Kornimate/medical-research-clean huggingface dataset:
study of the effect of capsinoid supplementation on brown adipose tissue in obese adolescents

Conditions: Obese Adolescents; Exercise; Diet Modification; Dietary Supplement

Summary: among the new strategies being considered for the treatment of obesity and its metabolic complications, the activation of brown adipose tissue (bat) from white adipose tissue looks promising. interest in the study of bat has increased over the last 5-10 years in response to the discovery of functional bat in humans. the bat is a tissue specialized in regulating energy expenditure by producing heat through the oxidation of fatty acids contained in the multiple lipid droplets of brown adipocytes. this adipose tissue does not play a storage role, but rather an anti-obesogenic one, thanks to its high metabolic and energetic activity. in addition to exposure to cold, which is the major physiological inducer of brown adipocytes, it seems that exercise and the intake of "adrenergic" foods can activate the tab and potentially induce a change from white to brown tissue via the production of adrenalin and myokines. acute and/or chronic effects of thermogenic food supplements have been reported on bat activation and energy metabolism. the most conclusive of these involve the capsinoids found in sweet peppers and chillies. weight loss also improves bat activation. the bat has already been identified in children. a decrease in its volume and activity from childhood to adolescence and during puberty has been reported. the main objective of this randomized controlled double-blind study is to investigate the effects of capsinoid dietary supplementation on bat activity in obese adolescents. our general working hypothesis is that capsinoid supplementation, combined with dietary management, leads to an increase in bat activity.


Eligibility criteria:
inclusion criteria: * member or beneficiary of a health insurance scheme * aged between 11 and 18 * body mass index z score corresponding to stage 2 obesity according to the curves of rolland-cachera et al., 1991 and an absence of weight loss of more than 5% of the total weight over the last 3 months. * effective contraception (in pubescent females) exclusion criteria: * known allergy to capsinoids and/or soya * inflammatory digestive pathology and/or history of digestive tract surgery * participation in another study or in a period of exclusion determined by a previous study * pregnant, parturient or breastfeeding * the holder(s) of parental authority or the adolescent refuse(s) to sign the authorisation or acceptance form, respectively. * it proves impossible to provide the adolescent or parental guardian(s) with informed information.
evidence for potassium restriction in hemodialysis

Conditions: Hyperkalemia, Diminished Renal Excretion

Summary: evoke-hd is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia. contrary to the traditional recommendations limiting the intake of high-potassium whole foods, such as fruits and vegetables, the investigators propose to switch the focus to foods containing potassium that is readily absorbed by the body (high bioavailability), such as potassium from additives, processed meats, milk, fruit juices and sugary drinks.

sixty adults receiving hemodialysis treatments with blood potassium levels ≥ 5.2 mmol/l on two occasions or more in the past three months will be randomly assigned to either the novel dietary counselling or the traditional approach. both groups will meet with the renal dietician again once a month for 20 to 30 minutes, but the content of the recommendations will be different. the intervention and follow-up period will last six months. the investigators will record pre-dialysis potassium, bicarbonate, phosphorus, calcium and parathormone levels, blood pressure, volume status, hospitalizations, medication, and dialysis prescription changes monthly and assess nutritional status and satisfaction with food at the beginning and at the end of the study. the study will be successful if 30% or more of the eligible patients agree to participate and complete the 6-month assessment.

Eligibility criteria:
inclusion criteria: * ≥18 years or older * receiving hemodialysis 3 times/week for ≥ 3 months * has at least two pre-dialysis serum potassium levels ≥5.2 mmol/l on any analysis in the past 3 months * can speak and understand french or english * has not missed more than 1 dialysis session in the previous 3 months. * is capable of providing informed consent. exclusion criteria: * is not expected to survive beyond 6 months * does not control their dietary intake (e.g., residents of high-dependency nursing homes) * significant cognitive impairment precluding understanding of the dietary recommendations.

Keywords: potassium hyperkalemia hemodialysis nutrition
retrospective analysis of clinical features in ventriculoperitoneal shunt infectionsin adults

Conditions: Ventriculoperitoneal Shunt; Infection

Summary: the objectives of this study are: * to describe the incidence of clinical features in adults with internal ventriculoperitoneal (vp) shunt infections, * to determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and * to evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.

information from medical records of patients seen by the pi will be collected and analyzed to describe the incidence of clinical features in adults with internal ventriculoperitoneal shunt infections, to determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and to evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.

Eligibility criteria:
inclusion criteria: * adults (age \>= 18 yrs) with vp shunts (ventriculoatrial \[va\], and other cerebrospinal fluid \[csf\] catheters will not be included). * cases will include patients with a diagnosis of vp shunt infection. * controls will be patients with a clinical suspicion of shunt infections with negative csf cultures. exclusion criteria: * patients with meningitis from community acquired organisms (e.g. streptococcus pneumoniae, neisseria meningitidis, listeria monocytogenes and haemophilus influenzae).

Keywords: shunt internal ventriculoperitoneal
an open-label, single-arm longitudinal study with dupilumab for patients with atopic dermatitis

Conditions: Atopic Dermatitis; AD; Eczema

Summary: 24-week, open-label, single-arm longitudinal study of patients with ad, including a comparison between baseline values for adult patients with moderate-to-severe ad and untreated normal control patients. patients with ad: ≤24 to 29 weeks, including the screening period normal control patients: ≤2 days to 5 weeks, including the screening period. patients with ad: adults with moderate-to-severe ad whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable (eg, intolerance, other important side effects or safety risks) normal control patients: adults without ad or other atopic disease


Eligibility criteria:
inclusion criteria: all patients: * male or female, 18 years or older * willing and able to comply with clinic visits and study-related procedures * provide signed informed consent * have applied a stable dose of topical emollient (moisturizer) once daily for at least 7 days before the day 1 visit ad patients only: * chronic ad * eczema area and severity index (easi) ≥16 at screening and day 1 visits * investigator's global assessment (iga) ≥3 (on the 0 to 4 iga scale, in which 3 is moderate and 4 is severe) at the screening and day 1 visits * body surface area of involvement of ad (bsa) ≥10% at screening and day 1 visits * documented recent history (within 6 months before screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable exclusion criteria for all patients (not all inclusive): * prior use of dupilumab or other anti-il-4 treatments (prescription or as part of a clinical study) within 1 year of screening * treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) before the day 1 visit, whichever is longer * having used immunosuppressive drugs or phototherapy within the last 4 weeks * treatment with tcs or tci within 1 week before the day 1 visit * regular use (\>2 visits/week) of a tanning booth/parlor within 4 weeks before the screening visit
tinnitus patient preferences survey

Conditions: Tinnitus, Subjective; Tinnitus, Bilateral; Tinnitus, Noise Induced; Tinnitus, Hearing Loss, Cochlear Implant Users

Summary: the goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation). this survey covers the acceptance of a surgically-placed brain implant, of its associated risks related to the neurosurgical procedure, usability considerations, and the willingness/ability to pay for such a treatment. neurosoft bioelectronics will use the collected patients' feedback and usability preferences data for the development of a novel minimally invasive brain implant aimed at alleviating tinnitus.

neurosoft bioelectronics is developing a minimally invasive implantable solution for the treatment of chronic, subjective moderate-to-severe cases of tinnitus. the approach involves developing a state-of-the-art neurostimulation paradigm and incorporating invasive neuromodulation findings from leading experts in the field to create an effective solution. this solution aims to minimize patient's burden by offering a fully implantable system that does not require active patient engagement or repetitive adjustments of electrical stimulation parameters. instead, it will use a closed-loop feedback algorithm, that will be optimized through multi-target recordings and stimulation, to continuously adapt and refine the treatment. this type of solution could significantly increase the quality of life of affected individuals living with severe chronic tinnitus, for which only palliative and symptom management solutions exist today. as neurosoft bioelectronics is at the early stage of device development, we will use the collected patients' feedback and usability preferences data for refining clear users' and product's requirements.

Eligibility criteria:
inclusion criteria: * individuals aged 18 or older suffering from subjective tinnitus * self-reported or healthcare professional-diagnosed chronic (lasting 3 months or longer), subjective, burdensome tinnitus exclusion criteria: * individuals under 18 years of age * healthy volunteers without tinnitus

Keywords: tinnitus ibci brain implant survey risks acceptance user preferences patient preferences subjective tinnitus chronic tinnitus severe tinnitus catastrophic tinnitus invasive neuromodulation surgical treatment
changes in lipids and lipoproteins in hiv infected women after switch from protease inhibitor to raltegravir

Conditions: HIV Infections

Summary: this is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in hiv infected women with hyperlipidemia on boosted pi based regimen after switching their boosted pi to raltegravir at standard dosage with 400mg twice daily. this study aims to study the effect on metabolic profiles by switching hyperlipidemic hiv infected women from a pi based regimen to raltegravir.


Eligibility criteria:
inclusion criteria: * documented hiv-1 infection in female patients, age ≥18 years * patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (pi) for at least the previous 6 months * plasma hiv viral load \<50 copies/ml on current boosted pi containing regimen for ≥ 6 months prior to study entry * fasting ldl cholesterol \>130 mg/dl * fasting triglycerides \<450 mg/dl exclusion criteria: * history of virological failure during previous antiretroviral therapy

Keywords: hiv infection raltegravir switch hyperlipidemia women
physiopathology of sodium retention in acromegaly

Conditions: Acromegaly

Summary: acromegaly is a disease due to an excess of growth hormone that abnormally occurs in adulthood. it is due to a benign (non cancerous) tumor located in a particular part of the brain that secretes several hormones, the hypophysis. the excess of growth hormones in adults induces an increase in bone (resulting in large enlargement of extremities), and organs. the disease is complicated by the apparition of cardiovascular events including retention of water, salt in the tissues and increase in blood pressure, that altogether might major the mortality of the patients. the investigators recently got experimental data suggesting that the retention of water and salt is mainly due to the activation by the growth hormone of a renal transporter of sodium. because this transporter is highly sensitive to amiloride, a well know diuretic, the investigators hypothesize that this drug will be very efficient in treating the hypertension in patients, as compared to another diuretic, furosemide.

to prove this, we compared the response to amiloride administrated before and after treatment of acromegaly in the same subject. we will also compare the response to furosemide administrated before and after treatment of acromegaly in the same subject. we expected that the response to amiloride will be greater before than after treatment, while the response to furosemide will be lesser before than after treatment. detailed description: definition: extended description of the protocol, including information not already contained in other fields, such as comparison(s) studied. patients will be recruited in the department of endocrinology and reproductive diseases in bicetre university hospital and will be explored in the centre for clinical investigation of hegp. investigations will be performed during 4 separate day-hospital stays (2 pre-treatment and 2 post treatment) in the cic of hegp. the tests will consist of blood and urine sample collections before and after a single dose administration of furosemide or amiloride. the tests will be performed before treatment of acromegaly in random order and separated by 48hours, interval performed before treatment, and repeated in the same order after normalization of igf1 by appropriate treatment. the study will last for 2 years, with a 12 months maximal participation of each patient

Eligibility criteria:
inclusion criteria: * age 18 to 75 yrs * proven evolutive acromegalia with indication of treatment (surgical or medical) * controlled blood pressure (systolic bp \< 140 mmhg et diastolic bp \< 90 mmhg) * signed informed consent * efficient contraception in women exclusion criteria: * edematous state unrelated to acromegaly * history of sulfamide intolerance * hemoglobin \< 8g/dl * pregnant or breastfeeding women * inability to give informed consent * blood donation in the preceding 3 months

Keywords: growth hormone epithelial sodium channel hypertension a furosemide nasal mucosa
early diagnosis and treatment of sleep disordered breathing in lung cancer

Conditions: Lung Cancer

Summary: sleep-disordered breathing at night is a common medical problem. it leads to daytime fatigue, impairment in concentration and daily activities, and a higher risk of cardiovascular disease and life-threatening events. a particularly common form is obstructive sleep apnea (osa), and it is usually treatable with a high rate of patient satisfaction and improved quality of life using a continuous positive airway pressure (cpap) device. treatment of this condition improves nighttime low-oxygen levels by ensuring patency of the upper airways. research shows that in cancer, sleep disordered breathing is frequent. low oxygen levels overnight may cause tumors to grow: tumors deprived of oxygen grow more blood vessels to try to get more oxygen, and growing more blood vessels makes the tumor grow. this study aims to examine how treating sleep-disordered breathing may lessen blood-flow to lung tumors, and thus serve to ultimately block tumor growth. participants of this study will undergo sleep study and receive cpap therapy as a part of routine care.


Eligibility criteria:
inclusion criteria: * diagnosis of lung cancer in one of 2 sub-types: 1. newly diagnosed early-stage tumor 2. advanced-stage lung tumor undergoing serial contrast-ct imaging according to standard of care * diagnosis of a metastatic carcinomatous mass in the lung * positive study for sleep-disordered breathing (sdb) with intermittent hypoxia (ih) and clinical recommendation for cpap * ability and willingness to undergo baseline and repeat perfusion-ct imaging following 3- to 4 weeks of cpap therapy for sdb (regardless of cpap compliance). note: participants will undergo sleep study and receive cpap therapy as a part of routine care. exclusion criteria: * lung cancer with a negative sleep study (i.e., no sdb) * history of radio-contrast allergy * at excessive risk for contrast nephropathy (following standard radiology renal-risk criteria) * pregnancy

Keywords: lung cancer non small cell lung cancer nsclc small cell lung cancer sclc metastic lung mass sleep disordered breathing sdb obstructive sleep apnea
study to evaluate the efficacy and safety of vgr-r01 gene therapy in patients with bietti crystalline dystrophy

Conditions: Bietti Crystalline Dystrophy; Inherited Retinal Diseases

Summary: this is a phase 3 study to evaluate the efficacy and safety of vgr-r01 in subjects with bietti crystalline dystrophy. this is a multicenter, randomized controlled study which will enroll 45 subjects.

vgr-r01 is a novel aav vector carrying the human cyp4v2 coding sequence. this study is intended to assess the efficacy of vgr-r01 in subjects with bietti crystalline dystrophy (bcd) based on the change from baseline in best corrected visual acuity (bcva) of the study eyes. 30 subjects will be enrolled in the intervention group and will receive monocular administration of vgr-r01, and 15 subjects in the control group will not receive any intervention. after completion of the trial, the untreated eyes will receive administration of vgr-r01 in subsequent clinical trial.

Eligibility criteria:
key inclusion criteria: 1. able to provide informed consent and comply with requirements of the study; 2. ≥18 years and \<70 years of age; 3. confirmed diagnosis of bietti crystalline dystrophy and molecular diagnosis of cyp4v2 mutations (homozygotes or compound heterozygotes); 4. hand motion ≤ bcva ≤ 60 etdrs letters in the study eye; key exclusion criteria: 1. have insufficient viable retinal photoreceptor cells based on investigator's decision; 2. have current ocular or periocular infections, or endophthalmitis; 3. have any significant ocular disease/disorder other than bcd, including age-related macular degeneration, diabetic retinopathy, optic neuropathy, significant lens opacity, glaucoma, uveitis, retinal detachment, etc; 4. have intraocular surgery history except cataract surgery in the study eye; 5. have or potentially require of systemic medications that may cause eye injure; 6. have contraindications for corticosteroids or immunosuppressant; 7. unwilling or unable to have the planned follow-up; 8. abnormal coagulation function or other clinically significant abnormal laboratory results; 9. have malignancies or history of malignancies; 10. history of immunodeficiency (acquired or congenital); other protocol defined inclusion/exclusion criteria may apply.
analysis of lateralization of language in epileptic children by near-infrared spectroscopy (nirs)

Conditions: Epilepsy

Summary: recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. the reference test used up until very recently was the wada test, which consisted of injecting an anaesthetic (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in order to determine the predominant cerebral hemisphere for language. this invasive test has been progressively replaced by fmri, which is nevertheless difficult to perform in children under the age of 7 years. nirs therefore appears to be a useful alternative, which, in contrast with fmri, can be easily repeated and allows simple investigation of the various facets of language (e.g. expressive, receptive). in the gramfc unit, the investigators have acquired a unique know-how in the field of high-resolution nirs, both in epilepsy and in the development of language structures.


Eligibility criteria:
inclusion criteria: * children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated. exclusion criteria: * all children with severe congenital malformation * any refusal of a parent or child * any child with generalized epilepsy or diffuse interictal spikes * any child with a serious deterioration in the general condition and vital functions * any child with dermatitis of the face or scalp * children under 6 years

Keywords: children language nirs
effect of sildenafil on the microcirculatory blood flow and endothelial progenitor cells in systemic sclerosis

Conditions: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Limited; Raynaud Phenomenon

Summary: early phases of systemic sclerosis is characterized by inflammatory and microvasculature alterations. sildenafil citrate has been shown to have vasodilatory effects and to enhance vasculogenesis. the purpose of this study is to evaluate the effect of sildenafil citrate on hand blood flow of patients with systemic sclerosis, using laser doppler imaging.

progressive microangiopathy and endothelial dysfunction are identified in early phases of systemic sclerosis. these alterations may result in progressive reduction of vessel lumen, decreased blood flow, and a state of chronic hypoxia resulting in digital ulcers, digital pitting, and, in more severe cases, gangrene and amputation of the extremities. few studies aimed to evaluate the effects of sildenafil on the microcirculatory blood flow in patients with raynaud's phenomenon secondary to systemic sclerosis (ss). moreover, no study has evaluated the effect of this drug on the number and function of endothelial progenitor cells in ss patients. the relatively new technique of laser doppler imaging (ldi) allows an objective measurement of superficial cutaneous microvascular blood flow and constitutes a promising approach in the assessment of the digital microvascular vasoreactivity in response to cold stimulus or in response to treatment in ssc patients.

Eligibility criteria:
inclusion criteria: * systemic sclerosis according to the classification criteria of the american college of rheumatology (1980) with no more than 4 years since diagnosis * early systemic sclerosis as defined by leroy and medsger (2001) * 6 or more raynaud's crisis per week * written informed consent provided by the subjects prior to initiating study procedures exclusion criteria: * smoking * peripheral or central vasculopathy other than systemic sclerosis * uncontrolled diabetes * liver disease * pregnant or lactating woman * current use of cyclosporin, prostanoids, bosentan or any pde-5 inhibitors (including current sildenafil use during randomization) * history of stroke, myocardial infarction or life threatening cardiac condition within the last 6 months * history of surgical sympathectomy * systolic blood pressure \< 85mm hg * history of scleroderma renal crisis * known hypersensitivity to sildenafil or any of the excipients * history of retinitis pigmentosa * current use of nitrates

Keywords: sildenafil endothelial progenitor cells laser doppler imaging