Kornimate/medical-research-clean huggingface dataset:
ceftobiprole in the treatment of patients with staphylococcus aureus bacteremia

Conditions: Staphylococcus Aureus Bacteremia

Summary: the purpose of this study was to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated staphylococcus aureus bacteremia (sab).

patients were randomized 1:1 to ceftobiprole or the comparator regimen. randomization was stratified by study site, dialysis status, and prior antibacterial treatment use within 7 days before randomization. the three phases of the study were: 1. screening assessments of up to 72 hours prior to randomization 2. randomization and subsequent active treatment with intravenous (i.v.) study drug (ceftobiprole or daptomycin ± aztreonam). 3. post-treatment, comprising an end of trial (eot) visit (within 72 hours of last study-drug administration), day 35 (± 3 days), day 42 (± 3 days), and a post-treatment evaluation (pte) visit on day 70 (± 5 days) post-randomization.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * staphylococcus aureus bacteremia (sab), based on at least one positive blood culture obtained within the 72 h prior to randomization * at least one of the following signs or symptoms of bacteremia: 1. fever (e.g.≥ 38 °c/100.4 °f measured orally) 2. white blood cell count \> 10,000 or \ 10% immature neutrophils (bands) 3. tachycardia (heart rate \> 90 bpm) 4. hypotension (systolic blood pressure \< 90 mmhg) * at least one of the following: 1. sab in patients undergoing chronic intermittent hemodialysis or peritoneal dialysis 2. persistent sab 3. definite native-valve right-sided infective endocarditis by modified duke's criteria 4. other forms of complicated sab 5. osteomyelitis (including vertebral, sternal, or long-bone osteomyelitis) 6. epidural or cerebral abscess * other inclusion criteria have been applied exclusion criteria: * treatment with potentially effective (anti-staphylococcal) systemic antibacterial treatment for more than 48 h within the 7 days prior to randomization; exception: documented failure of bloodstream clearance * bloodstream or non-bloodstream concomitant infections with gram-negative bacteria that are known to be non-susceptible to either ceftobiprole or aztreonam * left-sided infective endocarditis * prosthetic cardiac valves or valve support rings, cardiac pacemakers, automatic implantable cardioverter-defibrillator, or left-ventricular assist devices * community- or hospital-acquired pneumonia * opportunistic infections within 30 days prior to randomization, where the underlying cause of these infections is still active * requirement for continuous renal-replacement therapy * women who are pregnant or nursing * other exclusion criteria have been applied

Keywords: ceftobiprole, daptomycin, staphylococcus aureus bacteremia, bloodstream infection
comparison between acrylic and soft liner telescopic overdentures regarding patient satisfaction

Conditions: Patient Satisfaction; Retention; Periodontal Health

Summary: conventional complete overdenture will be made to ectodermal dysplasia patients, a week after delivery and after 3 months patient satisfaction, retention and periodontal condition will be assessed. the denture will be taken from the patient for 2 weeks.acrylic telescopes will be replaced with soft liner and again patient satisfaction, retention and periodontal condition will be assessed a week after delivery and 3 months later.

upper and lower primary impressions will be carried out by using irreversible hydrocolloid (alginate, tropicalgin, normal setting, zhermack, italy) according to manufacturer's instructions using stainless steel stock trays. secondary upper impression is done with an acrylic special tray. border molding is done with putty consistency rubber base impression material, final impression with medium consistency rubber-base impression material (silicone impression material, elite p\&p, regular body-normal set, zhermack, italy) maxilla-mandibular relationship will be recorded using check bite technique. setting of artificial teeth will be performed and trial dentures will be tried in inside patients' mouth. the finished and polished dentures will be delivered immediately after the necessary occlusal adjustments and instructions regarding hygiene and maintenance. the patient will use the upper overdenture for 3 months. the overdenture is taken from the patient for two weeks, after which the maxillary overdenture will be adjusted by relieving acrylic opposite to the abutment about 2 mm using a metal stone. the relieved areas will be painted with an adhesive and the rest of the fitting surface of the denture will be painted with a separating medium. the soft liner (silicone based soft liner, mollosil, chairside soft relining-long term, detax, germany) will then be applied in the relieved areas to act as a secondary coping the base and catalyst will be mixed according to the manufacturer's instructions on a glass slab. the mix will be placed on the relieved area, seated in the patient's mouth, the patient is asked to bite in centric relation and the excess liner is removed with a lancet.

Eligibility criteria:
inclusion criteria: 1. partially edentulous ectodermal dysplasia patients with few remaining teeth. 2. cooperative patients with no history of psychological diseases. 3. length of maxillary remaining teeth should not be less than 4mm. exclusion criteria: - 1- patients with tempo-mandibular joint disorders or systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles. 2- patients allergic to acrylic resin.
the ple²no self-management and exercise program for knee osteoarthritis

Conditions: Osteoarthritis

Summary: the ple²no (in portuguese education and exercise free program for osteoarthritis) is a self-management and exercise program specific for elderly with knee osteoarthritis (oa), with the goals of managing oa symptoms, improving physical fitness, and developing self-efficacy and self-management of pathology.

participants were randomly assigned to one of two groups: (1) self-management and exercise (2) educational. both groups received glucosamine and chondroitin sulfate supplement during the intervention. blinding of participants was not possible due to the nature of the intervention; however, assessors were blinded to group allocation. the ple2no (in portuguese education and exercise free program for osteoarthritis) is a community-based program with two components: self-management and exercise. each session lasted 90 minutes, and the first 30 minutes corresponded to a self-management part and the remaining 60 minutes to the exercise program. the program was offered in a group format, encouraging peer interactions and socialization that can help counteract feelings of depression and isolation. the self-management program is based on the program developed at stanford university, the chronic disease self-management program which the purpose is developing self-efficacy based on social cognitive theory. the exercise program comprised both health related (strength, flexibility) and skill-related (agility, balance, speed and power) physical fitness components, and was based on fit an strong program, on exercise for people with arthritis (fepa) and also on the program takin control with exercise (arthritis foundation). the program will last for 3 months and 6 months of follow-up.

Eligibility criteria:
inclusion criteria: 1. age over than or equal to 60 years; 2. bilateral or unilateral oa of the knee diagnosed according to clinical and radiological criteria of the american college of rheumatology (acr)(altman et al., 1986); 3. independent mobility; 4. and reading and writing knowledge. exclusion criteria: 1. not be involved in another intervention program (exercise, education or physical therapy; 2. do not use supplements (chondroitin sulfate and / or glucosamine) for at least three months; 3. have other pathology (cardiovascular, respiratory, musculoskeletal, cancer) that prevents physical exercise; 4. mental / psychological state hindering understanding of the program; 5. having undergone surgery for knee replacement or going perform this surgery in the next eight months; 6. being allergic to shellfish; 7. have made injections of corticosteroids or hyaluronic acid in the last 6 months

Keywords: osteoarthritis self-management multi-component exercise
adls at the end of acute treatment for childhood leukemia and non-hodgkin lymphoma

Conditions: Childhood Cancer

Summary: reduced activity levels and reduced muscular strength could severely impair the activities of daily living (adls) in pediatric leukemia and non-hodgkin lymphoma patients. increased muscle strength is associated with improved accomplishment of adls and consequently greatest possible normality, autonomy and mobility. this associated investigation to the study with the clinicaltrials.gov identifier nct03934060 aims at collecting data in a comparison cohort with respect to adls in children and adolescents who did not receive a standardized strenght training intervention during the whole course of treatment.


Eligibility criteria:
inclusion criteria: * children and adolescents aged 4-18 years * at the end of acute treament for leukemia or non-hodgkin lymphoma * diagnosed and/or treated at the dr. von hauner children's hospital, university of munich * informed consent as documented by signature exclusion criteria: * medical contraindication to perform this unique test battery (e.g., acute bleeding risk, pain, nausea, acute orthopedic impairments) * inability to follow study procedures (e.g., language problems, mental retardation)

Keywords: activities of daily living leukemia non-hodgkin lymphoma physical activity motor performance
detection of fgfr gene mutations in the tumor tissue and urine of patients with urothelial carcinoma

Conditions: Bladder Cancer

Summary: this study aims to compare the correlation between fgfr mutations found in bladder cancer tissues and urine to develop a companion diagnostic method for predicting the effect of fgfr inhibitors using urine samples of the patients with urothelial cancer.

this study targets 92 patients with urothelial cancer, whose tissue (from scheduled surgery) and urine samples can be obtained, regardless of the treatment stage. ■ examination methods * fgfr mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods. * fgfr mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires. * bladder cancer subtyping will be performed by rna sequencing of tumor tissues or other methods. * analysis of paired tissues before and after chemotherapy will be performed on transurethral resection of bladder tumor (tur-bt) and cystectomy tissues before and after neoadjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: * suspected patients of urothelial cancer who will visit the national cancer center korea from the date of institutional review board (irb) approval to 2021 and with identified tumors in the bladder according to bladder endoscopy. * subjects who are scheduled for surgery (transurethral bladder tumor resection, radical bladder resection, and radical bladder ureterectomy) and have agreed to participate in the study exclusion criteria: * history of other active malignant tumors treated within 24 months * patients with either mental illness or who cannot participate in clinical trials at the judgment of other doctors * if patients and guardians do not want to participate in this study * history of having administered fgfr inhibitors in the past
efficacy of digital cbt-i intervention during pregnancy

Conditions: Insomnia in Pregnancy

Summary: this randomized controlled trial aims to evaluate the efficacy of cognitive behavioral therapy for insomnia in pregnant women. particularly, this study aim to explore the effect of this intervention in ameliorating insomnia symptoms and in preventing post-partum depression disorder. the experimental intervention is a digital cbt-i and the control intervention group is an assertive communication training. both interventions include a screening phase and will be delivered in a digital way and will be composed of 5 sessions. furthermore, both interventions protocol include a baseline, half time and follow up assessments.


Eligibility criteria:
inclusion criteria: * healthy pregnancy * women that not consume nicotine or alcool * bmi \< 30 * women who complains of insomnia or bad sleep quality exclusion criteria: * bmi\> 30 * complicated pregnancy * women who consume nicotine or alcool
eculizumab in primary mpgn

Conditions: Membranoproliferative Glomerulonephritis

Summary: membranoproliferative glomerulonephritis (mpgn) is the third or fourth leading cause of end stage renal disease among the primary glomerulonephritis. hyperactivation of the alternative complement pathway and familial forms for all types of mpgn have been reported suggesting that genetic abnormalities may play a predisposing role to the disease. in recent case reports eculizumab, a monoclonal antibody that binds to c5 to prevent formation of the membrane attack complex ,is a safe and effective therapy.


Eligibility criteria:
inclusion criteria: * biopsy-proven primary mpgn * creatinine clearance \>20 ml/min per 1.73m2 * 24-hour proteinuria persistently exceeding 3,5g in adults or exceeding 40mg/h/m2 in children (or exceeding 2mg protein/mg creatinine in children spot urine samples) * persistently low c3 levels in at least two consecutive evaluations * persistently high sc5b9 levels (\>1000 ng/ml) in at least two previous consecutive evaluations * written informed consent (by parents or tutors if underage) exclusion criteria: * age ≥75 years * secondary mpgn (evidence of infection, immunological disease including vasculitis, systemic diseases and proliferative disorders) * evidence at kidney biopsy evaluation of severe chronic histological changes that very unlikely could benefit of eculizumab therapy * concomitant steroid or immunosuppressive therapy for immuno-mediated disease * pregnancy or lactating * childbearing potential without effective contraception * any clinically relevant condition that might affect completion of the study participation and/or confound study results * inability to understand the potential risks and benefits of the study * legal incapacity

Keywords: membranoproliferative glomerulonephritis nephrotic syndrome proteinuria alternative complement pathway complement inhibition eculizumab
evaluation of a breast double block analgesia for the mastectomy with radical axillary lymphadenectomy surgery

Conditions: Mastectomy

Summary: this study evaluates the efficacy of the the pecto-intercostal fascial plane block (pif block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a pif block for the breast surgery. to obtain a correct prospective clinical trial completion we have to begin a new series of inclusion.

breast surgery is one of the most painful post-operative surgery. this surgery is well known to induce postoperative chronic pain. the paravertebral block, because of its efficacy and less invasive nature than epidural analgesia, is quickly becoming the reference technique for pain management of major breast surgery. peripheral regional anesthesia for the breast surgery appeared in the past few years. among these techniques are the pec block, serratus block and more recently the pecto-intercostal fascial plane block (pif block). currently in our hospital in every day's practice, we made an association of the serratus block and the pif block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the pif block). therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast. this technique was described by fajardo et al. they evoked the possibility of the association serratus and pif blocks and described this technique with a patient, but to our knowledge no evaluation of the efficacy of this procedure was made. the objective of your study is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association of blocks before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy. this is a purely observational study that assesses our current practice in this type of surgery. we already included a patient series but the clinical trial registration was made to late to do it correctly. to obtain a correct prospective clinicaltrials registration completion we have to begin a new series of inclusion.

Eligibility criteria:
inclusion criteria: * total mastectomy surgery with a complete axillary lymph nodes removal exclusion criteria: * age under 18 * contraindication to the surgery * refusal of the protocol by the patient

Keywords: breast surgery acute pain regional anesthesia
tolerability of mk0524a versus niacin extended-release (0524a-054)

Conditions: Hypercholesterolemia; Hyperlipidemia

Summary: this is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of mk0524a versus niacin extended-release. there will be 6 scheduled clinic visits and 2 treatment groups.


Eligibility criteria:
inclusion criteria: * patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides \< 500 mg/dl exclusion criteria: * patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (ldl-c) \>/= 130 mg/dl and/or not on a statin * patients with diabetes and ldl-c \>/= 130 mg/dl. patients with \>/= 2 heart disease risk factors and ldl-c \>/= 160 mg/dl. * patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.

Keywords: primary hypercholesterolemia or mixed hyperlipidemia
tramadol versus dexamethasone as adjuvant to levobupivacaine supraclavicular block

Conditions: Regional Anesthesia

Summary: the investigator's aim will be to compare the efficacy of perineural tramadol and dexamethasone added to levobupivacaine in prolonging postoperative analgesia in patient undergoing open reduction and internal fixation for forearm fractures. primary outcome: duration of postoperative analgesia. secondary outcome: include \[the anesthesia onset time, total rescue analgesic consumption in the 1st 24-hour and the presence of complications and side effects.

strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, alpha 2 agonists (as clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone . dexamethasone improves the quality and duration of peripheral nerve block over local anaesthetic alone. this is thought to be mediated by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge, and inhibiting potassium channel-mediated discharge of nociceptive c-fibres . tramadol is a unique opioid with two modes of action for inhibition of pain, an opioid action mediated by the μ receptor and a non-opioid action mediated by α-2-adrenergic and serotoninergic activity .the monoaminergic activity of tramadol inhibits the descending pain pathways, resulting in suppression of nociceptive transmission at the spinal level . tramadol also exhibits local anaesthetic properties by blocking k+ channels .many studies have characterized the effects of tramadol as an adjuvant to local anaesthetic in brachial plexus block .

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist physical status i-ii patients older than 18years and scheduled for internal fixation for forearm fractures * both sexes exclusion criteria: * patients with known allergy to the study drugs * skin infection at site of needle puncture * significant organ dysfunction * coagulopathy * drug or alcohol abuse * epilepsy and psychiatric illness that would interfere with perception and assessment of pain
cd19 cart cells for patients with relapse and refractory cd19+ b-cell lymphoma.

Conditions: B Cell Lymphoma

Summary: this is a clinical study to observe the maximum tolerated dose (mtd) and the safety and feasibility of chimeric antigen receptor 19 (cd19 cart) cells in relapsed and refractory patients with cd19+ b cell lymphoma.

this is a study for the patients with b cell lymphoma. maximum tolerated dose climbing test is expected into the group of 9 cases of patients. and phase ii expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. subjects will be collected their t cells and modify them, the modification is a genetic change, that cd19:4-1bb:cd28:cd3 modified t cells, in order to tells the t cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. the cart cells will then be expanded in vitro and then administered to subjects. the purpose of this study is observe the mtd and to assess the safety and feasibility of cart cells in the patients with relapsed and refractory cd19+ b cell lymphoma.

Eligibility criteria:
inclusion criteria: * 1. 18 years to 70 years, expected survival \> 3 months; * 2. cd19 positive b-cell lymphoma; * 3. kps \>80; * 4. having at least one measurable lesions; * 5. cardiac function: 1-2 levels; liver: tbil≤3uln，ast ≤2.5uln，alt ≤2.5uln; kidney: cr≤1.25uln; bone marrow: wbc ≥ 3.0×109/l, hb ≥90 g/l, plt ≥ 80×109/l）; * 6. no serious allergic constitution; * 7. no other serous diseases that conflicts with the clinical program; * 8. no other cancer history; * 9. no serious mental disorder; * 10. informed consent is signed by a subject or his lineal relation. exclusion criteria: * 1. pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test); * 2. uncontrolled active infection, hiv infection, syphilis serology reaction positive; * 3. active hepatitis b or hepatitis c infection; * 4. recent or current use of glucocorticoid or other immunosuppressor; * 5. with severe cardiac, liver, renal insufficiency, diabetes and other diseases; * 6. transaminase \>2.5uln, bilirubin \>3uln，creatinine\>1.25uln * 7. participate in other clinical research in the past three months; previously treatment with any gene therapy products; * 8. researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;