Kornimate/medical-research-clean huggingface dataset:
assessing cement-bone incorporation and adjacent segment degeneration following cement augmentation; an mri-pet follow-up

Conditions: Vertebral Fracture; Cement Augmentation

Summary: 3-year pet-mri follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.


Eligibility criteria:
inclusion criteria * men and women aged 18 to 70 years * minimum 3-year follow-up * single-level vertebral kyphoplasty * index surgery at universitätsspital zürich * mri-scan during initial treatment * informed consent provided exclusion criteria * combined with other operative procedure on the spine (e.g. dorsal instrumentation) * intraoperative intradiscal cement leakage * previous history of spinal surgery except on the cervical spine * metastatic disease with skeletal involvement * known chronic diseases of the bone metabolism other than osteoporosis * documented pregnancy (see also 6.3) * presence of implants not suited for mri (pacemaker, neuro-stimulators, pain pumps, insulin pumps, cochlea implants, metallic foreign bodies like bullet fragments)
impact of self-management strategies in self-reported bruxism

Conditions: Bruxism; Self-management; Pain; Proprioception; Temporomandibular Joint Dysfunction

Summary: this study aim to evaluate the effects of a 6-week self-management program on pain, muscle stiffness, and temporomandibular joint (tmj) functions in sedentary individuals aged 18-40 with bruxism. thirty-five individuals will be evaluated. bruxism will be assessed using the bruxism assessment questionnaire, while temporomandibular joint dysfunction (tmjd) will be evaluated using the helkimo clinical dysfunction index and the fonseca questionnaire. masseter muscle pain threshold will be measured with a digital algometer, muscle stiffness with a shore durometer, mandibular depression range of motion with a bicondylar caliper, and tmj proprioception with tmj position sense. assessments will be conducted pre-intervention and at the end of the fourth week.

the 4-week self-management program significantly increased the masseter pain threshold (p\<0.001) and reduced muscle stiffness at rest and during contraction (p\<0.001). tmjd severity, as measured by the helkimo index (p=0.010) and fonseca questionnaire (p\<0.001), was significantly reduced. additionally, tmj position sense and mandibular depression range of motion improved significantly (p\<0.001). self-management strategies positively impact bruxism symptoms, including pain, muscle stiffness, and tmj functions. these strategies should be considered an integral part of tmjd and bruxism management.

Eligibility criteria:
inclusion criteria: * adults aged 18 to 40 years * sedentary lifestyle * clinical diagnosis of sleep and/or awake bruxism exclusion criteria: * significant musculoskeletal disorders of the cervical or thoracic spine * chronic illnesses * neurological conditions affecting balance and postural control * pregnancy * the presence of dental prostheses * participants who missed more than 15 sessions

Keywords: bruxism self-management strategies proprioception muscle stiffness pain temporomandibular joint dysfunction
evaluating the efficacy and safety of roflumilast in patients with nash

Conditions: Non-Alcoholic Steatohepatitis (NASH)

Summary: study type :clinical trial main purpose :esnsure safety and efficacy of roflumilast to treat patients with non-alcoholic steatohepatitis background and aim: non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. there is no defined therapy for non-alcholic steatohepatitis (nash), therefore this study aimed at evaluating the efficacy and safety of roflumilast in patients with non-alcoholic nash. methods: this randomized controlled parallel study involved 55 patients with nash who were randomized into vitamin e group or control group (n=24) which received vitamin e 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily for three months. patients were assessed at baseline and after intervention through liver stiffness measurement (lsm) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (tnf-α), malondialdehyde (mda), transforming growth factor-beta 1 (tgf-ß1). in addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of the homeostatic model assessment for insulin resistance (homa-ir) were also assessed.


Eligibility criteria:
inclusion criteria: * patients with cytokeratine level \>240 iu/l. * adult patient (age \> 18 years old). * both sex. * overweight and obese. * patients with evidence of steatosis through imaging. * patient with mild to moderate elevation in aminotransferase activity (\>2 ,but \<5 times upper limit of normal ). * patient with hepatic steatosis index (hsi) \> 36. * patient with hair ( hypertension ,alanine aminotransferase level ,insulin resistance ) of 2 or 3. * fibroscan score \>7kpa and \< 12.5 kpa (f2 - f3). exclusion criteria: * alcohol consumer and smokers * patients with wilson's disease and hemochromatosis . * patients with viral hepatitis. * patients with cirrhosis . * patients with inflammatory diseases . * patients with other comorbid disease that elevate transaminases (congestive heart failure and malignancy). * patients on medications that interfere with lipid and carbohydrate metabolism.. * patients on stateogenic medications. * pregnancy and lactating women. * females on oral contraceptive pills.

Keywords: nash roflumilast lsm tnf-α mda tgf-ß1
renovated prediction model for difficult transoral and submental endoscopic thyroidectomy

Conditions: Thyroid Cancer; Thyroid Diseases; Thyroid Nodule

Summary: the investigators have previously proposed a prediction model for difficult transoral and submental thyroidectomy through a retrospective study. in order to better promote transoral and submental endoscopic approach for thyroid surgery and to set up an appropriate training course, the investigators aim to renovate and validate the prediction model through a prospective study.

male sex, age, bmi, neck length and certain thyroid disease such as thyroiditis and hyperthyroidism have been long cited as indicators of a difficult thyroidectomy. the investiagtors hypothesized that neck extension was critical to the exposure and visualization of the surgical field in the endoscopic thyroidectomy. therefore, several measurements were innovatedly integrated into the prediction model, including neck circumference, thyromental distance, sternomental distance, ratio of height-to-thyromental distance, ratio of height-to-sternomental distance.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm * clinical diagnosis of benign thyroid nodule with a maximum diameter not exceeding 6 cm * absence of suspicious lateral lymph nodes or distant metastases exclusion criteria: * participants with fusion or fixation of lymph nodes in the neck * participants with history of neck surgery or radiation * participants with vocal fold fixation by preoperative fibrolaryngoscope * participants with preoperative examination suggestive of extrathyroidal invasion * participants with a significantly restricted neck and/or jaw

Keywords: endoscopic thyroidectomy transoral and submental approach prediction model
fast track management in elective open infrarenal aortic aneurysm repair

Conditions: Aortic Aneurysm

Summary: fast track programs have been introduced in many surgical fields to minimize postoperative morbidity and mortality. morbidity after elective open infrarenal aneurysm repair is as high as 30%, mortality ranges up to 10%. in terms of open infrarenal aneurysm repair no randomized controlled trials exist to introduce and evaluate such patient care programs.

prospective randomization of patients admitted with infrarenal aortic aneurysm who undergo elective open repair in a "traditional" and "fast track" treatment arm. main differences consist in preoperative bowel washout (none vs. 3l cleaning solution) and analgesia (patient controlled analgesia vs. patient controlled epidural analgesia: pca vs. pcea). study endpoints are morbidity and mortality, need for postoperative mechanical ventilation and length of stay (los) on intensive care unit (icu).

Eligibility criteria:
inclusion criteria: * infrarenal aortic aneurysm * given written informed consent exclusion criteria: * contraindication for epidural anesthesia * suprarenal clamping

Keywords: elective open repair complications morbidity and mortality fast track patient management
a prospective cohort with patient navigation as an intervention for breast cancer patients

Conditions: Breast Neoplasm Malignant Primary

Summary: the objective of this observational study is to introduce a patient navigation system within the breast cancer unit at hospital central de maputo (moz) and gather data to assess the efficacy of patient navigation in enhancing oncological outcomes among this patient cohort. the primary inquiries it seeks to address are as follows: * can patient navigation reduce the duration (in days) between patient admission and the commencement of treatment? * does patient navigation influence overall survival rates when juxtaposed with historical cohorts from the local setting? participants will receive continuous support from a patient navigator starting from admission until the initiation of any oncological treatment.

-general objective: to implement an oncological navigation platform for breast cancer patients receiving treatment at maputo central hospital (hcm) over a proposed period of 12 months after project approval by the local irb. -specific objectives: * develop an oncological patient navigation system for breast cancer patients treated at hcm. * establish a prospective cohort of navigated breast cancer patients (with invasive or ductal carcinoma in situ) treated at hcm in 2024-25 (recruitment period of twelve months). * collect diverse epidemiological data from navigated patients during the proposed study period. * describe the following variables: time from first symptom until first medical consultation (in days), time from first medical consultation to cancer diagnosis (in days) and time from diagnosis to first treatment (either surgery or neoadjuvant treatment) in days. * compare time from first symptom to diagnosis (in days) and time from diagnosis to first treatment (in days) to a historical cohort published by brandão m. et al (the oncologist, 2021). * collect overall survival data in this cohort for thirty six months after last patient recruited for future publication.

Eligibility criteria:
inclusion criteria: * female * 18 years and older * will undergo breast cancer treatment at hcm * consent to participate exclusion criteria: * male * less than18 years of age * history of other previous malignancies (including breast cancer) * history of breast cancer treatment initiated elsewhere * lack of consent to participate

Keywords: breast cancer malignant neoplasm of the breast patient navigation carcinoma, intraductal, noninfiltrating
evaluation of efficacy and patient acceptance of sound amplifier téo first, in mild and moderate presbycusis patient 60 years of age and older, with no previous hearing aid

Conditions: Mild and Moderate Presbycusis

Summary: a personal sound amplifying device (pasp) like teo first is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. nevertheless, a lot of mild and moderate impaired hearing people don't want to buy and wear all day a real hearing aid. the goal of our study is to evaluate the benefit of such a device for mild and moderate presbycusis patient 60 years of age and older, with no previous hearing aid.


Eligibility criteria:
inclusion criteria: * wish to increase hearing * moral commitment to use the device * ability to understand the study * mild and moderate presbycusis (20 to 50 db average hearing loss at 500, 1000, 2000 hz and 4000 hz) * patient 60 years of age and older, * no previous hearing aid exclusion criteria: * inability to use the device * previous use of a hearing aid * local intolerance
feasibility study of at-home eeg monitoring for hypersomnia

Conditions: Hypersomnia; Narcolepsy

Summary: the central hypothesis is that home eeg monitoring (dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia.

this clinical study is a prospective, single group assessment which will enroll patients who are prescribed a multiple sleep latency test (mslt) at the fontana medical sleep center. patients will be mailed an actigraph and a dreem 3 system to undergo the following assessments: * 1 initial in-person sleep physician encounter to discuss your sleep symptoms and review the informed consent form * 1 week of actigraphy and dreem 3 system monitoring. actigraphy will be continuously monitored for 1 week to log sleep and wake periods. dreem 3 system will be monitored for the first 5 nights and the last 2 days will be 48-hour continuous monitoring (i.e., day and night). additionally, we will ask you to log your sleep/wake activity in a sleep diary. * 2 consecutive in-lab sleep studies within a 24-hour period * a few reminder telephone calls for at-home monitoring patients will have a follow up encounter with a physician after their in-lab visit. if a diagnosis is confirmed and treatment is initiated, the patient will be asked if they want to pursue treatment follow-up for the study. again, patient will wear the dreem 3 system and the actigraph during 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. then, for an additional continuous 48 hour measurement, patients will wear the dreem 3 system and actigraph (i.e. monitoring day and night). this procedure will occur once treatment is initiated as well as 1 month and 3 months after treatment initiation. patients will be asked to complete various sleep and quality of life questionnaires throughout the duration of the study. questionnaires should take approximately 10-15 minutes to complete.

Eligibility criteria:
inclusion criteria: * patients must be a kaiser permanente member * patients must be ≥ 6 years old. * patients must have an indication for multiple sleep latency test for a diagnosis of hypersomnia * patients are able/willing to consent and willing to undergo the electrophysiological routine assessments described in the protocol * patients do not meet any exclusion criteria exclusion criteria: * patients under 6 years old. * if a patient is taking a wake promoting medication and is unsafe to withdraw the medication during the 2 weeks prior to the in-lab polysomnography/multiple sleep latency study * patients suffering from mental and/or physical disorders that could interfere with the study protocol or the interpretation of the results (exclusion based on clinical judgment) * shift workers or patients working unusual hours will be excluded * patients not able to sign an informed consent form

Keywords: at-home sleep eeg-based monitoring dreem 3 system polysomnography (psg) multiple sleep latency test (mslt)
the study of association of helicobacter infections in biliary tract cancers

Conditions: Biliary Tract Cancer

Summary: biliary tract carcinoma (btc) includes gallbladder carcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma, intrahepatic cholangiocarcinoma. chronic infections of the biliary tract are major drivers of cancer. helicobacter species is one of the most established pro-oncogenic pathogens for gastric malignancy. however, its role in biliary tract cancers is under investigation. recently h. pylori has been associated with gallbladder pathologies like cholelithiasis, cholecystitis, choledocholithiasis, gallbladder polyps. however, some studies have also reported that chronic inflammation due to h. pylori infection causes biliary tract cancer. on the other hand, some studies have reported no association between h. pylori infection and gallbladder diseases. in addition to h pylori, h.bilis and h.hepaticus have a significantly higher incidence in bile from biliary tract and gallbladder cancer patients than in patients with gallstones/cholecystitis.this, together with the high prevalence of gallstones, makes it important to evaluate the role of helicobacter in biliary tract cancers. this study aims to compare the prevalence of helicobacter sp.(pylori, bilis, hepaticus). this study will include biliary tract carcinoma patients, benign biliary disease patients, high risk conditions for malignancy and voluntary healthy liver donors with no gallbladder pathology. hpe samples will be assessed and association of helicobacter sp will be studied among all 4 arms. patients who have received h pylori eradication therapy will be excluded. all the included samples will be assessed for helicobacter species using giemsa stain and dna pcr. results will be studied to compare the prevalence of helicobacter sp. in biliary tract malignancy and benign biliary diseases.


Eligibility criteria:
inclusion criteria: * biliary tract carcinoma patients who underwent resection patients undergoing cholecystectomy for benign biliary disease. voluntary healthy liver donors with no gallbladder pathology patients undergoing cholecystectomy for conditions with high risk of malignancy exclusion criteria: * patients who have taken h.pylori eradication previously in last three months.
improving motor skills: the role of music and encouragement

Conditions: Healthy

Summary: this study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. the interval between each intervention was set at seven days. the outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration. isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1rm on the dominant side of the body. during execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. the bar is held with the dominant arm while the other arm remains in a neutral position close to the body. it is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. the test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position.


Eligibility criteria:
inclusion criteria: to be included in the study, candidates had to be in good general health, with no medical conditions that could interfere with their ability to perform the test safely and effectively. in addition, to be considered trained, participants had to have performed 150 minutes per week of vigorous-intensity aerobic physical activity, in addition to muscle-strengthening activities, on at least two days per week. those who did not meet this standard were considered untrained. - exclusion criteria: exclusion criteria included a history of surgery to the arm, shoulder, or nearby areas that could limit the ability to perform the test. the use of medications that affect muscle function or pain perception was also a reason for exclusion, so that the test results could not be influenced by external factors. -

Keywords: muscle fatigue neuromuscular strategy performance semg motor recruitment motivation
breathomics in the diagnosis and prediction of radiotherapy-induced oropharyngeal mucositis in head and neck tumors

Conditions: Head and Neck Tumors; Breathomics; Volatile Organic Compounds; Radiotherapy-induced Oral Mucositis

Summary: radiotherapy-induced oropharyngeal mucositis (riom) is one of the most distressing side effects for patients with head and neck tumors during radiotherapy, requiring clinical physicians to manage it according to the severity of mucositis to alleviate symptoms and improve quality of life. however, traditional diagnosis of riom overly relies on subjective evaluation, lacks early sensitivity, and existing biomarker diagnostic methods suffer from insufficient efficacy, invasiveness, and inconsistent results. this study aims to explore the diagnostic and predictive value of exhaled breathomics in riom of head and neck tumors. by collecting exhaled breath samples from head and neck tumor patients undergoing radiotherapy and analyzing volatile organic compounds (vocs) using breath detection technology, we aim to develop and validate a non-invasive diagnostic and predictive model based on exhaled breathomics. the study will identify specific vocs as potential biomarkers, providing new tools for early diagnosis, timely prediction, and personalized treatment of riom.


Eligibility criteria:
inclusion criteria: * voluntarily sign informed consent. over 18 years of age. histologically confirmed head and neck tumors, treated with radiotherapy or chemoradiotherapy. ecog ps score: 0/1/2. exclusion criteria: * lung disease such as lung cancer, tuberculosis, and lung infections. inhalation anesthesia within 3 months. inhalation medication within 3 months. postoperative laryngeal cancer. concurrent serious uncontrolled medical conditions such as unstable heart disease requiring treatment, poorly controlled diabetes mellitus (fasting blood glucose \> 1.5 x upper limit of normal). participation deemed inappropriate in the judgment of the investigator.
bring-up 3 heart failure

Conditions: Heart Failure

Summary: the aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with heart failure with reduced ejection fraction (hfref); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (hf); - to monitor treatment patterns of all patients with chronic hf irrespective of the level of ejection fraction (ef).

observational, prospective, multicenter study conducted in a large, representative sample of italian cardiology centers. phases 1: 1. first educational intervention to discuss the recommendations of guidelines and treatment patterns in specific phenotypes of patients. 2. data collection for 3 months or up to 30 consecutive patients with chronic hf or acute hf (both de novo and worsening). 3. evaluation of the primary and secondary end-points of the study at 6 months after enrollment. modifications of treatments will be monitored during the 6 months follow-up. 4. second educational intervention to share the results of the first enrollment period of the study focusing the attention on existing gaps between guidelines recommendations and clinical practice. 5. new data collection for other 3 months or up to 30 consecutive patients with chronic hf or acute hf (both de novo and worsening). 6. additional evaluation of the primary and secondary end-points of the study at 6 months after enrollment. modifications of treatments will be monitored during the 6 months follow-up. 7. 12-month follow-up for all patients included in both enrolment phases of the study.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old. 2. males and females at birth. 3. any ejection fraction level (level of ejection fraction measured in the 6 months preceding enrollment). 4. ambulatory chronic hf or hospitalized de-novo or worsening hf. 5. signed informed consent diagnosis will be made by the local attending physician following the esc guidelines recommendations. exclusion criteria: 1. active neoplasia or very severe disease compromising short-medium term life expectancy. 2. participation in interventional studies. 3. patients already enrolled into the study from another participating center or in the previous enrolling phase.