Kornimate/medical-research-clean huggingface dataset:
optimization of a fast-track concept for knee joint replacement

Conditions: Knee Arthropathy; Postoperative Pain; Postoperative Complications

Summary: in an estimated 150,000 patients, a knee joint replacement is performed in germany every year. the perioperative care of the patients aims at an optimal surgical technique, which leads to a high functionality in the joint, and above all at an adequate pain treatment. patients experience pain especially intraoperatively and in the first days after the operation. the intensity of pain is a decisive factor that can hinder the patient's mobilization. in the kneeoptout study (ethics application number ea4/009/17), which has already been successfully carried out and approved by this ethics committee, it was shown that the use of local infiltration anaesthesia (lia) for pain therapy after primary knee endoprosthetics is comparable to catheter-supported regional anaesthesia (manuscript under review at the european journal of anaesthesiology). during surgery, the morphine requirement of patients in the lia group was significantly higher than that of patients who underwent catheterization. postoperatively, however, both subjective pain by vas and opiate consumption were comparable. in order to optimize the intraoperative opiate need/consumption, an early-intraoperative procedure for local infiltration anesthesia will now be compared with the previous late-intraoperative procedure. both procedures correspond to sop for the treatment of primary knee endoprostheses and are currently used depending on the surgeon's requirements.


Eligibility criteria:
inclusion criteria: • patients undergoing elective, primary knee joint replacement in combined general anaesthesia exclusion criteria: * heart insufficiency nyha \>2 * liver insufficiency \> child b * evidence of diabetic polyneuropathy * severe adipositas bmi \>40 * patients \< 18 years * pregnancy * in case of police custody * participation in a paralleled interventional rct in a time frame of 30 days * chronic opioid therapy \>3 months before scheduled surgery * allergy against medication required for surgery or anaesthesia

Keywords: eras pain knee arthroplasty joint pain regional anaesthesia
lifeseal™ preliminary study in subjects undergoing low anterior resection

Conditions: Rectal Cancer

Summary: a preliminary study in subjects undergoing low anterior resection


Eligibility criteria:
inclusion criteria: 1. subject, or authorized representative, signed a written informed consent 2. subject is at least 18 years of age 3. subject is scheduled for elective open resection 4. stapled anastomosis created within 10cm of the anal verge 5. subject is willing to comply with the follow-up requirements of the study exclusion criteria: 1. subject has a history of hypersensitivity to porcine derived gelatin or collagen 2. subject has unacceptable baseline hematological results 3. subject on chronic preoperative treatment with steroids and anticoagulants 4. subject with elevated liver function tests 5. subject with abnormal kidney function 6. subject with a bmi higher than 35 7. subject participating in any other study for either drug or device which can influence collection of valid data under this study 8. subject with a history of mi, cva or asa status iv or a life expectancy of less than 1 year 9. anastomosis was performed differently from what was defined 10. subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the lifeseal™ 11. subject has intraoperative bleeding in excess of 500cc 12. subject has peritoneal carcinomatosis
a multi-center study to determine the prevalence and influence of pertussis on copd exacerbation in shenzhen

Conditions: COPD Exacerbation; Pertussis

Summary: a prospective, multi-center, observational clinical trail. aim to evaluate the real incidence of chronic obstructive pulmonary disease (copd) pertussis and the impact of pertussis on copd exacerbation.

1. investigate the incidence and epidemiological characteristics of pertussis infection in copd population. 2. to explore the relationship between pertussis infection and copd exacerbation.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of acute copd exclusion criteria: - major diseases except copd; significant abnormality in laboratory examination; clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilation dysfunction; patients with a history of asthma, allergic rhinitis, or a blood eosinophil count of 2600/mm3 (0.6x10\^9/l) within 4 weeks; currently suffering from active tuberculosis; patients with life-threatening pulmonary embolism, or al-antitrypsin deficiency, or cystic fibrosis; patients who have undergone lung resection.
dyspnea threshold during 6 minutes walk test

Conditions: COPD

Summary: in view of the multiple limitations and restrictions relative to cpet (technical, time, physical...), determination of individualized training threshold from this evaluation is today not possible for a lot of patients. the aim of this study was to propose a new clinical tool from 6mwt for individualized exercise training: the dyspnea threshold (dt6).


Eligibility criteria:
inclusion criteria: * copd * with or without rest and/or ambulation oxygen therapy exclusion criteria: * exacerbation in the previous four weeks * with a restrictive or mixed respiratory syndrome, angina , recent heart attack (\< 1 month) or coronary progressive pathology * under beta-blockers * cognitive or motor problems which limit significantly comprehension or achievement of evaluations

Keywords: exercise training dyspnea threshold 6mwt
is conditioned pain modulation predictive of clinical improvement in patients with chronic low back pain?

Conditions: Low Back Pain

Summary: conditioned pain modulation (cpm) a measure of the effectiveness of the descending pain pathway and therefore a measure of the body's ability to perform endogenous analgesia. in subjects with normal function of the descending pain pathway, the net-effect during cpm testing is anti-nociceptive, or inhibition of the ascending pain pathway. in those with impaired descending pain pathway function, the response to cpm testing is pro-nociceptive, indicating that the body is unable to inhibit the pain signal, or may even amplify it. there is literature that supports the presence of impaired cpm, and therefore impaired descending pain pathway function, in numerus chronic pain conditions, including low back pain. impaired descending pain pathway function may be contributing to this chronic pain presentation. this study will give us information on whether a typical physical therapy plan of care is able to improve impaired cpm, and if cpm values are predictive of improvement in physical therapy.


Eligibility criteria:
inclusion criteria: * deers eligible * english speaking * age 18-64 years * odi baseline ≥25% * nprs baseline ≥3/10 * low back pain symptoms greater than 3 months * must be able to commit to at least six weeks of physical therapy interventions exclusion criteria: * serious spinal pathology (acute fracture, active cancer, inflammation, inflammatory arthropathy) * low back pain symptoms radiating below the knee * pregnancy * diagnosed neurological disease including traumatic brain injury, multiple sclerosis, chronic regional pain syndrome, and fibromyalgia. * history spinal surgery * currently under litigation related to low back pain * currently going through medical evaluation board (meb) * retiring or separating from the military within a year

Keywords: low back pain physical therapy conditioned pain modulation temporal summation
s-adhf：sarcopenia in patients with adhf

Conditions: Acute Decompensated Heart Failure

Summary: this is a prospective, multi-center, investigator-initiated observational cohort study. enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.this study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure.

guangdong provincial people's hospital will be the lead center, with an additional 4 hospitals designated as satellite centers for the study. enrollment of up to 500 participants adults aged over 18 years hospitalized for adhf is planned, with a minimum of of 195 cases each for patients with and without sarcopenia the sympathetic nervous activity, psychosocial factors, quality of life, physical function and baseline physical activity will also be observed and recorded at baseline. each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death. the primary clinical outcome is all-cause mortality at 6 months. other clinical outcomes of interest include cardiovascular mortality, all-cause hospitalisation, hf hospitalisation, the frequency and length of hospitalization of patient readmitted and survival time from enrollment to death of deceased patients. this study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure. s-adhf will provide important information and evidence on the clinical aspects of sarcopenia in patients with adhf, and will potentially and contribute to accurate risk stratification and optimal clinical management for patient with adhf.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. at least one symptom of heart failure upon admission:dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue. 3. at least two of the signs of heart failure (hf): distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure. pulmonary edema or pulmonary congestion (rales or chest x-ray/ct evidence of pulmonary congestion). peripheral edema. elevated b-type natriuretic peptide (\>100 pg/ml) or elevated n-terminal pro-brain natriuretic peptide (\>300 pg/ml). willingness to provide informed consent and cooperate with the follow-up exclusion criteria: 1. unable to understand and comply with protocol or to give informed consent 2. end-stage diseases other than heart failure, life expectancy \<1 year, such as malignant tumors 3. current or planned participation in a clinical trial.

Keywords: acute decompensated heart failure sarcopenia prognosis mortality kansas city cardiomyopathy questionnaire (kccq)
prognostic value of flow-mediated dilation in hospitalized covid-19 patients

Conditions: Covid19; SARS-CoV Infection

Summary: this study will evaluate the associations between vascular parameters and clinical outcomes in patients hospitalized with covid-19. the vascular function and structure of individuals with covid-19 admitted to the general hospital of the university of sao paulo will be assessed in the first 72 hours of hospitalization. then, participants will be followed up until hospital discharge/death. logistical regressions will be run to evaluate if vascular function/structure can predict icu admissions, intubation, thrombosis or death.

this is a prospective cohort study conducted at the general hospital of the university of são paulo medical school (hcfmusp). male and female participants with sars-cov-2 and recently admitted to the hospital (≤ 72 hours) will be recruited at the emergency department and outpatient clinics at the hcfmusp. immediately upon recruitment, participants will perform the assessment of flow mediated dilation of the brachial artery and the assessment of carotid intima-media thickness. subsequently, they will be followed during the entire period of hospitalization. the present study will employ as primary endpoint a composite of icu admission, intubation or mortality during the period of hospitalization. cardiovascular complications, such as arterial (ae), deep venous (dvp) or pulmonary embolism (pe) , acute myocardial infarction (ami), stroke, cardiac arrest, atrial fibrillation and acute kidney injury will be considered secondary endpoints. the association between the vascular parameters and clinical outcomes will be examined by a multivariate logistic regression.

Eligibility criteria:
inclusion criteria: * patients diagnosed with sars-cov-2 * recently admitted to the hospital (≤ 72 hours) * not yet proceeded to icu care exclusion criteria: * patients transferred from other hospitals * participants in delirium state * participants with a recent history of endotracheal intubation

Keywords: endothelial function flow-mediated dilation vascular function carotid intima-media thickness
a clinical trial on safety and efficacy of cbt-001 in patients with pterygium

Conditions: Pterygium

Summary: the objective is to evaluate the safety and efficacy of low dose and high dose cbt-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.

clinical hypotheses: 1. cbt-001 dosed twice daily is more effective than vehicle in: * reducing conjunctival hyperemia by demonstrating a statistically significant difference and clinically relevant improvement in the mean severity grade change from baseline. * preventing pterygium progression, by demonstrating a statistically significant and clinically relevant improvement on drug vs vehicle mean difference in the change in pterygium length from baseline. 2. cbt-001 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.

Eligibility criteria:
inclusion criteria: pterygium with conjunctival hyperemia exclusion criteria: pterygium removal within the last 6 months
l-arginine, symmetrical and asymmetrical dimethylarginine (sdma/adma) in acute kidney injury (aki)

Conditions: Acute Kidney Injury

Summary: the purpose of the study is to determine the association between acute kidney injury and serum levels symmetrical and asymmetrical dimethylarginine (sdma/adma) and their assumptive influence on mortality, renal function and on arterial stiffness.

acute kidney injury (aki) is a frequent complication with severe implications deteriorating overall prognosis. nitric oxide (no)-signal transduction plays an important role in mediating renal damage. no is produced by no-synthase (nos) with l-arginine as its substrate. endogenous l-arginine derivatives, asymmetric and symmetric dimethylarginines (adma/sdma), inhibit no-production directly (amda) by blocking nos activity or indirectly (sdma) by blocking cellular l-arginine uptake. it is well known that sdma and adma are markers of renal function (sdma) and cardiovascular risk (adma/sdma) in patients with chronic kidney disease (ckd). moreover, adma and sdma possibly even trigger cardiovascular risk in patients with ckd. however, there is only little information about the regulation and the influence of adma/sdma in acute kidney injury.

Eligibility criteria:
inclusion criteria: * acute kidney injury according to the definition of akin (acute kidney injury network) * no started renal replacement therapy (e.g. dialysis) exclusion criteria: * dialysis or continuous venovenous hemofiltration before recruitment * no recovery from kidney injury according to the definition of akin (acute kidney injury network) * palliative care * life expectancy is severely limited (\< six months) due to preexisting malignancy or other disease

Keywords: acute kidney injury asymmetric dimethylarginine symmetric dimethylarginine l-arginine arterial stiffness augmentation index pulse wave velocity
impact of anti-hiv treatment on labor productivity and costs in south africa

Conditions: HIV Infections

Summary: the purpose of this study is to determine the impact of anti-hiv treatment on the work attendance of employed people in south africa. the study will enroll participants from a large manufacturing and distribution firm in south africa.

little is known about the economic benefits of providing antiretroviral therapy (art) for hiv infected patients in sub-saharan africa and other resource-limited areas. in south africa, an increasing number of private sector firms are providing access to art for their employees. one of the barriers to such action, however, is the lack of available information on the success of art in restoring workers to full productivity, retaining skilled employees in the workforce, and reducing the costs of medical care and death and disability benefits. hiv infected employees on art may be absent from work less often than untreated hiv infected employees, but more often than hiv uninfected employees. this study will collect data from an independent hiv/aids disease treatment program and a large private sector employer in johannesburg, south africa to estimate the benefits and costs for businesses to provide art to eligible employees. the study will combine individual-level medical outcome and treatment cost data from the treatment program with data on employee work attendance and retention in the workforce from the participating employer. the work attendance of hiv infected employees enrolled in the hiv/aids treatment program (index participants) who are either taking art or receiving pre-art care will be compared with each other and with that of hiv uninfected employees. there are no study visits associated with this study; all data will be collected from medical records maintained by the hiv/aids treatment program and the participants' employer. the financial costs and benefits of the treatment program for the participating company will also be estimated.

Eligibility criteria:
inclusion criteria for all participants: * employed by participating company for at least 1 year prior to study entry inclusion criteria for index participants: * enrolled in the hiv/aids treatment program offered by the participating company exclusion criteria for index participants: * enrolled in the hiv/aids treatment program prior to 01/01/04 or after 06/30/05

Keywords: hiv aids labor productivity antiretroviral therapy south africa
study to evaluate the efficacy and safety of daglutril compared to placebo on top of losartan in type 2 diabetics with overt nephropathy and well controlled hypertension

Conditions: Hypertension

Summary: this study is to evaluate the end of treatment effect of daglutril compared to placebo on top of losartan.


Eligibility criteria:
inclusion criteria: * treated with optimized dose of losartan (constant dose for at least four weeks before randomization and throughout the whole study period) for at least four weeks * urinary albumin excretion ≥ 20 and \< 1000 µg/min * sitting systolic/diastolic blood pressure (sbp/dbp) \< 140/90 mmhg at the end of placebo run-in phase exclusion criteria: * known secondary hypertension * decompensated congestive heart failure

Keywords: blood pressure, diabetic nephropathy, proteinuria
vercise™ dbs dystonia prospective study

Conditions: Dystonia

Summary: to compile characteristics of real-world outcomes of boston scientific corporation's commercially approved vercisetm deep brain stimulation (dbs) systems for the treatment of dystonia.

to compile characteristics of real-world outcomes of boston scientific corporation's commercially approved vercisetm deep brain stimulation (dbs) systems for the treatment of dystonia. subjects' improvement in disease symptoms and overall quality of life will be assessed.

Eligibility criteria:
inclusion criteria (ic): * ic1. meets criteria established in the locally applicable vercise system directions for use (dfu) for dystonia. * ic2. at least 7 years old. parent or guardian consent is required in patients who are younger than 18 years at the time of consent. exclusion criteria (ec): * ec1. meets any contraindication in the vercise system locally applicable directions for use.
maternal care bundle to attenuate hypotension in cesarean section

Conditions: Hypotension; Cesarean Section Complications

Summary: cesarean section (cs) is a common obstetric surgery that can be performed by both general or regional anaesthetic techniques. hypotension is the most common complication of spinal anaesthesia, its incidence varying from 70% to 80 %, if severe, it can result in serious perinatal adverse outcomes, such as maternal nausea and vomiting, fetal acidosis and may be an important contributory factor for maternal death related to regional anaesthesia.

a variety of methods have been used for the prevention of post-spinal hypotension which includes the use of intravenous fluid, vasopressors, and physical methods such as table tilt, leg binders, and compression devices. however, a single technique is ineffective and a combination of interventions is suggested. a care bundle is a group of three to five evidence-based interventions that, when performed together, have a better outcome than if performed individually. a care bundle consists of a group of (usually) between three and five evidence-based interventions. these are related to a particular condition or event for patient care. care bundles are well known in the field of intensive care medicine such as ventilator-associated pneumonia (vap) care bundle, sepsis care bundle, and central line-associated bloodstream infection (clabsi) care bundle. to our knowledge, till now, no one has investigated a special care bundle in the field of anaesthesia. in this work, we will investigate the safety and efficacy of a special care bundle in controlling spinal induced hypotension.

Eligibility criteria:
inclusion criteria: * age more than 21 years old and less than 40 years. * patients are asa i (american society of anesthesiology physical status grade i) = (normal healthy patients) or asa ii (american society of anesthesiologists physical status grade ii) = (patients with mild systemic disease and no functional limitations). * none laboring, at term with singleton uncomplicated pregnancies. * delivery under spinal anesthesia, with height 150 to 180 cm * body mass index of at most 40 kg/m2. exclusion criteria: * parturient with peri-partum disorders as dm, htn, cardiac diseases, bronchial asthma or bleeding disorders * obesity: bmi \>40 * any known allergy to local anesthetic drugs or ondansetron. * apparent anatomical abnormalities or infections in the back region. * bleeding disorders e.g., thrombocytopenia, high inr, high pt in the chronic liver or impaired kidney). * refusal to participate in the study