Kornimate/medical-research-clean huggingface dataset:
mitochondria preservation by exercise training: a targeted therapy for cancer and chemotherapy-induced cachexia

Conditions: Cachexia; Rectal Cancer

Summary: this study aims to define the contribution of cancer and chemotherapy to muscle and systemic alterations that drive the onset of cachexia in rectal cancer patients and validate in human cancer cachexia (cc) the alterations in mitochondrial function and neuromuscular junction (nmj) observed in the experimental models, thus providing the rationale for potential anti-cachexia strategies based on exercise and or exercise mimetics.

this is a multicenter observational prospective cohort study in rectal cancer patients after neoadjuvant therapy (yctnm) stage ii, iii, and iv (ajcc 8th edit), clinically stratified in the pre-cachectic or cachectic stage according to fearon k et al. definition. that will be subject to curative or palliative surgery through any surgical approach. and a control subgroup of patients who will undergo any abdominal surgery type through any approach type for no neoplastic or inflammatory disease. the study will take place in four italian centers of colorectal surgery. will be run a preoperatory physical performance, and will be recorded the physical activity by wearing a smartwatch. the quantity of muscle will be estimated by the cross-sectional area (csa) or the skeletal muscle area (sma) from the magnetic resonance imaging (mri) or computed tomography ct, respectively, and the skeletal muscle index (smi). the muscular quality will be studied by the mean skeletal muscle radiation attenuation (smra) and mri proton density fat fraction (pdff). all these parameters will be calculated by a radiologist from the preoperative mri or ct imaging study. the study includes the analysis of preoperatory inflammatory and nutritional biomarkers. and a muscular biopsy harvested by the surgeon from the rectum or oblique abdominal during rectal resection-palliative surgery. the sample will undergo morphological and structural studies using histology, immunohistochemical, immunofluorescence, biochemical, and molecular analyses.

Eligibility criteria:
inclusion criteria: * patients with confirmed histopathological diagnosis of rectal adenocarcinoma yctnm stage ii, iii, or iv (ajcc 8th). * patients treated with neoadjuvant therapy. * patients that will be subject to curative intent or palliative surgery through any approach (open, laparoscopic, or robotic). * ability to sign the informed consent. exclusion criteria: * rectal cancer stage i or any stage without neoadjuvant therapy. * age \ 75 years * long steroid treatment for any cause. * emergency setting. * co-existent inflammatory bowel disease. * inflammatory comorbidities (liver failure, diabetes, metabolic acidosis, acute and chronic renal failure, sepsis, aids, acute and chronic hepatitis, autoimmune disorders, and chronic obstructive pulmonary disease). * healthy volunteers. * other (simultaneous) neoplastic disease
high intensity body-weight circuit training in type 2 diabetics

Conditions: Type2 Diabetes

Summary: exercise has been shown to be effective at improving fitness, as well as markers of glucose tolerance and control, in persons with type 2 diabetes. recently, several investigations have demonstrated that improvements are realized by patients with high intensity interval exercise which is characterized by periods of vigorous exercise alternated by periods of moderate exercise. typical interval training sessions require significantly less time to complete than traditional modes of exercise wherein moderate intensity activity is sustained for some time. this may be especially beneficial to those with type 2 diabetes, as lack of time is a frequently cited reason for not engaging in regular exercise. bodyweight circuit training carries the potential to similarly improve health and metabolic function in persons with type 2 diabetes, and may do so with even a smaller accumulation of exercise because this type of exercise involves a greater percentage of the trainee's muscle mass compared with common forms of interval training (e.g., treadmill or cycle exercise). the purpose of this study is to quantify the effects of 3-4 sessions per week of bodyweight circuit training sustained for 5-10 minutes per session on health-related physical fitness and glucose tolerance/control in people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes of at least 1 year * hemoglobin a1c level between 6.0% and 10% exclusion criteria: * currently engaging in a physical activity * currently taking exogenous insulin * undertaking a regiment or lifestyle modification intervention. * cardiovascular or pulmonary diseases.
the relationship between rheumatoid arthritis and osteoporosis and factors contributing to this connection

Conditions: RA & OP Relationship

Summary: this study aims to explore the association between ra and osteoporosis and highlight the risk factors that ra patients have that may cause or affect osteoporosis progress.

rheumatoid arthritis (ra) is an autoimmune chronic connective tissue disease that produces persistent systemic inflammation, with joint inflammation leading to function loss and joint destruction. it can finally lead to some serious systematic disorders, such as cardiovascular, pulmonary, skeletal, and psychological disorders. one of the most severe comorbidities of ra is osteoporosis (op), which is a chronic metabolic skeletal disease leading to an increased risk of low trauma fracture, and many factors can play a role in increasing this association including treating ra patients with glucocorticoid over a long duration, chronic joints inflammation, calcium malabsorption, age of the patients, and genetics. osteoporosis is characterized by microarchitectural deterioration of bone tissue and low bone mass. the most commonly used measurement for op is bone mineral density (bmd) and dexa (dual x-ray absorptiometry) scans. osteoporosis can result in devastating physical, psychosocial, and economic consequences. still, it is often overlooked and undertreated, in large part because it is clinically silent; there are no symptoms before a fracture occurs. epidemiological studies indicate that about 60-80% of ra patients have a comorbidity of op. these two kinds of complex diseases may share some common genetic mechanisms and biological processes. for example, proinflammatory cytokines including tnf-α, il-17, il-6, and il-1 have been reported to be closely associated with op, and they also play important roles in the development of ra. also, the inflammation in the joints increases bone absorption and makes ra patients susceptible to bone loss and osteoporosis development. one of the primary drugs recommended for the treatment of ra is a corticosteroid, glucocorticoid (gc). both systemic corticosteroid and intraarticular corticosteroid are proven to be risk factors for developing secondary osteoporosis and osteoporotic fracture. the risk increases with the long duration of use and using a high dose. longer duration and severity of ra were also indicated as independent risk factors for vertebral fractures. the american college of rheumatology (acr) recommended increasing the awareness of ra patients about bmd and getting dxa done for identifying a patient at risk of osteoporosis.

Eligibility criteria:
inclusion criteria: * patient more than 18 years old classified as rheumatoid arthritis based on acr/eular 2010 classification criteria. exclusion criteria: * patients with other clinical conditions that causes secondary osteoporosis as diabetes mellitus, renal, liver diseases, thyroid and parathyroid disorders.
music & memory: a pragmatic trial for nursing home residents with alzheimer's disease_part1

Conditions: Dementia

Summary: the purpose of this trial is to test the effects of a personalized music intervention (music and memory, inc.) on agitated and aggressive behaviors for nursing home residents with dementia.

the purpose of this study is to conduct a parallel, pragmatic, cluster randomized control trial of personalized music (music and memory) for nursing home residents with moderate to severe dementia living in 54 nursing homes (27 treatment, 27 control) from 4 nursing home corporations. music and memory is a personalized music program that uses portable music players to deliver individualized music to people with dementia at times when agitated behaviors are likely. \*\*this funding mechanism sponsored two parallel trials with different implementation strategies. in this trial, nursing home staff identify the music a resident with dementia may have preferred when s/he was young by asking family members and testing individual songs with the resident. details of the second parallel trial conducted under this funding mechanism are registered under "r33ag057451_part2."\*\* the aims of this study are: 1. to use a train-the-trainer model to implement the intervention with ongoing monitoring of the program's adoption and acceptance by nursing home residents with dementia; 2. to estimate the impact of music and memory on agitated and aggressive behaviors; and 3. to examine factors associated with variation in providers' adherence to the implementation of music and memory.

Eligibility criteria:
inclusion criteria for nursing homes: * owned by partnering health care corporations * medicare / medicaid-certified * have at least 20 eligible residents inclusion criteria for residents in eligible nursing homes * reside in eligible nursing home for last 90 days * have advanced dementia, defined by the presence of a dementia diagnosis and moderately or severely impaired daily decision-making exclusion criteria for nursing homes: * recent situations that may affect implementation (for example, bad state or federal quality assurance surveys, leadership turnover, or other competing demands) * previous use of music and memory exclusion criteria for residents in eligible nursing homes: * dislikes music * completely deaf
evaluation of an innovative medical device supporting orthopedic surgical interventions

Conditions: Fracture of Distal End of Radius

Summary: this study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery. aim of the study is the validation and comparison of the innovative medical device with the current standard method.


Eligibility criteria:
inclusion criteria: * patients with diastal fracture of the radius * patients with the mentioned fracture and indication for surgical treatment according to national guidelines * age \>/= 18 years of age * patients willing to participate and after having given their informed consent in written form exclusion criteria: * participation in other interventional clinical trials * pregnant or lactating women
brain and coordination changes induced by robotics and fes treatment following stroke

Conditions: Cerebral Stroke; Cerebrovascular Accident; Stroke

Summary: the long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. this study will compare treatment response to robotics versus functional neuromuscular stimulation.

methods. up to ninety-six chronic stroke subjects (\> 12 months post stroke) will be randomized to one of the treatment groups: wrist/hand functional electrical stimulation (fes)+whole arm motor learning group; shoulder/elbow robotics + whole arm motor learning group; and whole arm motor learning group. for all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. all three treatment groups will receive motor learning therapy. for the wrist/hand fes+whole arm motor learning group, there will be the addition of fes during treatment. for the shoulder/elbow robotics + whole arm motor learning group there will be the addition of robotics training. outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. measures will include muscle strength (manual muscle testing); coordination of joint movement (fugl-meyer coordination scale); motor control of target acquisition, pathway maintenance; and smoothness of movement (robotics measures); performance of 13 functional tasks (arm motor ability test); and quality of life (stroke impact scale). measures of brain function will be non-invasive and will include cognitive planning time, cognitive effort level, and location of brain activity during simple shoulder and arm movements. changes in brain function measures will reflect plasticity or adaptability in response to treatment.

Eligibility criteria:
inclusion criteria: * medically stable and at least 12 months post stroke. * difficulty using upper limb for functional tasks. * age \>21 years exclusion criteria: uncontrolled, chronic medical condition

Keywords: motor learning rehabilitation robotics therapeutic electric stimulation
a study of cd19/bcma chimeric antigen receptor t cells therapy for patients with refractory scleroderma

Conditions: Scleroderma; Autoimmune Diseases

Summary: a study of cd19/bcma chimeric antigen receptor t cells therapy for patients with refractory scleroderma

autoimmune diseases only show local pathological damage, but more often systemic lesions. if not diagnosed and treated in time or poorly controlled, a risk of disability or even death as the course of the disease progresses. studies have shown that b cells can present their own antigens to autoimmune t cells to promote the release of inflammatory factors, or they can differentiate into plasma cells to release autoantibodies, and play an important role in the occurrence and progression of autoimmune diseases. in recent years, it has become a major research focus to deplete b cells in patients or inhibit b cell function. this research focuses on car-t cells killing b cells. this fully reflects the application prospects of car-t cells in autoimmune diseases. based on the current research progress, our center intends to conduct research on the safety and effectiveness of cd19/bcma car-t cells in the treatment of refractory scleroderma

Eligibility criteria:
inclusion criteria: 1. scleroderma with positive cd19/bcma expression , and the conventional treatment is not effective and (or) no effective treatment 2. estimated survival time\> 12 weeks; 3. patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up; 4. patients or their legal guardians volunteer to participate in the study and sign the informed consent. exclusion criteria: * subjects with any of the following exclusion criteria were not eligible for this trial: 1. history of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; 3. pregnant (or lactating) women; 4. patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. active infection of hepatitis b virus or hepatitis c virus; 6. concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; 7. creatinine\>2.5mg/dl, or alt / ast \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 8. other uncontrolled diseases that were not suitable for this trial; 9. patients with hiv infection; 10. any situations that the investigator believes may increase the risk of patients or interfere with the results of study 11. platelets ≥30×10e9/l, and absolute lymphocyte count ≥1.0×10e9/l 12. methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease.

Keywords: scleroderma cd19 car t-cell therapy bcma car t-cell therapy
verify the effectiveness rtms using meg

Conditions: Tinnitus

Summary: the purpose of this study is to determine whether rtms are effective in the treatment of tinnitus

repetitive transcranial magnetic stimulation (rtms) of the dorsolateral prefrontal cortex (dlpfc) has an add-on effect for primary auditory cortex rtms in improving tinnitus-related distress. we aimed to investigate whether rtms of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness. linked to a neuronavigation system that is guided by magnetic resonance imaging (mri) of the frontal and temporal, rtms can suppress areas of cortical plasticity. this cortical reorganization can be demonstrated by magnetoencephalography (meg)

Eligibility criteria:
inclusion criteria: * diagnosis of chronic tinnitus * chronic subjective tinnitus for more than 6 months * pure tone average \<50 db hl in the ear where tinnitus is perceived * dominant tinnitus frequency measured between 4 and 8 khz * subject is naive regarding rtms * other concurrent treatments: a four-week washout from any other tinnitus * treatment or management program is required prior to entering this study * stable enough to complete this study per the opinion of the study physician * no restrictions, provided the dosages have been in place for at least 3 months * a three month washout from any other tinnitus treatment or management program is required prior to entering this study. exclusion criteria: * objective tinnitus or tinnitus with treatable cause * absolute thresholds \> 60 db on individual frequencies up to 8 khz * presence of intracranial or intraocular ferromagnetic materiel or particles cardiac pacemaker or other electronic implants (including cochlear implant) * serious heart disease or other unstable major medical condition personal history of central nervous system disorder, head injury, stroke or seizures * familial history of epilepsy; * concomitant medication with antidepressants and antipsychotics * pregnant women * severe depression * severe anxiety * others known contraindications to rtms or brain mri
treatment efficacy of leg cycling as part of physiotherapy treatment in elderly patients with hip fracture

Conditions: Hip Fractures

Summary: this study aims to evaluate whether a combination of cycling training as part of physiotherapy treatment will contribute more than conventional physiotherapy treatment for elderly patients after hip fracture surgery in their subacute phase of rehabilitation.

adults who have experienced a fall, followed by proximal hip fracture that required surgery, suffer from specific problems that interrupt the rehabilitation period in their subacute phase. various modes of treatment available as part of the physical rehabilitation but there is not enough data in the literature regarding the contribution of cycling training with leg cycle ergometer as part of conventional physiotherapy treatment in elderly patients after hip fracture surgery. this study evaluates whether the additional cycling to physiotherapy treatment will improve the functional ability, the balance performance while standing, hip muscle strength and pain level in those patients.

Eligibility criteria:
inclusion criteria: * proximal hip fracture with full or partial weight bearing indication. * surgical fixation ( nailing or total hip replacement or hemiarthroplasty) * pre-morbid function: walking independently or under supervision with or without assistance aid * cognitive function: mini-mental state examination score above 21 exclusion criteria: * pathological hip fracture. * unstable heart or pulmonary disease. * presence of other fractures as a result of the current fall. * neurological comorbidities ( cva, parkinson, ms ). * entering the rehabilitation center more than three weeks after hip surgery

Keywords: proximal hip fracture elderly patients physiotherapy leg cycling ergometer
feasibility and effectiveness of virtual reality & use of body weight support treadmill training in parkinson's disease

Conditions: Parkinson Disease

Summary: the primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with parkinson's disease


Eligibility criteria:
inclusion criteria: * idiopathic parkinson disease diagnosis * age under 80 years * severity of disease rated 2 or 3 at hoehn \& yahr scale exclusion criteria: * impaired cognitive functioning: score less than 24 on the mini mental state examination * neurologic conditions in addition to parkinson disease that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol * severe levodopa dyskinesia * pregnancy

Keywords: parkinson disease mobility balance virtual reality treadmill training
investigation of the effect of vitamin k3-lotion for the treatment of cetuximab induced folliculitis

Conditions: Folliculitis

Summary: the study aims to explore the benefit of topical vitamin k3 lotion for the reactivation/rephosphorylation of egf-receptor in the skin and the possible reduction in cutaneous side effects of egfr-inhibition. primary aim: the possible reduction of cutaneous side effects: folliculitis, dryness and redness of the skin. secondary aim: to explore any possible side effects of topical vitamin k3 lotion. methods: 36 patients with metastatic colorectal cancer or metastatic head and neck cancer allocated to treatment with chemotherapy and biweekly cetuximab. two equally sized areas of at least 10x10 cm on the back or chest of the patient is marked. patients receive in a double blinded procedure placebo lotion on one side and vitamin k3 lotion on the other side. the treatment may last for a maximum of two months and the patients are followed biweekly with photos, vas-scores, questionnaires and ctcae estimations. the patient will be able to take weekly photos at home during the weeks they are not seen at the outpatient clinic. during the treatment all other skin products or antibiotics is allowed and will be carefully registered by the health care professionals in the outpatient clinic. the patient may enter the trial in two different ways: 18 patients start treatment with study lotions at the time they start treatment with cetuximab. the other 18 patients start treatment with study lotions when folliculitis appears. patients are asked for 1.5 mm skin biopsies of both study areas of the skin before start of treatment and after 4 weeks of treatment with placebo lotion and vitamin k3 lotion. these biopsies will be investigated for egfr, phosphorylated egfr and other central downstream mechanisms. the biopsy part of the study is optional for the patient.


Eligibility criteria:
inclusion criteria: * planned or ongoing treatment with cetuximab * age at least 18 years * informed written consent according to local and national legislation exclusion criteria: * known disease that can influence either treatment, evaluation and the outcome of the current disease and treatment, including chronic dermatology * known hypersensitivity to menadion * concomitant treatment with vitamin k or vitamin k-antagonists * known psychological, family, sociological or geographic conditions which potentially can influence planned study treatment or follow-up

Keywords: vitamin k3 lotion cetuximab induced folliculitis