Kornimate/medical-research-clean huggingface dataset:
st2 for the management of heart failure - stade-hf

Conditions: Heart Failure; Diastolic Heart Failure; Systolic Heart Failure Stage C

Summary: heart failure (hf) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). it is also a major cause of health burden representing between 1.5 and 2 billions euros per year in france. approximately 75% of these costs are due to hospitalization. besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters. this study aims to assess the value of st2 in the management of patients admitted for hf to reduce readmission at one month.

background and rationale: heart failure (hf) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). it is also a major cause of health burden representing between 1.5 and 2 billions euros per year in france. approximately 75% of these costs are due to hospitalization. besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters. the natriuretic peptides are already available and widely used to this purpose. other biomarkers such as fibrosis markers are promising. in a recently published preliminary work of a cohort of 180 cardiac patients, st2 is proving to be a powerful prognostic biomarker. this study aims to assess the value of st2 in the management of patients admitted for hf to reduce readmission at one month. primary and secondary endpoints: primary endpoint: - interest of st2 to decrease rehospitalization at one month in patients admitted for hf in the cardiology department and / or internal medicine. secondary objective: * economic evaluation * clinical target: mortality, stay at hospital duration * impact on biological markers of hf, renal function population: any adult being hospitalized for any type of hf. a total of 300 patients will be over a period of 36 months, divided into 2 arms. methods: interventional, randomized, opened: the two strategies "st2 available" versus "st2 not available" will be compared the duration of patient participation is 12 months.

Eligibility criteria:
inclusion criteria: * heart failure hospitalization exclusion criteria: * other study * pregnancy, feeding * refusal * not possible to perform information

Keywords: heart failure st2 fibrosis
electromagnetic stimulation for the treatment of urge urinary incontinence and overactive bladder

Conditions: Urinary Incontinence, Urge

Summary: the purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.


Eligibility criteria:
inclusion criteria: * urinary urge incontinence * urinary frequency exclusion criteria: * primary complaint of stress incontinence * neurogenic bladder * overflow incontinence * functional incontinence

Keywords: urinary incontinence, urge peripheral nerve stimulation
physiotherapy assessment of patients referred to orthopaedic surgeon

Conditions: Musculoskeletal Pain

Summary: many patients with musculoskeletal pain in primary healthcare are referred to orthopaedic surgeon, however, a relatively low percentage of these patients are considered suitable for orthopaedic intervention. physiotherapists are suitable for musculoskeletal assessments and are used as such in many countries i.e. advanced practice physiotherapists or extended scope physiotherapists, however, this is not an existing model of care in sweden. to be able to consider this model for implementation in sweden it is necessary to evaluate it from a healthcare as well as from a patient perspective. the study is a randomised controlled trial. overall aim is to evaluate if a orthopaedic manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic surgeon bring any changes to referral routines, patient satisfaction and health-related variables when compared to standard practice.

the study is a randomised controlled trial. overall aim is to evaluate if a orthopaedic manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic surgeon bring any changes to referral routines, patient satisfaction and health-related variables when compared to standard practice. patients were randomised to either physiotherapy assessment or standard practice (orthopaedic surgeon assessment).

Eligibility criteria:
inclusion criteria: * patients referred for orthopaedic surgeon with sub acute (four weeks to three months) or chronic (\>three months) musculoskeletal pain who had the ability to understand written and spoken swedish. exclusion criteria: * diagnosed hallux valgus, ganglion or trigger finger.

Keywords: physiotherapy orthopaedic primary care
safety and efficacy study of bimatoprost/timolol fixed combination in patients wtih glaucoma or ocular hypertension

Conditions: Ocular Hypertension

Summary: the purpose of this study is to assess the safety and efficacy of bimatoprost/timolol fixed combination in the treatment of glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes * patient needs iop-lowering drug in both eyes exclusion criteria: * uncontrolled medical condition * contraindication to beta-adrenoceptor antagonist therapy
keep bifurcation single stenting simple

Conditions: Coronary Disease

Summary: kiss study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation pci procedures for side branch protection

in the treatment of bifurcation lesion, the role of side branch intervention for improving the safety of percutaneous coronary intervention (pci), when mb is treated according to the murray law with a proximal optimization technique (pot), remains unclear. the kiss study will evaluate the non-inferiority of no side branch intervention versus side branch ballooning, in the setting of single stenting with systematic proximal optimization technique.

Eligibility criteria:
inclusion criteria: 1. coronary artery disease requiring revascularization that is amenable to percutaneous coronary intervention (pci) 2. any de novo medina type bifurcation lesion with \>70% lesion in the main vessel by visual assessment except medina 0,0,1 if the planned strategy does not include a main branch stenting 3. side branch diameter compatible with a pci with stent implantation (≥ 2.25mm) 4. side branch requiring a protection wire according to operator evaluation 5. anatomy compatible with a proximal optimization technique 6. post main branch treatment (stenting then pot): absence of side branch occlusion or low flow associated with ongoing ischemia (either chest pain or st changes) 7. male or female patient \>18 years old exclusion criteria: 1. acute myocardial infarction with ongoing st-elevation 2. cardiogenic shock 3. requirement for ongoing hemodialysis 4. life-expectancy limited to \<12 months due to co-morbid condition 5. lesion involves the left main coronary artery 6. lesion requiring a double stenting 7. plan to treat \>1 other coronary vessel at the time of the index procedure 8. two lesions treated in the same session: unsuccessful pci on the single non bifurcation lesion in a non-target vessel before the treatment of the target lesion. 9. chronic total occlusion of any target vessel 10. left ventricular ejection fraction \<20% 11. side branch timi flow \<3 12. pre-dilatation of the side branch during the procedure prior to randomization 13. known allergy to aspirin 14. known allergy to clopidorel and prasugrel and ticagrelor 15. known allergy to stent drug elutant 16. known allergy to any other component of onyx resolute stent 17. ongoing participation in another investigational device or drug study 18. inability to provide informed consent 19. patients under judicial protection, tutorship or curatorship 20. pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures

Keywords: coronary disease bifurcation lesion
simulation-based education for managing stress in icu nurses

Conditions: Professional Stress

Summary: i. main outcome decrease of the stress evaluated 6 months after training. stress is defined as the presence of job strain as defined by karasek. ii. main secondary outcomes * icu nurses stress at one year * burnout * intent-to-leave the icu * quality of life iii. design prospective, randomized, open study comparing 2 groups of icu nurses: simulation group and control group nurses from 9 different adult icus will be included. stratification by icu will be done (to take into account differences between the icus regarding organization, activity, patients...). this study is observational because nurses can participate to this training when they want. the fact that nurses are in control group delays their participation to this training but does not forbid them to particpate. the nurses from control group will participate to training at the end of study. iv. specific measures control group: none simulation group: 5-day specific training with dedicated scenario done by an icu expert simulation team v. study duration 48 months vi. ethical aspects - reglementary concerns * study accepted by the comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé (cctirs) and by the commission nationale de l'informatique et des libertés (cnil) * information to the participants prior inclusion vii. study population job strain evaluated in a french study was 59% . the same rate was observed in a survey done in our institution (assistance publique hôpitaux de marseille). we therefore hypothesized that the intervention (simulation) should be able to reduce the job strain from 59% to 45% of the participants. with a power of 80% and a risk a of 5%, this study needs to include 185 patients per arm. to take into account few participants who will not complete the study, we aimed to include a total of 400 icu nurses. viii results an interim analysis will be performed after 200 inclusions


Eligibility criteria:
inclusion criteria: * icu nurses from adult icus with a professional experience in the actual icu of at least 6 months and no decision to leave the icu at the time of enrollment non inclusion criteria: * less than 6 months of professional activity in the actual icu at the time of enrollment * intent-to-leave in the next 6-month period * previous experience of this simulation program * pregnant women exclusion criteria : * icu nurses who leave their city during the study period * pregnant women who miss their job during at least 4 weeks during the study period
developing a novel digital therapeutic for the treatment of generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: the investigators propose to develop and adapt unwinding anxiety phone app specifically for individuals with generalized anxiety disorder.

the study aims are to (1) develop and refine unwinding anxiety for individuals with generalized anxiety disorder, (2) determine user engagement and acceptability as well as measure effect sizes of the program vs. treatment as usual, and (3) preliminarily test mechanisms of action. the knowledge gained will set the stage for a number of future studies related to further elucidating the mechanisms of mindfulness, and the clinical efficacy and utility of this type of training delivered via digital therapeutics in general. specifically, this study will provide necessary variances for powering larger phase 2 studies.

Eligibility criteria:
inclusion criteria: * owns a smart phone * gad - 7 is equal to or greater than 10 exclusion criteria: * if using psychotropic medication - not on a stable dosage for at least 6 weeks * medical disorder of the severity that would interfere with ability to participate * not being fluent in english (due to instructions provided in english) * as needed use (i.e. prn) of benzodiazepines * psychotic disorder, * previous mt (e.g. mbsr, other claritas mindsciences training programs).

Keywords: anxiety, worry, mindfulness, meditation
finite element and one point fixation

Conditions: Zygomaticomaxillary Complex Fracture

Summary: * a cone beam ct (cbct) scan of the patient, will be used to create a 3d scanned image of zmc * 3d images will be introduced to finite element (fa)software to evaluate stresses (mpa) and life time (cycle) for each model and determine which point of fixation is the best * after application this point of fixation on the patient * finite element analysis will be done again to verify the previous results


Eligibility criteria:
inclusion criteria: * fit to general anesthesia (ga) * isolated minimally displaced zygomaticomaxillary complex (zmc) fracture exclusion criteria: * absence of other facial trauma, mandibular condylar fracture
assessment of foot alignment and pressure after correction of varus knee by high tibial osteotomy or total knee replacement

Conditions: Varus Deformity

Summary: this study evaluated the change in foot alignment after tka or hto by prospectively analyzing the correlation between the knee joint and the foot deformity, the post-operative improvement in the foot deformity, and the long-term post-operative changes in foot alignment.

the mechanical alignment of the lower extremity is an important consideration in the long-term outcome following total knee arthroplasty (tka) or high tibial osteotomy (hto) . alignment between the hip and the ankle through the knee joint has been used in determining coronal alignment, based on the assumption that weight-bearing forces pass through the centre of the knee joint during neutral mechanical. however, the weight-bearing vector can be affected by hindfoot and midfoot alignment because load is transmitted not from the ankle joint, but from the ground reaction point. thus hindfoot alignment after knee correction may critically affect the longevity of the prosthesis most patients with some degree of knee joint deformity, which in turn may be associated with a deformity of the foot. in fact, an association between varus alignment of the knee joint and valgus alignment of the foot in osteoarthritis patients has been reported. because the subtalar joint compensates for the knee joint deformity , correction of the deformity after tka or hto can affect foot alignment. improvements in midfoot and hindfoot alignment have been noted in patients with osteoarthritis after correction of deformity. however, foot valgus may also persist, with little improvement after knee correction.

Eligibility criteria:
inclusion criteria: * all varus aligned knee admitted to assiut university hospitals (total knee arthroplasty or high tibial osteotomy) . exclusion criteria: * patient with prior surgery of knee or foot . -secondary osteoarthritis. -valgus knee.
time-restricted feeding as a dietary strategy against metabolic disturbances in humans

Conditions: Overweight and Obesity

Summary: this human dietary intervention study with a cross-over design aims to compare the effects of two isocaloric diets - early time-restricted feeding (trf) vs. late trf - on glycemic control and lipid metabolism in overweight and obese women.

the participants are randomly allocated to one of two study groups: in study group (a) participants will begin with the early trf (e-trf) intervention. they will consume their habitual food (and the habitual daily amount of food) between 8 am and 4 pm for two weeks. after a washout-phase participants will conduct the late trf (l-trf) and consume their habitual food between 1 pm and 9 pm for another two weeks. study group (b) receives the same interventions in the reversed order. both dietary regimens will result in 8-hr eating period and 16-hr fasting period during the 24h day.

Eligibility criteria:
inclusion criteria: * bmi 25-35 kg/m² exclusion criteria: * prior diagnosis of type 1 or 2 diabetes * weight changes \> 5% within past 3 months * current shift work or history of shift work * traveled across more than one time zone one month before the study * poor quality of sleep (psqi score\>10) * eating disorders, food intolerance/allergy, severe indigestion * pregnant or breastfeeding * severe internal or psychiatric disorders or other conditions that might influence the outcome of the study

Keywords: time-restricted feeding meal timing obesity glycemic control blood lipids inflammation sleep
cognition after osa treatment among native american people (catnap)

Conditions: Obstructive Sleep Apnea; Cognitive Change

Summary: this research project will develop and implement a motivational interviewing and electronic messaging intervention to address obstructive sleep apnea (osa), positive airway pressure (pap) adherence, and risk of alzheimer's disease and related dementias in american indians. the project will work with american indian elders, aged 50 years and older, from three northern plains reservations and surrounding communities. a total of 300 american indian elders with a confirmed osa diagnosis and prescribed pap therapy will be randomized to receive usual care consisting of pap therapy alone (control condition) or usual care plus the culturally informed catnap mi component (intervention condition).

the investigators will develop a multilevel 9-month culturally informed motivational interviewing and electronic messaging intervention- "cognition after obstructive sleep apnea (osa) among native american people" (catnap) to: 1) provide participants with motivational interviewing sessions to address obstructive sleep apnea (osa), positive airway pressure (pap) adherence, and risk of alzheimer's disease and related dementias (adrd) in american indians and 2) provide participants with electronic messaging to support pap adherence among american indian elders, aged 50 years and older. this study will explore the relationship between osa and cognitive function and evaluate osa as a mechanism for the strong association between sleep disorders and alzheimer's disease and related dementias (adrd). catnap will be implemented as a randomized controlled trial at 4 community sites serving american indians in the northern plains. a total of 300 american indian elders, aged 50 years and older, with a confirmed osa diagnosis and prescribed pap therapy will be randomized to receive usual care consisting of pap therapy alone (control condition) or usual care plus the culturally informed catnap component (intervention condition). the primary outcome is pap adherence and secondary outcome cognitive function. the study will partner with missouri breaks industries research inc., and missouri breaks durable medical equipment to monitor participants pap use, which is uploaded automatically to the cloud. outcomes will be measured at baseline, 3-months, and 9-months.

Eligibility criteria:
inclusion criteria: * age 50 years and older * self report american indian or alaskan native * diagnosed with obstructive sleep apnea * prescribed pap therapy and have a device * \*ability to understand written and spoken english; and * \*ability and willingness to follow all study protocols. exclusion criteria: * living in a household with someone who is enrolled in the study * already using pap device at medicaid recommended standards * cognitive decline, unable to consent on their own
positronic emission tomography (pet) imaging in post radiation evaluation of head and neck tumours (pet prevent trial)

Conditions: Cancer of the Head and Neck

Summary: the purpose of this trial is to determine the ability of positron emission tomography (pet) to detect residual cancer in neck lymph nodes of patients following curative treatment with radiation therapy for squamous cell cancer arising in the head and neck. patients with head and neck cancer (hnc) undergo treatment of curative intent; patients who are node positive (n2 n3 stages) undergo standard management which includes post-radiation planned neck dissection but two thirds of patients end up not having evidence of residual disease in neck dissection specimens; these patients could have avoided surgery. however, currently used standard tests, like computed tomography (ct) and/or magnetic resonance imaging (mri) cannot reliably predict who is post-radiation disease free.

pet-fluorodeoxyglucose scanning is an imaging test based on the increased uptake of radiolabelled glucose by tumour cells. pet might detect neck tumours better than other imaging tests. this is a cohort study in which patients with n2 n3 squamous cell carcinoma of the head and neck undergo a pet and a ct scan at baseline and then post-radiation therapy and chemotherapy. then, they undergo neck dissection surgery. the pet and ct results are compared with the presence or absence of tumours in the neck nodes. if pet is sufficiently accurate in predicting the presence or absence of tumours in the neck nodes, then a neck dissection could be avoided.

Eligibility criteria:
inclusion criteria: all of the following criteria must be satisfied: 1. histological evidence of squamous cell carcinoma of the head \& neck (t1-t4 arising in either the oral cavity, larynx \& pharynx, except nasopharyngeal carcinoma);or patients with histological evidence of squamous cell carcinoma metastatic to the neck and an unknown primary site after conventional workup without any of the following: i). clinically suspected skin primary or previous diagnosis of skin cancer arising in the head and neck area; ii). patients of asian or african decent -possible nasopharynx primary; iii). patients whose malignant adenopathy is confined to zone v -possible nasopharynx primary; and iv). patients whose malignant adenopathy is confined to zone iv (supraclavicular)-possible lung primary. 2. presence of advanced n2 or n3 neck disease. 3. planned for primary curative radiation therapy (± chemotherapy) followed by neck dissection eight to twelve weeks after completion of treatment. exclusion criteria: 1. presence of distant metastasis 2. recurrent tumour 3. prior neo-adjuvant chemotherapy 4. previous radiation therapy to intended treatment volumes 5. other active malignancy 6. surgically inoperable neck disease 7. unable to remain supine for 60 minutes 8. unfit to undergo general anesthetic or neck dissection for medical reasons 9. known hypersensitivity to ct contrast 10. pregnancy

Keywords: head and neck cancer diagnosis fluorodeoxyglucose positron-emission tomography pet oncology