Kornimate/medical-research-clean huggingface dataset:
the 22g franseen needle combined with different aspiration techniques for endoscopic ultrasound-guided fine-needle biopsy

Conditions: Pancreatic Diseases

Summary: the goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22g franseen needle combined with three different suction techniques (dry-suction, wet-suction, and slow-pull) in endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.

patients who met the inclusion criteria of this trial and did not meet the exclusion criteria were randomly divided into six groups according to the crossover grouping design. samples were collected using a 22g franseen needle in different suction sequences. the advantages and disadvantages of different suction techniques in terms of sample quality and diagnostic efficacy were compared to further clarify the optimal suction sampling scheme for endoscopic ultrasound-guided fine-needle biopsy using a 22g franseen needle.

Eligibility criteria:
inclusion criteria: （1）18-80 years old (inclusive), male and female; （2）patients with pancreatic solid mass \> 1cm detected by ct/mri/pet-ct or eus and requiring eus-fnb diagnosis. （3）written informed consent was obtained. exclusion criteria: 1. contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases; 2. bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs; 3. confirmed pregnancy or possible pregnancy; 4. pathological diagnosis has been obtained by other methods; 5. refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days; 6. other situations where eus-fnb could not be performed.

Keywords: 22g franseen needle solid pancreatic lesion aspiration technique endoscopic ultrasound-guided fine-needle biopsy
phenotype-tailored lifestyle intervention for obesity: a randomized trial

Conditions: Obesity

Summary: the purpose of this study is to develop an evidence-based precision medicine approach for obesity that enhances weight loss and promotes weight loss maintenance.


Eligibility criteria:
inclusion: • men or women between 18 to 65 years with obesity (bmi\>30kg/m2). exclusion: * weight change greater than 3% in the previous 3 months * history of bariatric surgery and bariatric endoscopy * untreated psychiatric disorders including binge eating disorders and bulimia * current use of aoms * history of use of medications affecting weight or energy intake or energy expenditure in the last 6 months * history of type 1 diabetes mellitus or uncontrolled medical conditions (e.g., uncontrolled hypertension) * women who are pregnant or plan to become pregnant, * any condition that limits their participation in the study * principal investigator discretion
comparison of ce-dbt and mri in patients with known breast lesions

Conditions: Breast Cancer

Summary: the purpose of this pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis (ce- dbt) and contrast enhanced dynamic magnetic resonance imaging (ce-mri) acquired as a part of a standard clinical workup.

this is a pilot study of ce-dbt scans to evaluate its utility relative to breast ce-mri. twenty women who have planned or received conventional breast mri imaging at unc hospitals will be recruited for the study. participants will be scanned with the dbt system after the administration of iodinated contrast agent. images will be acquired prior to the administration of contrast, followed by at approximately 2 minutes and 5 minutes. for the purposes of this study, imaging will focus on a single breast to simplify data acquisition.

Eligibility criteria:
inclusion criteria: * women at least 18 years old * planned or received conventional breast mri at unc hospitals within 3 months prior to or after the research scan * suspected breast lesion based on prior imaging (birads 4 or greater) * able to provide written informed consent exclusion criteria: * severe untreatable claustrophobia * implanted metallic devices, parts, vascular clips, or other foreign bodies (including breast implants) * known hypersensitivity to iodinated contrast agent or to any component of iodinated contrast refractory to standard medications (antihistamines, steroids) * impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels within the last 30 days prior to the research scan) unless anuric and on dialysis * any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-hcg results, obtained within 24 hours prior to the research scan, or on the basis of patient history, as defined by the unc irb sop 4801)
sthlm3 - prostate cancer diagnostic trial

Conditions: Prostate Cancer

Summary: sthlm3 is a paired diagnostic trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for aggressive prostate cancer


Eligibility criteria:
inclusion criteria: * age 50-69 * residential address in stockholm county exclusion criteria: * previous prostate cancer diagnosis * not able to comprehend inform consent material
systematic evaluation by an intensivist of hematological malignancy patients presenting with acute respiratory or hemodynamic failure

Conditions: Respiratory Insufficiency; Hematologic Malignancy

Summary: over the last two decades, the number of patients with hematological malignancies (hms) admitted to the icu increased and their mortality has dropped sharply. patients with hms increasingly require admission to the intensive care unit (icu) for life-threatening events related to the malignancy and/or treatments, with immunosuppression being a major contributor. whether the increase in icu admissions is related to increased referrals by hematologists and/or to increased admissions by intensivists is unknown. the criteria used for icu referral and admission decisions have not been extensively evaluated. finally, the links between admission policies and treatment-limitation decisions are unclear, but icus with broad admission policies may change the treatment goals based on the response to several days of full-code management. the aim of this study is to evaluate the impact of a systematic evaluation by an intensivist of hms patients presenting with acute respiratory and/or hemodynamic failure.


Eligibility criteria:
inclusion criteria: * patients hospitalized in a hematology unit * patients presenting with criteria for critical respiratory and/or hemodynamic condition and worsening during the next 4 hours 1. respiratory : oxygen saturation \ 3l/min, with either a worsening of saturation or increased oxygen needs within 4h 2. hemodynamic : systolic blood pressure \< 90 mmhg and remaining \< 90 mmhg within 4h despite ≥ 1l of crystalloid administration, or becoming \< 80 mmhg no matter the quantity of fluid (even if no fluid administration). exclusion criteria: * therapeutic limitations decided hematological investigators (moribund patients, uncontrolled allogenic graft,...) * do-not-reanimate directives * pregnant or breastfeeding women

Keywords: respiratory insufficiency hematologic malignancy intensive care unit
modifiable factors and glaucoma - rct

Conditions: Intraocular Pressure

Summary: there is growing awareness that environmental factors, behaviors and diet are intimately related to patient health and may play a role in the pathogenesis and progression of glaucoma. evidence from recent years has shown that some behaviors and environmental factors can affect the intraocular pressure, the primary risk factor for glaucoma. this study aims to investigate whether simple and common lifestyle inteventions such as sleeping with a head elevation, a high fiber diet, moderate aerobic exercise and moderation in caffeine intake could affect intraocular pressure and other outcomes.


Eligibility criteria:
inclusion criteria: * patients with glaucoma. exclusion criteria: * not able to attend follow-up * contraindication for treatment or follow-up
the effect of implementing hyper-acute stroke guidelines on decision-making for or against thrombolytic therapy for stroke in the emergency department

Conditions: Stroke

Summary: the objective of this study is to determine if the implementation of guidelines utilizing immediate ct perfusion and ct angiography in addition to non-contrast ct alters (reduces or increases) the time to decision-making for or against rt-pa in acute ischemic stroke, and by extension, time to therapy in treated patients and time to transfer from the department for all patients. a secondary objective is to determine if using ctp/cta-inclusive hyperacute stroke guidelines improves safety by decreasing symptomatic intracerebral hemorrhage and mortality in patients who receive rt-pa.


Eligibility criteria:
inclusion criteria: * patients presenting to the emergency signs and symptoms of acute ischemic stroke: impairment of language, motor function, cognition and/or gaze, vision or neglect. * patients with an nih stroke scale score \> 4 exclusion criteria: * age less than 19 * patient symptomatic for greater than five hours. intravenous thrombolytic therapy must be instituted within three hours of symptom onset in order to minimize the risk of intracerebral or symptomatic hemorrhage; other interventions such as intra-arterial thrombolytic therapy and clot retrieval allow for a six-hour window. one hour is an achievable time for arrival to institution of therapy, therefore a five-hour limit on enrollment allows the greatest number of patients the possibility of therapy. * inability to verify a clear onset of symptoms. as noted, time elapsed since the patient's last known baseline state is correlated to intracerebral and symptomatic hemorrhage, and therapy is approved only for patients with a clear time of onset.
the effect of whole blood viscosity on contrast-induced nephropathy development in patients undergoing percutaneous coronary intervention

Conditions: Percutaneous Coronary Intervention Patients

Summary: in our study, we aimed to investigate how whole blood viscosity (wbv) affects the development of contrast-induced nephropathy (cin) in patients undergoing percutaneous coronary intervention (pci).

in our study, 500 patients who applied to the cardiology clinic and underwent pci for elective procedure, st segment elevation myocardial infarction (stemi), and non-stemi were prospectively included. before the procedure, we calculated wbv using the formula \[(0.12 × hematocrit) + (0.17 × (total protein - 2.07)\]. we defined cin as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.

Eligibility criteria:
inclusion criteria: * patients between ages 18 and 90 * underwent pci in our hospital between exclusion criteria: * patients with chronic kidney disease (ckd) who underwent hemodialysis or peritoneal dialysis * patients who underwent to coronary bypass surgery within 48 h were excluded from the study.

Keywords: viscosity contrast nephropathy coronary intervention
prospective observational study based on a cohort of geriatric patients with hip fracture treated in the centers belonging to the giog group

Conditions: Hip Fractures; Older Patients; Comprehensive Geriatric Assessment

Summary: the study aims to collect the clinical activity and management data of the orthogeriatrics and orthopedics units participating in the study on a continuous and long-term basis. by collecting clinical data and comparing the performance of the various centers, the study aims to guide the participating centers towards the principles of good clinical practice in orthogeriatrics.

multicenter prospective cohort observational study. the enrollment period will be 5 years. an additional 4 months will be required to allow the last enrolled patients to complete the 120-day follow-up. it is estimated to enroll a total of 7,000 patients. to facilitate the participation in the study of non-university or irccs assistance departments, two methods of data collection will be possible: * high intensity: continuous data collection for the whole period of the study on all the incident cases * low intensity: data collection once a year on incident cases over a continuous period of 1 month, with a reduced number of variables. the choice of the level of intensity with regard to the data collection method will take place on a voluntary basis (each ou will actually choose the type of speed with which it intends to collaborate in the project, after communicating to the steering committee and to the biostatisticians of the study)

Eligibility criteria:
inclusion criteria: * fracture of the femur, regardless of the cause * age ≥ 65 years * willingness to participate in the study by the patient or a relative / caregiver, if the patient is unable to understand and is not "competent" at the time of the evaluation. * able to speak the italian language exclusion criteria: * none

Keywords: giog ( italian society of anesthesiology); geriatric orthogeriatric co-management
sensory re-learning of the upper limb after stroke

Conditions: Stroke

Summary: the overall aim of this study is to investigate if sensory re-learning in combination with task-specific training is more effective than task-specific training alone to improve sensory function of the hand, dexterity, the ability to use the hand in daily activities, perceived participation and life satisfaction.

more than half of stroke survivors suffer from sensory impairments of their affected upper limb (ul), which can lead to long term problems to use the ul in daily life, such as personal care, household- and leisure activities. few studies have evaluated if sensory re-learning in combination with task-specific training can improve the ability to perform daily hand activities and perceived participation. therefore, there is a need for more studies. this is a single-blinded pilot randomized controlled trial with two treatment arms. thirty persons with sensory impairments of the ul after stroke will be recruited and randomized to either sensory re-learning in combination with task-specific training or to task-specific training only. the training will consist of 2.5 hours of group training per session, 2 times per week for 5 weeks. assessments will be conducted pre- and post-training and at 3 months' after the intervention. descriptive statistics (mean (sd) or median (min- max) will be used to characterize the study groups. non-parametric statistics will be used for ordinal data and parametric statistics for continues data. to analyze between group differences, the mann-whitney test or independent sample t-test will be used and wilcoxon signed ranks test or paired t-test to analyze within group differences. the level of statistical significance will be set at p \< 0.05.

Eligibility criteria:
inclusion criteria: * sensory impairments (≤5 points in shape-texture identification test) of upper limb after stroke * ability to grasp and release an object * be able to understand oral and written information * 18-80 years of age * at least 6 months since stroke onset * be able to walk with or without an assistive device exclusion criteria: • sensory impairments of the ul due to other diagnosis than stroke

Keywords: stroke, upper limb, sensory training, rehabilitation
a study to evaluate immunogenicity of various schedules of inactivated polio vaccine

Conditions: Poliomyelitis

Summary: the study will evaluate the humoral immunogenicity in various schedule combinations of full dose inactivated polio vaccines (ipv) via intramuscular administration (im) and of the fractional dose of inactivated poliovaccine (f-ipv) via intradermal administration (id).

the study will be conducted in a setting where only ipv is being used for polio prevention in infant immunization schedules. the study population will include infants from uruguay, a pioneer country in immunization programs in latin america, where topv(trivalent oral polio vaccine) was used until 2012, after which the program changed to an all-ipv schedule without transition. the primary ipv immunization schedule in the country is as stand-alone vaccine at 2, 4 and 6 months of age, with a booster dose at 15 months. this setting allows the evaluation of ipv immunogenicity in a scenario where the circulation of any poliovirus is highly unlikely. infants will receive two or three doses of full dose ipv im or fractional dose f-ipv id, in various schedule combinations (6 and 14 weeks; 10 and 14 weeks; 14 and 36 weeks; 6, 14 and 36 weeks; 10, 14 and 36 weeks). immunological and safety assessments will be made after one dose, two doses and three doses. the study will be conducted in montevideo, uruguay and a total of 1493 infants will be randomized into 6 groups. other vaccines comprise dtpw-hb-hib (pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis b-hib vaccine), pneumococcal conjugate vaccine, rotavirus and will be administered concomitantly. optimum immunogenicity expected from the dose/s of ipv in the post-eradication era will have to be balanced with the cost and supply constraints of ipv. this study will be critical to determine how many doses of ipv and which schedule will be recommended for the post-eradication era after the cessation of opv (oral polio vaccine) usage globally.

Eligibility criteria:
inclusion criteria: * infants of 6 weeks of age (-7 to + 7 days) on date of first vaccination * healthy, as assessed from medical history and physical examination by a study physician * written informed consent obtained from parents or legal representatives that they have been properly informed about the study and are able to comply with planned study procedures exclusion criteria: * vaccinated with any poliovirus vaccine prior to inclusion * a household contact with opv vaccination history in the past 4 weeks * hiv infection or pharmacologic immunosuppression. * known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde) * uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections. * acute severe febrile illness on day of vaccination deemed by the investigator to be a contraindication for vaccination. * not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator.
preliminary biomechanical and usability study of an active ankle-foot orthesis for stroke survivors

Conditions: Stroke

Summary: this research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. gait pattern through an optoelectronic motion capture system will be analyzed. additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of quebec user evaluation of satisfaction with assistive technology (quest)

this research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. the device is composed by a passive orthosis structure which allows one degree of freedom (dof) among the sagittal plane and it includes two servomotors attached to the user's foot through velcro strips. gait pattern through an optoelectronic motion capture system will be analyzed. additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of quebec user evaluation of satisfaction with assistive technology (quest)

Eligibility criteria:
inclusion criteria: * hemiparesis caused by a stroke. * age between 18 and 65 years old. * post-stroke time more than 6 months. * independent walking. * minimum 90 degrees of dorsiflexion. * muscle tone in plantar flexors less than of equal to 3 on the modified ashworth scale. * ability to follow instructions. * voluntary participation. exclusion criteria: * skin alterations in the lower limb. * peripherical vascular alterations. * alterations in sensitivity in the lower limb. * pain of musculoskeletal origin in lower extremities or spine. * history of frequent falls. * cancer * previous history or suspected seizures. * patient who does not sign the informed consent.

Keywords: stroke ankle foot orthosis gait active orthosis
pilot study assessing insulin pump therapy in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: 16-week, open-label, multi-center pilot study. insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening a1c ≥ 7.0%) on an established regimen of either: 1) ≥ 2 oas (cohort a), 2) basal insulin ± oas (cohort b), or 3) basal-bolus insulin ± oas (cohort c) will initiate basal-bolus therapy with an insulin pump using a rapid-acting insulin analog.


Eligibility criteria:
inclusion criteria: 1. is 18 to 75 years of age, inclusive; 2. has a clinical diagnosis of type 2 diabetes mellitus; 3. is anti-glutamic acid decarboxylase (gad) antibody negative; 4. has an a1c ≥ 7.0% and ≤ 10.5%; 5. has a body mass index (bmi) ≥ 25 kg/m2 and ≤ 40 kg/m2; 6. is treated with either ≥ 2 oral antidiabetic agents (oa) or basal insulin ± oa(s) or basal-bolus insulin ± oa(s) for at least 3 months (subjects may also be treated with exenatide \[byetta\] or pramlintide \[symlin\]. 7. if on concomitant metformin, has serum creatinine \< 1.5 mg/dl (male) or \<1.4 mg/dl (female); 8. if female, has a negative urine pregnancy test exclusion criteria: 1. has experienced recurrent severe hypoglycemia (\> 2 episodes) requiring assistance during the past 6 months; 2. has clinical cardiovascular disease (cvd) as evidenced by prior myocardial infarction, stroke, arterial revascularization and/or angina with ischemic changes on ecg at rest, changes on graded exercise test, or positive cardiac imaging test results; 3. has abnormalities on the screening (visit 1) 12-lead ecg that are deemed by the investigator to be clinically significant; 4. is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route or potent inhaled,intrapulmonary, intranasal, or topical steroids that are known to have a high rate of systemic absorption; 5. currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be non-compliant; 6. has any significant medical condition, laboratory findings, or medical history that in the investigator's opinion may affect successful completion of the study and/or personal well-being;