Kornimate/medical-research-clean huggingface dataset:
study of actr t cell product in combination with trastuzumab in subjects with her2-positive advanced solid tumor cancers

Conditions: Solid Tumor; HER-2 Protein Overexpression

Summary: this is a phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (rp2d) of actr t cell product (actr707 or actr087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with her2-positive advanced malignancies.


Eligibility criteria:
inclusion criteria: * signed written informed consent obtained prior to study procedures * histologically-confirmed her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer * subjects must have previously received adequate standard therapy for treatment of their malignancy * for those with metastatic breast cancer, must have received her2-directed therapy including trastuzumab, pertuzumab and ado-trastuzumab in any breast cancer disease setting * for those with advanced gastric cancer, adequate prior treatment with her2-directed chemotherapy is required * at least 1 measurable lesion by irecist * able to provide fresh tumor biopsy or archived block specimen taken since time of most recent anti-her2 mab-directed therapy * ecog of 0 or 1 * life expectancy ≥ 6 months * lvef ≥ 50% by muga or echo * absolute neutrophil (anc) count ≥ 1500/ µl * platelet count ≥ 100,000/µl * hemoglobin ≥ 9g/dl * estimated gfr \>30ml/min/1.73m2 exclusion criteria: * glioblastoma multiforme or other primary cns tumors are excluded * clinically significant cardiac disease * clinically significant active infection * clinical history, prior diagnosis, or overt evidence of autoimmune disease * current use of more than 5mg/day of prednisone (or an equivalent glucocorticoid) * prior treatment as follows: * prior cumulative doxorubicin dose greater than or equal to 300 mg/m\^2 or equivalent * chemotherapy within 2 weeks of enrollment * external beam radiation within 2 weeks of enrollment (28 days if cns-directed therapy) * any monoclonal antibody (mab) or other protein therapeutic containing fc-domains within 4 weeks of enrollment * pertuzumab within 4 months of enrollment * experimental agents within 3 half-lives or 28 days prior to enrollment, whichever is shorter * allogeneic hematopoietic stem cell transplant (hsct) * prior infusion of a genetically modified therapy * pregnant or breastfeeding

Keywords: her2 actr actr087 actr707 t cell t cell product adoptive t cells gene therapy breast cancer gastric cancer gastro esophageal cancer immunotherapy solid tumor adenoid cystic carcinoma
efficacy of amals in treating language impairment in children

Conditions: Language Disorder

Summary: the goal of this proposal is to examine the efficacy of a manualized treatment intervention, amals: addressing multiple aspects of language simultaneously, which is designed to remediate semantic, morphological, and syntactic aspects of language in preschool children with language impairment. this study will target preschool children with language impairment living in a region characterized by nonmainstream dialects. questions driving this work are: 1. will children participating in the amals treatment exhibit greater semantic, morphological, and syntactic complexity on multiple outcome measures at the completion of the intervention compared to a discrete trial approach (dta) group? 2. will these gains be maintained at one-month follow up? 3. what is the impact of dialect on dependent variables, specifically morphosyntactic abilities? to answer these questions a randomized clinical trial will be conducted comparing amals, an integrated approach to treatment, with dta, an additive approach to therapy. in this study rather than restrict the ethnic and cultural backgrounds of this population, children's use of dialect will be uniquely identified and examined.


Eligibility criteria:
inclusion criteria: 1. demonstrate sufficient intelligibility as determined by a score of 85% on percent consonant correct (pcc) measures; 2. demonstrate sufficient phonological ability to use grammatical morphemes as determined by use of word-final /s, z, t, d/ on sound- in-word subtest from the goldman-fristoe test of articulation-2 (gfta; goldman \& fristoe, 2000) 3. nonverbal iq above 70 as scored on the columbia mental maturity scale (cmms; burgemeister, blum, \& lorge, 1972); 4. below 1sd on the diagnostic evaluation of language variation: norm-referenced test (delv; seymour, roeper \& de villiers, 2005); 5. below 1.39sd on the structured photographic expressive language test-preschool (spelt-p; werner \& kresheck, 1983); 6. documentation from teachers and/or parents of impressions of language status in comparison with peers; 7. more than one standard deviation below the mean on both levels 3 and 4 of the preschool language assessment instrument (plai; blank, rose, \& berlin, 1978). exclusion criteria: 1. english as the primary language 2. no oral-motor impairment 3. no hearing impairment 4. no co-morbid psychiatric or neurological impairments
effects of sustained-release oral sodium nitrite on postoperative pain and recovery following total knee arthroplasty

Conditions: Pain

Summary: this study will determine whether a drug called sodium nitrite helps improve pain and post-operative recovery associated with knee replacement surgery.

the goal of this study is to examine the potential for oral sodium nitrite supplementation to reduce postoperative pain and inflammation and improve functional recovery in individuals undergoing unilateral revision total knee replacement. a sustained release formulation of sodium nitrite (40 mg) administered twice daily will be compared with placebo for a 30-day treatment period. primary objectives are to evaluate pain and markers of functional improvement.

Eligibility criteria:
inclusion criteria: * male and female individuals aged 18-70 * ambulatory with knee pain for greater than 6 months prior to surgery, and willing and able to comply with all study requirements will be considered eligible. exclusion criteria: * severe hypertension (systolic blood pressure greater than or equal to 200 mmhg or diastolic blood pressure greater than or equal to 120 mmhg); * bmi greater than 45 kg/m2; * active smoker or stopped smoking within 6 months of enrollment; * active local or systemic malignancy, such as lung cancer or leukemia; * cardiovascular disease resulting in dyspnea at rest; * peripheral neurovascular disease; * anemia; * hematological disease (eg, coagulopathy, sickle cell disease/anemia); * hemoglobin variant; * glucose-6-phosphate dehydrogenase deficiency; * methemoglobin reductase deficiency; * known sensitivity to nitrites; * liver disease; * use of phosphodiesterase type 5 inhibitors; * use of sildenafil (viagra); * systemic treatment with antibiotics, immunosuppressants including corticosteroids, medications for migraine, allopurinol, tricyclic antidepressants, antihistamines, and/or nitrates currently or in the last month; * use of nitrovasodilators (e.g. gtn) within the last month; * use of protein pump inhibitors within the last month; * history of substance abuse; * recent surgery or hospitalization (within last 6 months); * inability to swallow a pill; * failure to provide full consent; * involvement with a worker's compensation, personal injury, or other legal matter related to participant health.
preoperative anaemia prevalence in surgical patients

Conditions: Anemia; Iron-deficiency; Folic Acid Deficiency; Vitamin B 12 Deficiency; Anaemia of Renal Disease; Anemia of Chronic Inflammation

Summary: preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality. anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin b12 or folate, and bone marrow diseases. among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. the aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin b12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery.

preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality. due to the potential risk of additional blood loss, anaemia represents a serious disease condition within the surgical field. especially patients undergoing major elective surgery are at risk of substantial blood loss. anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin b12 or folate, and bone marrow diseases. among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. the aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin b12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery. results will facilitate design of supplementation strategies to improve haemoglobin level before surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * written informed consent prior to study participating according to the national law requirements * patients undergoing major surgery * expected hospital stay with a minimum of 24 hours exclusion criteria: * preoperative autologous blood donation * patients with expected re-surgery within the planned 7-day recruitment period

Keywords: anemia
study of factors of genetic susceptibility associated to severe caries phenotype

Conditions: Dental Caries

Summary: alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for a matrix protein could increase the susceptibility of the enamel to caries after tooth eruption. to identify in young patients with severe caries incidence, the occurrence of mutations in several candidate genes which result in an alteration of the enamel microstructure that could explain the high caries susceptibility of the patient.

although its prevalence has decreased dramatically in european countries, dental caries remains a burden for the society and especially for certain groups of the population. for example, 80% of the carious lesions are diagnosed in about 20% of the children. for years, the aetiology of this disease has been mainly related to environmental factors but recent data support the possibility of a human genetic contribution. alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for a matrix protein could increase the susceptibility of the enamel to caries after tooth eruption. the main objective of this study will be to identify in young patients with severe caries incidence, the occurrence of mutations in several candidate genes which result in an alteration of the enamel microstructure that could explain the high caries susceptibility of the patient. with this aim, we will carry out a case- control multicentre european study on 250 young patients presenting several carious lesions and 160 young adults totally caries free. patients with systemic or enamel pathologies such as amelogenesis imperfecta will not be included in the study. the study will consist of 2 visits, 1: inclusion and genetic test based on a salivary sample and 2: after 6 months, communication of the genetic test result to the patient and his parents. the main evaluation criteria will be the finding of a mutation on the candidates genes not resulting in an amelogenesis imperfecta phenotype but associated to a severe caries phenotype. if a direct relation between a mutation and a severe caries phenotype was shown, all the classical approaches, prevention protocols and treatments of caries would need to be reconsidered.

Eligibility criteria:
inclusion criteria: * patients : presenting at least 3 active carious lesions aged 2 to 16 years old, written informed consent * volunteers : young adults 18 to 30 years old totally caries free exclusion criteria: * patients with systemic or enamel pathologies such as amelogenesis imperfecta * osteogenesis imperfecta * hypophosphatemia * hypodermal dysplasia * syndrome of prader willi * fluoroses * toxic enamel dysplasia * pregnancy or breast-feeding * hyposialorrhea * immunodepression status * chronicle diseases * anorexia or bulimia

Keywords: caries susceptibility,enamel matrix,candidate genes,mutation
timing of orthopaedic surgery in the multiply-injured patient: development of a protocol for early appropriate care

Conditions: Unstable Pelvic Ring Fracture; Unstable Acetabulum Fracture; Femur Fracture

Summary: early fixation of unstable fractures of the femur, pelvis, and acetabulum reduces some complication rates. however, in patients with multiple injuries, the optimal treatment of skeletal trauma may be affected by severe injury to the head, chest, or abdomen. the relationship between associated injury severity and the timing of definitive management of unstable fractures is not well-understood. the practice of "early total care," early definitive fracture management, has been criticized by some, who have suggested that additional hemorrhage with surgery may be associated with a deleterious systemic inflammatory response. the alternative extreme of "damage control orthopedics (dco)" has been recently proposed as a means of providing provisional stability of major skeletal injury, generally through external fixation. it is speculated that dco will diminish the potential for systemic compromise. however, the need for further (definitive) surgery on a delayed basis, and the potential additional complications and costs associated with this strategy are controversial. the investigators' goals are to define which injuries or parameters warrant delay of definitive orthopaedic care, and to determine what time interval for fracture fixation promotes optimal patient outcome. the investigators will assess the effects of fracture fixation on head injury, chest injury, abdominal injury, mortality, complications, patient outcomes, and costs.


Eligibility criteria:
inclusion criteria: * all patients at least 16 years of age treated at a major urban level 1 trauma center between the years 2000 and 2006, who had any of the following musculoskeletal injuries: * unstable pelvic ring fracture * unstable acetabulum fracture, or * femur fracture * patients will be included regardless of race or gender. isolated fractures will be included exclusion criteria: * low-energy pelvis and hip fractures will be excluded * patients younger than 16 years of age will be excluded
the aerobic & cognitive exercise study

Conditions: Mild Cognitive Impairment; Healthy

Summary: the purpose of this study is to clarify the benefits to brain health and thinking processes that result from different forms of exercise. this study will examine the effectiveness of cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with mci, and compare this with the individual cognitive, behavioral, and physiological effects of physical and mental exercise alone. the investigators hypothesis that cognitive benefit will be greatest for combined aerobic and cognitive exercise compared to physical and mental exercise alone.

this is a multi-site, randomized controlled trial. participants will be randomized into one of three conditions for six months: cybercycle-tour, cybercycle-game, or videogame alone. comprehensive evaluations will include: neuropsychological (e.g., executive function and memory), behavioral (e.g., compliance and effort/watts), physiological (e.g., cardiorespiratory fitness), biomarker (e.g., bdnf), and an expanded neuroimaging pilot. after the six-month intervention period, participants choose whether or not to continue exercising, using any of the three conditions.

Eligibility criteria:
inclusion criteria: * age 50+ * able to pedal recumbent stationary bicycle * available for regular exercise participation 3-5x/week for at least 6 months * physician permission to exercise exclusion criteria: * unstable heart condition or other significant cardiovascular history (e.g,. stroke) * meets criteria for alzheimer's or other dementia * significant history of other neurological disease (e.g., seizures, parkinson's, etc.) * physician denial to exercise

Keywords: mci exergaming cognition exercise older adults
greater china metabolic and bariatric surgery database

Conditions: Metabolic Surgery

Summary: metabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. in addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (t2dm), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (osahs) and polycystic ovary syndrome (pcos)in severely obese patients. however, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in chinese patients with obesity and encouraging future research in this field.


Eligibility criteria:
inclusion criteria: * be able to receive metabolic surgery, including but not limit to lsg and lrygb exclusion criteria: * can not be able to understand and willing to participate in this registry with signature

Keywords: metabolic surgery metabolic disease multicenter
evaluation of weight bearing after total hip and knee replacement

Conditions: Arthropathy of Hip; Arthropathy of Knee

Summary: the regime in the aftercare after total hip and knee arthroplasty(tha/tka) differs a lot between orthopedic surgeons concerning weight bearing. the type of implant and the way of implants' anchoring are considered. in the literature there is no data so far about the way patient take care of the recommended weight bearing during the first 6 weeks after tha and tka. over a one year period starting august 2010 all patients undergoing tka or tha at the investigators institution will have a technical device in their shoes (sole) to measure the load in each step they do in these shoes during the first 6 weeks. patients are asked to fill out a standardised pain protocol every day (vas) and document need of pain medication. the investigators recommend 20kg of weight on the operated leg for 6 weeks and full weight bearing at the end of week six. the investigators believe that patients will adjust weight bearing to their level of pain and not to their surgeons recommendations.


Eligibility criteria:
inclusion criteria: * received a tha or tka in the mentioned period of time * is able to walk on crutches * is able to understand our recommendations * signed informed consent exclusion criteria: * not able to walk on crutches * not able to understand our recommendations * other deformities of lower limbs

Keywords: weight bearing pain total hip arthroplasty total knee arthroplasty weight bearing after tka or tha
mindfulness meditation in chronic stress

Conditions: Aging

Summary: the study purpose is to evaluate efficacy of a mindfulness training intervention and learn about cognitive and physiological markers of stress.

subjects will first undergo a phone screening, and if eligible, they will complete three study visits at week 1, week 8, and week 15. the study visits involve at-home surveys, voice recordings, physical measures (height, weight, waist-to-hip ratio, and blood pressure), eeg recordings (including recordings of electrodermal activity and heart rate variability), computer tasks, in-lab saliva collection, overnight urine collection, 2-day saliva collection at bed waking, 30 minutes post-waking, afternoon, and bedtime, and a small handheld device that randomly administers eight short assessments in the subjects' natural environment. subjects will be randomized to receive a 6-week mindfulness meditation course either between the first and second study visits or between the second and third study visits. participants who receive training during the first and second visits will continue meditating until the third visit. the one-on-one instruction occurs once a week for 1 ½ hours, and participants are asked to listen to guided meditations and do other mindfulness-based tasks on a daily basis between sessions.

Eligibility criteria:
inclusion criteria: * ages 50-85 * good general health * experiencing stress * no current meditation practice * english speaking exclusion criteria: * cognitive impairment * neurological disease * major untreated depression

Keywords: stress mindfulness meditation
amygdala mri-tis for depression

Conditions: Major Depressive Disorder

Summary: the study utilizes a non-invasive deep brain stimulation (temporal interference, ti) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of mri-compatible ti technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of ti technology.


Eligibility criteria:
inclusion criteria: * participants must be aged between 18 and 65, with no gender restrictions; * a diagnosis of depression made by the study physician based on the diagnostic and statistical manual of mental disorders (dsm-5); * hamd-17 score of 17 or higher; * participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment; * eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol, and provide their signature on the informed consent form. exclusion criteria: * eligible participants must not have a history of psychiatric or neurological disorders, as judged by the investigator, which may impact the evaluation of the study's efficacy; * participants must not have a history of seizures or prior episodes of epilepsy; * the presence of metallic foreign objects within the cranial structure or metallic cardiac implants; * participants must not have a diagnosis of organic brain disease, nor a history of significant cranial trauma or neurosurgical intervention; * participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy); * the researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior; * pregnant or breastfeeding; * participants who are concurrently engaged in other clinical interventional trials; * participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied

Keywords: major depressive disorder deep brain stimulation ti stimulation