Kornimate/medical-research-clean huggingface dataset:
sleep, upper airway and dental occlusion in children with large overjet

Conditions: Overjet, Dental

Summary: this project examines sleep (e.g. prevalence of obstructive sleep apnea(osa)), dimension of upper airway, jaw function, well-being and quality of life in children with large overjet compared to a control group. in addition, the effect of treatment with a mandibular advancement device (mad) on sleep, upper airway and jaw function are examined, and how these factors affect the children's well-being and quality of life.

sleep is very important for children's growth, development and learning. the anatomy and size of the airway and position of the jaw can affect children's sleep. children with large overjet due to a posterior position of the mandible have smaller airways compared to children with neutral occlusion. reduced dimensions of the upper airways may increase the risk of impaired sleep quality and the sleep related breathing disorder obstructive sleep apnoea (osa), which causes symptoms e.g. failure to thrive, irritability, behavioural disorders, fatigue, which affects the children's growth, development, and learning negatively. children with large overjet due to mandibular retrognathia in denmark are offered orthodontic treatment in municipal dental care and are in most cases treated with a mandibular advancement device (mad) keeping the mandible in a forward position relative to the maxilla. mads are also used to treat adults with mild-moderate obstructive sleep apnoea while they sleep. this can reduce the number of apnoea periods by up to 75% as well as preventing daytime sleepiness. no previous study have examined sleep, upper airway, jaw function, well-being and quality of life in children with large overjet before, during and after mad treatment compared to a control group with normal occlusion.

Eligibility criteria:
inclusion criteria: overjet group: * horizontal maxillary overjet ≥ 6 mm and need of orthodontic treatment according to the danish procedure for screening the child population for malocclusion involving health risk. * informed consent from parent(s)/guardian(s) control group: * neutral occlusion * no history of orthodontic treatment * informed consent from parent(s)/guardian(s) exclusion criteria: * known general and/or craniofacial syndromes/diseases * known sleep disorders, included bruxism during sleep * chronic respiratory diseases and asthma6/12 * adenoid vegetations, hypertrophic tonsils and significantly reduces airflow through the nose (mouth breather), which need primary treatment. * dysfunction of masticatory muscles and temporomandibular joint, which need primary treatment.

Keywords: sleep upper airway dental occlusion jaw function overjet children adolescents
biomechanical mechanism of the change of the gait touch information after acl rupture

Conditions: Anterior Cruciate Ligament Injuries

Summary: high incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. acl injury is an ideal clinical model for studying knee osteoarthritis. to clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.

the purpose of this study is to identify the characteristics of the disease, diagnose the disease by computer and evaluate the rehabilitation based on gait touch information after acl rupture and reconstruction, combined with the methods of multi-body dynamics, machine learning and biomechanics analysis. methods: 55 healthy volunteers, 55 patients with acl rupture were recruited. three dimensional gait analysis and dynamic plantar pressure were used to test the kinematic and dynamic data of lower limbs and gait touch information when walking, jogging, stopping and jumping, and running side cutting. outcome evaluation indexes and statistical methods: the following indexes were measured repeatedly by two factor anova method, and the left and right sides and different rehabilitation time were used as the variables of repeated measurement: the biomechanics of the lower limb joint and the change of the biological characteristics of gait touch information were analyzed. to study the biomechanical status of different knee joints and the mechanism of the change of gait touch information. finally, based on the information of gait touch, a biomechanical evaluation model of knee joint during walking or jogging is established, which provides the exact basis for quantifying and evaluating the biomechanical state of knee joint under the dynamic load-bearing state of gait touch information.

Eligibility criteria:
inclusion criteria: * 18-35 years old * patients who have isolated acl injury and receive acl reconstruction surgery at peking university third hospital. * with isolated acl injury (an acl injury with no need for surgical repairs to other knee structures). * all participants have no known disorders or diseases other than acl rupture. exclusion criteria: * cognitive impairment * other injuries affecting movement performance.

Keywords: anterior cruciate ligament gait analysis plantar pressure multi-body dynamics modeling
quantitative in vivo biomarkers of oxidative stress in diabetes

Conditions: Type 2 Diabetes; Oxidative Stress

Summary: oxidative stress has been implicated in the development and complications of diabetes. hyperglycemia and insulin resistance or insufficiency in diabetes can cause oxidative stress by excessive reactive oxygen species and can increase damage and alter antioxidant status in nerve cells. antioxidant defense mechanisms protect against damage or restore oxidative damage. glutathione, a powerful antioxidant plays a key role in the first line of antioxidant defense and seems to be a sensitive indicator of oxidative stress in various diseases such as diabetes. glutathione functions in the regeneration of vitamin c which is another crucial antioxidant. both hyperglycemia and insulin insufficiency inhibit uptake of vitamin c. the brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin c will be studied.

the brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin c will be studied.

Eligibility criteria:
inclusion criteria: * 30-55 years of age * diabetic being treated with diet and any of the following: insulin, or other diabetic specific drug such as metformin, sulfonylurea or sitagliptin. * healthy subjects age and gender matched to diabetes patient exclusion criteria: * use of any anti-inflammatory or antioxidant medications other than small daily doses of aspirin (asa:325 mg) and a daily multivitamin * co-existing chronic inflammatory conditions such as crohn's disease, rheumatoid arthritis, chronic or acute infections * any concurrent neurological disease except for mild diabetic autonomic or peripheral neuropathy * postmeal c peptide \> 0.3 mg/dl * normal healthy subjects who have any abnormal inflammatory marker, hyperlipidemia, or concurrent disease * diseases associated with abnormal glutathione metabolism * elevated serum creatinine levels, abnormal complete blood count (cbc), abnormal liver function tests or elevated serum homocysteine * morbid obesity * history of hypoglycemic unawareness * pregnant women and women who are breastfeeding * patients with poor venous access * smokers * subject who consumes an excess of alcohol or abuses drugs * history or or presence of bleeding disorder or use of anticoagulant drug * history of oxalate renal calculi

Keywords: diabetes mr imaging vitamin c
pilot study of b-type natrieutic peptide (bnp) levels in patients with congenital heart disease(bnp)

Conditions: Congenital Heart Disease; Cardiovascular Disease

Summary: the object of this study is to measure the levels of b-type natriuretic peptide (bnp) in patients with congenital heart disease, normal individuals, and patients with acquired heart failure, and compare the results from each group.

enrollment: patients with congenital heart disease seen at emory clinics, adult congenital heart disease program, crawford long hospital will be asked to participate in this pilot study. sample size: 20 patients (5 in each group) screening phase: demographic data, medical history, physical examination including vital signs and room air oxygen saturation, and medications will be recorded. new york heart association functional class will be recorded. bnp levels: approximately 7 cc of blood will be collected. the blood will be analyzed for b-type natriuretic peptide on a rapid assay in the clinic. exercise tolerance: will be measured by a 6 minute walk test on day of visit echocardiogram: a complete echocardiogram including assessment of anatomy, ventricular function and valvular function will be performed following the phlebotomy. quality of life: the minnesota living with heart failure questionnaire will be administered on the day of collection of neurohormonal levels. a research nurse will be available to assist the patient if needed.

Eligibility criteria:
inclusion criteria:patients with a systemic right ventricle and a subpulmonic left ventricle-including patients with transposition of the great arteries (d-tga) who have undergone mustard and senning repairs (atrial switch procedures) and patients with congenitally corrected tga (l-tga) subpulmonic right ventricle in the absence of pulmonary hypertension (repaired tetralogy of fallot, congenital pulmonic regurgitation) 4-chambered heart age \> 18 years participants will have either acquired left ventricular dysfunction (ejection fraction \< 35%) or no known cardiac disease for the control group, individuals will have normal cardiac anatomy and normal left ventricular function (determined by echocardiogram) and no known cardiac disease. exclusion criteria: single ventricle and or single atria liver disease with portal hypertension renal disease requiring dialysis creatine \> 4.0 significant pulmonary hypertension (systolic pap \>60 mmhg by echo) uncontrolled systemic arterial hypertension (systolic \> 200 mmhg or diastolic \>105 mmhg) myocardial infarction or acute coronary syndrome within 2 months d-tga status post atrial switch procedure (jatene) intracardiac shunts inadequate echocardiogram windows coronary angioplasty 30 days

Keywords: congenital, bnp
systemic and local inflammatory biomarkers in the treatment of refractory diabetic macular edema

Conditions: Diabetic Macular Edema; Inflammation

Summary: the current study aims to investigate the relationship between systemic inflammatory biomarkers and local inflammatory biomarkers on oct in patients with treatment resistant diabetic macular edema(dme) and further explore the associations with treatment outcomes.

this study was designed as a prospective open-label non rondomised observational study. the study was registered between april 18, 2022 and october 18, 2023. it is planned to include 80 volunteer patients over the age of 18 who are being followed up with the diagnosis of naive dme in the retina department of prof dr cemil tascioglu city hospital and had poor response to the 3 consecutive initial monthly intravitreal bevacizumab loading dose. it was planned to evaluate systemic and local(oct biomarker) inflammatory biomarker levels before swiching intravitreal agents, which may include intravitreal ranibizumab or intravitreal dexamethasone implant. the markers planned to be checked in blood samples are: il-6, il-8, tnf-a, icam-1, mcp-1, vegf, hba1c, crp, esr, haemogram, creatinine, ast, alt, cholesterol. patients were followed up monthly for 3 months after the switching. it was aimed to evaluate the level of systemic inflammatory biomarkers and the associations with treatment effectiveness. in addition, local oct biomarkers (serous macular detachment and hyperreflective foci, etc.) and their relationship with treatment results were examined.

Eligibility criteria:
inclusion criteria: * who had refractory dme after 3 consecutive initial bevacizumab therapy * treatment-naive exclusion criteria: * who had underwent anti-vegf treatment previously * systemic inflammatory disease * who had ocular surgery 6 months prior to enrollment * uncontrolled hypertension * \<18 years old

Keywords: diabetic macular edema biomarkers inflammation optical coherence tomography
study of the acceptability and psychosocial impact of using a telepresence robot in the living space of inpatients

Conditions: Motor Disorders; Cognitive Disability

Summary: this study focuses on the mobile robot assist device for tele-interaction: the "covealink 2" robot. this telepresence robot is designed for remote use inside the home. it works with an internet connection (wifi or 4g). it consists of a control interface (an application installed on the smartphone or tablet of the hospitalized patient) and a mobile robot placed in the home of the hospitalized patient (composed of a mobile platform, a visualization screen whose tilt is adjustable remotely for better adaptation to the interlocutors and an audio communication system). from the app installed on his smartphone or tablet, the patient hospitalized in the center for a long time (2 months minimum) will be able to start remotely (from the center where he is hospitalized) the robot and have it move within his home to communicate with the people present at the time of use (family, friends, neighbors etc.).


Eligibility criteria:
inclusion criteria: * age ≧ 18 years old * affiliation to a social security scheme or beneficiary of such a scheme * having signed a free informed consent in writing * hospitalized in prm for a foreseeable period of at least 60 days * living space compatible with the movement of the robot (verified by a home visit by the center's occupational therapist) and equipped with wifi * cognitive and motor functions compatible with the use of the tablet or phone independently, with learning capabilities to use the robot and the completion of questionnaires and interviews remotely * medically stable exclusion criteria: * subject being in a period of exclusion from another protocol * mood and behavior disorders not stabilized * insufficient command of the french language * protected adults (guardianship / curatorship) * pregnant or breastfeeding women * persons deprived of their liberty * being unable to issue their consent * person who has already presented a form of addiction to technologies and / or video games
plasma extracellular vesicles in meningioma patients

Conditions: Meningioma

Summary: while surgical resection remains the primary treatment approach for symptomatic or growing meningiomas, radiotherapy represents an auspicious alternative in patients with meningiomas not safely amenable to surgery. biopsies are often omitted in light of potential postoperative neurological deficits, resulting in a lack of histological grading and (molecular) risk stratification. in this prospective explorative biomarker study, extracellular vesicles in the bloodstream will be investigated in patients with macroscopic meningiomas to identify a biomarker for molecular risk stratification and disease monitoring.

in total, 60 patients with meningiomas and an indication of radiotherapy (rt) and macroscopic tumor on the planning mri will be enrolled. blood samples will be obtained before the start, during, and after radiotherapy, as well as during clinical follow-up every 6 months. extracellular vesicles will be isolated from the blood samples, quantified and correlated with the clinical treatment response or progression. further, nanopore sequencing-based dna methylation profiles of plasma ev-dna will be generated for methylation-based meningioma classification. this study will explore the dynamic of plasma evs in meningioma patients under/after radiotherapy, with the objective of identifying potential biomarkers of (early) tumor progression. dna methylation profiling of plasma evs in meningioma patients may enable molecular risk stratification, facilitating a molecularly-guided clinical management in meningioma patients in the future.

Eligibility criteria:
inclusion criteria: * confirmed meningioma (histologically or mri/dotatoc-pet ct) * macroscopic tumor in mri (either as definitive rt, or following subtotal resection or relapse) * indication for radiotherapy * completed wound healing after surgical intervention) * alter ≥ 18 jahre * karnofsky performance score ≥ 60% * written informed consent * ability of subject to understand character and individual consequences of the trial * adequate contraception for women of childbearing potential exclusion criteria: * previous or known tumor diseases \< 5 years ago * previous (cerebral) radiotherapy * simultaneous chemo/immunotherapy * evidence that the patient cannot adhere to the study protocol (e.g., non-compliance) * the refusal of patients to participate in the study * participation in another clinical study or observation period in a competing trial
effect of exercise training in lung cancer

Conditions: Lung Cancer, Nonsmall Cell

Summary: to determine the effects of exercise training in patients with lung cancer during chemotherapy treatment. in currently accessible literature, majority studies, met-analysis, and systemic reviews are related to surgical procedures and post-op pulmonary rehabilitation of patients with lung cancer. in literature, gap related to the control group was observed also. the current study aimed to fulfill this gap by planning a structured intervention plan for the control group as well. it will also add in literature the deficiency of oncology rehab for patients receiving chemotherapy only.

literature suggested that a pulmonary rehabilitation program for patients with non-small cell lung cancer undergoing induction chemo-radiotherapy seems to improve respiratory function. it is particularly recommended for smokers and patients with respiratory impairment.

Eligibility criteria:
inclusion criteria: - diagnosed patients of stage 1 and 2 non-small cell lung carcinoma (nsclc) including adenocarcinoma \& squamous cell carcinoma the diagnosis was established within 6 wk prior to enrollment and was confirmed by histology. participants are undergoing lung cancer chemotherapy participant has the willingness to participate in training who physical fitness scores 0-1 able to perform 6-minute walk test (6mwt) at baseline exclusion criteria: * • participant with history of trauma and surgery * patients with lung disease other than lung cancer * uncontrolled hypertension or unstable coronary artery disease. * severe oa, bone or cns metastases. * hemoglobin \<10 g/dl * lower than 3,500 white blood cells per microliter of blood

Keywords: nonsmall cell lung cancer, chemotherapy, exercise training
a phase 2 study of ly2495655 in participants with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of ly2495655 in combination with standard of care chemotherapy.


Eligibility criteria:
inclusion: * unresectable or metastatic pancreas cancer; participants with previous radical surgery for pancreas cancer are eligible after progression is documented * participants may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreas cancer * ecog (eastern cooperative oncology group) performance status ≤ 2 * adequate organ function * have an estimated life expectancy of at least 12 weeks and in the judgment of the investigator, will be able to complete at least 2 cycles of treatment * ability to perform the indicated functional performance measures at baseline exclusion: * prior systemic therapy for unresectable/metastatic pancreas cancer * any medical or psychiatric condition, orthopedic or neuromuscular conditions that could limit participation or confound study results * currently taking medications that are considered both muscle building and performance enhancing (for example, androgen therapies, or anabolic steroids)
ensite precision™ 2.0 registry

Conditions: Cardiac Arrhythmias

Summary: the objective of this registry is to assess and characterize the use and performance of the ensite precision™ cardiac mapping system and the ensite precision™ software v2.0 in a variety of electrophysiological (ep) procedures and clinical settings. this registry will assess the clinical performance of the system in a controlled, real-world environment after commercial release. up to 500 subjects will be enrolled in up to 50 sites worldwide. data will be collected at enrollment/baseline, procedure and pre-discharge. there is no long-term follow-up required for this registry. the anticipated registry enrollment is about 6-7 months.

the use of the ensite precision™ cardiac mapping system will be assessed by collecting feedback from physicians/operators through specific questions. the performance of the ensite precision™ cardiac mapping system will be assessed by collecting procedure data and adverse events. a detailed data management plan will be established to ensure consistency of the data. this document will include procedures used for data review, database cleaning, and issuing and resolving data queries. if appropriate, the data management plan may be updated throughout the registry duration. all revisions will be tracked and document controlled. case report form data will be captured in a validated electronic database management system hosted by st. jude medical. centralized monitoring will occur through routine internal data review. this monitoring is designed to identify missing and inconsistent data, data outliers, and potential protocol deviations that may be indicative of site non-compliance. on-site monitoring may occur at the discretion of the sponsor.

Eligibility criteria:
inclusion criteria: * patients indicated for a cardiac ep study and ablation procedure using a 3d mapping system * over 18 years of age * ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations exclusion criteria: * contraindication to anticoagulation * presence of thrombus * implanted with mechanical prosthetic heart valve * recent (\<3 months) myocardial infarction or unstable angina or coronary artery by-pass * pregnant or nursing * individuals whose willingness to volunteer in a registry, in the judgment of investigator or public authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or mental disability, or adverse personal circumstances, or hierarchical influence