Kornimate/medical-research-clean huggingface dataset:
assessing the impact of "super-whey" vs. isonitrogenous whey on muscle protein synthesis

Conditions: Sarcopenia

Summary: skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many diseases and scenarios including ageing, bed rest/immobilisation, cancer and physical inactivity. despite the exact mechanisms causing muscle atrophy being not yet fully understood, "anabolic resistance" (reduced muscle building in response to protein feeding and exercise) is thought to be key, especially for age-related skeletal muscle losses (known as sarcopenia). as such, the search for optimal strategies (e.g., exercise and/ or nutritional interventions) to combat this anabolic blunting remains a hot-topic in scientific research. leucine, an essential and branched chain amino acid (eaa/bcaa), is thought to be the most potent aa for stimulating muscle protein synthesis (mps; the muscle building process). although, as a stand-alone supplement, leucine is unlikely to provoke a robust and prolonged state of mps, low doses of leucine-enriched mixed-eaas can elicit similar increases in mps as compared to a large dose of whey protein. as reduced appetite and increased satiety (feeling fuller) are common with advancing age, supplementation of a low-dose protein (i.e., leucine-enriched) that can adequately stimulate mps may contribute to muscle health maintenance in older adults and reduce satiation following a meal. this study aims to examine whether a novel whey protein with greater leucine content ("super-whey") has superior muscle building properties compared to a regular whey protein, at rest and after a single bout of exercise, in both young and older adults


Eligibility criteria:
inclusion criteria: * participant is in the desired age-ranges (young adults: 18-35 years; older adults: 65+ years). * participant is willing and able to give informed consent for participation in the study. * participant is physically able to perform resistance exercise exclusion criteria: * a bmi \ 35 kg/m2 * active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (bp \> 160/100), angina, heart failure (class iii/iv), arrhythmia, right to left cardiac shunt, recent cardiac event, copd, pulmonary hypertension or recent (6 mo) stroke * any metabolic disease * clotting dysfunction * a history of, or current neurological or musculoskeletal conditions (e.g. epilepsy) * lactose intolerance * having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
the impact of two different insulin dose calculation on postprandial glycemia after mixed meal.

Conditions: Diabetes Mellitus, Type 1

Summary: the aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * duration of type 1 diabetes longer than 12 months * insulin pump therapy longer than 3 months * treated by the same type of insulin longer than 3 months * written informed consent by patients and parents exclusion criteria: * celiac disease * diabetes related complications (e.g. nephropathy) * any disease judged by the investigator to affect the trial * withdrawal of consent to participate in the study

Keywords: diabetes type 1 insulin bolus prandial insulin requirement postprandial glycemia insulin pump therapy mixed meal
neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions retro-ion

Conditions: Sarcoma,Soft Tissue

Summary: the study is a randomized, open, prospective phase ii study. the aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 nci common terminology criteria for adverse events (nci-ctc-ae ) toxicity and / or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal sarcomas using protons or carbon ions before a subsequent tumor resection.

with retroperitoneal sarcomas, the patient benefits from neoadjuvant radiotherapy. due to the special physical properties of particles (protons and c12 carbon ions), in particular the steep lateral dose drop, an improved protection of adjacent risk organs is e.g. intestine, kidneys, liver etc. during the process of applying radiotherapy is possible. the primary study objective is to demonstrate the safety and conduct of study treatment and the incidence of grade 3-5 nci-ctc-ae toxicity and / or termination of preferred therapy for any reason. further target parameter is the proportion of applied therapies without the occurance of degree 3-5 nci-ctc-ae(s). the patients are randomized 1: 1 into the two arms (carbon ions vs. protons). patients receive 39 gy in (sd 3.0 gy) in 6 fractions per week. secondary study objectives are local control (lc), local progression-free survival from the start of therapy (lpfs), disease-free survival (dfs), overall survival (os) and quality of life (qol) determined according to the eortc-quality of life questionaire (qlq)- c30 questionnaire.

Eligibility criteria:
inclusion criteria: * histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable * karnofsky index of ≥ 70% * age from 18 years * completed patient information and written consent * ability to give consent exclusion criteria: * stage iv (distant metastases) * lymphogenic metastasis * metal implants at the level of the sarcoma, which influence the treatment planning * previous radiation therapy in the treatment area * desmoid tumors, peritoneal sarcomatosis, gist * simultaneous participation in another clinical study that could influence the results of the respective study * active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator) * pregnant women
a feasibility study of an online intervention for sexual rehabilitation in prostate cancer

Conditions: Prostate Cancer

Summary: background: prostate cancer (pca) is the most common cancer for men. when treated early enough it is typically curable. however, common treatments, such as radical prostatectomy and radiation therapy, often result in significant negative outcomes with regard to sexual, psychological and social function. both men and partners have identified the need for more information and support to address sexual health concerns after treatment. however, very few sexual rehabilitation interventions have been developed and rigorously assessed. purpose: the investigators propose to develop and pilot test a new program to meet the sexual health needs of men with pca and their partners using an online, professionally facilitated education/support program. the goals of the program are to improve sexual function, intimacy and mood for men and their partners after treatment for localized pca. the program will be offered through cancer chat canada, an existing and well-tested canadian platform for professionally facilitated support group programs. what participants can expect: a total of 24 men and their female partners (48 individuals) will be recruited and assigned to one of two groups. the first group will participate in the program immediately; the second group will be offered the program after a 5-month delay. the decision about which group will start immediately and which later will be made randomly (by chance). both groups of men and partners will be asked to complete questionnaires three times and, at the end of the program, to provide the researchers feedback about how satisfied they were with the program, the changes they made, things they learned as a result of the program, and suggestions for improving the program. participants must have access to a computer, an internet connection and be willing to attend online, chat room meetings each week for 1.5 hours for 6 weeks. implications: sexual rehabilitation is a high need for men affected by pca, but is difficult to access. the investigators hope to improve access to sexual health care through this study.


Eligibility criteria:
inclusion criteria: * men who have been treated for localized prostate cancer * and men must be 6-36 months post-prostatectomy or radiation (as primary treatment) of prostate cancer * must have a heterosexual, co-cohabiting partner who is willing to participate * must speak and read english * must be able to use a computer and have internet access exclusion criteria: * homosexual couples will not be included in this study * major self-reported psychiatric illness * couples who screen below 30 on the das (dyadic adjustment scale)

Keywords: prostate cancer psychosocial intervention sexual rehabilitation online intervention
effects of periodontal treatment on hiv-infected patients

Conditions: HIV/AIDS; Periodontal Diseases

Summary: periodontal diseases, such as chronic periodontitis (cp), frequently occur in immunosuppressed patients, including hiv-infected patients. the immunosuppression resulted by the hiv infection can justify the high frequency and the difficult in controlling the cp in this group of patients, raising the possibility of additional factors associated to the development of cp in hiv patients. the aim of this study is to determine factors that can be involved in the cp pathogenesis in hiv patients, including candida spp presence, and biomarkers involved on the inflammatory response against the microorganisms.

investigators will develop one quasi-experimental study in hiv patients (n=15) and non-hiv patients (n=15) presenting cp. candida spp count and salivary and gingival crevicular fluid concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. in order to minimize the influence of the immunosuppressive condition, patients have to present cd4 t lymphocytes \< 200cel/mm3 blood count, non-detectable viral load and the same protocol of antiretroviral therapy. additionally, investigators intend to determine the immunophenotypic profile of the gingival tissue through immunohistochemical analysis. this study was approved by the institutional review board of the school of dentistry of ribeirão preto (caae: 50004415.1.0000.5419), and all patients need to provide written informed consent.

Eligibility criteria:
inclusion criteria: * general for both groups/arms: patients with at least 15 teeth; with chronic periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical attachment loss \>4mm); no use of antibiotics for the 6 months previous to study enrolment. * for hiv-infected group: cd4 t lymphocytes \< 200 cel/mm3, stable haart for the 6 months previous to study enrollment. exclusion criteria: * general for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.

Keywords: chronic periodontitis candida spp histatin-5 lactoferrin
juvenile bipolar disorder outpatient program

Conditions: Bipolar Disorder; Attention Deficit Disorder With Hyperactivity

Summary: this is an outpatient program for children and adolescents with bipolar disorders. the naturalistic approach of the program will allow a proper investigation of the disorder, assessment of environmental and biological factors, the conduction of treatment studies, and follow-up of the subjects.

inclusion criteria: age 6-17 years old, male and female. bipolar disorder i, ii, and nos (subjects presenting episodes of distinct abnormally and persistently elevated, expansive, or irritable mood, accompanied by at least three -or four if the mood is only irritable - criteria b symptoms and present to a significant degree for at least 24 hours. severe mood dysregulation (smd), as defined by brotman et al. (american journal of psychiatry, 2007) exclusion criteria: presence of a diagnosis of pervasive developmental disorder, schizophrenia, drug use disorder, and any other counter indications to outpatient treatment (significant suicide or homicide risk) diagnosis: k-sads-pl-w wasi clinical interview outcome measures: cbcl for general psychopathology ymrs, cmrs-p, cmrs-t for manic symptoms cdrs and cdi for depressive symptoms snap-iv for adhd symptoms scared-c and scared-p for anxiety symptoms cgi for clinical impression, cgas for global functioning petersen pubertal scale mood symptom questionnaire for smd screening tests for leaning disorders family environmental scale, life events scale, expressed emotion adjective checklist, resilience scale, quality of life for environmental and psychological factors medication adverse events checklist

Eligibility criteria:
inclusion criteria: * 6-18 years-old; * bipolar disorder i, ii or nos * severe mood dysregulation exclusion criteria: * schizophrenia * pervasive developmental disorder * drug use disorder * severe suicidal or homicidal risk, counterindicating outpatient treatment

Keywords: bipolar disorder attention-deficit/hyperactivity disorder genetics environmental factors family factors
patient education in patients with chronic obstructive pulmonary disease (copd) - effect and costs

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of this study is to determine the long term effect of a self-help group in a patient education program for patients with chronic obstructive pulmonary disease (copd).

pulmonary rehabilitation is aimed to increase the level of health of patients with copd by increasing their self care ability. a recent updated systematic review concluded that evidence strongly supports respiratory rehabilitation as part of the spectrum of management of patients with chronic obstructive pulmonary disease (copd). studies of pulmonary rehabilitation programs lasting up to 18 months show that effects are mainly maintained throughout the duration of the program. the long term effect, however, is mostly studied for programs of shorter durations. some of the studies with shorter duration have found that the achieved benefit was lost or diminished during the follow up period, while others have found that the effect has been maintained up to 18 months. our necessity in the rehabilitative field is to find strategies to maintain benefits during time.

Eligibility criteria:
inclusion criteria: * (fev1) lower that 75% of predicted * the ability to participate in physical activity * not been hospitalized the last month. exclusion criteria: * contraindications for physical activity

Keywords: chronic obstructive pulmonary disease outpatient patient education pulmonary rehabilitation self-management
vitamin d and arterial stiffness in elderly

Conditions: Vitamin D Deficiency; Arterial Stiffness

Summary: investigators will examine arterial stiffness and pulse waveform analysis. subjects with vitamin d insufficiency will be recruited. a double blind randomized controlled study will examine the effects of standard dose vitamin d3 (800 iu) versus higher dose vitamin d3 (5000 iu)-given on a daily basis.in order to understand mechanisms of action by which vitamin d would improve arterial stiffness investigators will use biomarkers. oxidative and inflammatory stress will be measured by plasma f2-isoprostanes and sulforaphane levels.

cardiovascular disease disproportionately impacts the elderly. current practice targets vascular disease with aggressive lipid lowering combined with brachial bp regulation, but has only achieved a modest degree of success. there is a need to intervene at a much earlier stage. increased arterial stiffness is a marker for subclinical vascular disease and a sensitive predictor of ischemic stroke in the elderly. vitamin d deficiency is linked to an increased risk of vascular disease. there is an urgent need for well controlled randomized interventional studies in healthy elderly individuals demonstrating that vitamin d levels can improve vascular function in healthy elderly with vitamin d insufficiency. high dose vitamin d (5000 iu) replacement is required to improve systemic inflammation which may contribute to arterial stiffness and vascular aging. the hypothesis is that daily 5000 iu vitamin d3 will regress or at least prevent progression of arterial stiffness as assessed by the carotid-femoral pulse wave velocity. furthermore, investigators postulate that this improvement will be linked to improved oxidative and inflammatory status. investigators will measure plasma measurements of sulforaphane and plasma f2-isoprostane to assess the anti-oxidative mechanisms by which vitamin d could influence arterial stiffness.

Eligibility criteria:
inclusion criteria: * community dwelling adults (subjects) aged between 65 and 89 years of age * subjects should be ambulatory, living at home and capable of self-care * subjects should be able to drive an automobile independently and without assistance * subjects agree to home visitation by coordinators to assess pill counts or willing to come to ttuhsc for such a visit every 4 weeks ± 3 days * 25(oh) vitamin d value \< 30 ng/ml * subjects able to read and understand the english language exclusion criteria: * subjects unable or unwilling to have follow up for the duration of the study * subjects that cannot take a daily vitamin d supplement or unwilling to have multiple blood draws * subjects on peritoneal or hemodialysis or a life expectancy less than 2 years * subjects with sarcoidosis or diseases associated with hypercalcemia * subjects with prior cerebrovascular disease or memory problems * subjects with prior myocardial infarction or atrial fibrillation or on anticoagulants * subjects on medications for memory or cognitive issues or mental health * subjects unable to tolerate sphygamocor and complior testing protocol
clinical trial on diabetes expert patients programme

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine whether participation in a diabetes expert patients programme course is effective in self-management of a chronic condition such as diabetes, if it reduces haemoglobin a glycosylated levels, improves patient's quality of life, and prevents the use of some health services.

the intervention consists in taking part in a diabetes expert patients programme course led by a teaching patient who has experience on chronic disease since he also suffers diabetes. the course is intended for 10 to 15 patients and it is scheduled on 9-weekly sessions (about two hours each session). a nurse supervises the group and observes it without taking part neither on dialogs nor presentations; this nurse helps teaching patient only on logistic needs. first session main contents are on group operation rules (informed consent expression, confidentiality rules, ...), on reasons and expected results of this kind of self-care support programmes and on general aims and purposes. after explanations, patients are invited to answer a set of validated questionnaires on social, demographic and clinical data (including treatments and comorbidities), diabetes knowledge, self-care and self-assessment and quality of life. in this session body weight, arterial pressure and waist perimeter are also measured and registered. the most recent value (until three months before inclusion) of haemoglobin a glycosylated will be collected from the lab information system. the following sessions (from second to ninth) will approach several disease aspects like: what diabetes is, its diagnostic and treatment, acute and chronic complications, food and eating habits, physical exercise and healthy lifestyles, treatment (drugs and insulin) and disease self-control and self-care. when intervention finishes, a follow-up period starts. at eighth and at 14th month from inclusion, participants will be summoned to provide again answers to questionnaires on knowledge, self-care, and quality of life. at both times, levels of haemoglobin a glycosylated are also measured. patients assigned at control branch are summoned at inclusion to obtain complete baseline data, and also at month 8th and at month 14th. on these three occasions, these subjects answer the same questionnaires (including clinical, morbidity data and lab information) administered to intervention group patients.

Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 2 * older than 18 exclusion criteria: * dementia * psychosis * home nursing * mental disabled people * subjects unable to express themselves in spanish or catalan languages * health professionals * subjects included simultaneously in other lifestyle counseling or health education programmes
a feasibility study of the nativis voyager® system in patients with recurrent glioblastoma multiforme (gbm) in australia

Conditions: Glioblastoma Multiforme

Summary: this feasibility study will assess the effects of the nativis voyager therapy in patients with recurrent gbm who have either failed standard of care or are intolerant to therapy. the study will enroll and treat up to eleven subjects over six months. safety and clinical utility will be evaluated.


Eligibility criteria:
inclusion criteria: 1. subject has histologically confirmed diagnosis of gbm. 2. subject has failed or intolerant to radiotherapy. 3. subjects has failed or intolerant to temozolomide therapy. 4. subject has progressive disease with at least one measureable lesion on mri or ct. 5. subject is at least 18 years of age. 6. subject has a kps ≥ 60. 7. subject has adequate organ and marrow function. 8. subject has provided signed informed consent. exclusion criteria: 1. subject has life expectancy less than eight weeks 2. subject has received other investigational therapy within the last 28 days. 3. subject has received surgery within the last two weeks or not fully from prior surgery. 4. subject has a clinically significant electrolyte abnormality. 5. subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device. 6. subject has a metal implant, including a stent, in the head or neck that is incompatible with mri. 7. subject is known to be hiv positive. 8. subject is pregnant, nursing or intends to become pregnant during the study period. 9. subject is participating in other investigational research. 10. subject has any condition that at the discretion of the investigator would preclude participation in the study. 11. subject is unable or unwilling to comply with the protocol-required follow-up schedule.