Kornimate/medical-research-clean huggingface dataset:
anticoagulation for stroke prevention in patients with recent episodes of perioperative af after noncardiac surgery

Conditions: Stroke; Atrial Fibrillation

Summary: multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

aspire-af is a prospective, randomized, open-label trial of non-vitamin k oral anticoagulants (noacs) versus no oral anticoagulation in patients with transient perioperative atrial fibrillation and additional stroke factors after noncardiac surgery. the primary objective is to assess the effects of noacs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.

Eligibility criteria:
inclusion criteria: 1. noncardiac surgery in the past 35 days with at least one of the following: 1. an overnight hospital admission after surgery; 2. day surgery resulting in a large enough physiological insult to be able to cause perioperative af, as judged by the local investigator 2. ≥1 episode of clinically important perioperative af during or after their surgery; 3. sinus rhythm at the time of randomization; and 4. any of the following high-risk criteria: 1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a cha2ds2vasc score ≥3, or an elevated postoperative troponin level; 2. age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a cha2ds2vasc score ≥2, or an elevated postoperative troponin level; or 3. age ≥75 years. 5. provide written informed consent exclusion criteria: 1. history of documented chronic af prior to noncardiac surgery; 2. need for long-term systemic anticoagulation; 3. ongoing need for long-term dual antiplatelet treatment; 4. contraindication to oral anticoagulation; 5. severe renal insufficiency (crcl \<20 ml/min); 6. severe liver cirrhosis (i.e., child-pugh class c) 7. acute stroke in the past 14 days; 8. underwent cardiac surgery in the past 35 days; 9. history of nontraumatic intracranial, intraocular, or spinal bleeding; 10. hemorrhagic disorder or bleeding diathesis; 11. expected to be non-compliant with follow-up and/or study medications; 12. known life expectancy less than 1 year due to concomitant disease; 13. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; or 14. previously enrolled in the trial

Keywords: transient atrial fibrillation perioperative atrial fibrillation non-vitamin k oral anticoagulation noncardiac surgery probe design
national project on vaccines, covid-19 and frail patients

Conditions: COVID-19; Solid Tumor; Hematologic Diseases; Neurologic Disorder; Rheumatic Diseases

Summary: this is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for sars-cov-2 with pfizer-biontech or moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies.

the immune response to covid-19 vaccination will be assessed at the following time points: t0: the day of vaccination t1: the day of the booster dose according to the schedule of the two vaccines (pfizer/biontech or moderna) t2: between 5 and 7 weeks after t0 for those vaccinated with pfizer/biontech and between 6 and 8 weeks after t0 for those vaccinated with moderna. * t3: 12 (± 1) weeks after t0 * t4: 24 (± 2) weeks from t0 * t5: 52 (± 2) weeks from t0 prevention of sars-cov-2 infection will be assessed in terms of incidence of sars-cov-2 infections (nf molecular swab positive), and of sars-cov-2 infections requiring hospitalisation.

Eligibility criteria:
inclusion criteria: * any subject undergoing sars-cov-2 vaccination with pfizer-biontech or moderna vaccines may be included in the study if they belong to at least one of the subgroups listed below: 1. hematological tumors 2. solid tumors 3. rheumatological diseases 4. neurological diseases exclusion criteria: * na

Keywords: vaccination covid-19 frail patients
multi-model image of doxycycline in tao

Conditions: Thyroid Associated Ophthalmopathy

Summary: this study aims to evaluate the efficacy of doxycycline treating thyroid associated ophthalmopathy by multi-modal image.

thyroid associated ophthalmopathy is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. different degrees of exophthalmos, eyelid aperture, lid retraction and lid lag are common symptoms apprearing in tao. the improvement of exophthalmos is usually measured with hertel instrument and the change of eyelid is measured with millimeter ruler. all these measurements are subjective, low reliable and less accurate. tao can be classified into active phase and inactive phase according to the activity score and wait-and-see or surgery are widely chosen for patients in inactive phase. but still a progression and reoccurrence can be a big challenge for ophthalmologists. this is a perspective cohort study to evaluate the efficacy of doxycycline in tao by multi-model image.

Eligibility criteria:
inclusion criteria: * informed consent * age 18-70 years old * diagnosed with tao exclusion criteria: * sight-threatening tao with dysthyroid optic neuropathy * allergy of tetracycline * have contraindications of mri(metal pacemaker, fake teeth, foreign body and other materials which will disturb the examination)

Keywords: doxycycline thyroid associated ophthalmopathy extraorbital muscle orbit fat volume multi-modal image
investigating the effectiveness of mobilization on congenital muscular torticollis and deformational plagiocephaly

Conditions: Congenital Muscular Torticollis

Summary: this study investigates the effect of soft tissue mobilization in babies with neck muscle problem. babies received soft tissue mobilization or home exercises program

objectives: investigating the effectiveness of soft tissue mobilization in babies with congenital muscular torticollis and deformational plagiocephaly. design: a randomized controlled trial design setting: university research department participants:babies with congenital muscular torticollis, aged between 0-6 months, who had a head tilt from 5 to 20 degrees and no other health problems were the participants of the study. the study included two groups; home program group was seen once every six weeks, the study group in addition to the home program also received soft tissue mobilization three times in a week. all groups received a baseline home program consisting of positioning, handling strategies plus stretching, stretching and strengthening exercises, environmental adaptations and classical massage. babies were allocated to two groups by sealed envelope randomization. babies were evaluated initially, at sixth weeks, at 12 weeks and follow-up at 18 weeks with muscle function scale, head tilt and ear shift assessments which included photographing method, neck normal range of motions (lateral flexion and rotation) and plagiocephaly severity scale

Eligibility criteria:
inclusion criteria: * babies with congenital muscular torticollis and secondary deformational plagiocephaly * head tilt from 5 to 20 degrees * age between 0-6 months exclusion criteria: * have another health problem such as neurological, vertebral anomalies, craniosynostosis

Keywords: congenital muscular torticollis manual therapy infant
extension study to assess safety and efficacy of pimecrolimus in adult patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. in this study, the long-term safety and efficacy of pimecrolimus cream will be evaluated in japanese adult patients with atopic dermatitis. this study is a 6-month extension study following core study. this study is not enrolling patients in the united states


Eligibility criteria:
inclusion criteria: * patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator * patients who had given written informed consent to participation in this study exclusion criteria: * patients who failed in treatment compliance in the core study * patients who had a major violation of the protocol in the core study

Keywords: atopic dermatitis, asm981, pimecrolimus
effectiveness of music intervention on anxiety and physiological responses in critical ill patient

Conditions: Diabetic Ketoacidosis; Heart Disease, Ischemic; Stroke; GastroIntestinal Bleeding; Acute Kidney Injury; Heart Failure; Trauma; Septic Shock; Respiratory Failure; Pneumonia; Intracerebral Hemorrhage; Head Injury; Liver Diseases

Summary: music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. the effectiveness of music intervention in reducing anxiety of patients in intensive care unit (icu) is still unknown. the purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in icu. this study was conducted from january to june 2019. a total of 196 hospitalized icu patients were divided into two groups. subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. the primary outcome was anxiety. agitation sedation scale, sleep quality and physical parameters were selected to collect as secondary outcomes.there was no significant difference between the groups at baseline. the results of this study support that music can reduce anxiety and agitation levels in icu's patient. nurses can incorporate this intervention into the daily care in order to reduce the discomfort of patients.

background:music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. the effectiveness of music intervention in reducing anxiety of patients in icu is still unknown. objectives: the purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in icu. methods: this study was conducted from january to june 2019. a total of 196 hospitalized icu patients were divided into two groups. subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. the primary outcome was anxiety measured by visual analog scale. richmond agitation sedation scale, richards-campbell sleep scale and their physical parameters were selected to collect the secondary outcomes.

Eligibility criteria:
inclusion criteria: * aged 20 years or older and staying in an intensive care unit. * patients within 24 hours of admission (acute physiology and chronic health evaluation, apache ii score) ≦25 points. * can express their intentions by writing or shaking their heads. * can communicate in mandarin, taiwanese, hakka or english. * after explaining the purpose of the research, agree to participate and fill out the consent form. exclusion criteria: * dementia or mental illness are recorded

Keywords: music intervention anxiety agitation sleep quality intensive care unit
pre- and post-operative teg indices in patients with or without adenocarcinoma undergoing surgical resection

Conditions: Liver Cancer; Esophageal Cancer; Colorectal Cancer; Lung Adenocarcinoma; Control; Pancreas Cancer; Biliary Cancer

Summary: the investigators hypothesize that abnormalities in thromboelastography (teg) parameters in patients with liver, pancreas, biliary, esophageal, colorectal, and lung adenocarcinoma can serve as biomarkers for oncologic disease burden, cancer recurrence and overall survival as well as thrombotic and hemorrhagic post-operative complications. the investigators further hypothesize that there is histologic pathology correlates to pre-operative teg abnormalities, and that it identifies patients with virulent tumor biology.

aim 1: evaluate the correlation between pre-operative teg parameters and disease burden in patients with a new diagnosis of hepatopancreaticobiliary, esophageal, colorectal, and lung adenocarcinoma vs controls with no known malignancy. aim 2: explore if pre- and post-operative teg parameters vs routine clinical coagulation parameters (platelet count, prothrombin time \[pt\], partial thromboplastin time \[ptt\]) are predictive of pre- and post-operative thrombotic (deep vein thrombosis \[dvt\], pulmonary embolism \[pe\], stroke, myocardial infarct \[mi\]) and hemorrhagic complications. aim 3: evaluate if correction of teg parameters after surgery is predictive of curative resection and if the failure of teg parameters to correct after surgery or chemoradiothearpy is predictive of cancer recurrence and overall survival. aim 4: perform proteomic analyses on the tumor microenvironment of cancer tissue samples to investigate whether tumor histology and protein composition is associated with specific teg derangements that have been previously correlated to poor outcomes, potentially identifying a specific subtype of pancreatic cancer.

Eligibility criteria:
inclusion criteria: * new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma will be eligible for enrollment in the study * 18 years and older exclusion criteria: * under 18 years old * prisoners * those unable to provide informed consent * pregnant women * and those undergoing emergent or urgent operative intervention at the time of diagnosis
avanti - avelox® in acute exacerbations of chronic bronchitis

Conditions: Bronchitis, Chronic

Summary: the objective of this global non-interventional study is to evaluate the impact of acute exacerbation of chronic bronchitis(aecb) on the patient and the community as well as the safety and effect of a treatment with moxifloxacin tablets in daily life clinical practice. this includes data on the course of symptom relief, speed of return to normal daily life activities as well as records on adverse events. this study will be performed in accordance with international guidelines like emea (emea, eudralex volume 9a, pharmacovigilance for medicinal products for human use) as well as local laws.


Eligibility criteria:
inclusion criteria: * patients at least 35 years of age with a diagnosis of acute exacerbation of chronic bronchitis (aecb) and decision taken by the investigator to treat with avelox. exclusion criteria: * exclusion criteria must be read in conjunction with the local product information.

Keywords: acute exacerbation of chronic bronchitis (aecb) patients
chewing ticagrelor versus prasugrel in st-elevation myocardial infarction - a platelet reactivity study

Conditions: Acute Coronary Syndrome; STEMI

Summary: to examine the efficacy of chewing ticagrelor versus prasugrel in st-elevation myocardial infarction (stemi) patients on platelet reactivity.


Eligibility criteria:
inclusion criteria: 1. patients presenting with stemi 2. informed, written consent exclusion criteria: 1. age \ 75 years 2. active bleeding; bleeding diathesis; coagulopathy 3. increased risk of bradycardic events 4. history of gastrointestinal or genitourinary bleeding \<2 months 5. major surgery in the last 6 weeks 6. history of intracranial bleeding or structural abnormalities 7. suspected aortic dissection 8. any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, unconsciousness, known malignancies or other comorbid conditions with life expectancy \<1 year) 9. administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux. 10. concomitant oral or iv therapy with strong cyp3a inhibitors or strong cyp3a inducers, cyp3a with narrow therapeutic windows 11. known relevant hematological deviations: hb \<10 g/dl, plt\<100x10\^9/l 12. use of coumadin derivatives within the last 7 days 13. chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine 14. known severe liver disease, severe renal failure 15. known allergy to the study medications 16. pregnancy 17. human immunodeficiency virus treatment 18. the use of iibiiia receptor antagonists in the 48 hours before enrollment (if abciximab use then in the last 14 days). 19. if the patients cannot sign percutaneous coronary intervention (pci) informed consent for any reason.
codesign of an optical device to measure urine flow and volume

Conditions: Urinary Incontinence; Urinary Retention; Urinary Tract Infections; Overactive Bladder; Benign Prostatic Hyperplasia; Underactive Bladder

Summary: the study is seeking to understand the needs of patients and healthcare practitioners for an innovation in the way that changes in bladder function are assessed. this information will be used in the design and evaluation of a device, being developed in parallel, that assesses changes to the volume and flow of urine in order to determine changes in bladder function. in order to ensure development is optimal, the principal research objective is therefore to understand the needs of patients and healthcare practitioners (ranging from care home staff and gps in primary care, to urologists in tertiary referral centres).


Eligibility criteria:
inclusion criteria the participant is willing and able to give informed consent for participation in the study. aged 18 years or above. male or female. exclusion criteria the participant is unwilling or unable to give informed consent for participation in the study. aged 17 years or younger.
impact of peri-operative hyponatremia on postoperative outcomes in major hpb surgeries for cancers

Conditions: Carcinoma

Summary: the present study is being designed to study the impact and predictive nature of perioperative hyponatremia on post operative outcomes in patients undergoing major hpb surgeries for cancers. major hepatobiliary-pancreatic surgeries will be defined as follows- * pancreaticoduodenectomy, * hemihepatectomy or greater with or without caudate lobectomy * extrahepatic bile duct resection * extended cholecystectomy * distal pancreatectomy with or without splenectomy the primary objective of the study would be to compare post operative major morbidities and early mortality (\<90 day) in major hpb surgeries done for cancer patients with and without peri-operative hyponatremia. (\<135mmol/l). development of systemic complications and long term outcomes (overall survival and disease free survival) will also be evaluated. it will be an observational study consisting of both, a retrospective arm and a prospective arm. all consecutive patients undergoing major hpb surgery from 2010 till 30th june 2024 will be included in the study.

primary objective: to compare post operative major morbidities and early mortality (\<90 day) in major hpb surgeries done for cancer in patients with and without peri-operative hyponatremia. (\<135mmol/l) secondary objectives: to compare the following in patients undergoing major hpb surgeries for cancer in patients with and without peri-operative hyponatremia (\<135mmol/l) * post operative systemic complications and * long term outcomes * os- pod1 till death/ last follow up (30th sep 2024). * dfs- surgical resection till first detected recurrence of cancer or last follow up (30th sep 2024) without recurrence. * study design- observational study- retrospective and prospective. * study period- data collection will be done from time of ethical clearance till 30th june 2024. * intervention - none * monitoring and assessment- clinical profile of the patient and symptoms will be serially followed during the patients post operative opd visits. * statistical analysis: 1. continuous variables- with student t test and mann whitney u test as appropriate. 2. categorical data - chi square or fischer exact test. besides the above, appropriate analysis will be done at the time of final data analysis. 3. significance will be seen at 5 % level (p\<0.05). 4. adequate subgroup analysis and multivariate regression analysis will be done. * adverse effects - no adverse effect is expected to occur out of the study protocol. * stopping rule - not valid

Eligibility criteria:
inclusion criteria: 1. all patients undergoing major hpb cancer surgeries at ilbs from 2010 till 30th june 2024. exclusion criteria: 1. presence of diuretic (thiazide, frusemide), pain killer (indomethacin, ketorolac) induced preoperative hyponatremia. 2. patients with peri-operative diarrhea and vomiting due to infective cause leading to hyponatremia. 3. patients who did not have a preoperative serum sodium level recorded within 72 hours prior to surgery. 4. minor hpb cases.
novosyn® for trocar incision after laparoscopic appendectomy and cholecystectomy

Conditions: Appendicitis; Cholecystitis

Summary: the aim of this study is to evaluate if the application of a chlorhexidine coated suture (novosyn® chd) will reduce the colonization of bacteria in comparison to an uncoated suture (novosyn®) used for the closure of trocar wounds in laparoscopic surgery (appendectomy and cholecystectomy).

the bacteriostatic and bactericidal effect of novosyn® chd will be assessed by the incidence of surgical site infection (ssi) in each suture group until 30 days postoperatively. the frequency of infections (ssi: a1 and a2) is considered as a suitable parameter for the assessment of efficacy. it is expected that the use of the novosyn® chd suture will reduce the occurrence of infections (ssi: a1 and a2) 30 days postoperatively compared to novosyn suture (primary objective). ssi will be classified according to the centre of disease control and prevention (cdc), therefore the time point for assessment of ssi as set to 30 days postoperatively. furthermore, short-term and long-term complications, the handling of the suture material, length of postoperative hospital stay, costs, pain, quality of life, time to return to work, hernia rate including umbilical hernias and the cosmetic outcome will also be assessed as secondary objectives.

Eligibility criteria:
inclusion criteria: * patients undergoing a primary emergency or early elective (24h - 7 days) laparoscopic appendectomy or cholecystectomy. * written informed consent * age≥ 18 years * not incapacitated patient exclusion criteria: * open surgery for appendectomy or cholecystectomy * pregnancy * allergy or hypersensitivity to chlorhexidine * intraoperatively conversion from laparoscopic to open surgery * patients taking medical consumption that might affect wound healing

Keywords: minimal invasive surgery appendectomy cholecystectomy