Kornimate/medical-research-clean huggingface dataset:
carvedilol for prevention of esophageal varices progression

Conditions: Cirrhosis, Liver; Portal Hypertension

Summary: carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. but the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis b patients was unclear.

it has been concluded 40%-70% of chronic hepatitis b patients can achieve fibrosis/ cirrhosis reversion after effective anti-viral therapy. but there is still some patients progress to decompensation. esophageal varices are the main complication of cirrhotic patients. propranolol are widely used to prevent variceal bleeding in patients with large esophageal varices. it has been shown the efficacy of propranolol in the preventing of the progression from small to large varices reported no effect. recently, carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. but the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis b patients was unclear. the purpose of this study is to demonstrate the efficacy of carvedilol in the preventing of the progression from small to large varices in hepatitis b patients.

Eligibility criteria:
inclusion criteria: * male or female; * hbv-related liver cirrhotic patients with at least two years of antiviral therapy; * the presence of small or medium esophageal varices without red color sign; * hbv-dna\<1×10e3 iu/ml * signature of informed consent exclusion criteria: * previous presence of decompensated cirrhosis including ascites, bleeding and he (hepatic encephalopathy); * any contra-indications to beta-blockers including asthma, chronic obstructive pulmonary disease, allergic rhinitis, nyha (new york heart association) class iv heart failure, atrioventricular block, sinus bradycardia (hr \< 50 bpm), cardiogenic shock, hypotension (sbp \< 90 mmhg), sick sinus syndrome, insulin dependent diabetes, peripheral vascular disease. * allergic to carvedilol; * any malignancy that affects survival； * renal dysfunction； * history of beta-blockers within last 3 months； * history of surgery for portal hypertension；history of prior evl (endoscopic variceal ligation) or sclerotherapy, history of surgery for portal hypertension including portosystemic shunts, disconnection and spleen resection and transjugular intrahepatic portosystemic shunt； * severe systemic diseases； * refusal to participate in the study.

Keywords: portal hypertension esophageal varices carvedilol
contralateral strength-training after anterior cruciate ligament (acl) reconstruction

Conditions: Muscle Weakness After Anterior Cruciate Ligament Reconstruction

Summary: the main aims of the study are (1) to examine the impact of contralateral strength training on the quadriceps muscle function after acl surgery and (2) to compare the magnitude of cross-education induced by nmes versus eccentric strength training.


Eligibility criteria:
inclusion criteria: * patients scheduled for acl reconstruction surgery exclusion criteria: * concomitant lower limb injury or disorder * previous lower extremity open surgery on the contralateral lower limb * cardiac disease * pregnancy
pathogenesis and outcomes of sleep disordered breathing in chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: this research is being conducted to examine the effects of nasal insufflation of warm and humidified air through a small nasal cannula on sleep, breathing pulmonary function, and daytime exercise capability.

chronic obstructive pulmonary disease (copd) is associated with significant morbidity including substantial daytime fatigue exertional intolerance and ventilatory impairment, which hits a nadir in the morning. nocturnal disturbances in sleep and breathing are common in copd, although the impact of these disturbances on copd morbidity remains largely unknown. the hypothesis is that copd induces specific sleep and breathing disturbances that remain a substantial source of morbidity in this disorder. current therapy for treating nocturnal disturbances in sleep and breathing in copd including nocturnal oxygen has failed to improve morning fatigue and pulmonary function. this study promises to significantly alter our approach to the diagnosis and management of sleep disordered breathing in copd.

Eligibility criteria:
inclusion criteria: * consenting adults over the age of 21 * bmi \< 40 kg/m2 exclusion criteria: * diagnosed with sleep apnea (apnea and hypopneas of \>10 events/hr). * a sleep efficiency of \<30%, or a prior diagnosis of disorders that impair sleep architecture. * unstable cardiovascular disease (decompensated heart failure, myocardial infarction within the past 3 months, revascularization procedure within the past 3 months, unstable arrhythmias, uncontrolled hypertension (bp \> 190/110)). * severe renal insufficiency requiring dialysis. * liver cirrhosis. * a recent acute illness in a 6 weeks period prior to the sleep studies. * we will exclude subjects with severe daytime hypoxemia (oxyhemoglobin saturation (sao2) \<80% or partial pressure of oxygen (pao2) \<55 mmhg at rest). * chronic use of sedatives or respiratory depressants that would affect sleep quality (e.g., benzodiazepines or other hypnotics or narcotics). * pregnancy. * tracheostomy or other significant oropharyngeal or nasopharyngeal surgery, in the last 6 months. * narcolepsy and other neurological disorders such as parkinson's disease. * severe hepatic insufficiency. * bleeding disorders or coumadin use. * allergy to lidocaine or benzocaine. * language/dementia/psychiatric issues - the participant must be able to provide consent.

Keywords: copd sleep supplemental oxygen breathing mechanics nasal insufflation
frequency and clinical evolution of olfactory and taste disorders in covid-19 patients

Conditions: COVID-19 by SARS-CoV-2 Infection

Summary: a novel coronavirus sars-cov-2 has arose in 2019 in wuhan, china. beside the classical semiology of this infection, numerous patients described olfactory and teste disorders. these symptoms are not described in this coronavirus, neurotropism of coronaviridae has been documented before. the aim of the study is to evaluate prevalence of anosmia and dysgeusia (olfactory and taste disorders) in coronavirus diagnosed patients and compare with different clinical conditions. the second endpoint is to evaluate the duration of these symptoms in order to better understand the semiology of this infection.


Eligibility criteria:
inclusion criteria: * covid-19 diagnosed
margin-based vs. robust photon radiotherapy planning in imrt of hn-sqcc

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: this is a research study to evaluate the quality of life and amount of dry mouth experienced as a result of radiotherapy in subjects who have squamous cell carcinoma of the head and neck (hn-sqcc). this study will compare the side effects experienced based on the method to plan radiotherapy, margin based or robust.

this is a prospective randomized pilot clinical trial, stratified by primary tumor site, to evaluate the degree of xerostomia and quality of life (qol) in subjects with hn-sqcc treated with radiation therapy under margin-based and robust radiotherapy treatment plans. margin-based plans will use both biological (biological optimization) and physical objectives whereas robust planning will use physical objectives for sparing of the parotid glands. intensity-modulated radiation therapy (imrt) and standard chemotherapy will be used. qol (quality of life) will be measured using the european organisation for research and treatment of cancer (eortc) quality of life questionnaire (qlq)-c30 questionnaire and eortc qlq-h\&n35 (head and neck) module before radiotherapy (baseline) and then 3, 6, 9 and 12 months after radiotherapy. xerostomia will be measured in study subjects using two patient-reported scoring systems completed by each subject before radiotherapy and then 3, 6, 9, and 12 months after radiotherapy: late effects normal tissue task force (lent)-subjective, objective, management, analytic (soma) lent/soma grading system and the university of michigan's xerostomia questionnaire (xq). the data collected by this randomized pilot clinical trial will be used to inform the design of, and decision-making for, future larger studies that seek to compare different methods of radiotherapy planning in the treatment of hn-sqcc.

Eligibility criteria:
inclusion criteria: * histological documentation of squamous-cell carcinoma of the head and neck (hn-sqcc) * older than 21 years of age * subject is eligible for routine chemo-radiotherapy for treatment of hn-sqcc * informed consent is obtained * karnofsky performance of at least 70 points exclusion criteria: * women with a positive urine pregnancy test are excluded from this study; women of childbearing potential must agree to refrain from breast feeding and practice adequate contraception * unable to comply with study procedures * use of saliva stimulating prescription drugs such as evoxac or salagen * unable to receive standard chemotherapy

Keywords: xerostomia robust photon radiotherapy margin based radiotherapy
study of treatment choice in patients with localized prostate cancer

Conditions: Prostate Cancer

Summary: rationale: gathering information about patients with prostate cancer may help doctors learn more about how patients choose treatment options. purpose: this study is looking at treatment choice in patients with localized prostate cancer.

objectives: primary * to evaluate the importance of prostate cancer treatment characteristics to men with localized prostate cancer. * to determine to what extent men will choose the strengths and weaknesses of one treatment over a different set of strengths and weaknesses of another treatment when making a choice between them. secondary * to determine the correlation between attributes that are important to men and baseline demographics, functional status, and disease risk characteristics. outline: this is a multicenter study. patients complete a 'discrete choice experiment' questionnaire presenting three treatment options based on 8 aspects of treatment. attributes relevant to men with prostate cancer (e.g., sexual health, urinary function, return to normal activities \[work, gardening, sports, shopping\]) that apply to surveillance, radical therapies and new minimally-invasive therapies have been selected for consideration. baseline demographics such as age, working/retired/unemployed/household income, prostate cancer characteristics (psa level, gleason grade, stage), baseline functional status (genitourinary function), and final treatment choice will also be collected in order to ascertain whether there is any relationship and association between patient preferences for treatment and these baseline demographics. individuals will be asked to choose between the three treatment profiles.

Eligibility criteria:
disease characteristics: * histological diagnosis of adenocarcinoma of the prostate on transrectal or transperineal template prostate biopsies * clinical stage ≤ t2c n0 m0 (radiological t3a allowed) * local staging imaging as per guidelines to demonstrate localized disease (e.g., mri, ct, and/or bone scan) * no metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging * no prior prostate surgery for cancer control (e.g., radical prostatectomy, high-intensity focused ultrasound ablation, cryosurgery, or photodynamic therapy) or other treatment for prostate cancer * gleason grade ≤ 7 * serum psa ≤ 15 ng/ml patient characteristics: * not specified prior concurrent therapy: * see disease characteristics * no prior radiotherapy * no androgen suppression/hormone treatment within the previous 12 months for prostate cancer

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer
risk factors associated with infection after spine surgery

Conditions: Deep Surgical Site Infection; Spine Surgery

Summary: surgical site infection (ssi), particularly deep ssi, is one of the most serious complications after spinal surgery. evaluating the risk of ssi and, correspondingly, prescription of prophylactic measures are extremely important to prevent ssi and avoid potentially devastating consequences. a retrospective study was conducted aiming to develop a point-based prediction model of deep surgical site infection in patients receiving open posterior instrumented thoracolumbar surgery.

data of 3,419 patients in 4 hospitals from jan 1, 2012 to dec 30, 2021 were retrospectively collected and were evaluated aiming to develop a point-based prediction model of deep surgical site infection in patients receiving open posterior instrumented thoracolumbar surgery. clinical knowledge-driven, data-driven and decision tree model was used to identify predictive variables of deep ssi. internal validation was performed by using bootstrapping methods.

Eligibility criteria:
inclusion criteria: patients who previously received open posterior instrumented thoracolumbar surgery exclusion criteria: 1. were aged \< 18 years; 2. underwent surgery for the spinal infection, spine revision surgery, or cervical operation; 3. were diagnosed as superficial ssi; 4. died in hospital; 5. diagnosis of ssi was not determined; 6. had missing data more than 10% were excluded.
study of rapastinel as monotherapy in major depressive disorder (mdd)

Conditions: Depressive Disorder, Major

Summary: the study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of rapastinel, compared to 10 mg of vortixetine and placebo in participants with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for mdd * current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at visit 1 * have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode * if female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test exclusion criteria: * dsm-5-based diagnosis of any disorder other than mdd that was the primary focus of treatment within 6 months before visit 1 * lifetime history of meeting dsm-5 criteria for: 1. schizophrenia spectrum or other psychotic disorder 2. bipolar or related disorder 3. major neurocognitive disorder 4. neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study 5. dissociative disorder 6. posttraumatic stress disorder 7. mdd with psychotic features * significant suicide risk, as judged by the investigator
a study of decitabine given to adults with advanced-stage myelodysplastic syndromes

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (mds) given a daily dosing schedule of decitabine.


Eligibility criteria:
inclusion criteria: 1. must sign an institutional review board (irb) -approved informed consent form. 2. must be 18 years of age or older. 3. must have a diagnosis for mds fitting any of the recognized french-american-british (fab) classifications and international prognostic scoring system (ipss) greater than or equal to 0.5 as determined by complete blood count (cbc), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. if fab classification is refractory anemia (ra) or refractory anemia with ringed sideroblasts (rars), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks. 4. if receiving erythropoietin(procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug. 5. if receiving darbepoetin(aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug. exclusion criteria: 1. must not have a diagnosis of acute myeloid leukemia (aml) or other progressive malignant disease. 2. must not have received any investigational agent within the 30 days preceding the first dose of study drug. 3. must not have uncontrolled cardiac disease or uncontrolled congestive heart failure. 4. must not have an active viral or bacterial infection.

Keywords: myelodysplastic syndrome decitabine dacogen mgi pharma
evaluating bubble-papr for healthcare workers

Conditions: Covid19

Summary: this project will produce a low cost, ergonomic, hood integrated papr for use initially within the nhs. it will focus on user centred design, engineering optimisation, feasibility testing, certification and intellectual property protection. this study will evaluate the pre-ce marked bubble papr prototype ppe in the clinical environment and gather usability data from consenting participants (staff).

aim: to develop low cost, ergonomic, personal protective equipment to prevent virus transmission to nhs healthcare workers. this project aims to address these problems by taking a user centred design approach to develop and manufacture a highly functional hood integrated personal air purifying respirator (hi-papr) at a low cost. the design team brings together manchester university nhs foundation trust (mft) icu frontline clinical staff, an experienced product design consultancy, designing science limited (dsl) and the technical expertise of the school of engineering at the university of manchester (uom). the project will run through a rapid design and evaluation cycle in simulated and clinical environments to refine the concept to meet regulatory requirements. the final product could be used in primary/secondary care and in the community and will be ready for wide-scale manufacture and supply for the uk nhs within six months of the project start. this study will evaluate bubble papr in the clinical environment and gather usability data from frontline healthcare staff. we hypothesise that: * the bubble papr will meet or exceed the british and european standards for paprs. * that participating staff who subsequently use the papr will rate the ppe as: * more comfortable than current ppe * safer than current ppe * easier to communicate with colleagues than current ppe * easier to communicate with patients than current ppe our research question is: • do clinical staff report that the bubble papr is more comfortable than current ffp3 facemasks.

Eligibility criteria:
inclusion criteria: provision of informed consent; bedside clinical staff (medical, nursing, allied healthcare professional) who manage patients with covid-19 disease during routine clinical duties. exclusion criteria: refusal to participate; unable to, or unwilling to wear the bubble papr
the multicenter atorvastatin plaque stabilization (maps) study

Conditions: Symptomatic Carotid Stenosis; Hypercholesterolemia; Indication for Carotid Endarterectomy

Summary: the impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. however, a short-term benefit has been documented for patients treated with statins in acute coronary syndromes and other clinical settings. these observations strengthened the hypothesis of additional, so-called pleiotropic actions of statins. the investigators therefore sought to investigate how different lipid-lowering strategies (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of carotid plaque over a short-term period of three months. specifically the investigators tried and dissect the ldl-c lowering impact on plaque cellular composition as compared to the lipid-independent contribution on plaque macrophage and smooth muscle cells.

patients (with total cholesterol (tc) ranging between 5.83-7.64 mmol/l), never treated with lipid lowering drugs, with symptomatic carotid stenosis \>70% (nascet criteria), and therefore eligible for carotid endarterectomy, were recruited. all patients were enrolled within 30 days from the clinical event, and randomized to one of three treatment groups. each group, composed of 20 patients, received atorvastatin 10 mg/day (at-10 group), or atorvastatin 80 mg/day (at-80 group), or cholestyramine (questran, bristol myer squibb) 8 g/day plus sitosterol (unilever) 2.5 g/day (c-s group) for three months prior to the vascular procedure. a placebo group was not included for ethical reasons due to the high cardiovascular risk profile in this population.

Eligibility criteria:
inclusion criteria: * symptomatic carotid stenosis \> 70% (nascet criteria) * eligibility for carotid endarterectomy * total cholesterol level between 5.83 and 7.64 mmol/l * never treated with lipid lowering drugs exclusion criteria: * previous lipid lowering therapy * total cholesterol \ 7.64 mmol/l * evidence of chronic inflammatory disease (clinical and laboratory). * patients at high risk for cerebrovascular events (i.e. ulcerated carotid plaque, recurrent tias).

Keywords: atherosclerosis macrophages carotid arteries statin
postoperative pain after volar plating for distal radius fractures

Conditions: Distal Radius Fractures

Summary: the investigators undertook to evaluate early postoperative pain levels after the volar plating of distal radius fractures performed under regional anesthesia, and to determine whether periarticular multimodal drug injections into the joint, ligament, periosteum, subcutaneous tissue, and skin, and into interosseous and superficial radial nerves (as an additional sensory nerve block) provide additional pain management benefits.

to evaluate whether periarticular injections (pi) had additional pain management benefits, patients were randomly allocated to two groups, that is, the pi and no-pi groups, using a randomization table. members in the pi group received intra-operative periarticular injections and additional sensory nerve blocks just before skin closure. for the periarticular injections and additional sensory block, local analgesic solution was injected into the wrist joint, joint capsule, periosteum, subcutaneous tissue, skin, and around the anterior and posterior interosseous nerves and the superficial radial nerve. a volume of 2ml was injected into the joint capsule and periosteum, and of 3ml into the wrist joint, subcutaneous tissue, skin and into each nerve. the anterior interosseous nerve was blocked in the course of the pronator quadratus and posterior interosseous nerve in the 4th dorsal extensor compartment. the mixture of anesthetics consisted of 2 ampules of ropivacaine hcl (naropin®, 0.75%, 7.5mg/ml, 20ml/ⓐ), 1 ampule of morphine sulfate (5mg/ⓐ), 1 ampule of epinephrine hcl (1mg/ml, 1ml/ⓐ) and normal saline 20cc.

Eligibility criteria:
inclusion criteria: * distal radius fracture with or without a styloid fracture not requiring surgery exclusion criteria: * multiple trauma * a combined distal radio-ulnar joint instability or a large ulnar styloid fragment requiring fixation * regularly narcotics user * those with a psychiatric illness, a major systemic illness or a known allergy or contraindication to opiates or local anesthetics.

Keywords: periarticular injection