Kornimate/medical-research-clean huggingface dataset:
the complementary effect of ear acupressure on older patients with chronic insomnia

Conditions: Insomnia

Summary: ear acupressure is commonly applied to treat insomnia in oriental clinical practice but lacking the evidence of the randomized controlled trial (rct)of ear acupressure on insomnia. in this study, a rct is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.

even though there have been many advances in the pharmacological treatment of insomnia, many patients with insomnia visit complementary and alternative medicine (cam) specialists for help due to fear of the side effects of long-term treatment with hypnotics. acupuncture is commonly used to treat insomnia in the field of cam. among the different methods of acupuncture, it has been noted that ear acupressure (placing magnetic pellets on the auricular points), which has the advantage of being non-invasive and easily carried out, shows possible effects whereby there is improvement in the sleep quality of old adults. however, it is lacking of the evidence of the randomized controlled trial (rct) of ear acupressure on insomnia. insomnia is related to homeostatic dysregulation of autonomic nervous system (ans). ear acupuncture and its related techniques are believed to act through the reticular formation and the ans may thus result in an amelioration of illness. in this study, a rct is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.besides, the changes of ans function (measured by heart rate variability) are recorded to evaluate the role of ans in the treatment of insomnia.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary insomnia exclusion criteria: * diabetic neuropathy * cardiac arrythmia * liver disease (alt\> 120 u/l) * renal disease (cr\> 2 mg/dl) * severe depression

Keywords: insomnia ear acupressure
crossover bioequivalence study of oxcarbazepine 600 mg suspension under fed conditions

Conditions: Seizures

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' oxcarbazepine suspension 600 mg under fed conditions


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to oxcarbazepine or any comparable or similar product.
effects of an early prehospital administration of tranexamic acid on hyperfibrinolysis in multiple trauma

Conditions: Hyperfibrinolysis; Haemorrhage; Mortality

Summary: severe external and internal bleedings are common in multiple trauma patients. uncontrollable blood loss is the cause for about one third of all trauma deaths. a number of blood clotting mechanisms are known to be triggered by major blood losses. these mechanisms shall secure the organisms from loosing even more blood. to avoid an overshooting clotting behavior, inhibiting mechanisms occur as well. an important inhibiting (or fibrinolytic) mechanism is the fibrinolysis that is based on the conversion of plasminogen to plasmin. in severe bleeding situations this mechanism tends to overshoot and therewith contributes to the severity of the bleeding. this phenomena is called hyperfibrinolysis and is found in approximately one third of all multiple trauma patients. mortality rates are increased in these patients. tranexamic acid is an antifibrinolytic drug that inhibits the conversion from plasminogen to plasmin and therefore is able to limit the effects hyperfibrinolysis. a large study showed positive influence of tranexamic acid on mortality rates and blood loss in severely injured patients, when it was administered in an early clinical setting. in this study we want to answer the question wether a hyperfibrinolysis can be seen in an early prehospital (on the scene) setting and how it is influenced by an early prehospital administration of tranexamic acid.

in patients suffering from multiple trauma the initially responding emergency physician on the scene will take a blood sample for thrombelastometry immediately after i.v. access is established. according to the initial trauma life support protocols a number of patients will receive a dose of tranexamic acid during the initial treatment on the scene or during transport to the hospital. a second blood sample will be taken after arrival in the resuscitation area of the hospital. thrombelastometric measurements will be performed with both blood samples and the extent of hyperfibrinolysis in both samples will be compared. in a second step the outcome of the patients who received tranexamic acid on the scene will be compared to those who did not receive the drug before reaching hospital.

Eligibility criteria:
inclusion criteria: * multiple trauma iss \> 15 * age \> 18 years exclusion criteria: * no informed consent * inclusion to an interventional clinical trial * death of the patient on the scene or before the hospital was reached * delayed thrombelastometric measurement (\> 4 hours)

Keywords: multiple trauma polytrauma hyperfibrinolysis tranexamic acid thrombelastometry
poly-unsaturated fatty acids in the preservation of dietary effects on hepatosteatosis and energy metabolism in type 2 diabetes

Conditions: Type 2 Diabetes; NAFLD; Obesity; Dyslipidemia; Hypertension; Metabolic Syndrome

Summary: basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. nevertheless, in early and late stage of t2dm, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. the researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term t2dm patients. this core comparison is dealt with in the dina-d study (published elsewhere). polyphem targets specific dietary approach to preserve the achieved metabolic improvements from dina-d phase 1. nutritional factors will be pufas and bcaas.

basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. nevertheless, in early and late stage of t2dm, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. the researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term t2dm patients. this core comparison is dealt with in the dina-d study (published elsewhere). polyphem targets specific dietary approach to preserve the achieved metabolic improvements from dina-d phase 1. nutritional factors for the maintenance period within dina-d (11 months) will be pufas and bcaas, provided by walnuts and custom-made muffins containing walnuts, sunflower oil and isomaltulose.

Eligibility criteria:
inclusion criteria: * male and female subjects * 18-79 years old * type 2 diabetes exclusion criteria: * renal insufficiency * anaemia * immunosuppression * previous symptomatic cancer diagnosis * acute cardiovascular disease (stroke, coronary syndrome) * pregnancy and lactation * severe psychiatric disorders * corticoid or other immunosuppressive therapy
perioperative ketamine for pain with gastric bypass

Conditions: Laparoscopic Gastric Bypass Surgery; Ketamine

Summary: opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. in patients with sleep apnea, opioids may increase the risk of severe apnea. ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients. this study is being done to find out if intraoperative ketamine infusion combined with continuation for twenty-four hours post-surgery provides superior pain control and decreases post-operative opioid use versus standard non-ketamine therapy.


Eligibility criteria:
inclusion criteria: 1. patients undergoing laparoscopic gastric bypass at mayo clinic in arizona 2. bmi is ≥ 35 kg/m2 3. consent is able to be obtained as per mayo clinic policy exclusion criteria: 1. intolerance to ketamine 2. history of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis with psychotic features 3. presence of unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, hypertension emergency, acute transient ischemic attack (tia) or stroke) 4. presence of acute elevation of intracranial or intraocular pressure 5. presence of seizure disorder 6. history of substance abuse or addiction 7. creatinine greater than 1.5 mg/dl 8. end-stage liver disease 9. pregnancy 10. patients with chronic pain and/or chronic opioid therapy will not be excluded to more closely replicate the study patient population of interest. however, patients taking greater than 50 morphine equivalents (me) per day for greater than 1 month prior to surgery will be excluded.
photobiomodulation therapy and nerve density for patients with diabetic or chemotherapy-associated neuropathy

Conditions: Neuropathy; Neuropathy, Diabetic; Neuropathy Toxic

Summary: this study seeks to determine if photobiomodulation (pbm, or low level laser light) affects the growth and distribution of nerves int he skin. our previous study demonstrated that the treatment we use here was effective at reducing the symptoms of neuropathy (as measured by the modified total neuropathy score) in patients who had been treated with chemotherapy. the current effort is designed to repeat this confirm this observation using a more extensive battery of survey as well as to begin to elucidate the mechanism through which photobiomodulaiton produces the effect. we will also be attempting to determine if diabetic patients differ in terms of response from chemotherapy patients

consenting patients with self-reported neuropathy following either diabetes or administration of chemotherapy, will undergo sensory testing and skin biopsies of the the foot and leg prior to initiating treatment. they will undergo pbm 3 times weekly for 6 weeks with with a follow-up biopsy performed at the conclusion of therapy and sensory testing throughout. patients will have one remote evaluation at 26 weeks to determine whether the effect, if any extinguishes.

Eligibility criteria:
inclusion criteria: self reported neuropathy following exposure to diabetes or chemotherapy * willingness to undergo biopsies and 6 weeks of therapy exclusion criteria: * pregnancy * active cancer treatment

Keywords: chemotherapy chemo-induced cipn
design and testing of a web-based tool for the improvement of end-of-life planning in patients with advanced cancer

Conditions: Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm

Summary: this clinical trial examines a web-based tool, in partnership with peacefully, inc, designed to improve end-of-life planning among patients with advanced cancers. this program helps users prepare comprehensively for end-of-life (e.g., medical wishes, legal estate planning, financial planning and transfer of accounts, legacy building, and emotional support). it is expected that this web-based end-of-life planning program may reduce distress and improve end-of-life preparation among advanced cancer patients.

outline: patients are randomized to 1 of 2 groups and their engagement in end-of-life planning is assessed at baseline and four weeks post-randomization. group i (intervention): patients receive peacefully's web-based tool to help with end-of-life planning on day 7. group ii (control): patients receive standard of care. after completion of study, patients are followed up at 4, 12, and 24 weeks post-randomization.

Eligibility criteria:
inclusion criteria: * diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer and/or disease progression following at least first line systemic therapy * access to a computer or mobile device * the ability to provide informed consent exclusion criteria: * not fluent in english * severely cognitively impaired (as measured by short portable mental status questionnaire scores of \< 6) * too ill or weak to complete the interviews (as judged by the interviewer)
silver-impregnated suprapubic catheters (spc) in urogynecology

Conditions: Infection Associated With Catheter; Urinary Tract Infection

Summary: the purpose of this study is to compare urinary tract infection rates among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter compared to the standard suprapubic catheter.

urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. however, urinary tract infections(uti) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from uti with an associated mortality of 10%. there are many different types of catheters available for use. standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. specialized catheters have been developed with the aim of reducing infection. strategies generally involved coating the inner, outer or both surfaces of the catheter with antimicrobial materials. these materials can be antibiotic or antiseptic with the most common antiseptic material used being silver. silver ions are bactericidal, are used safely when applied topically to humans and used in controlling infections. previous studies comparing uti rates in transurethral catheters have reported a significant reduction of uti rate in silver-alloy catheters with a range of 5-12% compared to standard catheters with a range of 7-50%. there are no studies comparing the uti rate in silver-alloy supra-pubic catheters to standard supra-pubic catheters. the investigators hypothesize that this study will show a statistically significant decrease in uti rate among the individuals with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.

Eligibility criteria:
inclusion criteria: * patients requiring intra-operative placement of suprapubic catheters as part of routine post-operative care for repair of vaginal anterior compartment prolapse i.e. patients undergoing anterior colporrhaphy, burch colposuspension, with or without mid-urethral sling exclusion criteria: * known uti at time of surgery * unable to provide informed consent * use of chronic intermittent self-catheterization pre-operatively * use of chronic prophylactic antibiotics * use of antibiotics for any indication other than uti during peri-operative and 6-week post-operative period * presence of fistula involving urogenital tract * use of chronic steroids or immunosuppressant * immunocompromised patient

Keywords: cauti uti
ocular changes in vitiligo patients on therapy

Conditions: Vitiligo; Chorioretinopathy; Chorioretinitis

Summary: vitiligo patients on systemic and local therapy may have some ocular adverse effects associated with the disease and its therapy.

chorioretinal changes associated with vitiligo therapy could address patients visual acuity and life style. early detection of these changes can help these patients to evade such adverse effects.

Eligibility criteria:
inclusion criteria: * vitiligo patients on systemic and local therapy that regularly visit dermatology clinic at banha university. * normal subjects seeking regular ophthalmic examination at ophthalmology clinic at banha university. exclusion criteria: * patients with known chronic retinal diseases that may alter oct-a parameters as age related macular degeneration and diabetic retinopathies. * patients that refuse to participate in this study.

Keywords: vitiligo chorioretinitis
enlighten: exercise and nutritional interventions for cognitive and cardiovascular health enhancement

Conditions: Cognitive Impairment, no Dementia (CIND)

Summary: enlighten will examine the effects of exercise, the dietary approaches to stop hypertension diet (dash), and a combined exercise and dash intervention on cognitive function among adults with cardiovascular disease (cvd) risk and cognitive deficits. participants will be randomized to one of the three treatments, or a health education control condition, for 6 months, and will complete assessments of cvd health and cognitive function before and after treatment.

cardiovascular disease (cvd) is the leading cause of death and disability in the united states, affecting more than 81 million american adults. it is well established that risk factors such as hypertension, diabetes, and hyperlipidemia not only place individuals at risk for cvd, but also place them at risk for neurocognitive impairment and dementia. cvd risk factors have been shown to be associated with a cascade of neurophysiologic and neuroanatomic changes, resulting in cognitive impairment and dementia. exercise and diet have been shown to improve cvd risk factors and also appear particularly promising lifestyle approaches for preventing dementia among individuals at risk, such as those with cognitive impairment, no dementia (cind). enlighten is a randomized clinical trial of diet and exercise among patients with cind.

Eligibility criteria:
inclusion criteria: * age 55 years or older * sedentary * score of 19-25 on the montreal cognitive assessment battery or verbal fluency score of =\< 12 or animal fluency score of =\<15 * at least one cardiovascular risk factor (hypertension, diabetes, cholesterol, obesity, current smoking, or family history) or a documented history of cardiac disease (myocardial infarction, coronary artery bypass grafting, peripheral vascular disease, \>70% stenosis, or mild stroke without residual deficit) exclusion criteria: * any significant neurological disease other than cind, such as parkinson's disease, multi-infarct dementia, huntington' s disease, progressive supranuclear palsy, brain tumor, normal pressure hydrocephalus, subdural hematoma, seizure disorder, multiple sclerosis, or history of head trauma with persistent neurological deficits * psychotic disorder within the past two years (dsm iv criteria) or acutely suicidal * history of alcohol or substance abuse or dependence within the past two years (dsm iv criteria) * history of schizophrenia * any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol including a history of systemic cancer within the past 5 years (nonmetastatic skin cancers are acceptable) * myocardial infarction (within the past 3 months) or unstable or severe congestive heart failure (e.g. class iii-iv heart failure) * end-stage pulmonary disease; uncontrolled diabetes mellitus or uncontrolled hypertension(systolic bp\>170 or diastolic bp \>100 mm hg on medication) * musculoskeletal disorders precluding the ability to exercise (e.g. severe arthritis)
study that will evaluate the brazilian population with copd.

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Summary: observational, prospective, multicenter cohort study with consecutive inclusion of copd patients. eligible patients will be those with severe and very severe copd according to the gold 2024 (global initiative for chronic obstructive lung disease) guidelines being followed at participating hospitals. the severity of copd is related to the exacerbation rate, which in turn is related to the progression of the disease and the occurrence of complications and death. there is no national data on this subgroup.

this is a prospective multicentre cohort, non-interventional study. the design is to have multiple medical centres representing the regions of brazil. each region has a different exposure to risk factors like tobacco smoke, biomass burning and environmental pollution, has a different population composition and density, degree of urbanization and education level. there are also some inferred genetic differences due to previous colonization and miscegenation. \*cat (copd assessment test) ou caat (chronic airway assesment test) poderão ser usados intercambiavelmente. the patients will be enrolled in non-random consecutive method and will be followed up for 12 months. there will be on-site visits at inclusion (v0), 6 and 12 months. there will tele-consults at 3 and 9 months to gather relevant clinical data, with special interest at exacerbation. there will be 8 participating centres in brazil, representing all 5 regions (north, northeast, midwest, southeast and south). they will be teaching hospitals, regional reference hospitals, tertiary hospitals or high complexity hospitals. the data will be collected on each site and will be adjudicated by the aro team.

Eligibility criteria:
inclusion criteria: * patients of both sexes, aged 18 years or older, with confirmed copd according to gold 2024: previous or current exposure and spirometry (fev1/fvc =2 or cat \>=10); or * gold e (\>=2 moderate or 1 severe exacerbation - hospitalization); or * gold 3 and 4 (fev1 \<50%). exclusion criteria: * advanced fibrosing interstitial lung disease (extent \>=50%); and/or * high-risk pulmonary hypertension (on triple therapy); and/or * active cancer - on systemic therapy