Kornimate/medical-research-clean huggingface dataset:
exercise capacity and fatigue in heart failure patients with and without inspiratory muscle weakness

Conditions: Heart Failure

Summary: in patients with heart failure, diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. patients exhibit reduced exercise capacity, peripheral and respiratory muscle strength, decreased respiratory function, increased dyspnea, fatigue, and worsened quality of life. however, it is unclear how these parameters will change in patients with inspiratory muscle weakness. therefore, the study aimed to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness and healthy controls

it is believed that respiratory muscle abnormalities develop earlier and more extensively than extremity muscle abnormalities in heart failure. diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. heart failure patients exhibit increased airway resistance and ventilatory response during exercise. fatigue and dyspnea are common symptoms associated with exercise intolerance and decreased quality of life in heart failure patients.there is no study in the literature comparing functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness (imw). the aim of the study was to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without imw and healthy controls. the study was planned as a cross-sectional, retrospective. heart failure patient were divided into imw group or not imw group due to their mip values. also healthy controls who were matched for age-gender were included.

Eligibility criteria:
inclusion criteria: * hf patients were being aged over18 years * clinically stable at least four weeks * having no change in medications over three months the inclusion criteria for healthy controls were being aged over 18 without a chronic disease exclusion criteria: * having unstable angina, acute myocardial infarction, uncontrolled hypertension, significant valvular disease, history of malignancy or orthopedic, rheumatologic, neurological, or pulmonary diseases the exclusion criteria for the healthy controls were having any chronic or systemic disease, and having physical limitation

Keywords: heart failure exercise capacity respiratory muscle
a study on the safety and effectiveness of ibi318 combined with conventional tace (ctace) as a perioperative treatment for potentially resected hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this phase ib study is to assess the safety, tolerability and effectiveness of ibi318 in combination with conventional tace (ctace) in patients with potentially resected hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years and ≤ 75 years at the time of consent. 2. hepatocellular carcinoma confirmed by histology/cytology. 3. lesions with measurable disease at baseline by mrecist. 4. barcelona clinic liver cancer stage a or b for hepatocellular carcinoma exceeding milan criteria. 5. child-pugh: \<=6 6. adequate organ and bone marrow function. exclusion criteria: 1. with fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues. 2. having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma. 3. potential liver transplant candidates 4. have a history of hepatic encephalopathy or have a history of liver transplantation. 5. with clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
adaptive radiotherapy using plan selection for bladder cancer

Conditions: Adverse Effects for Adaptive RT of Bladder Cancer

Summary: this protocol describes a phase 2 clinical trial of online adaptive radiotherapy, using a library of 3 dose plans corresponding to small, medium and large size bladder. the procedure includes 'common toxicity criteria for adverse effects'(ctcae) for registration of adverse effects (baseline, every 2'nd week during rt, 2 weeks, 3, 6, 12 and 24 month after rt) as well as cinemr for intra-fractional motion (baseline and every week during rt). patients receive standard non-adaptive rt in the first week. delineations of the bladder on the cone-beam scans (cbct) from first week of treatment are used for planning the small and medium size bladder plans. large size plan are the standard non-adaptive treatment plan used for the first week of treatment. a margin of 5 mm for intra fractional movement is used.

after inclusion patients are asked about their adverse effects by an oncologist using ctcae (version 4.0) questionnaire. a planning ct-scan is acquired and for the first 10 patients also a mr-scan for intra fractional motion is acquired. the mr sequence is repeated every week during radiotherapy. the first week of treatment a standard non-adaptive imrt-plan is used and cbct-scans are acquired before and after treatment. the cbct-scans are used for delineation of the bladder on the cbct-scans from the first 4 fractions. the adaptive plans are generated from the union of the first 4 cbct-bladders and the planning ct bladder (medium size) and the volume contained in at least 2 out of the 5 bladder volumes (small size). details can be found in the reference list. from the 6'th fraction the treatment is performed using the most appropriate size of treatment plan. ctcae is repeated every other week during radiotherapy and 2 weeks, 3, 6, 12 and 24 month after radiotherapy.

Eligibility criteria:
inclusion criteria: * histologically proven bladder cancer * age over 18 years * urothelial or planocellular carcinoma * stage t2 t4a * stage n0m0 * suitable for radiotherapy * ecog/who performance status 0-2 exclusion criteria: * suspected or confirmed distant metastases * previous surgery in the small pelvis * inflammatory bowel disease

Keywords: adaptive radiotherapy bladder cancer
intraoperative monitoring of the pelvic autonomic nerves

Conditions: Rectal Cancer

Summary: one of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is the main cause of urogenital dysfunction influencing postoperative quality of life. costs for diagnostics and treatment of short and long-term urogenital dysfunction are immense. varying degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal cancer despite potentially nerve-sparing total mesorectal excision (tme). the study will examine the impact of a newly developed continuous monitoring device for preservation of urogenital function in patients with tme for rectal cancer. 188 patients will be included in the prospective, randomized, single-blind, parallel group multi-centre trial including two arms (tme with and without intraoperative continuous monitoring of pelvic autonomic nerves). the primary efficacy endpoint is the change in urinary function measured by international prostate function score (ipss) 12 months after surgery. genital functions measured as secondary endpoints. the application of the continuous intraoperative neuromonitoring device could enhance the objective intraoperative confirmation of pelvic nerve sparing surgery. the investigators hypothesis is that the use of his device minimizes the risk of postoperative urogenital dysfunction in patients with tme for rectal cancer. an enormous reduction of treatment costs is to be expected.


Eligibility criteria:
inclusion criteria: * informed consent * histologically confirmed carcinoma of the rectum (≤ 16 cm from anal verge) * fit for radical surgery * total mesorectal excision * age 18-80 years exclusion criteria: * history of operation of the urinary tract (e.g. prostatectomy) * pacemaker * emergency operation * multivisceral resection in the pelvis * partial mesorectal excision * eligibility for local excision (tem, intestinal wall resection) * ongoing infection or sepsis * severe untreated physical or mental impairment * pregnancy or breastfeeding * women of childbearing potential who are not using a highly effective birth control method * missing preoperative data on urogenital or anorectal function * simultaneous participation in another clinical trial * previous participation in this clinical trial * lack of cooperation with the trial procedure

Keywords: rectal cancer total mesorectal excision pelvic autonomic nerve preservation neurostimulation urogenital function quality of life
evaluation of the brakes and levers on the use of an e-health application for osteoarthritis patients

Conditions: Osteoarthritis, Knee

Summary: osteoarthritis is the most common articular disease affecting the joint in a comprehensive and progressive manner. it is a chronic pathology correlated with age since nearly one in two adults is affected by osteoarthritis. the care of osteoarthritis is based on pharmacological and non-pharmacological treatment. the latest recommendations support the non-pharmacological part including regular physical activity, therapeutic education and weight loss. today tools are lacking for the patient and the practitioner to ensure long-term motivation and support. connected objects, as future-oriented tools, are a customizable way to meet the expectations of both patients and professionals. the main objective of this study is to analyze the expectations regarding the use of a smartphone application for monitoring and support in the practice of exercises and regular physical activity in patients osteoarthritic. the secondary objective is to collect information on the use of connected objects dedicated to the management of osteoarthritis by patients and health professionals.

this study is aimed at patients with predominant knee osteoarthritis and health professionals with a link to the pathology. a semi-directed interview according to a pre-established interview guide will be performed. interviews are conducted by trained professionals and recorded with a dictaphone. self-questionnaires are submitted to the patient after the interview. the recordings are transcribed as quickly as possible in text format. the verbatim will then be coded (axial coding) then grouped by categories and then by themes. the objective is to determine the expectations of patients and health professionals regarding a smartphone application dedicated to osteoarthritis. this study will serve as a basis for designing a tool of this type to improve the long-term management of osteoarthritis.

Eligibility criteria:
inclusion criteria for patient : * patient with osteoarthritis according to the criteria of the acr (american college of rheumatology), symptomatic and diagnosed in advance of inclusion by a specialist physician or not inclusion criteria for professional : -selected health professionals must be in practice at the time of inclusion. general practitioners, mpr (physical and rehabilitation medicine), rheumatologists, physiotherapists, apa (professor of adapted physical activity) and pharmacists caring for arthrosic patients, either salaried or liberal and on the volunteering base. exclusion criteria: * patients who do not meet the diagnostic criteria of the acr (american college of rheumatology) * patients with comprehension disorders which make it impossible to maintain and fill out questionnaires. * refusal to participate or already included in a therapeutic education workshop.

Keywords: osteoarthritis ehealth therapeutic education connected objects
effect of lower extremity ankle foot orthoses in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (afo, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (emg) and walking endurance, in select individuals living with parkinson's disease.

this study will be 10 weeks long. following fitting with unilateral or bilateral custom-fabricated afos the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. each training session will be 45-60 minutes in duration. various outcome measures will be completed at the following times: time of consent (t1), treatment 1 at time of brace delivery (t2), week 5 (t3), and week 10 (t4). subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. new diagnosis with direct consequences affecting gait training, 2. inability to tolerate the study afo(s).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of parkinson's disease * between the ages of 50 and 75 * ability to walk 150 feet independently over level surfaces with or without an assistive device * stable medication usage for the duration of the study (10 weeks) * obvious gait dysfunction (observational gait analysis) * score of greater than 22 on the short orientation-memory-concentration test exclusion criteria: * body mass index of greater than 35 * dorsiflexion range of motion less than neutral (90 degrees) * any other uncontrolled health condition for which gait training is contraindicated

Keywords: parkinson's disease ankle foot orthosis (afo) gait
iodinated contrast agents and risk of hypothyroidism in young children in the united states

Conditions: Hypothyroidism

Summary: this study will estimate the incidence of hypothyroidism in a pediatric population of children under age 4, based on data from the us-based kaiser permanente northern california database, which were exposed to iodinated contrast agent through having a diagnostic procedure.


Eligibility criteria:
inclusion criteria: * children under age 4 in the kaiser permanente northern california (kpnc) database, who had a diagnostic procedure with an iodinated contrast agent. * participants should be member of the kpnc for at least 3 months before the iodinated contrast exposure, except where the child is under 3 months of age at time of initial exposure, and 2 weeks after the exposure. exclusion criteria: * diagnosis of hypothyroid any time prior to the iodine contrast exposure. * lab values for low thyroid (tsh \> 5 mu/l for children) any time before the exposure * thyroid replacement therapy, hashimoto thyroiditis, or congenital hypothyroidism any time prior to exposure.

Keywords: hypothyroidism, children, iodinated contrast agents, retrospective cohort, database
to evaluate the safety and pharmacokinetic characteristics of aju-c711 in healthy adults

Conditions: Hypercholesterolemia

Summary: to evaluate the safety and pharmacokinetic characteristics of aju-c711 in healthy adults


Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged ≥ 19-year-old 2. weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(bmi) of 18 to 30 kg/m2 3. those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings 4. those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ecg results during screening tests 6. those who agree to contraception during the participation of clinical trial 7. those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial exclusion criteria: 1. those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug 2. those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days 3. those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study 4. those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug 5. those who exceeding an alcohol consumption criteria alcohol: men - 21 glass/week, women - 14 glass/week (1 glass: soju 50 ml, liquor: 30ml or beer 250ml) 6. those who has under * those who are hypersensitive to component of the investigational product and have the medical history * those with active liver disease or persistent elevation of aminotransferase levels of unknown * those with severe hepatic impairment or biliary atresia and cholestasis * those taking cyclosporin * those with myopathy * those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema * those who has genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption 7. those who has a history of mental illness 8. those who are deemed unfit by the investigators to participate in the clinical trial for other reasons 9. women who are pregnant or who may be pregnant and breastfeed
pulse wave analysis in advanced heart failure

Conditions: Left Ventricular Assist Device; Heart Failure; Intra-aortic Balloon Pump; LVAD Clot; LVAD-related GI Bleed

Summary: a comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post left ventricular assist device (lvad) patients.

pulse waveforms, especially central pressure waveforms, are predictive of cardiovascular events. peripheral waveforms have been correlated to central waveforms. peripheral waveforms can be easily measured through applanation tonometry. in this study the investigators hypothesize: 1. that previously established peripheral tonometry techniques would apply to patients with advanced heart failure, including continuous flow lvads and facilitate serial evaluation of central hemodynamics without invasive monitoring. 2. that temporary changes in lvad speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms. 3. that clinical events involving lvad will have characteristic frequency spectra.

Eligibility criteria:
inclusion criteria: 1)18 years of age or older 2)advanced heart failure as defined by need for iabp or lvad 3)one or more of the following: * current inpatient heart failure treatment with intra-aortic balloon pump (iabp)-iabp group •≤ 1 week post-lvad implantation with current iabp support-iabp/lvad group •≥ 3 mo post-lvad placement and scheduled for lvad speed optimization with echocardiography.-post-lvad group * post-lvad placement with suspected gi hemorrhage or lvad thrombosis-lvad event group 4)voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. exclusion criteria: 1. clinical status will not permit pause of iabp (iabp and iabp/lvad groups) 2. unable to undergo echo or oversewn or patched aortic valve (post-lvad group)

Keywords: lvad iabp heart failure thrombosis hemorrhage
use of a pressurized face mask for preventing respiratory complications after chest surgery

Conditions: Lung Resection

Summary: evaluation of efficacy and safety from 6hours of 7 cmh2o cpap after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve.

multicenter randomized clinical trial. 460 patients randomly assigned to treatment and control groups will be studied. the main variables are the frequency of atelectasis or pneumonia, defined by clinical and radiological criteria, the fio2/pao2 ratio, 7 and 24 h after weaning, and hospital stay.

Eligibility criteria:
inclusion criteria: * undergoing thoracic surgery including resection of lung parenchyma. * to have given signed consent to enter in the study. exclusion criteria: weaning in the first 4h after the intervention end. * suspected bronchopleural fistula at the admission to the surgical icu. * patients with facial problems or a history of intolerance to cpap masks. * having significant bullous emphysema defined as the presence of more than 5 contiguous bullae \ 2 cm or dystrophy bullosa, not in the area to dry and having had a previous pneumothorax. * known obstructive apnea hypopnea syndrome known or some form of noninvasive ventilation prescribed. * immunocompromised patients, or having used an immunosuppressor drug at least one month prior to surgery with potential (except corticosteroids administered by inhalation)
dexmedetomidine versus magnesium infusion in reducing agitations in pediatric patients undergoing adenotonsillectomy

Conditions: Postoperative Agitations in Pediatric Patients

Summary: the aim of this study is evaluating the efficacy and safety of dexmedetomidine versus magnesium for reducing emergence agitation after adenotonsillectomy in children. secondary outcome is to reduce child needs for analgesics and to reduce their dose.

preoperatively, intravenous access using emla cream will be established in the ward. child will be introduced to information about ga, or and surgery. this information will include pictures of the staff and the or, facemask, blood pressure cuff, etc. the child will move from ward to pre-anesthesia care unit accompanying his/her parents and anesthesia doctor to establish bonding. cooperation on induction will be evaluated by using four-point scale with score of 1 to 2 being satisfactory and 3 to 4 being unsatisfactory. if the child develop agitation (score 3 or 4) emergency midazolam 0.1 mg/kg iv will be given and the child will be ruled out of study. monitors for non-invasive blood pressure, heart rate, electrocardiogram (ecg), pulse oximetry (spo2) will be attached. induction of anesthesia will be done using 8% sevoflurane in oxygen gas with atracurium 0.5 mg/kg and fentanyl 0.5 mcg/kg to facilitate tracheal intubation. the patients will be divided into three groups: ogroup a (dexmedetomidine group): patients will receive dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it. ogroup b (magnesium group): patients will receive magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it. ogroup c (control group): patients will receive normal saline 0.9% infusion maintenance of anesthesia will be done by using of sevoflurane 2% in oxygen gas. controlled mechanical ventilation will be done to maintain normocapnia. rescue doses of fentanyl (0.5 mcg/kg) will be given if the patient develop pain. intraoperative pain is defined as development of tachycardia (\> 20% of baseline heart rate reading) and hypertension (\>20% of baseline mean arterial blood pressure reading) .

Eligibility criteria:
inclusion criteria: * asa i or ii. * age group: 4-12 years old. * the procedure expected to be completed within 1 hour. exclusion criteria: * patients with expected difficult airway management. * lack of consent. * known adverse effects to dexmedetomidine. * mental retardation developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure..etc.) * hemodynamically unstable patients. * persistent cough or high airway secretions. * clinical signs of active infectious disease. * coagulopathy (inr \>1.5). * obesity (bmi \>30 kg/m2 ). * surgical complication

Keywords: dexmedetomidine, magnesium sulphate, agitations