Kornimate/medical-research-clean huggingface dataset:
cytokine regulation of natural killer receptors in inhibiting activated t cell function

Conditions: Cervical Cancer; Breast Cancer; Endometrial Cancer; Cancer

Summary: in this study proposal, the investigators will extend their previous studies and examine the kinetic cytotoxic activity with concordant expression of inhibitory natural killer (nk) receptors (inkr) on activated t cells. the inhibitory role of cytokines will be defined by utilizing the investigators' previously established models of mixed lymphocytes and tumor cells coculture to analyze the expression and activity of cytokines involved in the regulation of inkrs on cancer-encountered t cells.

in our extended studies, we have directly examined the expressions of various inhibitory natural killer cell receptors (inkrs) on tumor-infiltrating lymphocytes (tils) derived from human cervical cancer (cc) by triple-color flow cytometry with combination of different surface markers. we found up-regulated expression of certain inkrs (cd94/nkg2a) in tils and in mixed lymphocyte-cancer cell cocultures. in our previous studies, we demonstrated that certain cytokines, including il-10, tgf-beta (sheu et al, journal of immunology, 2001, 167:2972-2978), and il-15 (sheu et al, cancer research, 2005, 65:2921-2929) can be expressed by cc cells. we further demonstrated that activated t cells bear inkrs which inhibit cytotoxic activity. inkrs are proposed to restrain the t cell receptor (tcr)-mediated cytolysis. we found that cc cells had altered hla-a, -b, and -c molecules in a cancer microenvironment. the acquisition of both nk-like activity and expression of inkrs by these t cells is parallel to prevent damage to normal host cells. however, there is also limited knowledge about the regulatory role of inkr expression in t cell cytotoxicity.

Eligibility criteria:
inclusion criteria: * cancer patients * healthy volunteers exclusion criteria: * immunosuppression * hiv carrier

Keywords: cervical cancer breast cancer t lymphocyte nk receptor
via disc np registry 3.0

Conditions: Discogenic Pain; Back Pain; Back Pain, Low

Summary: registry is to observe and trend patterns of care and outcomes for patients treated with via disc np.

the registry is intended to collect data for patients having received treatment with via disc np.

Eligibility criteria:
inclusion criteria: 1. willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 2. 18 years of age or older 3. literate, able to speak and read english, and able to complete questionnaires independently 4. subject received a via disc np injection with 1 or more levels within 90 days of the baseline visit. exclusion criteria: 1. participant did not receive via disc np injection 2. participant is pregnant (self-reported, no special study pregnancy testing needed). 3. any contraindications as noted in the via disc np instructions for use 4. previous treatment with via disc np

Keywords: back pain
a case management intervention to prevent er visits in hiv-infected persons

Conditions: HIV

Summary: case management has become an integral part of hiv care. there is little science however demonstrating its effectiveness. this is a randomized, controlled trial of a phone call intervention after an er visit to see if this can reduce further er visits, hospitalizations, deaths, and cost.

one year retrospective look at outcome measures followed by a one year trial of a phone call after each er visit in half of the group. outcomes measured are cost, er visits, hospitalizations, death, length of stay. adults only, english or spanish, questionnaire on depression, appointments, drug use with referral to case management services, drug rehab services, or followup appointments. time for intervention is recorded to estimate cost.

Eligibility criteria:
inclusion criteria: * patient in our clinic as of 4-1-04 exclusion criteria: * \<18 years old

Keywords: hiv case management
predictive clinical diagnosis of rheumatoid arthritis flares using non-invasive infra-red thermal imaging and an ai/ml algorithm

Conditions: Rheumatoid Arthritis

Summary: the hypothesis for this clinical research project is that the severity of ra may be detected and predicted using an optimized ml/ai algorithm that uses infrared thermal images of inflamed joints and standard clinical ra-related markers (i.e., esr and crp) by computing das-28 esr scores in real-time. the infrared thermal images coupled with clinical laboratory markers and the ml/ai algorithm are expected to assist a practicing clinician in the ra diagnosis and the prediction of the occurrence of flares in ra patients. physicians who use this technology, would need minimum training and will be able to accurately and reliably diagnose ra using a cheaper method which does not involve incident radiation emitted by other imaging modalities such a x-ray, musculoskeletal (msk) ultrasound, or a magnetic resonance imaging (mri). the aim would be to have the infrared thermal imaging devices at remote va clinics that do not have a rheumatology specialist where veterans can go for their inflammatory arthritis flare and get this image by the local va rn. these clinical results can then be assessed by and discussed with a rheumatologist via telehealth visits.

objective #1: to assess the clinical feasibility of implementing a novel, physician assisting, diagnostic approach for ra when compared to conventional ra examination and diagnostic procedures. this prospective, non-interventional study will assess clinically assess and diagnose the severity of ra in sero-positive ra patients experiencing active flares by using conventional examination and diagnostic methods, and compared those with a physician-assisting, diagnostic approach that involves the use of an infrared thermal imaging device, which detects heat waves to be correlated between ra patients and control subjects (i.e., those who do not have ra or who are in remission). standard clinical laboratory values will be documented from the ehr system as well and will include esr (sedimentation rate) and crp (c-reactive protein). objective #2: to develop and optimize a ml/artificial intelligence(ai) algorithm that would process and analyze thermal images and assist in the predictive diagnosis of ra using the das-28 esr score for those thermal images of the inflamed joints of patients. this study will predict the probability of an actual flare occurrence and its severity in ra patients by using an optimized, physician assisting ml/ai algorithm that processes and analyzes thermal images from sero-positive ra patients in pain and experiencing flares and that calculates the das-28 scoring system in real-time

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis exclusion criteria: * non complaince
evaluating the effects of intermittent oro-esophageal in tracheotomy patients with neurogenic dysphagia

Conditions: Neurogenic Dysphagia; Tracheotomy Patients

Summary: neurogenic dysphagia refers to swallowing disorders caused by the damage of swallowing central or peripheral nerves and muscles. according to statistics, about 50% of patients with neurological diseases will be complicated with neurogenic dysphagia. common diseases include stroke, dementia, parkinson's disease and neuromuscular diseases. dysphagia has a great impact on the quality of life of patients, and is related to malnutrition, aspiration pneumonia and even death. in severe cases, tracheotomy is required to maintain airway patency and discharge secretions. the common nutritional support methods for patients with neurogenic dysphagia after tracheotomy are nasogastric or nasointestinal tube placement and percutaneous gastrostomy. intermittent oro-esophageal tube feeding (ioe) is a new nutrition method proposed by scholars in recent years. studies have shown that it can improve the swallowing function of patients with dysphagia while meeting the nutritional needs of patients, so as to effectively improve the quality of life of patients. however, there are few studies on patients with dysphagia after tracheotomy. this study aims to compare the intervention effects of two kinds of tube feeding methods in patients with neurogenic dysphagia after tracheotomy.


Eligibility criteria:
inclusion criteria: * diagnosis of neurogenic dysphagia； * acute phase has passed, weaning time \> 48 hours, tracheotomy time \>1 week; in accordance with the decannulation process of tracheotomy patients formulated by our center in 2018; * steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment； * gastrointestinal motility is good, can tolerate more than 150ml/h feeding pump speed; * willing to sign an informed consent form. exclusion criteria: * structural swallowing disorders, such as oral, pharyngeal, larynx, esophagus and other anatomical abnormalities caused by swallowing disorders; * the clinical condition was unstable, accompanied by heart, lung, brain and other important organ dysfunction; * severe cognitive dysfunction, confusion, unable to cooperate.
sub-total parathyroidectomy reduces vascular calcification in haemodialysis patients

Conditions: Hemodialysis

Summary: the aim of this study was to evaluate whether successful sub-total parathyroidectomy retards cardiovascular calcification in patients with hemodialysis and to investigate the mechanism .

hyperparathyroidism (phpt) in patients with end-stage renal disease have been shown to have an increased morbidity and mortality mainly due to cardiovascular disease. the precise mechanism of cardiovascular disease in phpt is not well understood . the excess in cardiovascular mortality is significantly and independently related to serum calcium, the connection between the biochemical disturbances and the cardiovascular disorders in phpt patients is not necessarily a cause-and-effect relationship. indeed, the impact of surgical cure of hyperparathyroidism on cardiovascular risk factors and mortality is controversial. some studies suggest that cardiovascular risk markers remained unaltered after sub-total parathyroidectomy.

Eligibility criteria:
inclusion criteria: * the patients receiving hemodialysis treatment, with elevated intact parathyroid hormone (ipth) levels \> 800pg/ml on two or more occasions. * patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan. exclusion criteria: * patients with significant background valvular heart disease * patients who are unfit for general anaesthesia * patients with acute myocardial infarction within recent two months * patients with poor general condition * patients with plans for living related kidney transplant within 1 year * patients with previous history of parathyroidectomy

Keywords: hemodialysis sub-total parathyroidectomy
diagnostic performance of a new method for the echocardiographic assessment of coronary arteries abnormalities

Conditions: Coronary Artery Anomaly

Summary: coronary artery anomalies (caa) are a rare congenital condition, accounting abnormalities of origin, course, destination, size, and number of the coronary vessels. in normal hearts, the coronary arteries, the left and right coronary arteries (lca and rca, respectively) originate from the two facing aortic sinuses of valsalva, so-called left and right. to overcome the echocardiographic limitations, the investigators designed, studied and implemented in our institute a specific echocardiographic-based two-dimensional non-doppler 4-views approach for the diagnosis of caa.

the method consisted of 4-caa-focused specific views, routinely available from any echocardiographic exam: parasternal short-axis (psax), parasternal long-axis (plax), apical 4/5-chambers views. psax, the traditional approach, along with the plax, and the apical 4/5-chambers views. a hallmark of caa was considered the absence of a proper visualization of the origin of the coronary arteries from the aortic root. in addition, the presence of the ring sign, visualized from the plax was considered as abnormal. this sign is of interest when an aberrant left or right caa is suspected. a coronary artery originating from the contralateral aortic sinus, along its intramural course, crosses the mid-anterior line of the circular aorta to reach the sinus of valsalva of its intended origin. consequently, its cross-section should be visible in an orthogonal view traversing the mid-long axis of the aorta, namely the parasternal long-axis view.

Eligibility criteria:
inclusion criteria: * patients undergoing their first echocardiographic examination exclusion criteria: * already known congenital heart disease and cardiomyopathies

Keywords: coronary arteries abnormalities coronary arteries anomaly coronary origin from the wrong sinus of valsalva echocardiography
a study to test the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active psoriatic arthritis (psa).


Eligibility criteria:
inclusion criteria: * an institutional review board (irb)/independent ethics committee (iec) approved written informed consent form is signed and dated by the subject * subject is male or female at least 18 years of age * female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception * documented diagnosis of adult-onset psoriatic arthritis (psa) meeting the classification criteria for psoriatic arthritis (caspar) for at least 6 months prior to screening with active psa and must have at baseline tender joint count (tjc) \>=3 out of 68 and swollen joint count (sjc) \>=3 out of 66 * subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (ccp) antibodies * subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (pso) * subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the investigator * subjects currently taking nsaids, cyclooxygenase 2 (cox-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (mtx), leflunomide (lef), sulfasalazine (ssz), hydroxychloroquine (hcq) and/or apremilast can be allowed if they fulfill specific requirements prior to study entry exclusion criteria: * female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study * subjects with current or prior exposure to any biologics for the treatment of psoriatic arthritis (psa) or psoriasis (pso) * subject has an active infection or a history of recent serious infections * subject has known tuberculosis (tb) infection, is at high risk of acquiring tb infection, or has current or history of nontuberculous mycobacterium (ntmb) infection * subject has a diagnosis of inflammatory conditions other than pso or psa. subjects with a diagnosis of crohn's disease, ulcerative colitis, or other inflammatory bowel disease (ibd) are allowed as long as they have no active symptomatic disease at screening or baseline * subject had acute anterior uveitis within 6 weeks of baseline * subject has any active malignancy or history of malignancy within 5 years prior to the screening visit except treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer * subject has a form of pso other than chronic plaque-type (eg, pustular, erythrodermic and guttate pso, or drug-induced pso) * presence of active suicidal ideation, or moderately severe major depression or severe major depression * subject has a history of chronic alcohol or drug abuse within 6 months prior to screening

Keywords: psoriatic arthritis psa bimekizumab
breast radiotherapy audio visual enhancement for sparing the heart

Conditions: Breast Cancer

Summary: this study investigates the breathe well device to test whether it is superior to the existing treatment standard of the varian realtime position management (rpm) system in assisting patients with deep inspiration breath hold.

recent studies have demonstrated an increased risks of cardiac disease in breast cancer radiotherapy patients. for patients diagnosed \<50 years old, the risks for cardiovascular diseases/events were increased by 24-82% comparing left and right breast radiotherapy. the deep inspiration breath hold (dibh) technique addresses this problem by reducing the heart dose by up to half, thus potentially reducing the increased rate of major coronary events by 20%. providing patients with visual feedback in addition to audio guidance has been demonstrated to improve the reproducibility of the dibh technique by 95% and stability by 80%. breathe well is a new audiovisual feedback device that may increase the accuracy and workflow of implementing dibh for breast cancer patients.

Eligibility criteria:
inclusion criteria: * left-sided breast cancer patients (invasive and in situ) * supine positioning of the patients. * ability to perform a ≥20s breath hold * \>18 years old * an ecog score in the range of 0 to 2 * able to give written informed consent and willingness to participate and comply with the study * patients must be able to read and complete questionnaires in english exclusion criteria: * involvement or at risk regional lymph nodes * pregnant / lactating women

Keywords: breast cancer radiation dibh cardiac toxicity
hypercoagulability study using haemostatic techniques in patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Thrombosis; Blood Coagulation Disorder

Summary: descriptive study, in which the haemostatic profile of ambulatory patients with ibd will be analyzed by means of rotem and other techniques, such as the thrombin generation test and the study of platelet function by flow cytometry.

descriptive study, in which the haemostatic profile of ambulatory patients with ibd will be analyzed by rotational thromboelastometry (rotem) and other techniques, such as thrombin generation test and platelet function study by flow cytometry. the results of these measurements will be subsequently compared between the different ibd patient groups, stratified by activity and other risk factors, as well as with healthy controls, in order to define in which of these situations a significant prothrombotic risk exists, and which part of the coagulation cascade conditions that risk. after this, we will describe the incidence and prevalence of thromboembolic events in the follow-up of these patient groups. finally, an attempt will be made to determine, according to the results of the study if any of the situations outside the classic recommendations would be subsidiary to receive chemoprophylaxis for the thromboembolic events. the aim of this study is to determine the possible state of hypercoagulability of ambulatory patients with inflammatory bowel disease, stratified according to the characteristics of their disease, by using rotem as well as the thrombin generation test. platelet function will also be evaluated by flow cytometry.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * patients diagnosed with uc according to ecco criteria, in ambulatory follow-up in the ibd unit, stratified in remission and mild or moderate ambulatory management activity, determined by clinical (simple clinical colitis activity index: sccai), biological (fecal calprotectin: cf), and/or endoscopic (mayo index) criteria: remission: defined as a sccai \ 2, and/or cf \> 150, and/or may index \>= 1 and \<3. * patients diagnosed with cd according to ecco criteria, in ambulatory follow-up in the ibd unit, stratified according to remission and mild or moderate ambulatory management activity, determined by clinical criteria (harvey-bradshaw index: hbi), biological criteria (cf) and/or endoscopic criteria (simple endoscopic score-cd: ses-cd): remission: hbi \ =6 and \ 150, and/or ses-cd \>=3 (\>4 if isolated ileal affectation) and \<=15. exclusion criteria: * patients with a previous history of venous or arterial thromboembolism * patients with recent hospitalization or surgery in the last 3 months. * women who are pregnant, undergoing treatment with oral contraceptives or who have received oral contraceptives in the last 3 months. * patients undergoing anticoagulation and/or active antiaggregation treatment * patients with severe activity criteria * patients with other concomitant conditions that favor thrombosis events

Keywords: blood coagulation blood coagulationtests thrombelastography
comparative evaluation of pharmacokinetics and safety of bcd-055 and remicade in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: asart-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of bcd-055 (infliximab manufactured by jsc biocad, russia) and remicade when used as multiple iv infusions for the treatment of ankylosing spondylitis.

asart-1 study is the first step of clinical evaluation of infliximab biosimilar manufactured by jsc biocad, russia.the aim of this study is to establish that bcd-055 is equivalent to remicade in terms of pharmacokinetics and safety when used by the standard regimen in patients with ankylosing spondylitis (as). the study will enroll 90 patients with active as, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive bcd-055 iv at a dose 5 mg/kg on week 0, 2, 6, 14 and 22; patients from the second group will receive remicade at the same regimen.

Eligibility criteria:
inclusion criteria: * signed informed consent * active ankylosing spondylitis, which exists in patient within last 3 months * basdai score \> or equal to 4 points, spinal pain (by vas) \> or equal to 4 points * history of nsaid use for the treatment of as within last 3 months * adequate renal and liver function * absence of severe abnormalities in complete blood count * consent to use adequate contraception * ability to follow protocol procedures exclusion criteria: * previously use of any biologic for as treatment * total ankylosing of the spine * known allergy to chimeric proteins or any excipients of bcd-055/remicade * hepatitis b, active hepatitis c, hiv, syphilis * known tuberculosis * latent forms of tuberculosis * any bacterial infection diagnosed within last month which required oral antibiotics (within last 2 weeks) or parenteral antibiotics (within last 4 weeks) * drug or alcohol abuse * any other disease which can affect assessments or masking some symptoms of as (severe osteoarthrosis, nervous disorders with impairment of sensory or motor functions, another inflammatory joint disease apart from as, etc.) * severe uncontrolled hypertension * chronic heart failure * decompensated renal or liver disorders * severe uncontrolled diabetes mellitus * chronic obstructive lung disease, atopic bronchial asthma, angioedema in anamnesis * any mental disorder, incl. severe depression or/and suicide thoughts/actions in anamnesis * unstable angina pectoris * myocardial infarction within last 12 months other exclusion criteria could be found in the full study protocol