Kornimate/medical-research-clean huggingface dataset:
impact of photobiomodulation (pbm) on biomarkers of radiation lymphedema and fibrosis in head and neck cancer patients

Conditions: Radiation Lymphedema; Radiation Fibrosis; Head and Neck Cancer

Summary: radiation fibrosis syndrome (rfs) is a general side effect of radiation therapy (rt) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy and organ dysfunction. some of the side effects that encompass rfs in the head and neck (hnc) population include decreased ability to fully open the mouth (trismus), neck pain and tightness (cervical dystonia), lymphedema (swelling), difficult with speech and swallowing and salivary hypofunction. although there is level i evidence demonstrating the benefit of photobiomodulation (pbm) therapy to prevent acute mucositis in hnc patients treated with rt, there is only limited data regarding its impact. this is a clinical trial to compare active treatment (pbm-therapy) with sham control (sham- therapy). up to 60 patients will be randomized to the two groups with equal allocation to estimate the efficacy (soft tissue thickness) of external photobiomodulation (pbm) with light-emitting diode (led) planned therapy for the treatment of radiation fibrosis syndrome (rfs) in head and neck cancer (hnc) patients who have undergone radiation therapy (rt) compared with sham control.


Eligibility criteria:
inclusion criteria: * patients treated with radiation for head and neck cancer who are ≥ 3 months \< 36 months post-rt (last rt). * patients who received at least 50gy of bilateral neck rt. subjects who received rt or concurrent chemoradiation (chemort) therapy for hnc are eligible. * no evidence of disease as documented by imaging 3 months after completion of rt. * common terminology criteria for adverse events (ctcae) fibrosis score ≥ 2 at enrollment. * patient who has body mass index (bmi) \>30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas cannot be identified by clinical objective assessment of fibrosis. * willing to comply with all study procedures and be available for the duration of the study. exclusion criteria: * woman who are pregnant or planning to become pregnant or breast-feeding. * patients enrolled on another drug or device investigational trial for prevention or treatment of lef. * patients deprived of freedom, under supervision or guardianship. * patients unable to attend to scheduled visits due to geographical, social or mental reasons. * patients who received prior pbm therapy for rt toxicities in the last year; * patients who report being photosensitive. * patients who have chronic immunosuppression or are on current immunosuppressive therapies. * any patient who, in the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason.
trunk rotation and lateral flexion exercises in stroke patients

Conditions: Stroke, Acute

Summary: in this study we want to introduce the beneficiary combine effects of chest mobilization and chest physiotherapy exercises by using cough peak flow meter and chest expansion in stroke patients. by using theses combine exercises physiotherapist can develop target rehabilitation strategies for stroke survivors.

stroke is a neurological deficit and acute focal injury of the by a vascular cause, including cerebral infarction, intracerebral hemorrhage and subarachnoid hemorrhage and is a major cause of disability and death worldwide. 2nd most deadly cause of death and disability in patients. this disease have long lasting effect on human body and also cause complication of lung function like pneumonia and respiratory distress function syndrome for this purpose to reduce chest complication and neurological defect use of chest physiotherapy and chest mobilization exercises are introduce so that hospital stay of patients reduces and recovery at high speed according to previous studies there is very strong relationship between trunk muscles and respiratory muscle with pulmonary function and physiotherapist can develop target rehabilitation strategies for stroke survivors.however in previous studies age group of patients acute subacute or chronic and diaphragmatic breathing are not included for the improvement of effective cough.

Eligibility criteria:
inclusion criteria: * both gender * age \> 50 * right or left hemiplegic acute stroke patients * diagnosed cases of stroke patient * duration: 4 weeks being diagnosed * can sit with at least 10sec * can perform exercises with active assistance * patients who easily perform exercises * patients who response to commands exclusion criteria: * patients with serious comorbidities like cancer * uncontrolled hypertension sbp \> 140mmhg and dbp \> 90mmhg * vitally unstable patient's * red flags for physiotherapy i.e. sudden dizziness, unexplained pain during exercise, chest pain. * dvt deep vein thrombosis

Keywords: stroke trrom trunk rotation range of motion tlfrom trunk lateral rotation range of motion cpf cough peak flow meter
clinical trial for the evaluation of melatonin in the treatment of pressure ulcers

Conditions: Pressure Ulcer

Summary: melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment.

melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment. in order to o determine the efficacy of melatonin in healing pressure ulcer it has been designed a multicentre, single-blind, randomized clinical trial comparing melatonin cream as an experimental pressure ulcer treatment versus control group with standard treatment based on moist environment wound healing with a time frame of 8 weeks. in order to assess the healing rate, changes in resvech 2.0 scale scores will be measured, as well as the ulcer surface reduction. to avoid variability in measuring ulcer surface, it will be done by using software helcos after taking a photograph of the wound weekly. an intention-to-treat analysis will be carried out. the t-test or mann-whitney will be used to check difference of means in the reduction of the area of the ulcer and variation in the resvech 2.0 scale. survival curves will be used to check possible differences in the follow-up time until epithelization.

Eligibility criteria:
inclusion criteria: * present at least one category ii, iii or iv pressure ulcer according to national group for the study and assessment of pressure ulcers (gneaupp) classification. * ulcer area between 1 and 100 cm2. * people over 18 years of age who have freely given their informed consent in writing of their own volition or it has been given on their behalf by a legal guardian exclusion criteria: * ulcer of category i, non-classifiable or affecting internal tissues, but with no break in the skin * people currently undergoing chemotherapy treatment or who have done so in the previous 6 months * people with a presumed life expectancy of less than 6 months or in palliative care.

Keywords: melatonin, ischemia
the effect of lower limbs neural mobilization in subjects with cervical pain.

Conditions: Neck Pain

Summary: no studies have investigated the effects of a sciatic nerve mobilization in subjects with neck pain. this study aims to determine the immediate effects of a lower limbs neural mobilization on cervical range of motion and on the perception of pain in the most common trigger points located in the cervical musculature.

a convenience sample will be used to obtain subjects the subjects will be recruited through posted advertisements on social networks. the inclusion and exclusion criteria will be applied to the volunteers. the sample wil comprise university students and administrative workers with neck pain. the subjects will be screened by a screening questionnaire and all of them, they will be required to sign an inform consent before participating to the study. after signing it, they will be randomly divide into control group subject to a placebo technique and the intervention group subject to an active mobilization of the sciatic nerve. to assess changes in cervical articular range, will be used, a cervical goniometer (crom) and for changes in pressure pain threshold of the trigger points will be used a mechanical algometer. furthermore, to asses changes in pain perception will be used a visual numerical scale. the statistical analysis will be performed using the statistical program spss 25.0, comparing the results between both groups.

Eligibility criteria:
inclusion criteria: * to spend more than 3 hours at the computer. * to have or have had neck pain during the last 3 weeks. exclusion criteria: * to have had traumatisms, traffic accidents and surgeries in the last 2 months. * to have taken any analgesic tablets before the treatment. * to be in a physiotherapy treatment.

Keywords: neck pain neural mobilization myofascial trigger point sciatic nerve
transcranial magnetic stimulation in primary progressive aphasia

Conditions: Primary Progressive Aphasia

Summary: primary progressive aphasia (ppa) is a clinical syndrome characterized by the neurodegeneration of language brain systems. three main clinical variants are currently recorgnized (nonfluent, semantic, and logopenic ppa). nowadays, there are no effective treatments for this disorder. transcranial magnetic stimulation (tms) is a technique based on the principle of electromagnetic induction of an electric field in the brain. it has been used as a non-invasive therapy in different disorders, such as depression, bipolar disorder, parkinson's disease, and in the rehabilitation of post-stroke aphasia. recent studies have shown how repetitive tms improved language characteristics in alzheimer's disease, and there are initial data in patients with ppa. this research project investigates the effect of repetitive tms in patients with ppa. investigators will perform a personalized tms treatment for each patient (brain region, type of stimulation/inhibition, etc.), according to the specific characteristics of each patient and with the final aim to generate a computational model.


Eligibility criteria:
inclusion criteria: * must be clinically diagnosed of ppa according to current diagnostic criteria (gorno-tempini et al. 2011) with pet-fdg confirmation. * clinical dementia rating 0-1. exclusion criteria: * contraindications for tms or mri * history of epilepsy * pregnancy * other language disorder previous to the diagnosis of ppa * neuroimaging not suggestive of ppa
maternal gestational weight gain and microbiota of maternal and infant

Conditions: Pregnancy; Gestational Weight Gain; Microbiota

Summary: a prospective, multicenter, observational cohort study including about 550 mother-infant pairs in beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and their infants.

purpose to evaluate whether mothers' gestational weight gain is associated with differences in maternal and their infants gut microbiota characteristics. methods and analysis this is a prospective, multicenter, observational cohort study including about 550 mother-infant pairs from pumch and other 3 hospitals in beijing. after signing consent form, every participant will bring home a weighting scale for checking and record the weight every week from they enrolled to a year postpartum. the blood samples, fecal samples, vaginal swabs and oral swabs of the mothers will be collected at first, second, third trimester and postpartum 42 days. the infants' fecal samples will be collected at 0\~3, 14, 42 days and 3, 6, 9, 12 months after born. questionnaire for mothers (diet, exercise, antibiotic and probiotic usage, oral hygiene habits etc.) and their infants (delivery mode, feeding pattern, antibiotic and probiotic usage etc.), as well as the medical records will be collected along with the sample collecting. bio-specimen will be tested by 16s rrna gene sequencing. logistical regression and covariance analysis will be used to determine the relationships between the demographic data, gestational weight gain and microbiota composition.

Eligibility criteria:
inclusion criteria: * ensure a regular prenatal check in the clinical centers. * 20-45 years old. * 8-13 gestational weeks. * singleton. * fully understand and voluntarily sign the informed consent. exclusion criteria: * iui or ivf-et pregnancy. * smoking or drinking. * antibiotics exposure within a month. * with metabolic syndrome, hypertension, diabetes or dyslipidemia before pregnancy. * with digestive disease, uncontrolled thyroid disease.
respiratory muscles and work of breathing in children

Conditions: Neuromuscular Diseases; Congenital Diaphragmatic Hernia; Lung Diseases; Cardiac Diseases; Scoliosis; Diaphragmatic Impairment; Respiratory Muscle Impairment

Summary: respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. the use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management. the primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.

respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. the use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management. respiratory muscle testing by means of esogastric measurements may allow assessing the effect of pharmacological treatment by comparing respiratory muscle strength before and after a few months with treatment. moreover, esogastric measurements can be used to better adapt mechanical ventilation or to determine the possibility of weaning from the respiratory support. the primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.

Eligibility criteria:
inclusion criteria: * patients aged less than 18 years old with primary or secondary impairment of respiratory muscles and followed at necker hospital * patients under spontaneous breathing or noninvasive or invasive mechanical ventilation * written informed consent exclusion criteria: * no social insurance * significant psychomotor retardation * absence of cooperation * significant agitation * hemodynamic instability * acute condition or temporary drug treatments that may interfere with the results of the respiratory muscle explorations

Keywords: respiratory muscle testing respiratory muscle strength work of breathing esogastric pressures diaphragmatic dysfunction diaphragmatic paralysis
impact of meal fatty acids on postprandial vascular reactivity

Conditions: Cardiovascular Disease

Summary: cardiovascular disease (cvd) is the leading cause of death in women. premenopausal women have a lower risk of cvd compared with men of a similar age. however, the incidence of cvd increases greatly after the menopause. the risk of heart disease is strongly associated with the health of an individual's blood vessels. it is thought that changes to the type of fat the investigators eat in their diet may affect the normal functioning and elasticity of the blood vessels, as well as affect cholesterol levels in the blood. types of fat in the diet include monounsaturated fats (found mainly in olive oil), n-6 polyunsaturated fats (found mainly in sunflower oil) and saturated fats (found mainly in dairy products, such as butter and cheese). since the investigators are in the fed (or postprandial) state for up to 18 hours of the day, it is important to see how these different fats affect the investigators blood vessels and blood fats over the course of the day after eating a meal. the aim of this study is to determine how consuming meals rich in saturated fats, n-6 polyunsaturated fats or monounsaturated fats influence the normal functioning and elasticity of the blood vessels throughout the day in postmenopausal women. a secondary aim is to determine the effects of these different dietary fats on a range of accepted heart disease risk markers including circulating levels of fats (lipids) and glucose in the blood.


Eligibility criteria:
inclusion criteria: * postmenopausal (not menstruated for at least 1 year) * plasma triacylglycerol (tag) between 0.8 and 4.0 mmol/l * body mass index (bmi) between 18-35 kg/m2 * total cholesterol (tc): \<8 mmol/l * systolic blood pressure \<160 mmhg and diastolic blood pressure \<100 mmhg * non-smoker exclusion criteria: * having suffered a myocardial infarction/stroke in the past 12 months * diabetic (diagnosed as fasting blood glucose \>7 mmol/l) or suffering from other endocrine disorders * suffering from renal or bowel disease or have a history of cholestatic liver or pancreatitis * on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation * history of alcohol abuse * on hormone replacement therapy (hrt) * planning or on a weight reducing regime * taking nutritional supplements (e.g. fish oil, calcium) * anaemic: haemoglobin \<11.5 g/dl

Keywords: cardiovascular disease fatty acids vascular function blood pressure plasma lipids insulin resistance endothelial activation
quetiapine in social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (sad). the hypothesis is that quetiapine will be effective and well-tolerated for patients with social anxiety disorder.

this is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.

Eligibility criteria:
inclusion criteria: * adult outpatients 18-65 years of age * primary diagnosis of social anxiety disorder, using dsm-iv criteria * minimum cgi severity score of 4 at baseline * minimum bsps score of 20 at baseline * written informed consent * negative serum pregnancy test for women of childbearing potential exclusion criteria: * current dsm-iv diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition * any current primary anxiety disorder other than sad or current primary depression * history of substance abuse or dependence with the last 6 months * suicide risk or serious suicide attempt within the last year * clinically significant medical condition or laboratory abnormality * women of childbearing potential who are unwilling to practice an acceptable method of contraception * concomitant medication use for psychotropic purposes * history of hypersensitivity to quetiapine

Keywords: quetiapine social anxiety disorder antipsychotic pilot study
multiple dose study of safety and pharmacokinetics of medi0618 in healthy volunteers

Conditions: Chronic Pain

Summary: this is a single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of medi0618 in healthy male and female volunteers. subjects will receive medi0618 or placebo administered by intravenous infusion or subcutaneous injection. safety, tolerability and pharmacokinetics of multiple ascending doses of medi0618 will be assessed.


Eligibility criteria:
inclusion criteria: * healthy men and women of non-child bearing potential * aged 18 to 50 years, inclusive * weigh more than 50 kg * body mass index between 18 to 30 kg/m2 * healthy, in the opinion of the principal investigator * able to understand and comply with the protocol requirements exclusion criteria: * participation in another clinical study with a study drug within 5 half-lives of that study drug or within 3 months prior to screening, whichever is longer * donation of blood or plasma within 2 months prior to screening and until after the final follow-up visit * poor venous access * history of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations, immunoglobulins or biologics * prescence of any clinically significant illness, such as cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastro-intestinal, urologic, immunologic or endocrine disease or disorder * history of cancer within 5 years of screening * history of drug abuse * use of prescriptions or non-prescription medicines within 7 days or 5 half-lives, whichever is longer, prior to administration of study treatments * any clinical abnormality on complete physical examination, vitals signs, ecg or clinical laboratory test results at screening or between screening and randomisation