Kornimate/medical-research-clean huggingface dataset:
the effects of a positive expiratory pressure (pep) on dyspnea and dynamic hyperinflation during exercise in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: from the relationship between pathophysiology of chronic obstructive pulmonary disease (copd), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators hypothesize that 1. positive expiratory pressure (pep) breathing will reduce dyspnea more than normal breathing during exercise in mild to moderate copd patients. 2. pep breathing will improve dynamic hyperinflation during exercise more than normal breathing in mild to moderate copd patients. 3. pep breathing will improve cardiorespiratory function during exercise than normal breathing in mild to moderate copd patients.

expiratory airflow limitation is the pathophysiological hallmark of chronic obstructive pulmonary disease (copd) that leads to air trapping and increases in dynamic hyperinflation (dh) and consequently causes dyspnea during exercise. although pursed lips breathing is a simple technique that provides a positive back pressure may retard the airway collapsed, but previous studies showed an unsuccessful reduction of dh which might cause by insufficient back pressure. and thereby a conical positive expiratory pressure (c-pep) has been developed in our laboratory to generate back pressure higher than pursed lips breathing. moreover, an effect of pep on dh has not carried out in patient with copd. therefore, the objective of the present study was to examine effects of a c-pep on dh and respiratory response during exercise in patient with copd.

Eligibility criteria:
inclusion criteria: * patients with stable mild-to-moderate copd (both stages: fev1/fvc \< 70%. mild stage: fev1 ≥ 80% predicted; moderate stage: 50% ≤ fev1 \< 80% predicted according to global initiative obstructive lung disease (gold) guideline). * free of exacerbations for more than 4 weeks (as defined by a change to pharmacological therapy, admission to hospital or er or unscheduled clinic visit). * good communication exclusion criteria: * older than 70 years old * musculoskeletal problems that limit mobility * cardiovascular disease * neurological or psychiatric illness * patient on long term oxygen or domiciliary noninvasive positive pressure ventilation * any other comorbidities which would affect ability to undertake exercise test

Keywords: chronic obstructive pulmonary disease dynamic hyperinflation dyspnea recovery positive expiratory pressure exercise
helios china registry: evaluation of the helios stent in a 'real-world' patient population

Conditions: Coronary Artery Disease

Summary: the study aims to evaluate the safety and efficacy of biodegradable polymer sirolimus-eluting coronary stent system (helios) in patients with coronary artery disease . the primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven target lesion revascularization at 1 year follow-up.

this is a prospective, multicenter, single arm clinical registry investigating the safety and efficacy of biodegradable polymer sirolimus-eluting coronary stent system(helios) in patients with coronary artery disease . the helios (kimley medical, shenzhen, china) completed biodegradable polymer sirolimus-eluting stent (ses) is a novel polylactic-co-glycolic acid (plga),polymer cobalt-chromium des with titanium oxides (tio) film as the tie-layer.in total, we plan to recruit 3000 patients (helios)in real world setting. the patients will be followed clinically at 1-, 6- month and 1-, 3-, 5-year. all clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee.

Eligibility criteria:
inclusion criteria: 1）18-85 years old, male or non-pregnancy female; 2）patients with coronary artery disease who match the indication of stent implantation; 3）patients who can understand the nature of the study, agree to participate and accept clinical follow-up exclusion criteria: 1. patients who can not tolerate the material or medication in this study; pregnancy or lactation women 2. patients who had participated in another investigational drug or device trial that has not completed the primary endpoint; 3. patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol
postural balance of the adult

Conditions: Postural Balance

Summary: description of the geometrical configuration of the skeleton with regard to gravity line by patients suffering from spinal disorders that may induce postural troubles

in clinical routine, 3d analysis of postural balance is only made using clinical examination. when dealing with specific pathologies, in particular spine disorders, a better understanding of the balance could help better treat and prevent late complications. this prospective study aims at describing the pathologies of the musculoskeletal system using 3d reconstruction of the spine, the pelvis and the inferior limbs with regard to gravity line by patients suffering from postural trouble and defining new parameters to assess postural balance

Eligibility criteria:
inclusion criteria: * affiliated to social insurance * informed of the benefits, the risks and the conduction of the study and have given their free informed consent. for patients * medical prescription for an eos™ exam, or for frontal and lateral full-spine radiographs or for a pangonogram. for healthy volunteers * 50 years old exclusion criteria: for patients * patients that neither need any eos™ exam, nor face \& lateral full-spine radiographs, nor pangonogram. for healthy volunteers * children or young adults (\<50) * psychiatric or neurologic deficit. * anterior surgery of spine or inferior member * chronic back pain * recent acute back pain

Keywords: balance spine disorders equilibrium
umbilical cord mesenchymal stem cells for the repair of large area burn wounds

Conditions: Large Area Burns

Summary: this study intends to adopt a prospective, open, and randomized controlled research method to explore the effectiveness and safety of using human umbilical cord mesenchymal stem cells to treat large-scale burn wounds, in order to break through the limitations of various current treatment methods, explore new clinical treatment methods, promote the repair and healing of skin lesions, and further improve the cure rate and quality of life of patients.

large area deep burn patients, due to extensive skin defects in their limbs that cannot be repaired by the body itself, need to undergo skin grafting surgery to seal the wound. although skin transplantation can partially meet the needs of wound sealing, the skin scar hyperplasia after transplantation and healing is significant, affecting the appearance and motor function of the limbs. moreover, the healed skin lacks dermal tissue and sweat glands and other skin accessories, resulting in poor skin quality after wound healing, and accompanied by obvious discomfort such as fear of heat, itching, and pain, which seriously affects the patient's quality of life. mesenchymal stem cells have high differentiation potential and can differentiate across embryonic boundaries into epithelial tissue cells such as skin. they can also secrete various cytokines to produce chemotactic and anti apoptotic effects, promoting the formation of wound neovascularization and wound healing. human umbilical cord mesenchymal stem cells, due to their convenient and painless source, have become good seed cells for promoting wound healing.

Eligibility criteria:
inclusion criteria: 1. selected patients are voluntary and sign an "informed consent form"; 2. burn wound area ≥ 20% tbsa, and iii ° wound area ≥ 2% tbsa; 3. age range from 18 to 65 years old, regardless of gender; 4. plan to perform two or more limb iii degree wounds with scab cutting and autologous skin grafting surgery for treatment; 5. no severe heart, lung, blood system, or nervous system diseases; 6. there are no clear complications such as systemic infections. exclusion criteria: 1. patients who do not agree to participate in this experimental study; 2. age\ 65 years old; 3. patients with definite malignant tumors, aids, diabetes, and autoimmune diseases; 4. pregnant or lactating patients; 5. individuals with systemic dysfunction; 6. patients with acute and chronic liver and kidney diseases; 7. poor compliance makes it difficult to complete the experiment.

Keywords: large area burns human umbilical cord mesenchymal stem cells wound healing
bright light therapy for post-covid-19 fatigue

Conditions: Post COVID-19 Condition

Summary: this is a randomized placebo-controlled trial to examine the efficacy of two-week bright light therapy for patients with post-covid-19 fatigue.

this randomized placebo-controlled trial aims to evaluate the efficacy of blt in reducing fatigue symptoms after covid-19 infection. the second aim of the study is to explore the effects of blt on insomnia, depression and anxiety symptoms. method: each eligible participant will be randomized to either i) bright light therapy (blt) or ii) dim red light (placebo) treatment for 30-minutes daily at their habitual wake time for a total of two weeks. participants will be evaluated at baseline, 2nd (end of treatment), and 4th week (post-treatment 2-week) for fatigue and other symptoms.

Eligibility criteria:
inclusion criteria: * age 18 or above * capable to give informed consent * covid-19 infection confirmed by pcr test or a rapid antigen test (rat) with onset of at least three months * reports new onset or exacerbation of fatigue after onset of covid-19 and lasted for over two months * scoring 7 or above for the item "worst level of fatigue during the last 24 hours" in the brief fatigue inventory exclusion criteria: * a current or past history of bipolar disorder, schizophrenia, neurodevelopmental disorder, organic mental disorder; intellectual disabilities or substance use disorder. * presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma. * significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview. * regular shift-workers * trans-meridian flight in the past 3 months and during the study * currently receiving any structured psychotherapy * self-reported untreated sleep disorders (e.g. severe insomnia, obstructive sleep apnea, restless leg syndrome), psychiatric illness (e.g. depression), or medical conditions associated with fatigue (e.g. anemia, heart failure, autoimmune disorders) * enrolment in another clinical trial of an investigational medicinal product or device.

Keywords: covid-19 long covid fatigue
a study to evaluate coronary atherosclerosis in patients with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the natural history of coronary atherosclerosis development and progression over time by ccta and to identify risk factors attributable to the development of coronary atherosclerosis in a korean dm population.

patients with diabetes mellitus, who underwent initial ccta (coronary computed tomographic angiography) at the diabetes center of the asan medical center between february 2008 and june 2012, will be evaluated for inclusion in the study. all dream-ccta study patients will undergo follow-up ccta based on order from their primary physician. ccta and demographic data, medical history, cardiovascular risk factors, and laboratory data was collected in case report forms at the time of the initial ccta and at the time of follow-up ccta.

Eligibility criteria:
inclusion criteria: * age 19 years or older * asymptomatic patients with type 2 dm who had undergone initial ccta evaluation at the diabetes center of the asan medical center between february 2008 and june 2012 * willing and able to provide informed written consent exclusion criteria: * blood test results that the creatinine level exceeds 1.5 mg/dl * a person with a history of anaphylaxis or allergic shock associated with a contrast medium * pregnant women * unable to undergo follow-up ccta * uninterpretable ccta
effects of lactobacillus paracasei ps23 on anti-fatigue

Conditions: Fatigue

Summary: this research is to explore the effects of supplementing lactobacillus paracasei ps23 to reduce fatigue and improve physical fitness after exhaustive exercise.

studies have found that the intestinal flora of athletes is different from that of ordinary people, and short-chain fatty acids play a very important role. previous animal experiments have found that supplementing with specific probiotics can slow down muscle loss in aging mice. in addition, clinical studies have found that supplementing with probiotics can improve sports performance by regulating the intestinal flora and related metabolites. therefore, the purpose of this research is to explore the effects of supplementing lactobacillus paracasei ps23 to reduce fatigue and improve physical fitness after exhaustive exercise. this study compares supplementary samples with placebo and adopts a double-blind study design.

Eligibility criteria:
inclusion criteria: * healthy adult men and women aged 20-40 who are generally non-athletic players exclusion criteria: * bmi≧27 * known allergy to probiotics * have current or history of inflammatory bowel disease * patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks * those who have taken medication such as anti-inflammatory pain killer or antibiotics in the past one month * smoker and alcoholic * who have been injured within 6 months * who has been diagnosed and treated of cardiovascular disease, hypertension, metabolic disease, asthma, or cancer * have undergone surgery of liver, bladder, or gastrointestinal tract * who has conflict of interest with pi
evaluation of maxy-g34 in breast cancer patients treated with tac (docetaxel, adriamycin, cyclophosphamide) chemotherapy

Conditions: Chemotherapy-Induced Neutropenia; Breast Cancer

Summary: this is an investigation of the safety and efficacy of maxy-g34 in breast cancer patients treated with tac chemotherapy. maxy-g34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six chemotherapy cycles.


Eligibility criteria:
key inclusion criteria: 1. males and females at least 18 years of age 2. diagnosis of high-risk stage i, ii or iiia breast cancer suitable for adjuvant tac chemotherapy as based on investigator judgment 3. candidates for tac chemotherapy, and no prior treatment with anthracyclines key exclusion criteria: 1. received chemotherapy within last 3 month prior to screening, or expected to receive any chemotherapy other than tac and / or immunotherapy between screening and 30 days after last planned study drug administration 2. any clinically significant findings on history or examination that, in the opinion of the investigator, would preclude administration of tac chemotherapy in the full dose, including abnormal liver function, inadequate cardiac function or clinically significant cardiac disease, neuropathy or other disease 3. prior bone marrow or peripheral blood hematopoietic stem cell transplant 4. any active cancer or history of prior malignancy within the last 5 years except carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin or any surgically cured malignancy diagnosed 5 years or more before diagnosis of breast cancer

Keywords: neutropenia breast cancer chemotherapy
pain relief investigation of neuromodulation therapy in adult humans

Conditions: Chronic Musculoskeletal Pain

Summary: the study is being performed to determine the efficacy and safety of fralex neuromodulation therapy (f-nmt), delivered by the fralex prima device, in reducing chronic musculoskeletal pain.


Eligibility criteria:
neonatal procalcitonin intervention study

Conditions: Sepsis

Summary: in neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values. the investigators hypothesize that procalcitonin (pct) has a reliable negative predictive values to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal early-onset sepsis with unchanged outcome. this study is designed as a multi-center, prospective, randomized intervention trial. the duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the probability of infection during hospitalisation. in the pct group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive pct values are within the normal range.

detailed description according our pilot study (see reference). this trial is designed to exclude a difference in rate of re-infection or death greater than 2%. assuming a 2% reinfection/death rate in each group, 770 patients are required for a power of 80% at alpha=0.05. to allow for some unevaluable cases 800 per group will be included. based on the data of the pilot study (see reference), with a number of 770 per group a difference between mean antibiotic therapy durations of 10 hours can be detected at two-sided alpha of 0.05 with a power of 95%.

Eligibility criteria:
inclusion criteria: * term and near term infants with a gestational age \> 34 weeks * suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy * parental consent exclusion criteria: * surgery in the first week of life * severe congenital malformations

Keywords: procalcitonin sepsis newborn intervention study
ceramic-on-ceramic versus ceramic-on-hxlpe tha

Conditions: Osteoarthritis, Hip; Avascular Necrosis of the Femoral Head; Arthropathy of Hip; Hip Arthr

Summary: methods to reduce the revision rate of total hip arthroplasties (thas) because of wear-related issues are important to examine, particularly because younger patients have a disproportionately high risk of revision. the investigators hoped to follow up patients and see if long-term harris hip scores and womac scores better in younger patients with a ceramic-on-ceramic (coc) tha compared with those with a ceramic-on-highly-cross-linked polyethylene (cop) tha.

high success rates obtained in the general population have stimulated for total hip arthroplasty (tha) in young and active patients. although there have been substantial improvements in tha, bearing surface wear and osteolysis are major factors limiting the durability of thas in young and active patients. during the last decade, alternative bearings have been developed, including highly cross-linked polyethylene (hxlpe) and ceramic-on-ceramic (coc) bearings, with the potential to reduce wear and osteolysis in younger, more active patients. despite contemporary cementless tha with coc bearings giving excellent clinical and radiographic outcomes, there is concern about squeaking, fracture of the ceramic head or acetabular insert or fretting and corrosion (trunnionosis). although hxlpe have been reported to reduce polyethylene wear, there is concerned about a potential decrease in toughness, tensile strength and resistance to the propagation of fatigue cracks in a long-term follow-up. several noncomparative studies of coc and cop tha have reported promising results in terms of harris hip scores, radiographic findings, and survival rates, yet we are aware of no long-term comparative clinical studies with a coc tha and a cop tha in the same younger patients. this study aimed to see if long-term harris hip scores and western ontario and mcmaster universities osteoarthritis (womac) score better in younger patients with a coc tha compared with those with a cop tha.

Eligibility criteria:
inclusion criteria: * bilateral end-stage hip arthrosis exclusion criteria: * inflammatory arthritis, foot and ankle disorders, dementia, stroke history, high dislocation of hip, patients older than 55 years
strategy to improve adherence of roflumilast

Conditions: Chronic Obstructive Pulmonary Disease

Summary: main adverse events of roflumilast are weight loss, loss of appetite, insomnia, headache, diarrhea, vomiting, and nausea. although the majority of these adverse reactions were mild or moderate. they occurred mainly at the beginning of therapy and mostly resolved with continued treatment around for two weeks according to experiences of clinicians. these adverse events occur more often in roflumilast 500 μg than 250 μg, having negative impact on compliance of patients at the early stage of treatments. thus, investigators aim to compare the drop-out rates between the usual dosage (roflumilast 500 μg once daily) and the dose escalation (roflumilast 250 μg once daily for 4 weeks and then escalating dose of 500 μg once daily).


Eligibility criteria:
inclusion criteria: 1. male or female older than 40 years 2. clinical diagnosis of copd (confirmed with a post-bronchodilator forced expiratory volume in 1 s \[fev1\]/forced vital capacity \[fvc\] ratio ≤70%) at least 4 weeks prior to the study and post-bronchodilator fev1 is 50% or less than the predicted value 3. former smokers or current smokers with at least a 10 pack-year history 4. a history of exacerbation (scheduled/unscheduled visits to primary care physicians, specialists or allied healthcare professionals, or emergency room, or hospitalization due to purulent sputum or increased sputum, or increased dyspnea) in the previous year (at least one) 5. chronic bronchitis (cough and sputum production for at least three months within two years) 6. able to have the signed written informed consent prior to any study-related procedures. exclusion criteria: 1. copd exacerbation or respiratory infection 4 weeks prior to the baseline visit 2. known a1-antitrypsin deficiency 3. need for long-term oxygen therapy 4. moderate to severe liver impairment (child-pugh b or c) 5. severe immunological diseases (e.g. hiv infection, multiple sclerosis, lupus erythematosus, etc) 6. severe acute infectious diseases 7. cancers 8. subjects being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term) except short-term systemic corticosteroids) 9. latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster 10. subjects with congestive heart failure (nyha grades 3 and 4) 11. subjects with a history of depression associated with suicidal ideation or behavior 12. clinically meaningful bronchiectasis 13. pregnancy or breast feeding, or female subjects of childbearing potential unwilling to use effective contraception 14. patients with known hypersensitivity to roflumilast or rescue medication and their ingredients 15. patients with previous roflumilast therapy within past 3 months
dose escalation of different concentrations of zk 245186 in atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to determine the safety and efficacy of three concentrations of zk 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.


Eligibility criteria:
inclusion criteria: * diagnosis of atopic dermatitis (hanifin and rajka criteria) * mild to moderate atopic dermatitis at beginning of study * wash-out periods for systemic and topical treatments for atopic dermatitis * females must use effective contraception exclusion criteria: * pregnant or lactating women * conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study * wide-spread atopic dermatitis requiring systemic treatment * diagnosed with immunocompromised status * skin diseases - other than atopic dermatitis - in the treatment area * mental handicap or legally incompetent