Kornimate/medical-research-clean huggingface dataset:
effect of exercise on risk-factors of elderly women

Conditions: Atrophy

Summary: the purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.

the human aging process is associated with a significant increase of risk factors (i.e. osteoporosis, coronary heard disease, diabetes) and a decline in neuromuscular function impacting independence of the subject. osteoporosis, diabetes type ii and arteriosclerosis are diseases known to correlate with age. participating in regular sport activities elicits numerous favorable effects that contribute to "healthy aging". unfortunately all existing studies which focus on specific diseases or conditions favour dedicated exercise regimes. however, the complex risk factor scenario of older adults requires multi-purpose exercise programs with impact on all relevant risks. furthermore so far no exercise study longitudinally determines the effect of an ambulatory exercise program on health cost considering the specific health policy framework of germany. we hypothesize that regular exercise 1. significantly impact relevant osteoporosis, cardiovascular diseases and diabetes risk factors in elderly subjects 2. significantly reduces health costs in elderly community living women

Eligibility criteria:
inclusion criteria: * community living caucasian woman ≥ 65 years; live expectation \> 2 years exclusion criteria: * secondary osteoporosis * cvd-events including stroke * participation in other studies * medication with impact on bone during the last 2 years: * bisphosphonates * parathormone * strontium * hrt, anabolic steroids * calcitonin * natriumflourides * active vit-d-metabolites * cortisone \> 5 mg/d * medication with impact on falls * low physical performance (\<50 watt during ergometry) * excessive alcohol-intake

Keywords: exercise intervention elderly woman risk factors health costs osteoporosis cardiovascular diseases diabetes higher age
best clinical endpoints that likely induce worse prognosis in interstitial lung diseases

Conditions: Interstitial Lung Disease

Summary: this prospective cohort study will investigate whether progression of the interstitial lung diseases is related to specific clinical endpoints and their changes over time. longitudinal data of patients will be compared to an age-matched control group during a follow-up of at least two years.


Eligibility criteria:
inclusion criteria: 1. patients with interstitial lung disease: * age between 40 and 75 years old upon inclusion; * diagnosis of interstitial lung disease; * clinical stability for at least 4 weeks prior to inclusion; * absence of any comorbidity that interferes with the performance of tests; 2. age-matched control group: * age between 40 and 75 years old upon inclusion; * absence of any comorbidity that interferes with the performance of tests; exclusion criteria (both groups): * participants that present severe or unstable cardiac disease identified during the cardiopulmonary exercise testing; * participants with cognitive deficit that interfere with any of the tests;

Keywords: interstitial lung disease prognosis clinical endpoints association
a study of roactemra/actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this open-label study will evaluate the safety, tolerability and efficacy of roactemra/actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (ra) on background non-biologic dmards who have an inadequate response to current non-biologic dmards. patients will receive 8 mg/kg roactemra/actemra as an intravenous infusion every 24 weeks for a total of 6 infusions. the anticipated time on study treatment is 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * moderate to severe active rheumatoid arthritis (das28\>/=3.2) of \>/=6 months duration * body weight \</=150 kg * patients are on one or more non-biologic dmards at a stable dose for a period \>/=8 weeks prior to study treatment * patients with inadequate clinical response to a stable dose of non-biologic dmard exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization * rheumatic autoimmune disease other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis * history of or current inflammatory joint disease other than rheumatoid arthritis
evpome versus alloderm in subjects reconstructed with large defect mandibular resection

Conditions: Mandibular Injuries

Summary: the purpose of this study is to compare the safety and effectiveness of performing oral reconstructive surgeries using either alloderm, a product commonly used for this purpose, or alloderm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, evpome.


Eligibility criteria:
inclusion criteria: * be an adult over 18 years of age * have a free fibular graft placed more than six months ago that has been used for restoration of mandibular continuity. * be in need of surgery to increase the vestibular fold of the grafted mandible for placement of a dental prosthesis to restore function exclusion criteria: * any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol of interpretation of the results difficult * a history of syphilis, hiv, hepatitis b or hepatitis c * pregnancy or planning to become pregnant * known or suspected allergy to bovine (cow) protein * receiving radiation * currently smoking or using tobacco products * talking medication that can result in gingival enlargement (cyclosporine, dilantin, calcium channel blockers) * allergy to any of the following antibiotics gentamycin, cefoxitin, lincomycin, polymyxin b, vancomycin, cephalosporins, or clindamycin * allergy to polysorbate 20

Keywords: vestibuloplasty
correlation of electroencephalogram with postoperative delirium during cardiac surgery

Conditions: Electroencephalogram; Postoperative Delirium

Summary: the purpose of this study is to explore characteristic changes of eeg epileptiform discharges in patients under cpb and correlation with pod

cardiac surgery under cardiopulmonary bypass (cpb) as a result of the surgery itself great trauma and cpb this special process can lead to cerebral hypoperfusion, cerebral ischemia, increased in patients with postoperative neurological complications, the incidence of postoperative cognitive dysfunction can up to 44-53%.postoperative delirium (pod) is not only increase the incidence of postoperative cognitive dysfunction forward, affect the quality of postoperative recovery and increased hospital costs, also associated with postoperative mortality. although the clinical use of different drugs and technology improve the pod, but due to the mechanism is still unclear, is still lack of effective control measures. electroencephalogram (eeg) can measure the cerebral cortex and subcortical local potential activities, to reflect the activities of the neurons in the brain. cpb can cause the abnormal vibration of brain waves, epileptiform discharges is the result of abnormal discharge of brain neurons, which is correlated with the occurrence of cognitive dysfunction.but whether eeg epileptiform discharges is related to the pod is uncertain.while epileptic seizures can be treated with anticonvulsant drugs, so the detection and treatment of early epileptic seizures may have important clinical significance for the occurrence of pod. therefore, the main purpose of this study is to explore characteristic changes of eeg epileptiform discharges in patients under cpb and correlation with pod, offer the theoretical foundation for delirium early warning and prevention.

Eligibility criteria:
inclusion criteria: 1. asa ii-iii; 2. no cognitive impairment was assessed one day before surgery; 3. patients undergoing elective cpb cardiac surgery(valvular heart surgery and coronary bypass surgery) and signed informed consent. exclusion criteria: 1. non-cpb surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease; 2. stroke, schizophrenia, depression, parkinson's disease, epilepsy or dementia; 3. inability to communicate with language impairment or major hearing or visual impairment; 4. liver function child-pugh grade c, severe liver dysfunction; 5. severe renal insufficiency requires preoperative renal replacement therapy; 6. a past history of intraoperative knowledge.

Keywords: electroencephalogram epileptiform discharges postoperative delirium cardiac surgery
motor system activation with transcranial direct current stimulation and physical exercise to reduce pain in elderly

Conditions: Chronic Pain

Summary: physical exercises are known to reduce chronic pain in elderly individuals by activating the motor system. however, it seems that exercises are not effective for everyone. the investigators believe that elderly individuals with altered corticospinal tract will be those in whom the exercise alone are not sufficient to relieve pain. for those patients, adding an exogenous stimulation of the motor system such as transcranial direct current stimulation (tdcs) would facilitate the corticospinal tract, and consequently, would help exercises to relieve chronic pain. the investigators hypothesize that combining tdcs with the exercises will be more effective than exercises alone, but only in individuals who initially show low corticospinal projections.

prevalence and intensity of chronic pain increases substantially with age. according to several studies, physical exercises are effective to reduce chronic pain in elderly. however, it seems that exercises are not effective for everyone. one of the hypotheses raised is that the people in whom the exercises have no effect would be those with an alteration of the corticospinal tract. transcranial direct current stimulation (tdcs) is a non-invasive neurostimulation technique known to facilitate the corticospinal tract when applied over the motor cortex. elderly suffering from chronic pain will be recruited in this double-blind, parallel-group, randomised control trial. participants will be randomized to receive exercises combined to real tdcs (5 daily sessions, 2 ma, 20 minutes) or to sham tdcs. intervention will last 8 weeks at a rate of 3 workouts per week.

Eligibility criteria:
inclusion criteria: * to have musculoskeletal chronic pain * not to change medication and life habits during the study exclusion criteria: * people physically active before the study (more then 150 min of moderate to vigorous exercise par week) * to have an uncontrolled cardiovascular disease * to have orthopedic limitation or contraindication to physical exercise * to have contraindication to tdcs * to have contraindication to tms * to have contraindication to mri

Keywords: transcranial direct current stimulation physical exercise corticospinal projections
positive psychology for chronic pain self-management

Conditions: Chronic Pain

Summary: learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. community health workers (chws) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. the goal of this study is to conduct a randomized pilot and feasibility trial of a positive psychology-based chronic pain self-management intervention delivered by chws, in conjunction with mobile health tools, in a sample of 50 older adults recruited from community sites in detroit, michigan. this study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.


Eligibility criteria:
inclusion criteria: * english-proficient * ambulatory with or without assistive device * community-living * have a cell or landline phone * have internet access (home or elsewhere); * self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>4 (0-10 scale) average pain level over last week; \>1 day/previous 30 when pain made it difficult to do usual activities. exclusion criteria: * serious acute illness or hospitalization in last month * planned surgery in next three months * severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit
phase i/ii study of linperlisib plus chidamide for r/r cutaneous t-cell lymphoma: a prospective, single-center study

Conditions: Cutaneous T-cell Lymphoma

Summary: hdac inhibitor chidamide and pi3k inhibitor linperlisib has shown clinical activity as mono therapy in ptcl. the combination of duvelisib and romidepsin is highly active against relapsed and refractory t-cell lymphomas including cutaneous t-cell lymphomas (ctcls). the aim of this study is to further explore the efficacy and safety of hdac inhibitor chidamide combined with pi3k inhibitor linperlisib in the treatment of relapsed and refractory ctcls.


Eligibility criteria:
inclusion criteria: * ages 18-75; * mycosis fungoides and sezary syndrome confirmed by histopathology; * patients with measurable lesions, with or without extra-cutaneous lesions, and clinical stage iib-ivb; * no remission or relapse after at least one systemic therapy (including total body electron irradiation, becarodine, retinoic acid, interferon, photoseparation and replacement, methotrexate, chidamide, etc.); * ecog score of 0-2; * adequate bone marrow hematopoietic function: neutrophil count (anc) ≥1.5×109/l, platelet count (plt) ≥80×109/l, hemoglobin (hgb) ≥90g/l; * adequate organ function: nyha grade 1-2, lvef≥50%, alt\ 93%@ra, scr\>60ml/(min·1.73m2); exclusion criteria: * acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged qt interval (\> 450ms in men and \> 470ms in women) within 6 months; * uncontrolled active infections; * active hepatitis b and c infection (hepatitis b virus dna over 1×103 copies /ml is excluded, hepatitis c virus rna over 1×103 copies /ml is excluded) * pregnant or lactating women; * investigators judged that they were not suitable to participate in the study
retinal detachment after lens surgery in the nearsighted

Conditions: Retinal Detachment; Lens Diseases; Short-Sighted

Summary: this study aims to study the incidence of retinal detachment in the nearsighted myopic after phakoemulsification lens surgery and use of posterior chamber foldable soft implants with a follow-up of 5 years and preliminary results at 3 years.

major advances have been made in the field of lens surgery over the last 20 years which has significantly reduced the per and postoperative complications of this surgery. retinal detachment remains the most feared complication of this surgery in the nearsighted. there is currently an increasing popularity in the international ophthalmic community for the correction of ametropia, particularly nearsightedness, by ablation of the non-cataracted lens, referred to as refractive lensectomy. however, no recent study reports the complications of this procedure with the use of modern surgical techniques. this study aims to study the incidence of retinal detachment in the nearsighted myopic after phakoemulsification lens surgery and use of posterior chamber foldable soft implants with a follow-up of 5 years and preliminary results at 3 years.

Eligibility criteria:
inclusion criteria: * signed informed consent form. * male or female aged 20 to 60 included. * myopia: axile, united or bilateral. * degree of myopia: axial length of the eye to be operated ≥ 26 mm, measured by ultrasound a or b. * preoperative visual acuity of the eye to be operated ≥ 0.2. * crystalline eye to operate natural: clear or opacified (allowed: cataract complicating a myopic implant and cataract after corneal refractive surgery. exclusion criteria: * history of retinal detachment on the eye to be operated or the eye to help. * history of glaucoma of the eye to operate. * intraocular pressure of the eye to operate ≥ 21 mmhg. * history of diabetic retinopathy. * history of anterior or posterior intraocular inflammation in the year preceding surgery. * history of vitreoretinal syndrome (stickler's disease ...). * unstable systemic pathology in the month preceding the preoperative check-up (visit 1) (example: uncontrolled hypertension, diabetes with abnormal glycemia, thyroid disorders, uncontrolled autoimmune diseases, etc.) or deemed by the investigator to be incompatible with the study (example: hepatic or renal insufficiency, all severe chronic organic diseases: metabolic, endocrine, neoplastic, hematological, etc., severe psychiatric diseases). * pregnancy, breastfeeding. * history of filter surgery of the eye to be operated. * history of vitreoretinal surgery of the eye to be operated (authorized after day 0). * patient unable to understand the instructions of the study or not likely to comply with the course of the study and treatment. * participation in another clinical trial in the month preceding the start of this study, at the same time as this study. * patient not covered by the french social security system. * major patient under guardianship.

Keywords: phacoemulsification
evaluation of vegf polymorphism as predictive factor in metastatic colorectal cancer treated with folfiri plus bevacizumab

Conditions: Metastatic Colorectal Cancer

Summary: -1498c/t vegf polymorphism, as suggested by a recent retrospective analysis, seems to have a role in predicting the efficacy of bevacizumab plus folfiri in first-line treatment of metastatic colorectal cancer patients. the present study aims to prospectively evaluate the predictive role of this polymorphism in metastatic colorectal patients receiving the same treatment.


Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal adenocarcinoma; * measurable metastatic disease according to recist criteria; * patients receiving bv plus folfiri as first-line treatment; * written informed consent; * availability of blood samples for genetic analysis.- exclusion criteria:

Keywords: vegf polymorphism bevacizumab
a comparing study between alt02(trastuzumab biosimilar) and herceptin® in healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to compare alt02 (trastuzumab biosimilar) and herceptin® (us-licensed trastuzumab and eu-licensed trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.


Eligibility criteria:
inclusion criteria: * healthy male subjects * have a body weight over 50.0 kg and a body mass index over than 18.5 and less than 30.0 kg/m², inclusive. exclusion criteria: * any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis b, hepatitis c, or hiv found during medical screening. * positive urine drug screen or alcohol breath test at screening. * history of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs. * any reason which, in the opinion of the qualified investigator, would prevent the subject from participating in the study. * clinically significant electrocardiogram (ecg) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmhg, diastolic blood pressure lower than 50 or over 90 mmhg, or heart rate less than 50 or over 100 bpm) at screening. * history of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[1 unit = 150 ml of wine, 360 ml of beer, or 45 ml of 40% alcohol\]). * history of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[pcp\], and crack) within 1 year prior to screening. * use of trastuzumab or another monoclonal antibody for a medical condition or in the context of another clinical trial. * participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration. * use of medication other than topical products without significant systemic absorption: 1. prescription medication within 14 days prior to dose administration; 2. over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily); 3. a depot injection or an implant of any drug within 3 months prior to dose administration. * donation of plasma within 7 days prior to dosing. donation or loss of blood (excluding volume drawn at screening) of 50 ml to 499 ml of blood within 30 days, or more than 499 ml within 56 days prior to dosing. * hemoglobin \<128 g/l and hematocrit \<0.37 l/l at screening.

Keywords: her2 positive breast cancer trastuzumab biosimilar
a research study to investigate how well nnc0165-1875 in combination with semaglutide works in people with obesity

Conditions: Obesity

Summary: the study is looking at a new medicine to help people lose weight. in this study participants will either get semaglutide and nnc0165-1875 or semaglutide and a "dummy" medicine (placebo). which treatment participants get is decided by chance. participants will get 2 injections per week, on the same day. participants will have to take the study medicine by use of a pre-filled pen. a pen is a medical tool with a needle used for injections under the skin. the study doctor or staff will show participants how. the study will last for about 26 weeks. participants will have 17 visits at the clinic with the study doctor. at 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.women: women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. women who are able to become pregnant can participate if they agree to use contraception during the study.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * male or female, age above or equal to 18 years at the time of signing informed consent. * bmi 30.0-45.0 kg/m\^2 (both inclusive) at the screening visit. exclusion criteria: * hba1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening. * history of type 1 or type 2 diabetes mellitus. * treatment with glucose-lowering agent(s) within 90 days before screening.