Kornimate/medical-research-clean huggingface dataset:
corelab remotely echocardiographic imaging acquisition in cardiac resynchronization therapy candidates

Conditions: Heart Failure

Summary: purpose of the observational study is to assess the capability of a satellite tele-echocardiography (ste) system to acquire and transmit echocardiographic images and clips to an echocardiographic core laboratory (ecl) in a real time mode without loss of quality. additionally the prognostic efficacy of specific echo parameters in the cardiac resynchronization therapy response will be evaluated.

corelab-crt is a prospective multi center italian observational study. all echo images and clips will be transmitted by using an integrated satellite transmission system. all echo assessments performed in accordance to the centers clinical practice will be also used to investigate the prognostic efficacy of echo parameters in term of response to the cardiac resynchronization therapy (crt). all commercially available multi-chamber crt-d devices from any manufacturers are allowed in this observational study. any compatible market released right atrial, right ventricular and left ventricular lead from any manufacturer is allowed. the echocardiography device models used to perform echo imaging for all patients participating in this analysis are ge vivid 7, ge vivid 9 and ge vivid i, according to the model used in the clinical practice of the hospital.

Eligibility criteria:
inclusion criteria: 1. nyha class ii, iii and ambulatory iv with: * qrs complex duration ≥120msec; * ejection fraction ≤35%. 2. optimized medical treatment; 3. patient in sinus rhythm; 4. patient is willing and able to sign an informed consent form. exclusion criteria: 1. unstable angina, or acute myocardial infarction, coronary-aortic bypass graft or percutaneous transluminal coronary angioplasty within the past 3 months; 2. cerebral vascular attacks or transient ischemic attack within the last month; 3. chronic atrial arrhythmias, paroxysmal atrial fibrillation events; 4. patients already implanted with an icd or a crt device; 5. pacemaker dependency or ventricular pacing percentage ≥10%; 6. valvular disease with an indication for surgical correction ≤12 months survival expectancy; 7. mechanical right ventricular valve; 8. patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints; 9. pregnancy or breastfeeding; 10. previous heart transplant; 11. refusal of study informed consent; 12. expected lack of compliance during follow-up; 13. patient is less than 18 years of age; 14. patient's life expectancy is less than 6 months in the opinion of physician.

Keywords: cardiac resynchronization therapy satellite tele-echocardiography
a continuation study of the aeriseal® system administered at 3 to 4 sites during a single treatment session for lung volume reduction in patients with advanced emphysema

Conditions: Pulmonary Emphysema; Chronic Obstructive Pulmonary Disease(COPD); Lung Diseases

Summary: the purpose of this study is to assess the long term safety and efficacy of aeriseal system treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.

emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. the most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come. the aeriseal system is a novel device system being developed for the treatment of advanced emphysema. the aeriseal system is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

Eligibility criteria:
inclusion criteria: * patients must have been enrolled in the 03-c10-002plv aeris' investigational study and completed a minimum of 12 weeks of follow-up following aeriseal system treatment.

Keywords: polymeric lung volume reduction (plvr) bolilogic lung volume reduction (blvr) aeriseal treatment device breathing copd emphysema heterogeneous homogeneous pathologic processes respiratory tract diseases lung diseases pulmonary disease, chronic obstructive
cohort of peripheral t cell lymphoma

Conditions: Lymphoma, T-Cell, Peripheral; Febrile Neutropenia

Summary: prospective, observational cohort study of peripheral t cell lymphoma. purpose is to investigate the complication including febrile neutropenia in the era of pegylated g-csf prophylaxis.

prospective evaluation of frequencies of febrile neutropenia or infectious complications in a homogeneous population of patients with peripheral t cell lymphoma

Eligibility criteria:
inclusion criteria: 1. treatment naive peripheral t cell lymphoma subtypes are as followings: anaplastic large cell lymphoma angioimmunoblastic t cell lymphoma peripheral t cell lymphoma-nos enteropathy-associated t cell lymphoma hepatosplenic t-cell lymphoma subcutaneous panniculitis-like t-cell lymphoma primary cutaneous gamma-delta t-cell lymphoma primary cutaneous cd8+ aggressive epidermotropic lymphoma 2. scheduled to receive chemotherapy of curative intent 3. 19 years old or over 4. expected survival is more than 6 months 5. informed consent exclusion criteria: 1. other histology than those described above * extranodal nk/t cell lymphoma * other than peripheral t cell lymphoma 2. other combined malignancy 3. previous history of chemotherapy or radiation therapy 4. no informed consent
chewing muscles in bruxers

Conditions: Bruxism

Summary: the aim of this study was to determine the relationship between autonomic nervous system activity and tonus, stiffness and elasticity of temporalis and masseter muscles in individuals with bruxism and to compare them with healthy controls.

individuals diagnosed with bruxism and healthy individuals as a control group will be included in the study. firstly, the purpose of the research and evaluation methods will be explained to the participants. individuals who volunteer to participate in the study and meet the inclusion criteria will be included. approval will be obtained from the individuals to be evaluated with the 'informed voluntary consent form'. individuals will then fill in the descriptive data form. the intensity of pain in the masticatory muscles of all participants at rest and during chewing will be measured by visual analogue scale, autonomic nervous system activity (heart rate variables) will be measured by polar h10 chest strap, and the tonus, stiffness and elasticity of the temporalis and masseter muscles will be measured by myoton device. the evaluations are planned to take an average of 20 minutes for each participant. the evaluations of the participants will be made only once and will not be evaluated again.

Eligibility criteria:
inclusion criteria: * diagnosed with bruxism between the ages of 18-65, * a history of bruxism for at least 6 months, * individuals with masseter muscle pain ≥4 at rest and during mastication * control group: healthy individuals aged 18-65 years exclusion criteria: * masseter botox application in the last 6 months, * with regular use of analgesics and anti-inflammatories affecting the oss, * smokes 20 or more cigarettes daily, * with regular alcohol use of 1-2 glasses per day, * daily coffee consumption of 6 cups or more, * cardiovascular, respiratory and central nervous system diseases, * presence of infection or tumoural structures within intraoral structures, * multiple ear piercings, * with tmj disc displacement and joint degeneration, * cervical or tmj fracture, systemic disease, musculoskeletal problem with evidence of specific pathological condition, * any surgical operation related to cervical or tmj problem, * less than 6 months of cervical or tmj-related physiotherapy and rehabilitation services, * the one with facial paralysis, * diagnosed psychiatric illness * participants who have communication difficulties in speaking and understanding turkish or who are unable to understand the exercises

Keywords: autonomic nervous system bruxism masseter
effectiveness of a pre-adolescent inter-generational intervention to address hiv and obesity

Conditions: Hiv; Obesity

Summary: the study evaluates an intervention, the circle of life initiative, which was developed to address hiv and obesity prevention. we evaluated whether the combined hiv and obesity intervention increased knowledge, enhanced skills, and/or promoted healthy behaviour among pre-adolescent students (9-12 years old) and their parents.

the circle of life initiative had both a school and home component, each comprising a learning curriculum, environmental support, and activity-based constituents that aimed to increase student knowledge and skills, and to engage parents. trained educators delivered lessons about hiv and obesity to all grade 6 students at 5 government-run schools. the classroom curriculum for students required delivery of a five-hour face-to-face intervention delivered weekly through 10 30-minute lessons. students were asked to communicate their learnings to their parents at home. parents were requested to read through the lesson in a workbook and to sign acknowledgement that they had read the content. the workbook contained shared student-parent homework activities that took approximately 30 minutes per week.

Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: inter-generational outcomes pre-adolescents
weight gain and adipose tissue

Conditions: Obesity

Summary: this study aims to examine the role of weight gain in adipose tissue immune cell influx and development of obesity related cardiometabolic disorders. adipose tissue-mediated chronic systemic inflammation is implicated in the development of cardiometabolic disorders in obesity. therefore, resolution of adipose tissue inflammation may be key to ameliorating obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease. proinflammatory cytokines contribute to the initial influx of immune cells into adipose tissue during weight gain. however, mechanisms regulating these cytokines in the adipose tissue milieu and the effects of weight gain on adipose tissue are not completely understood. the study proposes to investigate the molecular events contributing to increased infiltration of macrophages and t-cells into adipose tissue during weight gain. the central hypothesis is that in lean subjects (with low body fat mass), healthy fat gain which is associated with decreased expression of proinflammatory cytokines. however, in obesity (high body fat mass), adipose tissue is altered, which permits increased expression of inflammatory cytokines and further fat gain results in influx of immune cells. to test the hypothesis, adipose tissue from well characterized lean (control, with low body fat) and obese individuals (with high body fat) at baseline and after a modest 5% weight gain will be used. adipose tissue samples after subsequent weight loss will also be examined. for this study, obesity will be defined by body composition rather than body mass index (bmi), as several studies have shown that bmi does not adequately define obesity and several individuals with normal bmi may indeed have high body fat mass. individuals with body fat content ≤25% for men, \& \ 25% for men, ≥35% for women will be considered obese.


Eligibility criteria:
inclusion criteria * age: 18 to 40 (inclusive) years * bmi 18.5 \<30 kg/m2 * gender: both males and females will be allowed to participate in the study * predominantly sedentary * absence of any chronic medical conditions other than seasonal or environmental allergies * on no prescription medications other than second generation antihistamines (cetirizine , fexofenadine, desloratadine, loratadine, etc), oral contraceptive pills, or intrauterine devices * not a current smoker or tobacco user * not pregnant or breast feeding and not intending to become pregnant or breast feed * lean (low body fat mass) (body fat content ≤ 25% for men, \ 25% for men, ≥ 35% for women) n=7 * ability to provide written informed consent exclusion criteria * vulnerable study population will be excluded * presence of chronic diseases such as diabetes, and cardiovascular disease * pregnancy * anemic (hemoglobin \<13.5 g/dl for men and \<12.0 g/dl for women) * postmenopausal * smoking * use of chronic medications (aspirin, statin, anti-inflammatory drugs) * subjects found to have significant sleep disorders will be excluded * dietary restrictions including lactose intolerance, and vegan diet * eating disorders that may interfere with weight gain and weight loss
metabolomics and genetic diagnosing pancreatic neuroendocrine tumors in men1 patients

Conditions: Multiple Endocrine Neoplasia

Summary: objectives: the aim of the present study is to assess the significance of metabolomics and genetics in diagnosing and survival evaluation for pnet in the periodic follow-up of men1 patients. aim 1: to evaluate the relationship of serum global metabolic profiles with subsequent development of aggressive pnet and evaluate patients survival in a nested case-control study of men1 patients who have developed aggressive pnets (cases) and men1 patients who have developed non-aggressive pnets (controls). aim 2: validate the top serum metabolites identified from aim 1 in men1 patients who have developed aggressive pnets and men1 patients who have developed non-aggressive pnets, using a targeted metabolomics approach. aim 3: prospectively identify the potential mirna biomarkers of serum with mirna sequencing in men1 patients who have developed aggressive pnets (cases) and men1 patients who have developed non-aggressive pnets (controls). aim 4: validate the potential mirna biomarkers identified from aim 1 in men1 patients who have developed aggressive pnets and in men1 patients who have developed non-aggressive pnets, using a targeted qrt-pcr approach (in serums), as well as to see the relationship of potential mirna biomarkers with patients survival.


Eligibility criteria:
inclusion criteria: 1. the study will include all patients with a confirmed men1 diagnosis (clinical, genetic or familial criteria). 2. no prior history of pnet. exclusion criteria: n/a

Keywords: multiple endocrine neoplasia men1 aggressive pancreatic neuroendocrine tumors pnet non-aggressive pancreatic neuroendocrine tumors metabolomics genetics biomarkers
dextromethorphan, memantine monotherapy, or combined use of dextromethorphan and memantine in amphetamine addiction

Conditions: Amphetamine Addiction; Pharmacotherapy

Summary: the investigators will conducted a randomized double-blind placebo-controlled study to investigate the treatment outcomes of add-on low dose dextromethorphan (dm), memantine (mm), or dextromethorphan and memantine combination (dm+mm) in amphetamine-type stimulants use disorder patients.

the investigators will conducted a randomized double-blind placebo-controlled study to investigate the treatment outcomes of add-on low dose dextromethorphan (60mg/day, dm), memantine (5 mg/day, mm), or dextromethorphan (60mg/day) and memantine (5mg/day) combination (dm+mm) in amphetamine-type stimulants use disorder patients. the investigators will recruit 120 patients with atsud in three years and allocate participants to add-on dm, mm, dm+mm or placebo group in a 1:1:1:1 ratio (participants will also undergo usual psychosocial interventions).the investigators will follow up the participants for 12 weeks and measure the treatment responses, urine drug tests, craving scales and side effects to evaluate the therapeutic effects of add-on dm, mm, or dm+mm. neuropsychological assessments, tests for inflammatory parameters and neurotrophic factors, and brain functional magnetic resonance imaging (fmri) will also be evaluated during 12-weeks follow up.

Eligibility criteria:
inclusion criteria: 1. signed informed consent by patient or legal representative. 2. male or female patient aged ≧20 and ≦65 years. 3. a diagnosis of atsud according to dsm criteria made by a specialist in psychiatry. 4. patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study. exclusion criteria: the presence of any of the following will exclude a patient from study enrollment: 1. women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study. 2. females who are pregnant or lactation. 3. other major axis-i dsm-iv diagnosis other than atsud, except for tobacco use disorder, ats induced mood or psychotic disorders. 4. current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation. 5. history of allergy or intolerable side effects of dm or mm. 6. suicidal attempts or risks during screen or study period. 7. presence of active infectious or autoimmune disease.

Keywords: amphetamine-type stimulants use disorder, dextromethorphan, memantine, inflammation, neurodegeneration, functional magnetic resonance imaging
non-invasive brain modulation for weight maintenance

Conditions: Obesity

Summary: this is a study of overweight men and women. everybody will receive a very low calorie diet to eat in place of meals for 10 weeks. during the last two weeks of the diet, half of the patients will receive an intervention to activate parts of their brain that can help them eat less. the other half of the patient will receive a placebo or sham intervention. the intervention will involve a small electric current given every day for 10 days. everybody will be monitored for 16 more weeks (total of 26 weeks) while on a weight maintenance diet to see if the intervention helps people keep the weight off.


Eligibility criteria:
inclusion criteria: 1. men and women age 20-55 years old 2. bmi 30-50 kg/m2 3. willing to undergo 10 week supervised vlcd exclusion criteria: 1. obesity due to a known secondary cause (cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery 2. subjects who have a known history of diabetes, fasting blood sugar \>125 mg/dl or using any anti-diabetic drugs 3. changes in lipid lowering or anti-hypertensive regimen within 3 months of screening 4. hemoglobin \ 1.5 mg/dl 5. qt interval \>440 ms on ekg 6. subjects with unstable psychiatric conditions as assessed by a psychologist 7. allergy or intolerance to components of the mixed meal challenge 8. additional contraindications to receive transcranial direct current stimulation (tdcs): 1. personal or family history of seizures, epilepsy or other unexplained loss of consciousness. 2. current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.). 3. prior neurosurgical procedure or radiation treatment to the brain. 4. known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis 5. implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, tens unit, ventriculoperitoneal shunt or any metallic implant on the head. (note: intake of centrally acting medications will be allowed, as there is no evidence that any medication can increase the risk of adverse effects during tdcs.) 9. subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit 10. any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient
identify possible errors on home use blood pressure monitors by usability reasoning

Conditions: Hypertension

Summary: medical devices are designed and manufactured by subjective design process that was only based on engineers' direct concepts to essential principles sets for the device. a home user may not easily use or operate the piece of medical device through the interfacing components as the designer's expected such as the meaning when pushing a button or switching a knob, even the required procedure needed when a certain display shown to fulfill some knowledge dependent judgment. in addition, the incompatible interfacing designed communication between a user and the device may cause possible errors that may trigger further negative consequences during the use of the device to a innocent home user. the aim of this research is to closely understand the consequent results of human factor engineering or usability engineering practices of various types or models of marketed home-use blood pressure monitors (bpm) in real use.

the aim of this research is to closely understand the consequent results of human factor engineering or usability engineering practices of various types or models of marketed home-use blood pressure monitors (bpm) in real use. participants of the intended user population interact with marketed bpms in research to assess ease of learning, ease of use, effectiveness and efficiency of use, memorability, safety, and/or user appeal among the many possible attributes of interest. with these understanding and analysis of human factors engineering / usability engineering (hfe/ue) practiced status, it can help manufacturers to capture the required and diversified hfe/ue essences with the minimum or limited professional technical resources in hand some more efficiently.

Eligibility criteria:
inclusion criteria: * age between 20-75 years * capable of operating the blood pressure measure machine provided by the study * willing to operate the provided device and accept video taping from shoulder and below * willing to fill the study questionnaire and to provide feedback after use of the device exclusion criteria: * vulnerable population (including pregnant woman, disabled, etc)

Keywords: hypertension device errors human factor engineering usability engineering
corneal changes after crosslinking in keratoconus patients compared to the untreated fellow eye

Conditions: Keratoconus

Summary: the purpose of this retrospective study is to assess corneal changes (keratometry, pachymetry) and change in visual acuity (va) in keratoconus patients after unilateral crosslinking treatment compared to the untreated fellow eye. the corneal measurements obtained preoperatively and 2 to 14 months postoperatively using a pentacam rotating scheimpflug camera are analyzed. furthermore, pre-existing or actual ocular pathology or/and ocular surgeries as potential factors involved in treatment outcome are also evaluated.


Eligibility criteria:
inclusion criteria: * keratoconus patients after unilateral crosslinking treatment exclusion criteria: * morphological changes of the cornea caused be ocular infection or trauma (e.g. corneal scarring) * other pre-existing corneal surgery (e.g. corneal transplantation, implantation of intrastromal corneal ring segments)

Keywords: crosslinking keratoconus keratometry pachymetry pentacam