Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability of nva237 in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study will assess of the efficacy and safety of a once-daily, 50µg inhalation of nva237 in moderate to severe chronic obstructive pulmonary disease (copd) patients over 26 weeks treatment.


Eligibility criteria:
inclusion criteria: * male or female adults aged ≥40 years, who have signed an informed consent form prior to initiation of any study-related procedure * with moderate to severe stable copd (stage ii or stage iii). * current or ex-smokers who have a smoking history of at least 10 pack years (ten pack- years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years). * post-bronchodilator fev1 ≥30% and \< 80% of the predicted normal, and post-bronchodilator fev1/fvc \< 0.7 at visit 2 (day -14) (post means: record fev1 and fvc 45 min after administering ipratropium). * symptomatic patients, according to daily electronic diary data between visit 2 (day -14) and visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3 exclusion criteria: * with a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. * patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 600/mm3 (at visit 2) or onset of symptoms prior to age 40 years. patients without asthma but who have a blood eosinophil count \>600/mm3 at visit 2 are excluded. * patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder. * patients with lung lobectomy or lung volume reduction or lung transplantation. * patients with known history and diagnosis of α-1 antitrypsin deficiency. * patients who have had a copd exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to visit 1 patients who have had a respiratory tract infection within 6 weeks prior to visit 1. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic obstructive pulmonary disease (copd) nva237
prediction of long-term outcome in aortic stenosis after valve intervention

Conditions: Aortic Stenosis

Summary: patients with severe aortic stenosis accepted for transcatheter intervention or open surgery are included before the intervention, and then followed up with clinical visits during the first year after intervention. imaging with echocardiography and computed tomography (ct) are performed together with additional imaging with magnetic resonance imaging (mri) and positron emissions tomography (pet)-ct in a subgroup of the study population. blood samples, physical performance and questionnaires with focus on frailty and heart failure are also collected at each visit. a follow up with information of the outcomes after 2-5 years will be performed through national registries.


Eligibility criteria:
inclusion criteria: * accepted for aortic valve intervention exclusion criteria: * no able to follow the study protocol
application of radiomics in breast cancer

Conditions: Breast Cancer; Ultrasound; Elastography; Pathology; Radiomics

Summary: little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (ceus) )and pathological prognostic factors in breast cancer. the aim of this study was to explore the correlation between ultrasound characteristics and pathological prognostic factors using radiomics.


Eligibility criteria:
inclusion criteria: clinical diagnosis of breast cancer exclusion criteria: missing pathology missing follow-up results missing data
transcutaneous pulsed radiofrequency and corticosteroids injections in management of pain in lateral epicondylitis

Conditions: Transcutaneous; Pulsed Radiofrequency; Corticosteroids Injections; Pain; Lateral Epicondylitis

Summary: the aim of the study is to compare between transcutaneous pulsed radiofrequency and corticosteroids injections in management of pain severity, forearm pain, functional disability and patient capability to operate daily activities in patients with lateral epicondylitis

lateral epicondylitis (le), or tennis elbow, is the most common elbow pain condition. pain in the lateral aspect of the elbow, especially the extensor tendon origin (extensor carpi radialis brevis \[ecrb\] and extensor digitorum communis \[edc\]), is the most consistent symptom. it affects up to 3 % of the population and is usually an overload injury that often follows minor and often unrecognized trauma to the extensor forearm muscles of the forearm. transcutaneous pulsed radiofrequency treatment is a noninvasive, needleless, painless, office/outpatient treatment that requires no recovery, sedation, or anesthesia. we were encouraged to research transcutaneous pulsed radiofrequency as a treatment option because of favorable outcomes in previous trials. therefore, transcutaneous pulsed radiofrequency treatment used successfully in a type of orthopedic surgeries, we designed this trial to examine it in the management of pain in lateral epicondylitis.

Eligibility criteria:
inclusion criteria: * age from 18-65 years. * both sexes. * symptomatic lateral epicondylitis for more than 6 months. lateral epicondylitis was diagnosed when pain is elicited by two or more of these diagnostic exams: 1. palpation of the lateral epicondyle. 2. resisted wrist extension (thompson test). 3. chair test. with the shoulder flexed to 60° and the elbow extended, the patient attempts to lift a chair weighing 3.5 kg. exclusion criteria: * severe systemic diseases (diabetes or rheumatoid arthritis). * cervical radiculopathy. * major trauma or prior surgery in the tendon of the elbow. * morbid obese patients (body mass index (bmi) of \>35 kg/m2). * infection at site of injection. * bleeding diathesis and coagulopathy. * patients who didn't consent to completing visual analog scale , rated tennis elbow evaluation (prtee), disabilities of the arm, shoulder, and hand (quick dash) questionnaire. and refuse to participate in the study.
perfect project - part 1 - study 1

Conditions: Diabetes Prevention; Obesity Prevention

Summary: the objectives are to test the acute effects of different extruded pulse snacks on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products. the investigators hypothesize that snack products containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack products.


Eligibility criteria:
inclusion criteria: * normoglycemic (\<5.6 mmol/l) and normotensive (systolic blood pressure \<140 mm hg and diastolic blood pressure below \< 90 mm hg) * bmi of 18.5-29.9 kg/m2 exclusion criteria: * restrained eaters * regularly skip breakfast * smokers * those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year * competitive sports or athletic training at a high intensity * those unable to walk for an hour continuously
stabilizing mood and sleep with blue blocking eyewear in bipolar disorder

Conditions: Bipolar Disorder

Summary: the study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (\<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder. when in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 pm to 8 am daily for 7 days. after this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime).

the study is a 2-arm single-blind rct to assess the effects of blue blocking (bb) or clear glasses as an acute 7-day antimanic intervention and as a 3-month mood stabilizing maintenance intervention. bb or clear glasses will be applied in addition to outpatient tau for bd. participants will be recruited among patients treated for bd in specialized outpatient clinics within the mental health center copenhagen. the active intervention is bb-glasses that eliminate 99 % of light with a wavelength below 530 nm, whereas the clear glasses filter out only 15% of short wavelength light (low filtration (lf). participation includes 3 months use of the designated eyewear along with daily electronic self-monitoring of mood, sleep and activity as well as participation in a 2-day baseline assessment and a total of 3 follow-up visits including clinical assessment interview, questionnaires, and actigraphic (48 hours) and pupillometric assessments at day 9, week 5 and week 15. participants will be included during hypomanic or manic state and begin treatment with an antimanic dosage of 14 hours (6 pm - 8 am) for 7 consecutive days. subsequently, during the 3-month follow-up period, the dosage (hours using the glasses) can be adjusted according to the current state, with use for 14 hours during hypomanic/manic phases and 2 hours before bedtime during euthymic and depressive states. outcome assessors will be blinded to the treatment assignment and patients will be informed that they are randomized to eyewear with either high or low filtration of light. patients will be randomized on a 1:1 basis with stratification according to sex and outpatient clinic.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder * ymrs-score \>13 * age 18-60 years * speaks and writes danish at a level equal to mother tongue exclusion criteria: * not willing or able to adhere to the protocol * severe eye disorder or eye trauma * treatment with betablockers * sleep disturbances not related to bd (e.g, sleep apnea, restless legs syndrome) • • substance abuse * unwilling to use the electronic self-monitoring system, the monsenso system * prior/current use of bb glasses * current/planned pregnancy * night shift work * suicidality
oxytocin and approach-avoid in grief

Conditions: Prolonged Grief Disorder; Bereavement

Summary: this is a completed project which was initiated prior to january 18,2017 background: theoretical models of complicated grief (cg) suggest that maladaptive approach (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive avoidance of reminders) behaviors interfere with a person's ability to integrate the loss and recover from their loved one's death. due in part to conflicting evidence, little mechanistic understanding of how these behaviors develop in grief exists. we sought to (1) identify behavioral differences between cg and non-cg groups based on implicit bias for grief-, deceased-, and social-related stimuli, and (2) test the role of the neuropeptide oxytocin in shaping approach/avoidance bias. methods: widowed older adults with and without cg completed an approach/avoidance task measuring implicit bias for personalized, non-specific, grief-related, and other stimuli. in a double-blinded, randomized, counterbalanced design, each participant attended both an intranasal oxytocin session and a placebo session. aims were to (1) identify differential effects of cg and stimulus type on implicit approach/avoidance bias \[placebo session\], and (2) investigate interactive effects of cg, stimulus type, and oxytocin vs. placebo on approach/avoidance bias \[both sessions\].


Eligibility criteria:
inclusion criteria: • adult individual experiencing death of a spouse or partner between 6 and 36 months prior to enrollment exclusion criteria: * inability to comprehend english; * medical contraindications for other components of the study, * active suicidality * active homicidality * active psychotic symptoms * ongoing major health conditions such as cancer; uncontrolled hypertension; and medications likely to impact the oxytocin system (e.g., systemic corticosteroids). * pregnant status or suspected pregnant status * premenopausal status

Keywords: oxytocin approach/avoid older adults complicated grief
relaxation treatment in total knee arthroplasty

Conditions: Relaxation; Joint; Total Knee Arthroplasty; Exercise

Summary: surgical techniques and treatment methods of the arthroplasty have been improved and the results after total knee arthroplasty (tka) are generally good. however, some patients have suboptimal postoperative results with respect to pain and physical functioning and may not be satisfied with the results of their tka. psychological symptoms were found to be associated with these suboptimal results. the aim of the present study is to determine weather relaxation techniques had beneficial effects on pain, sleeping quality, functional status and physiological symptoms in tka patients during their hospital stay.


Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis, female patients who are scheduled for unilateral total knee arthroplasty surgery, were included in the study. exclusion criteria: * having a previous knee or hip surgery or fracture, diagnosis of rheumatoid arthritis, severe obesity (bmi\>40 kg/m2), sensory and motor disorders in the operated limb, inability to understand pain assessment.
non-invasive methods for predicting decompensation of chronic liver disease

Conditions: Chronic Liver Disease and Cirrhosis

Summary: preliminary studies have suggested that non-invasive methods can not only be applied to csph but also to predict the risk of decompensation in cirrhosis. however, there is a lack of clinical evidence, and more research is needed to provide such evidence. especially in china, where the etiology of cirrhosis is prevalent, there is a large population of patients with hepatitis b cirrhosis undergoing antiviral treatment. exploring the value of non-invasive methods in predicting decompensation events in these patients can not only expand the clinical application of non-invasive methods but also provide effective non-invasive screening and management strategies for patients with cirrhosis at different risk levels. primary objective: the main purpose of this study is to evaluate the predictive effectiveness of non-invasive methods (based on liver and spleen stiffness) for the occurrence of decompensation in chronic liver disease (cld). secondary objectives: to establish different predictive models for the occurrence of decompensation in cld and to assess their predictive effectiveness as non-invasive methods for decompensation in cld. approximately 2334 individuals will participate in this study at 17 different health care setting.the study will last for 4 years, including 1 year of enrollment and 3 years of follow-up. patients will be seen at 6-month intervals, and all examination results of patients as well as decompensation events, liver cancer, and death will be recorded.


Eligibility criteria:
inclusion criteria: * aged over 18 years and under 80 years; ② underlying chronic liver disease (etiology not specified); * liver stiffness measurement (lsm) greater than 10 kpa or cirrhosis (diagnosed by imaging or histology); * voluntarily signing an informed consent form. exclusion criteria: * have undergone orthotopic liver transplantation or transjugular intrahepatic portosystemic shunt (tips) procedure; * history of liver cancer or other types of cancer diagnosed in the past or currently; * acute or chronic portal vein thrombosis; ④ history of splenectomy or splenic embolization; ⑤ currently in a decompensated stage (with complications such as variceal bleeding, moderate to severe ascites, hepatic encephalopathy, etc.).
epidemiology of venous thrombosis and pulmonary embolism

Conditions: Cardiovascular Diseases; Pulmonary Embolism; Venous Thrombosis

Summary: to investigate venous thromboembolism in two carefully conducted prospective epidemiologic studies of african american and white adults -- the atherosclerosis risk in communities (aric) study and the cardiovascular health study (chs).

background: venous thromboembolism, comprising deep venous thrombosis (dvt) and pulmonary embolism (pe), is a major contributor to morbidity and mortality in the united states. nevertheless, no comprehensive, prospective, population-based epidemiologic studies have simultaneously examined lifestyle, molecular, and biochemical risk factors for this important disease. design narrative: deep venous thrombosis and pulmonary embolism cases were identified and verified in order to estimate incident rates of hospitalized venous thromboembolism in the combined aric and chs cohorts. the association of venous thromboembolism was determined prospectively with demographic and lifestyle factors, plasma lipids, medical history, and hemostatic components (including fibrinogen, platelet count, factors viic and viiic) using existing aric and chs data. a nested case control study was conducted using stored pre-diagnosis blood and dna specimens to determine the prospective associations of venous thromboembolism with the following: levels of procoagulant or anticoagulant factors and related genetic variants (including factor v leiden), fibrinolytic factors (e.g., plasminogen activator inhibitor-1) and related genetic variants, markers of thrombin activation, and other potentially important biochemical or related genetic factors (e.g., homocysteine). the study was renewed in 2003 to extend event follow-up for four more years and to conduct longitudinal analyses of incidence and potential risk factors not fully explored such as diet, frailty, hormone replace therapy and obesity interactions. it was renewed in 2008 to conduct a genome wide association study. it was again renewed in 2013 and 2017.

Eligibility criteria:
inclusion: in the aric or chs cohorts already exclusion: not in the aric or chs cohorts
thrombus aspiration in myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: treatment of myocardial infarction (blood clot in the arteries of the heart) has improved after introduction of 24/7 balloon angioplasty to open the blocked artery. however, the clot itself is not routinely removed but recent data in smaller trials indicate that this might improve recovery and prognosis. in this multicenter study of 5000 patients referred to scandinavian hospitals for myocardial infarction the investigators test the hypothesis that patients randomized to treatment with thrombus aspiration (removing the blood clot by manual suction) before conventional angioplasty will have a reduced risk of death, fewer rehospitalisations, fewer new myocardial infarctions, reduced risk of heart failure, better coronary artery flow after angioplasty and greater reduction of infarct size compared to patients randomized to conventional angioplasty alone.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of st-segment elevation myocardial infarction * correspondence between ecg findings and culprit artery pathoanatomy * a minimum of 50% stenosis in culprit artery by visual estimate * possibility to perform thrombus aspiration exclusion criteria: * need for emergency coronary artery bypass grafting * inability to provide informed consent * age below 18 years * previous randomization in the taste trial

Keywords: heart disease myocardial infarction angioplasty thrombus aspiration
place of ecmo in the management of severe refractory ards associated with covid-19

Conditions: Respiratory Distress Syndrome

Summary: describe covid-19 patients who are receiving ecmo-vv respiratory replacement and what happens to them.


Eligibility criteria:
inclusion criteria: * patient over the age of 18; * diagnostic covid-19 by rt-pcr; * hospitalisation in resuscitation for the management of complications related to covid-19 * implanted ecmo-vv during hospitalisation; * patient agreeing to participate in the study exclusion criteria: * sujet under guardianship or trusteeship * sujet under safeguard of justice

Keywords: respiratory distress syndrome ards sars-cov-2 extracorporeal membrane oxygenation ecmo veno-venous ecmo
paravertebral block for postoperative analgesia in children undergoing lateral incision cardiac surgery with cbp

Conditions: Postoperative Pain

Summary: this study aims to compare the effect of paravertebral block and local infiltration anesthesia on postoperative analgesia in children undergoing lateral incision cardiac surgery with cardiopulmonary bypass. the researchers hope to investigate whether children who undergo paravertebral block experience less postoperative pain, have fewer postoperative complications, and recover more quickly.


Eligibility criteria:
inclusion criteria: 1. children aged 6-14 years old; 2. children who have atrial septal defect or ventricular septal defect scheduled for lateral incision cardiac surgery with cardiopulmonary bypass; 3. inform consent signed by the parent or legal guardian. exclusion criteria: 1. patients who were intubated, on mechanical circulatory support, or with intravenous inotropes before surgery; 2. emergency surgery or redo cardiac surgery; 3. body weight more than 50kg; 4. diagnosed as severe pulmonary hypertension; 5. left ventricular ejection fraction less than 45% in most recent echocardiography before surgery; 6. allergic to ropivacaine or other regular anesthetics, analgesics or other medications regularly used in the study; 7. preoperative platelet counts less than 100\*109/l, coagulopathy or bleeding tendency ; 8. preoperatively using antiplatelets or anticoagulants; 9. diagnosed with scoliosis or other contraindications for pvb.

Keywords: postoperative analgesia paravertebral block pediatric cardiac surgery enhanced recovery after surgery