Kornimate/medical-research-clean huggingface dataset:
efficacy of self-hypnosis for weight loss in type 2 diabetics

Conditions: Obesity; Diabetes Mellitus, Type 2; Weight Reduction

Summary: randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics.

study subjects: approximately 74 type ii diabetics will be randomized. key inclusion criteria: overweight (bmi≥25), motivated to lose weight, and are at least 18 years of age. key exclusion criteria: pregnant women or women of childbearing age, currently taking medications for weight loss, enrolled in another clinical trial, or planning on having bariatric surgery. any patient who is taking medication prescribed by a physician for depression, anxiety, or any other psychiatric disorder will be excluded. patients on glucocorticoids in excess of prednisone 7.5 mg or equivalent will also be excluded. study design: all patients who pass screening will be administered the ipq test®\[6\]. this test stratifies patients on how they use their imagination, an important factor necessary to reach their goals. this is predictive of their potential to "persist" toward agreed upon goals. patients will be divided into groups as follows: (raw score 49-96 = high responders; raw score 0-48 = low responders). ultimately, subjects will be divided into four groups: the assignment of "high" versus "low" responders will be based on the results of the ipq® test. subjects will then be randomly assigned to intervention versus control in a 1:1 fashion. optimally, there should be equal numbers in each group; however, the group sizes may be unequal depending on the relative proportions of high versus low responders. the four groups will be as follows: group i (high responders) will receive self-hypnosis using the gift™ (goal image focusing technique)\[7\] as the main means of autosuggestion and self/group motivation to lose weight. group ii (low responders) will receive self-hypnosis (without the gift™ system) and self/group motivation to lose weight. group iii (high responders) will receive standard nutrition, diet, and exercise counseling by a cde (certified diabetes educator) to serve as a control group for group i. group iv (low responders) will receive standard nutrition, diet, and exercise counseling by a cde (certified diabetes educator) to serve as a control for group ii.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * bmi greater than 25 exclusion criteria: * pregnant women of of childbearing age * currently taking weight loss medications * enrolled in another clinical trial * currently taking medications for depression or anxiety * currently taking prednisone \>7.5 mg day

Keywords: obesity diabetes mellitus, type 2 weight reduction
long-term outcomes in terms of disability and quality of life for patients undergoing posterior cranial fossa craniectomy in the context of compressive cerebellar hematoma

Conditions: Craniectomy; Quality of Life; Cerebellar Haematoma; Handicaps Physical; Handicap Mental

Summary: posterior cranial fossa craniectomy has been shown to improve patient survival. the level of autonomy, disability and quality of life of survivors has been little studied and still underresearched,. in this context, an assessment of the level of disability and of the quality of life after performing a posterior craniectomy seems relevant.

investigators are carrying out a retrospective observational, single-center study, in three intensive care units in the grenoble hospital center. every patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at grenoble university hospital between 01/01/2010 and 01/01/2020 were enrolled in this study. the main objective is to assess the level of disability and the quality of life of patients who have had a posterior cranial fossa craniectomy. the primary outcome is the mrs(modified rankin score) measured at least one year following the icu discharge. secondary outcomes are the mrs(modified rankin score) measured at discharge from the rehabilitation department, the gos (glasgow outcome score) measured at least one year following the discharge from intensive care, and the sf36 (the short form 36)from the medical outcome study, score assessing the quality of life, collected via phone call.

Eligibility criteria:
inclusion criteria: * patient who underwent a posterior cranial fossa craniectomy in the context of an acute cerebellar hematoma between january 01, 2012 to january 01, 2020. * adult man or woman * hospitalized in intensive care * no opposition from the patient or a loved one to a telephone contact to determine the sf36 (the short form) quality of life scale, from the medical outcome study. exclusion criteria: * subject under guardianship or subject deprived of liberty * early limitation of active therapy before 48 hours.
study of ono-4578 and xelox/folfox plus bevacizumab in colorectal cancer

Conditions: Colorectal Cancer

Summary: to evaluate the tolerability and safety of combination of ono-4578 and ono-4538 and the standard of care xelox + bevacizumab or the safety of combination of ono-4578 and ono-4538 and the standard of care folfox + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent colorectal cancer.


Eligibility criteria:
inclusion criteria: * unresectable colorectal cancer * life expectancy of at least 3 months * patients with ecog performance status 0 or 1 exclusion criteria: * patients with severe complication * patients are unable to swallow oral medications
uas-rbs: a safety study

Conditions: Refractory Benign Strictures

Summary: a novel stent, called universal partially covered removable self-expanding stent and anchoring system for the treatment of refractory benign esophageal strictures (uas-rbs) was designed to improve the treatment of benign esophageal refractory strictures with a novel stent. this study aims at evaluating the safety of this new device.

refractory strictures are defined as benign esophageal strictures who do not achieve acceptable symptom relief despite an intensive dilation schedule. considering the failure of balloon or mechanical dilation other techniques such as intralesional injection of corticosteroids or stents placement were developed. self-expandable metal stents, plastic stents and biodegradable stents are also used in that indication. in a meta-analysis of 18 studies with 444 patients, clinical success was achieved in 41 percent of patients. stent migration occurred in 29 percent of patients, and adverse events occurred in 21 percent. a self-expending nitinol stent has been design to reduce the migration risk. the stent is partially covered on both extremities, allowing the formation of small hyperplasia in the middle part of the stent. this design with the inner sheet (usually, when using fully covered stents, the sheet is outside) allows formation of hyperplasia (therefore reducing the risk of migration) but partly controlled by the inner sheet to reduce the risk of lumen occlusion. by this design, the balance between hyperplasia formation to avoid the risk of migration and reducing the risk of lumen occlusion could be entailed stable esophageal calibration. the uas-rbs system is a reversible procedure to treat refractory benign esophageal strictures through stent implantation. above standard of care monitoring, safety assessment of the procedure and device performance decreases the risk and unforeseen events.

Eligibility criteria:
inclusion criteria: * benign esophageal refractory stricture no more than 40 mm in length. * more than two dilations to at least 16 mm in diameter with symptoms relapse within 6 months. * last dilation to 16 mm no more than 6 months before study procedure. * dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at the time of measurement. * willing and able to comply with the study procedures and provide written informed consent to participate in the study. exclusion criteria: * stricture within 2 cm of the upper esophageal sphincter. * dysphagia related to motility disorder. * planned adjuvant radiation therapy post esophagectomy. * esophageal stent in place. * active erosive esophagitis. * sensitivity to any components of the stent or delivery system. * concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. * currently enrolled in another clinical trial.
from the gut to the strut: reducing inflammation for healthy muscles

Conditions: Inflammation; Sarcopenia; Gut Permeability

Summary: this research aims to evaluate the effectiveness of a dietary supplement on reducing inflammation and improving muscle health. the product is a food supplement notified to the ministry of health consisting of: hydroxymethylbutyrate, carnosine, lactoferrin and magnesium, which help reduce inflammation and intestinal permeability and to improve muscle health.


Eligibility criteria:
inclusion criteria: * sarcopenic patients aged 55-85. sarcopenia will be diagnosed according to the european working group on sarcopenia in older people (ewsgop-2) criteria by muscle strength or chair stand test. exclusion criteria: * severe kidney disease (glomerular filtration rate \<30 ml/min), * moderate-to-severe hepatic failure (child-pugh class of b or c), * endocrine diseases associated with disorders of calcium metabolism (with the exception of osteoporosis), * psychiatric disorders, * cancer (in the previous 5 years), * hypersensitivity to any investigational food component * subjects taking protein/amino acid supplements (up to 3 months prior to the study). * patients not capable of taking oral therapy and those receiving or having indication for artificial nutrition or included in another clinical nutrition trial
troponin t as risk stratification tool in peripheral arterial occlusive disease

Conditions: Peripheral Arterial Occlusive Disease

Summary: study hypothesis: elevated troponin t is a marker of increased mortality in patients with peripheral arterial occlusive disease (paod).

troponin t and i are established risk markers in patients with acute coronary syndrome. only recently, troponin i was found to be elevated in patients with acute critical limb ischaemia. in another study, troponin i was associated with a higher mortality in patients with chronic critical limb ischaemia followed over two years. in a longitudinal study design we intend to follow all patients that were treated for symptomatic paod (fontaine stages ii-iv) from 01/2007 to 12/2007 in our department of angiology. main outcome parameters are death and the occurrence of major vascular events and revascularization procedures during follow-up.

Eligibility criteria:
inclusion criteria: * symptomatic peripheral arterial occlusive disease * aged \>/= 18 years exclusion criteria: * unstable angina or acute coronary syndrome \< 14 days * percutaneous coronary intervention \< 14 days * other interventions or disease associated with troponin t release (i.e., acute pulmonary embolism, aortic dissection, heart valve replacement, acute heart failure, non-ischemic cardiomyopathy, heart surgery, thoracic trauma, endocarditis, myocarditis

Keywords: peripheral arterial occlusive disease mortality cardiovascular events amputation peripheral arterial revascularization
vitamin d supplementation and regulatory foxp3+ t cells in the gut

Conditions: Immune Tolerance

Summary: in this pilot study the investigators aim to investigate the effects of vitamin d supplementation on regulatory foxp3+ t cells in the gastrointestinal mucosa in healthy women and men.

this is a monocentric, open pilot study, with the aim to evaluate the effect of vitamin d supplementation on regulatory foxp3+ t cells in the gastrointestinal mucosa in healthy women and men. the primary goal is to evaluate the influence of vitamin d supplementation on the regulatory foxp3+ t cells in the gastrointestinal mucosa under controlled conditions within 2 months. the secondary study goals are to evaluate the effect of vitamin d supplementation on peripheral induced tregs and on other important immune cells in the tissue (nk, nkt cells and lpcd) and in the blood (nk, nkt cells, th17, th1, th2 cells) within 2 months.

Eligibility criteria:
inclusion criteria: * 18-40 years * non smoker * bmi: 20-30 kg/m² * healthy exclusion criteria: * hypercalcemia \> 2,65 mmol/l * pregnancy * chronic diseases

Keywords: vitamin d regulatory t cells gut
effect of dialysis dose and membrane flux in maintenance hemodialysis

Conditions: End Stage Renal Disease

Summary: objectives: i. evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end stage renal disease. ii. compare the efficacy of high versus low flux dialyzer membranes.

protocol outline: this is a randomized, multicenter study. patients are stratified by center, age, and diabetes prior to dialysis initiation. patients are randomly assigned to 1 of 4 groups: moderate dose dialysis, low flux membrane; high dose dialysis, low flux membrane; moderate dose dialysis, high flux membrane; or high dose dialysis, high flux membrane. moderate dose is a target ekt/v of 1.05 and high dose is 1.45. the dose and delivery of dialysis are measured monthly by the equilibrated fractional clearance of urea (ekt/v) calculated with double pool kinetics. patients are dialyzed 3 times a week in the shortest possible time (minimum 2.5 hours), adjusted for adequate fluid removal. general medical care, protein and calorie intake, and dialyzer reuse and other aspects of dialysis therapy are standardized. the protocol document lists approved dialyzers; no unsubstituted cellulosic membranes are permitted. the intervention phase of this study is 5 years. patients are followed for survival.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * end stage renal disease that requires in-center hemodialysis 3 times/week on hemodialysis for at least 3 months (6 months following renal transplant) * no scheduled renal transplant from living donor --prior/concurrent therapy-- * no concurrent intervention studies unless ancillary to this protocol no concurrent investigational drugs --patient characteristics-- * hepatic: albumin at least 2.6 g/dl by nephelometry no cirrhosis with encephalopathy or abnormal pt * renal: urea clearance (interdialytic) no greater than 1.5 ml/min per 35 liters total urea volume * cardiovascular: no new york heart association class iv congestive heart failure despite maximal therapy no unstable angina no new onset angina no recent exacerbation of frequency, duration, or severity of angina * pulmonary: no chronic pulmonary disease requiring supplemental oxygen * other: not hospitalized in acute or long term care facility at entry no active malignancy requiring chemotherapy or radiotherapy no aids no active systemic infection, e.g., tuberculosis or fungal infection no mental incompetence or other contraindication to protocol therapy not pregnant geographically available for treatment at participating institution no more than 20 missed treatments/year

Keywords: end stage renal disease rare disease renal and genitourinary disorders
atricure bipolar radiofrequency ablation of permanent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: ablate is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the atricure bipolar system for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. subject is greater than or equal to 18 years of age 2. subject has history of permanent atrial fibrillation as defined by the acc/aha/esc guidelines 3. subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following: * mitral valve repair or replacement * aortic valve repair or replacement * tricuspid valve repair or replacement * coronary artery bypass procedures * atrial septal defect repair * patent foramen ovale closure 4. subject's left ventricular ejection fraction ≥ 30% 5. subject is able and willing to provide written informed consent and comply with study requirements 6. subject has life expectancy of at least 1 year exclusion criteria: 1. stand alone af without indication(s) for concomitant cabg, valve surgery, asd repair, or pfo closure 2. previous cardiac ablation including catheter ablation, av-nodal ablation, or surgical maze procedure 3. wolff-parkinson-white syndrome 4. prior cardiac surgery (redo) 5. class iv nyha heart failure symptoms 6. prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit 7. documented mi within 6 weeks prior to study enrollment 8. need for emergent cardiac surgery (i.e. cardiogenic shock) 9. known carotid artery stenosis greater than 80% 10. la size greater than or equal to 8cm 11. current diagnosis of active systemic infection 12. severe peripheral arterial occlusive disease defined as claudication with minimal exertion 13. pregnancy or desire to get pregnant within 12-months of the study enrollment 14. preoperative need for an intra-aortic balloon pump or intravenous inotropes 15. renal failure requiring dialysis or hepatic failure 16. requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia 17. therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders

Keywords: atrial fibrillation af ablation arrhythmia racing heart afib surgical ablation
analysis on aefi surveillance data for live attenuated varicella vaccine

Conditions: Varicocele

Summary: the purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.


Eligibility criteria:
inclusion criteria: * the registered permanent residence or resident place are local (reside more than 3 months); * participant preventive inoculation of varicella vaccine in 2014-2015; * adverse reactions occurred and should be reported in the aefi monitoring system. exclusion criteria: * subjects with a known allergy to any ingredient of the vaccine, and with any allergy history to any vaccine; * subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases, and catching cold and fever; * subjects with uncontrolled seizures and other progressive neurological diseases, with a history of guillain-barré syndrome.

Keywords: vaccine safety
the effect of exercise and/or diet on health related parameters

Conditions: Overweight and Obesity

Summary: the study evaluates the effect of exercise and/or diet during on body weight, body composition and health related blood parameters. participants are overweight sedentary females, allocated to four different groups: normal diet, low-carb-high-fat diet, normal diet + exercise, low-carb-high-fat diet + exercise.

diet and exercise can both be efficient tools to reduce bodyweight, get healthier body composition and improve many different health related blood parameters such as cholesterol and glucose tolerance. exercise has superior effect on skeletal muscle in the context of glucose tolerance, but adherence to exercise program can be a huge challenge for overweight individuals. while exercise has profound effect on metabolic health, diet has been superior when it comes to weight reduction. previous studies have shown that 5-7% weight loss can improve glucose tolerance, measured as reduced fasting glucose and reduced 2-hour post prandial glucose. we wish to see if the combination exercise and diet is superior to diet only when it comes to over all health.

Eligibility criteria:
inclusion criteria: * women * sedentary * premenopausal * caucasian * bmi 26.9 - 36.1 * age 33-4 * living close to, or in oslo. exclusion criteria: * pregnancy * breast-feeding * smoking or tobacco use * previous medical history of cardio-vascular disease (cvd) * previous medical history of diabetes * previous medical history of endocrine disorder * previous medical history of kidney disease * use of lipid lowering medication * use of diabetes medication

Keywords: low-carbohydrate-high-fat diet (lchf) low-density-lipoprotein (ldl) high-density-lipoprotein (hdl) triglycerides (tg) lipids glucose tolerance (gt) insulin resistance (ir) body composition weight
fh ortho shoulder observatory

Conditions: Trauma; Arthropathy Shoulder

Summary: this study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma. in this type of intervention, one or more medical devices distributed by fh ortho sas may be used by surgeons. this study meets the requirement for post-market clinical follow-up (pmcf) as defined in the european medical device regulation (mdr 2017/745). it therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit/risk of the medical devices concerned. this study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.


Eligibility criteria:
inclusion criteria: 1. any patient undergoing implantation of medical devices distributed by fh ortho sas for shoulder arthroplasty and traumatology, used in accordance with their approved labelling, in one of the centres participating in the observatory (retrospectively or prospectively) 2. patient is at least 18 years of age 3. patient agreeing to participate after having been informed orally and in writing (with written consent if required locally) in some countries, such as france, the patient will have to be socially insured to be included in the study. exclusion criteria: 1. patient unable to participate in the study and/or complete the questionnaires 2. refusal of patient participation -
bioequivalence study of didanosine in children treated for hiv

Conditions: HIV Infections

Summary: the purpose of this study is to show that the administration of 400/mg/m2/day of didanosine(ddi) during the meal is bioequivalent to the administration of 240/mg/m2/day of didanosine during fasting, in hiv infected children treated by a arv combination including ddi

the didanosine is one of the reverse transcriptase inhibitors. this drug is efficient against the viral replication of the hiv. licensing for the children was obtained in june, 1992. the main problem of the didanosine is its poor bioavailability: although gastro-resistant capsules were developed, its bioavailability remains dependent on alimentation. taking a meal 1-2 hours before the administration of ddi leads to a reduction of 50% of its bioavailability as well for the child as for the adult. it is therefore recommended to take ddi during fasting period. this regimen in some cases can decrease therapeutic observance. a pharmacokinetic study of ddi will be conducted during the meal with 240 mg/m2/day during fasting period compare to 400 mg/m2/day during the meal. 26 patients, aged more than 6 years old, will be included and randomised in 2 groups. the first group will take the standard dose of ddi during 28 days during fasting period (phase a), then the high dose during the meal during 28 days (phase b). the second group will take first the phase b and secondly the phase a. patients will be sequentially evaluated both after the first and the second period of treatment for pharmacokinetics and biological analysis.

Eligibility criteria:
inclusion criteria: * children treated by the didanosine capsules more than 3 months * viral load \< 50 copies/ml * written informed consent * normal renal function exclusion criteria: * lack of observance * any treatments which can interact with ddi * no written informed consent * weight \> 60 kg

Keywords: hiv disease in children hiv children didanosine bioequivalence pharmacokinetics treatment experienced