Kornimate/medical-research-clean huggingface dataset:
diet, obesity and genes (diogenes)

Conditions: Obesity; Metabolic Syndrome; Type 2 Diabetes; Cardiovascular Disease

Summary: study title: diogenes, a randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.

diogenes is a randomised controlled dietary intervention study in obese/overweight families (adults and children) in 8 different european countries, testing the efficacy and safety of diets differing in glycaemic index (gi) and protein content. the 8 centres are divided into "shop centers" and "instruction centers", that provide different kind of dietary intervention and for a different length(see below): the 2 shop centers (denmark \& the netherlands): dietary periods and clinical examinations: 1. clinical examination 1 with anthropometry, blood etc. 2. 8 week low calorie diet (lcd) period (800-1000 kcal/day)(adults only) 3. clinical examination 2 with anthropometry, blood etc. 4. 6 months dietary intervention period 1 (supermarket period)(family) 5. clinical examination 3 with anthropometry, blood etc. 6. 6 months dietary intervention period 2 (dietary instruction period)(family). 7. clinical examination 4 with anthropometry, blood ect. 8. 12 months free-living period with no dietary intervention. (family) 9. follow up (only body weight registration) the 6 instruction centers (uk, crete, germany, spain, bulgaria, czech republic) dietary periods and clinical examinations: 1. clinical examination 1 with anthropometry, blood etc. 2. 8 week low calorie diet (lcd) period (800-1000 kcal/day). (adults only) 3. clinical examination 2 with anthropometry, blood etc. 4. 6 months dietary intervention period (dietary instruction period). (family) 5. clinical examination 3 with anthropometry, blood etc. 6. 6 months free-living period with no dietary intervention. (family) 7. follow up (only body weight registration) note that, during the first 6 month intervention all families from the shop centers are provided all foods free of charge "supermarket period", whereas in the "instruction centers", the families receive dietary instruction only "instruction only".

Eligibility criteria:
inclusion criteria: * families with healthy adults and children exclusion criteria: * various

Keywords: diogenes diet intervention family glycemic index protein
quality of life assessment before and after essure removal

Conditions: Patients Presenting Essure Device Attributed Symptoms

Summary: to evaluate quality of life before and after laparoscopic removal of the essure® system. women who complain about symptoms attributed to the essure® device are expected to have an improved quality of life postoperatively.

tubal sterilization is a widely used method of contraception. the hysteroscopic sterilization method (essure®; bayer, germany) was approved in 2007 in france. increasing patients reports of complications, such as bleeding pain, allergies, fatigue or articular pain have raised concerns about the safety device. women suffering of alleged complications of the essure® device ask for surgical removal. but, only few studies have assessed essure® removal in terms of quality of life. this observational study contains two parts will be conducted at two academic tertiary care center (montpellier - marseille): * a prospective part having received a favorable opinion from a committee for the protection of persons, * and a retrospective part having received a favorable opinion from the institutional review board (irb), local ethics committee patients: women requesting surgical management for removal of essure® for alleged adverse effects. assessment tools : quality of life with the short form 36 (sf-36) health survey questionnaire (pre-operatively and at 1 and 3 months) hospital anxiety and depression (had) scale (pre-operatively and 3 months) preoperative imaging, procedure characteristics, including the essure® removal method, operative findings, perioperative complications, histopathologic report, and length of hospital stay will be collected.

Eligibility criteria:
inclusion criteria: * patients carrying essure® * patients requesting surgical removal of essure® * patients with adverse effect * being affiliated or benefiting from a french social security system exclusion criteria: - patients with guardianship or curators

Keywords: adverse effects salpingectomy essure® device ablation cornual resection
tablet-based aphasia therapy in the acute phase after stroke

Conditions: Aphasia; Stroke, Acute

Summary: as aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits, it is now thought that intensive aphasia therapy is effective, even in the chronic phase following stroke. however, as intensive aphasia rehabilitation is difficult to achieve in clinical practice, tablet-based aphasia therapies are explored to further facilitate language recovery. although there is mounting evidence that computer-based treatments are effective, it is also important to assess the feasibility, usability and acceptability of these technologies, especially in the acute phase post stroke. the investigators assume that tablet-based aphasia therapy is a feasible treatment option for patients with aphasia in the acute phase following stroke. the researchers also believe that the specific app that will be used in therapy is user-friendly and that it will be well accepted by this specific patient population.

the study is a prospective study, with each participant undergoing testing approximately within three days after inclusion in the study (immediately prior to tablet-based aphasia therapy). based on the results of diagnostic testing (standard of care in the acute phase), therapy will be tailored for each individual. after two short training sessions, patients will independently practice with the app during hospitalisation, guided by a user-friendly instruction sheet. patients will be encouraged to practice as much as possible, with a minimum of 30 minutes per day. exercises will be selected by the speech-language therapist based on diagnostic results and will be adjusted for difficulty and type of exercise during treatment based on performance rates. the aim of the study is to investigate the feasibility, usability and acceptability of a tablet-based aphasia therapy in patients with aphasia in the acute phase following stroke.

Eligibility criteria:
inclusion criteria: * diagnosed with aphasia after an ischemic or hemorrhagic stroke * maximum 2 weeks post-stroke * minimum 18 years old * a minimum proficient language level of dutch * imaging (ct or mri) prior to inclusion * signed informed consent exclusion criteria: * presence of severe psychiatric disorders and/or cognitive disorders that hinder the use of the tablet-based aphasia therapy
solution-focused mindfulness: impact on students' self-esteem, mindfulness, and anxiety

Conditions: Healthy

Summary: students have some problems related to stress and anxiety during their university years when they go through important transitions and change processes in their lives. in this sense, mindfulness program based on solution-focused approach is considered to raise the mindfulness levels of students, reinforce their self-esteem, and lower their anxiety levels. therefore, this study comprehensively examined the effects of mindfulness program based on solution-focused approach on the self-esteem, mindfulness levels, and anxiety of university students. a significant difference was found between the scores of the students before and after the program on their trait anxiety levels, mindfulness, and self-esteem levels. in this case, it could be asserted that the mindfulness program based on the solution-focused approach had positive effects on their self-esteem, mindfulness, and anxiety levels of the students.


Eligibility criteria:
inclusion criteria: * to be a third and fourth year student of samsun ondokuz mayıs university faculty of education, * not working in a private or state institution, * not having a disease that prevents sitting or walking in order to be able to perform the applications, * having anxiety about the future (it will be questioned whether it is present in the preliminary interview) exclusion criteria: * have a diagnosed serious physical illness or chronic disease, * having a diagnosed psychiatric illness, * having experienced the loss of a family member or loved one within the last six months, * history of substance abuse, suicide attempt or self-harm,

Keywords: mindfulness self-esteem, solution-focused therapy anxiety university students
12-month open-label extension study of intepirdine (rvt-101) in subjects with alzheimer's disease: mindset extension

Conditions: Alzheimer's Disease

Summary: this 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (rvt-101) for subjects with alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study rvt-101-3001 (double-blind study).

this 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (rvt-101) for subjects with alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study rvt-101-3001. various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

Eligibility criteria:
inclusion criteria: * completed last on-treatment visit of the lead-in study rvt-101-3001 exclusion criteria: * any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Keywords: alzheimer's disease rvt-101 donepezil
study of surgery in patients with idiopathic macular hole

Conditions: Idiopathic Macular Hole; Surgery

Summary: the purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades.

the purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.

Eligibility criteria:
inclusion criteria: * patients with imh * patients signed the icf * patients with course of imh less than 3 years exclusion criteria: * patients with hyper myopia * patients with traumatic macular hole * accompanied or secondary of other fundus disease * open or reopen after receiving mh surgery * patients with retinal detachment * received vitrectomy due to other diseases * glaucoma cannot be controled by medication * patients with other retinal or choroidal disease that may affect va * poor patients compliance * poor condition that cannot undertake the surgery * dioptric media opacities which make it difficult to exam fundus or measure on oct
methadone oxytocin option

Conditions: Substance Abuse; Opioid Dependence; Methadone Treatment

Summary: the purpose of the study is to examine the effects of intranasal oxytocin administration on social cognition in patients receiving methadone maintenance treatment (mmt), examine the effects of intranasal oxytocin administration on opioid craving and on the subjective effects of methadone, and examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in patients receiving mmt. hypothesis 1: patients will perform better on measures of social cognition (including affect recognition and recognition of sarcasm) after administration of oxytocin compared with placebo. hypothesis 2: patients will demonstrate lower craving for opioids and greater subjective effects of methadone after administration of oxytocin compared with placebo. hypothesis 3: patients will demonstrate increased implicit preferences for social stimuli and decreased implicit preferences for drug related stimuli after administration of oxytocin compared with placebo.


Eligibility criteria:
inclusion criteria for patients: * primary diagnosis of opioid dependence according to dsm-iv tr * opioid of choice be either heroin or oral opioid analgesics * currently be on stable dose of methadone with no dose change in the last 14 days inclusion criteria for healthy volunteers -no diagnosis of mental disorder according to dsm-iv tr exclusion criteria for patients and healthy volunteers: * epilepsy * current illicit drug use (within the past one month) * current sever depression with suicidal thoughts and/or actions * addiction to alcohol or drugs other than opiates, caffeine, or nicotine * psychotic illness * bipolar disorder * brain trauma * severe neuropsychological disorder * kidney disease (i.e., kidney stones, recurrent bladder infections, or known kidney failure) * sensitivity to preservatives (in particular e216, e218, and chlorobutanol hemihydrate) * nasal obstruction, discharge, or bleeding * cardiovascular problems (e.g., heart disease, history of heart attacks), high blood pressure (hypertension) * habitually drink large volumes of water

Keywords: oxytocin syntocinon social cognition social approach behaviors
emg response in forearm and neck muscles when comparing surgical techniques.

Conditions: Surgical Fatigue

Summary: surgeons are performing an increasing number of minimal access procedures because these offer certain advantages including improved recovery times. however, this also results in surgeons operating for longer periods which inevitably increases the already known prevalence of work-related musculoskeletal (msk) injuries amongst surgeons. work-related msk disorders account for 26 - 47.5% of illnesses and injuries due to overexertion and repetitive use, in professionals with ergonomically challenging jobs. robotic-assisted laparoscopic surgery (rals) is a modern technology that could help mitigate these msk problems and thereby improve patient care. in comparison to standard laparoscopic surgery (ls), rals offers steadier wrist movements with a reduced fulcrum effect, thus benefiting the patient. no study has compared the demands of rals vs. ls on musculoskeletal fatigue (and subsequent injury risk). the investigators need to determine whether a career using rals is associated with better musculoskeletal health of surgeons than standard ls when performing complex minimally invasive procedures. the study will recruit surgeons who perform prostate and bowel surgical procedures who have experience using rals and/or ls. surgeons will complete a series of validated questionnaires before and after each surgery to subjectively determine musculoskeletal strain/pain and will have body composition quantified. they will be fitted with emg (to measure muscle fatigue) whilst performing real-life surgery. analysis of data gathered will be used to show what the short- and long- term musculoskeletal demands are and in turn determine if these are associated with changes in motor control. the researcher's postulated hypothesis is that rals should have less musculoskeletal effects both short and long term on surgeons, therefore, highlighting the fact that the implementation of rals should be less controversial, because in the long run, the most expensive objects in the operating room are the personnel.


Eligibility criteria:
inclusion criteria * either a laparoscopic or robot-assisted laparoscopic surgeon. * good musculoskeletal health. * adult. exclusion criteria: * procedures with major complications (above 50% more time than the average for that surgery). * significant co- morbidities that could affect the results of the study. significant symptoms of musculoskeletal disorder. * anything the investigator feels will affect the study's measurements of safety.

Keywords: fatigue laparoscopic surgeon wellbeing robotic surgery emg
comparison of preoperative ultrasound guided pectoralis nerve block placement versus intra-operative placement: a prospective randomized trial

Conditions: Post-operative Pain

Summary: this study investigates the use of post-operative on-q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively.


Eligibility criteria:
inclusion criteria: * presenting for breast reconstruction w/ planned two-stage, sub muscular tissue expander placement. exclusion criteria: * pregnant, prisoners, cannot consent, history of chronic pain or pain medication use
the serum angiotensin converting enzyme and lysozyme levels in patients non-infectious and infectious uveitis

Conditions: Sarcoidosis; Tuberculosis

Summary: this study evaluates the significance of differences in serum angiotensin converting enzyme and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and infectious diseases.

increased serum levels of angiotensin converting enzyme and lysozyme are considered as inflammatory markers for diagnosis of sarcoidosis which is an autoimmune inflammatory disease. sarcoidosis, ankylosing spondylitis and behcet's disease are the most common autoimmune inflammatory diseases involving the eye. elevated serum angiotensin converting enzyme levels have also been reported in tuberculosis. syphilis and tuberculosis are the most common infectious diseases involving the eye.

Eligibility criteria:
inclusion criteria: * subjects have ocular inflammation diagnosed as sarcoidosis, ankylosing spondylitis, behcet's disease * subjects have ocular infection diagnosed as tuberculosis and syphilis * subjects have refractive errors only exclusion criteria: * subjects using ace inhibitors, systemic steroids, immunosuppressive or immunomodulatory therapies

Keywords: angiotensin converting enzyme lysozyme ankylosing spondylitis behcet's disease sarcoidosis syphilis tuberculosis ocular inflammation
cost of adverse events related to how often follow-up occurs among patients with cancer that has spread

Conditions: Melanoma

Summary: this study is a real-world retrospective claims analysis to assess and compare ae-related hcru and medical costs among patients with different follow-up frequency after initiating a melanoma therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with metastatic melanoma * initiated at least 1 treatment for metastatic melanoma after 2011 * continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date * patients who received at least 1 dose of study drug in ca209-067
exercise consultation for type 2 diabetes patients in real life

Conditions: Diabetes Mellitus, Type 2

Summary: the prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide, in france and especially in the french west indies.this chronic disease is associated with premature mortality and various debilitating complications which can be prevented by optimal control of glycaemia, blood pressure and lipids. diabetes management includes lifestyle modification and medication. despite numerous studies supporting the benefits of frequent physical activity for people with type 2 diabetes, an estimated 60±80% of this population remain sedentary. promotion of physical activity in current diabetes care seems to be inadequate. the aim of this randomized controlled trial is to evaluate the medium-term effectiveness (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 dm diagnosed within 10 years prior the inclusion * 18-70 years old * signed written informed consent * diabetes treatment regimens : * diet only * oral antidiabetic drug * oral antidiabetic drugs with long acting insulin analog * oral antidiabetic drugs with glp 1 analog exclusion criteria: * minors * patients with concurrent medical conditions preventing exercise * pregnancy or intention to become pregnant during the study * inability to read and write french * history of participating in our education program during the past two years * usual sporty activities * change in diabetes treatment during the three months prior to study enrollment * no written informed consent

Keywords: diabetes
effectiveness of feswt in the treatment of cts

Conditions: Carpal Tunnel Syndrome

Summary: the carpal tunnel syndrome (cts) is the most common entrapment neuropathy in the general population.the focus extracorporeal shock wave (fewst) is a non invasive treatment for various diseases. feswt is new and potential treatment for peripheral nerve entrapment/ peripheral neuropathy . but there is still little known about the effects and long term effects of feswt in the treatment of cts.

the aim of this study is to determine the effectiveness of feswt in patients with carpal tunnel syndrome compared to participants receiving only night splint. therefore 40 patients with mild to moderate cts (verified by nerve conduction velocity) will be randomized to receive either feswt (1-session a week for 3 weeks) or sham feswt(1-session a week for 3 weeks). all subjects will be asked to wear night splints. evaluation will be performed at baseline (vas, hand grip, electrodiagnostic parameters, questionnaires), 3 weeks (vas, hand grip, questionnaires), 12 and 24 weeks (vas, hand grip, electrodiagnostic parameters, questionnaires) after treatment.

Eligibility criteria:
inclusion criteria: - mild to moderate cts verified by nerve conduction velocity exclusion criteria: * metabolic diseases * blood clotting problems * systemic diseases * polyneuropathy * chemotherapy during the study * corticosteroid therapy * use of anticoagulation * history of trauma/surgery or nerve lesion of the teated extremity * cts surgery on the affected hand * icd/ pacemaker implantation * other therapy for the affected hand during the study * acute inflammation or infections * severe mental illnesses/psychiatric diseases * severe neurological diseases

Keywords: focused extracorporeal shock wave therapy
contrast-induced nephrotoxicity as assessed by the kidney load-to-damage relationship

Conditions: Contrast Induced Acute Kidney Injury

Summary: we previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, ldr) characterizes the intrinsic nephrotoxicity of the contrast. aim of the present study is to compare, through the assessment of the ldr slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-c changes as the ldr dependent variable.

we previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, ldr) characterizes the intrinsic nephrotoxicity of the contrast and it may allow for reliable comparative evaluations among small sized study groups randomized to different contrast media. the aim of the present study is to compare, through the assessment of the ldr slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-c changes as the ldr dependent variable.

Eligibility criteria:
inclusion criteria: * patients candidate to coronary angiography and/or angioplasty and * baseline creatinine clearance \< 60 ml/min exclusion criteria: * patients with stemi * patients with shock * known allergy to contrast media * prior contrast administration within 1 month * current use of nonsteroidal anti-inflammatory drugs

Keywords: acute kidney injury contrast media cystatin-c