Kornimate/medical-research-clean huggingface dataset:
effect of low dose colchicine on the incidence of poaf

Conditions: Atrial Fibrillation; Cardiac Surgery; Colchicine Adverse Reaction

Summary: the prior end-af study by the same group showed that 1 mg of colchicine didn't decrease the incidence of af after cardiac surgery. the current study, end-af low dose study, will test 0.5 mg colchicine vs. placebo in preventing af after cardiac surgery.

af after cardiac surgery leads to excess mortality and morbidity. colchicine was used in several studies to lower the incidence af but the results were generally disappointing. there was no benefit in reducing af and there was a high incidence of gi side effects especially diarrhea, often leading to stopping the medication. however, a recently published meta-analysis showed that colchicine reduced af, but again warned of the high incidence of gi side effects. the maintenance dose of colchicine used in these studies was 1 mg daily it is hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower af after cardiac surgery without the prohibitive gi side effects patients will be randomized to colchicine vs. placebo started the day before surgery and continued until hospital discharge. the primary efficacy endpoint will be the incidence of af. the primary safety endpoint will be the gi side effects

Eligibility criteria:
inclusion criteria: * all patients aged 18 years or above undergoing elective cardiac surgery. * sinus rhythm and no previous af * agreed to sign informed consent. exclusion criteria: * known severe liver disease or current transaminases \>1.5 times the upper normal limit * current serum creatinine \>2.5 mg/dl * known myopathy or elevated baseline preoperative creatine kinase * known blood dyscrasias or significant gastrointestinal disease * pregnant and lactating women * known hypersensitivity to colchicine * current treatment with colchicine for any indications * emergency surgery

Keywords: atrial fibrillation cardiac surgery colchicine
ctdna in subjects with muscle-invasive bladder cancer treated with trimodality therapy

Conditions: Bladder Cancer; Muscle-Invasive Bladder Carcinoma

Summary: the purpose of this prospective biospecimen collection study is to evaluate the feasibility of measuring circulating tumor dna (ctdna) in subjects with muscle-invasive bladder cancer (mibc) treated with trimodality therapy consisting of a maximal transurethral resection of bladder tumor followed by radiation and concomitant chemotherapy. cancer cells have unique genes that determine the characteristics of tumors, such as how they will respond to different treatments. the tumor tissue will be used to determine the genes present in cancer cells. tumor cells sometimes release fragments of dna into the blood or urine (circulating tumor dna or ctdna) and measuring levels of ctdna may be a way to monitor cancer and predict to determine which treatment works better and what will be the outcome of cancer. urine, blood, and tumor tissue are called biospecimens. biospecimens can help researchers understand how the human body works. researchers may develop new tests to monitor diseases or new ways to treat diseases. plasma and urine specimens will be collected before, during, and after the standard-of-care treatment. this study will estimate the feasibility of collecting plasma ctdna detection in subjects with mibc. if this information can be successfully collected and processed, the usefulness of ctdna to predict tumor response to certain kinds of treatment or disease progression will be evaluated.


Eligibility criteria:
inclusion criteria: 1. written informed consent was obtained to participate in the study and hipaa authorization for the release of personal health information. 2. a diagnosis of muscle-invasive bladder cancer with a plan to treat it with surgery, radiation, and chemotherapy 3. subjects are willing and able to comply with study procedures based on the judgment of the investigator. exclusion criteria: all subjects must not meet any of the following exclusion criteria prior to enrollment to participate in this study: 1. any serious medical or psychiatric disorder that would interfere with the subject's ability to give informed consent. 2. incarcerated individuals.

Keywords: circulating tumor dna biospecimen surgery radiotherapy chemotherapy trimodality
the australia and new zealand multicentre upper gastrointestinal endoscopic tissue resection study

Conditions: Cancer of Stomach; Oesophageal Cancer; Gastric Cancer; Gastric Adenocarcinoma; GI Cancer; GIST; Neuroendocrine Tumors; Gastric Neoplasm; Esophageal Neoplasms

Summary: to determine the long term outcomes of endoscopic submucosal dissection (esd), endoscopic full thickness resection (eftr) and submucosal-tunnelling endoscopic resection (ster) for upper gastrointestinal neoplastic lesions

to collect prospective observational data on patients undergoing esd, eftr or ster for ugi neoplastic lesions * lesion characteristics including histology * procedural outcomes * safety outcomes * efficacy outcomes

Eligibility criteria:
inclusion criteria: * ugi neoplastic lesions \> 10mm * lesions for esd limited to the mucosal and/or submucosal layer or * lesions for eftr limited to the muscularis propria layer or * lesions for ster limited to the submucosal and/or muscularis propria layer * aged 18 years or older exclusion criteria: * age less than 18 * unable to give informed consent * pregnant or lactating patients * patients with bleeding diathesis or who cannot discontinue adp blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally
the effect of individualized precision therapy programs in patients with btc

Conditions: Biliary Tract Neoplasms

Summary: this is a prospective cohort study. patients who meet the inclusion criteria will be enrolled in this study. the samples of biliary tract tumors will be collected. genome sequencing, mini-pdx and pdx will be performed according to the requirement of individualized precision therapy programs. suitable drugs will be chose according to drug screening results. os and pfs will be compared with traditional chemotherapy to evaluate the effect of individualized precision therapy programs.

in this prospective cohort study, patients who are eligible for inclusion criteria will enroll in the study. after bile duct tumor samples were collected, whole genome sequencing, drug screening ( including mini-pdx and pdx) will conduct. suitable drugs will be decided according to the different genomics classification, and then to develop individualized precise treatment programs. the investigators hope to achieve the following objectives: ① through the establishment of individualized precision therapy programs to improve the overall survival of bile duct malignancy (btc)； ② to study the molecular typing of the prognosis of biliary malignancy; ③ to construct a database of btc gene bank, as well as for drug screening information.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of biliary malignancies * the expected survival time is longer than 3 months * pks score\> 60 points * willing to take part in the study exclusion criteria: * can not or refuse to collect tumor samples * refused to accept the relevant treatment method

Keywords: bile duct tumor individualized precise treatment programs
antibiotic observatory for respiratory diseases, apart from tuberculosis and reportable diseases

Conditions: Antibiotic Sore Tongue

Summary: the study aimed to determine the distribution of respiratory infections in tunisian population and evaluate the frequency of antibiotics prescribed according to current international recommendations.

it is an observational, cross-sectional, multicenter, national clinical study . the study was carried out from january 2018 to august 2018 in tunisian population involving 57 primary care outpatient centers and 6 emergency departments from the 24 departments of the country . we included all patients with lower and upper respiratory tract infections (rtis) who have recieved antibiotic treatment. lower respiratory tract infection (lrti) include pneumonia and acute bronchitis. acute upper respiratory tract infection (urtis) include rhinitis, pharyngitis/tonsillitis, and laryngitis. rhinitis, also known as coryza, is irritation and inflammation of the mucous membrane inside the nose. the protocol of our study includes the demographic characteristics and the history of the sample as well as the symptomatology at inclusion. the data from the clinical examination were reported by the investigating doctor. after the diagnosis retained by the doctor is noted with the management of the patient which includes additional explorations if they have been requested. finally, the investigating doctor specifies the antibiotic therapy prescribed.appropriateness of antibiotic prescription was assessed in patients managed in the eds . we used the mai score (medication appropriateness index) wich includes 10 criteria. for each criterion, the evaluator rates whether the medication is appropriate, marginally appropriate, or inappropriate. support is provided through explicit definitions and instructions.the mai has been used in observational and interventional studies.its feasibility, content validity, predictive validity, and reliability have been demonstrated in ambulatory settings. the maximum score is 20 which translates into maximum inappropriateness. if a patient is on multiple drugs, this test can be repeated for each drug in order to determine a total mai score.

Eligibility criteria:
inclusion criteria: * patients with lower and upper rtis who recieved antibiotic treatment. exclusion criteria: * not obtained informed consent, specific respiratory infection such as tuberculosis, life-threatening emergency necessitating hospitalization or non-probabilistic antibiotic therapy and contraindication to antibiotic use

Keywords: antiobiotic, respiratory tract infections appropriateness
long-term treatment effect of intravitreal ant-vegf in branch retinal vein occlusion

Conditions: Branch Retinal Vein Occlusion

Summary: retinal vein occlusion (rvo) is the second leading cause of retinal vascular disease in patients older than 50 years.the prevalence varies from 0.7% to 1.6% in the literature. visual recovery depends on ischemic damage of the retina, the occurence of macular edema (me) and the development of neovascular glaucoma. the occurence of me is the main reason for visual loss and frustrates visual recovery among patients with both central or branch rvo. therapeutic options that have been used and discussed over the years are the treatment with anticoagulants, fibrinolytics, corticosteroids, acetazolamide and isovolemic haemodilution. furthermore, surgical options like vitrectomy and radial optic neurotomy were used. panretinal photocoagulation and grid pattern photocoagulation had established as additional tool to induce chorioretinal anastomosis. nevertheless, the effectiveness and the evidence of these different treatment options could not be verified and remains mostly unknown. nowadays, intravitreal anti-vegf application had become the treatment of choice for me secondary to rvo. multi-center studies have already shown the effectiveness of anti-vegf treatment to reduce intraretinal fluid and retinal hemorrhages (bravo, cruise). unfortunately, often high numbers of re-treatments become necessary over the years. in our knowledge, there are no reports showing more than 3 years treatment effects of antiangiogenic drugs in patients with brvo. however, the results of treatment effect longer than 3 years are important, as the mean age \< 70 years with an onset of brvo has been estimated in about 60% of all cases. in addition, most patients with regard to the application of anti-vegf treatment in real clinical setting, there is only rare experience concerning need of optimum time duration for follow-up at the departments. hence, the present study aimed to evaluate the long-term clinical outcomes, safety and therapeutic benefit of a flexible dosing regimen of intravitreal anti-vegf therapy in patients with me secondary to brvo.

this cross-sectional study evaluates a series of patients with me due to rvo who were available for at least 4 years' follow-up examination. the patients received either intravitreal ranibizumab (ivr) or bevacizumab (ivb) in a flexible dosing regimen

Eligibility criteria:
inclusion criteria: * macular edema secondary to branch retinal vein occlusion exclusion criteria: * aphakia, glaucoma

Keywords: branch retinal vein occlusion central retinal thickness visual acuity central reintal sensitivity
the use of palliative non invasive ventilation in acute respiratory failure. ovni study.

Conditions: Acute Respiratory Failure

Summary: the purpose of this study is: * to estimate the frequency of the use of non invasive ventilation * to estimate the frequency of the use of palliative non invasive ventilation * to evaluate the impact of non invasive ventilation * to propose some recommendations

the purpose of this study is: * to estimate the frequency of the use of non invasive ventilation * to estimate the frequency of the use of palliative non invasive ventilation * to evaluate the impact * to propose some recommendations

Eligibility criteria:
inclusion criteria: * acute respiratory failure * hospitalization in icu * age \>= 18 years exclusion criteria: * patients who have already participated to ovni
needle-free jet injection of lidocaine during lumbar puncture

Conditions: Pain

Summary: background: the j-tip device allows an intradermal needle-free jet injection of 1% buffered lidocaine. this study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants. methods: randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. all patients were administered the j-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.

background: lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. the j-tip device allows an intradermal needle-free jet injection of 1% buffered lidocaine. this study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants. methods: randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. all patients were administered the j-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. vital signs were recorded during the procedure. facial expressions as well as crying times were video recorded from start to finish. independent reviewers assigned pain scores based on the validated neonatal facial coding system with possible scores ranging from 0-5.

Eligibility criteria:
inclusion criteria: * fever in infants less than 3 months exclusion criteria: * toxic appearance, altered level of consciousness, age greater than 3 months or less than 4kg of weight

Keywords: pain lidocaine lumbar puncture j-tip
2 phase use of educational materials in head and neck cancer center

Conditions: Head and Neck Cancer

Summary: the goal of this study is to assess the experience of our patients with head and neck cancer in regard to the information they receive, their symptoms, and their understanding of their diagnosis, to determine ways to improve upon these aspects of patient care in the future.

there will be two phases of the study. in "phase i", 30 participants will be recruited for assessment of information satisfaction, psychological stress, illness perception, and symptom burden throughout their head and neck cancer treatment without any intervention. this group will represent the current standard of care in the head and neck group and serve as a "historical control" for the second group. in "phase ii", which will occur after "phase i" group, 30 new participants will be recruited to receive a handbook and to have it integrated into their cancer care. the same participant reported outcome measures of information satisfaction, psychological stress, illness perception, and symptom burden will be assessed such that comparisons between phases can be made. this will serve as a pilot study of the implementation and maintenance of an educational intervention in clinical practice and how it affects participant-reported outcomes. comparison of these two groups of participants will provide the baseline data to plan future interventions.

Eligibility criteria:
inclusion criteria: * adult patients (greater than 18 years old) with a new diagnosis of head and neck cancer. * patients who have a treatment plan including both chemotherapy and radiation. * patients who will be undergoing treatment at massachusetts general hospital cancer center. * ability to speak and read in english in order to be able to complete questionnaires with minimal assistance required from a family member. exclusion criteria: * patients with head and neck cancer who have a treatment plan only including single modality therapy (ie just radiation, just surgery, or just systemic therapy) * patients who cannot speak, read and write in english with minimal assistance from a family member. * patients with cognitive impairment that would preclude the patient signing informed consent or understanding the materials. * patients who will not be receiving their cancer treatment at mgh.

Keywords: head and neck cancer
post-transfusion platelet count

Conditions: Leukemia; Multiple Sclerosis

Summary: the purpose of this study is to identify how the platelet count, complement system and endothelial markers are affected over time, after platelet transfusion in 4 different hematological patient groups.

patients who are hospitalized at the clinic for hematology diseases at the skåne university hospital (sus) in lund, sweden with a central venous catheter or port-a-cath and should receive platelet transfusion due to thrombocytopenia are asked to participate in the study. some patients who are being considered for platelet transfusions on several occasions will be able to attend more than one time in this study. after signed informed consent blood samples are drawn from the central line before, immediately after and then approximately. 1, 4, 8, 16 and 24 hours following the platelet transfusion. the platelet count (plc) will then be taken daily following 4 days. sample size. data from previous studies (norol-98) shows that the plc after platelet transfusion rises by 33 ± 25 x109/l (mean ± sd) 12 hours post-transfusion in patients with acute myeloid leukemia or pre-conditioning prior to bone marrow transplantation. the investigators want to show the same rise in the plc after 12 hours with 80% power and 5% alpha risk of error for each group resulting in the sample size 13 per group and a total of 65 patients.

Eligibility criteria:
inclusion criteria: * patients admitted to the clinic of hematology diseases, skåne university hospital, lund, sweden belonging to either of the groups described in paragraph 8 above and are prescribed platelet transfusion. exclusion criteria: * patients with aplastic anemia or treatment with antithymocyte globulin (atg)

Keywords: platelet count platelet transfusion complement factors endothelial markers stem cell transplantation
the effectiveness of low level laser therapy on particular joint points and acupuncture points on knee joints in grade iii knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: lllt is in use to treat different musculoskeletal condition. osteoarthritis is one of the conditions needing lllt for therapeutic effects. lllt has been used in different previous studies using different points on joint and also on acupuncture points. this study is going to compare the effectiveness of lllt on both points. omega xp device is going to be used in this study.

lllt is a non-invasive modality to treat variety of musculoskeletal conditions. photobiomodulation has been studies for last two decades in different perspectives and on different musculoskeletal condition. studies suggest profound results due to effect of lllt at the cellular level. osteoarthritis is one of the most common debilitating musculoskeletal condition affecting people worldwide. statistics indicate an increase in this debilitating condition in future. knee oa is more common amongst other oa of the body. lllt has been used in previous studies to see the impact on pain and functional performance in knee oa. lllt has been used on different points on knee joint and also applied on acupuncture points of the knee joints. different outcomes were used to assess lllt effectiveness including pain, rom and even different biomarkers. this study is going to use lllt on different particular joint points of knee and also acupuncture points of the knee joint and compare the outcomes. this study will present evidence for the clinicians to use lllt on either the particular joint points or acupuncture points for better clinical outcomes.

Eligibility criteria:
* inclusion criteria: * pain in the knee joint ( minimum 30/100 on vas ) * kellgren-lawrence grade iii knee oa * acr criteria for knee oa with radiological findings including ; * age 35 and above * joint crepitus * less than 30 minutes of morning stiffness * exclusion criteria: * knee oa grade other than iii. * any contraindication of lllt including; * pregnancy * carcinoma involving knee area * steroids and nsaids use
directed topical drug delivery for treatment for pasc hyposmia

Conditions: Post Acute Sequelae Covid-19 Hyposmia

Summary: this is a phase ii randomized, double-blinded, placebo-controlled study to evaluate the efficacy of topical intranasal treatment of beclomethasone vs. placebo for improved olfactory function.

eligible participants are randomized to receive either beclomethasone or placebo intranasally via a microsponge twice on day 1 and day 14. study duration is three months and includes 4 in-person study visits: 2 visits for drug administration at baseline and week 2, and 2 follow-up visits at week 6 and week 18. participants will be expected to complete the smell identification test (sit) and questionnaire on olfactory disorders (qod) at baseline, week 6, and week 18. the investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.

Eligibility criteria:
inclusion criteria: * post-covid hyposmia lasting greater than 3 months following covid19 by history * male or female, aged 18 years or older exclusion criteria: * pregnancy or lactation * known allergic reactions to components of microsponge (including shellfish) or to beclomethasone * known diagnosis of glaucoma * febrile illness within 1 week * treatment with another investigational drug or other intervention within 3 months * active sinonasal disease by nasal exam, i.e. rhinosinusitis, nasal polyps * adults unable to consent * prisoners, employees or subordinates * individuals who are not yet adults (infants, children, teenagers)

Keywords: covid-19 smell loss hyposmia