Kornimate/medical-research-clean huggingface dataset:
comparing high and low dose iron treatments for people on peritoneal dialysis: the paladin study

Conditions: Peritoneal Dialysis; Anaemia; Iron Deficiency, Anaemia

Summary: chronic kidney disease affects a significant portion of the uk population, with approximately 3.5 million adults diagnosed. at its most severe stage, end-stage kidney disease, individuals require frequent dialysis treatment. one form of dialysis, known as peritoneal dialysis, involves introducing and removing fluid from the abdominal cavity to help filter out toxins from the body. the kidneys are involved in various hormonal processes, including those responsible for producing red blood cells, making anaemia a common consequence of kidney failure. when designing a clinical trial to evaluate the effectiveness of any treatment, it is essential to determine the number of suitable and willing participants, as well as those who can complete all required tests and measurements. identifying the most appropriate measurement to assess the impact of intravenous iron (iron injected directly into veins) is crucial to ensure that any observed changes are meaningful to people with ckd and their carers. to address these considerations, the investigators will conduct a pilot feasibility trial. in this trial, individuals with kidney disease undergoing peritoneal dialysis will be randomly assigned to receive either high-dose or low-dose intravenous iron, or oral iron therapy. over twelve months, the investigators will monitor their anaemia response, symptoms of kidney disease, quality of life, physical performance (such as the ability to walk for six minutes), and cognitive function. additionally, the investigators will assess the impact of each intervention on the frequency of blood transfusions, whether those on oral iron require intravenous iron, and any changes in the dosage of erythropoietin-stimulating agents (drugs that increase blood production).


Eligibility criteria:
inclusion criteria: * males and females aged ≥18 years. * able to give informed consent * serum ferritin \<700ug/l * transferrin saturation level \<40% * no intravenous iron for last 4 weeks before randomisation (patients may be pre-identified and included after 4-week washout period) * received maintenance peritoneal dialysis therapy for at least 4 weeks * expected to remain on peritoneal dialysis therapy for duration of study exclusion criteria: * inadequate dialysis deemed by responsible clinician * probability of need for transfusion within 1 week of enrolment * anticipated major surgery that the responsible clinician feels will impact response to treatment * haemochromatosis / haemosiderosis or alt \>x3 normal * are deemed to be most suited to best-supportive or end-of-life care at time of screening * women of childbearing potential not using effective means of contraception * have been involved in another medicinal study (ctimp) within past 4 weeks * known allergy or adverse reaction to oral or intravenous iron preparations * crp \>50, tsats \>40%, sf \>700 at time of recruitment * active infection, hiv, active hep b or c * are unable or unwilling to consent to or complete the study procedures
study to assess the benefit of midodrine in the treatment of patients with neurogenic orthostatic hypotension

Conditions: Hypotension, Orthostatic

Summary: the purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (proamatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ecg, using the tilt table test.


Eligibility criteria:
inclusion criteria: * the male or female subjects must be 18 years of age or older and ambulatory. (subjects must not require assistance with a walker or wheelchair to perform regular daily activities at all times.) * women of childbearing potential must have a negative serum beta hcg pregnancy test at screening and baseline. * the subject has been diagnosed with symptomatic orthostatic hypotension due to parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathy (i.e. neurogenic orthostatic hypotension). * the subject manifests one of the following symptoms while standing or has a history of one of the following when not treated for orthostatic hypotension: dizziness, lightheadedness, feeling faint or feeling like they may black out. * the subject is willing and able to undergo the procedures required by this protocol including morning office visits, assessment completion, protocol compliance and participation in the wash-out period. * the subject has signed an institutional-review-board approved written informed consent form prior to any study procedures taking place. exclusion criteria: * the subject is a pregnant or lactating female. * the subject has pre-existing sustained supine hypertension greater than 180 mm hg systolic and 110 mm hg diastolic. * the subject is taking medications such as vasodilators, pressors, diuretics, ace inhibitors, angiotensin receptor blockers, beta-blockers, combined alpha and beta-blockers, maoi's, herbals or specific mixed effect medications. * the principal investigator deems any laboratory test abnormality clinical significant. * the subject has a diagnosis of any of the following disorders at the time of screening: pheochromocytoma; cardiac conditions including: congestive heart failure within the previous 6 months, myocardial infarction within the previous 6 months, symptomatic coronary artery disease, history of ventricular tachycardia, or uncontrolled cardiac arrhythmias; thyrotoxicosis; uncontrolled diabetes mellitus (uncontrolled defined as a hgba1c greater than or equal to 10%); history of cerebrovascular accident, transient ischemic attack (tia) or symptomatic carotid artery stenosis within the previous 6 months; history of coagulopathies; pulmonary hypertension; severe psychiatric disorders; renal failure (creatinine equal to or greater than 2 times the upper limit of normal) * the subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of the tests and/or measurements administered in this trial, or that might increase the risk to the subject.
acupuncture for dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: this study is about the effectiveness of acupuncture treatment on dry eye syndrome. study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. this is a randomized, patients-assessor blinded, sham acupuncture controlled study. additionally, the investigators will assess the safety of acupuncture treatment.


Eligibility criteria:
inclusion criteria: * patients who have had dry eye syndromes in single eye or in both eyes e.g. other disorders of lacrimal gland: dry eye syndrome (icd-10: h04.1). he or she must have both of the conditions below: 1. patients who have had such symptoms like ocular itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing 2. patient whose tear film break-up time (but) is below 10 seconds and measured tear amount is below 10mm/5sec by schirmer 1 test exclusion criteria: * those who have defects of eyelid or eyelashes * those who have acute infection of eyelid, eyeball or accessories of eye * those who have stevens-johnson syndromes or pemphigoids * those who have vitamin a deficiency * those who have any defects of eye or accessories of eye by external injuries * those who have undergone any surgical operation for eye during last 3 months * those who are using contact lens * those who have any difficulties about eye opening or eye closing due to facial palsy * those who have undergone punctual occlusion surgery * those who have used any kinds of anti-inflammatory eyedrops for recent 2 weeks (steroids, cyclosporin or autologous serum eyedrops) * those who have systemic immune therapy * those who are pregnant or have any plan for pregnancy * those who are not appropriate to this study by investigators decision

Keywords: acupuncture dry eye syndrome ocular surface disease index schirmer test tear film break-up time
the effectiveness of chlorhexidine gluconate on prevention of catheter-related bloodstream infections

Conditions: Central Venous Catheter Related Bloodstream Infection; Catheter-Related Infections; Bloodstream Infection Due to Central Venous Catheter

Summary: catheter-related bloodstream infections are associated with increased mortality, morbidity, and length of hospital stay. the incidence has decreased significantly with the strict implementation of preventive bundle cares and checklists in intensive care units. bathing with solutions containing chlorhexidine has been included in preventive strategies in recent years. although some studies have shown that chlorhexidine bathing reduces the frequency of hospital-associated infections, there are important differences in management of practice and adherence to practice in different facilities. the majority of the studies conducted include adult patients. according to the cdc guidelines, chlorhexidine bathing is recommended for children over 2 months of age to prevent catheter-related bloodstream infection. the aim of this study is to investigate the effect of daily bathing with 2% chlorhexidine gluconate solution in preventing catheter-related bloodstream infections in pediatric patients with temporary central venous catheters.

in patients with a central catheter for longer than 48 hours, the diagnosis of bloodstream infection will be recorded as laboratory-confirmed bloodstream infections according to cdc diagnostic criteria. microorganisms detected in cultures will be classified as gram-positive and gram-negative or fungal agents. infection with the resistant microorganism will be compared with the control group. catheter colonization; be defined as bacterial growth of more than 15 colonies in the semiquantitative culture or 1000 colonies in the quantitative culture of the catheter segment or hub without clinical symptoms. patients in both groups with a central catheter for longer than 48 hours will be treated with a standard bath every 72 hours. in addition to the control group, patients in the study group will be treated daily with 2% chlorhexidine gluconate, and the patients in these two groups will be compared in terms of catheter-related bloodstream infections and catheter colonization.

Eligibility criteria:
inclusion criteria: * patients between the ages of 2 months and 18 years who had a temporary central venous catheter * patients whose follow-up is continued for at least 48 hours with a central venous catheter exclusion criteria: * patients younger than 2 months of age * patients with a intensive care unit stay shorter than 48 hours * immunosuppressive patients * patients with a history of allergic reaction to chlorhexidine * patients with skin lesions that interfere with skin cleansing with chlorhexidine * patients whose family did not give consent

Keywords: chlorhexidine gluconate catheter-related bloodstream infections
standardization research of tcm syndrome differentiation and treatment on advanced breast cancer

Conditions: Breast Cancer; Bone Metastasis

Summary: the purpose of this clinical research study is to learn if the clinical effects of combined chinese herbal medicine with endocrine therapy is better than endocrine therapy alone in improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

objectives: * evaluate the effect of the chinese herbal medicine on relieving the bone pain for patients with breast cancer bone metastasis. * evaluate the effect of the chinese herbal medicine on improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis. outline: this is a randomized,multicentric, placebo-controlled, double-blind study. patients are dynamic randomized to one of two treatment arms. * arm i:patients receive traditional chinese medicine(trial drugs) and endocrine therapy for 3 months. * arm ii:patients receive placebo and endocrine therapy for 3 months. all patients will be followed up for another 3 months with the trial drugs and endocrine therapy. according to the sample size estimate:there are 296 patients (148 per treatment arm)will be collected in this trial.

Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer and hormone receptor positive. * bone metastasis and have a measurable foci. * tcm syndrome type is deficiency of both vital energy and yin ;maladjustment of chongren with deficiency yang syndrome. * the karnofsky score ≥60. * vas score ≥3. * expected survival at least 6 months or greater. * age between 20 to 70(include 20 and 70). * the function of cardiovascular,hepar,renal and hematopoieses is relatively normal. exclusion criteria: * women during the pregnancy or breast feeding. * with a cardiovascular,hepar,renal,hematopoieses or other serious complications. * be allergic to the trial drugs. * participating in other trials.

Keywords: breast cancer bone metastasis traditional chinese medicine(tcm)
review of breast abscess management

Conditions: Breast Abscess

Summary: breast abscesses are an unfortunate pathology that develop in patients, and treatment is often painful and unpleasant. the goal of this study is to identify risk factors associated with failure of aspiration as a primary intervention as opposed to incision and drainage in the hopes of adequately treating patients at initial presentation.

the pendulum has now swung toward minimally invasive aspiration as the primary treatment modality, with multiple studies reporting superior cosmetic results. however, patients in these studies often required repeat breast aspirations, and sometimes ultimately required incision and drainage. aspiration first for treatment of breast abscess may not be a wise choice for all patients if it results in increased antibiotic days, return to emergency department (ed)/increased cost, or prolonged pain from multiple procedures. several studies have identified varying risk factors for aspiration failure as primary intervention for breast abscesses. more data is needed to confirm the true risk factors for failure.

Eligibility criteria:
inclusion criteria: * • ≥18 years of age * new diagnosis of n61.1 recorded in their electronic medical record (emr) exclusion criteria: * • \<18 years of age * pregnant * incarcerated
evaluation of effectiveness of gsk biologicals' pneumococcal conjugate vaccine 1024850a against invasive disease

Conditions: Infections, Streptococcal; Streptococcus Pneumoniae

Summary: the aim of this study is to assess the effectiveness of gsk biologicals' pneumococcal conjugate vaccine (gsk1024850a), administered according to different vaccination schedules, against invasive disease caused by s. pneumoniae or h. influenzae as well as vaccine impact on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions. this study will also explore vaccine impact on occurrence of respiratory tract infections (rtis), including acute otitis media (aom) in a subset of children in turku area.

the protocol posting has been updated with regards to the enrolment of subjects and outcome measures following protocol amendment 2, 22 august 2011.

Eligibility criteria:
inclusion criteria: * male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination. * written informed consent obtained from parent(s) or from the guardian(s) of the subject. exclusion criteria: * previous vaccination with any registered, non-registered or investigational pneumococcal vaccine other than the study vaccine, or planned use during the study period. if a child belongs to a high risk group for pneumococcal infections for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program. * previous vaccination against hepatitis b virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period. * previous vaccination against hepatitis a virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period. * known severe hypersensitivity to any component of the study vaccines, including neomycin. * any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.

Keywords: pneumococcal conjugate vaccine invasive disease respiratory tract infections haemophilus influenzae streptococcus pneumoniae acute otitis media pneumonia
assessment of bioimpedance and vitamin d and lv mass in pd patients (fluid study)

Conditions: Disorders Associated With Peritoneal Dialysis

Summary: the main purpose of this study is to compare the effects of using bio-impedance analysis to guide management of fluid status versus routine clinical care on heart structure. in addition, vitamin d is being assessed to determine its effect on heart structure.

patients on peritoneal dialysis are frequently hypervolemic which is associated with deleterious changes in left ventricular (lv) architecture including increased lv mass. in dialysis patients, increased lv mass is associated with death. recent randomized trials have demonstrated that increasing small solute clearance is not associated with improved outcomes - hence an increased interest in the management of volume control in esrd patients. bioimpedance analysis is inexpensive, safe and easy to use and appears to be more useful than other techniques to assess volume status in dialysis patients. in addition, dialysis patients are vitamin d deficient and this is also associated with an increased lv mass and its inherent complications. this study will evaluate the use of bioimpedance analysis versus usual care to assess and manage volume status and the use of vitamin d versus placebo in peritoneal dialysis patients and its effect on lv mass as measured by cardiac mri.

Eligibility criteria:
inclusion criteria: * age ≥18 years * on peritoneal dialysis exclusion criteria: * contraindication to mri including presence of a pacemaker, defibrillator, ferromagnetic cerebral aneurysm clips, cochlear implants or eye prosthesis, neurostimulators, shrapnel in vital locations, surgery within 6 weeks, severe claustrophobia and severe obesity * previous amputation * life or technique expectancy \< 1 year * pregnancy * peritonitis in previous 3 months * currently using more than one extraneal bag per 24-hours * known icodextrin allergy * currently using non-baxter pd solutions * inability to provide consent * allergy to cholecalciferol * serum calcium \> 2.55 mmol/l

Keywords: peritoneal dialysis impedance, bioelectric hypertrophy, left ventricular fluid status volume overload congestive heart failure cardiovascular outcomes randomized controlled trial
exercise training in venous insufficiency

Conditions: Venous Insufficiency

Summary: the aim of this study is to evaluate the effects of exercise training in addition to compression therapy on clinical severity, vein diameter, reflux and quality of life in venous insufficiency patients.

volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to istanbul university istanbul medical faculty cardiovascular surgery department will be included this study. participants will be randomly allocated 2 groups using the 'research randomizer' website. in both groups, a common evaluation protocol will be applied to the patients. exercise training in addition to compression bandages will be applied to first group, compression bandages will be applied to second group.

Eligibility criteria:
inclusion criteria: * diagnosis of venous insufficiency with duplex ultrasonography * classification of ceap (clinical-etiological-anatomical-pathological) used in venous insufficiency is c3-c4-c5-c6 * ankle-brachial index (abi) is less than 0.7 * possibility to communicate in written and verbal in turkish * have a level of cognitive ability to understand the instructions given exclusion criteria: * presence of deep vein thrombosis * ulceration or open burn wound in lower extremity greater than 4 cm * presence of infected ulceration * cardiorespiratory insufficiency * orthopedic, rheumatologic or neurological comorbidities restrain the exercise in lower extremity * presence of a psychiatric illness requiring the use of prescribed medicines

Keywords: venous insufficiency exercise compression bandages duplex doppler ultrasonography
evaluating a lifestyle intervention to prevent recurrence of diabetic foot ulcers

Conditions: Diabetic Foot; Diabetic Foot Ulcer; Foot Ulcer, Diabetic; Foot Wound

Summary: people with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. these diabetic foot ulcers (dfus) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. while wearing special shoes to reduce pressure on the feet is essential for healing and preventing dfus, many people struggle to follow this treatment plan once their ulcers have healed. this study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring.

diabetic foot ulcers (dfus) are a significant complication of diabetes, responsible for 80% of lower extremity amputations in the united states and posing a substantial burden on patients and society. despite treatment, up to 23% of dfus remain unhealed at 12 months, with recurrence rates of 40% within a year and 65% within three years. proper offloading of foot pressure and glucose control is crucial for preventing recurrent dfus, especially in cases of neuropathy. while standard clinical practice includes patient education and therapeutic footwear prescription, adherence to offloading treatment often falls short due to non-medical factors such as insufficient understanding and difficulties integrating offloading into daily routines. to tackle these challenges, we propose a lifestyle-focused intervention, conducted by trained occupational therapist (ot), aiming at fostering consistent self-care habits and routines.the objective of this pilot trial is to evaluate the feasibility acceptability of a lifestyle-focused ot intervention for enhancing offloading treatment in high-risk individuals with a history of healed dfus.

Eligibility criteria:
inclusion criteria: * age \>= 21 years * healed diabetic foot ulcer within the past twelve months * able to walk independently (use of a cane is acceptable) exclusion criteria: * current active diabetic foot ulcer * history of amputation beside toe or part of the foot * non-ambulatory at baseline * self-reported deafness/blindness.

Keywords: diabetic foot ulcer, lifestyle intervention