Kornimate/medical-research-clean huggingface dataset:
longitudinal cohort study comparing 2 surgical techniques in patients with class 3 obesity and type 2 diabetes

Conditions: Obesity; Type 2 Diabetes

Summary: wight loss surgery provides good glycemic control in type 2 diabetes. the technique of "roux-en-y gastric bypass" is more effective than the "adjustable gastric band" on weight loss. this longitudinal cohort study will compare the effectiveness of the roux-en-y gastric bypass and adjustable gastric banding on glycemic control in type 2 diabetes and explore the responsible mechanisms. the evaluation will be made preoperatively and 1 year later as assessed by the decline in hba1c. an evaluation will also be carried out after a weight loss of 10% to indicate whether the observed difference is independent of weight loss.

type 2 diabetes is a condition often associated with obesity and often difficult to control. in patients with severe obesity, surgical treatment allows a sustainable weight loss and higher than that obtained with other treatments available. in most cases, surgery also reduces significantly the comorbidities of obesity and diabetes in particular. among the various technical options, adjustable gastric band (agb) is the simplest and by far the most used in france. roux-en-y gastric bypass (rygb) is a more complicated intervention combining gastrointestinal malabsorption- duodeno-jejunal and gastric reduction and allows a higher weight loss. several studies also suggest that the technique has a remarkable efficiency on glycemic control, justifying the extension of its readings/indications. no study controlled, however, has compared these two techniques. the objective of this study is to compare the efficiency of rygb vs agb on glycemic control in type 2 diabetes. although some studies have compared agb and rygb, none have compared their effectiveness on post prandial glucose control in patients with diabetes. it is generally recognized that the effectiveness of rygb on diabetes is independent of the weight loss, but this has never been demonstrated. by demonstrating the superiority of rygb vs agb, and identifying the responsible mechanisms, the study will expand the indications of rygb in the treatment of type 2 diabetes. weight loss surgery offers a unique model for the clinical study of the pathophysiology of type 2 diabetes. main objective: * to compare the effectiveness of rygb vs agb on glucose control in obese patients with type 2 diabetes. secondary objectives: * demonstrate that the better outcome achieved with rygb is independent of weight loss. * identify the mechanisms underlying the better outcome of rygb

Eligibility criteria:
inclusion criteria: * age between 18 and 70 years and * bmi \> 35 * type 2 diabetes * obesity for more than 5 years or * normoglycemia * bmi\< 30 exclusion criteria: * secondary obesity due to an endocrinopathy * chronic pathology (neoplasia, cirrhosis, disease of system) * psychosis, alcoholic addiction or narcotics. * contre-indications to the anaesthesia

Keywords: type 2 diabetes obesity gastric bypass adjustable gastric banding bmi > 35. obesity for more than 5 years
evaluation of return to work rehabilitation

Conditions: Sick Leave; Occupational Health

Summary: long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole. hence, the need for documented effective vocational rehabilitation programs is pressing. vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain). in contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g. social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal-, unspecific- and common mental disorders. aim of this study is to investigate whether a group based rehabilitation program for musculoskeletal, mental or unspecific complaints can facilitate return-to-work (rtw), thereby testing two multicomponent return-to-work rtw rehabilitation programs.


Eligibility criteria:
inclusion criteria: * living in the counties of trøndelag * on sick leave 2-12 months * current sick leave status of 50% - 100% * icpc-2 (international classification of primary care, second edition) diagnosis within the l (musculoskeletal), p (psychiatric) or a (unspecific disorders) categories exclusion criteria: * alcohol or drug abuse * serious somatic or psychological disorders * a specific disorder requiring specialized treatment * pregnancy * currently participating in another treatment program * insufficient norwegian speaking or writing skills to participate in group session and fill out questionnaires * scheduled for surgery within the next 6 months * serious problems with functioning in a group setting

Keywords: absenteeism rehabilitation return to work
the guiding significance of pupil monitoring in the perioperative period

Conditions: Pupil Diameter; Pupil Contraction Rate; Pupil Light Reflection

Summary: the pupil diameter is affected by both sympathetic and parasympathetic nerves, and its latency and response amplitude mainly reflect the functional status of the parasympathetic nerve. clinically, the diagnosis of neurological diseases can often be made based on changes in pupils. an appropriate depth of anesthesia can cause minimal damage to the body after surgery, thereby reducing the impact on brain function and cognitive function. the occurrence of postoperative delirium will have adverse effects on the prognosis of patients, such as prolonging the hospital stay, increasing the mortality of patients after surgery, and increasing early postoperative cognitive dysfunction.


Eligibility criteria:
inclusion criteria: * elderly patients undergoing general anesthesia for tracheal intubation, aged ≥65 years, operation time ≥2 hours, asa classification i-iii, and postoperative hospital stay for at least one week. exclusion criteria: 1. it is known that this study involves persons who are allergic to general anesthetics; 2. patients with previous eye diseases; 3. head and neck surgery is not conducive to measurement; 4. patients with preoperative mmse score less than 24 points or dementia due to various diseases; 5. patients planning to undergo neurosurgery; 6. those who use sedatives or antipsychotics before surgery; 7. patients with known central nervous system diseases, such as mental illness; patients with hearing or vision impairment and unable to communicate normally.

Keywords: pupil cognitive dysfunction recovery
assessment of an iphone application on glycemic control in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of the study is to assess whether an electronic self-management tool, specifically an iphone application entitled bant, can improve glycemic control in adolescents who have type 1 diabetes mellitus (t1dm).

type 1 diabetes mellitus (t1dm) is among the most common chronic diseases affecting children, adolescents and adults. while intensive patient self-management can optimize blood glucose (bg) to near-normal levels, it is a challenge for many tidm patients to continuously achieve this. these difficulties are compounded in the adolescent population, who struggle with daily self-management and therefore may increase their risk of t1dm complications. due to this observation an electronic self-management tool, in the form of an iphone application called bant, was developed. this app guides the analysis of bg data and suggests changes in treatment, while also using social network and rewards to encourage and reinforce self-care behaviors, such as frequent self-monitoring of blood glucose levels (smbg). by primarily measuring changes in hba1c levels, the study will assess if bant and its features are associated with improved glycemic control in the adolescents who use it.

Eligibility criteria:
inclusion criteria: * t1dm as defined by 2008 canadian diabetes association (cda,2008)guidelines, with duration ≥ 1 year * age 11-16 years, inclusive at enrollment in the trial * 2 of the participant's last 3 a1c results prior to enrollment, including the most recent, falling between 8.0% - 10.5% * have been followed for at least 6 months in the current diabetes clinic exclusion criteria: * non-english speaking adolescents as the version of bant being used in the randomized control trial (rct) is only offered in english at this time.
spectral correlates of impulsivity in patients with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: transcranial electrical stimulation (tes) is a non-invasive form of brain stimulation that has previously been to shown to have therapeutic potential in traumatic brain injury (tbi) patients. in this study, the study team will use a brain activity monitor (electroencephalogram, eeg) and a computer-based task to observe the effects of different forms of tes, like transcranial direct current stimulation (tdcs) and transcranial pulsed current stimulation (tpcs), on impulse control and sustained attention in people with tbi. additionally, the study team will measure how much tdcs and tpcs affect the brain activity of a specific area of the brain associated with impulse control and attention. problems with response inhibition have been shown to make rehabilitation more difficult for people with tbi. it also reduces social functioning and can also negatively affect job performance, which ultimately lead to a decreased quality of life. a better understanding of the effects of tes in tbi patients could be informative in finding out what its therapeutic potential is for this population.


Eligibility criteria:
inclusion criteria: * subjects referred to the pi for management of tbi * subject is at least 3 months post-injury at the time of consent * ages 25-70 exclusion criteria: * subjects with the inability to consent for themselves * subjects with body habitus that does not allow the eeg cap to be properly placed * presence of scalp injury or disease * allergic reaction to topical lidocaine jelly * prior intracranial surgery or skull-fracture over vlpfc * presence of hemorrhage on intracranial imaging * prior brain radiotherapy * prior history of intracranial tumor, intracranial infection, or cerebrovascular malformation * subjects with the inability to see and read from a computer screen * history of any form of seizures prior to tbi or within 6 months of study participation * pregnancy
indocyanine green and rectosigmoid endometriosis

Conditions: Endometriosis, Rectum; Bowel Endometriosis

Summary: indocyanine green is a fluorescent dye used for the intraoperative evaluation of tissue perfusion. the aim of this study is to evaluate a possible correlation between rectosigmoid vascularization and surgical and clinical data including pre and post-operative bowel symptoms in patients needing surgery for rectosigmoid endometriosis.

patients with symptomatic rectosigmoid endometriosis requiring laparoscopic surgery are included in the study. before surgery, bowel symptoms are assessed using validated questionnaires (knowles-eccersley-scott-symptom questionnaire and gastrointestinal quality of life index). indocyanine green is administered through peripheral line. a near-infrared (nir) camera-head enables real-time direct visualization of bowel perfusion before and after the removal of the rectosigmoid nodule. rectosigmoid tract perfusion is assessed before and after the removal of the nodule. to estimate the vascularization, a scale with a score between 0 and 4 is used. after complete removal of rectosigmoid nodule, the post-operative follow-up will be the same as usual after intestinal endometriosis surgery. postoperative bowel symptoms are evaluated using the same questionnaires.

Eligibility criteria:
inclusion criteria: * diagnosis of deep endometriosis based on clinical and transvaginal/transabdominal ultrasound examinations and, when necessary, magnetic resonance * patients with indication for removal of endometriosic lesions by laparoscopic surgery * obtaining informed consent exclusion criteria: * known or suspected allergy to iodine * previous rectal surgery * history of active pelvic infection * intra-abdominal or pelvic malignancy * pelvic radiation therapy * hyperthyroidism * liver dysfunction * serum creatinine \> 2.0 mg/dl
[68ga]ga-nota-rw102 pet imaging in the diagnosis of pd-l1-expressing lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the aim of this study was to establish and optimize the imaging method of \[68ga\]ga-nota-rw102, as well as its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent was evaluated in patients with non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * patients with pd-l1-positive non-small cell lung cancer 1. age between 18 and 65 years old, gender is not limited. 2. patients with ct findings that can be occupied on the lung with a diameter greater than 1cm or more who have not undergone surgery. 3. lung cancer patients with a clinical diagnosis of positive pd-l1 expression; 4. written informed consent must be signed by the subject or his/her legal guardian or caregiver. 5. willingness and ability to cooperate with all programs of this study. exclusion criteria: * subjects meeting any of the following criteria will be excluded from the study: 1. severe hepatic and renal insufficiency; 2. targeted therapy prior to radiotherapy or pet/ct scan. pd-l1 expression in existing lesions was assessed by immunohistochemistry using antibody clone 22c3. renal function: serum creatinine less than or equal to the upper limit of the normal range; 3. liver function: bilirubin, ast(sgot)/alt(sgpt) less than or equal to the upper limit of the normal range. 4. history of serious surgery in the last month. 5. those who have participated in other clinical trials during the same period.

Keywords: non-small cell lung cancer positron-emission tomography
russian national registry of laao

Conditions: Atrial Fibrillation

Summary: the first russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (laao) using the watchman device and the amplatzer cardiac plug. this government-funded catheter-based laao program was started in september 2015 and was completed in december 2017. data collection was finished in december 2018. five clinics agreed to participate in the study. patients' baseline characteristics, procedure, and follow up data were collected according to established registry protocol. patients were followed at 45 days, 3, 6 and 12 months after enrollment. at each follow-up visit, the data regarding clinical events and healthcare utilization was collected.


Eligibility criteria:
inclusion criteria: * age ≥18 years nonvalvular atrial fibrillation, * cha2ds2vasc ≥2, * high risk of hemorrhagic events, * non-compliance with pharmacological anticoagulant therapy exclusion criteria: * significant mitral valve disease, * left ventricular ejection fraction \<35%, * the tendency to systemic thrombosis, * severe co-morbidities

Keywords: atrial fibrillation left atrial appendage stroke prevention occluder watchman device amplatzer cardiac plug
assessment of the prevalence and the impact of the covid-19 epidemic in the french flight crew in 2020

Conditions: Covid19; SARS-CoV Infection

Summary: the aeronautical community was also affected and greatly impacted economically and socially by the covid-19 pandemic. away from the acute phase, the epidemiological impact and the consequences of this disease within the french aviation flight crew population must be assessed. this study is aimed at providing original epidemiological data among civil and military aircrew, prior to possible prevention strategies or countermeasures to optimize risk management in terms of aviation safety and to promote, if necessary, future targeted studies.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * professional military aircrew * presenting himself/herself for a periodic medical exam exclusion criteria: * under 18 years of age * parachutists * non-professional aircrew * presenting himself/herself for a first medical exam * pregnant woman, parturient, breastfeeding
a 6 month safety extension study of mbgs205

Conditions: Hypogonadotropic Hypogonadism

Summary: phase iib, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of bgs649 in male obese subjects with hypogonadotropic hypogonadism (hh)

this is a 6 months, active treatment, extension study, open to subjects who have completed full 24 weeks in study mbgs205 (a phase iib multicentre, double-blind, dose-ranging, randomised, placebo-controlled study evaluating safety and efficacy of bgs649 in male obese subjects with hypogonadotropic hypogonadism \[hh\]).the main purpose of study mbgs206 is to evaluate long term safety and efficacy parameters in subjects after 12 months exposure with bgs649.

Eligibility criteria:
inclusion criteria: * participating in study mbgs205 and completion of the 24 week treatment period without meeting any discontinuation criteria of study mbgs205 * in opinion of the investigator has been compliant with the requirements of the study mbgs205 protocol. exclusion criteria: -meeting any of the discontinuation criteria of initial study mbgs205

Keywords: hypogonadotropic hypogonadism testosterone
follow up study 5-6 years after ilit with 2 concomitant allergens, birch and grass

Conditions: Allergic Rhinitis

Summary: 52 patients that had previously participated in the rdbpc study of intralymphatic immunotherapy (ilit) with 2 concomitant allergens, birch and grass, with nct02423707, were eligible for an open follow up 5-6 years after treatment.

bakground: intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. with ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. the protocol that has been used so far is three injections with one month interval. the effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. no long term follow up have been performed. objective: to investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ilit with two concomitant allergens, birch and grass. methods: 52 patients that had previously participated in the rdbpc study were asked to participate in this open follow up.

Eligibility criteria:
inclusion criteria: - moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific ige antibodies exclusion criteria: * uncontrolled or perennial asthma * other pulmonary disease * known autoimmune or collagen disease * chronic infection * other significant disease * severe atopic dermatitis * use of beta blockers or angiotensin converting enzyme inhibitors as antihypertensive medications * symptomatic sensitization to house dust mite or furry animals with daily exposure * chronic upper airways disease * pregnancy * nursing * obesity with bmi \>30 * withdrawn informed consent
montessori intervention for individuals with dementia: a feasibility study from pakistan

Conditions: Dementia; Memory Impairment

Summary: the study has both quantitative and qualitative components. the objective of the quantitative study is: 1. to culturally adapt and refine montessori activities for people living with dementia in pakistan. 2. to determine the feasibility and acceptability of culturally-adapted group based montessori intervention for people with dementia in pakistan. 3. to build capacity and capability in dementia research (researcher training) the objective of the qualitative study is: to explore views on perceived effectiveness and sustainability of the study.

pakistan is the sixth most populous country in the world. mental health services are limited in pakistan particularly older adults mental health services are almost nonexistent. according to a recent report in pakistan currently 8 million people are of age 65 and above who have long term physical and psychological health conditions. this is a tough challenge for the country due to its poor economic condition.hence, there is a need to develop programs that can help and improve the health-related quality of life of this population in low resource settings.we need to do a lot more work to address this issue. one possible low-cost, accessible, non-pharmacological intervention for bpsd (behavioral psychiatric symptoms of dementia) is the montessori approach which is evidence based.the aim of the proposed project is to explore the feasibility and acceptability of using the montessori intervention for people with dementia in pakistan.

Eligibility criteria:
inclusion criteria: * participants with the following characteristics will be invited to participate in the study; * diagnosed with any type of dementia according to dsm v. * montreal cognitive examination scale with a cutoff score 10 * age 60 years or older * residents of study catchment area * able to communicate in urdu or english * not having any serious visual or hearing impairment * capacity to consent to study participation * willing to come to (care home, hospitals, research centre) for session. * willing to participate in up to 60 minutes session of the intervention, twice a week. * having a study partner (spouse or adult child caregiver) who agrees to participate in the study exclusion criteria: * participants with the following characteristics will not be eligible for the study; * advanced stage dementia * participants diagnosed with severe mental or physical illness which, in the judgement of the pi, precludes them from safely participating in the study. * unable to give consent to take part in the study

Keywords: memory impairment, montessori intervention, neurocognitive disorder
a multi-centre clinical study in spinal cord injury patients in mainland china and hong kong

Conditions: Spinal Cord Injuries

Summary: to establish a solid foundation, e.g. a network and a coordinating centre for testing new sci therapies in forthcoming randomised controlled multi-centre clinical trials following international standards and guidelines.

this is a multicentre, observational, registry study of outcome data on sci patients in mainland china and hong kong. the target population consists of patients who have a sci, where acute sci is defined as \ 12 months post-initial sci surgery. a total of 600 patients (300 acute and 300 chronic) will be enrolled from 6 cities in mainland china (namely: beijing, shanghai, guangzhou, ningbo, xi'an and kunming) and hong kong. the duration of the study will be one year, with a total of 4 visits.

Eligibility criteria:
inclusion criteria: general 1. male or female adult subjects, 18 to 65 years of age 2. have a clinical diagnosis of sci, defined by mri 3. voluntarily signs and dates an informed consent form, approved by an institutional review board (irb)/independent ethics committee (iec), prior to any study-specific procedures acute sci study group: 4. has an acute sci (defined as \< 7 days post-injury) chronic sci study group: 4. has a chronic sci (defined as \> 12 months post-initial sci surgery) exclusion criteria: general 1. severe head injury 2. is medically or mentally unstable according to the judgement of the investigator 3. history of multiple sclerosis or peripheral demyelinating disease 4. likely to have experimental therapy 5. any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol