Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of three doses of aclidinium bromide compared to placebo and to an active comparator in chronic obstructive pulmonary disease (copd) patients.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved bid drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (copd).after 7 days on treatment. every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. the trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.


Eligibility criteria:
inclusion criteria: 1. males and non-pregnant, non-lactating females aged ≥ 40. 2. patients with a clinical diagnosis of stable moderate to severe copd, according to the global initiative for chronic obstructive lung disease (gold) guidelines: (http://www.goldcopd.com) and stable airway obstruction. post-salbutamol fev1/fvc \< 70% at screening visit (visit 1) (i.e., 100xpost-salbutamol fev1/fvc \<70%). 3. current, or ex-cigarette smoker with a smoking history of at least 10 pack-years. 4. patient whose fev1 at the screening visit measured between 10-15 minutes post inhalation of salbutamol is 30% \< fev1 \<80% of the predicted normal value (i.e., 100 x post-salbutamol fev1/ predicted fev1 must be \< 80% and ≥ 30%). 5. female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception. 6. patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent. exclusion criteria: 1. history or current diagnosis of asthma. 2. clinically significant respiratory conditions other than copd at the time of inform consent signature 3. hospitalisation due to copd exacerbation within the previous 3 months. 4. signs of a copd exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks. 5. clinically significant cardiovascular conditions 6. presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction. 7. presence of narrow-angle glaucoma. 8. qtcb) above 470 milliseconds in the ecg performed at screening visit, 9. patient who does not maintain regular day/night, waking/sleeping cycles

Keywords: copd
proton radiation for the treatment of pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas

Conditions: Non-rhabdomyosarcoma Soft Tissue Sarcoma; Bone Sarcoma

Summary: the main purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.

* participants will receive radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks, depending on how much total dose the tumor requires. the radiation doctor will see the participant once each week to monitor and record any side effects they may have from radiation treatment. * a special device will be made for each participant to help them hold still during the treatment. this may either be a mask or foam cradle, depending on the area to be treated.

Eligibility criteria:
inclusion criteria: * biopsy proven nrsts or bone sarcoma * less than or equal to 30 years of age * patients must have been treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated * patients must be willing to receive follow-up care for a minimum of five years after treatment at mgh and annual visits unless it is too difficult to return to mgh for follow-up care. in that event, the patient or guardian must be willing to have their outside medical information released in order to track the results of treatment * they or their legal guardian must give their informed consent * timing of radiation may be according to concurrent protocol exclusion criteria: * co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury of collagen vascular disease * patients who are pregnant * previous treatment with radiation therapy * concurrent adriamycin or gemcitabine chemotherapy is planned, unless on a concurrent protocol

Keywords: proton beam radiation
trastuzumab-deruxtecan in patients with triple-negative metastatic her2-low breast cancer: real-world experience in brazil

Conditions: Breast Cancer

Summary: a national, multicenter, retrospective, observational study (real-world evidence-rwe) aimed to assess the efficacy of trastuzumab-deruxtecan (t-dxd) in patients with triple-negative (re\<10%) metastatic her2-low breast cancer.

data from study destiny-04 have established t-dxd as the standard second-line treatment for her2-low breast tumors. in that study, about 90% of the population had estrogen-positive receptor (er+) tumors, under-representing negative er population. the investigators propose to assess t-dxd efficacy in her2-low/er ≤10% patients in brazilian population by means of a rwe analysis. endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.

Eligibility criteria:
inclusion criteria: * aged above 18 years old; * have advanced, hormone receptor negative (er ≤10%), her2-low (1+ or 2+/fish negative) breast cancer; * have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line; * do not have active cns metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months. exclusion criteria: * have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms); * have other active neoplasms (except from non-melanoma skin tumors); * have serious or active non-oncology lung diseases; * have other primary and concurrent breast tumor with differing receptor profiles.
permeability enhancement to reduce chronic inflammation

Conditions: End Stage Renal Disease; Inflammation

Summary: chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. it is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. dialyzers made by membranes with increased pore size (high cut-off dialyzer hco1100) may be beneficial in the elimination of inflammatory mediators and may improve the inflammatory status. hypothesis: in this study it will be investigated whether the treatment with hco1100 will improve the inflammatory status of chronic dialysis patients.


Eligibility criteria:
inclusion criteria: * dialysis treatment for ≥ 3 months * dialysis 3x weekly * vascular access by fistula or cvc providing qb of ≥ 250 ml/min * dialysis with high-flux dialyzer for a minimum of 2 weeks before begin of study * crp \> 5mg/l at least once within 12 weeks before inclusion * age \> 18 and \< 99 years * ability to give written informed consent exclusion criteria: * missing informed consent form * clinically manifested infection or current crp-value \> 50mg/l * serum albumin \< 35g/l * intake of immune suppressive medication * pregnancy or lactation * participation in a different study

Keywords: inflammation dialysis
the effectiveness of group-delivered revised guided written exposure therapy for ptsd and subclinical ptsd among chinese adolescents

Conditions: PTSD

Summary: the study aims to examine the effectiveness of the group-delivered revised written exposure therapy (wet-r) for post-traumatic stress disorder (ptsd) and subclinical ptsd among chinese adolescents with a randomized controlled trial. the study will recruit 70 participants, with 35 randomized to the wet-r group and 35 randomized to the waiting list (wl) group. the wet-r intervention consists of 5-8 group sessions. the primary outcome cpss-5-i (child ptsd symptom scale-interview version for dsm-5) and pcl-5 ( ptsd checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.


Eligibility criteria:
inclusion criteria: 1. adolescents aged 10-18 years. 2. meeting full or subthreshold ptsd (up to one symptom missing) diagnostic criteria according to the child ptsd symptom scale-interview version for dsm-5 (cpss-5-i). 3. if taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks. 4. capable of writing and understanding written instructions. exclusion criteria: 1. presence of severe psychopathology necessitating immediate medical attention 2. moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future 3. evidence of a moderate or severe traumatic brain injury 4. currently undergoing psychotherapy specifically for ptsd.

Keywords: ptsd written exposure therapy randomized controlled trial adolescents
effect of orthoses and underfoot vibration on balance in neuropathy

Conditions: CMT - Charcot-Marie-Tooth Disease; Peripheral Neuropathy; Hereditary Peripheral Neuropathy; CMT1A

Summary: a cross-sectional study which will look at the effects of afo's and vibrating insoles on balance performance in people with cmt disease.

balance impairments and falls are more common in people who have charcot marie tooth disease (cmt) than in people without the condition. cmt is a condition which affects the nerves causing a variety of symptoms including sensation impairments and weakness. the impairments are usually most evident in the feet and hands, but they can progress very slowly moving closer to the trunk. ankle foot orthoses (afo's) are often prescribed to help with walking and daily function. so far the effects of afo's on standing balance in people who have cmt have not been looked at. insoles are also often prescribed to realign foot deformity and reduce pain. insoles which give a vibratory input have had a positive impact on walking in older people but have not been looked at in balance and in cmt. insoles which give a vibration feedback to the sole of the foot when worn have been designed. this study will look at whether the use of afo's and the vibratory insoles have an effect on standing balance in people with cmt or related peripheral neuropathy. balance measurements will be taken in a single session comparing a variety of postures. patients will be recruited from neurology outpatient clinics at the national hospital of neurology and neurosurgery.

Eligibility criteria:
inclusion criteria: 1. clinical or genetically confirmed diagnosis of cmt or related peripheral neuropathy 2. mixed sensory and motor presentation 3. over 18 years 4. able to stand unsupported for five minutes 5. able to walk for 50m with or without a walking stick or orthotic devices exclusion criteria: 1. presence of other significant neurological disorders (such as multiple sclerosis, cerebrovascular diseases, epilepsy, movement disorders), or major comorbidities (e.g. vestibular dysfunction, use of medication which may affect balance, cognitive impairment, presence of medical conditions in which exercise training may be detrimental). 2. presence of peripheral neuropathy caused by a condition other than cmt. 3. limb surgery during the six months prior to screening (or planned before final assessment). 4. women of child-bearing age if they are pregnant, planning a pregnancy during their time in the study or in the 12 weeks following giving birth. this is due to the effects of pregnancy on balance.

Keywords: physiotherapy physical therapy balance posturography
electronic monitoring of events for diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: diffuse large b cell lymphoma is the most common malignant lymphoid hemopathy. more than half of the patients will be cured with an rchop-type immunochemotherapy protocol (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone). monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. patients are the best candidates to report them. managing these events should improve quality of life and reduce costs. the aim of this study is to assess the feasibility of monitoring these events by a web application (oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell b lymphoma in first-line treatment with r-chop.


Eligibility criteria:
inclusion criteria: 1. patient with untreated large b cell lymphoma requiring a first line treatment by rchop or r-mini-chop 2. patient aged 18 years or older at the time of signing informed consent form 3. additional intrathecal or/and intravenous treatment with methotrexate allowed, if indicated 4. eastern cooperative oncology group (ecog) performance status \< 3 5. patient with internet access (or has someone at home who can help send patients' symptoms or complete the form) 6. patient enrolled in social security 7. patient has given his written consent ahead of any specific protocol procedure exclusion criteria: 1. patient with symptomatic brain metastases, 2. patient deprived of their liberty, under guardianship or trusteeship 3. patient is being treated for another cancer and has not been cured 4. patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol 5. patient cannot submit to the protocol for psychological, social, familial or geographical reasons 6. patient is pregnant or breastfeeding

Keywords: oncolaxy web-application electronic patient reported outcomes
study comparing mini-incision versus 2-incision approach for total hip replacement

Conditions: Osteoarthritis

Summary: the purpose of the research is to determine if there is a difference between two of the commonly used less invasive techniques (surgical methods that use a smaller incision or cut in the skin) used to perform total hip arthroplasty (replacement of your painful hip with a new ball and socket). it is unclear which of these techniques is associated with a faster recovery and lower risk of complications.

recently, surgical techniques and surgical instruments have been developed to limit the dissection required to perform a total hip arthroplasty. proponents of these procedures feel that it is associated with less perioperative blood loss, less pain and an accelerated recovery while critics have raised concerns that the more limited exposure may negatively impact component position and increase the risk of perioperative complications. among less invasive surgical techniques, two of the different approaches utilized include a "mini-incision" posterior approach which aims to limit the amount of dissection associated with a standard posterior approach to the hip and a 2-incision technique which seeks to further limit soft tissue disruption by taking advantage of intermuscular planes and the use of fluoroscopic guidance. while the mini-posterior approach utilizes an abbreviated exposure which is familiar to most surgeons, the 2-incision approach is a more novel approach and critics of this approach feel that its technically demanding nature may be associated with a higher risk of complications and component malposition. proponents of the 2-incision approach feel that this approach is less invasive, more muscle sparing and leads to substantial improvements in patient rehabilitation and recovery with potential longer-term benefits in terms of improved function. the goal of this project is to compare the use of a mini-incision posterior approach and the 2-incision approach in primary total hip arthroplasty via a prospective randomized trial.

Eligibility criteria:
inclusion criteria: * diagnosis of hip osteoarthritis * age greater than 18 years * willingness to undergo a neuraxial anesthetic for the procedure * female patient greater than one year postmenopausal, surgically sterile or using an accepted form of contraception exclusion criteria: * use of any medication that may impact platelet aggregation within 10 days of surgery * chronic use of coumadin for anticoagulation * the use of low molecular weight heparin postoperatively * clinically significant systemic disease or laboratory abnormalities * a primary hematologic disorder * recent gastrointestinal or intracranial bleeding * any contraindication to anticoagulant use * history of previous ipsilateral hip surgery * a body mass index of greater than 30 * significant hip deformity that precludes the use of standard implants * use of only general anesthetic during surgery

Keywords: hip arthroplasty minimally invasive
deep brain stimulation in laryngeal dystonia and voice tremor

Conditions: Laryngeal Dystonia; Spasmodic Dysphonia; Tremor; Dystonia

Summary: the goals of this project are 1) to determine the incidence of neurological voice disorders in patients with dystonia and essential tremor undergoing deep brain stimulation (dbs), 2) investigate the neuroimaging and intracranial neurophysiology correlates of voice dysfunction in these subjects, and subsequently 3) determine the effects of dbs on voice function.

loss of voice control, which is critical for conveying effective spoken communication, is often a significant feature in patients with movement disorders, such as dystonia and essential tremor. voice dysfunction, however, has been overshadowed clinically by a focus on limb motor symptoms. for example, deep brain stimulation (dbs) effectively reduces limb dystonia and tremor in these patients, but the modulation of voice symptoms by dbs has been vastly understudied. it is assumed that the production and modulation of voice are regulated by the basal ganglia-thalamo-cortical network in a loop architecture that is common to all motor behaviors. there is, however, little empirical data to inform our specific understanding of how voice function is encoded in basal ganglia-thalamo-cortical interactions. the overall goal of this research is to use a combination of invasive and non-invasive human neuroscience to improve our understanding of the incidence and neural correlates of neurological voice disorders (laryngeal dystonia and voice tremor) in patients with isolated dystonia and essential tremor undergoing dbs surgery. the investigators will use simultaneous electrocorticography (ecog) and subcortical activity recording in dystonia and tremor patients who are awake and speaking during dbs implantation surgery. the results of this research will inform the development of strategies for closed-loop brain stimulation specifically to treat neurological voice dysfunction that can be tested in a subsequent clinical trial.

Eligibility criteria:
inclusion 1. clinical indications to proceed with dbs implantation, as determined by the clinical multidisciplinary movement disorders board, including: a) definitive diagnosis of essential tremor or dystonia, b) medically refractory disease, c) adequate performance on neuropsychological evaluation as determined by a licensed clinical neuropsychologist. 2. the ability to comply with test directions, complete pre-operative task training, and provide informed consent. 3. age 18-80 years. exclusion 1. inability to understand or perform the task outlined in the protocol during a pre-surgery training session. 2. significant hearing loss. 3. cortical venous anatomy that could potentially obstruct ecog electrode placement, as determined by the surgeon, visualized on pre-op mri or during surgery.
nosocomial bacterial and fungal chest infections in cirrhotic patients

Conditions: Nosocomial Infection

Summary: hospital acquired chest infections are common complications in hospitalized cirrhotic patients. infectious complications are the most common cause of mortality in cirrhotic patients with bronchopneumonia early antibiotic treatment at the base of culture and sensitivity is an optimal therapeutic approach in cirrhotics with nosocomial pneumonia intensive care unit acquired pneumonia is the leading infection in critically ill patients and a major cause of morbidity and mortality despite recent major advances in antimicrobial therapy, supportive care, and the use of a broad range of preventive measures

aim of the work 1. to estimate the frequency and risk factors of nosocomial chest infections in cirrhotic patients . 2. to determine the causative pathogens of nosocomial chest infections in patients with cirrhosis including fungal infections in order to establish our local empirical antimicrobial protocol. 3. to define the impact of nosocomial chest infections on survival of our patients. 4. to develop an effective and continuous surveillance program and infection control measures to reduce the burden of these infections as well as morbidity , mortality , hospital stay ,hospital cost and to achieve quality of care . 5. to motivate pharmaceutical companies to create a new umbrella coverage of antimicrobials through the ongoing knowledge of the changes in microbial resistance pattern inside hospitals

Eligibility criteria:
inclusion criteria: * all cirrhotic patients , decompensated , child pug score b or c ,may have hepatocellular carcinoma , other comorbidities may present as (diabetius mellitus , hypertension , heart disease and renal impairment ) , both sex and with clinical suspicion of chest infections acquired after 48 hours of admission exclusion criteria: * patients have any chronic chest disease * patients have severe immunosuppression (neutropenia after chemotherapy or hematopoietic transplant, drug-induced immunosuppression in solid-organ transplant or cytotoxic therapy, and hiv-related disorders.
are comorbidities related to frequent severe exacerbations of aecopd

Conditions: Chronic Obstructive Lung Disease; Acute Exacerbation of COPD; Comorbidities and Coexisting Conditions

Summary: introduction: relationship between comorbidities and copd is two-sided. while the number of comorbidities increasing, the frequency of acute exacerbations of copd (aecopd) is increasing, too. comorbidity indexes can be used for recognition of comorbidities while managing copd patients. in the present study, it is aimed to compare comorbidity indexes such as charlson comorbidity index, comcold and cote in the matter of exacerbation frequency. method: subjects hospitalized for aecopd, admitted to the study. exacerbation severity, frequency, further exacerbations for a 1-year period in the follow-up period and cci, comcold and cote scores were recorded. high and low comorbidity groups were compared for aecopd frequency, severity, and further exacerbations.


Eligibility criteria:
inclusion criteria: * copd patients * admitted to the ward for aecopd exclusion criteria: * not giving informed consent * unable to perform pft * lost to follow-up