Kornimate/medical-research-clean huggingface dataset:
autologous tumor-infiltrating lymphocyte injection (gt201) for the treatment of metastatic/recurrent advanced solid tumors

Conditions: Solid Tumor

Summary: this study is a single-center, single-arm phase i clinical trial. a total of 30 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study. an "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (fc regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.the study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period


Eligibility criteria:
inclusion criteria: 1. voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol 2. at least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes 3. eastern collaborative oncology group (ecog) physical fitness status score of 0 or 1. exclusion criteria: 1. failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment 2. people with uncontrolled tumor-related pain as judged by the investigator 3. risk of major bleeding as assessed by investigators 4. have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function 5. any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy 6:history of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (dmso), human serum albumin (hsa), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7：women who are pregnant or breastfeeding; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.
life balance and bimanual activities after stroke

Conditions: Stroke

Summary: the flemish version of the life balance inventory (lbi), measuring central constructs of life balance, will be validated in a stroke population. upon approval by the ethical committee, stroke patients will be recruited when they are at least six months post stroke (n = 30). the lbi will be administered twice with one week interval, and demographic, socio-economic variables and other measures of health related quality of life will be collected. next, an observational prospective longitudinal study will be set up. we will recruit stroke patients in three rehabilitation centers within one week after admission in the rehabilitation center. patients will undergo a baseline evaluation and will be re-assessed at discharge from the rehabilitation center, at six months and at 12 months post stroke. a standardized clinical assessment battery, measuring motor, sensory, cognitive, mental and functional outcomes as well as personal and environmental factors will be administered. this observational study will explore recovery patterns of bimanual activities after stroke from baseline evaluation to six and 12 months after stroke. also the predictive value of motor, sensory, cognitive and mental outcomes on bimanual activities at six and 12 months post stroke is studied, based on data collected on admission to the rehabilitation center. finally, changes over time in life balance and its determinants will be examined at six and 12 months post stroke. the predictive value of motor, cognitive and functional outcomes on life balance at one year post stroke will be examined, based on data collected on admission to the rehabilitation center. furthermore the influence of bimanual activities on life balance will be explored in the chronic stage after stroke.


Eligibility criteria:
inclusion criteria: * first-ever stroke, as defined by the who criteria * assessed and included within the first week after admission in the rehabilitation center and within the first six weeks after stroke onset * unilateral motor impairment in the upper limb (ul - fügl-meyer score ≤ 60) * minimally 18 years old * substantial cooperation to perform the assessments * written informed consent exclusion criteria: * other neurological impairments with permanent damage such as multiple sclerosis or parkinson's disease * a subdural hematoma, tumor, encephalitis or trauma that lead to similar symptoms as a stroke
epidemiology of cardiovascular risk factors in women (healthy women study)

Conditions: Cardiovascular Diseases; Heart Diseases; Depression; Carotid Artery Diseases; Menopausal Syndrome

Summary: to determine cardiovascular risk factors and the change in risk factors during and following the menopause.

background: in 1983, when the healthy women study began, there was a paucity of epidemiological studies of cardiovascular risk factor changes and risk of heart disease related to natural menopause. the healthy women study was one of the few in which the status of premenopausal women was followed carefully through and subsequent to the menopause. the study also included detailed behavioral and biological measures, as well as important environmental factors related to the determinants of these risk factors. design narrative: a cross-sectional study was conducted to determine the relationship between risk factors, behavioral, psychosocial, and other environmental determinants. a five year longitudinal follow-up of the women evaluated changes over time in risk factors related to the perimenopausal and postmenopausal periods. longitudinal follow-up after the menopause continues in order to determine the relationships among changes in behavior, hormones, habits, and risk factors. the women had home interviews, baseline examinations, follow-up of menstrual cycles, and a six-month self-administered questionnaire. risk factors studied included behavioral factors, glucose and insulin, obesity, exercise, cigarette smoking, nutrition, lipoproteins, blood pressure, and hormones. surgical menopause and the use of exogenous hormones were also studied. although not part of the original protocol, measurements of fat distribution, coagulation factors, apoproteins, sodium-lithium counter-transport, and sodium-hydrogen exchange in platelets were added. the study was renewed in 1995 to continue follow-up to determine characteristics of changes in risk factors, behavioral/psychological attributes and to determine the relationship between risk factors, and their changes and atherosclerotic plaque and wall thickness. studies are conducted on the interrelationship of lifestyle and behavioral attributed to sex-steroid hormones and insulin and the level of hormones to atherosclerosis. a determination is made of the association of lifestyle to amount and distribution of body fat measured by dexa and ct of the abdomen. the study has been renewed several times and ends in november of 2007.

Eligibility criteria:
inclusion criteria: women had to be premenopausal and have an intact uterus and ovaries exclusion criteria: hypertension, diabetes, heart disease, major cancer or stroke
study to assess effectiveness and safety of zanubrutinib for patients with marginal zone lymphoma treated in italy under the named patient program (npp)

Conditions: Marginal Zone Lymphoma(MZL)

Summary: observational, non-interventional, retrospective, multicentre study focusing on efficacy and safety of zanubrutinib in daily clinical practice in patients with relapsed/refractory (r/r) marginal zone lymphoma.

due to the rarity of the condition and the novelty of its application, the study is intended to be exploratory, with the aim of providing interim evidence on which to plan future studies in larger populations. data will be collected from the start of therapy until 6 months after the end of therapy, when applicable.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of relapsed/refractory marginal zone lymphoma 2. patients who received at least one dose of zanubrutinib under the named patient program (d.m. 7 sep 2017), between january 2021 and october 2023 3) age≥18 at start of zanubrutinib therapy. 4) signature of written informed consent to study participation and personal data processing. exclusion criteria: 1) relapsed/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.

Keywords: zanubrutinib
clinical evaluation of the efficacity of epilepsy surgery in infants and children

Conditions: Epilepsy

Summary: the pediatric neurosurgery service of the rothschild foundation (paris) is the french leader center for surgery of epilepsy in infants and children. postoperative follow-up of these children is performed during medical and neurosurgical consultations in order to assess the frequency of attacks and to reduce medication. on average, two postoperative consultations are carried out between 3 and 5 months and between 12 and 18 months. beyond 18 months, some children may benefit from long-term monitoring at this center, but most children are followed by their neurologist . therefore, the center has no rigorous and systematic collection of standardized data on the outcome of these patients. the purpose of this study is to evaluate the efficacy of the epilepsy surgery in children with a monitoring of 3 years.


Eligibility criteria:
inclusion criteria: * child treated surgically for epilepsy at the rothschild foundation (paris, france) exclusion criteria: * parental opposition to the participation of their child to the study
the effectiveness of a positive psychology app in the general population

Conditions: Mental Health; Well-being; Depression; Anxiety; Adults; App; Positive Psychology

Summary: the corona crisis has a negative impact on the mental wellbeing of the dutch population. positive psychology exercises (ppos) can potentially improve mental well-being and reduce mild and moderate psychological complaints. previous research has shown moderate to large effects of ppos on well-being in people with reduced wellbeing and psychological symptoms at baseline. the university of twente developed an app (training in positivity; tip) based on an effective intervention. the goal of this study is to investigate the effectiveness of tip in the general population in people experiencing reduced mental wellbeing as a result of the corona crisis. people using the app will be compared to a waiting list control group.


Eligibility criteria:
inclusion criteria: 1. the participant is at least 18 years old 2. the participant has an e-mail address and is in possession of a smartphone or tablet with access to the internet. 3. the participant is willing to do a positive psychology exercise 6 days a week for 3 weeks 4. the participant has sufficient command of the dutch language to be able to complete questionnaires and exercises. 5. the participant gives consent to participate in the study using the online informed consent procedure. exclusion criteria: 1. the presence of severe anxiety symptoms: a score of 15 or higher on the generalized anxiety disorder 7 items (gad-7) 2. the presence of severe depressive symptoms: a score of 20 or higher on the patient health questionnaire (phq-9).
bladder endometriosis: evaluation in mri of the involvement of the posterior inferior wall

Conditions: Endometrial Bladder Disease

Summary: evaluate mri criteria for involvement of the posterior inferior wall of the bladder in patients with endometrial bladder disease.

purpose: to retrospectively evaluate on mri the local staging with assessment of ureteral orifices extension in bladder endometriosis./ materials and methods: institutional review board approval for this study was obtained and waived written informed consent. the mr images of 39 patients operated for bladder endometriosis over a 6 years period in 3 university lyon hospitals were reviewed. two experienced readers reported the vesical repletion volume, the largest lesion size, the location and extension of the lesion within the bladder wall, the distance between the ureteral orifices and the lesion when the vesicovaginal wall was involved, the presence of muco-sub mucosal complex edema and the association with external adenomyosis. mr images were compared with surgical and pathological findings. efficacy parameters were calculated with 95% confidence interval (ci).

Eligibility criteria:
inclusion criteria: * patient operated for pelvic endometriosis with bladder resection. * performing a preoperative pelvic mri with at least 2 perpendicular t2 planes exclusion criteria: * refusal to use clinical data and exploration acquired * absence of interpretable preoperative pelvic mri
an evaluation of the michigan state innovation model in washtenaw and livingston counties

Conditions: High Utilization of Emergency Departments

Summary: this study will examine the effects of a care management program on the health and health spending outcomes of patients residing in michigan's washtenaw and livingston counties.

in 2017, the state of michigan will offer enrollment in care management services to a set of patients in washtenaw and livingston counties who are predicted to be high-frequency users of emergency departments. this is a quality improvement initiative. the center for healthcare research and transformation (chrt) will administer this enrollment and collect patient data. the principal investigators will conduct a study that uses the data from this quality improvement initiative to compare the outcomes of the treatment and control groups. specifically, the study will examine whether the care management services had an effect on the number of emergency department visits and the total healthcare spending of the patients in the treatment group. the present study therefore is the second of two related projects - the first is the chrt-administered random assignment and enrollment of patients into care management services. the present study is a secondary analysis of the data produced by the first project. this protocol registration and results submission refers to the secondary analysis component wherever applicable, and where not applicable, describes the information relevant to the chrt project. for example, while the present study does not assign anyone into treatment or control groups, the sample description indicates "probability sample" to describe the way in which chrt intends to enroll patients.

Eligibility criteria:
inclusion criteria: 1. reside in washtenaw or livingston counties or have an unknown address; 2. have a probability of being admitted to an emergency department (ed) in washtenaw or livingston counties that exceeds a threshold value in a predictive model; exclusion criteria 1. patients referred by a community provider 2. patient declines to consent
capsaicin 8% patch for spinal cord injury neuropathic pain

Conditions: Spinal Cord Injuries; Neuropathic Pain

Summary: a prospective case control study to determine the effectiveness and longevity of 8% capsaicin patch(es) in treating neuropathic pain in persons with spinal cord injury. the investigators will study spinal cord injury patients at south texas veterans health care systems spinal cord injury inpatient unit and outpatient clinics.

the investigators will recruit \~ 20 patients with chronic spinal cord injury (sci) and chronic neuropathic pain (\>6months) below level of injury who have failed multiple pharmacological agents. pre-study data collection will include subjective description of pain, baseline visual analog scale (vas), numeric pain rating scale (nprs), a numerical scale such as short form (sf) 36 form that measures quality of life parameters, subjective functional independence (fim) scores, and pain diagrams will be obtained on each participant. written informed consent will be obtained. after randomization patients will be assigned to a different sequence of treatment. all patients will receive either the treatment and control patches in a randomized order for a total of three treatment periods (control, treatment, treatment for example). when assigned to received treatment arm of study patients will receive qutenza capsaicin 8% patch(es) applied for 1 hour after pre- treatment with topical lidocaine. the control group will receive a low dose (0.04%) amount of capsaicin in patch form using an identical application procedure. investigators will give each patient a diary to self record daily vas/nprs scores. investigators will then schedule routine f/u via telephone call at 2, 4, 8, and 12 weeks post application to accurately report onset of relief and obtain nprs scores at 2, 4, 8, 12 week points. patients will follow up in clinic at the end of the 12 week study to repeat data collection using our quality of life scale (sf 36) and fim scores. investigators will then use data analysis to record percentage of reduction in nprs/ vas, and changes in sf 36 and fim scores at any given time point vs baseline. for those that continue to have pain relief at 12 week mark we will periodically call every 4 months after study completion to assess for total duration of pain relief for up to 1 year post application.

Eligibility criteria:
inclusion criteria: 1. diagnosis of sci 2. neuropathic pain below level of injury 3. surface area of pain no larger than 2 patches 4. failed or did not tolerate gabapentin 3600mg/day, pregabalin 600mg/day, capsaicin cream and/or lidocaine cream 5. skin over painful area intact exclusion criteria: 1. pain over open wound 2. previously documented allergy to capsaicin 3. superficial burn over area of pain 4. premorbid (before sci) neuropathic pain 5. hiv/aids neuropathy
the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug concentration or area under curve (auc)/minimum inhibitory concentration (mic)?

Conditions: Methicillin-resistant Staphylococcus Aureus Septicemia

Summary: the purpose of this study is to evaluate which is the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug level or auc/mic.

several studies have shown auc/mic to be the better pharmacokinetic-pharmacodynamic parameter for clinical effectiveness of vancomycin. however, the 2009 consensus guideline for vancomycin therapeutic monitoring continued to recommend trough serum concentration monitoring in the clinical setting. in 2011, patel et al showed that highly difference between auc(72-96h) and cmin(96h). different dosing and creatinine clearance may reach the same trough drug level with different auc. the investigators wonder whether trough drug level can serve as a substitute marker for auc and as a parameter for vancomycin therapeutic monitoring. in this study, the investigators will calculate auc/mic of vancomycin with published formula, analyze its correlation with patient's clinical outcome and compare that with trough drug level.

Eligibility criteria:
inclusion criteria: * inpatients of national taiwan university hospital * age above or equal to 20 years old * positive methicillin-resistant staphylococcus aureus blood culture * receiving vancomycin therapy for definitive use * undergoing therapeutic drug monitoring (had serum vancomycin concentration level) exclusion criteria: * age below 20 years old * without details of vancomycin dose and frequency * vancomycin treatment shorter than 72 hours * without renal function data (serum creatinine level, creatinine clearance) * without infection-related clinical outcomes (lab data such as white blood cell count , seg, c reactive protein , body temperature records) * receiving renal replacement therapy * therapeutic drug monitoring before reaching steady state * with abnormal and undefined serum concentration

Keywords: vancomycin therapeutic response monitoring auc/mic
clinical and molecular biological data collection and analysis in patients with tbi

Conditions: Traumatic Brain Injury

Summary: clinical evaluation is crucial in the clinical diagnosis, treatment, and prognosis prediction in patients with traumatic brain injury (tbi). however, the existing evaluation systems are not perfect, because many factors are not taken into account, for example, there is a lack of molecular diagnostic criteria for evaluating patients with tbi. we attempt to collect the patient's clinical data and combine it with neuroimaging, as well as molecular biomarkers generated by single-cell sequencing to assess their neurological status and outcome. the clinical and molecular data collection and analysis will be helpful to evaluate the patient's neurological condition and predict the patient's outcome more accurately.

specifically, eligible patients will be treated surgically. in one group, injured brain tissue removed during decompression and resection will be preserved in a tissue preservation solution. in another group, brain tissue in the surgical trajectory during surgical resection of the brain lesion (for example, gliomas, meningiomas, schwannomas) will be also preserved in the solution. then these tissues will be analyzed through high-throughput single-cell sequencing and bioinformatics analysis. in order to obtain the most changed biomarkers, we will pick up the top 10 cell subgroups with 10 expression biomarkers in each subgroup to compare them with the results analyzed in the mice brain tissue. the target biomarkers will be validated in the cerebrospinal fluid (csf) and blood in patients with tbi for the patient's neurological status evaluation and outcome prediction. at the same time, the patient's pre- and postoperative clinical data (including, gender, age, gcs score, pupil light reflection, ct results, etc) will also be collected. a regression model will be generated to estimate the relationship between the patient's neurological status and these independent variables. in addition, the association between a patient's prognosis and these factors will also be analyzed. roc curve will be used to compare our regression model to the established gcs score scale and marshall ct grading.

Eligibility criteria:
inclusion criteria: * ct/mri confirmed tbi; * the time from onset to the emergency room (er ) within 12h; * the systolic pressure (sbp) ≥ 90 mmhg; * patients willing to participate in this study with signed informed consent. exclusion criteria: * patients who are not suitable for surgery (gcs score 3 points, dilated and fixed bilateral pupils, pregnant women, etc.); * pre-injury life expectancy ≤ 1 year (malignant tumor); * previous history of acute myocardial infarction, abnormal immune function, and blood-related diseases; * without informed consent.

Keywords: traumatic brain injury molecular biomarkers single-cell sequencing high-throughput sequencing
study of naltrexone for methamphetamine addiction

Conditions: Methamphetamine Dependence

Summary: the purpose of this study is to determine whether methamphetamine-dependent individuals will use less methamphetamine when treated with naltrexone. the study will also investigate whether individuals with the mu opioid receptor gene variant a118g will use less methamphetamine than individuals without a118g.


Eligibility criteria:
inclusion criteria: * age between 18 and 50 years * patient is agreeable to conditions of study and signs consent form

Keywords: meth methamphetamine addiction methamphetamine treatment naltrexone vivitrol a118g oprm1