Kornimate/medical-research-clean huggingface dataset:
the spine promco study

Conditions: Lumbar Disc Herniation; Spondylolisthesis; Spinal Stenosis

Summary: our primary objective is to design a cohort to determine the treatment outcome of different surgical interventions of the degenerative lumbar spine highlighting the expediency and value of the current surgical treatment program.

this observational prospective unicenter cohort study includes patients who are eligible for elective lumbar spine surgery due to a degenerative spine disease (e.g. herniated disk, spinal canal stenosis, discopathy and spondylolisthesis). an enrolment rate of at least 80% is pursued within minimal 1.5 years of inclusion. a digital survey is used including self-reporting questionnaires that pertain to outcomes as pain, functionality and disability (comi back), health status (eq-5d-5l), re-operations and complications, and satisfaction. the survey is sent at given time-intervals (e.g. baseline 2 weeks prior to surgery, 6 weeks post surgery and 6, 12, 36 months post surgery). besides descriptive statistics and multivariate analysis, an economic evaluation will be performed from a societal perspective.

Eligibility criteria:
inclusion criteria: * all patients who are eligible for elective surgery of the lumbar spine. * all patients with degenerative disorder of the lumbar spine including: herniated disk, stenosis, discopathy and spondylolisthesis. * patients must be able to fill in the questionnaire online * patients with imaging (magnetic resonance imaging (mri)) confirmed lumbar disc herniation, stenosis, discopathy, or listhesis. * elective cases * patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis. exclusion criteria: * patients who cannot speak nor read the dutch language * patients who are not able to complete the digital questionnaires, according to the including doctor * patients with fractures, primary infections of the spine, or with spinal malignant- cies. * patients in a traumatic setting.

Keywords: patient related outcome measures prognosis degenerative spine disease
rituximab combined with eshap in patients with relapse or refractory diffuse large b cell lymphoma (dlbcl)

Conditions: Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and toxicity of rituximab combined with eshap (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large b cell lymphoma (dlbcl).

the salvage therapy in the patients with dlbcl is still controversial. the investigators conducted this study to evaluate the efficacy and tolerability of rituximab combined with eshap in the patients with dlbcl. the patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like chop or other chop-like regimens.

Eligibility criteria:
inclusion criteria: * age range 18-70 years old * histological confirmed diffuse large b cell lymphoma * ecog performance status no more than 2 * life expectancy of more than 3 months * relapse or refractory after the first-line chemotherapy of dlbcl * no evidence of bone marrow involvement * normal laboratory values: hemoglobin \> 8.0g/dl, neutrophil \> 1.5×109/l, platelet \> 80×109/l, serum creatine \< 1× upper limitation of normal(uln), serum bilirubin \< 1× uln, alt and ast \< 1.5× uln exclusion criteria: * pregnant or lactating women * serious uncontrolled diseases and intercurrent infection * the evidence of cns metastasis and bone marrow involvement * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * history of allergic reaction/hypersensitivity to rituximab

Keywords: dlbcl rituximab eshap efficacy toxicity
brexpiprazole as adjunctive therapy in adults with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in participants with major depressive disorder (mdd) with a current depressive episode.

this is a phase 4, multicenter, open-label, flexible dose trial designed to assess the effects of brexpiprazole (flexible dose; 0.5 to 2 milligrams \[mg\], once daily \[qd\]) as adjunctive therapy to antidepressant therapy (adt) on life engagement in participants with mdd. this trial is being conducted in line with the canadian product monograph.

Eligibility criteria:
inclusion criteria: * male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent. * primary diagnosis of mdd and in a current non-psychotic major depressive episode (mde) as defined by diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of adts in their current mde, including current adt. * participants with a patient health questionnaire 9-item scale (phq-9) ≥ 15 at the screening and baseline visits, if separate. exclusion criteria: * participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial. * participants with a concurrent dsm-5 diagnosis of the following will be excluded: * schizophrenia or schizoaffective disorder * bipolar i or bipolar ii disorder * post-traumatic stress disorder * dementia * eating disorder * borderline personality disorder * antisocial personality disorder * participants with a suicidality score of 3 based on inventory of depressive symptomatology self-report (ids-sr) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.

Keywords: mdd depression brexpiprazole
impact of the qatar 2022 fifa world cup on ped use and misuse patterns

Conditions: Emergencies; Epidemic Disease; Pediatric ALL; Electronic Medical Record

Summary: a retrospective cohort study to explore the impact of the fifa world cup 2022 qatar on paediatric emergency department attendance at two tertiary centres during unprecedent winter viral epidemics.

earlier studies have reported contradictory relationship between major sporting events and paediatric emergency department attendance. none were conducted during an epidemic surge. the fifa football world cup 2022 was held for the first time in its history during the winter period in the northern hemisphere during unprecedented cumulative waves of respiratory syncitial virus (rsv), influenza and severe acute respiratory syndrome coronavirus 2 (sars-cov-2) epidemics. this study aims to measure the impact of such a global major sporting events on the pattern of paediatric emergency department use and hospital admissions during a peak epidemic season in 2 tertiary hospitals. the study hypothesis was that major sporting events, even during an epidemic peak, can reduce the number of paediatric emergency department visits compared with periods without a sporting event. major sporting events could serve as a model for identifying human behaviours and patterns leading to paediatric emergency department misuse, in order to develop public health interventions to better rationalise health-seeking behaviours.

Eligibility criteria:
inclusion criteria: * all patients exclusion criteria: * none

Keywords: pediatric emergency medicine emergency service hospital pediatrics epidemics respiratory syncytial viruses influenza, human sars-cov-2 sports
naproxen sodium er pharmacokinetic study

Conditions: Pain

Summary: to determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.


Eligibility criteria:
inclusion criteria: * healthy ambulatory, male and female volunteers between 18-55 years of age with a body mass index (bmi) of approximately 18 to 30kg/m2, and a total body weight \>50 kg (110 lbs) * results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the principal investigator and the sponsor * female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g oral or patch contraceptives, intrauterine device, nuvaring, depo-provera, or double-barrier and have a negative pregnancy test at screening and day 0 of each dosing period. female subjects of non childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy * be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol * provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial exclusion criteria: * history of hypersensitivity to aspirin (asa), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products * history of gastrointestinal bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (nsaid) therapy. active, or history of recurrent peptic ulcer/ hemorrhage (two or more distinct episodes of proven ulceration or bleeding) * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies * have taken asa, asa-containing products, acetaminophen (acetyl-para-amino-phenol or apap) or any other nsaid (over the counter (otc) or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment * smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum) * have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial * alcoholism or drug abuse within 2 years prior to the screening visit * participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit
changing the vulnerable brain: a neuromodulation study in alcohol dependence

Conditions: Alcohol Dependence

Summary: this current project investigates the effect of a single session of right dlpfc repetitive transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol dependent patients and healthy controls.


Eligibility criteria:
inclusion criteria: * alcohol dependence * currently abstinent exclusion criteria: * psychoactive medication * not eligible for mri (metals or claustrophobia) * (familial) history of epilepsy * current psychiatric disorders (besides alcohol dependence)

Keywords: repetitive transcranial magnetic stimulation emotion regulation craving
double-blind, placebo-controlled study of oral dimebon in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study will evaluate the safety and potential benefit of dimebon as compared to placebo in patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: 1. males or females greater than or equal to 50 years of age. 2. diagnosis of alzheimer's disease according to diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv tr) and mini mental state exam between 10 and 24, inclusive and modified hachinski ischemia score less than or equal to 4. 3. brain imaging such as mri and/or ct within one year of enrollment. 4. subjects must have a guardian or caregiver who assists the subject at least 5 days per week (at least 3 hours/day). 5. subjects must be able to cooperate with drug administration (including the ability to ingest oral medications) and study procedures and abide by study restrictions. 6. subjects must have at least 6 years of prior education and should have previously (in pre-alzheimer's condition) been capable of reading, writing and communicating effectively with others. 7. subjects must be willing and able to give informed consent or have a mentally competent legal representative authorized to provide informed consent on their behalf. 8. residence in an assisted care facility is allowed if subject is living independently. exclusion criteria: 1. major structural brain disease 2. major medical illness or unstable medical condition within 6 months of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions. 3. residence in a nursing home or assisted care facility that provides the subject with 24-hour care and supervision. 4. women who are pregnant, nursing, or if of child-bearing potential not using a medically accepted, highly effective method of birth control. 5. active alcohol dependence or drug abuse. 6. use of the following medications within 60 days prior to enrollment:cognition enhancing agents, narcotic analgesics, low potency neuroleptics, antihypertensive agents with frequent central nervous system (cns) side effects, anti-parkinsonian medications, medications with central anticholinergic activity, medications for epilepsy, lithium. 7. participation in an investigational drug or device study within 30 days prior to study entry, or 60 days prior to study entry if the investigational drug study involved therapy for alzheimer's disease.

Keywords: dimebon, alzheimer's disease, alzheimer's disease assessment scale-cognitive subscale (adas-cog)
t lymphocyte subsets in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: 1. study the distribution of peripheral blood t lymphocyte subsets among ulcerative colitis patients. 2. correlation of t-cell subsets to therapeutic response/ disease activity. 3. assess the value of circulating igg anti-integrin αvβ6 in uc.

ulcerative colitis (uc) is an idiopathic, chronic inflammatory disease of the large intestine, frequently involving the rectum, and characterized by chronic and recurrent mucosal inflammation and ulceration. although its cause is not well understood, current evidence suggests innate and adaptive immunity play critical roles in its pathogenesis. one of the main classes of immune cells that are affected by and contribute to uc is t cells. t-lymphocytes comprise a complex collection of highly differentiated t-cell subsets playing key roles in the regulation and the effector phase of the immune response. cd4+ t cells were found over-activated and proliferated in uc patients, which can induce disorders of the cytokine network and increase the occurrence of colitis. once intestinal pathogens or inflammatory mediators are not cleared in time, pro-inflammatory mononuclear phagocytes (mnps) or polymorphonuclear leukocytes (pmns) are often recruited to promote the polarization of naive cd4+ t cells into th1, th2, th17, treg and other subsets of cells. the balances th17/ treg cells are important for maintaining intestinal homeostasis. once the proportion th17 cells increases, it often induces the production of pro-inflammatory cytokines that promote colonic inflammation, whereas treg cells are usually secrete interleukin-10 (il-10) and transforming growth factor-β (tgf-β) for anti-inflammatory regulations. uc-associated inflammation is also characterized by huge number of activated b cells and plasma cells, the latter being involved in the production of cytotoxic granules, immunoglobulins, and various autoantibodies, recent studies have highlighted a novel autoantibody against integrin αvβ6 in the serum of patients diagnosed with uc. recently, targeting immune cells to inhibit inflammation has become a research hotspot. biological therapies are highly effective hallmark therapies in uc. despite their widespread use, the impact of these agents on the composition of the adaptive immune system is largely unexplored. knowledge on such effects in uc could clarify the mechanism of action of these therapies, provide information about the status of the adaptive immune system, and could help finding cell-based markers.

Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of ulcerative colitis among both sexes. * age \>18 years old. exclusion criteria: * age \<18 years old. * patients who refuse to participate in the study. * patients who have other autoimmune disease.
efficacy and safety of tislelizumab for lung adenocarcinoma with asymptomatic brain metastatic

Conditions: Lung Adenocarcinoma

Summary: brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. this study explore the efficacy and safety of tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of lung adenocarcinoma with asymptomatic brain metastatic. meanwhile, related biomarkers were explored to provide theoretical basis for efficacy evaluation and resistance mechanism.


Eligibility criteria:
inclusion criteria: 1. patients with metastatic (stage iv) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on ajcc stage viii; 2. patients with brain metastases confirmed by imaging; 3. patients with asymptomatic bms after initial diagnosis, local bms surgery or radiotherapy; 4. ecog ps: 0-1; 5. measurable target lesions outside the skull (as per recist 1.1); 6. life expectancy greater than 3 months; exclusion criteria: 1. patients had been treated with immune checkpoint inhibitors such as anti-pd-1, pd-l1, or ctla-4 therapy; 2. the patient had received systemic chemotherapy as advanced treatment; 3. patients with egfr mutation or alk gene translocation; 4. the patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration; 5. clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;
prostate sabr with intra-prostatic sabr boost

Conditions: Prostate Cancer

Summary: stereotactic ablative radiation (sabr/sbrt) will be prescribed to a dose of 35 gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the mr detected nodule up to 50gy. the pelvic lymph nodes and seminal vesicles will also receive 25 gy in 5 weekly fractions.


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate adenocarcinoma * high-risk prostate cancer, defined as at least one of: t3, gleason 8-10, or psa \> 20 ng/ml * willing to give informed consent to participate in this clinical trial exclusion criteria: * prior pelvic radiotherapy * contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * contraindication to prostate mri * no evidence of castrate resistance (defined as psa \< 3 ng/ml while testosterone is \< 0.7nmol/l. patients could have been on combined androgen blockade but are excluded if this was started due to psa progression. * definitive extrapelvic nodal or distant metastatic disease on staging investigations.
non invasive measurement of cardiac index by impedance cardiography

Conditions: Pulmonary Hypertension

Summary: pulmonary hypertension (ph) is defined as a pulmonary arterial mean pressure (meanpap) ≥ 25 mmhg in the right heart catheterization. there are different forms of ph defined in the classification of dana point 2008. ph is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like echocardiography, stress echocardiography and cardio pulmonary exercise testing. for prognosis of ph patients the limitation of the pulmonary circulation is very important. therefore the cardiac index (ci) is a good parameter for the right ventricular function. the gold standard for ci measures is the thermodilution, an invasive method performed during right heart catheterization.

in this study the investigators want to evaluate the impedance cardiography (icg) as a non invasive method for ci measurement. an alternating current of max 400µa and 45 khz is conducted through the body. the way of the smallest resistance is the blood in the aorta. the impedance changes with the pulsatile blood flow. out of the impedance change there can be calculated the ci.

Eligibility criteria:
inclusion criteria: * patients who have right heart catheterization written informed consent exclusion criteria: * patients who don't have right heart catheterization no written informed consent

Keywords: pulmonary hypertension cardiac index impedance cardiography
the effects of joint effusion on proprioception

Conditions: Osteoarthritis

Summary: the purpose of this study is to assess the effects of joint effusion on proprioceptive status in patients with knee osteoarthritis (oa).

proprioception is a sensory modality that provides feedback on the internal status of the body and enables us to perceive joint position and motion. osteoarthritis (oa), also called degenerative joint disease, is a major musculoskeletal condition characterized by loss of articular cartilage that leads to pain and loss of function. the most commonly affected joint is the knee, and oa may result in changes that affect not only intracapsular tissues, but also periarticular tissues, such as ligaments, capsules, tendons, and muscles. many studies have examined the proprioceptive status of knee oa, and subjects with knee oa are known to have impaired proprioception compared with age-matched controls. joint effusion is a common symptom associated with chronic degenerative joint condition, but the effects of effusion on knee joint proprioception have not been investigated in detail. a volume of 20 ml of normal saline was injected into the knee joint cavity of subjects in the experimental group under ultrasonographic guidance. proprioceptive acuity was assessed by active repositioning of the lower limb using an electrogoniometer to measure knee joint position sense (jps) under both non-weight-bearing and weight-bearing conditions twice, with a 20-min rest interval.

Eligibility criteria:
inclusion criteria: or at least two of criteria 2-6 established by the american college of rheumatology (acr): 1. kellgren and lawrence (k/l) grade ≥ii 2. morning stiffness \<30 min in duration 3. crepitus on movement of the knee joint 4. bony tenderness at the knee joint margins 5. palpable or visible bony enlargement 6. no palpable warmth. exclusion criteria: 1. the presence of knee joint effusion determined by ultrasonography 2. a history of knee injury or surgery 3. a history of knee injection within 3 months 4. a history of inflammatory arthritis 5. taking anticoagulants 6. balance or gait disturbance 7. diabetes mellitus.

Keywords: effusion osteoarthritis knee