Kornimate/medical-research-clean huggingface dataset:
technical feasibility of routine intraoperative cholangiography during elective rigid-hybrid transvaginal natural orifice transluminal endoscopic cholecystectomy

Conditions: Gallstone Disease

Summary: while gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. transvaginal hybrid-notes cholecystectomy has been demonstrated effective and safe. however it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. this observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. the investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * symptomatic gallstone disease * age \> 18 years * written informed consent exclusion criteria: * age \< 18 years * not able to understand informed consent * pregnancy * vaginal atresia * florid vaginal infection * gynecological neoplasia * allergy to iod * missing informed consents * emergency procedure

Keywords: transvaginal notes cholecystectomy cholangiography symptomatic gallstone disease
quetiapine for delirium prophylaxis in high-risk critically ill patients

Conditions: Psychomotor Agitation

Summary: scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically ill, trauma/surgical patients. prophylaxis also reduced ventilator duration and icu length of stay.

objective: to evaluate the efficacy of scheduled quetiapine for delirium prophylaxis in critically ill, trauma/surgical patients identified as high-risk for delirium utilizing a validated prediction model. design: prospective, open-label, single-center study. setting: trauma/surgical intensive care unit at an academic medical center. patients: eighty two adult trauma/surgical patients who were admitted to the intensive care unit and were at high-risk for the development of delirium (pre-deliric score ≥50%, past medical history of dementia, past medical history of alcohol misuse, or past medical history of drug abuse). interventions: patients were randomized by unit location to receive pharmacologic prophylaxis for delirium (quetiapine 12.5 mg every 12 hours) or no pharmacologic prophylaxis for delirium within forty-eight hours of admission to the intensive care unit. measurements: the primary end point was the incidence of delirium during admission to the intensive care unit (icu). secondary end points included time to onset of delirium, icu and hospital lengths of stay, icu and hospital mortality, duration of mechanical ventilation, and adverse events. delirium was assessed using the confusion assessment method for the intensive care unit.

Eligibility criteria:
inclusion criteria: * trauma/surgical patients admitted to the trauma/surgical icu exclusion criteria: * sustained rass of -4/-5 during the complete icu admission * presence of a condition preventing delirium assessment * anticipated or known icu length of stay of less than 48 hours * taking antipsychotics prior to admission * history of schizophrenia, epilepsy, parkinsonism, or levodopa treatment * primary neurologic event/injury with gcs ≤ 9 during the first 48 hours of icu * current treatment with a continuous infusion neuromuscular blocking agent * pregnancy * screened positive for delirium upon admission to the icu.
acute myocardial infarction and unstable angina patients with pcsk9 inhibitor usage study

Conditions: Lipid Metabolism; Cardiovascular Diseases

Summary: acute coronary syndrome (acs) is a lethal disease, reduced low-density lipoprotein (ldl) cholesterol due to inhibition of proprotein convertase subtilisin/kexin 9 (pcsk9) reduces cardiovascular events and improve cardiovascular prognosis. we assuming that pcsk9 inhibitor could bring metabolic change in serum, in order to investigate the metabolic modification, we conduct this clinical trial.


Eligibility criteria:
inclusion criteria: * new diagnosis acs patient by serum biomarker and coronary arteriography. exclusion criteria: * severe renal dysfunction acute or chronic bacterial and viral infections sleep apnea cancer
remote study of an electronic means to characterize bowel movements in adult populations

Conditions: Irritable Bowel Syndrome; Healthy

Summary: a remote study to find out if a mobile phone application (healthmode stool) can serve as a useful tool to track and characterize daily bowel movements. the application provides participants with a single place to record their bowel movements either as a part of their general health self-monitoring, or because they may be dealing with a bowel movement condition. the minimal study duration is 1 month, and participants can continue using the application up to 2 years.


Eligibility criteria:
inclusion criteria: * females and males over 18 years old * willing to use their own/personal mobile phone (iphone 6 or higher, running ios 11 or higher) for participation * willing to share demographic data with the sponsor of the study * willing to follow app use instructions during the course of the study * willing to log the bowel movement events on a daily basis with manual input of additional characteristics * willing to complete survey instruments as described in study procedures * willing to provide electronic informed consent * able to read and understand the english language well enough to complete electronic informed consent exclusion criteria: * new to healthmode stool application: * no additional exclusion criteria. or * current healthmode stool user: * is an active participant in any other study using healthmode stool app in its protocol.
zar2007: r-chop in folicular lymphoma patients no treated previously. consolidation with 90y ibritumomab tiuxetan (zevalin®) versus maintenance treatment with rituximab (mabthera®)

Conditions: Lymphoma

Summary: after conventional induction treatment with r-chop (rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to: a: consolidation with one dose of 90y ibritumomab tiuxetan (zevalin®) 0,4 mci/kg b: maintenance with 375 mg/m2 of rituximab every 8 weeks during 24 months

the study will evaluate the benefit of consolidation treatment with 90y ibritumomab tiuxetan (zevalin®) or maintenance with rituximab (mabthera®) in terms of progression free survival, after induction with chemotherapy and rituximab in folicular lymphoma patients no treated previously. the other aims are, evaluate the global survival, event free survival, time until next treatment, response rate after consolidation or maintenance treatment, quality of life, security of two branches and relation cost-efectivity

Eligibility criteria:
inclusion criteria: * folicular lymphoma cd20-positive, grade 1, 2 or 3a, confirmed in previous 4 months. * patients no treated previously. * ann arbor stage ii, iii o iv. * symptoms or signes wich indicate necesary treatment (gelf criteria): * ganglionar or extraganglionar mass * b symptoms * ldh or b2-microglobuline increased * 3 ganglionar territory afected (\> 3 cm) * esplenomegalia * compresive syndrome * pleural/peritoneal effusion * secondary medular insufiency due to infiltration * age\> 18 years and \<75 years. * ecog \< 2 * adecuate hematological function: hemoglobin \> 8,0 g/dl (5,0 mmol/l); ran \>1,5 x 109/l; platelets \> 100 x 109/l * no pregnant women. women and man should use an appropiate anticonceptive method during the study and one year after * informed consent exclusion criteria: * transformation in high grade lymphoma * fl grade 3b. * skin or gastro-intestinal primary lymphoma * history of cns diseases ( or cns lymphoma) * previous treatment * regulary treatment with corticosteroids (permited \< 20 mg/day prednisone or equivalent). * previous cancer diseases * major surgery in 28 days before inclusion in study. * creatinine \> 2,0 mg/dl (197 mmol/l) * bilirubin \> 2,0 mg/dl (34 mmol/l), ast (sgot) \> 3 x upper normal limit. * hiv infection or active infection vhb o vhc \< 4 weeks before inclusion. * other complicated diseases criteria investigador: * life expectancy \< 6 months. * hipersensibility to ibritumomab tiuxetan, rituximab, other murines proteins or any excipients. * treatment in other experimental study in previous 30 days * any medical o psicologycal condition that can modify the capacity to give the consent

Keywords: folicular lymphoma consolidation maintenance
leisure physical activity and barriers to physical activity

Conditions: Disabled Persons

Summary: people with disabilities are less physically active than the general population. currently, the level of leisure physical activity of people who are members or users of apf france handicap and their barriers to physical activity are unknown. the apf france handicap association is a national movement for the defense and representation of people with disabilities and their families. it represents all types and severities of disability. the objective of this study is to describe the level of leisure physical activity of people who are members or users of apf france handicap and their barriers to physical activity.

this is a national transversal study aiming at studying the level of leisure physical activity among people with disabilities, members or users of apf france handicap. the study is based on a survey by questionnaire to the apf france handicap community. the survey is distributed between april and june 2023 through a public communication campaign (emails, posters, website, social networks, etc.). data on leisure physical activity, barriers to physical activity and quality of life will be collected. the questionnaire has been translated in simplified french to facilitate its understanding. this is a survey that collects data anonymously and follows the mr004 methodology.

Eligibility criteria:
inclusion criteria: * members or users of apf france handicap * people with disability * agreeing to participate in the survey exclusion criteria: * none

Keywords: exercise cross sectional studies social inclusion
long term trajectories of sma patients receiving or not disease-modifying treatments

Conditions: Spinal Muscular Atrophy

Summary: this is an observational multicenter retrospective and prospective study on natural history of sma also considering the 'new natural history' secondary to the availability of commercially available therapies. all the patients enrolled to date in the italian registry, if not part of clinical trials, will be included in the present study.

this is an observational multicenter retrospective and prospective study on natural history of sma also considering the 'new natural history' secondary to the availability of commercially available therapies. all patients affected by spinal muscular atrophy 5q, irrespective of genotype, phenotype, age, treatment status or gender will be enrolled in the study . the study aims to i) better understand the natural history of the disease in untreated patients in terms of functional aspects, concomitant illnesses, quality of life ii) describe the patterns of disease progression in treated and untreated patients in terms of functional aspects, concomitant illnesses, quality of life iii) describe all the patients treated with the available therapies in italy, in terms of demographic (age, location etc..) and epidemiological data all data from patients included in the study will be collected at each visit, following the clinical care protocols of each centre. following care recommendation patients are generally routinely assessed at least every 6 months and, in many cases, every 4 months. we plan to obtain * longitudinal changes in untreated patients: the possibility to access reliable retrospective data will provide the opportunity to record long term functional data in untreated patients. * yearly analysis of longitudinal changes in treated patients: * two-year results of the validation of new measures (sma hi, smais): reporting the validation process (inter- and intra-observer reliability, internal consistency) and changes in relation to functional measures

Eligibility criteria:
inclusion criteria: all patients with mutationsin the sman1 gene exclusion criteria: unable to proviude consent
placental assessment in diabetic mothers

Conditions: Diabetes

Summary: diabetes mellitus is one of the major heath problems

maternal and fetal effects are edpected to be more than in diabetic mothers

Eligibility criteria:
inclusion criteria: * in control group a non diabetic pregnant women exclusion criteria: * diabetic pregnant women and the reverse in group b
evaluating a type 2 diabetes prevention program

Conditions: Type 2 Diabetes; PreDiabetes

Summary: this study aims to test the effectiveness of a type 2 diabetes (t2d) prevention program for individuals who have been diagnosed with prediabetes compared to a t2d educational control group. project health is an obesity prevention program and has produced a 42% to 53% reduction in future onset of overweight/obesity and also produced greater reductions in negative affect compared to assessment-only controls that persisted. project health has been adapted to prevent onset of t2d among individuals with prediabetes. the study aims to test the effectiveness of project health at reducing bmi, hba1c levels, increase physical activity and improve glucose control.


Eligibility criteria:
inclusion criteria: 1. between the ages of 18 and 65 2. overweight (bmi between 25 and 40 kg/m2) 3. diagnosed with prediabetes, defined as having elevated hba1c (5.7-6.4%). exclusion criteria: 1. not between the ages of 18 and 65 2. not overweight (bmi between 25 and 40 kg/m2) 3. not diagnosed with prediabetes, defined as having elevated hba1c (5.7-6.4%).

Keywords: prevention type 2 diabetes prediabetes group intervention
a study to assess the accuracy of magnetocardiography (mcg) to diagnose true ischemia in patients with chest pain in the ed

Conditions: Chest Pain; Emergency Medicine

Summary: the purpose of the research is to see if patients that come to the emergency department with chest pain can be more accurately and more quickly diagnosed by magnetocardiography (mcg) to see if their chest pain is caused by coronary ischemia (reduced blood flow to the heart) in patients with normal or have non-specific changes on the ecg vs other causes by other reasons.

hypothesis: mcg can accurately, and in real-time, identify an acute coronary syndrome for patients presenting to the emergency department (ed) with chest pain and is faster than current practice. aims, purpose, or objectives: our primary objective is to measure the diagnostic accuracy of the mesuron avalon-h90 mcg device to detect acs (unstable angina, nstemi) in emergency department patients who present with acute chest pain when compared to the current goal standard. our secondary objectives are as follows: * to study the ability of mcg to rule in or rule out acs in real-time. we will assess the value of the mcg results in conjunction with the heart pathway score. this will include looking at the diagnostic test accuracy, sensitivity and specificity of the device when used in conjunction with and without the heart pathway score, including versus excluding the troponin level (as the results of this is usually delayed by 45 minutes to 1 hour). in this way, we hope to demonstrate this technology may decrease ed length of stay in chest pain patients and decrease time to diagnosis. the comparison goal standard will be the cardiology diagnosis, the result of serial troponins, or the ed diagnosis depending on the disposition of the patient. * to estimate ability of mcg for prognostication for major adverse cardiac events (mace) at 3 days, 7 days, 30 days and 90 days.

Eligibility criteria:
inclusion criteria: * patients presenting to the ed with acute chest pain when an acs is on the differential diagnosis. * patient willing and able to give informed consent. exclusion criteria: * st elevation \> 1 mm on any two contiguous ecg leads. * hemodynamic instability (sbp \>220 or \ 160). * pregnant patients. * incarcerated patients (fmc patients). * patients with a pacemaker or defibrillator. * metal implants in the body (that are not mri safe). * patients that are unable to lie down in the mcg machine or stay still. * patients who are unable to understand the informed consent process (ex: non-english speakers without an available interpreter, cognitive delay). * patients without the capacity to provide written informed consent
study for prevent chronification migraine through prediction of response to treatment with anti-cgrp antibodies

Conditions: Migraine

Summary: being able to predict each patients response to a specific treatment can mean a significant improvement in socioeconomic costs, but above all in their quality of life. with the present study, the investigators aim to analyze in a combined way different clinical, biological and neuroimaging variables, which allow the clinical staff to anticipate the response to treatment with anti-cgrp monoclonal antibodies in patients with migraine.

the study consists of an initial visit coinciding with the start of treatment, a subsequent visit after 6 months of treatment and finally another after 12 months, coinciding with the end of treatment. in case of worsening after suspension, a clinical visit will be carried out at the time of worsening to evaluate the reintroduction of the drug and in case of reintroduction, a visit will be carried out after 3 months. if patients do not worsen, a visit will be made 6 months after completing treatment. at each visit, demographic and clinical variables will be collected. in addition, 3 blood tests will be performed corresponding to the beginning of treatment, after 6 months and a month and a half from the last infiltration. likewise, a brain mri will be obtained prior to the start of treatment. these blood samples and neuroimaging data will be processed for subsequent analysis.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 65 years. * caucasian ethnicity. * patients diagnosed with migraine with and without high-frequency episodic aura (more than 8 days of migraine per month) or chronic by a neurologist expert in headaches and according to the criteria proposed in the international classification of headache diseases, 3rd edition (ichd- 3). * have at least one year of history of migraine. * patients must maintain stable preventive treatment in the previous month and not have received botulinum toxin in the month prior to starting the monoclonal antibody. * patients able to describe their clinical situation and the characteristics of their headache. * grant your informed consent. exclusion criteria: * patients who present with another type of non-migraine headache, with the exception of headache due to excessive use of analgesic medication. * neurological focus in the examination. * pregnancy or breastfeeding period. * patients with cognitive deficiency or pathology that may prevent or hinder the correct completion of the study. * patients who require changes in preventive treatment during the first 6 months after starting treatment with monoclonal antibodies. * patients who present any significant adverse effect that requires withdrawal or change of anti-cgrp drug.

Keywords: migraine headache antibodies antibody monoclonal antibody anti-cgrp anti cgrp cgrp prediction treatmen migraine treatment treatment with anti-cgrp monoclonal antibodies anti-cgrp antibodies anti-cgrp antibody anti-cgrp monoclonal antibodies migraine and antibodies migraine and cgrp
level of anxiety in patients undergoing invasive foot surgery

Conditions: Anxiety Postoperative; Surgery

Summary: in recent decades, preoperative anxiety has been studied by numerous authors from different medical-surgical specialties, however, there are no studies in the scientific literature on anxiety prior to surgical procedures in the area of minimally invasive foot surgery at the osteoarticular level. the aim of the present study was to determine the level of preoperative anxiety and information using the amsterdam preoperative anxiety and information scale in patients undergoing minimally invasive podiatric surgery, as well as to determine the socio-demographic and surgical factors associated with preoperative anxiety.


Eligibility criteria:
inclusion criteria: * be over18 years old. * asa i and ii (american society of anesthesiologists). * autonomous capacity to fill out the surveys and participate in the study exclusion criteria: * mental and/or emotional disorders. * incapacity to understand. * people medicated with anxiolytics before the surgery. * chronic pain in the foot and/or analgesic treatment for chronic pain. * did not fulfill the postoperative recommendations. * contraindication to the study's medical guideline.

Keywords: anxiety surgery minor surgical procedures postoperative pain
extracellular rna markers of liver disease and cancer

Conditions: Hepatocellular Carcinoma; Biliary Tract Cancer; Cirrhosis; Liver Diseases

Summary: the study will examine and evaluate the use of extracellular rna in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery

the goal is to identify an extracellular rna candidate for the detection and diagnosis of liver cancers such as hepatocellular cancer or biliary cancer, and chronic liver diseases. the use of selected exrna biomarkers for diagnosis of hepatocellular cancer (hcc) or biliary tract cancers in patients with cirrhosis will be evaluated in a prospective case-control study. the study will create a registry of patients who have chronic liver disease, cirrhosis, liver and biliary tract cancers. a risk factor questionnaire will be administered to facilitate identification of risk factors for development of liver cancer. patient information will be obtained from the medical record, and include demographics, medical history, liver disease, smoking and alcohol history, etiology, family history, and clinical laboratory data.

Eligibility criteria:
inclusion criteria: * lab results from within the previous 90 days. * diagnosis of hcc or biliary tract cancer * diagnosis of cirrhosis based on histology, imaging, or ultrasound. * diagnosis of a chronic liver disease without cirrhosis. exclusion criteria for the hcc/biliary tract cancer group: * prior solid organ transplant. * previous cancer history with the last 5 years (excluding non-melanoma skin cancer), participation in a treatment trial for hcc exclusion criteria for the cirrhosis and chronic liver disease groups: * prior solid organ transplant. * previous or current cancer history within the past 5 years (excluding non-melanoma skin cancer).

Keywords: liver cancer cholangiocarcinoma (cca) cirrhosis hepatitis bile duct cancer hepatocellular carcinoma (hcc) hepatobiliary carcinoma hepatoma liver mass