Kornimate/medical-research-clean huggingface dataset:
the perfect-cr implementation study

Conditions: Myocardial Infarction; Risk Reduction

Summary: the goal of this open-label cluster-randomized effectiveness-implementation hybrid trial is to study whether a) audit and feedback of cardiac rehabilitation service delivery within a national quality registry and b) structured implementation support can improve center-level adherence to guidelines and short and long-term patient-level outcomes.

administering secondary prevention via structured cardiac rehabilitation (cr) programs for patients who have suffered a myocardial infarction (mi) reduces mortality and morbidity and improves quality of life. still, treatment goal achievement at patient-level and service delivery at center-level are sub-optimal and there is a large variation in program structure and delivery at center-level. using an open-label cluster-randomized effectiveness-implementation hybrid trial design, the primary objective of this study is to prospectively evaluate whether a) audit and feedback of cr processes and structures within the national cardiac registry swedeheart and b) supporting cr centers in implementing cr guidelines can increase center-level guideline adherence. the secondary objectives are the following: * at baseline, to cross-sectionally evaluate the association between center-level adherence to guidelines and patient-level outcomes * to prospectively study whether audit and feedback of cr processes and structures within the swedeheart registry can improve short- and long-term patient-level outcomes * to prospectively evaluate whether supporting cr centers in implementing cr guidelines can improve short- and long-term patient-level outcomes * to evaluate the acceptability, adoption, fidelity, implementation cost, and cost effectiveness of the implementation support all cr centers in sweden (approximately 75 centers) will be offered participation in the study. collectively these centers attend to approximately 8000 patients/year. patient-level outcome data will be retrieved from national registries.

Eligibility criteria:
centre-level inclusion criteria: * centres report to the swedeheart registry exclusion criteria: * unwillingness to participate in the study patient-level inclusion criteria: * diagnosis of a type 1 mi registered in the swedeheart registry * age 18-79 years at discharge from hospital * attended at least two follow-up visits at cr centres included in the study exclusion criteria: * none

Keywords: myocardial infarction cardiac rehabilitation secondary prevention audit implementation practice facilitation
irritable bowel syndrome survey in gastroenterological adult outpatients in china

Conditions: Irritable Bowel Syndrome (IBS)

Summary: the primary objective of this study is to estimate the overall prevalence of ibs medically diagnosed and diagnosed using rome iii or iv criteria in gi adult outpatients in china.

this is a multicentre, nationwide and cross-sectional study carried out in china, covering 30 sites and 3000 patients totally. as for the ratio of tertiary to secondary general hospitals is approximately 1:4 in china, 6 tertiary and 24 secondary hospitals will be randomly selected in this study.to adapt the representativeness of the data with the operational feasibility, 30 tertiary and 120 secondary hospitals will be randomly selected over the 6 geographic regions (north, northeast, east, south central, southwest and northwest). among those, 1 tertiary and 4 secondary hospitals in each region will be further selected based on gi department setup, willingness to participate in the study, capability and primary investigator's consideration. within participated hospitals, subjects will be enrolled consecutively from all the outpatients of gi department to minimize selection bias. 3000 subjects will be allocated to tertiary and secondary hospitals with a ratio of 1:1. in general, 250 subjects will be enrolled from tertiary hospitals and 250 subjects will be enrolled from secondary hospitals for each region. during the subject enrolment, the investigator will firstly explain the purpose of the study to consecutive gi patients and written informed consents will be obtained. then qualified patients will be given a questionnaire and finish it during waiting time. after receiving questionnaires, ibs diagnosis will be made by investigators based on rome iii or rome iv ibs diagnostic criteria. subjects will be identified as medically diagnosed with ibs if they have been diagnosed by their clinicians. and subjects will be classified as ibs sufferers without medical diagnosis if they satisfy rome iii or rome iv diagnostic criteria and have not received ibs diagnosis from physicians. for ibs patients, either medically diagnosed or diagnosed with ibs criteria, investigators will collect all the information on demographic features, disease characteristics and current treatment status. for non-ibs patients, only demographic information will be collected.

Eligibility criteria:
inclusion criteria: 1. provision of subject informed consent 2. consecutive female and/or male gi outpatients aged 18 years and over exclusion criteria: 1. subject with a cognitive condition and unable to finish the questionnaire 2. subject has an acute or chronic non-gi condition; e.g., doesn't record a 'yes' response to the question, 'do you have a gut problem?'
clinical characteristics of patients with leukemia and covid-19

Conditions: Leukemia, Acute; Covid19; Leukemia, Lymphoblastic

Summary: the purpose of this study is to describe the main clinical characteristics of patients with de novo acute lymphoblastic leukemia treated inside the third level hospitals converted to coronavirus disease 2019 (covid-19) attention for the metropolitan area of mexico city.

retrospective, observational study in patients with diagnosis of acute lymphoblastic leukemia, according to the criteria of the world health organization, from april 2020 to december 2020. patients was cared for in the hematology department of the hospital regional de alta especialidad de ixtapaluca or the hospital general de méxico. both hospitals have been assigned as coronavirus disease 2019 (covid-19) hospitals, limiting the access, number of outpatient visits and chemotherapy protocols. real-time polymerase chain reaction (rt-pcr) test for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) was performed for patients with respiratory symptoms or history of contact with suspected / confirmed cases of covid-19 upon having a positive rt-pcr test, patients were transferred to a respiratory isolation unit to continue their recovery. support treatment for covid-19 was based on local considerations.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the world health organization. exclusion criteria: * age less than 18 years * incomplete medical records
genetic modifiers of cystic fibrosis related diabetes

Conditions: Cystic Fibrosis Related Diabetes

Summary: this research is being done to find the genes and other factors that are responsible for differences among persons with cystic fibrosis. we are particularly interested in the factors that relate to the development of cystic fibrosis related diabetes (cfrd).

the study is recruiting people with cystic fibrosis (cf). the medical record is being extracted, and a blood sample is taken for dna. the dna samples are tested for variation both at the cystic fibrosis transmembrane conductance regulator (cftr) gene (the cf gene) and over the entire rest of the genome. using large numbers of people with cf, and knowing who does and does not have cfrd, we identify genetic variations that associate with cfrd. knowing these variations allows us to better understand the causes of cfrd, and with enough information, better to predict cfrd and identify people at particularly high or low risk of cfrd. people participating in this study also have the option to participate in related studies of other metabolic traits in cf such as over- and underweight.

Eligibility criteria:
inclusion criteria: * any person with cystic fibrosis and his/her parents. exclusion criteria: * none

Keywords: cf cfrd diabetes genetic modifiers
study of thrombin generation during the 3 first cycles of chemotherapy in patients with newly diagnosed multiple myeloma

Conditions: Multiple Myeloma

Summary: patients with multiple myeloma (mm) are at increased risk of venous thromboembolic event, especially in newly diagnosed patients and during induction treatment with thalidomide in combination with dexamethasone. this association was mainly heightened during the 3 first months of chemotherapy. several coagulation abnormalities have been described. laboratory tests measuring the overall thrombophilic tendency might be useful to assess thrombosis risk. the aim of this study is to compare thrombin generation by calibrated automated thrombogram during the 3 first cycles of chemotherapy in patients with newly diagnosed mm.


Eligibility criteria:
inclusion criteria: * inscription to medical assurance * patients who gave their written consent * patients with newly diagnosed multiple myeloma required chemotherapy exclusion criteria: * patients with renal failure who need to undergo hemodialysis * patients with indication for curative anticoagulant therapy * patient with 3 month follow-up not possible * patient with life expectancy \< 6 month

Keywords: multiple myeloma newly diagnosed thrombin generation tfpi tissue factor pathway inhibitor protein s thrombosis chemotherapy
relationship between cmr-derived parameters of ischemia / reperfusion injury and timing of cmr in stemi

Conditions: Myocardial Infarction

Summary: this a prospective observational study including patients with st-segment elevation myocardial infarction undergoing cardiovascular magnetic resonance for clinical reason during the index hospitalization. this local registry stemmed from multi-center european registry on cardiovascular magnetic resonance


Eligibility criteria:
inclusion criteria: * diagnosis of stemi * undergoing cmr during the index hospitalization exclusion criteria: * refractory cardiogenic shock * claustrophobia * egfr\<30 ml/min/1.73m2
qsymia as an adjunct to surgical therapy in the superobese

Conditions: Obesity; Metabolic Surgery; Weight Loss; Bariatric Surgery Procedures

Summary: this study tests the efficacy of the medication, qsymia, as an adjunct therapy in superobese individuals planning to undergo weight loss surgery. individuals taking the medication before and after surgery will be compared to historical controls who had surgery without taking the medication.

while there is obvious focus on the obesity epidemic that affects approximately one-third of the u.s. population, one subgroup within the epidemic remains on the fringe of scientific study and effective treatment options. the super obese patient, in this instance defined as those with a bmi ≥ 50 kg/m2, presents a difficult treatment challenge in managing this level of obesity. while bariatric surgery, including roux-en-y gastric bypass and biliopancreatic diversion with duodenal switch, have been shown to be effective in severe obesity (bmi ≥ 40 kg/m2), the risks involved with surgical intervention in the super obese patient are high. qsymia provides a potential opportunity to develop an effective treatment plan that would be an adjunct to surgical intervention in the super obese patient. use of qsymia in addition to a low-calorie dietary prescription pre-operatively would effectively decrease weight prior to surgical intervention, lowering surgical risk to some extent. additionally, if continued post-operatively, qsymia as an adjunct to the post-surgical dietary plan would potentially extend the weight loss horizon so that the probability of the typical weight loss plateau at 12-18 months is decreased.

Eligibility criteria:
inclusion criteria: * bmi ≥ 50 kg/m2 * determined to be a good candidate for surgery based on medical and psychological exam. * willing to participate in a 3-6 month medically supervised weight loss plan prior to surgery. * planning to remain in the reasonable vicinity of the wake forest baptist health - weight management center for the duration of the study. exclusion criteria: * history of prior weight loss surgery (removal/conversion from band to sleeve will not be excluded) * pregnant (women of childbearing potential will complete a pregnancy test (blood draw) to make sure they are not pregnant at the time that they initiate the medication). ongoing monitoring of pregnancy status is the responsibility of the patient and they are instructed as such in the consent form. * ongoing use of weight loss medication * contraindications to use of qsymia, including pregnancy, history of glaucoma, unstable cardiac disease (unstable angina, recent heart attack or stroke (in the past 6 months), uncontrolled arrhythmia), hyperthyroidism, taking monoamine oxidase inhibitors (maois) or allergy to either topiramate or sympathomimetic amines like phentermine.
cross-sectional follow-up on digestive and social functions of spn

Conditions: Solid Pseudopapillary Tumor of the Pancreas; Pancreas Cancer

Summary: an observational cross-sectional follow-up study on the quality of life (two aspects, digestive physiological and social psychological functions) of solid pseudopapillary neoplasm of the pancreas (spn) patients recruited in pumch from 2001 to 2026. the quality of life is evaluated by a questionnaire made up of eight validated scales.

solid pseudopapillary neoplasm of the pancreas (spn) is a rare tumor with uncertain malignant potential. it is a rare entity of pancreatic tumor with low potential malignancy, constituting 1% to 3% of pancreatic tumors and 10%-15% of pancreatic cystic neoplasm. although the reported cases of spn have been increasing rapidly all over the world during the last two decades, its long-term follow-up studies in large cohorts remain missing. from this, this observational cross-sectional follow-up study on the digestive physiological and social psychological functions of spn patients aims to achieve a comprehensive understanding on how spn and surgery affects the quality of life. patients are recruited in pumch from 2001-2026 with a definite pathological diagnosis. the quality of life after surgery is evaluated by a questionnaire made up of six validated scales (digestive physiological functions via: 8 symptoms scale of the eortc core quality of life questionnaire (eortc qlq-c30); gastrointestinal symptom rating scale questionnaire (gsrs); social psychological functions via: sense of coherence-9 questionnaire (soc-9); patient health questionnaire-9 questionnaire (phq-9), general anxiety disorder-7 questionnaire (gad-7) ; post-traumatic embitterment disorder 21 questionnaire (pted-21); work ability index questionnaire (wai); body image scale questionnaire (bis)). to our knowledge, this is the largest spn cohort worldwide and the first study to concentrate on the quality of life of spn after operations.

Eligibility criteria:
inclusion criteria: * spn patients with pathological diagnosis after surgery * approval to participate * patients with valid and complete questionnaires results inspected by two experienced surgeons exclusion criteria: * refusal to participate * patients with invalid or incomplete questionnaires results

Keywords: solid pseudopapillary neoplasm of the pancreas surgery follow up digestive physiological function social psychological function
a novel technology-assisted home based aerobic exercise programme for individuals with parkinson's disease

Conditions: Parkinson Disease

Summary: this study aim to evaluate the (1) feasibility of a novel mobile application ( combat pd) that support a home-based gamified aerobic exercise program in individuals with mild parkinson's disease (pd). the study aims to further explore (2) the effectiveness of combat pd in improving adherence to prescribed home-based exercise program; and (3) the clinical effectiveness if combat pd in improving motor and non-motor function in pd.

this study aim to evaluate the (1) feasibility of a novel mobile application ( combat pd) that support a home-based gamified aerobic exercise program in individuals with mild parkinson's disease (pd). the study aims to further explore (2) the effectiveness of combat pd in improving adherence to prescribed home-based exercise program; and (3) the clinical effectiveness if combat pd in improving motor and non-motor function in pd.

Eligibility criteria:
inclusion criteria: 1. aged 30-75, diagnosed with parkinson's disease, with mild disease severity (hoehn and yahr stages i to ii) 2. sedentary lifestyle 3. receive a stable dose of dopaminergic medication for at least 4 weeks prior to study inclusion 4. has a smart phone device exclusion criteria: 1. uncontrolled hypertension, arrhythmia, or unstable cardiovascular status 2. poorly controlled diabetes mellitus 3. advanced kidney disease 4. bmi \> 30 5. recent cerebrovascular event/ concussion/ fall in the last 6 months 6. significant cognitive impairment (moca\<21) 7. any other medical/orthopaedic/psychiatric condition that would interfere with ability to participate in the study 8. no stable internet or smart device access 9. inability to fill up self-reported questionnaires 10. attendance at any regular exercise programme up to 4 weeks prior to study inclusion

Keywords: exercise gamification
clinical evaluation of the safety and performance of microwave coagulation using the hs1 instrument

Conditions: Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract

Summary: clinical evaluation of the safety and performance of microwave coagulation using the hs1 instrument for actual or potential non-variceal bleeding in the upper gastrointestinal (gi) tract


Eligibility criteria:
inclusion criteria: * patient or authorised representative able to comprehend and sign the informed consent form. * actual or potential non-variceal bleeding in the upper gi, including angiodysplasia or avm malformations such as dieulafoy's lesion with a glasgow-blatchford score of greater than 1 exclusion criteria: * as stated in the contraindications in the hs1 ifu; * aged \<18 years of age * those described as vulnerable populations in en iso 14155; * patients with a known coagulopathy (congenital); * concurrent participation in another experimental intervention or drug study * unwilling or unable to provide informed consent. * a patient whose glasgow-blatchford score is 1 or less
oral care protocol for preventing ventilator- associated pneumonia

Conditions: Pneumonia

Summary: the nosocomial pneumonia remains to be a major complication for patients who were incubated with ventilation. most cases are attributed to increased bacteria flora in oropharyngeal secretion and aspiration of those organisms. research indicates that the gram-negative bacteria grows in upper air way and trachea rapidly during the initial 2-4 hospital days and the dental plague also increased dramatically at the first 5 days. about 50% cases with prolonged intubation experienced temporal swallowing disorders and majority of them recovered 7 days post weaning. some evidence exist suggesting that oral care could reduce bacterial flora, prevent aspiration, and subsequently decrease the incidence of ventilation-associated pneumonia for this group of high risk patients. this study aims to evaluate the effectiveness of a standardized oral care protocol in improving oral hygiene and reducing the incidence of pneumonia on a sample of surgical patients at intensive care unit.


Eligibility criteria:
inclusion criteria: * patients newly admitted to sicu who were under ventilator support for 48\~72 hours exclusion criteria: * with pneumonia present

Keywords: oral hygiene
mixed reality in mitraclip implantation: preliminary case series

Conditions: Mitral Regurgitation

Summary: the study aims to evaluate the impact of mixed reality (mr) technology, particularly using hololens 2.0 and specialized software for three-dimensional dicom image visualization, on mitraclip implantation procedures. this preliminary case series includes a comparative analysis of four mitraclip implantations, assessing procedural efficiency, radiation exposure, and operator stress through both physiological and subjective measures.

the advent of mixed reality (mr) technology, especially when integrated with hololens 2.0 and specialized software for three-dimensional dicom image visualization, offers promising avenues for enhancing precision and spatial awareness in interventional cardiology procedures. this case series aims to preliminarily evaluate the impact of mr on mitraclip implantation processes, setting the foundation for a comprehensive pilot study.

Eligibility criteria:
inclusion criteria: * adults aged over 18 years * patients diagnosed with mitral valve regurgitation requiring mitraclip implantation * ability to provide informed consent and comply with study procedures exclusion criteria: * patients with contraindications for mr technology (e.g., mri incompatibility) * individuals unable to comply with study procedures due to physical or cognitive impairments * pregnant or breastfeeding women

Keywords: mitraclip, mixedreality hololens dicom rendering support
pretherapeutic paraaortic lymphadenectomy in women with locally advanced cervical cancer versus definitive chemoradiotherapy

Conditions: Overall Survival Comparison Between the 2 Arms

Summary: this is an international, prospective, multicenter and randomized phase iii study designed to determine if patients with locally advanced cervical cancer have longer overall survivals with pretherapeutic paraaortic surgical staging when compared to radiologic staging.

all eligible patients will be equally randomized between the 2 following treatment groups: * standard of care arm: standard chemoradiation (whole pelvis chemoradiation therapy). * experimental arm: pretherapeutic paraaortic lymphadenectomy followed by tailored chemoradiation. pretherapeutic lymphadenectomy will be performed via the laparoscopic extraperitoneal or transperitoneal approach using either traditional laparoscopy or robotically-assisted laparoscopy. the surgery (extraperitoneal or transperitoneal laparoscopic lymphadenectomy) is considered investigational. chemoradiation treatment (with either pelvis or tailored radiation) is considered as standard treatment approved in france for the treatment of cervical cancer.

Eligibility criteria:
inclusion criteria: 1. women with clinical stage from 1b2 to 4a cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma. 2. women with fdg-pet positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes (see addendum below) and negative paraaortic nodes. 3. women with planned treatment of primary definitive chemoradiation therapy. 4. patient information and written informed consent form signed. 5. age ≥ 18 years old. 6. eastern cooperative oncology group (ecog) performance status (ps) ≤ 2. 7. life expectancy ≥ 3 months. exclusion criteria: 1. women with stage 1a or 1b1 cancer. 2. women with prior radiotherapy to the pelvis or retroperitoneal surgery. 3. women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma. 4. women with fdg pet positive high common / paraaortic lymph node metastasis confirmed by biopsy (see addendum below). 5. women who have undergone simple or radical hysterectomy prior to radiotherapy. 6. women with planned treatment of radiotherapy only (without chemotherapy). 7. women with planned treatment of palliative radiotherapy. 8. women with metastatic disease outside of pelvis. 9. women who have completed treatment for other malignancies (except non-melanomatous skin cancer) \< 5 years from their new diagnosis of cervical cancer. 10. women who are pregnant, women who are likely to be pregnant or are breastfeeding. 11. women with any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent or compliance to study procedures. 12. women not affiliated with social security system in france. 13. women deprived of liberty or under guardianship.