Kornimate/medical-research-clean huggingface dataset:
prehabilitation soft-tissue sarcoma of lower limb

Conditions: Soft Tissue Sarcoma

Summary: this study is about preparing people with cancerous tumours, soft-tissue sarcoma (sts), in the leg to recover more quickly from surgery. prehabilitation or "surgery school" is done before surgery while undergoing other cancer-related treatments. to test this idea, two groups will be formed. one group will have the prehabilitation program and the other group will have the same amount of attention from the research team who will visit them at the time of the radiotherapy sessions to provide support and any information they may need.the results of the study will indicate whether it is a good idea to conduct a bigger study that would involve many centres in canada.

this study is about preparing people with cancerous tumours, soft-tissue sarcoma (sts), in the leg to recover more quickly from surgery. prehabilitation or "surgery school" is done before surgery while undergoing other cancer-related treatments. the tumour can be anywhere in the leg so exercises must be specially designed for each person. this process is novel and therefore has to be tested to see if it is practical and if it helps people recovery more quickly. to test this idea, two groups will be formed. one group will have the prehabilitation program and the other group will have the same amount of attention from the research team who will visit them at the time of the radiotherapy sessions to provide support and any information they may need. assessments of how well participants can do basic activities of daily living will be assessed at study entry, just prior to surgery and then at 2, 6 and 12 weeks after surgery. other measures of recovery will be distance covered while walking for six minutes, quality of the walking, and how quickly participants can walk outdoors for 1000 steps, and then 3000, 5000 and 9000. the investigators will ask participants which of these outcome measures they think best reflected their recovery and why. the investigators will also assess whether people were willing to enter the study and complete all the processes required. the results of the study will indicate whether it is a good idea to conduct a bigger study that would involve many centres in canada.

Eligibility criteria:
inclusion criteria: * deep lower extremity soft-tissue sarcoma (buttock to foot) * histologically or cytologically-proven soft-tissue sarcoma (excluding superficial location) of the lower extremity. exclusion criteria: * patients with metastatic disease (distant or nodal) * both and upper and lower extremity involvement

Keywords: prehabilitation walking capacity gait quality of life
the prevelence of hbb c.93-21 g-a in β thalassemia patients

Conditions: Beta-Thalassemia

Summary: * to design an amplification-refractory mutation system (arms) for the dna diagnosis of the ivs i-110 (g\>a) \[hbb:c.93-21g˃a\] mutation. * to detect the prevelence of the mutation among assiut university hospital patients. * phenotype/genotype correlation of the mutation.

* the β-thalassaemias result from over 300 gene mutations (kurtoğlu a,et al 2016) * these mutations are regionally specific and the spectrum of mutations has been determined for most at-risk populations. the strategy for identifying β-thalassaemia mutations is usually based on knowledge of the common mutations in the ethnic group of the individual being screened (old jm, 2007). the β globin gene mutation \[hbb:c.93-21g˃a\] or ivs i-110 (g\>a) is the most common β globin gene mutation in the mediterranean region (old jm, 2007). . there is no consensus about the % of the mutation among β thalassemic patients in egypt \[has been reported (25.8%) by el-gawhary et al. 2007, (33.75%) by soliman et al. 2010, (48%) by el-shanshory et al. 2014, (22%) by elmezayen et al. 2015 and (34%) by elhalfawy et al. 2017\]. according to the hbvar site, it represents 33% of the β globin gene mutations in the egyptians. 28.5% according to henderson s ,et al 2009 . * the mechanism of this mutation depends on formation of a new splicing site resulting in 80% abnormal spliced mrna and 20% normal mrna . * the molecular characterization of the globin gene mutation is necessary for definite diagnosis, genetic counseling, and in prenatal diagnosis. * the amplification-refractory mutation system (arms) is a simple method for detecting any mutation involving single base changes or small deletions. * the dna is analyzed after amplification by pcr for detection of point mutation ivs i-110 (g\>a) by using primer pairs that only amplify individual alleles.

Eligibility criteria:
inclusion criteria: * β thalassemia (suspected \& clinically diagnosed cases) exclusion criteria: * iron deficiency anaemia, anaemia of chronic disease, types of haemolytic anaemias other than thalassemia, other types of thalassemia and hb variants.
a pharmacovigilance evaluation and assessment of the prescribing practice for tygacil in usual health care setting

Conditions: Infection

Summary: to assess the efficacy and safety of tygacil in the usual german hospital setting. the main goals are: to assess the efficacy of tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily medical practice (safety of tygacil); to determine whether patients are optimally dosed with tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy; to observe the potential resistance development against tygacil in germany; to determine which antibiotic agents are chosen for a combination therapy with tygacil; to determine to which antibiotic substance non-responders to tygacil are switched; to assess the duration of the intravenous therapy with tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with tygacil; to collect information on profile, comorbidities and characteristics of patients treated with tygacil.

non-interventional study: subjects to be selected according to the usual clinical practice of their physician.

Eligibility criteria:
inclusion criteria: * actual or planned therapy with tigecycline. * at least 18 years old. exclusion criteria: * hypersensitivity to antibiotics or tigecycline.
percutaneous tumor ablation vs partial nephrectomy for small renal mass: the impact of histologic variant and tumor size

Conditions: Renal Cell Cancer

Summary: the aim, of this study is to investigate recurrence rates in patients with t1 renal cell carcinoma (rcc) undergone partial nephrectomy (pn), radiofrequency ablation (rfa) or cryoablation (cryo).

the aim of our study was to compare oncologic outcomes in terms of recurrence and competing causes of mortality in patients undergone either pn, radiofrequency ablation (rfa) or cryoablation (cryo) focusing on tumor volume and histologic variant. retrospectively were evaluated data from 665 (81.4%), 68 (8.3%) and 83 (10.3%) patients who underwent pn, rfa and cryo, respectively. kaplan-meier curves depict recurrence-free survival (rfs) rates in the overall population and after stratifying according to tumor's histology (namely, clear cell rcc and non-clear rcc) and size (namely \<2 cm and 2-4 cm). multivariable cox regression model was used to identify predictors of recurrence. cumulative-incidence plots evaluated disease recurrence and other causes of mortality (ocm).

Eligibility criteria:
inclusion criteria: * radiologic diagnosis (ct chest-abdomen or mri abdomen with contrast medium) of renal neoplasm * renal neoplasm of clinical stage t1a (≤4 cm) n0m0 * age \>18 years * informed consent * absence of other neoplasm exclusion criteria: * patients refuse partial nephrectomy and/or percutaneous renal ca and are candidates for active surveillance * patients who are candidates for radical nephrectomy

Keywords: kidney neoplasms nephrectomy radiofrequency ablation cryosurgery recurrence
a nutrition intervention to lower blood pressure in adolescents

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the efficacy of a 12-week, clinic-based, behavioral nutrition intervention emphasizing fruits, vegetables, and low fat dairy compared to routine nutrition care on changing diet quality and blood pressure post-treatment and at short-term follow-up in adolescents with hypertension.

among youth, hypertension is no longer a rare disease, affecting about 7 million children and adolescents. numbers are increasing with the evolving pediatric obesity epidemic in the us. more adolescents than children have primary hypertension, which tracks into adulthood and has been linked with preclinical indicators of adverse cardiovascular events in adults. early prevention and intervention efforts are needed to address this increasing public and individual health problem. the purpose of this project is to evaluate the immediate and sustained impact of a 3-month clinic-based behavioral nutrition intervention emphasizing a diet high in fruits, vegetables, and low fat dairy, and low in fat and sodium (the dash intervention) versus routine nutrition care on changing diet quality and blood pressure in adolescents with pre-hypertension or hypertension. the dash intervention will include a printed participant manual, 1 individual counseling session with a dietitian, 4 mailings and 10 telephone calls on behavioral strategies to promote dietary change. routine care will include 1 individual counseling session with a dietitian on dietary guidelines consistent with those of the national high blood pressure education program. adolescents with prehypertension or hypertension will be randomly assigned to the dash intervention or routine nutrition care after pre-treatment assessment. post-treatment and at 3-month follow-up, outcome measures will be assessed including dietary intake and blood pressure. our expectations are that the dash intervention will significantly improve dietary quality and blood pressure in adolescents with elevated blood pressure compared to that observed as a result of routine nutrition care. the findings from this study are expected to improve the manner in which hypertension among adolescents is being treated in the clinical setting and contribute to the enhancement of the cardiovascular health of the target population.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of prehypertension or stage 1 hypertension * age 11-18 years * english speaking exclusion criteria: * stage 2 or secondary hypertension * target organ damage or symptomatic hypertension * type 1 or 2 diabetes * treated with anti-hypertensive medications or other blood pressure altering medications * are unwilling to stop use of vitamins, minerals or antacids containing calcium or magnesium * do not have full medical clearance from a physician to participate

Keywords: nutrition adolescent nutrition blood pressure hypertension diet therapy patient education
savr: impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance in a real-world setting.

Conditions: Cardiovascular Diseases

Summary: the impact registry represents a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years that includes data of patients undergoing aortic valve replacement with the edwards inspiris resilia aortic valve™. the impact registry will be performed in up to 25 participating sites across germany, austria and switzerland. a minimum number of 500 patients (20 patients per center) will be enrolled. patients will undergo follow-up visits at baseline, surgery, pre-discharge, year 1, year 3 and year 5.

the inspiris resilia aortic valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. the tissue is created by treating bovine pericardial tissue with edwards integrity preservation. it incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation. the novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard perimount valve in an ovine model (flameng et al., 2015). the resilia tissue has been studied in the commence trial: two year data show that the nyha class improved in 65.7% of patients, effective orifice area after implantation was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmhg; and paravalvular leak was none/trivial in 94.5% of patients (mild to moderate in 0.5%) (puskas et al., 2017). on the sizes 19 - 25 mm the inspiris resilia aortic valve™ has been outfitted with the vfit technology, which incorporates two novel features designed for potential future valve-in-valve procedures: fluoroscopically visible size markers and an expandable cobalt chromium alloy band. no clinical data are available that evaluate the use of the inspiris resilia aortic valve™ in patients to date.

Eligibility criteria:
inclusion criteria: 1. patient is at least 18 years old 2. patient has an aortic valve vitium and requires an aortic valve replacement with the edwards inspiris resilia aortic valve™ 3. patient is scheduled to attend yearly follow-up visits at the registry center up to 5 years 4. patient provides written informed consent prior to the procedure and in case of emergency after the procedure. exclusion criteria: 1. disability and / or other circumstances under which the patient is not capable to understand the nature, significance and scope of the clinical trial 2. active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery 3. patient has a life expectancy ≤ 12 months for any reason 4. valve implantation is not possible in accordance with the device ifu 5. pregnancy

Keywords: surgical aortic valve replacement (savr) inspiris resilia durability hemodynamics
lymphomyosot for ankle edema following fracture

Conditions: Ankle Injuries; Fracture

Summary: ankle fractures are invariably complicated by severe soft-tissue swelling which can significantly prevent surgical repair (open reduction and internal fixation - orif) of the fractured bone for up to two weeks. the delay in surgical treatment can increase the risk for local skin and bone complications, as well as for deep venous thrombosis. lymphomyosot® is a non-prescription, homeopathic complex drug which has been used for more than 70 years throughout europe and the u.s., primarily for tissue edema and swelling. this is a randomized, placebo-controlled, double blind pilot study evaluating the effectiveness of homeopathic combination drug lymphomyosot® compared to placebo treatment. the study will take place at the shaare zedek medical center in jerusalem, israel. adult patients (age 18 years and older) admitted to the orthopedic department with acute ankle fractures which require orif repair will be assessed for inclusion in this study. the primary outcome measure to be evaluated is the fracture-orif waiting period. other measures to be evaluated are: peri-malleolar circumference; pain (as measured by nrs and analgesic use); duration of hospital stay; and complications such as poor wound healing, blisters, and the development of deep vein thrombosis.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * patients with a fracture of the ankle requiring orif * signed informed consent form. exclusion criteria: * refusal or inability to give informed consent * bilateral fractures of the foot or ankle, open fractures, poly-trauma, contralateral limb amputation * currently on anticoagulation therapy * clinical indication for immediate surgery. * ability to undergo surgery on the day of the fracture , or where soft-tissue edema was not the cause which prevented immediate surgery * any additional injury that prevents partial weight-bearing. * a concomitant fracture of another long bone in the ipsilateral leg * if the patient suffers from a systemic disease such as diabetes, malignant tumor, severe peripheral vasculopathy, and/or metabolic disease * concurrent participation in another study * inability to comply with the study protocol

Keywords: ankle fracture edema surgical repair homeopathy lymphomyosot
yogic breathing exercise for people with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis; Myasthenia Gravis

Summary: the aim of this study is to understand how well a 6-week virtual yogic breathing exercise program (ybep) will improve breathing, speech, and emotional well-being in people with amyotrophic lateral sclerosis (als).

the study will employ a rct to test the two hypotheses. the study will incorporate a 2 x 2 two-way factorial design with repeated measures at three time points. the two between-subject factor conditions will be participation in a yogic breathing exercise program (ybep) versus a waitlist control condition that will be evaluated at baseline, and immediately post-program. thirty adults with als will be recruited for this study. hypothesis #1: adults with als who participate in a ybep will demonstrate improvement in breathing, and emotional well-being compared to waitlist controls at the conclusion of a 6-week ybep.

Eligibility criteria:
inclusion criteria: 1. confirmed als or myasthenia gravis diagnosis 2. age \>18 yrs old; 3. ability to follow multistep commands, 4. on a stable dose of medications for \>60 days, 5. fvc ≥30% predicted, 6. access to internet and a computer or smartphone that can perform videoconferencing. exclusion criteria: 1. life expectancy is less than 6 months, 2. severe hearing or visual impairments that prevent online learning (breathing exercise), or 3. current participation in another clinical trial during the study period that can affect the outcomes of the study.

Keywords: amyotrophic lateral sclerosis
ureteroscopy with and without safety guidewire

Conditions: Urolithiasis

Summary: the purpose of this study is to investigate the impact of a safety guidewire (sgw) on the results of ureteroscopy for urolithiasis. study hypothesis: routine use of sgw has no impact on the results of ureteroscopic treatment of urolithiasis.

the use of sgw is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure. however, sgw may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter. the intention of this study is to compare the results of endoscopic stone treatment with and without the use of sgw.

Eligibility criteria:
inclusion criteria: * patients with urolithiasis planned for ureterorenoscopic treatment

Keywords: ureteroscopy
a randomized controlled study comparing three single-incision devices for female urinary stress incontinence

Conditions: Urinary Incontinence

Summary: the prevalence of urinary stress incontinence in middle age women is rated at about 30%. to date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized. recently, single-incision devices have been proposed. one of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. the employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (pop) and women whose stress incontinence raised after surgical correction of (severe) pop. poor data coming from randomized controlled trials (rcts) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.

women with genuine urinary stress incontinence not associated with pop will be enrolled and randomized in three groups (arm 1, arm 2 and arm 3). all patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. at time of surgery, all patients will be randomized in three surgical treatment groups (arm 1, 2 and 3). patients of arm 1 will be treated with positioning of ajust (bard urological division, covington, ga, usa), patients of group 2 will be treated with positioning of miniarc (ams, minnetonka, mn, usa) and patients of arm 3 will be treated with positioning of tvt secur system (ethicon, somerville, nj, usa). during the study, the clinical outcomes, and the adverse experience will be evaluated in each patient. data will be analyzed using the intention-to-treat principle and a p value of 0.05 or less will be considered significant.

Eligibility criteria:
inclusion criteria: * genuine stress incontinence exclusion criteria: * pregnancy * \<12 months postpartum * systemic disease and/or drugs known to affect bladder function * current chemotherapy or radiation therapy * urethral diverticulum * augmentation cytoplasty * artificial sphincter * genital prolapse equal to or more than second degree * history of severe abdominopelvic infections * detrusor instability and/or intrinsic sphincter dysfunction * other gynecologic pathologies * bmi \>30

Keywords: single-incision sling stress incontinence surgery treatment female urinary stress incontinence
intestinal microflora in colorectal cancer (crc) after chemotherapy

Conditions: Gastrointestinal Neoplasms; Colorectal Cancer; Effects of Chemotherapy; Tumor Immunity; Malnutrition

Summary: probiotics modulate the gut microflora and immune status in crc,which can reduce the side effects of chemotherapy such as diarrhea,infection,neutropenia etc.

chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications; probiotics may restore the intestinal immunity, mucosal barrier, and nutrient absorption.the adverse effects of chemotherapy and the malnutrition status may be relieved via probiotic administration.

Eligibility criteria:
inclusion criteria: * patients scheduled for chemotherapy after radical resection of colorectal cancer exclusion criteria: * palliative resection of colorectal cancer * antibiotic,probiotic or prebiotic usage within 1months * other malignancy * history of other abdominal surgery * coagulopathy or bleeding disorders * pregnant or breast-feeding(for females) * impaired liver or renal function

Keywords: gut microflora colorectal cancer chemotherapy immunity nutrition
study of meloxicam capsules to treat osteoarthritis pain

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether meloxicam \[test\] capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.


Eligibility criteria:
inclusion criteria: * primary diagnosis of functional class i-iii oa of the hip or knee * chronic user of nonsteroidal anti-inflammatory drugs (ndaids) and/or acetaminophen for oa pain * discontinued all analgesic therapy at screening * for women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control exclusion criteria: * history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nsaids, including meloxicam * requires continuous use of opioid or opioid combination products to control oa pain of the knee or hip * clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease * significant difficulties swallowing capsules or unable to tolerate oral medication * previous participation in another clinical study of meloxicam capsules or received any investigational drug or device or investigational therapy within 30 days before screening