Kornimate/medical-research-clean huggingface dataset:
treatment of reflux with sleeve gastrectomy

Conditions: Reflux Disease, Gastro-Esophageal; Hiatal Hernia; Reflux Esophagitis

Summary: in 2008, the world health organization (who) report found that 0.5-1.5 billion people aged 20 years and above suffer from overweight (body mass index (bmi) ≥ 25) and obesity (bmi ≥ 30 kg / m2) stated. who estimates that the number of overweight and obese people will reach 2.3 and 0.7 billion, respectively, by 2045. bariatric surgery has been developed in response to the number of obese patients living in the world and the complications caused by obesity. the most common type of bariatric surgery against obesity is laparoscopic sleeve gastrectomy (lsg). as after any surgical operation, complications may occur after laparoscopic sleeve gastrectomy. additional operations may be required to correct complications such as bleeding, anastomotic leak, gastric volvulus, infection, dyspepsia, hiatal hernia, bile and/or acid reflux. the incidence of gastroesophageal reflux disease (gerd) is significantly increased in obese patients compared to the incidence in normal individuals. various studies have shown that obesity causes delayed gastric emptying due to increased abdominal pressure, esophageal motility disorders, especially hypotensive lower esophageal sphincter pressure (\<10 mm hg), finally the development of hiatal hernia (hh), whose prevalence in the obese population is significantly higher than in non-obese patients. various surgical methods have been presented to prevent postoperative de-novo gastroesophageal reflux and de-novo hiatal hernia that occur after lsg. curorrhaphy is one of these techniques that is accepted to prevent the formation or exacerbation of postoperative gerd and hiatal hernia. in this surgical technique, after the diaphragmatic crura are completely exposed at the level of the lower esophageal sphincter (les), the hiatal hernia, if present, is reduced into the abdomen. afterwards, z surgical sutures are applied to the diaphragmatic crura to make the diaphragmatic esophageal ring narrow enough. in this way, it is aimed to strengthen the diaphragmatic crus. findings following cruroplasty for gerd prevention are varied. although some authors state that the technique does not provide an advantage in preventing postoperative gerd, some studies have shown cruroplasty to be effective. in this study, investigators aimed to show that the technique of simultaneous cruroplasty and single suture omentopexy with lsg is a treatment for gerd and hh, which are very common in obese patients, and a preventive technique for de-novo gerd seen after lsg.


Eligibility criteria:
inclusion criteria: * obesity, exclusion criteria: * eating disorder or mental disorder * misunderstanding of the protocol * psychiatric contraindication * patient participating in another interventional clinical research protocol involving a drug or medical device * pregnant, breastfeeding
evaluation of immunological, microbiological and metabolomic profiles in copd

Conditions: COPD; Emphysema; Chronic Bronchitis; Smoking

Summary: copd is a significant health problem worldwide. it affects more than 10% of patients over the age of 40. according to the world health organization, it is the third most common cause of death among adults in the world, and the number of patients is continuously growing. hence, all measures aimed at a better understanding of copd pathogenesis, the course of the disease, and limitations in treatment efficacy seem critically important. since 2008 our team has provided a substantial output in understanding the pathophysiology of airway inflammation in obstructive lung diseases. in our studies, we systematically evaluated selected cytokines concentrations in different respiratory samples to determine their mutual relations and to determine the role of cytokines in airway inflammation more precisely. however, there is still a large gap in our understanding of copd. it is hypothesized that in copd pathogenesis, additional factors, like genetics, autoimmune processes or deviated microbiota are involved. each of the mentioned factors leads to a different type of immune response with a different effect on the airways. we believe that using more advanced laboratory methods (i.e. metabolomics and airway microbiome analysis) alongside the well-established ones (i.e. cellular and cytokine composition) will allow for an adequate characterization of inflammation. the study will include 50 copd subjects and 50 smokers without copd and 20 control subjects (never smokers) who meet the inclusion and exclusion criteria (table 1) and give an informed written consent to participate in the study. all study participants will undergo the following procedures: peripheral blood sample collection, chest hrct imaging (without contrast), lung function assessment (spirometry with a bronchial obstruction reversibility test, bodyplethismography, diffusion lung capacity for carbon monoxide (dlco), sputum induction with sterile hypertonic saline (nacl).


Eligibility criteria:
inclusion criteria: * age ⩾ 40 years, * written informed history of smoking ⩾ 10 pack-years * copd diagnosis (post- bronchodilator fev1/fvc \< lln) * stable copd (min. 3 months) exclusion criteria: * history of asthma or current lung disease (exception: solitary nodules), respiratory failure * use of inhaled or oral steroids in the 3 months prior to the study, * infection of the respiratory tract or exacerbation in the 3 months prior the study * uncontrolled comorbidities such as: systemic connective tissue diseases, malignancy, uncontrolled cardiovascular diseases, chronic paranasal sinusitis, * contraindications to sputum induction
chemical debridement and leg ulcers

Conditions: Venous Leg Ulcers; Mixed Ulcer

Summary: a pilot study to investigate the relative effectiveness and safety of chemical wound debridement and curettage in the treatment of venous and mixed aetiology leg ulcers.

a pilot study to investigate the relative effectiveness and safety of chemical wound debridement versus the curettage wound debridement in the treatment of venous and mixed aetiology leg ulcers in the united kingdom

Eligibility criteria:
inclusion criteria: * participants with a venous leg ulcer or mixed aetiology ulcer. * duration of wound ≥ 6 weeks ≤ 5 years * wound is ≥ 5 cm2 ≤ 200cm2 * presence of at least 25% visible slough within the wound bed * the participant must be able to understand the study and provide written informed consent * no clinical signs of infection exclusion criteria: * known hypersensitivity or contraindications to any of the wound treatments, dressings or compression bandaging to be used in the trial * current local or systemic antibiotics in the week prior to inclusion * clinically infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema * prolonged treatment with immunosuppressive agents or high dose corticosteroids * participants who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse) * participants who have participated in a clinical trial on wound healing within the past month * participants with a known history of non- adherence with medical treatment

Keywords: chemical debridement mechanical debridement topical dessicating agent venous leg ulcer chronic wound
tolerability and activity of brivaracetam (brv) in patients with diffuse gliomas

Conditions: Brain Tumor

Summary: the purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.

in this study, subjects will receive usual treatment for their brain tumor. in addition, they will be given brivaracetam at a dose of 50 mg twice daily.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor * patients must be able to provide informed consent exclusion criteria: * a pre-existing seizure disorder or epilepsy syndrome prior to tumor diagnosis * active maintenance therapy with an antiepileptic seizure drug (aed) prior to diagnosis of tumor * patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor * predicted life expectancy of less than 6 months from the time of screening * pregnancy * patients with clinically significant hepatic disease (elevated aminotransferases \[bilirubin, alkaline phosphatase\] \> 3 times upper limit normal) * patients with stage 4 or greater renal disease (gfr \<30 ml/min/1.73 m2) * patients who are unable to swallow a tablet * patients with active suicidal ideation or a history of suicide attempt or other serious psychiatric disorder having required hospitalization within the previous 2 years.

Keywords: brain tumor brivaracetam epilepsy
intensified chemotherapy in crc after resection of liver metastases

Conditions: Colorectal Cancer; Liver Metastases; Chemotherapy

Summary: randomized, open label, multicentre phase ii trial followed by phase iii comparing overall survival after having selected the best experimental arm.


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the colon or rectum without previous resection, or clinically asymptomatic (with or without stent) * hepatic unresectable metastases r0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver. * not optimally resectable metastases * extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable. * synchronous and metachronous hepatic metastases * who performance status 0-1 * adjuvant chemotherapy allowed, except oxaliplatin and irinotecan based combination. * no prior treatment of the liver metastases, whatever. * life expectancy equal or more than 3 months exclusion criteria: -
influence of closed suction drainage after total knee replacement.

Conditions: Total Knee Replacement

Summary: the aim of the study will be to compare functional outcomes, basic morphology results, number of blood transfusions, costs of hospitalization, and inflammation factors, following total knee replacement (with use of one type of endoprosthesis) comparing use of closed suction drainage (csd). use of closed suction drainage may have influence on patients functional outcome.

patients with primary knee osteoarthritis will be included in a randomized controlled trial and assigned to total knee arthroplasty with or without closed suction drainage. subjects will be evaluated preoperatively, 1-day, 3-, 6- and 12-month postoperatively. change in morphology results will be measured by comparing preoperative and postoperative levels of haematocrite, haemoglobin, erythrocytes, and platelets. change in the number of blood transfusions will be measured by analyzing the number of needed transfusion of packed red blood cells in the postoperative period during stay in the hospital. change in levels of inflammation factors will be measured by analyzing the level of c-reactive protein in first and third day postoperatively. change in body temperature wille be measured daily by analyzing body temperature from day of the surgery until the day of discharge from the hospital presence of haematoma will be evaluated daily in the postoperative period by clinical examination. change in western ontario and mcmasters university osteoarthritis index (womac) pain score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively change in western ontario and mcmasters university osteoarthritis index (womac) function score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively costs of hospitalization will be measured by comparing cost of hospitalization between two analyzed groups

Eligibility criteria:
inclusion criteria: * patient's consent for anticipation in the study * arthroplasty in one knee exclusion criteria: * patient's lack of consent for anticipation in the study * haematological diseases * reoperations in the area of endoprosthesis * medical history of any surgical intervention on the lower limb

Keywords: total knee arthroplasty tkr drainage haematoma
us phase iii study of apd421 in ponv

Conditions: PONV

Summary: a comparison of the efficacy of apd421 and placebo in the prevention of ponv in patients at moderate-to-high risk of ponv.


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years of age * patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital exclusion criteria: * patients scheduled for outpatient/day case surgery * patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery * patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block * patients who are expected to remain ventilated for a period after surgery * patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
an intervention to reduce prehospital delay to treatment in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: this study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease.

delay to treatment from the onset acute coronary syndrome (acs)continues to be a significant cause of morbidity and mortality. this study was conducted to evaluate a tailored education and counseling program designed for individuals at high risk for a future event. study hypothesis: the central hypothesis of this study was that a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of ami in patients already identified as having ischemic heart disease. patients were randomized to receive a nurse-administered education and counseling intervention designed to promote early presentation for medical treatment in the face of cardiac symptoms or to usual instructions by their healthcare provider. primary \& secondary endpoints: the primary endpoint of this trial was prehospital delay time, i.e., time from onset of symptoms to arrival at the hospital. the secondary endpoints were: use of the emergency medical system; use of aspirin; healthcare resource utilization; and knowledge, attitudes and beliefs about heart disease.

Eligibility criteria:
inclusion criteria: * a diagnosis of ischemic heart disease, confirmed by their physician or medical record * lived independently (i.e., not in an institutional setting). exclusion criteria: * complicating serious co-morbidity such as a psychiatric illness or untreated malignancy * neurological disorder with impaired cognition * inability to read or understand english. * major uncorrected hearing loss

Keywords: patient education acute coronary syndrome prehospital delay to treatment
polymethyl methacrylate and (pegt/pbt) centralizer by the uncemented bihapro thp

Conditions: Osteoarthritis

Summary: the purpose of this study is to analyse if the alignment of the stem and the number of complications of the new resorbable pegt/pbt centralizer are comparable to the standard pmma centralizer during the placement of an uncemented bihapro hip prosthesis.

for a correct placement and early fixation of an uncemented hip prosthesis, a centralizer is used. normally, the centralizer is made of pmma, the same material as bone cement. when a revision is needed, pmma is difficult to remove, which is one of the reason not to use a cemented hip prosthesis. with a pmma centralizer, still pmma will remain in the bone and needs to be removed in case of a revision. pegt/pbt is a reabsorbable material, which gives stability during the first month after the placement of the hip prosthesis. however, pegt/pbt is reabsorped afterwards and, therefore, will not interfere with a revision procedure. the goal of this study is to analyse if the pegt/pbt is as safe as pmma in terms of alignment, direct postoperative complications and clinical results. therefore, 100 patients indicated for a cementless bihapro hip prosthesis which have signed an informed consent are included and randomised over the used centralizers using a weighted randomisation method. all patients will be treated equally. the patients are examined preoperatively, 1 day, 6 weeks, 3, 6, 12, 24 en 48 months postoperatively using an x-ray, the harris hip score and a patient questionnaire, the womac and sf36.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * diagnosis: osteoarthritis * indicated for a primary hip prosthesis exclusion criteria: * previous hip surgery * no informed consent * active infection in hip * immature skeleton * rheumatoid arthritis, m. paget

Keywords: hip prosthesis centralizer uncemented
pragmatic cyclical lower extremity exercise trial for parkinson's disease

Conditions: Parkinson Disease

Summary: identification of an effective disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral) is an unmet need in parkinson's disease (pd). increasing evidence indicates high intensity aerobic exercise is a candidate to alter pd progression. the primary aim of this study is to examine the disease-altering capabilities of a long-term, high-intensity aerobic exercise intervention. a multi-site pragmatic randomized controlled trial design has been selected. individuals with pd will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (ucc). subjects in the home exercise group will receive an indoor stationary bicycle delivered to their home for a 12 month exercise period. individuals in the ucc group will continue their current level of physical activity. motor and non-motor assessments will be conducted at the main campus of the cleveland clinic or the university of utah at enrollment, 6 months, and 12 months. each assessment will last approximately one hour.

overview of experimental design: the study is a randomized controlled clinical trial designed to examine the disease-altering capabilities of a 12 month aerobic exercise program for individuals with pd. a total of 252 individuals with pd will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (ucc). subjects in the home exercise group will receive a commercially available peloton indoor stationary bicycle delivered to their home for a 12 month exercise period. individuals in the ucc group will continue their current level of physical activity. both groups will undergo a series of motor and non-motor assessments at enrollment, 6 months, and 12 months to measure disease progression of the 12 month period. additionally, data will be used to develop a prognostic model to predict 12-month change in movement disorder society - unified parkinson's disease rating scale iii (mds-updrs iii) for patients participating in a home-based high-intensity aerobic exercise program.

Eligibility criteria:
inclusion criteria: * adult with a diagnosis of idiopathic pd by a physician or physician extender * hoehn and yahr stage i-iii * demonstrate the ability to safely mount and dismount the peloton stationary cycle * in-home wireless network (wifi; required for peloton system exercise data transmission) exclusion criteria: * participation in pharmaceutical or behavioral disease modifying pd-related clinical trial or study * diagnosis of dementia or any neurocognitive impairment that compromises one's ability to provide informed consent * implanted deep brain stimulation electrodes * if the american college of sports medicine (acsm) screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation. * any musculoskeletal issue that would limit one's ability to engage in exercise * neurological disease other than parkinson's disease (i.e. multiple sclerosis, stroke)

Keywords: exercise
assessment of urinary ngal to predict aki in children receiving multiple nephrotoxic medications

Conditions: Acute Kidney Injury; Nephrotoxicity

Summary: nephrotoxic medication (ntmx) exposure is one of the most commonly cited causes of acute kidney injury (aki) in hospitalized children, and is the primary cause of aki in 16% of cases. through initial work at cincinnati children's medical center, ntmx exposure was found to be potentially modifiable and the associated aki is an avoidable adverse safety event. currently, only serum creatinine monitoring is available to monitor for ntmx-associated aki. the hypotheses of this ninja ngal study are that (1) urine ngal is highly sensitive to detect ntmx-associated aki, and (2) bedside test of urine from high risk ntmx-exposed patients are adequate and reliable compared to urine ngal measured from the clinical platform.


Eligibility criteria:
inclusion criteria: * receiving 3 or more nephrotoxic medications on the same day or * receiving 3 or more days of an intravenous aminoglycoside or vancomycin exclusion criteria: * currently being treated for a urinary tract infection * presence of an acute kidney injury prior to enrollment

Keywords: aki ngal
resuscitation registry - surrogate markers of outcome after cardiac arrest

Conditions: Cardiac Arrest

Summary: the aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. these patients are comatose. conscious patients are unsuitable for prognostication.

the aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. these patients are comatose. conscious patients are unsuitable for prognostication. this will be a prospective mono-center survey (department of intensive care medicine, university hospital bern), evaluating the survival and neurological outcome after cardiac arrest. the study will be performed in cooperation with the department of neurology and neuroradiology, university hospital bern. inclusion: all patients surviving resuscitation after cardiac arrest older than 18 years. detailed medical and neurological examination including 6-lead continuous eeg, 10/20 eeg and somatosensory evoked potentials, standard blood tests including neuron-specific enolase (nse) and cerebral mri will be assessed during the first 72 hours after cardiac arrest. structured telephone interviews to determine outcome parameters (cerebral performance category cpc, modified ranking scale mrs) will take place at day 30, after 3 and 12 month. the results of the registry could identify early comatose patients after cardiac arrest with no chance of a good neurological recovery and regain consciousness to avoid unjustified expectations of relatives and prolonged life-sustaining therapies. a good neurological recovery is defined as a cpc of 1 and 2 or a mrs 0-2. an unfavourable neurological outcome will be defined as persistent vegetative state and death (cpc 4 and 5, mrs 5-6).

Eligibility criteria:
inclusion criteria: * age at least 18 years * down time ≤ 20 minutes (down time = time breakdown to start of professional resuscitation) * persistent stable circulation without further need of cpr * glasgow coma scale \< 8 after return of spontaneous circulation exclusion criteria: * cardiac arrest due to neurological causes (stroke, intracerebral hemorrhage, subarachnoid hemorrhage, sudep - sudden unexpected death in epilepsy) * cardiac arrest due to unobserved asystole