Kornimate/medical-research-clean huggingface dataset:
evaluation of a treatment and education programme for type 1 diabetic patients (primas)

Conditions: Type 1 Diabetes

Summary: this study is a randomized prospective trial with 6-month follow up. a non-inferiority hypothesis is tested. a new developed treatment and education programme for type 1 diabetic patients (primas) will be tested compared to an established treatment and education programme (german dttp). primary outcome variable is glycemic control at 6-month follow up. secondary outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms, diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin treatment, hypoglycemia awareness.

both programmes consists of 12 lessons with a length of 90 minutes. eligible type 1 diabetic patients in a diabetologist practice are pooled and randomised either to the new developed primas programme or to an established education programme for type 1 diabetic patients (dttp - treatment and education programme for intensified insulin treatment) as an active comparator.

Eligibility criteria:
inclusion criteria: type 1 diabetes, diabetes duration \> 4 weeks, age 18 - 75 years, bmi 20 - 40 kg/m², a1c 7 - 13 %, ability to understand, speak and write german language, written informed consent. exclusion criteria: current treatment of psychological or psychiatric disorder, dementia or severe cognitive impairment, severe organic disease (e.g. terminal renal disease, cancer with poor prognosis), preventing a regular participation in the training course, pregnancy.

Keywords: diabetes mellitus, education, self management
epidemiology of sleep-disordered breathing in adults

Conditions: Sleep Disorders; Cerebrovascular Disorders; Cardiovascular Disease; Neurologic Disorders; Mood Disorders

Summary: to characterize the natural history and biologic spectrum of sleep disordered breathing (sdb) and other sleep problems and disorders, and test hypotheses regarding the causes and consequences of sdb and other sleep problems and disorders.

background: recent research has shown that sleep disordered breathing (sdb) is much more common than previously thought. while it is known that in clinic samples, sdb is associated with hypertension, cardiovascular disease and mortality, little is known about the natural history of this disorder, particularly in the general population, nor about the causal role of known risk factors. the knowledge obtained from the results of this study will help advance the field of sleep disorders medicine. information about longitudinal effects and causal relationships may be applied to clinical situations, thus reducing the morbidity and mortality associated with this disorder. design narrative: in this longitudinal study, follow-up polysomnography and other protocols are conducted on an established cohort of men and women (age 30-60 years at the time of initial recruitment in 1989), currently enrolled in the wisconsin sleep cohort study. the study aims to : 1) describe the natural history of sdb across middle and older age; 2) investigate associations of sdb with early and intermediate markers of cardiovascular dysfunction, damage, and cardiovascular disease; 3) investigate the longitudinal association of sdb in accelerated cognitive decline; 4) investigate the association of sdb and adverse sleep characteristics with age-related risk factors and outcomes.

Eligibility criteria:
inclusion criteria: * employee of one of the 4 wisconsin state agencies * age 30-60 in 1988 exclusion criteria: * current pregnancy * unstable or decompensated cardiopulmonary disease * airway cancer * recent upper respiratory surgery
reverse trendelenburg positioning and its effect on outcomes: a retrospective study of consecutive patients

Conditions: Aspiration, Respiratory; Hypoxia; Perioperative Period; Supine Position

Summary: the purpose of this study is to investigate whether intraoperative reverse trendelenburg positioning decreases postoperative hypoxemia and perioperative pulmonary aspiration rates.

intraoperative pulmonary aspiration can cause death and lead to morbidity. in addition, reliable estimates of aspiration rates are uncertain. in part, this ambiguity relates to the lack of prospective data. relevant studies are retrospective chart reviews or results from voluntary reporting databases. furthermore, aspiration diagnosis can be imprecise. the finding is certain when there is aspiration of bile or particulate matter from the tracheobronchial tree or there is endoscopic visualization. however, the diagnosis is presumptive when there is intraoperative or postoperative development of a new chest x-ray infiltrate and attendant tachypnea, hypoxia, wheezing, or changes in ventilator airway pressures. most patients undergoing general endotracheal anesthesia are in the supine or horizontal position. however, evidence from the literature demonstrates that the supine position in mechanically ventilated patients is a risk for aspiration and ventilator associated pneumonia (vap). during intensive care unit (icu) mechanical ventilation, the institute for healthcare improvement recommends elevating the head of the bed to prevent pulmonary aspiration and vap. other investigations have shown a profound relationship between horizontal positioning and intra-operative aspiration. there is substantial operating room, icu, and animal investigative evidence that aspiration occurs despite the presence of a cuffed endotracheal tube. likewise, previous work by this group showed a 30% perioperative hypoxemia rate, which was significantly associated with horizontal positioning. the post-operative length of hospital stay was 2 days longer with hypoxemia, compared to no hypoxemia (p \<0.0001) and this represented a total of 300 additional days for the 2 months of the study. the purpose of this retrospective study is to repeat the investigation after adopting a recent policy change of 10-degree reverse trendelenburg position as the routine for surgical patients, unless deemed inappropriate by either the anesthesiology or operating room nursing staff.

Eligibility criteria:
inclusion criteria: * patients undergoing endotracheal intubation and general anesthesia * age ≥18 years * glasgow coma scale score ≥13 (prior to tracheal intubation) * american society of anesthesiologists classification i-iv * pre-operative pulmonary stability exclusion criteria: * tracheal intubation prior to emergency department arrival * cardiac and thoracic surgical patients

Keywords: hypoxemia reverse trendelenburg
telemedicine and forensic odontology

Conditions: Dental Caries

Summary: the aim of this study is to identify the expectations of experts in forensic odontology on telemedicine. this study could improve, in multiple cases post mortem body identification.

experts in forensic odontology will have to complete a questionnaire that will reveal their expectations and knowledge on telemedicine.

Eligibility criteria:
inclusion criteria: - experts in forensic odontology members of the afio or uio association exclusion criteria: - dentist who not practicing forensic odontology

Keywords: public health forensic odontology telemedicine identification post mortem dentist who is an forensic odontology expert member of the afio or uio
regional strategy for transfer for mechanical thrombectomy

Conditions: Stroke; Ischemic; Large Vessel Occlusion

Summary: a mono-centre observational study with the aim of compare clinical outcome at 3 month on patients admitted with recent cerebral infarct and intracranial large vessel occlusion in the anterior circulation who are eligible for mechanical thrombectomy in three different position : patients admitted first in the comprehensive stroke center of montpellier, those transferred after proximity stroke unit or prehospital bypass for patients with high suspicion of large vessel occlusion.to the comprehensive stroke center of montpellier

multiple rct has recently proved the superiority of mechanical thrombectomy compared to the best medical therapy (bmt) on patients with recent cerebral infarct and anterior circulation intracranial large vessel occlusion. in the occitanie-est region (ex languedoc roussillon), comprising 6 stroke unit, only the comprehensive stroke unit of the chu de montpellier has a centre of interventional neuroradiology (nri) that can perform mechanical thrombectomy. patients suspected of stroke are referred to the nearest su, then the candidates for thrombectomy, are transferred secondarily to the stroke center in montpellier. currently, there is no evidence that an initial management in a proximity stroke unit and a secondary transfer for a mechanical thrombectomy is associated with a loss of chance for patients, compared to patients initially treated at the stroke center regional reference. the objective of the study is to compare clinical outcome on patients admitted first in the comprehensive stroke center of montpellier those transferred after proximity stroke unit or directly admitted when high suspicion of large vessel occlusion.

Eligibility criteria:
inclusion criteria: 1. patient, admitted to the emergency department head and neck of the chu de montpellier, over 18 years old, without limit of upper age 2. with tia or cerebral infarction (confirmed by brain imaging (mri or ct scan), acute (time of stroke symptoms or discovery of patient ≤ 12 h) 3. with anterior circulation intracranial large vessel occlusion (m1, t or proximal m2), confirmed by arterial imaging (magnetic resonance angiography-mra- or angioscanner) 4. no objection of the patient or their representative to being included in the cohort exclusion criteria: 1. patient with severe intercurrent pathology impacting the short-term vital prognosis and making follow-up impossible 2. predictable impossibility of patient follow-up

Keywords: ischemic stroke mechanical thrombectomy
effect of probiotic inersan and doxycycline in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. the need was fulfilled by the introduction of probiotics and bacterial replacement therapy. the term probiotic is derived from the greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. food and agriculture organization and who have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.


Eligibility criteria:
inclusion criteria: 1. subjects in both sexes 2. age 25 - 60 yrs 3. subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in \> 30 % of the probing sites 4. subjects in good general health exclusion criteria: 1. antibiotic therapy in the past 2 months 2. allergic to doxycycline or probiotics 3. subjects with diabetic mellitus, hypertension and psychiatric disorders 4. subjects who are pregnant/ lactating 5. smokers and/or alcoholics 6. subjects who have undergone any periodontal therapy within last 6 months.
post-operative quality of life evaluation for different anesthesia techniques for arthroscopic shoulder surgery

Conditions: Rotator Cuff Injury

Summary: randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.


Eligibility criteria:
inclusion criteria: patients who agree to participate in the study will be asked to sign the informed consent and the hipaa form. inclusive criteria are: * 18-75 years of age * asa physical status i-iii * bmi \< 35 kg/m2 exclusion criteria: * all open shoulder procedures * patient having difficulty understanding the instruction on using the anesthetic infusion pump * contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy) * significant neurologic disorders of the upper extremity * psychiatric or cognitive disorders * history of substance abuse or chronic opioid use

Keywords: shoulder arthroscopy 24-week follow-up quality of life rehabilitation achievement rotator cuff repair
evaluation of the efficacy of surfaktant in preterm infants by lung ultrasound

Conditions: Lung Ultrasound Scores

Summary: to compare the lung ultrasound scores after two different natural surfactant administration as a parameter reflecting lung inflation. poractant alfa decreases lung ultrasound scores as efficient as beractant treatment

outcomes: improvement of lung usg scores after surfactanct and the difference between groups at different time points (2nd and 6hr). secondary outcome: the correlation between lung usg scores and clinical scores (silverman scores), fio2 and pco2 levels, failure of weaning to noninvasive ventilation after surfactant preterm infants of 32 gestational weeks and below, who admit to the nicu with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.

Eligibility criteria:
inclusion criteria: * preterm infants of 32 gestational weeks and below, who admit to the nicu with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled. exclusion criteria: * major congenital anomalies.

Keywords: lung rds surfaktant
implementation of a tumor response assessment program integrating the shared medical decision into the organ preservation strategy for rectal cancer patients

Conditions: Rectal Cancer

Summary: the adoption of total mesorectal excision (tme) has standardized rectal cancer surgery and improved oncological outcomes. in locally advanced rectal cancer, neoadjuvant radio chemotherapy (nacrt) has further improved oncological benefit. although these strategies result in good 5-year disease-free survival rates, they are associated with significant morbidity, in particular permanent long-term bowel, urinary and sexual dysfunction. in rectal cancer management, the main objective of organ preservation is to avoid or reduce morbidity and impact on quality of life after rectal resection, without compromising oncological outcomes. the aim of this project is to evaluate the efficacy of a defined response monitoring program, including a shared decision process, as a strategy for assessing tumor response in locally advanced rectal cancer after neoadjuvant therapy. this is a national, phase iii, randomized, open-label, multicenter clinical trial comparing the tumor response monitoring program with shared decision-making, versus standard tumor response assessment in organ preservation strategies in rectal cancer.


Eligibility criteria:
inclusion criteria: * patient aged 18 to 80 * histologically proven lieberkuhnian adenocarcinoma with mss status ; * patient who has or is due to receive neoadjuvant treatment (4 to 6 courses of (m)folfirinox or folfox chemotherapy + cap 50 radiochemotherapy or cap 50 radiochemotherapy alone); * before any neoadjuvant treatment: * tumor classified t2t3 (on mri) * n0-n1 (≤ 3 positive lymph nodes \* or size ≤ 8 mm) (on mri) * \* positive node = node size \> 5 mm minor axis and/or morphologically suspicious appearance tumor size ≤4 cm (on mri) * no distant metastasis (m0)_ tap scan or pet scan * ≤ 8 cm from anal margin (on mri) (clinical examination\*) \*if the clinical examination is not possible, then the source data is that of the mri. * no invasion of the anal canal and/or sphincters (internal and external) (on mri) * operable patient * ability to comply with the protocol and follow-up appointments (repeated assessment consultations and close follow-up if randomized to the experimental group); * person affiliated with or benefiting from a social security scheme; * free and informed consent signed by the patient. exclusion criteria: * patients with a history of chemotherapy or pelvic irradiation (excluding neoadjuvant treatment) * contraindication to pelvic mri * patients with msi status undergoing immunotherapy * other concomitant cancer or history of cancer within 5 years, with the exception of carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured * women who are pregnant, likely to become pregnant, or who are breast-feeding; * person under guardianship, curatorship or safeguard of justice, or person deprived of liberty. * unable to undergo medical follow-up for geographical, social or psychological reasons.
bariatric surgery and pharmacokinetics of paracetamol

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on paracetamol are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics acetaminophen
special drug use-results survey for long-term use (fostamatinib)

Conditions: Chronic Idiopathic Thrombocytopenic Purpura

Summary: the purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.

the purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.

Eligibility criteria:
inclusion criteria: * patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.
a retrospective study to examine the effect of cmf stimulation on primary acdf patients

Conditions: Degeneration of Cervical Intervertebral Disc

Summary: a retrospective parallel group comparison study to support expansion of the indication of the company's fda approved spinalogic™ device to include the cervical spine. the spinalogictm device was initially approved by fda as an adjunct to one- or two-level lumbar fusion (p910066/s011). it is a non-invasive bone growth stimulator (bgs) that generates a combined magnetic field (cmf) that has been proven to accelerate bone healing and fusion in the lumbar spine.


Eligibility criteria:
inclusion criteria * male or female aged 18-75 years. * primary anterior cervical discectomy fusion (acdf) and required two level spinal fusion or were active smokers and required either single or two level spinal fusion. * pain vas score \>5 and/or extreme weakness at target operative level(s). * at least one post operative clinical outcome assessment (vas pain/ ndi/oc score) at each follow up interval. * completed 6 month follow up visit or time to fusion assessment, whichever is sooner. exclusion criteria * treated with a bone growth stimulator device other than the spinalogictm cmf device. * previous cervical vertebrae fusion surgery at any level (posterior or anterior approach) * systemic administration of any type of corticosteroid, antineoplastic, immune- stimulating or immunosuppressive agents within 30 days of primary acdf surgery and/or within 12 weeks post-operatively. * active history of systemic malignancy at pre-operative assessment or during 12- month follow up period. * untreated malignant neoplasm(s) or underwent radiotherapy or chemotherapy at pre- operative assessment or during 12-month follow up period. * implanted with cardiac pacemaker or implantable cardioverter defibrillator at pre- operative assessment or during 12-month follow up period. * pregnant at pre-operative assessment or during 12-month follow up period. * mental or physical condition that would interfere with post-treatment assessments and/or care (e.g., neuromuscular disease, psychiatric disease, * paraplegia, quadriplegia, etc.) at pre-operative assessment or during 12-month follow up period. * prescribed non-steroidal anti-inflammatory, calcium channel blockers and/or diphosphonate therapy within 12-weeks of surgery period. * prescribed bone morphogenic protein (bmp) during 12-month follow up period. * implanted with a titanium cage during the primary acdf that precludes an outcome determination via plain radiographs. * osseous or ligamentous spinal trauma at pre-operative assessment or during 12- month follow up period. * paget's disease at pre-operative assessment or during 12-month follow up period. * absence of x-ray fusion assessment documentation at 6 months follow-up visit.
impact of myofascial release on preventing dysphagia in the elderly community

Conditions: Dysphagia

Summary: the goal of this clinical trial is to explore the impact of myofascial release training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address the effects of myofascial release training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants are required to undergo a continuous three-week (21 days) myofascial release training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. it involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. the goal of this clinical trial is to explore the impact of myofascial release training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address the effects of myofascial release training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants are required to undergo a continuous three-week (21 days) myofascial release training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility criteria:
inclusion criteria: * age over 60 years old. * no hospitalization within the past six months. * with clear consciousness and able to cooperate with questionnaires and training. * the elderly people who voluntarily participate and agree to adhere until the end of the study. * dysphagia exclusion criteria: * complicated with severe liver and kidney failure, tumors, or hematological disorders. * physical disability. * difficulty in mobility.