Kornimate/medical-research-clean huggingface dataset:
retrospective case series of covid19+ patients undergoing orthopedic surgery

Conditions: Coronavirus Infection; Orthopedic Disorder; Bone Fracture; Bone Metastases; Bone Neoplasm

Summary: over the last months, the rizzoli orthopedic institute in bologna, italy, has drained orthopedic urgencies from all other hospitals in the urban and suburban area. in this context urgencies are defined as fractures and primary or metastatic bone lesions with indication to non-deferrable surgery. a subset of these patients tested positive for sars cov 2, either before or after the surgical procedure. anesthesiological clinical management of covid19 cases is complicated by the consequences of the viral infection on respiratory and cardio-vascular systems, renal function and coagulation. similarly, management of asymptomatic patients is challenging because of the lack of data on possible specific complications. this study will report a snapshot of our early experience on perioperative clinical management of patients undergoing orthopedic surgery in the presence of sars cov 2 infection, ascertained or not at the time of surgery.

this is a monocentric, retrospective, observational study. the study will analyze all medical records of patients that underwent major or non-delayable orthopaedic surgery from the 1st of march 2020 to the 30th of june 2020 with known ongoing coronavirus infection or postoperative diagnosis via nasal swab test collected at rizzoli orthopaedic institute. medical history, anthropometrical, clinical, radiological, and biochemical data will be inserted in a database. primary objective will be to estimate population mortality in the time frame from surgery to hospital discharge. secondary objectives will be estimation of correlation between sars-cov2 infection and main postoperative complications. mortality and site infection rate will be compared among the cohort and pre-covid19 similar data. continuous variables will be summarized using median and interquartile range while dichotomic variables will be expressed as absolute and relative frequencies. frequencies and outcomes will be reported as absolute frequency (observed / total) and relative percentage. association between independent variables and outcomes will be tested with multivariate analysis, hypothesis testing (t-test or mann-whitney) and fisher's exact test according to the type of variable and its distribution (and the experimental question at hand). variables showing statistically significant association (p\<0.1), will be used to build a multivariate logistic regression model with dichotomic dependent variable. statistical significance threshold will be set to 0.05.

Eligibility criteria:
inclusion criteria: * patients urdergoing non-deferrable orthopaedical surgery * ascertained sars-cov-2 infection detected by nasopharyngeal swab before of after the surgery * written, signed informed consent to the trial. exclusion criteria: * lack of signed informed consent.

Keywords: coronavirus orthopedic surgery sars cov 2 covid19
mild cognitive impairment, use of qeeg as a prognostic marker

Conditions: Mild Cognitive Impairment

Summary: multi center study of six memory clinics in four nordic countries in validating a prognostic diagnostic investigation of qeeg in mild cognitive impairment (mci). the study is in two parts, the first one is a follow up of a previous study conducted in 2011-2013 and the second half is new recruitment with two years follow up. end points are diagnosis of a dementing disorder, primarily dementia of alzheimer´s type.

the nordic network in dementia diagnostics (nidd) conducted a study in 2011-2013 on qeeg using a method of statistical pattern recognition (spr) in six academic memory clinics in four nordic countries. in the current study, those from the former study diagnosed either with mild cognitive impairment (mci; n= 120) or with subjective cognitive impairment (sci; n=60) are contacted again and evaluated for cognitive impairment. the eeg registered at entry in the former study is considered in relation to their current diagnosis (sci,mci or dementia) and thereby, the prognostic value of the method is evaluated. in the second part of the study (n=120), new patients evaluated in the memory clinics and diagnosed with mci (not sci) are invited to participate for a two year follow up. in the diagnostic work-up, simple screening tests and information from a close relative form the basis of the cognitive status (sci;mci, dementia). in evaluating the cause of cognitive impairment, detailed neuropsychological testing is performed as well as mri of the brain and csf for alzheimer´s markers. qeeg with spr analysis is registered but the clinician is blinded to its outcome. the end point in both parts of the study is a diagnosis of a dementing disorder.

Eligibility criteria:
inclusion criteria: group 1: individuals diagnosed with either sci or mci during 2011-2013 group 2: individuals diagnosed with mci at entry of the study - exclusion criteria: * age \ 85 years * medically or psychologically unstable * living outside the capital region

Keywords: mci alzheimer´s disease lewy body dementia eeg
the effect of hyperbaric oxygen therapy on inflammatory parameters induced by a heat injury model

Conditions: Secondary Hyperalgesia; Inflammation

Summary: hyperbaric oxygen may reduce neurophatic pain and promote wound healing. established anti inflammatory effects of hbo may contribute to this effect. in a previous publication the investigators studied the effects of hbo on secondary hyperalgesia using a well established heat injury model. in a new - blinded study design, the investigators wish to investigate and- or confirm previous results, i.e. that hbo therapy reduce secondary hyperalgesia and improving therapy of severe pain conditions.

hyperbaric oxygen (hbo) reduces neuropathic pain, promote healing of hypoxic, chronic wounds and sores caused by radiation therapy. nitric oxide (no) is a contributing factor to the prolonged anti-nociceptive effect of hbo treatment. in addition, hbo stimulates the formation of reactive oxygen and nitrogen forms, reduces beta-2 integrin function, and reduces contact of leukocytes to the endothelial surface of the capillaries, improves microcirculation and causes decreased monocyte chemokine synthesis. it is the interaction of these mechanisms involved in hbo's anti-inflammatory effect. how hbo reduces pain and inflammation in humans has not been established. in healthy subjects, investigators have shown that hbo has a reducing effect on the mechanism, which at the level the of spinal cord amplifies the number and and the extension of pain impulses. subjects who were given hbo therapy initially developed significantly less secondary hyperalgesia than the control group several weeks later by the new heat injury suggesting a protective, preconditioning effect. as in the previous experiment (nct02025686) preconditioning effects will be assessed by means of measurements of thermal thresholds, pin-prick thresholds, erythema indices and secondary hyperalgesic areas (i.e. area under the curve per minute). similarly,differences in the sequence of sessions (i.e. first session hbo;second session ambient pressure condition or first session ambient pressure condition;second session hbo) will be analyzed accordingly. in an improved blinded study design investigators will now investigate the effect of hbo treatment using the same cutaneous heat injury model, as in the first study. investigators expect to finally be able to confirm previous results thereby improving treatment of severe pain conditions.

Eligibility criteria:
inclusion criteria: * male * speaks and understands danish language * understood and signed informed consent before medical examination exclusion criteria: * younger than 18 years of age * hypertension * not able to perform equalization of ears and sinuses * persons who present with a medical history of previous pneumothorax and/- or who may be considered of increased risk of pneumothorax * diabetics, epilepsia,asthma * neurological deficits including cognitive as well as psychomotoric disorders * claustrophobia

Keywords: reduction of secondary hyperalgesia and/-or local inflammation
study of weight development over time

Conditions: Obesity; Insulin Resistance; Weight Reduction; Weight Gain

Summary: the investigators will study the influence of fat cell size/number and adipose function on weight development over very long time periods (years). by comparing fat biopsies obtained at baseline and after \>7 years, the investigators will determine the association between adipose morphology/function and changes in weight or development of cardiometabolic complications (e.g. insulin resistance, type 2 diabetes, dyslipidemia and hypertension).

the investigators will ask all subjects that have previously been examined at the investigators laboratory (from 1992 and forward) in studies of adipose tissue function if they are interested to participate in a new study. the minimal follow up time is 7 years. saved blood samples and samples from old fat biopsies will be analyzed together with samples from new examinations. the investigators plan to examine the subjects in the same way as performed at the baseline examinations. this includes estimation of total body fat using bioimpedance, venous blood samples for determination of insulin, glucose and lipids, subcutaneous fat biopsies with determination of fat cell size/number, lipolysis/lipogenesis as well as analysis of adipokine secretion. in selected patients, baseline examinations included dexa-measurement (dual energy x-ray absorptiometry) for determination of body fat distribution as well as hyperinsulinemic euglycemic clamp. in these cases, the same type of examinations will be repeated at their follow up visits.

Eligibility criteria:
inclusion criteria: * participated in previous examination at our lab at least 7 years ago. * no blood samples or adipose samples saved from last examination exclusion criteria: * decline to participate after invitation. * serious illness or mental disorder. * warfarin or other new oral anticoagulant that increase risk of bleeding.
collaborative targeted case management in improving functional status in patients with stage iii-iv cancer

Conditions: Cognitive/functional Effects; Malignant Neoplasm; Pain

Summary: this randomized clinical trial studies collaborative targeted case management in improving functional status in patients with stage iii-iv cancer. collaborative targeted case management may improve functional mobility, improve quality of life, and reduce pain and health care utilization in patients with advanced cancer

primary objectives: i. establish the comparative effectiveness of the collaborative care to preserve performance in cancer (cope) trial arms in preserving functional mobility. ii. to assess the comparative cost-effectiveness and cost-utility of the cope interventions. outline: patients are randomized to 1 of 3 arms. arm i: patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months. arm ii: patients undergo enhanced usual care as in arm i and participate in an individualized conditioning program delivered telephonically by the fitness care manager (fcm) and adapted, as required, by a local physical therapist for 6 months. arm iii: patients undergo enhanced usual care as in arm i, participate in an individualized conditioning program coordinated by the fcm as in arm ii, and receive optimized pain management through a nurse pain care manager (pcm) for 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis of stage iii or stage iv cancer * life expectancy \> 6 months * ambulatory post acute care (apc) score between 53 and 66 * ability to complete questionnaire(s) by themselves or with assistance * provide informed written consent * have working phone to communicate with study team * fluent in english * sufficient auditory acuity * intact cognitive status exclusion criteria: * patient is within 2 months of a major surgical procedure
dresden corneal disease and treatment study

Conditions: Corneal Ectasia; Corneal Disease; Corneal Astigmatism; Keratoconus; Keratopathy

Summary: the purpose of this study is long-term follow up of patients with corneal diseases to analyze the quality of surgical interventions and diagnosis. corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. for these patients, surgical intervention (e.g. corneal cross-linking) is performed, in case of disease progression. overall, a long-term follow up is needed to evaluate an early disease progression as well as corneal stability after surgical intervention.

corneal ectasia (e.g. keratoconus) is a corneal disease that is characterized by irregular steepening of corneal curvature, stromal thinning and reduced biomechanical properties. as a result of this, visual acuity is reduced and can improved by spectacles in early state or with rigid gas permeable contact lenses in mild as well as advanced stage of the disease. furthermore, in moderate and advanced cases stromal scarring occurs that affected the vision negatively. therefore, a corneal transplantation is needed. since the introduction of corneal cross-linking, the amount of corneal transplantations has been reduced. it is necessary to perform closely examinations to detect the progression of the disease as well as post-operatively follow-ups to confirm treatment success. parameters being analyzed are: age, sex, refraction, family history, known duration of ectasia, previous ocular surgery, systemic diseases, systemic and topical medication; biomicroscopy, anterior optical coherence tomography (oct), scheimpflug-based tomography (pentacam), biomechanical assessment (ocular response analyzer and corneal visualization with the scheimpflug technology), optical biometry, confocal microscopy, endothelium cell count.

Eligibility criteria:
inclusion criteria: * corneal disease * corneal ectasia exclusion criteria: * pregnancy * age under 18 years

Keywords: cornea ectasia keratoconus cross-linking keratoplasty
functional capacity and quality of life following septal myectomy in patients with hcm

Conditions: Hypertrophic Cardiomyopathy

Summary: investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.

the objective of this study is to examine change in quality of life and functional capacity as respectively measured by, quality of life questionnaires and six-minute walk test distance, following septal myectomy in patients with obstructive hypertrophic cardiomyopathy, as compared to prior to surgery.

Eligibility criteria:
inclusion criteria: * scheduled to undergo septal myectomy. * established diagnosis of obstructive hcm defined as: lvh thickness ≥15mm left ventricular outflow tract gradient ≥50mmhg exclusion criteria: * prior septal myectomy or alcohol septal ablation * prior myocardial infarction * uncontrolled arrhythmias including ventricular tachycardia and atrial fibrillation * uncontrolled hypertension * angiographically documented coronary stenosis \>50%, if available at time of screening * inability to provide informed consent * inability to walk without assistive devices * peripheral artery disease with claudication
response-based treatment of high-risk neuroblastoma

Conditions: Newly Diagnosed High Risk Neuroblastoma

Summary: the purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy.

although the outcome of high-risk neuroblastoma improved after the introduction of high-dose chemotherapy and autologous stem cell transplantation (hdct/autosct), the outcome still needs to be unsatisfactory. in the investigator's previous study, good responders who had greater reduction of tumor volume after induction chemotherapy showed lower relapse-free survival compared to poor responders.simultaneously, the reduction in tumor volume also was greater in patients who died of treatment related mortality than patients who had relapsed tumors. these findings suggest that tailoring treatment intensity according to the early tumor response to induction chemotherapy may improve patient outcomes. so, in this study investigators tailored the treatment intensity of high dose chemotherapy according to the treatment response to induction chemotherapy.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed high risk neuroblastoma * patients with informed consent exclusion criteria: * patients with progressive disease or relapse * patients who underwent high dose chemotherapy before * patients with organ dysfunction as follows (creatinine elevation \> 3 x upper limit of normal, total bilirubin \> 3 x upper limit of normal, aspartate transaminase/alanine transaminase \> 5 x upper limit of normal), ejection fraction \<40% * pregnant or nursing women

Keywords: neuroblastoma high risk tandem high dose chemotherapy
chronic obstructive pulmonary disease (copd) and advance directives

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to evaluate if the participation of copd patients to a workshop on advance directives increases the number of patients who write them.

chronic obstructive disease is a common disease and should be the third leading cause of death in 2020. patient hospitalized for an exacerbation of their copd have a median survival of 2 years and 50% risk of being rehospitalized within 6 months. copd patients may have symptoms that impair their life quality significantly and sometimes more than patients with cancer. this is particularly the case for dyspnea, which is frequently present. in the study, investigators propose the setting up of health workshop on advance directives. this workshop is for sever or very severe copd patients during their hospital stay in the post-acute care and pulmonary rehabilitation service. in this unit, investigators welcome patient from all the region of ile de france for a hospital stay of approximately 6 weeks. a first workshop will take place during the third week of their care to inform them about copd, exacerbations, prognostic and advance directives. then, a personal interview with patients who have participated to this workshop will take place to collect their advance directives and their degree of satisfaction about this process.

Eligibility criteria:
inclusion criteria: * copd gold 3 or 4 and curtis criteria exclusion criteria: * left to the discretion of the investigator if he finds that it will not be beneficial for the patient : for example if the workshop is judged to be at risk of being anxiety-provoking

Keywords: copd palliative care advance directives exacerbation dyspnea
a clinical trial of stp0404 in adults with hiv-1 infection

Conditions: HIV-1-infection

Summary: the purpose of this study is to evaluate the antiviral effect, safety, tolerability, and pharmacokinetics of stp0404 in adult participants living with human immunodeficiency virus type 1 (hiv-1) infection.


Eligibility criteria:
inclusion criteria: * have a confirmed hiv-1 infection in the documented medical record or at screening. * have never received any arts (i.e., treatment-naïve) before screening or only received one arv regimen (2 or 3 drugs) at least 12 weeks before screening and/or received any monotherapy ≤10 days in a clinical trial setting at least 12 weeks before screening. participants with a documented history of prep and/or pep therapy but discontinued at least 8 weeks prior to screening are also eligible for inclusion. * have a cd4+ cell count ≥200 cells/mm3 at screening. exclusion criteria: * have a hepatitis b surface antigen or positive hepatitis c virus antibody at screening. an hcv confirmation (hcv rna test) will be performed at a central laboratory if the hcv antibodies screening result is positive. if the hcv rna test result is negative, the participant will be eligible. * have a positive drug screen for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, heroin, or phencyclidine. however, if in the opinion of the investigator, positive drug screen results may be due to prescription medication for therapeutic purposes (e.g., prescription adderall for adhd), eligibility decision shall rely on the investigator's medical judgment and should be documented. * have a history of regular alcohol consumption, defined as an average weekly intake of \>14 drinks (males) or \>7 drinks (females), within 6 months of screening and/or has positive alcohol screen at screening and baseline. * have received the following treatments as prep or pep (≥1 dose) prior to screening: monoclonal antibodies, hiv-1 maturation inhibitors, and long-acting instis (such as cabotegravir). * pregnant or lactating females. * have a history of clinically relevant pancreatitis or hepatitis within the previous 6 months. * participant received any allosteric hiv-1 integrase inhibitor (allini, ≥1 dose) and/or received any long-acting arvs (marketed or investigational, ≥1 dose) prior to screening. * have previously failed an instis-containing regimen.
exercise, prediabetes and diabetes after renal transplantation.

Conditions: Diabetes Mellitus

Summary: this study is designed to evaluate the feasibility of exercise to reverse prediabetes after transplantation to prevent posttransplantation diabetes mellitus (ptdm).

the hypothesis of the study is that exercise will promote the reversibility to normal glucose metabolism in patients with prediabetes and eventually reduce the incidence of ptdm in renal transplant. the main objective of the study is to induce the reversibility of prediabetes by means of exercise. additionally, the secondary objectives are: (a) to evaluate the compliance of exercise (b) improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and hdl cholesterol.

Eligibility criteria:
inclusion criteria: * age \> 18 years old. * renal transplantation: beyond 6-12 months after transplantation with stable renal function * ifg: 100-125 mg/dl and igt 140-199 mg/dl. * ability or capacity to perform exercise. exclusion criteria: * clinical conditions that preclude the treatment with exercise i.e. clinical instability: active infection, cancer, acute cardiovascular disease, advanced renal disease, pulmonar hypertension, chronic obstructive pulmonary disease, severe reumatological disorders, arthrosis, arthritis limb amputation, etc. * inability to understand the protocol. * severe psychological disease. * ptdm. * diabetes before transplantation.

Keywords: prediabetes exercise late post transplant diabetes mellitus (ptdm) renal transplantation