Kornimate/medical-research-clean huggingface dataset:
evaluation of short-term effects of tourniquet use in different ways during total knee arthroplasty

Conditions: Osteoarthritis

Summary: to study the short-term effects of tourniquet use in different ways in total knee arthroplasty,60 patients were randomly divided into 2 groups (30 cases/group): group a using the tourniquet throughout the operation, and group b using the tourniquet starting from the implantation of prosthesis to the completion of the operation. operation time, total measured blood loss, intraoperative transfusion volume, and complication were recorded. hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb circumference, pain score, and knee joint range of motion were also recorded preoperatively and in postoperative 3,7 and 14 days.investigators want to observe the difference between the two groups. hypothesis was made that patients in group b may feel better after operation for short time use of tourniquet.

objective: to study the short-term effects of tourniquet use in different ways in total knee arthroplasty. methods: 60 patients were randomly divided into 2 groups (30 cases/group): group a using the tourniquet throughout the operation, and group b using the tourniquet starting from the implantation of prosthesis to the completion of the operation. operation time, total measured blood loss, intraoperative transfusion volume, and complication were recorded. hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb circumference, pain score, and knee joint range of motion were also recorded preoperatively and in postoperative 3,7 and 14 days.

Eligibility criteria:
inclusion criteria: * patients eligible for the study included those who underwent initial unilateral tka for osteoarthritis or rheumatoid arthritis. exclusion criteria: * patients with diabetes, hemorrhagic disease, hb \< 100 g/l, peripheral neurovascular disease, malignant tumors, history of vascular thrombosis, or history of infection in the lower limb were excluded

Keywords: tourniquet total knee arthroplasty blood loss limb swelling limb circumference
comparison of self-inflicted deep wrist injuries to traumatic deep wrist injuries

Conditions: Deep Wound; Wrist Injuries

Summary: self-inflicted wrist injuries require special psychiatric knowledge and tactical skills. there is no protocol for treating such injuries. we analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

self-inflicted wrist injuries are regularly treated in hand surgery centers. these injuries involve risks that require special psychiatric knowledge and tactical skills. there is no protocol for treating such injuries. therefore, the investigators analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

Eligibility criteria:
inclusion criteria: * deep wrist injury from 2008-2018 * treated in university hospital schleswig-holstein * agreed to retrospective analysis, questionnaires and hand function assessment exclusion criteria: * non-compliance

Keywords: deep wrist injury self inflicted traumatic wrist injury
ada gene transfer into hematopoietic stem/progenitor cells for the treatment of ada-scid

Conditions: Immunologic Deficiency Syndromes

Summary: this is a phase i/ii protocol to evaluate the safety and efficacy of ada gene transfer into hematopoietic stem/progenitor cells for the treatment of adenosine deaminase (ada)-deficiency. this condition is an autosomal recessive form of severe combined immunodeficiency (scid) characterized by impaired immune responses, recurrent infections, failure to thrive and systemic toxicity due to accumulation of purine metabolites. transplants from an human leukocyte-antigen (hla)-identical sibling donor is the treatment of choice, but available for a minority of patients. the use of alternative bone marrow donors or enzyme replacement therapy is associated with important drawbacks. the drug product studied in this protocol consists of autologous cluster of differentiation (cd)34+ hematopoietic stem/progenitor cells engineered ex vivo with a retroviral vector encoding the therapeutic gene ada. the engineered cd34+ cells are infused following a nonmyeloablative conditioning with busulfan to make space in the bone marrow. the study objectives are: a) to evaluate the safety and the clinical efficacy of gene therapy, in the absence of enzyme replacement therapy; b) to evaluate the biological activity (engraftment, ada expression) of ada transduced cd34+ cells and their hematopoietic progeny. c) to evaluate the immunological reconstitution and purine metabolism after gene therapy.

the safety of the study will be evaluated by description of all adverse events and adverse drug reactions. the study is aimed at reaching the minimum sample size of ten patients.

Eligibility criteria:
inclusion criteria: * ada-scid with no hla-identical sibling donor available * pediatric age and at least one of the following criteria: * inadequate immune response after peg-ada for \> 6 months * patients who discontinued peg-ada due to intolerance, allergy or auto-immunity * patients for whom enzyme replacement therapy is not a life long therapeutic option exclusion criteria: * hiv infection * history or current malignancy * patients who received a previous gene therapy treatment in the 12 months prior to receiving strimvelis * any other conditions dangerous for the patients according to the investigator

Keywords: scid gene therapy adenosine deaminase retroviral vector
assessment of educational strategies in heart failure patients presenting to the emergency department for care

Conditions: Heart Failure

Summary: this study evaluates the impact of a new education-based intervention on outcomes in un- and under-insured heart failure (hf) patients presenting to the emergency department (ed) for care. intervention patients will receive personalized education regarding their condition, pre- and post-testing of their hf knowledge base, and ed standard of care during the enrollment (index) visit. patients will then be contacted via telephone 30 days post-index visit for re-testing and reinforcement of previously learned material. patients in the control group will receive ed standard of care.

in 2015, 12.8% of adults ages 19-64 in the united states lacked any form of health insurance. an even greater number fell under the umbrella of under-insured. studies indicate that the un- and under-insured receive less preventive care, are diagnosed at more advanced disease stages, and have higher mortality rates than their insured counterparts, due to the lack of accessible primary care services. these issues are most readily evident in patients with chronic conditions. when a preventable, chronic condition worsens, these patients have no choice but to visit the ed to address their most immediate health concerns, leaving the underlying chronic problem untreated. hf is a particularly burdensome chronic problem for patients of all socioeconomic statuses and one of the leading causes of ed and hospital readmissions. numerous educational efforts have been tested in an attempt to reduce hf readmissions but have met with mixed results. consequently, hf patients are generally seen as refractory to educational and management strategies. the investigators propose here a new, targeted educational intervention designed to improve patient outcomes and readmission rates in un- and underinsured hf patients.

Eligibility criteria:
inclusion criteria: * patients with a pre-existing documented diagnosis of hf presenting to the ed exclusion criteria: * 1) patients in unstable condition requiring immediate medical attention, 2) hemodynamically unstable, 3) age \< 18 years, and/or 4) incarcerated.
metabolic and clinical effect of alpha-lipoic acid administration in schizophrenic subjects

Conditions: Metabolic Evaluation; Cardiac Complications

Summary: the therapeutic use of ala in schizophrenia has recently been investigated in human populations. a case series explored the effiacy of ala as a novel agent to treat antipsychotic-induced obesity, at a dose of 1200 mg/d (range between 600 and 1800 mg/d); reporting the key effect to be a reduction in body weight and bmi after a 12-week treatment. in a pilot open-label trial, 100 mg/d of ala was administrated as a general adjuvant to antipsychotics therapy, with no significant improvement in bmi, abdominal circumference, blood count, or liver enzymes. finally, another study investigated the effects of 500 mg/d of ala on plasma adiponectin levels, fasting glucose, and aspartate aminotransferase activity, with no significant effect on the metabolic parameters. based on this background, ala may be a potentially interesting therapeutic agent to improve the metabolic effects of atypical antipsychotics. the purpose of this study was to assess: (1) the efficacy of ala on metabolic factors and (2) its safety and potential therapeutic effects in a sample of schizophrenic patients in stable therapy with atypical antipsychotics.


Eligibility criteria:
inclusion criteria: * dsm-5 criteria for schizophrenia, * aged between 18 and 60 years old * in stable atypical antipsychotic monotherapy (clozapine, olanzapine, quetiapine, or risperidone) for least 3 months. exclusion criteria: * treatment with more than one atypical antipsychotic, current treatment with insulin/oral hypoglycaemic/lipid-lowering agents * significant concomitant medical pathologies * organic brain disorders * history of alcohol or substance dependence (excluding nicotine) * dementia * mental retardation * pregnancy/breastfeeding.

Keywords: alphalipoic acid schizophrenia
certolizumab in crohn's disease patients with loss of response or intolerance to infliximab

Conditions: Crohn's Disease

Summary: to assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from crohn's disease (cd) and previously treated with infliximab


Eligibility criteria:
inclusion criteria: * subjects with crohn's disease * previous treatment failure to infliximab (intolerance and/or no response) exclusion criteria: * obstructive intestinal strictures * recent bowel resection * proctocolectomy or total colectomy * current total parenteral nutrition * short bowel syndrome * all concomitant diseases or pathological conditions that could interfere with crohn's disease assessment or to be harmful for the well being of the patient * previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Keywords: crohn's disease certolizumab pegol
testing the accuracy of a personal heart rhythm monitor to detect prolonged paroxysmal atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation; Stroke

Summary: this study aims to determine the sensitivity and specificity of a personal heart rhythm monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting more than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard' for arrhythmia detection.

the investigators aim to recruit 30 volunteers with implantable devices (either conventional pacemakers, with an atrial lead or implantable loop recorders, devices inserted under the skin to monitor the heart rhythm). they will be attending for their routine pacemaker checks in a number of clinics in surrey. potential participants will have documented prolonged paroxysmal atrial fibrillation (paf, an intermittent irregular heart rhythm which is known to predispose to stroke), lasting at least 12 hours, identified in the last month prior to the pacemaker check. willing patients will then be issued with a phrm (personal heart rhythm monitor) device to make heart rhythm recordings for 3 months. they will do this twice-daily for 30 seconds for this period. at the end of the 3 month period patients will undergo a final pacing device check. identification of prolonged paf using the phrm device will be compared to the implantable device.

Eligibility criteria:
inclusion criteria: * prolonged af (defined as an episode at least 12 hours duration) in the last month whilst attending routine pacemaker check * pacing requirement \< 25% during the last month exclusion criteria: * lack of capacity * inability to use the personal heart rhythm monitor due to cognitive or physical impairment * commencement of new anti-arrhythmic drug since last pacemaker check

Keywords: intermittent cardiac monitoring implantable device
pilot testing of a real-time oncogeriatric teleconsultation system using the total cancer care™ database

Conditions: Oncology Problem

Summary: the main purpose of this study is to pilot a real time electronic consultation with an oncogeriatric information team (ogit) located at moffitt using total cancer care (tcc). investigators want to see for which type of patients this information is the most useful, and work out the practical ways of making this process work.

this is a multicenter study to test a real time consultation system using the total cancer caretm database (tcc) cohort at the h. lee moffitt cancer center, tampa, florida, usa. the purpose is to make moffitt's expertise available to private practice oncologists throughout florida. an oncologist seeing an older patient with a difficult case could send key patient parameters to a senior adult expert at moffitt. the tcc concierge would extract from the tcc database patients with similar characteristics. the oncogeriatric information team (ogit) would review those cases and provide a summary report of treatments received and outcomes. the treating oncologist could then use that as an on-demand case series to help in the decision making. in order to pilot and build up the large scale intervention, several steps are necessary. the first step was a scenario testing with vignettes, which allowed tracing the most effective way of retrieving and formatting the information. the next step will be a pilot testing of the intervention in real time with one private practice. primary aims: to assess which format of expert-vetted database consultation and patient selection is the most useful to a private practice oncologist. we will test a model of approach and gain feedback on subjective utility and objective treatment modification profiles, in order to target a future study towards the stakeholders most likely to benefit. impact of the consultation on treatment plan (per pre-post e-mails). availability of similar patients in the tcc database.

Eligibility criteria:
inclusion criteria: * patients aged 70 or older with a documented malignancy seen at lynn cancer institute (lci), as a new or established patient, and for whom a treatment decision has to be made. * signed written informed consent exclusion criteria: * patients younger than 70 years of age * inability to consent * inability to complete the study questionnaires (assistance for physical impairments is allowed) * urgent treatment decision need

Keywords: population 70 years and older geriatric oncogeriatric senior adult
hlx35(egfr×4-1bb bispecific) in patients with advanced or metastatic solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors; Squamous-cell Non-small Cell Lung Cancer

Summary: this phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of hlx35 administered as a single-agent by iv infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. this study has two parts: phase 1a dose escalation and phase 1b dose expansion.


Eligibility criteria:
inclusion criteria: * volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (icf); * age ≥ 18 years; * phase 1a dose escalation: patients must have histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy; * phase 1b dose expansion: patients must have a histological or cytological diagnosis of squamous non-small cell lung cancer (egfr h score ≥200 confirmed by central lab) which is advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy; * measurable disease according to recist version 1.1; * eastern cooperative oncology group (ecog) performance status 0 or 1; * expected survival 12 weeks; * adequate organ function; exclusion criteria: * systemic anti-cancer treatment or investigational agents in the 28 days prior to the first study dosing; * patients who still have persistent ≥ grade 2 toxicities from prior therapies; * active cns metastasis; * history of any secondary malignancy in the past 5 years; * active autoimmune disease; * human immunodeficiency virus (hiv) infection;
imaging biomarkers of delayed sequelae in trauma brain injury

Conditions: Traumatic Brain Injury; Parkinson's Disease

Summary: the purpose of this study is to learn if a new brain imaging technology called datscan can detect subtle changes in the brain that are similar to those seen in early parkinson's disease (pd). the results of this study may provide more information about a possible association between mild to moderate traumatic brain injury (mtbi) and pd. the objectives of this study are to define and describe a group of approximately 7,122 mtbi subjects and 7,122 subjects without mtbi (mtbi-) seen in the emergency rooms of northshore university healthsystem during the years 2006-2011, and to select from willing eligible subjects a random sample of 100 mtbi subjects and 100 mtbi- subjects (of the same age and gender) to undergo written informed consent, neurological examinations, blood drawing for dna extraction and storage, and datscan brain imaging. the investigators will compare the findings from persons who experienced mtbi (cases) to persons without a history of brain injury (mtbi- or "controls").

this study is being done to learn if a new brain imaging technology called datscan can detect subtle changes in the brain ("biomarkers") that are similar to those seen in early parkinson's disease (pd). the results of this study may provide more information about a potential link between mild to moderate traumatic brain injury (mtbi) and pd. we will compare findings from persons who experienced mtbi ("cases") to persons without history of brain injury (mtbi-or "controls"). this study may provide preliminary data that might be used to help design future long-term studies. the investigators propose scientific studies with one specific aim and two hypotheses: specific aim: to determine if one year post emergency room (er) visits, datscan uptake (ioflupane i123 injection and single photon emission computerized tomography) is lower in subjects exposed to mtbi (defined as a closed head trauma that results in loss of consciousness or amnesia for less than 24 hours) than in subjects not exposed to mtbi (without closed head trauma; mtbi-). hypotheses: hypothesis #1: mtbi is a risk factor for parkinson's disease (pd). hypothesis #2: datscan is able to detect subclinical pd (as measured by a dopamine transporter deficiency) in mtbi subjects.

Eligibility criteria:
inclusion criteria: * mtbi or mtbi- survey respondents * ages 18-100 years * without a history of parkinsonism or tremor exclusion criteria: * history of parkinsonism or tremor * lugol or iodide allergy * contraindicated medications for datscan * pregnancy or nursing mothers * renal or liver impairment

Keywords: tbi pd
cohort of hepatitis b research of amsterdam

Conditions: Hepatitis B

Summary: hepatitis b is a form of liver disease caused by a dna-virus, called hepatitis b virus (hbv). infection can result in an inflammation of the liver parenchyma with various clinical manifestations ranging from an asymptomatic course to jaundice. after contact with the virus the immunological response of the host determines the clinical outcome leading to either viral clearance or a chronic infection. although several factors are responsible for the development of chronic hbv-infection, one of the factors is a weak and transient cd8+ t-cell responses after hbv infection. in chronic hepatitis b, inflammation can lead to scarring which is the driving force to fibrosis and cirrhosis. some immunological parameters, like a newly discovered subset of il-17 producing t helper cells (th17 cells), may influence the disease progression of hbv. in the cirrhotic patient, eventually there is an increased risk of hepatocellular carcinoma (hcc) leading to liver failure. recent literature in asian patients with chronic hepatitis b showed that serum hbv viral load is a strong predictor for the development of cirrhosis, independent of hepatitis b e- antigen status and serum alanine transaminase level. it is unclear whether these results can be extrapolated to non-asian (caucasian and african) populations because of differences in host (hla background) and viral (hbv genotype) factors. the aim of this study is to elucidate the question whether historic hbv viral load is associated with the risk of hbv-related cirrhosis or mortality in a cohort of non-asian individuals with chronic hepatitis b infection.

during one visit, the nurse will assess the quality of life of the included patients with the use of a health assessment questionnaire. this questionnaire is derived from a standardized questionnaire to assess the quality of life in patients, the sf-36. participation will require a single visit to the outpatient clinic of public health service. during this visit a short history and physical examination related to chronic liver disease will be performed. during the same visit a single venapunction and a single hepatic elastography (fibroscan) will be performed.

Eligibility criteria:
inclusion criteria: * hbsag-positivity * serum sample available from the screening programme at the public health service * still living and alive in amsterdam or diemen and address traceable by general practitioners or municipal authorities. * non-asian (both parents not born in asia) * between 18-65 years old * capable of giving informed consent and capable of traveling to the public health service exclusion criteria: * subjects coinfected with human immunodeficiency virus (hiv) * subjects coinfected with hepatitis d virus (hdv) * subjects coinfected with hepatitis c virus (hcv) * subjects who are unable to come to the outpatient clinic * subjects incapable to give informed consent due to legally incompetence