Kornimate/medical-research-clean huggingface dataset:
the impact of prehabilitation bundle on perioperative outcome for frail elderly patients undergoing major abdominal surgery

Conditions: Complication, Postoperative; Perioperative/Postoperative Complications

Summary: this study aims to study the efficacy of a preoperative "bundle" of interventions, which consists of preoperative physiotherapy, nutritional support and cognitive exercises on elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes. there will be two arms, intervention and control.

frailty is a geriatric syndrome, defined as an increased vulnerability to stressors leading to a state of decreased physiological resistance. it is characterised by a "constellation of symptoms and signs that describe the heterogeneous response of older adults to physiological and metabolic challenges." while frailty is not necessarily synonymous with chronological age, it is more prevalent among the older adult population and is associated with up to a threefold increased risk of mortality or major morbidity postsurgery. thus, it has become critically important for healthcare systems to develop strategies designed to improve clinical outcomes in this high-risk population when undergoing surgeries. currently there is no clear intervention that has been proven to modify the syndrome of frailty or its impact on postoperative outcomes. this study investigates a novel multidisciplinary approach that can be implemented within a short time frame prior to surgery. we plan to study the efficacy of a preoperative "bundle" of interventions, which consists of preoperative physiotherapy, nutritional support and cognitive exercises on elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes based 1) length of hospital stay 2) functional recovery from surgery 3) post-operative complications.

Eligibility criteria:
inclusion criteria: 1. patients attending the preoperative evaluation clinic, sgh at least 11 days prior to his/her elective major abdominal surgery. major abdominal surgery is defined as an intraperitoneal surgery with expected length of stay beyond 2 days. for patients who attended the clinic more than 11 days prior to surgery date, they will be informed to start their prehabilitation bundle 10 days prior to surgery. 2. aged 65 and above 3. diagnosed as frail based on fried criteria score 3and above 4. able to understand and follow the prescribed cognitive and physical exercise exclusion criteria: 1. patients with parkinson disease, previous stroke, neuromuscular disorders and those taking carbidopa/levodopa, donepezil hydrochloride or antidepressants as previous studies have found that these medications may cause symptoms that are similar with domains of frailty. 2. patients who are not able to communicate

Keywords: physiotherapy inspiratory muscle training perioperative medicine postoperative outcomes preoperative nutrition elderly, frail
comparison of empaglifozin and vildagliptin in type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with type 2 diabetes mellitus open labelled, multi-centric, parallel, randomized control trial in type 2 diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin (50 mg once or twice daily) assessed for efficacy \& safety parameters to be measured at both the baseline and 24-week visits.

background: diabetes is a rampant disease that keeps on getting more and more people affected each year. over 200 million people have been affected worldwide due to this disorder, and many have contracted various cardiovascular complications due to uncontrolled diabetes. though an easily manageable disease, if left untreated, diabetes can be fatal. therefore, it is necessary to have drugs available which control diabetes and also limit the progression of complications that could arise due to it. objective: the aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with type 2 diabetes mellitus methods: open labelled, multi-centric, parallel, randomized control trial to be conducted at the department of diabetes \& endocrinology of two tertiary care hospitals in karachi, pakistan. the participants will undergo screening and then were randomized into two groups. the first group received empagliflozin (10 mg once or twice daily), and the second group received vildagliptin (50 mg once or twice daily. hba1c, high-density lipoprotein (hdl) levels., systolic blood pressure, fasting blood glucose, and body weight will be measured at both the baseline and 24-week visits.

Eligibility criteria:
inclusion criteria: female and male patients of age 30-65 years with confirmed diagnosis of "type 2 diabetes mellitus". uncontrolled type 2 diabetes mellitus (\> 7% hba1c patients on monotherapy of metformin for the past three months on a fixed dose of 1500 mg /day along with lifestyle modifications were included in this study. bmi ranges from 18-45 kg/m2 were considered fit for this study. egfr ≥ 60 ml/min/1.73 m2 exclusion criteria: pregnant female or female patients planning to conceive during the study period were excluded from this study. "type 1 diabetes" or "secondary diabetes" resulting from specific causes patients with advanced diabetic complications. patients with any other terminal disease(s) requiring long-term medications. patients involved in other trials on therapy with sglt-2i or dpp4-i 3 months before study enrollment patients on insulin or any other oral hypoglycemic drugs except metformin. serum creatinine levels ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men

Keywords: type 2 diabetes mellitus empagliflozin vildagliptin efficacy safety
fibrosing ild biomarkers that rule acceleration

Conditions: Pulmonary Fibrosis; Sarcoidosis

Summary: fibralung is a prospective cohort study with biobank of samples from patients with pulmonary fibrosis, aiming to explore the molecular determinants of different clinical outcomes, acute exacerbations and mortality. we expect to gain deeper insight into fibroproliferative common pathways, particularly between idiopathic pulmonary fibrosis and fibrotic hypersensitivity pneumonitis, paving the way for new biomarkers that reflect the progressive phenotype, that eventually will support new targeted therapies. other idiopathic interstitial pneumonias, connective tissue disease-related interstitial lung diseases and sarcoidosis patients will be also recruited and their biological samples stored for further analyses.


Eligibility criteria:
inclusion criteria: * patients aged between 18-80 years * people undergoing blood collection, lung biopsy and/or bal as part of their diagnostic workup * willingness to undergo the follow-up protocol evaluations * treatment-naïve for disease-modifying drugs * an hrct scan performed within the last 12 months showing ≥10% fibrosis extent of the lungs exclusion criteria: * people who cannot give informed consent * pregnancy
efficacy of olanzapine, netupitant and palonosetron in controlling nausea and vomiting associated with highly emetogenic chemotherapy in patients with breast cancer

Conditions: Nausea Post Chemotherapy

Summary: this is a longitudinal, one arm, prospective phase ii study, designed to evaluate the efficacy of olanzapine netupitant and palonosetron in the controll of nausea and vomiting induced by highly emetogenic chemotherapy.

the population of the study is women diagnosed with breast cancer, who will start chemotherapy (doxorubicine and cyclophosfamide). we will evaluate the control of nausea and vomiting in the first cycle of chemotherapy, utilizing netupitant (300mg) + palonosetron (0,56mg) in day 1 and olanzapine 5mg starting on day 0, given once a day for five days. the primary endpoint of this study is complete response rate (no nausea, no emesis no use of rescue medication).

Eligibility criteria:
inclusion criteria: * breast cancer hitologically confirmed * 18 years and older (adult, older adult) * patients about to start use of doxorubicine 60mg/m2 + cyclophosfamide 600mg/m2 * no previous chemotherapy for breast cancer exclusion criteria: * patients not capable of completing the questionnaire * patients with other condition that could cause nausea and emesis * use of opioids * use of antipsychotic medications * patients not capable of taking medications orally

Keywords: olanzapine emetogenic chemotherapy breast cancer nausea
ciprofloxacin dry powder for inhalation (dpi) in non-cystic fibrosis bronchiectasis (non-cf be)

Conditions: Bronchiectasis

Summary: the purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

number of participants with adverse events will be covered in adverse events section.

Eligibility criteria:
inclusion criteria: * patients with a proven and documented diagnosis of non cf idiopathic or post infectious bronchiectasis * stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks exclusion criteria: * forced expiratory volume in 1 second (fev1) \ 90% predicted * active allergic bronchopulmonary aspergillosis * active and actively treated non tuberculosis mycobacterial (ntm) infection or tuberculosis * primary diagnosis of chronic obstructive pulmonary disease (copd)

Keywords: ciprofloxacin dry powder for inhalation exacerbation bronchiectasis
evaluating the true magnitude of hypoglycemic events after the initiation of sulfonylurea

Conditions: Type 2 Diabetes

Summary: sulfonylurea are known to be associated with a risk of hypoglycaemia. however, little is known about the real frequency of asymptomatic or unreported hypoglycemia and their impact on glycemic control and quality of life among patients using sulfonylureas (sus). the frequency of hypoglycemia is probably underestimated since self-monitoring of blood glucose (smbg) fail to identify asymptomatic episodes, especially among patients with higher risk of hypoglycemia unawareness (longer diabetes duration, elderly, recurrent hypoglycemia, etc.). no previous studies have reported total hypoglycemia as measured by continuous glucose monitoring system (cgms) in a large group of canadians, therefore underestimating the true incidence of these events. as with age hypoglycemia perception is reduced and consequences can be increased due to frailty, elderly could be especially sensitive to the risk of hypoglycemia. documentation of the total number of hypoglycemia is a relevant objective to really appreciate the potential impact of sus in the canadian context. the investigators propose a multicenter observational prospective study in order to study the incidence of hypoglycaemia measured by cgms among patients with type 2 diabetes mellitus (t2dm) newly prescribed a su. the investigators propose to perform a baseline testing (pre-initiation of the su), at initiation (first week after the first dose of the su) and after a 3 months follow-up of treatment, including medical history measures, quality of life and diabetes treatment satisfaction. in patients with t2dm not at goal (a1c \>7.0 mmol/l), and newly prescribed a su, the objectives and hypotheses of the study are to estimate the incidence rate of hypoglycaemia as measured by continuous glucose monitoring system (cgms) over a total of 3 weeks period following the initiation of the su.


Eligibility criteria:
inclusion criteria: * type 2 diabetes according to canadian diabetes association definition * initiation of a su at baseline * a1c: 7.0% to 10.0% * willing and able to comply with study procedures exclusion criteria: * current or previous usage (during the last 3 months) of insulin or repaglinide * use of medication known to interfere with glucose metabolism * insulin requiring patient: catabolic state and/or ketonuria * currently using cgms or within the last 3 months * recent severe hypoglycemia (\<3 months) * pregnancy or breast-feeding * limited life expectancy, high level of functional dependency, extensive coronary disease at high risk of short term ischemic events or multiple major co-morbidities

Keywords: type 2 diabetes sulfonylurea hypoglycemia quality of life
efficacy and safety of tace in combination with icis for hcc: a real-world study

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (tace) in combination with immune checkpoint inhibitors (icis) in patients with hepatocellular carcinoma (hcc) .

transarterial chemoembolization (tace) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. this provides a theoretical basis for tace combined with immune checkpoint inhibitors (icis) in hepatocellular carcinoma (hcc) patients. the purpose of this study is to evaluate the safety and efficacy of tace in combination with icis in patients with hcc. this real-world study also explores the optimal combined treatment and outcome of hcc patients for providing further information for clinical practice and trials.

Eligibility criteria:
inclusion criteria: 1. diagnosed with hcc by radiology, histology, or cytology; 2. patients who underwent tace combined with icis therapies ( with or without molecular targeted therapies) were included in the study group. for patients in the study group, icis therapies were received before the tace or within 2 months after tace and at least one cycle of immunotherapy has been received; 3. during the same period, patients who underwent tace without the combination of icis therapies ( with or without molecular targeted therapies) were included into the control group; 4. patients who underwent tace combined with icis therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with tace or immunotherapy. exclusion criteria: 1. exceeding the time interval of the combination therapy defined above; 2. missing follow-up data;

Keywords: hepatocellular carcinoma transarterial chemoembolization immune checkpoint iinhibitors real-world study
kyphosis evaluation using spinescan®

Conditions: Kyphosis

Summary: the purpose of this study is to evaluate the accuracy of spinescan® with standard lateral x-rays of the spine in patients monitored for kyphosis.

kyphosis is usually a developmental deformity of the spine in the sagittal plane. once diagnosed, serial x-rays are used for followup. these are usually required at yearly intervals. spinescan® is a computerized digital inclinometer, design for evaluating angular spine deformities. patients examined in the spine clinic with recent x-rays will be examined with spinescan® and it's results compared with the classical radiological assessment.

Eligibility criteria:
inclusion criteria: * patients examined in scoliosis clinic for kyphosis with recent lateral spine x-rays. * age: 7 years old and above. exclusion criteria: * less than 7 years old. * no informed consent.

Keywords: spinescan® kyphosis
safety, tolerability, and pharmacokinetics of multiple ascending doses of simotinib hydrochloride in patients with advanced nsclc

Conditions: Non-small Cell Lung Cancer

Summary: the primary objective is to assess the safety and tolerability of multiple doses of simotinib hydrochloride in nsclc patients. the secondary objective is to determine the pharmacokinetic (pk) profile and explore the preliminary anti-tumor activity.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed diagnosis of advanced nsclc, who were previously treated with at least one platinum-based chemotherapy regimen, but had disease relapse; * patients have ended their chemotherapy or radiotherapy at least 4 weeks prior to study entry and have recovered from any previous toxicity; * egfr mutation positive (such as e19del、l858r、l861q、g719x, etc.); * patients with at least one measurable lesion meeting recist; * ecog performance status 0-2; * life expectancy ≥12 weeks; * adequate bone marrow function: anc ≥1.5 × 109/l, plt≥80 ×109/l, hb ≥90 g/l; * adequate hepatic function: serum bilirubin ≤ 2 × uln, ast and alt ≤ 2.5 × uln, and ≤ 5 × uln are acceptable if the liver has tumor involvement; * adequate renal function: endogenous creatinine clearance rate (crcl) ≥ 60 ml/min or serum creatinine ≤ 1.5 × uln; * females with childbearing potential must have a negative pregnancy test within 7 days prior to treatment and use an approved contraceptive method during the study; * males must be surgically sterile or use an approved contraceptive method during the study. exclusion criteria: * patients who were previously treated by egfr inhibitor or other molecular targeting drugs (micromolecular drugs or monoclonal antibodies) such as iressa, tarceva, sutent, nexavar, sprycel, erbitux, nimotuzumab, icotinib, herceptin, etc.; * the known hypersensitivity to simotinib or any of the excipients; * concurrent treatment with rifampin, rifabutin, rifapentine, dexamethasone, phenytoin sodium, carbamazepine, phenobarbital, hypericum perforatum, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin; * cns metastasis diagnosed recently which has not received surgery or radiotherapy; * evidence of interstitial lung disease; * pre-existing idiopathic pulmonary fibrosis as evidenced by ct scan at baseline; * any serious or uncontrollable systemic disease (such as unstable respiratory disorders, cardiovascular, hepatic or kidney disorders); * any unstable systemic disorders (including active infection, uncontrollable hypertension, unstable angina pectoris, congestive heart failure, liver and kidney disorders or metabolism disease); * other malignancies diagnosed within the last 5 years with the exception of completely cured cervical cancer in situ, or basal and squamous cell skin cancer; * any remarkable eye disorders, especially severe dry eye syndrome, keratoconjunctivitis sicca, herpes keratitis; * history of nerve or psychiatric disorders, including epilepsy or dementia.

Keywords: simotinib non-small cell lung cancer
microbiological diagnosis of infectious keratitis to pathogenic fastidious germs

Conditions: Infectious Keratitis

Summary: infectious keratitis are favored by the circumstances causing the small trauma of the corneal epithelium, corneal surgery, corneal dryness under health system such as sjögren's syndrome rheumatoid arthritis, or much more frequently wearing contact lenses. if the majority of infectious keratitis are favourable, some lead to serious injury of the cornea, or even corneal perforation which result an endophthalmitis. this unfavourable evolution may lead to blindness due to corneal damage, the endo-ocular lesions or enucleation of the eyeball. this negative evolution is encountered while the infectious keratitis due to tedious germs of difficult diagnosis such as nontuberculous mycobacterial, fungal infections, fungal keratitis, amoebic keratitis, and certain viral keratitis. the microbiological diagnosis of routine is based on the systematic search for pathogens tedious from invasive sampling of cornea by vaccinostyle. we set up a new non-invasive corneal swab diagnostic method.

primary purpose: compare the ability diagnostic of non-invasive sampling swab corneal versus the gold standard, (invasive vaccinostyle uptake) for the systematic search for pathogens tedious in corneal specimens. hypothesis: the diagnostic strategy using a microbial testing of cornea method has a sensitivity of 90% and a specificity of 80% or more over the policy diagnostic using a sampling by vaccinostyle method. primary outcome measures: sensitivity, specificity, positive and negative predictive values, diagnostic odds ratio.

Eligibility criteria:
inclusion criteria: * patient is more than 18 years old. * patient with a prescription of a microbiologic diagnostic of keratitis * patient who do not declined to have his medical records reviewed for research * patient with health insurance exclusion criteria: * minor patient (\<18 years). * pregnant or breastfeeding women. * major patient under guardianship. * patient in vital emergency. * private patient liberty or under court order. * patient refusing to sign the informed consent form
randomized study of 3,4-diaminopyridine for lambert-eaton myasthenic syndrome

Conditions: Lambert-Eaton Myasthenic Syndrome

Summary: objectives: i. evaluate the safety and effectiveness of 3,4-diaminopyridine (dap) in the treatment of patients with lambert-eaton myasthenic syndrome (lems). ii. determine the side-effects and benefits associated with dap.

protocol outline: this is a randomized, double blind, placebo controlled study. patients are randomized to receive 3,4-diaminopyridine (dap) or placebo orally 3 times daily for 5 days, after which treatment is discontinued and patients are observed for at least 24 hours. at the end of the blinded study, patients may then elect to take open label dap orally 3 times daily for 6 months; those who do so are monitored for clinical effects and side effects for at least 6 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- lambert-eaton myasthenic syndrome (lems) based on weakness that predominates in proximal limb muscles and electromyography (emg) findings of small amplitude muscle responses to nerve stimulation, which decrease further during nerve stimulation at 5 hz and which increase at least 2-fold after maximum voluntary contraction of the muscle for 10-20 seconds quantified myasthenia gravis (qmg) clinical score at least 5 --prior/concurrent therapy-- chemotherapy: no concurrent chemotherapy endocrine therapy: patients receiving immunosuppressants must be on the same dose of medication for at least 3 months prior to study entry radiotherapy: no concurrent radiotherapy surgery: no concurrent surgery other: patients receiving cholinesterase inhibitors must discontinue the medication at study entry if possible, or else be on the same dose of medication for at least 1 month prior to study entry --patient characteristics-- hematopoietic: no significant hematologic disease hepatic: no significant hepatic disease renal: no significant renal disease cardiovascular: no cardiac arrhythmia or significant cardiac disease neurologic: no seizure disorder other: not pregnant negative pregnancy test required of fertile women effective contraception required of fertile women

Keywords: lambert-eaton myasthenic syndrome neurologic and psychiatric disorders rare disease