Kornimate/medical-research-clean huggingface dataset:
characterization of capsule inflammation in patients exposed to silicone breast implants

Conditions: Breast Implant; Complications; Breast Expansion Prosthesis

Summary: the use of breast implants, both in cosmetic and restorative surgery, is common. it is a device consisting of a silicone elastomer envelope and the container of which may be silicone gel or saline. they can be texturing carriers (roughness) on the surface of their envelope. if silicone is considered inert and biocompatible, several phenomena should be noted: * implant placement results in the formation of a periprosthetic capsule which is the product of the inflammatory reaction and will isolate it from adjacent breast tissue * the periprosthetic capsule and adjacent breast tissue are chronically exposed to implant silicone. * silicone in implants, even intact, has been shown to diffuse through the shell into the periprosthetic compartment and adjacent breast tissue * there is a phenomenon of erosion of the surface of the implants, particularly textured, responsible for the release of silicone particles within the periprosthetic capsule * the rupture of the prosthetic envelope is a dreaded complication, due to the alteration of the aesthetic result and the possibility of leakage of silicone gel * since 2016, macrotextured implants have been implicated in the occurrence of anaplastic large cell lymphoma associated with breast implants (lac-aim) the presence of silicone in contact with tissues seems to promote an inflammatory environment, and this phenomenon seems increased if the implant is textured. chronic inflammation induced by these devices can therefore have harmful consequences in the long term. inflama study interested in the consequences of the presence of a silicone implant on local inflammatory phenomena within the periprosthetic capsule.


Eligibility criteria:
inclusion criteria: * women over the age of 18 years old * requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis for cosmetic surgery or breast reconstruction * subject not objecting to the use of personal data and/or biological samples * affiliation to or beneficiary of a french social security scheme. exclusion criteria: * transgender men and patients * pregnant women, and nursing mothers * persons deprived of their liberty by a judicial or administrative decision; * persons undergoing psychiatric care under duress; * persons admitted to a health or social establishment for purposes other than research * persons of full age who are subject to a legal protection measure or who cannot express their consent * subject being in the period of exclusion from another study or foreseen by the "national volunteer file".

Keywords: type of texturing of implants periprosthetic capsule fragment
spla2 in ebc during acute chest syndrome

Conditions: Sickle Cell Disease; Acute Chest Syndrome

Summary: secretory phosholipases a2 (spla2) are significantly elevated in the plasma of sickle cell disease patients with acute chest syndrome (acs), and similar enzymes have been measured in exhaled breath condensate (ebc), which is collected easily and non-invasively. the investigators hypothesize that spla2 will be measurable in ebc samples from sickle cell patients with acute chest syndrome.

the purpose of this research study is to test the ease and effectiveness of collecting exhaled breath condensate (liquid) to measure levels of a biomarker, secretory phospholipases a2 (spla2) in people with sickle cell disease during an attack of acute chest syndrome. spla2 levels have been reported to be much higher in persons with acute chest syndrome and might be useful to diagnose and to evaluate the effects of therapy. serial monitoring of plasma spla2 levels might lead to earlier or more accurate detection of acute chest syndrome and monitoring of its progression or improvement in patients with sickle cell disease. however, there is a significant inherent risk of frequent blood collection further dropping the blood (hemoglobin) levels of an already anemic patient. if spla2 can be measured in exhaled breath condensate, this non-invasive and well-tolerated sample collection might allow for serial monitoring of the enzyme without depleting the patient's already diminished blood supply.

Eligibility criteria:
inclusion criteria: 1. diagnosis of sickle cell anemia (the most severe types of sickle cell disease) as demonstrated by one of the following genotypes: hbss, hbsβ0 2. age ≥ 7 and \< 40 years 3. diagnosis of acs as defined below 4. ebc collection able to be initiated within 48 hours of diagnosis of acs definition of acute chest syndrome to be used: new radiographic pulmonary infiltrate of at least one complete lung segment in addition to 2 or more of the following symptoms: fever, chest pain, dyspnea, tachypnea, hypoxia. given the small number of subjects in this feasibility study, we are using the more conservative definition in order to ensure samples are from patients with true acs. this will increase the likelihood that spla2 levels will be high enough for measurement. exclusion criteria: 1. blood product transfusion in the previous 3 months (due to potential alterations in biomarkers, including spla2) 2. chronic inflammatory conditions other than sickle cell (due to elevation from baseline of spla2 in inflammatory conditions) 3. physical inability to correctly breathe into the mouthpiece for the required amount of time without compromising respiratory status 4. intubated patients (though ebc can be measured in intubated patients, we will not include this subpopulation for the purpose of this study) 5. pregnancy (due to the hematologic and respiratory changes that physiologically occur during gestation)

Keywords: acute chest syndrome secretory phospholipases a2 exhaled breath condensate sickle cell disease
an evaluation of internet-based carbohydrate counting education for adolescents with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: helping individuals with diabetes to control their blood sugars through self-management is an important goal, and counting carbohydrates (cho) remains a key part of diabetes education and management. there is very little research examining cho counting education with adolescents who have type 1 diabetes (t1dm). the purpose of this pilot study is to evaluate a newly developed internet-based teaching module of cho counting for adolescents, ages 12-17 years, with t1dm and who do not regularly cho count and require instruction. a secondary aim is to assess feasibility for a future, larger-scale clinical trail. an effective web-based cho counting tutorial could be used to strengthen current diabetes education programs and may serve as a basis for developing other teaching modules. advantages of web-based teaching include convenience, increased accessibility, and the ability to review and reinforce teaching concepts through repetition. it may also encourage adolescents to take the initiative for their own diabetes care, beginning with a self-directed, active learning experience.


Eligibility criteria:
inclusion criteria: * adolescents aged 12-17 years with a diagnosis of t1dm for more than 1 year * followed at the sickkids diabetes clinic * have access to a computer with internet connection * able to communicate in english exclusion criteria: * patients with type 2 diabetes, medication-induced diabetes or other forms of non t1dm * patients with celiac disease, due to differences in prescribed dietary regimen * patients who are unable to communicate in english * no computer or internet access * patient with cognitive delay impeding their ability to learn cho counting * patients who have attended a cho counting class within the past 6 months * patients who do not eat the foods presented on the planned meal \& snack trays

Keywords: type 1 diabetes mellitus adolescents carbohydrate counting glycemic control self-management t1dm
using eeg to predict depression treatment response to rtms in patients with major depression

Conditions: Major Depression; Repetitive Transcranial Magnetic Stimulation

Summary: repetitive transcranial magnetic stimulation (rtms) is a promising, novel, non-invasive therapy for depression. the study is looking at changes in specific electroencephalogram parameters in depressed patients treated with rtms can serve as predictors of depression treatment response among cancer patents undergoing rtms treatment of depression.

the study will be a prospective, single arm trial in which a set of patients who will be treated for major depression using repetitive transcranial magnetic stimulation (according to fda approved rtms standard care practices) also will undergo eeg recording before repetitive transcranial magnetic stimulation treatment begins, and at the completion of treatment. the hamilton depression rating scale will be given to participants by the neuropsychiatrist at baseline and weekly intervals till the completion of treatment. the neuropsychiatrist investigators expect to see about 12 patients per year who meet treatment criteria for repetitive transcranial magnetic stimulation. therefore, it is expected to recruit 24 subjects into the research study over a two-year period.

Eligibility criteria:
inclusion criteria: * diagnosed with cancer * comorbid diagnosis of major depressive disorder * age ≥ 18 years * baseline hamilton depression rating scale (hdrs) score ≥ 18 * failed one or more adequate antidepressant trials (including selective serotonin reuptake inhibitors or ssris, selective norepinephrine reuptake inhibitors or snris, tricyclic antidepressants or tcas). a failed treatment response may be due to lack of antidepressant efficacy or intolerable side effects. exclusion criteria: * history of seizure or epilepsy * history of concussion * history of bipolar disorder * comorbid psychotic disorder * primary brain tumor or metastasis to brain * active comorbid substance use disorder * history or current diagnosis of dementia * current pregnancy * unable to attend regular treatment sessions * any other condition in which a physician investigator feels may subject the participant to undue risk

Keywords: rtms
post-stroke pain tavns

Conditions: Stroke; Pain

Summary: the purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (tavns) can change the way participants perceive pain. investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain. the goal is to determine if there is a pain reduction after ear stimulation.

in this study, investigators main goal is to establish transcutaneous auricular vagus nerve stimulation (tavns) as an effective non-invasive neuromodulation method for analgesia of post-stroke upper extremity pain. participants are required to have an ischemic or hemorrhagic stroke that occurred at least 6 months prior and are currently suffering upper extremity pain. each participant will undergo an in-person visit. participants will first finish the pain questionnaires and have quantitative sensory testing (qst) conducted to determine baseline pain thresholds. participants will then receive 30 minutes of tavns (either active or sham). upon the completion of the stimulation intervention, participants will then be tested for another qst and pain questionnaires. aim 1: test the safety and feasibility of tavns in participants with chronic post-stroke upper extremity pain. over the last 8 years, investigators have demonstrated that tavns is safe and feasible in several different populations in our previous studies. specifically, investigators have demonstrated that tavns is well tolerated and safe for participants with chronic stroke in our previous clinical trial. in this study, investigators will further verify the safety and feasibility of tavns in the population with chronic post-stroke upper extremity pain. aim 2: investigate whether tavns can modulate pain in this population compared to sham. in this single-visit, double-blinded, sham-controlled pilot trial, investigators will compare changes in post-stroke upper extremity pain scores and pain threshold derived from qst before and after a 30-minute tavns intervention, as well as between active and sham tavns. the findings will help investigators understand whether tavns can modulate pain in this population.

Eligibility criteria:
inclusion criteria: * age 18-80 * have the capacity and ability to provide one's own consent in english and sign the informed consent document. * ischemic or hemorrhagic stroke that occurred at least 6 months prior * unilateral stroke lesions in the left hemisphere * right upper extremity pain exclusion criteria: * primary intracerebral hematoma or subarachnoid hemorrhage * documented history of dementia * documented history of uncontrolled depression or psychiatric disorder * uncontrolled hypertension despite treatment, specifically sbp (systolic blood pressure) / dbp (diastolic blood pressure) \>=180/100mmhg * pregnancy
randomized controlled trial of home telemonitoring for elderly people

Conditions: Diabetes Mellitus; Chronic Heart Failure; Chronic Obstructive Pulmonary Disease

Summary: the dreaming clinical trial is part of the dreaming project, which has the objective to demonstrate that the dreaming platform consisting of integrated health monitoring, alarm handling and videoconferencing services produces clinical benefits to its users and economic benefits to the health authorities. the study evaluates the long-term (30 months) effect of continuous use of the dreaming subsystems and is testing the hypothesis that such use is superior to usual care alone in reducing the deterioration of health related quality of life that is associated to age and chronic disease. it also tests the hypothesis that the dreaming environment is superior to usual care in delaying the transfer to nursing or elderly homes and in reducing the incidence and duration of hospitalisation episodes. the trial will also evaluate the cost-effectiveness of the dreaming platform. outcomes are assessed in six different health care systems (denmark, estonia, germany, italy, spain and sweden) and will represent a basis for the adoption of dreaming services by the respective health authorities.

homes of participants are equipped with environmental sensors, motion detection, and with wireless sensors for blood pressure, blood glucose, body weight, blood oxygen saturation, peak expiratory flow and electrocardiogram. disease related parameters are monitored at least daily and the measured values are transmitted to a central monitoring unit. in case of abnormal values, health alarms are generated and transmitted to the local health authorities to trigger eventual intervention by the physicians and nurses who normally follow the participants. participants and health professionals can stay in contact via an easy to use, home television based videoconferencing system. participants are also equipped with a a personal alarm and gps-enhanced localisation system.

Eligibility criteria:
inclusion criteria: inclusion criteria: * diagnosis of chronic heart failure * diagnosis of diabetes mellitus * diagnosis of chronic obstructive pulmonary disease only in the case that the number of recruited participants is not sufficient, inclusion criteria can be extended to one or more of the following conditions: * history of myocardial infarction * history of stroke (brain ischemia or hemorrhage) * history of falls within the last two years * hospitalization during the last two years (for every reason) exclusion criteria: * not willing to participate (e.g non signing informed consent) * inability to use the dreaming equipment * significant impairment of language comprehension or expression (aphasia) * diagnosis of dementia * completely dependent on others for the activities of daily living * living without access to isdn or dsl service

Keywords: telemedicine
minimal residual disease evaluation on cryopreserved ovarian fragments in younger patients treated for acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation. this pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.


Eligibility criteria:
inclusion criteria: * patient diagnosed with aml * at least one molecular marker identified at aml diagnosis * patients who undergo ovarian tissue cryopreservation for fertility preservation in complete remission, before hematopoietic stem cell transplantation. exclusion criteria: * other diagnostic * no marker available at aml diagnosis * no bone marrow/ovarian fragment available at the time of complete remission

Keywords: acute myeloid leukemia fertility preservation ovarian cryopreservation minimal residual disease
the study of infection and cell inflammation in peritoneal dialysate

Conditions: Peritonitis; Kidney Failure

Summary: a progressive decline of plasma triggering receptor expressed on myeloid cells-1 (trem-1) concentration indicates a favorable clinical evolution during the recovery phase of sepsis. the expression of trem-1 in dialysate of peritoneal dialysis patients was not yet documented. we will collect the dialysate of peritonitis in peritoenal dialysis patients and analyze the time serial change.

the triggering receptor expressed on myeloid cells-1 (trem-1) is a member of the immunoglobulin superfamily, and its expression is upregulated on phagocytic cells in the presence of bacteria or fungi (1). several experiments by bouchon and colleagues showed that trem-1 mediates the acute inflammatory response to microbial products. human tissues infected with bacteria are infiltrated with neutrophils and macrophages that express high levels of trem-1. conversely, trem-1 is only weakly expressed in samples from patients with noninfectious inflammatory disorders. in addition, trem-1 is shed from the membrane of activated phagocytes and can be found in a soluble form in body fluids. the presence of a soluble form of trem-1 in samples of bronchoalveolar lavage fluid from mechanically ventilated patients has been shown to be a good indicator of infectious pneumonia. during sepsis, a progressive decline of plasma strem-1 concentration indicates a favorable clinical evolution during the recovery phase of sepsis. in addition, baseline strem-1 level may prove useful in predicting outcome of septic patients. we will collect the dialysate of peritonitis in peritoneal dialysis patients and analyze the time serials change.

Eligibility criteria:
inclusion criteria: peritoneal dialysis patients, dialysis period for more than 3 months. exclusion criteria: age younger than 18 years old, pregnant or lactating women. (pre-menopause women, capable of bearing children will undergo pregnancy test)

Keywords: peritonitis, peritoneal dialysis, dialysate
the evaluation of a novel nasal pillows mask for the treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this investigation is a prospective, non randomized, non blinded study. this investigation is designed to evaluate the performance, comfort and ease of use with the f\&p trial nasal pillows mask amongst obstructive sleep apnea (osa) participants.

visit 1 will involve the participants consented in to the trial. participants will be fitted with the f\&p trial nasal pillows mask for use in-lab. the participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night. the mask will be returned to the institution at the conclusion of the trial and the participant will return to their previous mask. the institution will recruit all participants within 1 week of the beginning of the study.

Eligibility criteria:
inclusion criteria: * adult (18+ years of age) * able to give consent * apnea hypopnea index (ahi)≥ 5 on diagnostic night * prescribed pap for osa * existing nasal pillows mask user exclusion criteria: * inability to give consent * patients who are in a coma or a decreased level of consciousness * anatomical or physiological conditions making automatic positive airway pressure (apap) therapy inappropriate (e.g. unconsolidated facial structure) * commercial drivers who are investigated by new zealand transport agency * current diagnosis of carbon dioxide (co2) retention * pregnant or may think they are pregnant
lec proliferation in vivo and in-vitro

Conditions: Posterior Capsule Opacification

Summary: investigate the proliferative capacity of individual lens epithelium capsule specimens in vitro and correlate it to the risk of developing pco

cataract, the clouding of the eye's lens, is still the leading cause of blindness worldwide. until now surgery is the only therapy available for the disease. cataract surgery is nowadays considered a safe and efficient therapy. however, one of the most frequent complications of cataract surgery is posterior capsule opacification (pco), which results in diminished postoperative visual acuity. pco occurs due to a robust wound-healing response, where remaining lens epithelial cells in the capsular bag start to migrate and proliferate. the lens capsule is divided into an anterior, an equatorial, and a posterior region. the anterior and the equatorial region consist of a single layer of cuboidal epithelial cells, whilst the posterior region is formed of fibers. in the adult lens proliferation occurs almost exclusively in the equatorial region and although the central part of the lens epithelium exhibits very low mitotic activity, it was shown in experiments that cell in this area are also stem cells. there are three possible reasons for the generation of pco: intraoperative factors (dependening on the amount of remaining cells in the capsular bag), intraocular lens factors, and interpersonal factor (patient-specific factors). aim of this study is the generation of an in-vitro model of posterior capsule opacification. therefore, the investigators will analyse the proliferative capacity of lens epithelial cells on the lens capsule, which is removed during cataract surgery, in a cell culture model. the investigators then compare the proliferative capacity between young and old patients, between both eyes of the same patient, and in different forms of cataract.

Eligibility criteria:
inclusion criteria: * age-related cataract. * patients in the age group of 21 years and older. * patients with uncomplicated cataract. * patients without any relevant systemic or ocular morbidity. * patients with well dilating pupils. * written informed consent prior to any study specific action. exclusion criteria: * patients with complicated cataract. * patients with big differences in locs scale between the two eyes. * patients having corneal pathology. * patients with any form of ocular inflammation. * patients with glaucoma, retinal pathologies. * patients with traumatic cataracts, subluxated and dislocated lens, prior h/o ocular surgery, pseudoexfoliation. * any intraoperative complications like posterior capsule rupture. * in case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age).

Keywords: lens capsule proliferation