Kornimate/medical-research-clean huggingface dataset:
a phase 3, multicenter, open-label continuation study in moderate to severe asthmatic subjects who completed flutiform hfa pmdi study sky2028-3-005

Conditions: Asthma

Summary: the objective of this study is to assess the long-term safety and efficacy of flutiform hfa pmdi 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study sky2028-3-005.


Eligibility criteria:
inclusion criteria: * 1. documented use of an inhaled corticosteroid for at least 4 weeks prior to the day 1 (baseline) visit and at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids). subjects who enroll in this study sky2028-3-006 immediately upon completion of study sky2028-3-005 have automatically satisfied this criterion. subjects who enroll in this study sky2028-3-006 after completion of study sky2028-3-005 within 24 weeks must use inhaled corticosteroid therapy at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids) for at least 4 weeks prior to the day 1 (baseline) visit. * 2. females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hcg) pregnancy test at the day 1 visit * 3. subject is judged to be in good general health as determined by the investigator. * 4. demonstrate satisfactory technique in the use of pmdi. exclusion criteria: * 1. subjects who prematurely discontinued from the study sky2028-3-005. * 2. life-threatening asthma within the past year. * 3. history of systemic (oral or injectable) corticosteroid use within the past 12 weeks, * 4. an upper or lower respiratory infection within 4 weeks prior to the day 1 (baseline) visit. * 5. significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis). * 6. recent history of smoking, alcohol, substance abuse and/or psychiatric illness, * 7. subjects who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, quinidine type antiarrhythmics, or potent cyp 3a4 inhibitors such as ketoconazole within the past 1 week.

Keywords: moderate to severe
anterior knee pain in mobile bearing versus fixed bearing in tka

Conditions: Joint Diseases; Arthritis Knee; Arthroplasty Complications

Summary: osteoarthritis is the most common cause of chronic joint disease, and its incidence has increased due to the high average life expectancy, in addition to the high incidence of obesity. total knee arthroplasty is currently an accepted treatment for severe degenerative conditions and there are various implant systems with special features depending on component geometry, degree of fit of the articular surfaces, and fixation techniques. a tibial component with mobile polyethylene has been developed as an alternative to fixed polyethylene because it has theoretical advantages in terms of increasing the range of motion, reducing wear conditions, and reducing the incidence of anterior knee pain when the articular surface of the patella is not resurfaced.

the study is a randomized controlled clinical trial where the sample will be collected within one year from the date of approval of the scientific research council at damascus university. the sample consists of patients undergoing a total primary knee arthroplasty without patellar resurfacing following primary arthritis knee. the patients will be randomly divided into two groups. the first will be a primary total knee arthroplasty with a mobile bearing, and the second group with a fixed bearing. then the patients will be followed for at least one year. the data of the patients included in the study will be collected before the surgical operation, then the surgery; followed up for at least one year after it, and then compared between the two groups in terms of a range of motion and functional and clinical results according to the knee society score (kss) and the anterior knee pain scale, and patient satisfaction assessment according to the forgotten joint scale (fjs).

Eligibility criteria:
inclusion criteria: * patients with expected primary total knee arthroplasty exclusion criteria: * mediolateral instability * infective arthritis * severe deformity * revision * patients with severe obesity according to the body mass index (bmi \< 35).

Keywords: mobile bearing fixed bearing knee arthroplasty
a study in patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: the purpose of this study is to investigate the efficacy and confirm the safety of e0302 in patients with amyotrophic lateral sclerosis (als) by assessing changes in scores of survival rate and functional rating scale.


Eligibility criteria:
inclusion criteria: 1. patients who are able to submit written informed consent. if patients are duly capable of study consent but are unable to sign (or affix a seal) by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation. 2. patients who are aged 20 years or older at the time of obtaining informed consent. 3. patients who have clinically definite als, clinically probable als, or clinically probable-laboratory supported als as specified in the revised el escorial airlie house diagnostic criteria. 4. patients who are at stage 1 or 2 of the severity criteria for als. 5. patients within 3-year elapsed time period from disease onset at the start of observation period. 6. patients who can visit study site for out-patient treatment. exclusion criteria: 1. patients who underwent tracheostomy. 2. patients who experienced non-invasive positive pressure ventilation. 3. patients whose percent-predicted forced vital capacity (%fvc) is \>=60%. 4. patients with multiple disturbances of conduction detected by nerve conduction test. 5. patients with neurological symptom(s) due to vitamin b12 deficiency. 6. patients who initiated newly introduced riluzole therapy after starting the observation period. or those who received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation. 7. patients with cognitive impairment. 8. pregnant women or women with a possibility of becoming pregnant. 9. patients or their partners who are not willing to use reliable contraception. 10. patients with severe disease in the renal, cardiovascular, hematological, or hepatic system (severe disease will be judged referring to "ministry of health, labor and welfare" (mhlw) drug safety dept. notification no. 80, drug safety classification criteria for severity of adverse drug reaction by medicinal products, grade 3). 11. patients with malignant tumor. 12. patients who participated in another clinical study within 12 weeks before starting the observation period. 13. patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock). 14. patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Keywords: amyotrophic lateral sclerosis (als) motor neurons muscular atrophy lou gehrig's disease
sleep disorders and quality of life in patients with multiple sclerosis

Conditions: Sleep Disorder

Summary: 1. to determine sleep disturbance in different types of multiple sclerosis. 2. to asses the effect of sleep disturbance on quality of life in patients with multiple sclerosis. 3. correlation between sleep disturbance in different types of multiple sclerosis.

multiple sclerosis(ms) is a neurodegenerative disease of the central nervous system that commonly affects young adults. the disease is characterized by neurological symptoms that may lead to long-term physical disability. patients with ms have many other problems associated with their disease, as obstructive sleep apnea (osa) that characterized by obstructions of the respiratory tract throughout the night leadind to wake up the patients many times to achieve the right muscle tone and receive adequate oxygenation. most patients with ms complain from poor sleep.it may be due to pain, fatigue, depression and immunotherapy that have been considered as potential factors, which could have role in sleep disturbances among ms patients.restless leg syndrome (rls) may trigger sleep disorders, especially insomnia, in patients with ms. patients with sleep disorders may complain excessive daytime sleepiness, impaired concentration, altered mood, and fatigue. they are at risk to develop other problems,as vascular diseases, obesity, and diabetes, which further threaten long-term health.so patients with ms have lower quality of life(qol) than healthy ones. multiple sclerosis quality of life-54 (msqol-54) questionnaire is the most common and standardized disease-specific questionnaire that based on the generic sf-36 qol instrument.

Eligibility criteria:
inclusion criteria: 1. all patients fulfill the criteria of case definition of multiple sclerosis. 2. gender: both sexes are included. 3. willingness to participate in the study and to be subjected to the disease-related examinations and assessments. 4. willing and able to provide informed consent. exclusion criteria: 1. patients unable to give informed consent. 2. patients with history of psychiatric disorders or collagen disease such as behcet's disease or other neurological or medical disease
treatment of angioedema attacks in adolescent and adult patients 12 years and older with hae type i or ii with sebetralstat

Conditions: Hereditary Angioedema

Summary: the sebetralstat early access program (eap) provides early access to the investigational medicinal product (imp) sebetralstat to eligible and approved type i or ii hereditary angioedema (hae) adolescent and adult post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating physician determines they might benefit from this treatment.


Eligibility criteria:
inclusion criteria: * at least 12 years of age. * able to provide written, informed consent or assent. * confirmed diagnosis of hae type i or ii. exclusion criteria: * confirmed diagnosis of hae with nc1-inh or acquired angioedema. * confirmed pregnancy or breast-feeding. * any clinically significant medical condition or medical history that, in the opinion of the treating physician, would interfere with the patient's safety. * known hypersensitivity to sebetralstat or its excipients. * patient with a medical history or known to have severe hepatic impairment (child pugh c). * patients who require sustained use of strong cytochrome p450 3a4 inhibitors or inducers.
teta burst versus 10 hz repetitive transcranial magnetic stimulation i̇n neuropathic pain: a sham controlled comparison

Conditions: Neuropathic Pain

Summary: neuropathic pain is a common complication after spinal cord injury (sci), which significantly affects the patient's quality of life and may be resistant to pharmacological treatment. in our study, we aimed to evaluate the efficacies of intermittent theta burst (itbs) and high frequency (10 hz) repetitive transcranial magnetic stimulation (rtms) by comparing them with each other and with sham stimulation, in the treatment of neuropathic pain resistant to pharmacological treatment in patients with sci. question 1: i̇s rtms anda itbs treatment, useful for pain severity and the effect of pain on daily functions, in the treatment of neuropathic pain in sci question 2: are rtms and itbs treatments effective in depression in patients with neuropathic pain after spinal cord injury?

pharmacological treatments may be insufficient to limit neuropathic pain. therefore, research continues for safe and effective new treatments. transcranial magnetic stimulation (tms) is a non-invasive brain stimulation method that modulates the cortical excitability of the motor area to which it is applied. theta burst stimulation (tbs) is a new rtms method consisting of stimulation sequences in a special pattern. it stands out with its ability to deliver high pulses in a short time and its high capacity to induce cortical plasticity. intermittent tbs (itbs) and high frequency rtms facilitate excitability in the motor area where it is applied, and this effect is used in pain treatment. pain modulation with these methods has been tried in some studies. therefore, repetitive magnetic stimulation of the motor cortex by these two methods may be good options for the treatment of neuropathic pain resistant to pharmacological treatment in patients with sci.

Eligibility criteria:
inclusion criteria: * between the ages of 18-65, * traumatic/non-traumatic spinal cord injury (\>4 months), * for \>3 months, despite pharmacological treatment (no dose or medication changes have been made for at least 1 month), brief pain inventory (bpi)-part 1 average pain score is ≥4/10, neuropathic pain at the injury level and/or below (dn4 ≥4 /10) patients exclusion criteria: * pain attributed to causes other than neuropathic pain (e.g. musculoskeletal pain, pain resulting from diabetic polyneuropathy), having a history of epilepsy, dementia, cognitive impairment, neurodegenerative disease, * having a history of psychiatric illness (except reactive depression), * having a lesion in the brain due to vascular, traumatic, tumoral or infectious reasons, * having a history of alcoholism, * having an intracranial metallic implant, * having a cardiac pacemaker, * pregnant patients

Keywords: repetitive transcranial magnetic stimulation intermittent teta burst stimulation spinal cord injury depression pain
the effect of a high fiber diet and high-intensity interval exercise in patients with hfpef

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: this study is trying to find out how best to improve common measures of health and survival in those diagnosed with heart failure with preserved ejection fraction (hfpef) through the implementation of 4 weeks of an exercise training program consisting of high intensity interval training, dietary approaches to stop hypertension (dash diet), or a combination of the two. currently there are not established guidelines that have been shown to improve clinical end points in those with this hfpef.

in the face of a rapidly growing population of older, hfpef patients, there remains a need to identify ideal rehabilitative therapies to enhance improvements in the physical function of these patients. pharmacological trials in this population have been characterized by a failure to significantly improve exercise tolerance and hard clinical outcomes and this is likely due to their singular cardiovascular focus. exercise appears to be a promising intervention to improve cardiorespiratory fitness and reduce cardiovascular risk. further, evidence-based dietary guidelines for patients with heart failure are lacking. although a high-protein, low-carbohydrate diet is associated with improvements in traditional cv risk markers in patients with heart failure, it may raise cardiovascular risk in this population by adversely affecting endothelial function, increasing susceptibility to myocardial ischemia, and by inducing a pro-inflammatory state due to increased bacterial and lps translocation through the ischemic gut. thus, the investigators will explore the effects of the high-carbohydrate, high-fiber dash diet due to its potential to have salutary effects on vascular risk in this population. in this study, the investigators will examine the singular and combined effects of exercise and a dash diet in patients with hfpef on markers of cardiovascular risk.

Eligibility criteria:
inclusion criteria: * ≥40 years of age * diagnosed with heart failure with preserved ejection fraction * nyha class ii-iii symptoms * physician clearance to undergo exercise training * physician clearance to consume dash diet * complete covid-19 vaccination status exclusion criteria: * unstable angina * myocardial infarction in the past 4 weeks * uncompensated heart failure * nyha class iv symptoms * complex ventricular arrhythmias * musculoskeletal contraindications to stationary bicycling exercise * symptomatic severe aortic stenosis * acute pulmonary embolus * acute myocarditis * uncontrolled hypertension * medication non-compliance * unable to follow dash diet * food allergies (nuts, wheat) * pregnant women

Keywords: hiit dash high fiber hfpef heart failure
imatinib in covid-19 disease in aged patients.

Conditions: SARS Virus

Summary: high-throughput screening studies identified abl kinase inhibitors (including imatinib) as inhibitors of coronaviruses sars and mers. the sars-cov-2 coronavirus depend on abl2 kinase activity to fuse and enter into the cells. pharmacokinetic studies demonstrated that ic50 of imatinib for abl1, bcr-abl1 and abl2 kinase inhibition is less than 1 microm (around 0.3 microm) below the expected trough plasmatic concentrations of imatinib 400 mg/day (1.7 microm). the ec50 of imatinib for the inhibition of the virus is under investigation but we now have a first estimates with ec50 close to 2.5 microm. this plasmatic concentration is achievable with imatinib 800 mg/d. we hypothesize that clinically achievable imatinib concentration will block the first round of cell to cell virus infection and therefore stop or prevent from sars-cov-2 infection in human. based on our 20 years' experience of prescribing imatinib in patients, we expect that most of the adverse events and pharmacological interactions of imatinib can be anticipated and corrected. the eligible population will be aged (\>70y) patients hospitalized for a non-severe covid-19 disease for less than 7 days. patients will be randomized 1/1 between standard of care and imatinib 800 mg per day during 14 days. the primary endpoint will be the death rate by 30 days. secondary endpoint will include progression to severe civid-19 disease, safety, outcome at 3 months. we plan to randomize 90 patients in order to show a 10% benefit in term of death rate reduction from 16% to 6%.


Eligibility criteria:
inclusion criteria:. patient aged \> 70y 2. patient with a documented covid-19 disease by sars-cov-2 rt-pcr (if no test is available, suspected covid-19 disease on ct scan). 3. initial phase (≤ 7 days) of covid-19 disease 4. non severe covid-19 disease 5. signed informe consent exclusion criteria: 1. patient in palliative care 2. severe covid-19 disease (spo2 ≤ 94% with o2 ≥ 5 l/min) 3. contra-indication to imatinib 4. therapy with warfarin (heparin allowed) 5. stage ii to iv congestive heart failure (chf) as determined by the new york heart association (nyha) 6. peripheral edema grade \> 2 7. known hbv, hbc or hiv infection 8. known hepatic failure 9. patient under legal protection
noninvasive measurement of the cerebral autoregulation in neonates and infants with complex congenital heart disease

Conditions: Complex Congenital Heart Disease

Summary: feasibility of non-invasive cerebral autoregulation measurement at the picu and impact of changes in oxygen supply

cerebral protection is a major issue in the treatment of neonates and infants with complex congenital heart disease, because most common long-term morbidities of newborn heart surgery are related not to the heart, but instead to the cognitive challenges experienced by this population. disruption of cerebral autoregulation in the postoperative period may contribute to brain injury in these patients. blood pressure management, respirator management and red blood cell transfusion management after cardiopulmonary bypass surgery using endpoints such cerebral autoregulation monitoring might provide a method to optimize organ perfusion and improve neurologic outcome from cardiac surgery in the vulnerable postoperative period. primary objectives: feasibility of non-invasive cerebral autoregulation measurement at the picu: identification of the range of mean arterial blood pressure (map) with optimal vasoreactivity (mapopt), indicating intact cerebral autoregulation. secondary objectives: impact of decreased oxygen delivery, increased cerebral oxygen extraction, decreased cardiac output, arterial hypotension, severe hypoxemia and/or severe anemia on cerebral autoregulation.

Eligibility criteria:
inclusion criteria: * term (37-42 weeks gestation) newborns * pre- or postnatally diagnosed critical congenital heard disease (chd) * admitted to the pediatric cardiac intensive care unit at the children's hospital of tübingen exclusion criteria: * birth weight \<2 kg * history of neonatal depression (5-min apgar\<5, cord blood ph\<7.0, sepsis, or birth asphyxia) * perinatal seizures * evidence of end-organ injury * preoperative cardiac arrest * significant preoperative intracerebral hemorrhage such as grade 3 or 4 intraventricular hemorrhage.
evaluating factors affecting survival in colon and rectum cancer

Conditions: Colon Cancer; Rectum Cancer

Summary: colorectal cancers are frequent among cancers of the gastrointestinal system. whether there are any differences between survival in rectum and colon cancer patients is controversial. this study aimed to compare survival in the surgically treated rectum and colon cancers and determine the factors affecting survival.

colorectal cancers are frequent in the gastrointestinal system. it is the 4th most common cancer after lung, prostate, and bladder in the male population and it is the 3rd after breast and thyroid cancers in the female population according to world health organization. it is considered significant morbidity and mortality cause and is estimated to develop in more than 1.000.000 individuals annually worldwide. colorectal cancers form 10% of all cancers in the female and male populations. it is the 2nd most common cause of death among cancers in the united states of america. in studies, it is stated that the risk of developing colorectal cancer in an individual is 5-6%. also, the risk of death of an individual due to colorectal cancer was determined as 3%. in the last 50 years, the rate of colorectal cancer mortality decreased in the female population while it did not change in the male population. whether there is a difference in survival time between rectum and colon cancers is controversial. with the development in neoadjuvant treatment approaches, poor prognosis in past years got better. recent studies show that the prognosis in rectum cancers is better than in colon. nevertheless, factors affecting prognosis other than treatment for both colon and rectum cancers are not clarified. in this study, the investigators aimed to evaluate the surgically treated rectum and colon cancer patients' survival and factors affecting survival time.

Eligibility criteria:
inclusion criteria: patients who were operated and diagnosed histopathologically as adenocarcinoma were included. exclusion criteria: inoperable and recurrent colorectal cancer patients and patients that were diagnosed with other than adenocarcinoma were excluded from the study.

Keywords: survival prognostic factors