Kornimate/medical-research-clean huggingface dataset:
correlation analysis of t-lymphocyte subsets and prognosis in autologous stem cell transplantation (asct) for lymphoma

Conditions: Lymphoma

Summary: this is a retrospective, single-center, non-randomized, non-controlled study. this study aims to explore the effect of t-lymphocyte subsets changes in immunologic reconstitution and prognosis in lymphoma patients who were treated by autologous stem cell transplantation.

high dose chemotherapy combined with autologous peripheral blood stem cell transplantation is the consolidation treatment for advanced lymphoma patients and approved for treating recurrent and refractory lymphoma by prolonging progression-free survival significantly while also improving quality of life. evidences to date, have validated that changes of t-lymphocyte subsets after autologous stem cell transplantation associated closely with immunologic reconstitution, and have produced amazing effects in prognosis. whether t-lymphocyte subsets changes could serve as an effective index for prognosis has been a serious question for lymphoma patients treated by autologous stem cell transplantation. in this study, the investigators explore the changes of t-lymphocyte subsets in lymphoma patients before and after autologous stem cell transplantation, and evaluate the significant effect of t-lymphocyte subsets changes in immunologic reconstitution and prognosis in these patients.

Eligibility criteria:
inclusion criteria: 1. men and women≥18 years, \<65 years; 2. lymphoma patients treated by autologous stem cell transplantation for the first time; 3. ecog ≤ 2; 4. ccr ≥ 50 ml/min; 5. alt, ast and tbil≤2.5-fold upper normal range; 6. satisfactory heart and lung function; 7. women of reproductive potential must have a negative pregnancy test. male and female of reproductive potential must agree to practice birth control during the study and one year post study; 8. good compliance and sighed informed consent voluntarily. patients should be conformed to all inclusion criteria above. exclusion criteria: 1. prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma; 2. senior or uncontrolled virus injection: hiv, tp, hepatitis virus; 3. serious complications; 4. lvef\<55%; 5. atopy or allergy to biological product derived from colibacillus; 6. women who are breastfeeding, pregnant or refused to practice contraception; 7. severe mental or nervous system diseases; 8. severe abnormalities of heart, lung and central nervous system symptoms; 9. patients with sickle cell disease, erythronoclastic anemia or other hematological disease which has an impact on medullary hematopoiesis; 10. enrolled in other study currently or 30 days before screen; 11. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study. patients conformed to any of above criteria should be excluded from this study.
s9903: whole brain radiotherapy followed by stereotactic radiosurgery for limited malignant melanoma brain metastases

Conditions: Melanoma (Skin); Metastatic Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. stereotactic radiosurgery may kill more tumor cells. purpose: phase ii trial to study the effectiveness of radiation therapy followed by stereotactic radiosurgery in treating patients who have brain metastases from malignant melanoma.

objectives: i. estimate the 6 month intracranial progression rate and 6 month overall survival rate in patients with limited brain metastases from malignant melanoma undergoing whole brain radiotherapy followed by stereotactic radiosurgery boost. ii. evaluate the qualitative and quantitative toxic effects of this regimen in these patients. outline: patients undergo whole brain radiotherapy 5 days a week for 3 weeks, followed 3-5 weeks later by stereotactic radiosurgery. patients are followed every 3 months until death. projected accrual: a total of 60 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: histologically proven malignant melanoma at primary or any metastatic site bidimensionally measurable disease by mri scan must have 1-6 enhancing brain metastases if at least 2 lesions are present, only 1 lesion may be greater than 3 cm in maximum diameter patient characteristics: age: not specified performance status: swog 0-2 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: no concurrent biologic response modifier or immunotherapy chemotherapy: no concurrent chemotherapy with whole brain radiotherapy prior systemic chemotherapy allowed endocrine therapy: not specified radiotherapy: no prior stereotactic or conventional radiotherapy to any field of the brain surgery: prior surgical resection of brain metastases allowed (provided 1 or 2 measurable brain metastases remain)

Keywords: stage iv melanoma recurrent melanoma tumors metastatic to brain
efficacy and safety of vatelizumab in patients who completed treatment in study dri13839

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: primary objective: to assess the long-term safety of vatelizumab in ms patients secondary objective: to assess the long-term efficacy of vatelizumab

the maximum study duration per patient will be 192 weeks, including a treatment period of 96 weeks and post-treatment safety follow-up period of 96 weeks.

Eligibility criteria:
inclusion criteria: patients who completed the 12-week treatment period in dri13839. exclusion criteria: * any clinically significant or ongoing adverse events, or laboratory abnormalities from dri13839 that per investigator judgment would adversely affect the patient's participation in the long-term extension study. * confirmed platelet count below the lower limit of normal at any time during dri13839. * pregnancy or breast-feeding. * other protocol defined exclusion criteria may apply. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
family centered occupational therapy on play skills and participation of children with asd

Conditions: Autism Spectrum Disorder

Summary: play skills and participation of children with autism spectrum disorder (asd) have been restricted by their core symptoms, resulting in heightened parenting stress and affected family daily life. this research aims to improve play skills and participation of children with asd through 'family-centered occupational therapy', thereby leading to positive outcome for not only the child but also the whole family.

play skills and participation of children with autism spectrum disorder (asd) have been restricted by their core symptoms, resulting in heightened parenting stress and affected family daily life. this research aims to improve play skills and participation of children with asd through 'family-centered occupational therapy', thereby leading to positive outcome for not only the child but also the whole family. 60 children age 2\~6 with asd will be recruited in our research, and divided into either experimental or control groups according to primary caregivers' (will be referred to as caregivers thereafter) decision whether to receive treatment in our hospital (ntuh) or not. caregivers' decision is based on the convenience of transportation to ntuh. the children with asd in the experimental group will receive family-centered occupational therapy three times a week for 6 months. the intervention goals, determined by discussing with caregivers, will often be the most important aspect of play skill and participation of children with asd, which concern caregivers most. caregivers will be equipped with the skills of guiding children with asd in play and participation in their daily life. the outcome assessments will include : (1) the child's developmental skills and the severity of asd as measured with psychoeducational profile, third edition (pep-3) and childhood autism rating scale (cars) respectively, (2) the child's play skill and participation as measured with goal attainment scale (gas), vineland adaptive behavior scale-chinese version (vabs-c) and revised knox preschool play scale (rkpps) respectively, (3) family related factors as measured with parenting stress index short form (psi/sf), family outcomes survey (fos), family empowerment scale (fes) and home observation for measurement of the environment (home). pre- and post-intervention comparison on the outcome measures within the experimental group, and group comparison on the outcome measures will be conducted to examine the effectiveness of family-centered occupational therapy. results of the study will provide empirical evidence for evidence-based occupational therapy practice in the field of play skills and participation of children with asd.

Eligibility criteria:
inclusion criteria: * patient diagnosed with autism spectrum disorder * age 2\~6 years old exclusion criteria: * patient with other disease, like seizure or other systemic disease

Keywords: family-centered autism spectrum disorder occupational therapy participation play
ketogenic diet health and longevity

Conditions: Ketogenic Dieting; Ketoses, Metabolic; Ketosis

Summary: the goal of this pilot intervention is to learn about how a well-formulated ketogenic diet (wfkd) impacts various health factors in generally healthy adults. the main questions it aims to answer are: * establish whether an 8-week isocaloric, wfkd improves body composition and metabolic biomarkers in adults without chronic disease. * examine changes in transcriptomic sequencing pathways pre- and post-wfkd intervention. * explore gut microbial changes in adults without chronic disease that consume a wfkd. participants will follow a well-formulated ketogenic diet for 8-weeks. study procedures include: * weekly body weight tracking * daily urinary ketone assessment * pre/post stool samples for gut microbiota analyses * pre/post dxa scans * diet quality tracking through 3-day food records


Eligibility criteria:
inclusion criteria: * 30 to 55 years * speaks english as primary language * bmi 20.0-34.9 kg/m\^2 exclusion criteria: * certain medications (statin, blood pressure, thyroid hormone replacement, etc.) * prior medical diagnosis of type 1 or type 2 diabetes mellitus, cancer requiring chemotherapy or radiation therapy within 5 years, cardiac event, gi disorders, traumatic brain injury/multiple concussions, hypertension, dyslipidemia, or any diagnosis deemed ineligible by study team * history of renal stones * currently lactating * already following a ketogenic diet * adherence to a specialized diet regimen that disallows compliance * use of tobacco or tobacco replacement products within 1 year

Keywords: ketogenic well-formulated ketogenic diet keto
quantitative assessment of lumbar facet joint degeneration, a retrospective study.

Conditions: Facet Joint Pain; Low Back Pain; Facet Joints; Degeneration ; Deep Learning ;Artificial Intelligence; Facet Joint Disease

Summary: observational study the purpose of this observational study was to understand the quantitative assessment of the degree of degeneration of lumbar facet joints, and to improve the weishaupt grading system by using gray-scale curve fitting and imaging parameters. the main questions it aims to answer are: how to realize quantitative analysis of lumbar facet joint degeneration in patients with chronic low back pain with mri? the mri information of patients with different grades of articular process joint degeneration has been statistically summarized in nearly 5 years


Eligibility criteria:
inclusion criteria: * (1) age range from 20 to 80 years old; (2) persisted chronic low back pain (clbp) more than 12 weeks; (3) complete preoperative x-ray and 1.5t mri examination. exclusion criteria: * (1) scoliosis, cobb angle\>20°; (2) lack of preoperative x-ray or mri examination; (3) 3.0t mri; (4) the interval between preoperative x-ray and mri examinations is more than one month; (5) previous lumbar spine internal fixation surgery; (6) lumbar spondylolisthesis \> 5 mm, with severe dislocation of facet joints; (7) intravertebral bone cement implantation; (8) severe spinal joint disease (e.g. mandatory spondylitis); (9) spinal tumors; (10) the maximum extension depth of modic changes (mc) relative to vertebral body height was greater than 25%.

Keywords: facet joint degeneration low back pain weishaupt grading system grayscale curve fitting
an it approach to implementing depression treatment in cardiac patients (iheart depcare)

Conditions: Depressive Symptoms; Coronary Heart Disease

Summary: the purpose of this study is to examine the effect of a brief electronic shared decision making (esdm) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms.

depression is common in patients with coronary heart disease and associated with increased cardiac morbidity and mortality. treating depressive symptoms appears to improve depressive symptoms and quality of life. despite expert recommendations to screen and treat depressive symptoms fewer coronary heart disease patients engage in depression treatment than the general population, perhaps due to 1) sub-optimal provider awareness and referral rates and 2) low self-efficacy, stigma and misattribution of depressive symptoms among coronary heart disease patients. in addition, few real world theory-informed implementation trials exist for improving screening and treatment in outpatient settings. the specific aim is to determine whether an electronic shared decision making (esdm) and behavioral activation tool improves depressive symptoms and treatment initiation in coronary heart disease patients with elevated depressive symptoms. to accomplish these aims, a hybrid effectiveness-implementation trial will be conducted using a pre-post design across socioeconomically diverse cardiology and primary care clinics.

Eligibility criteria:
inclusion criteria: * history of coronary heart disease * english or spanish speaking * elevated depressive symptoms (phq9 ≥10) * appointment at participating cardiology or primary care clinics exclusion criteria: * under the care of a psychiatrist \[\*\*on 6/22/2022, this exclusion criteria was removed for those clusters of clinics not already in the post-implementation period\*\*\] * diagnosis/history of psychosis or schizophrenia * diagnosis/history of bipolar disorder * attempted suicide * non-english or spanish speaking * dementia or severe cognitive impairment * non-elevated depressive symptoms * alcohol or substance abuse * pregnancy

Keywords: implementation science
therapeutic play and its effect on children's psychosocial well-being

Conditions: Therapeutic Play; Psychosocial Well-being; Nursing Care

Summary: the aim of this study was to evaluate the effectiveness of the therapeutic play-based intervention programme (totem), which was developed to reduce the negative psychosocial effects of the earthquake in children aged 4-6 years, and its effect on children's psychosocial well-being.

earthquakes are among the most impressive geological processes and are defined as an unpredictable natural disaster due to their destructive effects on people and structures. in turkey, a 7.7-magnitude earthquake occurred on 6 february 2023 at 04.17 local time, centred in kahramanmaraş, and another 7.6-magnitude earthquake occurred about nine hours later. in addition, more than 1000 aftershocks were recorded in the region and these events further increased the scale of the disaster. earthquakes have the potential to have profound and traumatic effects on people's psychological functioning. children are particularly affected by these effects due to their vulnerability during natural disasters. children who experience disasters may face various problems in physical, cognitive and socio-emotional development. therapeutic play intervention is based on the belief that play is a universal language that allows children to easily express their feelings and thoughts. this approach is an effective strategy that helps the child to explore their problems, seek solutions, express their feelings and emotional regulation. it also promotes cognitive development, reduces anxiety and stress, and increases confidence. providing appropriate support to children after a traumatic event such as an earthquake is critical for preventing future psychological problems. in this context, providing children with supportive approaches such as play therapy and conducting these methods by expert teams can contribute to children's well-being. therapeutic games play an important role by providing a universal language for children to express their emotions and cope with stress.

Eligibility criteria:
inclusion criteria: * being between the ages of 4-6 * having literate parents * having adequate turkish receptive-expressive language skills * not having a previously diagnosed psychiatric problem declared by the parents * not having participated in a training programme on psychosocial well-being before * not attending any pre-school education institution at the time of the training * volunteering to participate in the study by themselves and their parents exclusion criteria: * the participant wants to leave the study * the participant has not participated in one or more of the trainings to be given within the scope of the programme * the participant shows any diagnosed atypical development * children who show a level of resistance that disrupts their adaptation to normal life in pre-tests, during the study or in post-tests, children with anxiety disorder or other psychiatric problems

Keywords: child anxiety psychosocial status disturbance nursing care
efficacy of variable lidocaine concentrations in tumescent anesthesia for pain control during and after endovenous laser procedure; non-inferiority trial

Conditions: Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration

Summary: endovenous laser treatment is a minimally invasive procedure that has been shown to be a safe and effective treatment for varicose veins. essential to the successful ablation of refluxing veins by endovenous laser treatment is the use of tumescent anesthesia. one of the components of tumescent anesthesia is lidocaine, a commonly used local anesthetic. while lidocaine can be used safely as long as serum concentrations remain low, its use carries the risk of lidocaine toxicity. in order to minimize the risk of lidocaine toxicity it is desirable to use the minimum effective concentration of lidocaine needed to manage pain during a procedure. this study seeks to determine if a ¼ lower concentration of lidocaine in tumescent anesthesia will function as well as the standard dose for pain management in endovenous laser treatments. if we find that this is the case, we will be able to reduce the risk of lidocaine toxicity in patients undergoing endovenous laser treatment, while maintaining their comfort throughout the procedure. this will be achieved through a direct comparison of intra- and post-operative pain for patients randomized to receive either the ¼ tumescent lidocaine concentration or the standard lidocaine concentration.


Eligibility criteria:
inclusion criteria: * large saphenous vein treatment * 16-85 years old, good health * able to understand informed consent * eligible for evlt determined by physician exclusion criteria: * patients with know lidocaine sensitivity * bleeding disorders * pregnancy * congestive heart failure * liver dysfunction * patient ineligible for evlt

Keywords: lidocaine tumescent endovenous laser pain
prolaris enhanced risk stratification - an economic and clinical evaluation

Conditions: Prostate Cancer

Summary: one in 8 men will be diagnosed with prostate cancer during their lifetime. the majority of men diagnosed with prostate cancer have early stage disease, which can be managed in a variety of ways, ranging from monitoring to international treatment. however is it not always clear which treatment option is best. all men with newly diagnosed localised prostate cancer are assigned a disease risk category (low/intermediate/high risk). this is based on clinical findings and prostate biopsy results, but these factors are limited in their ability to distinguish between aggressive and indolent prostate cancers. the current risk grouping can make it difficult to plan appropriate treatment tailored and personalised to the individual patient. there is evidence reporting overtreatment of localised prostate cancer in the uk. however, many patients with aggressive disease are wrongly assigned a low risk categorisation and are recommended surveillance when better suited to more interventional treatment. myriad genetics have developed a test, called prolaris which measures how fast cells in a prostate cancer are dividing to assess its aggressiveness. the prolaris test is performed on routine prostate biopsy tissue, so patients are not subjected to any additional invasive investigations. in this study, led by leeds teaching hospitals nhs trust, the aim is find out if the prolaris® test score helps patients with newly diagnosed prostate cancer and their clinical team make better informed treatment choices that are tailored to the individual patient. the aim to achieve a prolaris risk score for 100 patients and determine the impact it has on treatment decision making. the research team will look at how the test fits into routine clinical practice, investigate the clinician and patient views and understanding on the test report and assess the quality of life of patients in the different risk and treatment groups.


Eligibility criteria:
inclusion criteria: * clinical suspicion of prostate cancer * able to provide informed written consent * no contraindication to prostate biopsy * newly diagnosed treatment-naive patient with histologically proven localised adenocarcinoma of the prostate * low or intermediate d'amico risk prostate cancer * sufficient quantity and quality of tissue remains from biopsy to perform genomic testing * no contraindication to radical treatment if diagnosed with localised prostate cancer * estimated life expectancy \>10 years exclusion criteria: * men with locally advanced, clinical node positive or metastatic disease * patients who lack capacity to consent to study participation * non-adenocarcinoma prostate cancer histology