Kornimate/medical-research-clean huggingface dataset:
systane® ultra preservative free lubricant eye drops

Conditions: Dry Eye

Summary: the purpose of this post-market clinical follow-up (pmcf) study is to assess the performance and safety of systane ultra preservative-free (pf) in subjects experiencing dry eye symptoms (group 1) and contact lens (cl) wearers experiencing discomfort due to cl-related dryness (group 2). statistical analyses will be presented by group. this study will be conducted in canada, australia, and new zealand.

subjects will participate in the study for approximately 30 days, with a phone call scheduled on day 15 ± 2 (visit 2) and a follow-up visit scheduled on day 30 ± 2 (visit 3). subjects will be asked to complete patient questionnaires on day 1 and at visit 3 (impact of dry eye on everyday life - symptom bother \[ideel-sb\] or contact lens dry eye questionnaire \[cldeq-8\] and comfortable wear time questions).

Eligibility criteria:
inclusion criteria: * subject must be able to understand and sign an informed consent form * subject with mild to moderate dry eye * subject with cl-related dry eye symptoms * other protocol-defined inclusion criteria may apply exclusion criteria: * has suffered any ocular injury to either eye in the past 3 months prior to screening. * has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study. * other protocol-defined exclusion criteria may apply
evaluation of topical and intravenous tranexamic acid in surgical treatment of lumbar degenerative disease

Conditions: Lumbar Disc Degeneration; Surgical Procedure, Unspecified

Summary: evaluation of topical and intravenous tranexamic acid in surgical treatment of lumbar degenerative disease


Eligibility criteria:
spirulina supplementation and cardiovascular risk in obese caucasians with treated hypertension

Conditions: Obesity

Summary: potential protective cardiovascular effect of spirulina maxima supplementation was studied in a double-blind placebo-controlled trial of obese subjects with treated hypertension, each randomized to receive spirulina or a placebo.

numerous publications have provided evidence of the effect of natural substances-supplements on improving endothelial function, and thus reducing the risk of cardiovascular diseases. spirulina maxima (arthrospira maxima) is a species of cyanobacterium, used as food additive because of its high levels of protein and essential nutrients, such as carotenoids, vitamins, and minerals. various studies point to a possible beneficial effect of spirulina on the concentration of blood serum lipids and fasting glucose,body weight or blood pressure, however, the results of studies pertained to the effects of spirulina in individuals who, at the time of trial, were not taking medications. the aim of the study was to estimate an effect of spirulina maxima supplementation on cardiovascular risk in obese caucasians with treated hypertension. the anthropometric parameters, blood pressure, insulin sensitivity, plasma lipid levels, and stress oxidative biomarkers were measured at the baseline and after 3 months of supplementation with spirulina or placebo in the group of obese, hypertensive patients receiving standard antihypertensive treatment.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) equal to or greater than 30 kg/m2 * age 25 to 60 years * stable body weight (\< 3 kg self-reported change during the previous three months) * well-controlled hypertension (meaning systolic blood pressure (sbp) less than 160 mmhg and/or diastolic blood pressure (dbp) less than 100 mmhg) with stable treatment for at least 6 months (the patients received one drug only) exclusion criteria: * secondary obesity or secondary hypertension * diabetes * a history of coronary artery disease * stroke * congestive heart failure * malignancy * a history of use of any dietary supplements within the three months prior to the study * a current need for modification of antihypertensive therapy * abnormal liver or kidney function * any clinically significant process * a history of infection in the month prior to the study * nicotine or alcohol abuse * or other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the protocol-specified efficacy assessments

Keywords: spirulina, placebo, obesity,antihypertensive treatment
impact of obstructive sleep apnea (osa) treatment on blood pressure control in chronic kidney disease

Conditions: Sleep Apnea; Chronic Kidney Diseases

Summary: the role of obstructive sleep apnea (osa) on chronic kidney disease (ckd) is not clear. this randomized clinical trial will test the impact of osa treatment on blood pressure (bp) and on the estimated glomerular filtration rate (egfr) in patients with ckd iiib and iv (egfr 44-15 ml/min). a polygraph will be performed to assess the presence of osa (defined by an apnea-hypopnea index ≥15 events/hour). patients with osa will be randomized to use continuous positive upper airway pressure (cpap) or to maintain optimized clinical treatment for bp control. antihypertensive medication adjustments will be allowed using a standard protocol for both groups by the same researcher, who will not have access to cpap follow-up. in addition to clinical (including bp and ambulatory bp monitoring, abpm) and laboratory assessments at baseline, we will follow up at 3 months, 6 months, 9 months and 12 months after randomization of the proposed outcomes. target organ damage analyses, such as the retina and echocardiography, will be performed at baseline and after 1 year of randomization. primary objective: to compare the effect of cpap on the need to adjust antihypertensive medication to control systolic bp (\<130mmhg) in patients with ckd; secondary objectives: 1) to evaluate the reduction in systolic and diastolic bp by office and abpm; 2) assessment of nocturnal bp dipping; 3) to evaluate the impact of osa treatment with cpap on egfr during follow-up; 4) to evaluate the impact of osa treatment with cpap on the evolution of albuminuria; 5) assessment of other target organ damage such as retinopathy and cardiac remodeling; 6) to evaluate the impact of osa treatment with cpap on the possible delay for renal replacement therapy or end-stage renal disease (egfr \<15ml/min and dialysis); 7) to evaluate the impact of osa treatment with cpap on the quality of life of patients with ckd. with a significance level of 5% and study power of 90%, two-tailed hypothesis testing, 74 patients with osa per group, i.e., 148 patients in total, will be required to assess the primary endpoint (we estimate that 25% and 50% of patients in control and cpap groups will not need to adjust their antihypertensive medication at follow-up, respectively).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of hypertension: use of oral antihypertensive drugs or systolic bp (sbp) \>140 mmhg and/or diastolic bp (dbp) \>90 mmhg on 2 office measurements or \>130x80 mmhg (24 hours abpm). * egfr by the ckd-epi equation between 45 ml/min/1.73m2 and 15 ml/min/1.73m2 (in conservative treatment of ckd). exclusion criteria: * professional drivers; * home supplemental oxygen users; * patients under current treatment for osa; * pregnant women; * patients with malignant neoplasms or terminal illnesses; * severe asthma or chronic obstructive pulmonary disease; * patients with systemic lupus erythematosus, amyloidosis or systemic sclerosis; * patients with a history of solid organ transplants.
comparison between two operational techniques for total knee replacement

Conditions: Gait, Unsteady; Knee Arthropathy; Surgery

Summary: advance knee osteoarthritis is treated by total knee replacement. since the first tkr in 1973 there has been continuous advance in implant technology as well as operative technique, yet current patient satisfaction after the procedure is accepted to be about 80%. there are a few operative techniques to perform tkr. until recently the most common technique is the anterior approach to the knee and then using mechanical instrumentation to make the bone cuts for the femur and tibia. a second popular technique is the anterior approach to the knee and then using a kinematic alignment to make the bone cuts. the investigators wish to compare short term results of the two operative techniques as evidenced in patient objective functional scores and also by evaluating the gait of the patients by using the rehagait analyzer pro by hasomed inc. magdeburg germany.


Eligibility criteria:
inclusion criteria: - patients after total knee replacement which was performed in our ward. exclusion criteria: * less than 6 months have passed after the procedure * inability to understand and fill out proms questionnaires. * inability to walk without aids for at least 20 meters.

Keywords: total knee replacement gait analysis proms mechanical aligment kinematic alignment
direct angioplasty for non st elevation acute coronary events: dance pilot study

Conditions: Acute Coronary Syndrome

Summary: this is a pilot feasibility study to evaluate if patients with st depression acute coronary syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/- stents will fare better that patients who are taken to the ward area and managed with drug therapy and stabilised for 24 hours before being taken to the catheter laboratory.


Eligibility criteria:
inclusion criteria patients presenting with symptoms (onset of symptoms ≤ 12 hours) of a suspected acute coronary syndrome (unstable angina or mi without persistent st elevation) characterised as follows * clinical history consistent with ongoing ischaemic chest pain and/or symptoms and * \>1mm st depression and/or ≥2mm t wave inversion in at least two adjacent ecg leads pathological t wave inversion in leads 1+4 suggesting 'lad syndrome' or ischaemic st depression/t wave inversion not fulfilling the above criteria that is felt in the opinion of the attending physician to represent an acute coronary syndrome. and * written informed consent main exclusion criteria 1. ≤ 18 years of age 2. previous coronary artery bypass grafting surgery 3. st elevation myocardial infarction 4. left bundle branch block (lbbb) 5. st depression seen in patients during paced mode only 6. heart rate ≥ 150bpm 7. cardiogenic shock or other catastrophic state 8. if in the opinion of the physician the patient is not suitable for revascularisation due to co-morbidity 9. patient participating in another clinical trial such that randomisation to dance would result in deviation from the protocol stipulations of either trial.

Keywords: st depression
supra-pectineal qls plating vs infra-pectineal plating in management of quadrilateral plate fractures

Conditions: Evaluation of QL Buttress Plating in QLP Fracture Fixation

Summary: the investigators conducted such a prospective randomized controlled study aiming to reach a satisfactory outcome and to compare supra-pectineal ql buttress plating versus infra-pectineal for management of anterior column with or without posterior hemi-transverse component and quadrilateral plate involvement.

our hypothesis was that supra-pectineal quadrilateral buttress plating provides much more rigid fixation and a strong buttress for medial wall migration, also it could correlate with a better functional and radiological outcome. however, there is a lack of knowledge in the prospective assessment of functional and radiological outcomes and follow up of postoperative complications of supra-pectineal quadrilateral buttress plating versus infra-pectineal plating in fixation of qls and to our knowledge, it will be the first study to include such measures of outcome together in a prospective randomized fashion.

Eligibility criteria:
inclusion criteria: * anterior column fracture acetabulum with qls involvement * anterior column posterior hemi-transverse fracture acetabulum with qls involvement * age between 16-60 years' old exclusion criteria: * open fractures * associated pelvic ring injuries that require intervention * associated internal organ injuries that require intervention * age less than 14 years and older than 60 years

Keywords: quadrilateral plate fractures anterior column fractures associated both column fractures infra-pectineal plating supra-pectineal quadrilateral buttress plating
interdisciplinary rehabilitation for chronic pain in primary healthcare

Conditions: Chronic Pain; Pain Management

Summary: purpose: the overall aim is to investigate the effect of interdisciplinary rehabilitation in primary health care (phc) for patients with chronic pain. specific questions: what is the effect of extended access to the interdisciplinary phc pain team + a booster session after finishing the rehabilitation program? does participation in phc interdisciplinary rehabilitation contribute to health improvements and are there predictors of this? method: a randomized controlled trial (rct). 200 patients with chronic pain that participate in interdisciplinary rehabilitation in primary healthcare in region västra götaland (vgr) in sweden will be included in the rct and randomized to intervention; standard care by the interdisciplinary teams in phc + extended access to the team and a booster session 3 months after the end of the rehabilitation, or control; only standard care by the interdisciplinary teams. outcomes are health related quality of life, pain intensity and other health aspects.

the participants will be randomly allocated to intervention or active control. all participants in both arms receive the standard care for interdisciplinary rehabilitation at any of the six phc pain teams in vgr. the teams consist of a physician, physiotherapist, occupational therapist and psychologist. all teams provide person-centred rehabilitation, aiming to increase physical activity and support behavioural changes, and to decrease symptoms and the impact of pain on the patients´ daily lives. the standard care interdisciplinary rehabilitation period contains both theoretical and practical components such as patient education, physical exercise and behavioural interventions. the sessions are mainly group-based. the duration of the rehabilitation period varies between 5 to 7 weeks + a follow-up visit after 3 months. the participants in the intervention arm also receive an extra booster-session 3 months after the standard follow-up. at the booster-session, the participant´s individual rehabilitation plan is followed-up and adjusted. this extra period also includes extended access to the team, meaning that the participants have the possibility to contact the team and, if needed, have digital or telephone contact. the participants complete a battery of questionaires included in the swedish quality registry for pain rehabilitation an also extra questionnaires provided to the participants through an electronic research form. data collection is made at baseline before starting the rehabilitation, directly after the 5 to 7 weeks rehabilitation period and 6, 12 and 24 months after baseline.

Eligibility criteria:
inclusion criteria: * persons participating in interdisciplinary team rehabilitation in primary healthcare in region västra götaland, sweden. exclusion criteria: * severe psychiatric disease, language difficulties that makes it impossible to complete the questionnaires

Keywords: randomised controlled trial primary care
navigated transcranial magnetic stimulation in tumor surgery

Conditions: Brain Tumors

Summary: maximizing surgical removal of brain tumors while minimizing neurologic deficits is challenging. functional brain tissue may reside close to or even within the abnormality, and inadvertent removal or disturbance of such areas can result in neurologic deficits. at present, the gold standard for identifying critical motor areas in tumor surgery is intraoperative invasive direct current stimulation (dcs) through a handpiece. more recently, new non-invasive preoperative method for brain mapping, functional magnetic resonance imaging (fmri), may be used to identify the eloquent motor areas. fmri signals used in localization of the motor areas are generated when the brain is activated during the performance of specific motor tasks. however, as fmri signals are also generated by sensory input, the resulting fmri map may include sensory as well as motor areas. nexstim has developed a navigated brain stimulation (nbs) system that uses tms with a software based navigational system that together may have more specific spatial accuracy. this study aims to determine whether navigated tms is able to identify the eloquent motor cortical areas in patients with brain tumors and to determine the clinical accuracy of the procedure by comparing it to results obtained by intraoperative dcs and fmri.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 years of age and over. * a brain tumor in the vicinity of the central region. * mild (bmrc grade 4/5) or no paresis. * obscured anatomy of the central region due to the mass effect/infiltrating growth pattern of the lesion * scheduled for elective surgery under general or local anesthesia. * no other known brain abnormalities by history or by structural mri. * mentally and physically able to undergo mr imaging (fmri, dti) and navigated tms studies * signed informed consent form. exclusion criteria: * implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump. * pregnant or trying to become pregnant. * history of alcohol abuse, illicit drug use or drug abuse or significant mental illness * hypertensive or hypotensive condition. * any condition that would prevent the subject from giving voluntary informed consent. * an implanted brain stimulator. * aneurysm clip or other metal in the head (except mouth * enrolled or plans to enroll in an interventional trial during this study. * scalp wounds or infections. * claustrophobia precluding mri * frequent seizures (\>1/week)
safety, pharmacokinetic and pharmacodynamic study of mp-376 in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: patients with cystic fibrosis (cf) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in cf patients. aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat cf patients with pulmonary infections caused by multi-drug resistant pseudomonas aeruginosa and other bacteria. high concentrations of mp-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms and reduce the emergence of resistant bacteria.

this trial will be a single-blind, placebo-controlled, dose escalating between cohorts, single and multi-dose, multi-center study to evaluate the safety, tolerability and pharmacokinetic profile of levofloxacin administered as mp-376 once, then twice daily for 14 days by the aerosol route to cf patients. study acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * \> 16 years of age * confirmed diagnosis of cystic fibrosis * positive sputum culture for p. aeruginosa within the past 6 months * patients are able to elicit an fev1 \>/= 40% of predicted value at screening * clinically stable with no evidence of acute respiratory or lower respiratory infections within 28 days prior to dosing * able to reproducibly perform spirometry measurements and be able to repeatedly produce sputum over several hours exclusion criteria: * use of any nebulized or systemic antibiotics within 4 weeks of starting study * history of hypersensitivity to fluoroquinolones or intolerance with aerosol medication * uncontrolled diabetes or abnormal renal function * tobacco use (smoking) in the last 30 days
effects of "telerehabılıtatıon based structured home program implementatıons" chıldren with cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of the study is to examine the effectiveness of telerehabilitation based structured home program implementations on functional status, activity and participation in preschool children with cerebral palsy.

the structured home program will consist of activities determined by the family members according to the functional level of the child and the activities child can't do, and which are determined according to the goals specific to the child. in order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided. after the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. video interviews will be the telerehabilitation part of the study. during routine physiotherapy and rehabilitation practices, activities organized by physiotherapists as one or two sessions per week according to the functional levels of children with cp. routine physiotherapy and rehabilitation applications include increasing postural control, gaining motor development steps, strengthening training, balance training, long-term stretching training, manual therapy, hydrotherapy, hippotherapy and neurodevelopmental therapy approaches. telerehabilitation-based structured home program applications, which are given in addition to routine physiotherapy and rehabilitation applications, and only individuals who receive routine physiotherapy and rehabilitation will be followed for 24 weeks. individuals who receive routine physiotherapy and rehabilitation will be monitored only for control purposes, and a structured home program will be given to the group that receives telerehabilitation based structured home program practices, which are given in addition to routine physiotherapy and rehabilitation applications. the researcher will not be included in the program of the group that only benefits from routine physiotherapy and rehabilitation practices. a total of three evaluations will be made for both groups, after the training before the training and after 12 weeks from the training.

Eligibility criteria:
inclusion criteria: 1. being in preschool period (3-5 years old) 2. receiving routine physiotherapy and rehabilitation services 2 sessions in a week 3. family members being active mobile phone or computer and internet users exclusion criteria: 1. uncontrolled epileptic seizures 2. incomplete assesments 3. family's discontinuation of treatment

Keywords: telerehabilitation cerebral palsy home program participation activity