Kornimate/medical-research-clean huggingface dataset:
evaluating the cost-effectiveness, efficacy, safety and tolerance of mepilex® ag versus silvadene®

Conditions: Second Degree Burn

Summary: the primary objective is to compare the incremental costs (direct and indirect) and benefits (healing outcomes, quality of life) of using foam silver dressing (mepilex® ag) to a silver sulfadiazine 1% cream (silvadene®) from the perspective of the health care provider. the secondary objectives are to investigate the safety, the tolerance and the performance on burn status including pain.

in- and/or out-patients at ten centers in the united states were included in this investigation. subjects included were 5 years of age and older who suffered from partial thickness burns. every patient was followed for 3 weeks.

Eligibility criteria:
inclusion criteria: * patients with a second degree burn covering 5% to 20% bsa. tbsa covered with burn is allowed to be up to 25%, allowing a maximum of 10% to be third degree burn (only the second degree burn should be treated) * burn of thermal origin * both gender with an age ≥ 5 years at randomization * signed informed consent * subjects who are younger than the legal consenting age must have a legally authorized representative exclusion criteria: * - burns equal to or older than 36 hours * burns of chemical and electrical origin * clinically infected burn (as judged by the investigator) * treatment of the burn with an active agent before study entry, ssd is allowed up to 24 hours prior to randomization * patients with necrotising leucocytic vasculitis or pyoderma gangrenosa. * diagnosed underlying disease(s) (e.g. hiv/aids, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment. * patients with insulin dependent diabetes mellitus * patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolon/day or equivalent. * use of immunosuppressive agents, radiation or chemotherapy within the past 30 days. * known allergy/hypersensitivity to any of the components of the investigation products. * patients with physical and/or mental conditions that are not expected to comply with the investigation. * participation in other clinical investigation(s) within 1 month prior to start of the investigation * pregnancy * previously randomised to this investigation
topical application of essential oils to treat onchomycosis

Conditions: Onychomycosis of Toenail; Fungal Infection; Toenail Infection

Summary: patients with documented onychomycosis of one or more toe nails will be treated with a daily application of a topical lacquer containing several essential oils.

the topical lacquer contains the following components: active ingredients: hydroxypropyl chitosan oleozon(r) - natural, ozonized sunflower oil. vitamin e tea tree oil cannabidiol vehicle: nanoparticle medium chain triglyceride oil

Eligibility criteria:
inclusion criteria: clinician observation consistent with probable onychomycosis of one or more toenails. positive polymerase chain reaction (pcr) for fungal infection or positive periodic acid schiff, biopsy, koh or culture for fungal infection - exclusion criteria: unwlling to discontinue current anti-fungal medication, oral or topical -
splenic hilar nodes in splenic flexure cancer

Conditions: Colon Cancer; Metastases, Lymphatic

Summary: report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. this mode of spread has not been previously characterized for these tumours.


Eligibility criteria:
inclusion criteria: * all splenic flexure cancer patients exclusion criteria: * no consent to data utilization
vessel resection and reconstruction of biliary tract cancers

Conditions: Biliary Tract Cancer

Summary: to investigate the vessel resection and reconstruction in biliary tract cancer.

the vessel resection and reconstruction of hepatic artery and portal vein in biliary tract cancer surgery is still controversial. in this study, we retrospectively evaluate the diagnostic image, pathology, peri-operative events, recurrence, and prognosis in these patients, as a multi-center surveillance.

Eligibility criteria:
inclusion criteria: * cases of vessel resection and reconstruction in biliary tract cancer. exclusion criteria:
lower urinary tract symptoms due to benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: aim of this study is to evaluate the effect of conducting self-management interventions on severity of lower urinary tract symptoms (luts) for patients with benign prostatic hyperplasia (bph). research hypothesis: to fulfill the aim of this study, the following research hypothesis was formulated: patients with benign prostatic hyperplasia will suffer less lower urinary tract symptoms (luts) after conducting self-management intervention than before conducting.

research design: quasi-experimental (pre-posttest) research design was utilized to conduct this study. this study was conducted at assiut urology and nephrology hospital. a purposive sample of 60 adult male patients diagnosed with benign prostatic hyperplasia were older than 40 years old, had no other factors influencing their urination, such as prostate cancer. patients had been assessed at base line using the following tools: tool (i): a structured interview questionnaire. tool (ii): international prostate symptom score (ipss). each patient will be assessed before conducting self-management intervention for socio-demographic data, clinical data, and patients' knowledge regarding self-management using the tool i. each patient will be assessed for lower urinary tract symptoms before conducting self-management intervention using tool tool ii(ipss). ipss is a scoring system used to screen for and diagnose bph as well as to monitor symptoms and guide decisions about how to manage the disease monitor lower urinary tract symptoms, it includes seven questions, about symptom of bph.each question had a range from 0 to 5 for its answer. maximum score of 35 points. on the basis of total score, the symptoms were categorized into mild (0 -7), moderate (8-19), and severe (20-35). after 3 months from conducting self-management intervention each patient was reassessed for clinical progression "severity" of lower urinary tract symptoms(luts)using (tools ii).

Eligibility criteria:
inclusion: * adult patients. * men. * clinical diagnosis of benign prostatic hyperplasia. exclusion: * prostate cancer. * severe symptoms necessitating surgical treatment. * uncontrolled diabetes. * end-stage cardiac disease or respiratory failure.
comparison of the effects of home exercise and isokinetic exercise program in subacromial impingement syndrome patients

Conditions: Home Exercise; Quality of Life

Summary: the aim of this study is to evaluate and compare the effects of home exercise program and isokinetic exercise program on pain, muscle strength, functionality, proprioception sensation and quality of life in patients with subacromial impingement syndrome.

the study was designed prospectively. a total of 50 patients with subacromial impingement syndrome according to clinical and mri findings with shoulder pain for at least 3 months were included in the study. patients were randomly divided into two groups. the first group (isokinetic exercise group, n = 25) was given isokinetic exercise. the second group(home exercise group, n=25) was given home exercise program. patients were evaluated before and after treatment and 3 months after the end of treatment. in the evaluation, vas, shoulder pain and disability index, constant murley scoring, shoulder disability questionnaire, health assessment questionnaire, pittsburgh sleep quality index, humic norm ii isokinetic device were used. at statistically evaluation of data student t test and mann whitney u tests were used. in qualitative datas comparison ki-kare test was used. significance was evaluated at the level of p\&lt; 0.05.

Eligibility criteria:
inclusion criteria: * shoulder pain and functional disability at least 6 months exclusion criteria: * instability of shoulder, stage 2-3 adhesive capsulitis, tendinitis or bursitis, cervical radiculopathy, underwent surgery, norological diseases
dexamethasone in herpes simplex virus encephalitis

Conditions: HSV Encephalitis

Summary: encephalitics is a serious condition in which the brain becomes inflamed (swollen). it usually happens as a direct result of virus, such as herpes simplex virus (hsv). hsv encephalitis is often treated with the drug acyclovir (an antiviral drug which slows the growth and spread of hsv in the body). despite this however, around 2 out of every 3 people will have memory difficulties long term. dexamethasone is a corticosteroid medication, which works by preventing the release of natural chemicals in the body which cause inflammation. it is possible that dexamethasone could help to reduce in swelling of the brain may improve the recovery of patients with hsv encephalitis. the aim of this study is to find out whether treatment with dexamethasone can improve long-term health outcomes in adults with hsv encephalitis.


Eligibility criteria:
inclusion criteria: - suspected encephalitis criteria: acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour\* persisting for \> 24 hours laboratory confirmed hsv by positive pcr on csf sample. * receiving intravenous aciclovir dosed at 10mg/kg tds or at a reduced dose in renal impairment * age ≥ 18 years * person affiliated to social security * written informed consent has been given by the patient or their legal representative exclusion criteria: * currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days. * history of hypersensitivity to corticosteroids * immunosuppression secondary to: * known hiv infection \& cd4 count under 200cell/mm3 * biologic therapy or other immunosuppressive agents \[azathioprine, methotrexate, ciclosporin\] * solid organ transplant on immunosuppression * bone marrow transplant * currently undergoing a course of chemotherapy or radiotherapy * known immunodeficiency syndrome \[other than hiv\] * known haematological malignancy * pre-existing indwelling ventricular devices * peptic ulcer disease in the last 6 months: defined as a peptic ulcer seen at previous endoscopy or an upper gastrointestinal bleed causing ≥ 2 unit haemoglobin drop * currently on an antiretroviral regime containing rilpivirine * patients under legal protection, administrative or judicial control * pregnancy / breast feeding and parturient * subject in exclusion period of another study

Keywords: dexamethasone hsv encephalitis
comparing efficacy and safety of tjo-083 in dry eye disease patients

Conditions: Dry Eye Syndromes

Summary: this is a prospective randomized study compared with active control and placebo arms.


Eligibility criteria:
inclusion criteria: * male or female, age 20 or over * patient who have been diagnosed with dry eye syndrome at least 6 months ago * screening both eyes, the corrected visual acuity is 0.2 or more * written informed consent to participate in the trial exclusion criteria: * screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease) * intraocular pressure(iop)\> 21 mmhg
prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices

Conditions: Gastric Varices; Cirrhosis

Summary: the purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. however, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.this study is a randomized controlled trial. the purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Eligibility criteria:
inclusion criteria: * 18 y.o. ≤age≤75 y.o.; * diagnosis of esophageal gastric varices by gastroscopy; * cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive; exclusion criteria: * age \ 75 y.o.; * never had the variceal bleeding episode before; * do not have endoscopic injection of tissue adhesive; * the cefotiam contraindications: such as allergies, pregnancy etc; * combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment); * known infection before endoscopic treatment (fever, microbial cultures positive, et al.); * massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics; * acute variceal bleeding within 5 days; * refuse to participate

Keywords: gastric varices endoscopic injection of tissue adhesive
safety study of sertindole versus risperidone under normal conditions of use

Conditions: Schizophrenia

Summary: the purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.

the committee for medicinal products for human use (chmp) requested a post-marketing study to ascertain that the favourable benefit-risk profile and low mortality rates seen in the clinical studies with sertindole would not be offset by higher mortality rates when sertindole was used under more normal conditions of use. it was recognised that, in a clinical trial setting, strict patient selection and monitoring could lead to higher compliance in patient management and thereby to a lower mortality rate. study 99824 was therefore designed in collaboration with the chmp as an open-label, randomised study with minimum study management that focused on mortality and general patient safety. the duration of the treatment period was not fixed. no efficacy measures were included.

Eligibility criteria:
inclusion criteria: * the patient has signed the informed consent form or, if he/she is not able to sign it (according to the ich gcp guidelines and the declaration of helsinki), the patient's legal representative has signed the informed consent form * the patient has been diagnosed with schizophrenia * based on the patient's clinical status, new or change of antipsychotic treatment is indicated * the patient is at least 18 years of age * the patient meets the criteria set out in the national spcs for sertindole and risperidone. for those countries in which sertindole was not marketed, the eu spc applied exclusion criteria: * the last treatment taken by the patient was sertindole or risperidone * the patient has never previously received any antipsychotic drug therapy * the patient has contraindications to treatment with either sertindole or risperidone * in addition to sertindole/risperidone, treatment with another antipsychotic is indicated * the patient is homeless * the patient has previously been included in one of the two h. lundbeck a/s post-marketing studies, 99823 or 99824 * the patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason
effect of melatonin on cardiovascular and muscle mass and function in patients with heart failure

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the main aim of this study is to investigate the effect of melatonin on clinical outcome, quality of life, and cardiovascular function of the patients with heart failure, as well as its effect on their skeletal muscle mass and function.

people with heart failure (hf) suffer from various comorbidities and complications which their management is as important as treatment of hf per se. an important complication of the hf is progressive decrease in muscle mass and function known as muscle wasting or sarcopenia. prevention, diagnosis, and treatment of muscle wasting is emphasized to improve prognosis and quality of life of the patients with hf. melatonin is a natural hormone which is secreted from pineal gland and is involved in circadian rhythm control. recent data delineates more important roles for melatonin in cellular metabolism and apoptosis, as well as acting as an antioxidant and anti-inflammatory agent in the body. experimental studies show that melatonin can have a beneficial role in muscle wasting in several chronic conditions such as heart failure. furthermore melatonin has been shown to have valuable effects on cardiovascular health, blood pressure, and endothelial function and it might benefit patients with heart failure. in this study the effect of melatonin on clinical outcome and quality of life of the patients with hf and their echocardiographic parameters, muscle mass, muscle function, inflammatory biomarkers, serum metabolic parameters, and serum oxidative stress markers will be studied.

Eligibility criteria:
inclusion criteria: * systolic heart failure with ejection fraction \< 40, either ischemic or dilated cardiomyopathy (dcm) * symptoms and medications of hf have been stable for at least three months * nyha class ii-iii * willing to participate in the study and providing informed consent exclusion criteria: * chronic comorbidities: insulin dependent diabetes, renal failure (gfr \ 35) * acute ischemic heart event or revascularization procedure in the last month * regular supervised exercise or ingestion of muscle hypertrophy supplementations in the last three months * vegetarian diet or sever restriction of protein in the diet in the last three months * occurrence of melatonin related adverse effects

Keywords: heart failure melatonin muscle wasting
repair of achilles sleeve avulsion: a new transosseous suture technique

Conditions: Achilles Tendon Rupture; Fracture, Avulsion

Summary: this retrospective study identified 12 patients with achilles sleeve avulsion from november 2013 to march 2016, aiming to explore a new transosseous suture technique for the repair of achilles sleeve avulsion and observe the short-term curative effect.

purpose: to explore a new transosseous suture technique for the repair of achilles sleeve avulsion and observe the short-term curative effect. methods:in total, 11 patients diagnosed with achilles sleeve avulsion underwent this new surgical technique and were followed for a mean time of 40 months. clinical outcomes were measured using the visual analog scale (vas), american orthopaedic foot \& ankle society (aofas) score, victorian institute of sports assessment-achilles (visa-a) score, tegner score, and time taken to return to activities. preoperative and postoperative mri, the ability to perform heel rise, and complications were also evaluated.

Eligibility criteria:
inclusion criteria: * clinical presentations and physical examination, routine ankle x ray and mri exclusion criteria: * calcaneal tuberosity avulsion fractures * achilles tendon rerupture * previous surgical procedure on the affected achilles tendon

Keywords: sleeve avulsion achilles tendinopathy suture, transosseous achilles tendon
treatment of cutaneous leishmaniasis with meglumine antimoniate versus meglumine antimoniate and allopurinol

Conditions: Leishmaniasis, Cutaneous

Summary: background: cutaneous leishmaniasis is a worldwide disease, endemic in over 88 countries, that has shown an increasing incidence over the last many decades. for the last 60 years antimony compounds are considered the treatment of choice. though their use is expensive, cumbersome, has many adverse effects and not effective in all patients, the search for a better alternative is still going on. low dose antimony compounds in combination with several agents have shown promise of reducing adverse effects of antimony compounds without compromising efficacy. allopurinol is one such agent which though promising lacks randomized, controlled trials to prove efficacy. the main objective of this study is to evaluate low dose sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium stibogluconate in terms of efficacy and adverse effects. methods and design: a multi-center randomized, controlled trial including 620 patients from endemic areas for leishmaniasis in pakistan will be undertaken to assess the research question. parasitologically confirmed cutaneous leishmaniasis will be included in the study. after evaluating the inclusion/exclusion criteria patients will be randomized to receive either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. during treatment patients will be admitted to hospital and monitored daily for the presence of adverse effects. follow up period will last six months during which patients will visits the research centers for assessment of healing process at monthly intervals.


Eligibility criteria:
inclusion criteria: * men and women between 18 and 50 years old. * cutaneous ulcers, nodules, plaques, of more than two weeks of evolution requiring systemic therapy. * positive parasitological diagnosis for cutaneous leishmaniasis. * patients that voluntarily accept to participate in the study and sign the informed consent. * disposition to be admitted to hospital, if necessary, and to attend all the visits punctually (initial, treatment and follow up). * acceptation of not using any other treatment for cutaneous leishmaniasis while in the study. exclusion criteria: * pregnant women. * presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of cutaneous leishmaniasis. * diffuse cutaneous leishmaniasis. * visceral leishmaniasis. * complete or incomplete treatment with antimony compounds in the last three months. * patients with history of hepatic, renal, or cardiovascular disease. * mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.

Keywords: cutaneous leishmaniasis of the old world
the effect of obstructive sleep apnea on medical outcomes after gastric bypass surgery

Conditions: Obesity; Sleep Apnea, Obstructive

Summary: obstructive sleep apnea (osa) is a syndrome characterized by repetitive episodes of airway obstruction during sleep, which result in low oxygen level in the blood and bad sleep quality. both of these effects are implicated in medical, neurological and cognitive disorders in subjects with osa. the purpose of this study is to examine how osa affects medical and neurobehavioral outcomes after gastric bypass surgery for weight loss in morbidly obese patients.


Eligibility criteria:
inclusion criteria: scheduled for laparoscopic roux-en-y gastric bypass (rygb) surgery presence or absence of osa confirmed by polysomnography comprehension of spoken and written english exclusion criteria: major psychiatric, neurological, or neuromuscular disorder history of untreated thyroid disease known diabetes mellitus history of stroke with or without apparent neurological deficits alcohol consumption which exceeds 2 drinks per day or drug abuse. undergone a sleep study in the past