Kornimate/medical-research-clean huggingface dataset:
post market study for vasq, an external support implant for arteriovenous fistula

Conditions: End Stage Renal Disease

Summary: vasq is an external support implant for arteriovenous fistulas created for dialysis access. this is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * treatment arm: end to side fistula supported with vasq * control: standard of care end to side fistula

structure this is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * treatment arm: end to side fistula supported with vasq * control: standard of care end to side fistula duration the primary endpoint is defined at 6 month post index procedure of fistula creation. patients will be further followed up to 12 months post index procedure. main study question what is the magnitude of benefit of the vasq device with regard to time to achieving a clinically functional avf as compared to a comparable contemporary standard of care cohort?

Eligibility criteria:
inclusion criteria: 1. patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical av fistula for dialysis access (per vasq ifu and investigator clinical judgment) and consent to take part in the study. 2. male and non-pregnant female participants. 3. age 18-80 years 4. patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months. exclusion criteria: 1. index procedure being a revision surgery of an existing fistula. 2. significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site) 3. unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the vasq. 4. known central venous stenosis or obstruction on the side of surgery. 5. pre-existing stents or stent grafts in the access circuit. 6. planned subsequent fistula superficialization procedure. 7. known coagulation disorder. 8. known allergy to nitinol. 9. expected kidney transplant within 12 months of enrollment. 10. inability to give consent and/or comply with the study follow up schedule. 11. insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 months). 12. participation in another interventional study that in the judgment of the investigator could confound study results.
non-contact endoscopy at covid-19 outbreak

Conditions: Gastrointestinal Disease; Infectious Disease

Summary: the covid-19 outbreak and spread throughout the world now constitutes a global public health emergency. direct contact between doctors and patients in daily practice bears potential risk of covid-19 infection, and telemedicine, or non-contact medicine, in this circumstance, offers an ideal solution. remote controlling capsule endoscopy system for gastric examination was recently developed and applicated in clinical practice.

the novel non-contact magnetically-controlled capsule endoscopy (mce) system (ankon technologies, china) adds a remote control workstation and a audio-visual exchange system to the original well-establish mce system, which consists of a robotic magnetic arm, a workstation (now bypassed) and a capsule endoscope, and boasts a 90% sensitivity and 94% specificity for diagnosing gastric focal lesions. this feasibility study aims to evaluate the technical success, clinical success and adverse events of the first clinical application of non-contact mce system.

Eligibility criteria:
inclusion criteria: * signed the informed consents before joining this study exclusion criteria: * dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy * refused abdominal surgery to take out the capsule in case of capsule retention * implanted pacemaker, except the pacemaker is compatible with mri * other implanted electromedical devices or magnetic metal foreign bodies * pregnancy or suspected pregnancy
the primary care - dementia assessment and treatment algorithm

Conditions: Dementia; Alzheimer's Disease

Summary: alzheimer's disease (ad) and related forms of dementia currently affect over 400,000 individuals in canada and the numbers of community dwelling older adults with ad is rapidly growing. ad is associated with over $15 billion annually in care costs. most individuals with ad are under the care of primary care providers (pcps) including family physicians and primary care nurses. the evaluation and management of ad is challenging for pcps and the quality of care provided to older adults with ad by pcp could be improved which would optimize outcomes for this vulnerable population. provision of quality care to older adults with ad involves implementation of best practices as outlined in guidelines such as the canadian consensus conference guidelines on the diagnosis and treatment of dementia. utilizing a group of dementia researchers, pcps, other knowledge users, and individuals affected by ad, this project will develop practical, clinically relevant resources for primary care physicians and nurses to aid in the evaluation of older adults with ad. a knowledge tool, the primary care - dementia assessment and treatment algorithm (data tool) will be introduced into several primary care settings in ontario using educational sessions with pcp with additional support from internet resource and a dementia care manager. the quality of dementia care provided to older adults newly diagnosed with ad will be assessed in the three years preceding the intervention compared to the year following the implementation. this project will also describe the process of knowledge exchange with pcps, including potential barriers and facilitators of knowledge uptake and examine if the care provided during the intervention was patient-centred through interviews with patients and caregivers. research objectives: 1. develop knowledge tools to facilitate assessment and treatment of ad by pcps based on best evidence; 2. transfer these knowledge tools into a variety of primary care settings in ontario; and, 3. evaluate the effects of this intervention on dementia quality of care, pcp application of knowledge, and the patient-centeredness of care.


Eligibility criteria:
primary care provider inclusion criteria: * primary care provider at participating sites primary care provider exclusion criteria: * primary care provider at non-participating site patient inclusion criteria: * community-dwelling at time of initial presentation to primary care provider * age 60 years or older at time of initial assessment by primary care provider * presenting to primary care providers with cognitive or functional symptoms suggestive of alzheimer's disease or other form of dementia * patient must have a caregiver or substitute decision maker patient exclusion criteria: * prevalent cases of dementia will be excluded from study population * individuals with dementia residing in long-term care or nursing homes

Keywords: primary care dementia knowledge translation quality of care qualitative methods alzheimer's disease
assessment of residual paralysis in patients who receive mini-dose atracurium during supraglottic airway insertion

Conditions: Postoperative Complications

Summary: this study aims to establish the incidence of residual paralysis in patients following administration of a mini- dose of atracurium (less than ed95 i.e. \<0.23mg/kg or \<15 mg in most patients) during supraglottic airway insertion and correlate it with the duration of time from drug administration to arrival at pacu. the secondary aim is to compare the incidence of residual paralysis in patients who receive full doses of atracurium (per body weight) with those who receive mini-doses.

post-operative residual paralysis may be defined as the incomplete recovery of muscle function following intra-operative administration of neuromuscular blockers (nmbs). this condition is associated with many negative patient outcomes such as: increased risk of aspiration; upper airway obstruction; and delayed post-anaesthetic care unit (pacu) discharge, amongst others. despite the increasing use of shorter acting agents, the prevalence of residual paralysis in the pacu remains high at 20-50%. nmbs are commonly used to facilitate endotracheal intubation and insertion of the supraglottic airway by obtunding airway reflexes. given the increasing use of mini-dose nmbs without post-operative reversal in clinical practice, there is a need to evaluate the incidence of residual paralysis in the patient population who have received mini-dose atracurium during the supraglottic airway insertion.

Eligibility criteria:
inclusion criteria: * adults above 21 years old * received either a mini-dose of atracurium or full dose of atracurium during the placement of the supraglottic airway * did not receive any neuromuscular reversal agent at any point of the operation. exclusion criteria: * patients with underlying neuromuscular disease * patients who received pre-operative medication that may affect neuromuscular transmission * patients who required additional doses of neuromuscular blockade at any point of the operation

Keywords: supraglottic airway mini-dose atracurium postoperative residual paralysis
antipsychotics and metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and quality of life.


Eligibility criteria:
inclusion criteria: * gender male * age 18-45 * debut drug-naive schizophrenics, * caucasians * consent given to take part in the project exclusion criteria: * compliance-problems * major lung-/kidney/hart/lever disorders * abuse of alcohol/drugs * diabetes 1 and 2 * antihypertensive * anticholesterol-reducing medication * patients under duress

Keywords: metabolic and endocrine changes in schizophrenic patients by antipsychotics treatment.
a phase i study of [177lu]lu-evs459 in patients with ovarian and lung cancers

Conditions: Ovarian Cancer; Lung Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177lu\]lu-evs459 and the safety and imaging properties of \[68ga\]ga-evs459 in patients aged ≥ 18 years with advanced high-grade serous ovarian cancer (oc) or locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (non-sq. nsclc).

the study will be done in two parts. the first part is called "escalation" and the second part is called "expansion". in both parts of the study, patients will initially be imaged with a \[68ga\]ga evs459 positron emission tomography (pet)/computed tomography (ct) or pet/magnetic resonance imaging (mri) scan. in the escalation part, different doses of \[177lu\]lu-evs459 will then be tested to identify recommended dose(s) (rd(s)) for further evaluation. the expansion part of the study will examine the safety and preliminary efficacy of \[177lu\]lu-evs459 at the rd(s) determined during the escalation part. the end of study will occur when at least 80% of the patients in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period.

Eligibility criteria:
key inclusion criteria: * age \>= 18 years old * patients with advanced high-grade serous ovarian cancer (oc) or locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (non sq. nsclc) with disease progression following, or intolerance to, at least 1 line of therapy key exclusion criteria: * absolute neutrophil count (anc) \< 1.5 x 10\^9/l, hemoglobin \< 10 g/dl, or platelet count \< 100 x 10\^9/l * qt interval corrected by fridericia's formula (qtcf) ≥ 470 msec * creatinine clearance \< 60 ml/min * unmanageable urinary tract obstruction or urinary incontinence * radiation therapy within 4 weeks prior to the first dose of \[177lu\]lu-evs459 other protocol-defined inclusion/exclusion criteria may apply.

Keywords: ovarian cancer non-squamous non-small cell lung cancer (non sq. nsclc) advanced solid tumors radioligand therapy (rlt) [177lu]lu-evs459 [68ga]ga-evs459 folate receptor (fr)
to study the efficacy of peg-ifn alpha in hbeag negative chronic hepatitis b patients after stopping nucleotide analogue therapy.

Conditions: Hepatitis B

Summary: * study population:person with hbeag negative chb on tdf/etv for more than 1 year * study design:prospective,interventional (single arm study) * sample size: all the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years * intervention: peg ifn 2b 1.5mcg/kg once every week for 48 weeks * monitoring and assessment: lft,hbv dna and hbsag at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, cbc every month and thyroid function test every 3rd month * adverse effects: the most frequently reported side effects of ifn-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. peg-ifn have myelosuppressive effects; however, neutropenia\\1000/mm3 and thrombocytopenia \\500,000/ mm3 are not common unless patients already have cirrhosis


Eligibility criteria:
inclusion criteria: - hbeag negative chronic hbv infection who are having hbv dna-undetectable. alt \ 1 year clinical relapse after stopping na will be defined as hbv dna\>2000iu/ml and alt \> 80iu exclusion criteria: - hbeag+ chb pregnancy cirrhosis on biopsy or lsm \>14 co-infection- hiv/hcv/hdv immunosuppressive therapy renal failure s.bilirubin\>2mg/dl patient having neutropenia
atherosclerotic cardiovascular risk in childhood and teen-age onset diabetes

Conditions: Atherosclerotic Cardiovascular Disease; Childhood Diabetes Mellitus; Juvenile Diabetes

Summary: for children and adolescents with diabetes, the pathological process of atherosclerotic cardiovascular disease(ascvd) can exist in early childhood and progress rapidly to subclinical ascvd. this study intends to explore the models for the prediction of ascvd risk in childhood and teen-age onset diabetes with different types.

atherosclerotic cardiovascular disease (ascvd) is the main cause of death in patients with diabetes. currently recognized ascvd risk assessment models are limited to adults with diabetes, but for children and adolescents with diabetes, the pathological process of ascvd can exist in early childhood and progress rapidly to subclinical ascvd. to sum up, this study intends to evaluate the high risk rate of ascvd calculated by the traditional qrisk3 model and its correlation with the occurrence of subclinical ascvd events through long-term follow-up of the natural history of diabetes onset in children and adolescents, and to explore the models for the prediction of ascvd risk in childhood and teen-age onset diabetes with different types. this study aims to help block the pathological process of ascvd in early duration, thereby reducing the occurrence of ascvd in childhood and teen-age onset diabetes.

Eligibility criteria:
inclusion criteria: 1. diagnosis of type 1 diabetes or type 2 diabetes 2. age of onset: \<18y 3. enrollment age: ≥18y 4. gender: male or female 5. diabetes duration ≥ 5 years exclusion criteria: 1. specific types of diabetes 2. clinical diagnosis of diabetes is unknown, and it belongs to untyped diabetes 3. pregnancy or lactation 4. received glucocorticoids, immunosuppressants, non-glycemic biological agents, and cytotoxic drugs in the past 3 months; non-steroidal pain relievers or antibiotics used for more than 1 week continuously 5. onset of acute complications of diabetes in the past 3 months 6. major trauma and surgery history in the past 3 months
pre-emptive analgesia efficacy of etoricoxib for postoperative pain

Conditions: a Single-Dose of Etoricoxib; Post-Operative Morphine Consumption; Total Pain Relief Over 8 Hr(TOPAR8); Post Transabdominal Hysterectomy

Summary: taken together, studies of the value of pre-emptive analgesia are inconclusive. this randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to test that a reduction in post-operative morphine consumption can be achieved by a single-dose of etoricoxib before induction of anesthesia.

patients undergoing transabdominal hysterectomy were randomized to a group taking a single dose (orally) of etoricoxib 120 mg (n = 18), etoricoxib 180 mg (n = 17) or placebo (n = 15) 2 hours before surgery under the same standardized general anesthesia. at the post-anesthetic care unit, intravenous morphine titration was given before starting self-controlled analgesia (pca) device. morphine consumption, pain relief score, sedative score, global evaluation score, and side-effects were recorded at 1, 2, 4, 8 and 24 h post-operatively. the primary end points were morphine consumption within 24-hr post-operatively and total pain relief over 8 h (topar8). patient global satisfaction was also assessed.

Eligibility criteria:
inclusion criteria: * the asa i or ii patients undergoing elective transabdominal hysterectomy with general anesthesia exclusion criteria: * patients with history of opioid addiction or chronic pain * allergy to other nonsteroidal anti-inflammatory, or asthma * concomitant use of tricyclic antidepressants, opioid analgesics, antihistamines, tranquilizers, hypnotics, sedatives, or systemic corticosteroids * those unable to understand the principle of patient-controlled analgesia(pca) device were excluded from the study

Keywords: abdominal hysterectomy, etoricoxib, morphine consumption, pre-emptive analgesia
biliary complication rates in living donor liver transplantation: a retrospective comparative study of stent versus non-stent groups

Conditions: Liver Failure; Living Donor Liver Transplantation; Biliary Complications; Biliary Stents

Summary: despite technological advancements in living donor liver transplantation (ldlt), biliary complications (bc), including biliary anastomotic stricture (bas) and bile leak (bl), remain unresolved issues that significantly affect patient outcomes. biliary stenting has emerged as a potential method for reducing bc in ldlt procedures; however, their necessity remains debated. this study aimed to assess the necessity of biliary stenting by retrospectively comparing the bile duct complication rates in ldlt using duct-to-duct anastomosis with or without biliary stenting.


Eligibility criteria:
inclusion criteria: * adults aged between 19 and 80 years at the time of liver transplantation. * patients who underwent liver transplantation surgery for liver disease performed by the department of surgery at chungnam national university hospital under the supervision of the principal investigator. * patients who signed the informed consent form before study registration (for future participants). exclusion criteria: * patients who have not signed the informed consent form or have insufficient understanding of the clinical trial protocol, making it difficult to accurately express their intention to participate. * patients deemed unsuitable for participation in this clinical study by the investigator.
physical and health outcomes with exercise in cancer survivors

Conditions: Breast Cancer Female; Exercise

Summary: this study aims to evaluate the effect of a physical exercise intervention model on breast cancer survivors and their adherence. the sample will consist of 30 women with a primary diagnosis of breast cancer. the intervention will be carried out in a highly complex oncology center in maceió-al, brazil, using the fitt components of the prescription: frequency (4 days a week), intensity (aerobic part through musical beats, subjective perception scale and resistance exercises through the number of maximum repetitions), the total time of each session will be 45 minutes. the intervention arms include combined exercise training and aerobic exercise (i.e., walking). adherence to each intervention evaluated in the 12-week intervention cycle will be measured in each session.

the study participants will be enrolled in a visit to a group of psychologic therapy women cancer survivors who met monthly and who have submitted to breast cancer treatment in a hospital in the city of maceió (al), brazil, classified as high complexity oncologic clinic. at this visit, the proposal for physical exercises will be presented in the hospital area. volunteers will be scheduled for an in-person visit and assessed for eligibility. those who meet all the inclusion/exclusion criteria will be invited to integrate the physical exercise intervention. the 12-week exercise intervention will consist of a combined exercise including an aerobic component (dance) and resistance training, and aerobic exercise (i.e., walking). participants will be evaluated pre- and post-intervention in terms of several health indicators. all ethical approvals were collected before study initiation.

Eligibility criteria:
inclusion criteria: 1. women; 2. adults; 3. confirmed diagnostic of breast cancer and with treatment completed (surgery, radiotherapy, or chemotherapy) within the previous six months. exclusion criteria: 1. present metastatic breast cancer; 2. any clinical condition that would make participating in the exercise intervention impossible.

Keywords: cancer survivors breast cancer physical exercise
the pharmacokinetics of 4% lidocaine gel when applied topically to the breasts

Conditions: Adverse Effects

Summary: the purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (topicaine) on the skin of the breasts and chest wall as recommended for pre-medication to reduce discomfort during screening mammography does not result in adverse effects, electrocardiogram (ekg) changes, or systemically toxic plasma concentration of lidocaine or its principal metabolite, monoethylglycinexylidide (megx).


Eligibility criteria:
inclusion criteria: * 35 years and older * intact skin on breasts and chest wall exclusion criteria: * sensitivity or allergy to lidocaine * liver or kidney dysfunction * pregnant * breast feeding * currently smoke or chew tobacco * used lidocaine products within 48 hours of baseline lab, ekg, or gel application * exhibit neurological or cardiac signs or symptoms prior to gel application * are taking antiarrythmic medications, ciprofloxacin, erythromycin products, or oral contraceptives * history of wolffe-parkinson-white syndrome (wpw) or congestive heart failure * heart rate below 60 or above 100 beats per minute * systolic blood pressure below 95 or above 180 mm hg * pr interval greater 200 msec, qrs duration greater than 120 msec, qtc greater than 450 msec, or evidence of wpw on ekg * have an automatic implantable cardioverter defibrillator (aicd) or cardiac pacemaker * have had cancer, surgery, trauma, or myocardial infarction in the past 6 months

Keywords: lidocaine pre-medication mammography pain safety