Kornimate/medical-research-clean huggingface dataset:
low energy surface waves for neurogenic bladder patients with indwelling catheters

Conditions: Neurogenic Bladder; Urinary Tract Infections

Summary: the uroshield device is a commercially available device with two parts: a disposable actuator which attaches to the external portion of the catheter and a portable battery. the device sends out low-frequency ultrasound waves which run along the surfaces of the catheter. these acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of biofilm. our objective is to conduct a pilot study to determine if the uroshield device can reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an indwelling catheter, as well as improve urinary quality of life and symptoms.


Eligibility criteria:
inclusion criteria: 1. \>18 years of age 2. spinal cord injury (\>1 year), multiple sclerosis (\>1 year), spina bifida, parkinsons (\>1 year) 3. indwelling catheter (urethral or suprapubic) for \>3 months, and used as primary bladder management mechanism 4. \>1 urinary tract infection in the last 12 months exclusion criteria: 1. intravesical botox in the last 6 months 2. chronic antibiotic suppressive therapy 3. active symptomatic uti on day of randomization 4. unable to understand written and spoken english 5. prior/current utilization of the uroshield device
pilot study of autologous anti-egfrviii car t cells in recurrent glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: chimeric antigen receptor (car)-modified t cells can mediate long-term durable remissions in recurrent or refractory cd19+ b cell malignancies, and are a promising therapy to treat glioblastoma, which is the most dangerous and aggressive form of brain cancer. egfrviii mutation (epidermal growth factor receptor variant iii, egfrviii) is the results of tumor specific gene rearrangement naturally happened in about 30% of glioblastoma patients and produces a mutated protein with neo-antigen that is tumor specific and is not expressed in normal human tissues. therefore, egfrviii is an attractive target for car t cell therapy. we have constructed a lentiviral vector that contains a chimeric antigen receptor that recognizes the egfrviii tumor antigen. a truncated egfr (tegfr) which lacks of the ligand binding domain and cytoplasmic kinase domain of wildtype egfr is incorporated into the car vector and is used for in vivo tracking and ablation of car t cells in necessary. this pilot study is to determine the safety and efficacy of autologous anti-egfrviii car t cells in patients with recurrent glioblastoma.


Eligibility criteria:
inclusion criteria: 1. abilities to understand and the willingness to provide written informed consent; 2. patients are ≥ 18 and ≤ 70 years old; 3. recurrent glioblastoma patients with measurable tumors. patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (\~54 - 60 gy, tmz). patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis; 4. malignant cells are egfrviii positive confirmed by ihc, quantitative pcr or sequencing; 5. karnofsky performance score (kps) ≥ 60; 6. life expectancy \>3 months; 7. satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm\^3; hemoglobin \> 10 g/dl; platelets \> 100000 /mm\^3; bilirubin \< 1.5×uln; alanine aminotransferase (alt) or aspartate aminotransferase (ast) \< 2.5×uln; creatinine \< 1.5×uln; 8. peripheral blood absolute lymphocyte count must be above 0.8×10\^9/l; 9. satisfactory heart functions; 10. patients must be willing to follow the orders of doctors; 11. women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study. exclusion criteria: 1. a prior history of gliadel implantation 4 weeks before this study start or antibody based therapies; 2. hiv positive; 3. hepatitis b infection or hepatitis c infection; 4. history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies; 5. history of allergic disease, or allergy to car t cells or study product excipients; 6. patients already enrolled in other clinical study; 7. patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
allometric-pace study

Conditions: Sinus Node Dysfunction

Summary: the goal of this observational study is to improve quality of life in sinus node dysfunction patients by utilizing allometric lower rate pacing (or called personalized lower rate, plr) in standard commercially available dual-chamber pacemakers. the primary objective is to achieve a significant improvement in patients' quality of life with use of plr pacing in comparison with the control group with nominal lower rate in patients with implanted dual-chamber pacemaker. the secondary objectives are to assess cardiac functional changes in echocardiography of ventricular mechanical performance with a plr pacing in comparison with the control group with nominal lower rate, and to assess the viability of using elevated blood pressure as a marker for undetected bradycardia and providing allometric rate to correct bradycardia-related increase in arterial systolic blood pressure.


Eligibility criteria:
inclusion criteria: * patients are at age of equal to or more than 60 years old * patients have plan to implant dual-chamber pacemaker * resting sinus heart rate is equal or less than 60 bpm, or average heart rate detected through 24-hour dynamic electrocardiogram is equal or less than 60 bpm * patients have diagnosis of snd. if patients have both sinus node dysfunction and av block, conduction system pacing shall be available * patients have a history of hypertension, two times of blood pressure measurements at office visit are equal to or more than 130 mmhg in systolic blood pressure, diastolic pressure is equal or less than 80 bpm exclusion criteria: * patients have or possible concomitant a diagnosis of heart failure, either reduced ef or preserved ef * patients have persistent or chronic atrial fibrillation or clinically significant paroxysmal atrial fibrillation * previously diagnosed with a history of organic heart disease: including congenital heart disease, coronary heart disease, old myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, cardiac amyloidosis, long qt syndrome, etc. * patients have a known secondary cause of hypertension * patients have hospitalization of a hypertensive emergency in the previous year * patients have a history of renal disease or renal-artery diseases * severe hepatic or renal dysfunction * active acute infection * patients cannot submit a signed informed consent form * patients are pregnant or plan to be pregnant during study period * patients participate in another study that will confound this study
evaluation of the benefits for overall health following cochlear implant treatment in the elderly population

Conditions: Hearing Loss

Summary: the purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.

the study is designed as an observational prospective repeated measures study with each subject acting as his/her own control. subjects are evaluated subjectively at pre- and post-operative intervals that coincide with their routine visits to the clinic. outcomes from routine practice and application of cochlear implant intervention are recorded through observational measures using clinical standards scales used widely in geriatrics and audiology. the study is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company cochlear. patients are approached for study participation prior to surgery by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.

Eligibility criteria:
inclusion criteria: * unilateral ci candidates with bilateral post-lingual deafness with intention to treat * ≥ 60 years at first unilateral cochlear implant * implant ear: meets all local criteria for cochlear implant treatment * contralateral ear: average pure tone thresholds indicate a moderately-severe to profound hearing loss (4 freq. average: 0.5, 1, 2 and 3 or 4 khz \> 56 dbhl). * willingness to participate in and to comply with all study procedures * fluency in languages used to assess clinical performance * appropriate expectations from routine cochlear implant treatment * able to decide on study participation personally and independently sign their consent exclusion criteria: * significantly/severely dependent or fragile * unable to provide consent personally * unable to complete questionnaires for self-assessment independently * unilateral hearing loss * sequential and simultaneous bilateral cochlear implant recipients * ossification or other cochlear anomalies preventing full electrode insertion * retro cochlear or central origins of hearing impairment. * significant comorbidities preventing study participation (e.g. blindness, immobility or in a wheel chair, severe aphasia) * medical contraindications to surgery * clinic standard fail criteria for cochlear implant candidacy in regards to chronic depression, dementia, and cognitive disorders. * unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device.

Keywords: cochlear implant treatment, aging adults
netrin-1 and placenta accreta

Conditions: Placenta Accreta

Summary: netrin-1 is a secreted protein, which was first identified as a neuronal guidance factor. it is expressed in a multitude of tissues as pancreas, lung, breast, and placenta. netrin-1 is a multifunctional protein, involved in cell polarity, adhesion, angiogenesis, apoptosis, migration, morphogenesis, and differentiation of various cell types. most of netrin-1 activity occur through signaling pathways induced by its two main receptors, dcc (deleted in colorectal cancer) and unc5h (uncoordinated-5 homolog). its receptors have been linked to the processes of apoptosis and angiogenesis. in absence of netrin-1, dcc and unc5h receptors lead to apoptosis. in contrary, in presence of netrin-1, receptors transduce molecular cascades leading to proliferation, differentiation and migration of the cells. netrin-1 has been involved in the pathogenesis of multiple diseases, as diabetes, cardiovascular diseases, and cancer. serum netrin-1 levels were high in preeclamptic patients.


Eligibility criteria:
inclusion criteria: * age between 20-40 years. * singleton pregnancy. * women with suspicion of pa by two-dimensional (2d) gray scale imaging and color doppler flow mapping exclusion criteria: * multiple pregnancy, * fetal anomalies, * preterm premature rupture of membranes, or infection * any medical disorders, such as thyroid dysfunction, hypertension, and gestational diabetes * patients with known bleeding disorders or on anticoagulant therapy.
the impaction of exercise training on bone mineral density in patients after total knee arthroplasty

Conditions: Knee Osteoarthritis; Arthropathy of Knee

Summary: rehabilitation after total knee arthroplasty (tka) should consider control of postoperative pain and swelling, protection of the healing graft, restoration of full range of motion symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee, hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional activities that are required for return to the normal daily life. the effects of concomitant injuries and surgical procedures must also be considered in planning an individualized rehabilitation program. however, it is still unclear regarding the optimal exercise prescription after tka. in the current study, the investigators plan to develop an exercise protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density assessment. the exercise prescription consisted of cyclic exercise, aerobic exercise and resistant training exercise for first, second and third year, respectively. cyclic exercise is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the exercise can be quantitatively determined. aerobic exercise is privileged by the cardiopulmonary endurance improvement, along with muscle strengthening in the associated muscle groups. resistance exercise is specified for the indicated muscle groups, especially knee extensors, flexors, ankle plantar flexor and dorsi flexor in tka reconstructed patients. the investigators hypothesis that using this cyclic exercise process can improve the body composition, muscle strength, bone mass density, level of oxidative damage indicators, gait performance, quality of life, knee joint range of motion, function of cardiopulmonary and fitness. this project will establish the scientific basis for rehabilitation protocol involving knee surgery.


Eligibility criteria:
inclusion criteria: * the inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (oa) and recommended to receive tka surgery. exclusion criteria: * the exclusion criteria were the patients with diabetes, neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
comparison of the effectiveness of three different treatment methods in myofascial pain patients

Conditions: Temporomandibular Disorder

Summary: the aim of this study was to compare the effectiveness of myofascial pain treatment methods.

three different metoda were taken into account: dry needling, occlusal sprint therapy and nsaid therapy.

Eligibility criteria:
inclusion criteria: * pain localized in the tmj or in the preauricular area. * no other analgesic treatment in the area of head and neck during last 12 months exclusion criteria: * inflammation in the oral cavity that emerge as a myofascial pain * earlier splint therapy * pharmacotherapy e.g oral contraception, hormone replacement therapy, -antidepressants * systemic diseases e.g. rheumatic, metabolic * lack of stability in the masticatory organ motor system * masticatory organ injury

Keywords: dry needling, occlusal splint, nsaid, nimesulide
efficacy of lower extremity mirror therapy on balance in children with hemiplegic cerebral palsy

Conditions: HEMIPLEGIC CEREBRAL PALSY

Summary: the study will be conducted to assess the efficacy of mirror therapy on balance in children with hemiplegic cerebral palsy.

hemiplegic cerebral palsy in the most common type of cerebral palsy that has permanent motor disorders and associated with life-long disability. the aim of study to assess the efficacy of mirror therapy on balance in children with hemiplegic cerebral palsy. seventy child with hemiplegic cerebral were enrolled in this study and were assessed for eligibility. their aged ranged from eight to twelve years. the children were assigned randomly into two equal groups. group (a) control group received traditional physical therapy program. and group (b) study group received the same traditional physical therapy program in addition to mirror therapy three times / weak for three successful months. biodex balance system was used to assess balance pre and post treatment. all children were assisted before and after three months of intervention.

Eligibility criteria:
inclusion criteria: * children's aged ranged from eight to twelve years. * children participated in this study will from both sexes. * their degree of spasticity will ranged from mild to moderate according to modified ashworth scale. * children with stable medical and psychological status. * children able to follow the verbal commands or instructions. exclusion criteria: * children with visual or auditory problems. * children with history of epilepsy. * children with history of surgical interference in lower limbs less than one year. * medically unstable children especially with cardiovascular disorders. * mentally retarded children. * un-cooperative children.

Keywords: cerebral palsy balance mirror therapy
a study of zanubrutinib plus anti-cd20 versus lenalidomide plus rituximab in participants with relapsed/refractory follicular or marginal zone lymphoma

Conditions: Relapsed/Refractory Follicular Lymphoma; Marginal Zone Lymphoma

Summary: the purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (r\^2) in participants with relapsed/refractory (r/r) follicular lymphoma (fl), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the international working group on non-hodgkin lymphoma (nhl) criteria based on n positron emission tomography and computed tomography (pet/ct), and to compare the efficacy of zanubrutinib plus rituximab versus r\^2 in participants with r/r marginal zone lymphoma (mzl), as measured by progression free survival (pfs) assessed by irc in accordance with ct-based lugano 2014 criteria.


Eligibility criteria:
key inclusion criteria: * histologically confirmed grade 1-3a fl or mzl * previously treated with ≥ 1 line of systemic therapy including anti-cd20 agent. must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy * need for systemic therapy for fl or mzl * measurable disease by computed tomography or magnetic resonance imaging * adequate bone marrow, liver and renal function key exclusion criteria: * transformation to aggressive lymphoma * requiring ongoing need for corticosteroid treatment * clinically significant cardiovascular disease * prior malignancy within the past 2 years * active fungal, bacterial, and/or viral infection that requires systemic therapy * prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (\< 24 months) note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: zanubrutinib bgb-3111 rituximab lenalidomide obinutuzumab
tissue distribution, pharmacokinetics, safety, and tolerability after a single dose of tnp-2092 in participants undergoing primary total hip or knee arthroplasty

Conditions: Prosthetic Joint Infection

Summary: this study will investigate tnp-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (tha) or a total knee arthroplasty (tka). tissue distribution is the primary objective, and plasma pharmacokinetics (pk), safety, and tolerability are secondary objectives.

this is a phase 1, open-label study to evaluate the tissue distribution, plasma pk, safety, and tolerability after a single 300 mg intravenous (iv) dose of tnp-2092 administered before induction of anesthesia in adult participants undergoing tha or tka. sixteen patients who are scheduled to undergo primary tha or tka will be enrolled. the enrolled participants who meet the inclusion/exclusion criteria will receive the study intervention (a single 300 mg iv dose of tnp-2092) 2 hours before induction of anesthesia on day 1. tissue samples from bone and synovial fluid will be collected during surgery and analyzed for tnp-2092 and cefazolin concentrations. plasma samples will be collected on day 1 and day 2 for pk analysis. safety and tolerability information will be collected on day 1 and day 2 at the clinical center, on day 7 by phone, and on day 14 at a final follow-up visit.

Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study only if all inclusion criteria are met: 1. male or females, 18 years of age or older 2. participants who require primary tha or tka 3. body mass index (bmi) \>=18 kg/m2 but \<=40 kg/m2 4. capable of giving signed informed consent exclusion criteria: participants are excluded from the study if any of the following exclusion criteria are met: 1. history or hypersensitivity or intolerability to any of the following drugs: any member of fluoroquinolones, rifamycin, cefazolin or tnp-2092 2. history of known methicillin-resistant staphylococcus aureus (mrsa) infections 3. presence of any surgical or medical condition that in the opinion of the principal investigator and the medical monitor that could impact the interpretation of the results of the study; 4. evidence of significant hepatic, hematologic or immunologic disease; 5. history or evidence of severe renal disease

Keywords: tnp-2092 tissue distribution tha tka safety pk
precise evaluation criteria for histological regression of nash fibrosis

Conditions: NASH; Liver Fibrosis

Summary: it is an observational study of nash patients with a calculated sample size of 220. liver biopsy-proven nash fibrosis with stage f2-f4 will be recruited in this study. a second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. patients will be followed up at baseline and every six months with h-crp, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.


Eligibility criteria:
inclusion criteria: * 18-70 years of age. * liver biopsy-proven nash fibrosis with stage f2-4. * signature of written informed consent. exclusion criteria: * patients with other liver diseases, including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, genetic metabolic liver disease, drug-induced liver diseases, and infected with hiv. * pregnant women. * patients have the following conditions before liver biopsy: hepatocellular carcinoma or suspected liver cancer; decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatorenal syndrome; other malignancy; undergone liver transplantation surgery; * patients with any other reasons not suitable for the study.

Keywords: nash liver fibrosis