Kornimate/medical-research-clean huggingface dataset:
assist control versus pressure support modes for domiciliary noninvasive ventilation in chronic respiratory failure

Conditions: Chronic Respiratory Failure

Summary: noninvasive ventilation is a therapeutic option in some patients with chronic respiratory failure. patients usually ventilate during nightime with a domiciliary ventilator either in assist control or in pressure support mode. the aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

the aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

Eligibility criteria:
inclusion criteria: * chronic respiratory failure * clinical symptoms of chronic alveolar hypoventilation * paco2 ≥ 45 mmhg in case of restrictive pulmonary disorder or paco2 ≥ 55 mmhg in case or obstructive pulmonary disorder exclusion criteria: * clinical exacerbation during the three previous weeks * previous treatment by domiciliary non invasive ventilation * previous treatment by non invasive ventilation for acute respiratory failure during the 3 previous months * bronchiectasis * duchenne muscular dystrophy * amyotrophic lateral sclerosis
conversations as a means to delay the onset of alzheimer's disease

Conditions: Mild Cognitive Impairment; Cognitive Change

Summary: past epidemiological studies have demonstrated that larger social networks, or more frequent social interactions, could have potential protective effects on the incidence of alzheimer's disease (ad). however, in those studies, indicators of social interactions were often broad, and included distinct elements that affected cognition and overall health. this project will examine whether conversation-based cognitive stimulation has positive effects on domain-specific cognitive functions among the elderly. face-to-face communication will be conducted through the use of personal computers, webcams, and user-friendly simple interactive internet programs to allow participants to have social engagement while staying at their home and also for the cost effective execution of the study.

participants are randomized into the control group (weekly 10 minutes phone check-in only) or experimental group (30 minutes daily video chat with standardized/trained conversational staff). user-friendly equipment and internet are provided.

Eligibility criteria:
inclusion criteria: * non-demented participants * willing to participate in daily conversation using internet/webcam with interviewers for 6 weeks * willing to monitor daily conversational amount using a digital recording device * willing informant who has frequent contact with the participant exclusion criteria: * have major illness or disabilities which interfere with interacting using the audio/video technology * diagnosed as dementia * mmse \< 24 at screening * geriatric depression scale (15 items) \>4 at screening

Keywords: behavioral intervention social engagement conversational engagement social network cognitive reserve alzheimer's disease
a non-interventional study of roactemra/actemra (tocilizumab) in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of roactemra/actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis. data will be collected from each eligible participant initiated on roactemra/actemra treatment by their treating physician according to local label for 6 months from start of treatment.


Eligibility criteria:
inclusion criteria: * adult participants, \>/= 18 years of age * moderate to severe rheumatoid arthritis * participants initiating treatment with roactemra/actemra on their physician's decision (in accordance with the local label), including participants who started treatment with roactemra/actemra in the 8 weeks prior to the enrolment visit exclusion criteria: * roactemra/actemra treatment more than 8 weeks prior to the enrolment visit * previous roactemra/actemra treatment in a clinical trial or for compassionate use * treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra * history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
microvascular response in diabetes mellitus

Conditions: Diabetes Mellitus

Summary: vascular and neurological mechanisms are both likely to be involved in foot ulcer. we recently reported on the hand an original transient pressure-induced vasodilation (piv) during a 5 mmhg/min increase of pressure strain using laser doppler flowmetry. this physiological response to non noxious external local pressure strain is a widely protective cutaneous mechanism. the impairment of piv in diabetic subjects may be relevant to the high prevalence of foot ulcer that occurs in these individuals. the aim of the project is to analyse the different physiopathological processes involved in piv impairment in diabetic subjects as compared to matched controls.

the whole study is a prospective observational study of diabetic type 1 and type 2 subjects focusing on the various physical, physiopathological or pharmacological mechanisms that may interfere with the normal response of the cutaneous microcirculation.the study is currently conducted under various parallel groups of patients and control subjects matched on age and sexe. techniques used for the study are only non-invasive investigations such as iontophoresis with laser doppler flowmetry, clinical and paraclinical non-invasive investigation of peripheral neuropathy, ultrasound imaging of peripheral arteries.

Eligibility criteria:
inclusion criteria: * diabetes exclusion criteria: * non diabetic neuropathy * peripheral arterial disease * pregnancy

Keywords: microcirculation laser doppler flowmetry neuropathy endothelial function
different metabolic effects of statins

Conditions: Hypercholesterolemia

Summary: the investigators hypothesize that pravastatin and rosuvastatin may have different metabolic effects in hypercholesterolemic patients.


Eligibility criteria:
inclusion criteria: * low-density lipoprotein cholesterol levels\>130 exclusion criteria: * overt liver disease chronic renal failure hypothyroidism myopathy uncontrolled diabetes severe hypertension

Keywords: statins insulin resistance
near infrared autofluorescence (niraf) detection for identifying parathyroid glands during parathyroidectomy

Conditions: Parathyroid Diseases; Parathyroid Dysfunction; Parathyroid Neoplasms; Parathyroid Adenoma; Hypercalcemia; Neoplasms, Glandular and Epithelial; Endocrine Gland Neoplasms; Adenoma; Hyperparathyroidism; Hyperparathyroidism, Primary

Summary: the goal of this study is to assess whether using pteye (aibiomed, santa barbara, ca) - a niraf detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. by being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. in addition, the number of frozen section biopsy and associated costs can be minimized. furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.

this is a prospective, single-blinded, randomized study comparing the use of pteye during parathyroidectomy to usual standard practice. primary objectives: i. assess the impact of pteye on intra-operative identification of parathyroid tissues. ii. assess the impact of pteye on improving efficiency of parathyroid surgeries. iii. assess the impact of pteye on minimizing risk of post-surgical complications. participants will be randomized to either the experimental or control arm. the surgeon will first take 5 baseline niraf measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the pteye console, as per device functionality requirements. the subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the pteye will indicate to the surgeon if the tissue is likely parathyroid or not. for patients assigned to the control arm, the surgeon will not use the pteye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. participants will be follow-ed up for up to 6 months after surgery.

Eligibility criteria:
inclusion criteria: * all adults \>=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery * all adult (\>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery exclusion criteria: * children and minors * pregnant women * patients with concurrent parathyroid and thyroid disease that require total thyroidectomy * patients with secondary or tertiary hyperparathyroidism

Keywords: near infrared autofluorescence parathyroidectomy intraoperative parathyroid identification persistent hyperparathyroidism persistent hypercalcemia failed parathyroidectomy repeat parathyroidectomy
nasal spray with glucose oxidase preventing common cold in pre-school children

Conditions: Upper Respiratory Tract Infections

Summary: to investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.

children below 4 years of age and in public day care were invited to participate in this prospective study. the children started with a visit to an ent doctor and after inclusion the children started to spray twice daily with glucose oxidase+glucose or only saline+glucose for 3 months. during this period the parents were asked to fill in a home protocol recording upper respiratory tract symptoms as: rhinitis, cough, fever, ear ache. after 6 weeks and 12 weeks the children had scheduled visits to the ent department, where an ent doctor examined the throat, nasal cavity and the ear drums for otitis media. after 12 weeks of treatment a nasopharyngeal swab was taken for bacterial culture.

Eligibility criteria:
inclusion criteria: * children below 4 years of age exclusion criteria: * none

Keywords: days with urti symptoms
a study to evaluate safety, efficacy and pharmacokinetics of paricalcitol for treatment of secondary hyperparathyroidism (shpt) in pediatric participants with stage 5 chronic kidney disease (ckd)

Conditions: Chronic Kidney Disease (CKD); Secondary Hyperparathyroidism (SHPT)

Summary: the main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with shpt associated with stage 5 ckd receiving peritoneal dialysis (pd) or hemodialysis (hd). the 24-week study is divided into two 12-week dosing periods (dosing period 1 followed by dosing period 2).


Eligibility criteria:
inclusion criteria: * participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (shpt). * participant must be diagnosed with chronic kidney disease (ckd) stage 5 receiving peritoneal dialysis (pd) or hemodialysis (hd) for at least 30 days prior to initial screening. * for entry into the washout period (for vitamin d receptor activator \[vdra\] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol. * for entry into the dosing period (for vdra-naive participants or vdra non-naive participants who have completed the washout period), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol. exclusion criteria: * participant is scheduled to receive a living donor kidney transplant within 3 months of screening or is a kidney transplant recipient. * participant is expected to discontinue peritoneal dialysis (pd) or hemodialysis (hd) within 3 months of the initial screening visit. * participant has had a parathyroidectomy within 12 weeks prior to screening. * participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a dose equivalent to more than \> 0.16 mg/kg/day or 5 mg prednisone/day, whichever is lower), 4 weeks prior to dosing. * participant is receiving calcimimetics at the time of screening or is expected to initiate calcimimetics at any time throughout the study. * participant is unable to take oral medications.

Keywords: chronic kidney disease paricalcitol hyperparathyroidism pediatric subjects peritoneal dialysis (pd) hemodialysis (hd) intact parathyroid hormone (ipth)
effects of intensive upper and lower limbs motor control therapy in cerebral palsy children

Conditions: Cerebral Palsy

Summary: the aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in cerebral palsy patients.

the aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in cerebral palsy patients. also to know paretns and caregivers perceptions.

Eligibility criteria:
inclusion criteria: * cerebral palsy exclusion criteria: -

Keywords: intensive therapy cerebral palsy
measuring head impacts in sports

Conditions: Brain Injuries; Brain Concussion

Summary: head impacts in sports can lead to brain injury even when the participant is wearing a helmet. the forces that contribute to brain injury from sports-related head impacts are not well understood. this study will test a new device to measure the speed of head impacts among football players.

each year, 50 to 70 million people in the united states participate in helmeted and unhelmeted sports with the potential for head impacts. such sports include football, soccer, hockey, basketball, and boxing. participating in these sports carries the risk of mild traumatic brain injury (mtbi). the biomechanics of head impacts that result in concussions or other mtbis are not well understood; however, it is thought that such impacts correlate with head accelerations. currently, there is no system that allows researchers to measure head acceleration in a large number of individuals during actual play. this is a major obstacle in understanding the mechanism of mtbi and its prevention. this study will evaluate a newly designed miniature device that uses head impact recording technology (hirt) to quantify head acceleration during impact in actual sports play. one hundred college football players will be enrolled in the study. data from hirt-instrumented helmets will be collected during normal team practice and games throughout a 5-month football season. data collected will be assessed to determine the incidence, magnitude, and duration of head acceleration during impacts on the sports field.

Eligibility criteria:
inclusion criteria * college football players

Keywords: mild traumatic brain injury
study of docosahexaenoic acid (dha) supplementation in patients with x-linked retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: objectives: i. evaluate the potential of nutritional docosahexaenoic acid (dha) supplementation to normalize the level of dha in red blood cells, and to retard the progression of visual function loss in patients with early stage x-linked retinitis pigmentosa.

protocol outline: this is a randomized, parallel, double blind study. patients receive 2 gel capsules per day of either docosahexaenoic acid (dha) enriched oil or a placebo oil. oral dha supplementation continues daily for 3 years. all patients are followed every 6 months for the 3 year duration of the study. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of x-linked retinitis pigmentosa early stage disease sufficient cone function determined by recordable erg (30 hz amplitude; greater than 0.32 microvolts) visual fields greater than 20 degrees sufficient rod function (greater than 3.0 microvolts amplitude) media clarity sufficient for fundus photography --prior/concurrent therapy-- no concurrent use of anticoagulant medication --patient characteristics-- * no chronic metabolic disease that may interfere with fatty acid metabolism * no bleeding of clinical significance

Keywords: ophthalmologic disorders rare disease retinitis pigmentosa
feasibility of simulation in therapeutic patient education for adult diabetic patients using the freestyle libre® device

Conditions: Insulin-Dependent Diabetes

Summary: the benefits of therapeutic patient education (tpe) have long been proven, but its implementation remains insufficient. it is only accessible to a part of the population and is too often limited to the acquisition of knowledge. tpe consists of supporting the patient in making decisions about his or her health, managing his or her life with the disease and treatment through the acquisition or maintenance of skills. simulation is a pedagogical method of creating fictional or reconstructed environments in order to develop skills, know-how and abilities for which direct instruction is impossible for ethical, economic or technical reasons. to date, it is recommended for the development of caregiver skills, and has been the subject of two studies among family caregivers. it seems likely that simulation will add value to the methods currently used in tpe. to our knowledge, no studies have been conducted on simulation-based tpe (s-tpe) with patients. a consensus conference, which is a rigorous method of comparing the opinions of experts in tpe, simulation, patient experts and caregivers, was held in order to determine the learning that could be developed through simulation and the conditions of use. however, since the patient is a specific type of learner, we hypothesize that there may be some additional conditions for the use of s-tpe. and the value of this approach remains to be demonstrated. since the use of s-tpe has never been studied with patients, a feasibility test would make it possible to evaluate, in the context of care, the possibility of its use and its acceptance by both patients and caregivers. this is necessary before considering a multicenter trial that demonstrates an interest in developing patient skills. it was decided to carry out this study in patients with diabetes, a condition for which tpe is a precursor. caregivers will be able to objectify the advantages and limitations of using s-tpe.


Eligibility criteria:
inclusion criteria: * adult who has provided non-opposition to participate in the study * insulin-dependent diabetic patient who has participated in a complete tpe program (3 sessions) for the implementation of a freestyle libre®. exclusion criteria: * person subject to a legal protection measure (curatorship, guardianship) * person subject to limited judicial protection * pregnant, parturient or breastfeeding woman * adulat patients unable to provide consent
phase ii trial of weekly or every 3-week ixabepilone for patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * has mbc that is measurable by recist or has nonmeasurable disease with serum ca27.29 (or ca15.3) ≥ 50 * has human epidermal growth factor receptor 2 (her2) negative breast cancer * prior chemotherapy is permitted with no limit on the number of prior regimens * two weeks or more have elapsed since last chemotherapy or radiation treatment * has an eastern cooperative oncology group (ecog) performance status (ps) of 0-2 * is female, ≥ 18 yrs of age * protocol defined appropriate laboratory values * negative pregnancy test within 7 calendar days prior to registration * has signed a patient informed consent exclusion criteria: * had prior treatment with ixabepilone or other epothilones * has her2+ disease * has a known, prior, severe (national cancer institute common terminology criteria adverse events \[nci ctcae\] grade 3-4) history of hypersensitivity reaction to a drug formulated in cremophor ® el (polyoxyethylated castor oil) * is receiving concurrent immunotherapy, hormonal therapy or radiation therapy * is receiving concurrent investigational therapy or has received such therapy within the past 30 days * has peripheral neuropathy \> grade 1 * has evidence of central nervous system (cns) involvement requiring radiation or steroid treatment. participants with stable brain metastases who are off steroids at least 2 weeks are eligible * is pregnant or breast feeding
laser therapy for pediatric burn scars

Conditions: Cicatrix, Hypertrophic; Burns

Summary: a new era of outcomes for pediatric burn patients has begun as burn care continues to improve. unfortunately, complete restoration of burn-injured skin may be limited by the development of hypertrophic scarring. treatment with laser therapy is one of the newest forms of scar therapy available. although laser therapy has only been adopted by burn clinicians within the last several years, early evidence suggests that it may offer significant benefits. thus the aim of this study is to investigate the effectiveness of using laser therapy to treat hypertrophic burn scars in pediatric patients by using a comprehensive set of subjective and objective scar assessment tools.


Eligibility criteria:
inclusion criteria: 1. age 1-18 years at presentation 2. patients with a hypertrophic burn scar that has been clinically diagnosed by a burn care specialist 3. hypertrophic burn scar resulting from any etiology 4. hypertrophic burn scar is ≥ 2 months post healing 5. ability to complete english- language questionnaires exclusion criteria: 1. patients with concomitant skin disease (i.e. chronic skin conditions, herpes infection) 2. patients with a history of keloid scarring 3. patients who cannot tolerate the intravenous (iv) sedation used to perform laser therapy procedures 4. patients who have had previous laser therapy procedures

Keywords: pediatric laser burn scar photothermolysis