which are peak tr velocity , the rv/lv basal diameter ratio, flattening of the ivs, rv acceleration time and/or midsystolic notching, ivc diameter with decreased inspiratory collapse and ra area.

chronic thrombo embolic pulmonary hypertension(cteph)is a progressive pulmonary vascular disease characterized by chronic obstruction of major pulmonary arteries with flow-limiting organized thrombi. in the clinical classification of the 6thworld symposium on pulmonary hypertension, cteph/chronic thromboembolic pulmonary disease(cted)are in group4, labeled as ph due to pulmonary artery obstruction. cteph should be considered in pe patients if:(1)they report symptoms that could be related to cteph or with frank right heart failure,(2)the ctpa used to diagnose acute pe shows signs indicative of cteph,(3)they have risk factors or predisposing conditions for cteph. recurrent venous thromboembolism(vte),post-thrombotic syndrome, bleeding ,and functional limitations as important outcome measures of acute pe treatment , dyspnea ,anxiety, chest pain ,post-thrombotic panic syndrome, and depression that lead to persistent functional limitations and/or decreased quality of life have been labeled as post-pe syndrome(pps),includes cteph. early diagnosis of cteph is important ,as it is the only form of ph that is potentially curable , but also challenging because signs of right heart failure only become evident in advanced disease stages and earlier disease stages are characterized by non specific or even absence of symptoms. the diagnostic work up of suspected cteph ,starts with trans thoracic doppler echocardiography, in addition to the peak tricuspid regurgitation velocity , the right ventricle/left ventricle basal diameter ratio, flattening of the interventricular septum, right ventricular acceleration time and/or mid systolic notching, inferior vena cava diameter with decreased inspiratory collapse and right atrial area are used echocardiographic signs to assess the probability of ph.

Eligibility criteria:
inclusion criteria: any patient diagnosed as acute pulmonary embolism ,aged between 18-80 years old which pulmonary embolism severity index (pesi) class iii-v or spesi ≥1, exclusion criteria: secondary causes for pulmonary hypertension severe kidney injury(egfr\>30 mg/dl/1.7m2) hepatic affection contraindication to anti-coagulation

Keywords: cteph
corneal de-epithelization associated with a therapeutic photokeratectomy in patients with evolutive keratoconus

Conditions: Keratoconus

Summary: keratoconus is a symmetrical, bilateral, non-inflammatory, idiopathic corneal pathology, characterized by a progressive corneal thinning. this disease leads to a bombing of the cornea, inducing a strong corneal astigmatism, responsible for a loss of visual acuity sometimes very important, non-correctable by lens of glasses. collagen cross-linking (cxl) and simple corneal de-epithelization are two common surgical technics aiming to slow the progression of this pathology. they consist in rigidifying the corneal structure in order to stabilize its deformation progression. even though these technics are commonly performed, none of these strategies has proven their efficiency. the effects of cxl can be due to the superficial scarring reaction as well as the effects of corneal remodeling induced by the de-epithelization phase during a cxl procedure, and not due to the covalent links between collagen and fibrils, formed by the biochemical reaction resulting from the uv-a exposition in the presence of riboflavine de-epithelization may be an equally effective treatment, when compared to cxl, but without long term secondary effects. its association with a therapeutic photokeratectomy (pkt, surgical technic used to regulate the corneal surface, and eliminate its opacities in order to recuperate the transparency of the cornea) will aim to improve the regularity of the anterior corneal surface, thus allowing a better epithelial attachment (adhesion) and may allow a stromal inflammatory reaction, favorable to the improvement of corneal biomechanics. pkt is a reliable technic; however it has not yet proven its efficiency in the treatment of keratoconus. the purpose of this study is to describe the effects of de-epithelization associated with a therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the proportion of patients who lost the evolutivity of their keratoconus, after 6 months and 1 year, after an intervention of de-epithelization associated with therapeutic photokeratectomy.


Eligibility criteria:
inclusion criteria: * patients aged from 15 to 45 years old * patients with an evolutive keratoconus * planned intervention (de-epithelization and photokeratectomy) exclusion criteria: * contra-indication to de-epithelization (active scarring corneal lesion) * pregnant women and breastfeeding * absence of the written consent to participate in the trial

Keywords: keratoconus photokeratectomy de-epithelization
the use of a community-based organization to change lifestyle characteristics related to non communicable diseases

Conditions: Diabetes; Hypertension; Stroke; Ischemic Heart Disease

Summary: this study attempts to implement a lifestyle intervention programme aimed at changing the dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old adults in the moh area, ragama and measure the effectiveness of the programme.

sri lanka as a developing nation needs to identify feasible and cost effective measures to face the epidemic of noncommunicable diseases(ncds) in the future. experiences gained over many years in the developed countries can be of great value in planning and implementing ncd prevention and control activities in the developing countries results from many studies have emphasized the fact that merely providing risk reduction measures for clinically high-risk people in health service settings would have only a limited impact in the whole country. on the other hand, if the population as a whole were to be targeted, even a modest risk factor and healthy lifestyle change would potentially have a huge public impact.this study attempts to implement a lifestyle intervention programme aimed at changing the dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old adults in the moh area, ragama and measure the effectiveness of the programme. outcome measures are process indicators, as measured by change in the dietary patterns, alcohol and tobacco consumption and physical activity. short term outcome indicators would be blood pressure and anthropometric measurements. the long term outcome indicators such as morbidity and mortality due to ncd will not be measured as this will be a short term study.

Eligibility criteria:
inclusion criteria: * adults between 25-60 years exclusion criteria: * adults with psychiatric disorders

Keywords: non communicable disease lifestyle modification community based organization community based study
differences in fat mass estimation formulas in physically active adult population and relation with skinfold sums.

Conditions: Body Weight Changes; Body Weight

Summary: the objective of the present study was to analyze the differences between the formulas used to estimate fat mass and to establish the existing relationship with the skinfold sum in anthropometry. a total of 2,458 active subjects participated in the study (mean age: 27.98±7.43 years-old). basic measurements and skinfolds variables were measured following the guidelines of the international society for the advancement in kinanthropometry (isak), and kerr, durnin-womersley, faulkner and carter equations were used to assess fat mass. significative differences were found between all the formulas for the percentage of fat mass and the fat mass in kilograms. the correlations among the skinfolds sums and the different equations were high and significative in all the cases. there were differences between all the formulas used to estimate the fat mass. the six or eight skinfold sums could be a valid and better alternative than the fat mass equations or the bmi to assess the subcutaneous fat mass in physically active adults.


Eligibility criteria:
inclusion criteria: * to be between 18 and 50 years old and to practice any sport in a regular basis exclusion criteria: * to have overweight or obesity

Keywords: fat mass body composition assessement health antropometry
observational study of triple combination therapy of zemidapa tab. and metformin in type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to evaluate the effectiveness and safety of the triple combination therapy of zemidapa tab. and metformin in patients with type 2 diabete mellitus


Eligibility criteria:
inclusion criteria: * type 2 dm patients who are receiving one of the following three therapies during which the patients are prescribed with zemidapa tab. for the first time at the discretion of the attending physician: 1. double combination therapy (metformin and a dpp-4 inhibitor other than gemigliptin) 2. triple combination therapy (metformin, a dpp-4 inhibitor other than gemigliptin, and a sglt-2 inhibitor) 3. triple combination therapy (metformin, a dpp-4 inhibitor other than gemigliptin, and sulfonylurea \[su\]) * patients with hba1c results and who signed the written consent form exclusion criteria: - patients contraindicated for the approved use of zemidapa tab. or have participated in another clinical study within 12 weeks
efficacy of mifepristone - prostaglandin analogue combination in medical termination of pregnancy beyond 7 weeks of amenorrhea

Conditions: Medical Termination of Pregnancy

Summary: this study is a non-interventional prospective, multicenter, longitudinal study conducted in france, among a representative sample of public and/or private birth control centers. the aim of the study is to assess, in real-life settings, the success rate of the protocol mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or beyond 7 weeks of amenorrhea.


Eligibility criteria:
inclusion criteria: * adult women (≥ 18 years old) with confirmed intra-uterine pregnancy consulting for medical termination of pregnancy * patients for whom the physician decides to use a mifegyne 600 mg and prostaglandin analogue combination for medical abortion * patients agreeing to participate in the study after having been informed orally by the physician and given the information sheet * informed patients accepting the computer processing of their medical data and their right of access and correction exclusion criteria: * patients with known hypersensitivity to mifepristone * patients with known hypersensitivity to prostaglandin analogues (misoprostol or gemeprost). * patients with severe and progressive disease * patients with ectopic pregnancy
spinal cord stimulation for painful diabetic neuropathy

Conditions: Diabetic Neuropathy; Pain; Peripheral Neuropathy

Summary: the purpose of this study is to evaluate spinal cord stimulation (scs) therapy in individuals who suffer from painful diabetic peripheral neuropathy. patients invited to participate in this study will be eligible for scs therapy, and will have already selected therapy with the advanced bionics precision system independent of possible inclusion in this study. the device, accessories, and procedures associated with device placement and the indications for use are all consistent with the current and approved product labeling.

the management of neuropathic pain is often difficult, and the available treatment options rarely provide complete relief. although prevention by means of glycemic control is the first priority, up to 20% of patients will develop diabetic peripheral neuropathy (dpn) and require active drug therapy. select anti-depressants, anti-epileptics, and opioids have generally been the first-line pharmacologic treatments for neuropathic pain. topical creams have been used to achieve local control. nonconventional therapies have included acupuncture and magnet therapy. however, all of these treatments have limited utility because of marginal efficacy. various forms of electric stimulation have been shown to improve the symptoms of dpn. advances in spinal cord stimulation technology have encouraged broader use of this treatment modality in the management of chronic painful dpn.

Eligibility criteria:
inclusion criteria: * have chronic neuropathic pain in at least one limb with a score of at least 3 using the michigan neuropathy screening instrument (mnsi) secondary to type 1 or type 2 diabetes * have chronic neuropathic pain for at least 12 months * be 18 years of age or older * be refractory to pain medication including gabapentin or the use of pain medication is contraindicated or not tolerated because of side effects or other medical condition * be an appropriate candidate for scs therapy and have already decided to use the precision system * be willing and able to comply with all study related procedures and visits * be capable of reading and understanding patient information materials and giving written informed consent exclusion criteria: * are a smoker * have any other chronic pain condition likely to confound evaluation of study endpoints * have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints such as peripheral vascular disease or neurological disorders unrelated to diabetic neuropathy

Keywords: pain implantable stimulation device neuropathy
a qualitative study on treatment adherence in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: qualitative observational study with the aim to explore medication adherence in a sample of patients with metastatic breast cancer. patients with metastatic breast cancer receiving or having received oral oncologic therapy, and attending the division of medical senology at the european institute of oncology, will be included and enrolled in this research project."

the aim of this research project is to assess the barriers and resources (both individual and environmental), as well as the psychological, clinical, and contextual factors that may influence adherence to pharmacological therapy in patients with actively treated metastatic breast cancer. this will be achieved through a qualitative analysis focused on pharmacological therapy and its administration methods. for this study, 4 focus groups will be conducted to identify the needs, barriers, and psychological, clinical, and contextual factors that may influence adherence to pharmacological treatment in patients with metastatic breast cancer, as well as their preferences regarding these treatments. the number of focus groups was determined in accordance with recommendations from the literature for identifying relevant themes, which suggest that to achieve an adequate level of saturation, four or more focus groups are necessary.

Eligibility criteria:
inclusion criteria: * age over 18 years old; * diagnosis of metastatic breast cancer; * availability of an internet connection and a pc or tablet (for remote focus groups); * signing of the informed consent. exclusion criteria: * presence of psychiatric or neurological conditions impairing the ability to comprehend the questions in focus groups or to express free consent to participate in the study; * presence of medical or oncological conditions other than metastatic breast cancer; * refusal to sign the informed consent.
clinical evaluation of hpt treated rigid contact lenses made from roflufocon d

Conditions: Ametropia

Summary: this will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. all subjects will wear the test lens in one eye and the control lens in the other eye. data from the first four weeks of test and control lens exposure will be used for the fda 510 (k) submission.


Eligibility criteria:
inclusion criteria: * willing and able to sign the informed consent form * aged ≥18 years old * experienced wearer of rigid gas permeable contact lenses * subject's habitual contact lenses must be made of contamac's optimum extra (roflufocon d) material * subjects must have owned spectacles or contact lenses prior to enrolment for this trial * spherical power between -10.00 d and +10.00 d (at vertex distance 0 mm) * corneal astigmatism ≤2.00 d exclusion criteria:• eye injury or surgery within 3 months immediately prior to enrolment for this trial * pre-existing ocular irritation that would preclude contact lens fitting * currently enrolled in an ophthalmic clinical trial * evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator * any use of medications for which contact lens wear could be contradicted, as determined by the investigator * current extended-wear users (sleep-in overnight) * current monovision lens wearers * current wearers of multifocal contact lenses * current wearers of toric contact lenses (front surface design) * current wearers of astigmatic contact lenses (posterior surface design) * has a reported "strong" comfort or vision preference between each eye with their habitual rgp lenses * unacceptable fit of habitual lenses * pregnant women and nursing mothers * best-corrected visual acuity worse than 6/9 (logmar: +0.20; snellen decimal: 0.63)
pgl2001 proof of concept study in symptomatic endometriosis

Conditions: Endometriosis

Summary: this is a phase ii, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor pgl2001 with concomitant, continuous neta administration for the treatment of pain symptoms suggestive of endometriosis. the target population will be women of reproductive age with symptoms suggestive of endometriosis.


Eligibility criteria:
inclusion criteria: * provide written informed consent prior to initiation of any study related procedures. * be a woman of reproductive age between 18 and 45 years inclusive. * present with clinical signs suggestive of endometriosis. * be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit. exclusion criteria: * be pregnant or currently lactating. * have diseases or suspected diseases which may cause pelvic pain not due to endometriosis. * have had any surgical treatment for endometriosis within the last 12 months. * have documented significant adenomyosis. * have participated in another clinical trial within the 30 days prior to the screening visit.
combined inhalational with intravenous amphotericin b versus intravenous amphotericin b alone for pulmonary mucormycosis

Conditions: Pulmonary Mucormycosis

Summary: to assess the safety and feasibility of combined inhalational and intravenous amphotericin b therapy for the treatment of pulmonary mucormycosis. and compare the efficacy of combined therapy with that of intravenous amphotericin b alone.

pulmonary mucormycosis is a relatively a rare disease with a high mortality. the angioinvasion associated with mucormycosis prevents efficient drug delivery at the diseased site. inhaled amphotericin b achieves drug levels in lung tissue and has been shown to be useful in several diseases including chronic pulmonary and allergic bronchopulmonary aspergillosis. further inhaled forms of amphotericin b are associated with less nephrotoxicity and other systemic adverse effects. the role of inhaled amphotericin b in pulmonary mucormycosis has been previously demonstrated in murine models and anecdotal reports. the study hypothesis is that combined therapy with inhalational and intravenous amphotericin b is likely to result in better outcomes as compared with intravenous amphotericin b alone for treatment of pulmonary mucormycosis

Eligibility criteria:
inclusion criteria: subjects with a clinicoradiologic suspicion of pulmonary mucormycosis will be enrolled if the diagnosis of mucormycosis is pathologically or microbiologically (smear showing aseptate hyphae, culture or molecular evidence showing mucorales) confirmed. cases of disseminated mucormycosis will be included, only if the pulmonary infection is confirmed pathologically or microbiologically from respiratory secretions or biopsy samples exclusion criteria: * lack of informed consent * hypersensitivity to amphotericin b or any component of the formulation * pregnancy * high likelihood of death within 48 h of enrolment * suspected pulmonary mucormycosis without histological or microbiologic proof