Kornimate/medical-research-clean huggingface dataset:
plasma-free replacement in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: to evaluate whether the technique of no plasma exchange is suitable for the treatment, clinical efficacy, safety, and suitability of multiple myeloma patients with m protein abnormality or renal failure.

multiple myeloma (mm) is the second most common hematological tumor after non-hodgkin's lymphoma. the tumor cells originate from plasma cells in the blood pulp and are classified as plasma cells blood myeloma plasmacytomas by the who tumor. it is characterized by abnormal proliferation of blood medullary plasma cells, accompanied by monoclonal immunoglobulin or light chain. few patients are classified as non-secretory mm that does not secrete m protein. multiple myeloma is often accompanied by multiple hemolytic damages, hypercalcemia, anemia, kidney damage, and a serious threat to the patients' lives, health, and quality of life, which have brought a heavy burden to society. large amounts of m protein pass through the kidneys. at times, it causes acute or chronic renal failure; m protein interferes with the activity of coagulation factors, blocking platelet function, inducing bleeding; and a large amount of m protein can also lead to hyperviscosity syndrome, increase circulatory resistance, and small blood vessel thrombosis plug, cause various neurological diseases such as blindness, and further aggravate the progression of kidney injury. patients with hematological myeloma nephropathy already existed at the time of diagnosis, severe patients may die due to renal insufficiency, so the patient was removed immunity globulin in the body to improve the signs of hyperviscosity and clinical symptoms is the focus of clinical research. in this study, on the basis of previous studies, albumin-free plasma exchange fluid treatment was given to analyze the effects of clinical symptoms, erythrocyte sedimentation rate, blood routine, albumin, renal function, calcium content, and immunoglobulin.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of mm 2. a stable condition after routine treatment 3. clinical diagnosis of renal insufficiency or m protein abnormalities 4．more than 18 years old 5．with liver and kidney function 6. with normal heart function; 7. physical condition score 0-2 (ecog score) 8. get informed consent from the patient or family member. exclusion criteria: 1. allergies or obvious contraindications to any drug; 2. myocardial infarction and cardiac insufficiency 3. other malignant tumors 4. tb patients and hiv positive patients 5．other blood system diseases 6. pregnant or lactating women; 7. not understand or follow the protocol; 8. allergy

Keywords: multiple myeloma cancer plasma exchange plasmapheresis
use of tamoxifen in systemic mastocytosis

Conditions: Systemic Mastocytosis

Summary: in this study, the investigators will determine the utility of tamoxifen, a non-cytotoxic agent, to improve quality of life, biochemical parameters, and bone marrow involvement in systemic mastocytosis patients having 1) up to 40% bone marrow infiltration by mast cells and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard "non-cytotoxic" medications regardless of the percentage bone marrow involvement by mastocytosis. the dose of tamoxifen will be 40 mg/day and the duration of treatment will be for one year. patients currently taking interferon alfa, imatinib mesylate, or cladribine will be excluded until these medications have been stopped.

not desired

Eligibility criteria:
inclusion criteria: * systemic mastocytosis exclusion criteria: * current treatment with imatinib mesylate, cladribine or interferon alpha.
neurophysiology of prophylactic treatment in migraine

Conditions: Migraine

Summary: this study aims to improve the pathophysiological understanding of migraine in in a longitudinal observational study investigating changes of established neurophysiological and imaging parameters in line with changes of the clinical phenotype. the study's focus is the investigation of mechanisms that are directly related to the cyclic character of migraine and its core structures. in this context, the primary endpoint is a change in the nociceptive blink reflex, an established brain stem reflex to study the trigemino-spinal system, associated with changes in migraine frequency and severity. in order to reliably detect changes in the trigeminal pain system, investigations are performed in patients before starting a prophylactic therapy and 3 months afterwards. several secondary endpoints are used to evaluate changes of multimodal sensory and cortical information processing. cerebral imaging will include examinations of structural and network effects of altered migraine disease activity.


Eligibility criteria:
inclusion criteria (migraineurs): * episodic migraine according to ichd (international classification of headache disorders)-3 criteria * headache documented over at least 3 months through a headache calender * scheduled for prophylactic therapy of their migraine exclusion criteria (migraineurs): * history of chronic migraine * current medication-overuse headache * neurological or psychiatric diagnosis other than headaches * chronic intake of central nervous system active drugs (antidepressants, antipsychotics etc.) * contraindications for magnetic resonance imaging * contraindications for transcranial magnetic stimulation inclusion criteria (controls): * not more than 3 years younger or older than matched control * gender similar to matched control * menstrual cycle equal to matched control (if female) exclusion criteria (controls): * more than 1 headache day/month * history of migraine

Keywords: blink reflex electroencephalography functional magnetic resonance imaging evoked potentials
the utility of a novel eye shield with reusable adhesive anchors for post-operative care after ophthalmic surgery

Conditions: Cataract; Eye Disease

Summary: the purpose of this research study is to evaluate the efficacy, patient preference, and utility of a novel eye shield that utilizes a different adhesive mechanism in comparison to the current standard of care. the aims are to see if this product could be incorporated into postoperative care in the future to improve patient satisfaction and compliance. the study will involve 20 patients during the postoperative timeframe after cataract extraction and intraocular lens placement (ceiol). these patients will be chosen from the clinic of dr. marc toeteberg who will plan to have both eye surgeries done within 3 months of each other. these patients will be randomized to either control or intervention group. intervention group will receive our novel eye shield prototype, while control group will receive an alcon plastic eye shield. both groups will receive the eye shields after surgery and will be sent home with these eye shields with normal postoperative care directions. patient will be directed to wear eye shields for 24 hours then at night for first 2 weeks after surgery, while adhering to postoperative eye drops regimen. after successfully healing and passing the postoperative timeframe for the first eye we will proceed to the second arm of the study. approximately 1-2 months after healing from the first surgery, patient will be scheduled for cataract surgery on the other eye, as is standard of care. after surgery on the second eye the patient will be given the other eye shield than what they received after the first surgery (control groups will receive the novel eye shield and experimental groups will receive the control eye shield). they will proceed to follow identical postoperative protocols after the second surgery. a short quantitative and qualitative questionnaire directly comparing the two eye shield experiences will be provided at the 1 month follow-up after the eye surgery.


Eligibility criteria:
inclusion criteria: * male or female cataract surgery patients of 18 years or older, with surgical plans for cataract extraction via phacoemulsification and intraocular lens placement. patient must be having plans to have both eye cataracts removed surgically in succession within 3 months of each other. exclusion criteria: * patients receiving more advanced intraocular surgery, even if that surgery includes cataract removal and intraocular lens placement, including trabeculectomy, microinvasive glaucoma surgery, vitrectomy, or any other ophthalmic procedure. pregnancy also an exclusion criteria.
effects of a 60-min repeated trunk flexion protocol on trunk neuromuscular properties.

Conditions: Occupational Exposure

Summary: an interventional study on the effects of repeated trunk flexion exposure on trunk neuromuscular properties.

an interventional study will include 16 healthy young adults. all participants will complete a 60-min protocol of intermittent trunk flexion. measurements of trunk neuromuscular properties will be performed prior to and following the 60-min protocol.

Eligibility criteria:
inclusion criteria: * physically active at least 3 hours a week exclusion criteria: * low back pain in the past 6 months * history of chronic low back pain * history of spinal or pelvic operation * hypermobility, more than 4 points on beighton scale * cardiovascular or systemic diseases * pregnancy

Keywords: bending, load, stiffness, elastography, deformation
patients preference with self-injection: the prism study

Conditions: Bruises

Summary: the purpose of this study is to determine which short-acting blood thinner (low-molecular-weight heparin \[enoxaparin\] or unfractionated heparin) is associated with less discomfort and bruising when given as a subcutaneous (under the skin) injection before and after a planned surgery or procedure in patients who temporarily stop warfarin.

increasing patient comfort and compliance: the bridging anticoagulation clinic strives to provide the highest quality of care to patients who require temporary interruption of warfarin therapy. an important component of optimizing patient care is minimizing patient discomfort with perioperative administration of short-acting anticoagulants (lwmh or ufh) used for bridging therapy, which, in turn, may optimize patient compliance with this treatment. this issue is especially relevant for patients who are receiving out-of-hospital treatment with lmwh or ufh because about 85% of such patients will be taught to self-administer this medication. this study seeks to determine if there is less discomfort and bruising associated with self-injection of lmwh than with ufh. minimizing injection site bruising: no studies, to our knowledge, have assessed the characteristics or clinical importance of bruising in patients receiving subcutaneous lmwh or ufh. thus, there is no evidence to support any association between bruising and discomfort. to bridge this gap in knowledge, we will document each injection site during the course of the study and measure the amount of bruising observed using a standardized photographic methodology. injection site bruising has the potential to cause medical problems if an injection site hematoma develops, which can become infected or can cause long-term discomfort.

Eligibility criteria:
inclusion criteria: 1. patient is receiving warfarin therapy with a target international normalized ratio (inr) of 2.0-3.5 2. patient requires temporary interruption of warfarin because of elective surgery or procedure. exclusion criteria: 1. history of allergy to heparin, including heparin-induced thrombocytopenia (hit) 2. bridging anticoagulation with low molecular weight heparin (lmwh) or unfractionated heparin (ufh) not indicated 3. impaired cognitive function or language barrier 4. creatinine clearance \< 30 ml/min 5. patient declines consent 6. patient is \< 18 years of age. 7. patient is not willing and able to self inject. 8. patient has significant visual or hand motor impairment

Keywords: warfarin clinical trial pain measurement heparin heparin, low-molecular-weight anticoagulants
study to evaluate efficacy of brief behavioral and sleep hygiene education with mindfulness intervention on sleep quality

Conditions: Sleep

Summary: sleep plays a fundamental role in both mental- and physical-health, with good sleep health including adequate duration and quality, appropriate timing, regularity, and absence of sleep disorders. the purpose of this study is to evaluate sleep in adolescent and if brief behavioral and sleep hygiene education with mindfulness intervention improves, sleep timing, sleep duration, sleep quality, anxiety/depression, and quality of life. during adolescence extensive physiological changes happen that make it easier for adolescents to stay up later, that may increase the time it may take them to fall-asleep and developing insomnia symptoms. at the same time psychosocial changes happen, that may may even have been further amplified in the last decade, with increase in social media use and evening screen-time. as sleep need is not decreased and with adolescents having to wake up at "socially acceptable times" rather than the endogenous sleep offset time, sleep duration may be shortened causing chronic sleep loss and daytime sleepiness. insufficient sleep in adolescents may affect their daytime functioning, causing fatigue and memory issues, affect school attendance and academic performance, affect mood, mental- and physical health, cause behavioral dysfunction and has been associated with worse health outcomes, adverse risk behaviors and even increase risk for accidents.this study should advance understanding of sleep in adolescents and if this simple interventions can be effective in improving their sleep and mental health. if effective larger studies will be needed to evaluate if there might be a value in implementing changes in the infrastructure of the educational system to better support sleep and mental health of adolescent.

the study is a prospective cross-sectional study implementing a brief behavioral and sleep hygiene education with mindfulness intervention in adolescents in the age-range of 16-19-years interested to participate and willing to sign a consent. sleep duration, sleep timing and sleep quality will be measured with objective home sleep test for three (3) week-nights and two (2) weekend-nights and sleep, anxiety and depression symptoms will be evaluated with subjective questionnaires before starting the 4-week intervention. after the 4-week intervention sleep, anxiety and depression symptoms will be evaluated again using both the objective home sleep test and questionnaires to measure if the intervention improved sleep timing, duration and/or quality as well as symptoms of anxiety and depression.

Eligibility criteria:
inclusion criteria: students interested to participate and able to sign enlightened consent exclusion criteria: atrial fibrillation or ventricular trigeminy severe and uncontrolled asthma or severe pulmonary disease moderate and severe obstructive sleep apnoea (osa)
hdr brachytherapy plus stereotactic ablative prostate radiotherapy for patients with intermediate and high-risk prostate cancer

Conditions: Prostatic Neoplasm

Summary: dose escalation is nowadays a standard strategy in radiotherapy for prostate cancer. besides, it is believed that due to the radiobiology characteristics of prostate cells (low alpha/beta ratio), the delivery of higher radiation doses per fraction could theoretically improve the efficacy of the treatment. in this context, the combination of prostate brachytherapy and external beam radiotherapy (ebrt) has proven to be the most effective method of dose escalation significantly improving disease control in randomized clinical trials. unfortunately, this strategy is also associated with an increased risk of acute and late adverse events compared to conventional ebrt alone. it has been proposed that this increase in adverse events could be related to the use low-dose-rate (ldr) brachytherapy and that high-dose-rate (hdr) brachytherapy (a more modern and accurate procedure) could reduce this risk. on the other hand, stereotactic ablative radiotherapy (sabr) is a high-precision radiation technique that allows the delivery of higher doses per fraction in fewer sessions, reducing the total treatment time. the investigators hypothesized that the combination of two highly conformal radiation techniques (hdr brachytherapy and sabr) could be well tolerated, while reducing total treatment time and therefore improving patient quality of life. this is a single arm phase ii clinical trial designed to test the feasibility, tolerability and impact on quality of life of the combination of high-dose-rate prostate brachytherapy and sabr for patients with intermediate and high-risk prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of adenocarcinoma of the prostate. * intermediate or high-risk disease (as per nccn criteria): * intermediate risk: * clinical stage ≤ t2c * gleason score 7 and initial psa ≤ 20 ng/ml. * gleason score ≤ 6 and initial psa \> 10 and ≤ 20 ng/ml. * high risk,at least one of the following: * clinical stage t3a-b. * gleason score 8-10. * initial psa \> 20 ng/ml. * life expectancy of more than 10 years * able and willing to complete expanded prostate index composite (epic) end eortc questionnaires * eastern cooperative oncology group (ecog) of 0 - 2. * willing to give informed consent to participate in this clinical trial * give competent informed consent to participate in this trial. exclusion criteria: * documented nodal or distant metastases. * previous pelvic radiotherapy. * clinical stage t4. * clinical stage t3a or t3b in which the coverture of the extraprostatic disease is not feasible (as deemed by the treating physician). * prostate volume \> 70 cc (measured on mri). * poor baseline urinary function defined as international prostate symptom score (ipss) \>17 * contra-indication to radical prostate radiotherapy * significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Keywords: high-dose-rate brachytherapy sabr sbrt quality of life
fibromyalgia integrative training for teens

Conditions: Juvenile Fibromyalgia

Summary: the purpose of this pilot randomized trial is to determine whether the fibromyalgia integrative training (fit teens) intervention is superior to cognitive-behavioral therapy (cbt) alone in reducing pain among adolescents with juvenile fibromyalgia (jfm). hypothesis 1: patients in the fit teens group will show significantly greater reduction in pain intensity than the cbt group at final study assessment (i.e., 3-month follow up). hypothesis 2: patients in both the fit teens and cbt groups will show significant reductions in functional disability and depressive symptoms at final study assessment (i.e., 3-month follow up).

cbt has been found to have beneficial effects on improving coping among adolescents with jfm and increasing patients' ability to engage in daily activities. the purpose of this study is to evaluate whether cbt can be enhanced with specialized neuromuscular training, in the new fibromyalgia integrative training (fit teens) intervention, to produce stronger pain reduction than cbt alone. neuromuscular training originates from the field of pediatric sports medicine and has been successfully used for injury prevention but has never before been utilized for pain management in jfm. this type of training emphasizes education and proper training in fundamental movement skills prior to the initiation of more vigorous physical activity and exercise. it is expected that the neuromuscular training integrated with established cbt techniques will enhance patients' ability to engage in exercise and to achieve better jfm pain control. adolescents with jfm will be randomly assigned to receive either the 8-week fit teens intervention or an 8-week cbt program with assessments at baseline, post-treatment and 3-month follow-up.

Eligibility criteria:
inclusion criteria: * males and females ages 12-18 * juvenile fibromyalgia (jfm) diagnosed by a pediatric rheumatologist or pain physician using 2010 american college of rheumatology (acr) criteria and confirmation with a tender point exam of ≥ 11 of 18 tender points upon palpation * functional disability score ≥13 indicating at least moderate disability * average pain intensity in the past week ≥ 4 on a 0-10 cm visual analog scale exclusion criteria: * comorbid rheumatic disease (e.g., juvenile arthritis, systemic lupus erythematous) * untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses) * documented developmental delay * any medical condition determined by their physician to be a contraindication for participation * on stable medications for 4 weeks prior to enrollment * currently in cbt or structured physical therapy program

Keywords: juvenile fibromyalgia pain in children musculoskeletal pain cognitive behavioral therapy coping skills training
ultrastructural collagen markers in ehlers danlos syndromes

Conditions: Ehlers-Danlos Syndrome; Classical Ehlers-Danlos Syndrome; Hypermobile EDS (hEDS)

Summary: establishing the diagnosis of ehlers danlos syndromes (eds)/generalized hypermobility spectrum disorders (g-hsd) is often problematic for patients. the absence of a precise unifying diagnosis in patients results in a significant emotional burden on the patient and caregivers, not to mention the hidden costs, including multiple recurring visits to several medical specialists and associated social and economic costs. to date, while collagen ultra-scale morphological heterogeneity has been used to comment on an eds diagnosis, the mechanical properties of the collagen remain mostly unexplored. from a biophysical point of view, collagen affected with heds can be described as biomechanically deficient. in the case of eds, the skin's abnormal elasticity can be directly related to the organization of the collagen network within the dermis. quantitative nanohistology (qnh) is a newer method to evaluate both the structural and mechanical properties of collagen in-situ histological sections. therefore, the aim of this study is to define histo-biophysical markers of two most common types of eds i.e. classical eds (ceds) \& hypermobile eds (heds) at the single collagen fibrils level and matrix and to further explore the origin of collagen fibril properties deficiency in heds and ceds.


Eligibility criteria:
inclusion criteria: * adults aged between 18 and 60 years who can provide informed consent in english * able to read, speak, and comprehend english without the assistance of a translator * have been diagnosed with hypermobile eds as per the 2017 eds criteria; or with genetically confirmed classical eds (age and sex-matched). this diagnosis is carried out by the uhn goodhope eds clinic routinely for all patients on the basis of clinical exam and genetic testing, if indicated. exclusion criteria: * subjects under the age of 18 * unable to speak, read and comprehend english * unable to provide consent (cognitive impairment) * pregnant women