Kornimate/medical-research-clean huggingface dataset:
adapted physical activity in a chemotherapy ambulatory care unit: feasibility and impact on fatigue, anxiety and depression in cancer patients

Conditions: Adapted Physical Activity and Cancer

Summary: physical activity has demonstrated efficacy in cancer prevention and improves quality of life and outcome in cancer survivors. patients undergoing chemotherapy, especially those with advanced disease, may have symptoms leading to inactivity. adapted physical activity (apa) among those patients could improve their tolerance to the treatment, and thereby their quality of life. apa could be beneficial to patients with curable disease as well as patients undergoing palliative chemotherapy. some studies suggest that fighting against loss of muscle mass could lead to a survival benefit. however, apa is not established in daily practice and has not yet been evaluated in a chemotherapy ambulatory care unit. primary aim of the study is to assess feasibility of an apa program in a chemotherapy ambulatory care unit of digestive, lung, hematological and dermatological cancers secondary aim is to measure the impact of an apa program on fatigue, anxiety, depression and handgrip strength in patients beginning chemotherapy or targeted therapy for a digestive, lung, hematological or dermatological cancer, of any stage.

assess feasibility of an apa program in a chemotherapy ambulatory care unit of digestive, lung, hematological, and dermatological cancers measure the impact of an apa program on fatigue, anxiety, depression, handgrip strength

Eligibility criteria:
inclusion criteria: * patients beginning chemotherapy or targeted therapy at uma-ch ambulatory care unit of reims, chu, for a digestive, lung, hematological or dermatological cancer, of any stage * patients who agree to participate to the study * major patient exclusion criteria: * patient with previous chemotherapy or targeted therapy in the uma-ch unit * patient under law protection * minor patient * patient with neurological defect preventing from any physical activity

Keywords: physical activity cancer chemotherapy daily care unit
nexavar post-marketing surveillance for hepatocellular carcinoma in japan

Conditions: Carcinoma, Hepatocellular

Summary: this study is a regulatory post-marketing surveillance in japan, and it is a local prospective and observational study of patients who have received nexavar for unresectable hepatocellular carcinoma (hcc). the objective of this study is to assess safety and effectiveness of nexavar under real-life practice conditions. this study is an all case investigation of which the enrollment period is 2 or 3 months (dependent on sites) for child-pugh a; for child-pugh b or c, the enrollment continues until agreement to stop with pharmaceuticals medical devices agency (pmda). all patients who have received nexavar will be recruited and followed one year since starting nexavar administration.


Eligibility criteria:
inclusion criteria: * patients who received nexavar for unresectable hepatocellular carcinoma exclusion criteria: * patients who are contraindicated based on the product label

Keywords: nexavar unresectable hepatocellular carcinoma
activation of hepatitis b virus (hbv) in hepatitis b surface antigen (hbsag) - negative but hepatitis b core antibody (anti-hbc) - positive patients

Conditions: Hepatitis B

Summary: individuals with resolved hepatitis b, characterized as hepatitis b surface antigen (hbsag)-negative and hepatitis b core antibody-positive, have latent hepatitis b virus (hbv) infection in their liver tissue. cytotoxic chemotherapy and hematopoietic stem cell transplantation sometimes trigger the reactivation of latently infected hbv, resulting in de novo hepatitis b. although de novo hepatitis b could cause acute liver failure or chronic hepatitis, an effective management strategy for de novo hepatitis b has not been well established. risk factors and effective management for de novo hepatitis b will be clarified.


Eligibility criteria:
inclusion criteria: * hbsag-negative but anti-hbc-positive exclusion criteria: * serum hbv dna-negative

Keywords: hepatitis b
maam study: avastin and macugen versus avastin versus macugen

Conditions: Macular Degeneration

Summary: the first results of anti-vascular endothelial growth factor (vegf) therapy were very promising and superior to established therapies. three different substances (all of them applied intravitreally) are available, but comparative studies have not yet been conducted. in this pilot study, the safety (number of adverse events) and efficacy (distance acuity testing retinal thickness measurement) of avastin and macugen applied as monotherapy will be compared to a combined treatment of avastin followed by macugen used for retreatment. at least equal results of the combined therapy are expected.

the role of vascular endothelial growth factor (vegf) in the pathogenesis of neovascular diseases like choroidal neovascularization (cnv) and proliferative diabetic retinopathy has been demonstrated in a series of publications. therefore intravitreally applied vegf antagonists have been used in the treatment of cnv in age-related macular degeneration (amd) and diabetic cases. three anti-vegfs are available: macugen® (pegaptanib), avastin® (bevacizumab) and lucentis® (ranibizmab). pegaptanib sodium is an aptamer designed to bind the vegf 165 isoform with high affinity. bevacizumab is a humanized monoclonal antibody to vegf designed for intravenous administration and approved for the treatment of colorectal cancer. ranibizumab is an anti-body binding site fragment that is derived from the same anti-vegf antibody as bevacizumab. the decrease of retinal thickness measured in the oct provides information concerning the amount of intraretinal fluid accumulation and therefore for the activity of a neovascular lesion. it has been proven that the aqueous humor levels of vegf of eyes with cnv are significantly higher than those of eyes without ocular or systemic diseases. the retinal thickness and the vegf concentration in the aqueous humor should give a good correlation to the anti vasogenic effect of the intravitreal treatment. in this study bevacizumab and pegaptanib as monotherapy should be compared with a combined therapy of bevacizumab applied first with pegaptanib used for retreatment. the benefit of this combined therapy should be that an initial blockage of all vegf isoforms is necessary whereas for retreatment the blockage of the most important isoform in the pathogenesis of cnv is sufficient and the normal function of the retinal pigment epithelium and the choriocapillaris is not affected.

Eligibility criteria:
inclusion criteria: * age \> 50 years * predominantly occult cnv * greatest diameter of the lesion \< 5400µm * distance acuity \> 0.1 exclusion criteria: * complicating general disorders inflicting with healing process * vision threatening diseases other than cnv * prior treatment for cnv * ophthalmic surgery within 4 weeks * not consented patients

Keywords: age-related macular degeneration macugen avastin
evaluation of investigational hearing instrument features

Conditions: Hearing Loss

Summary: the goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss. the main questions it aims to answer are: how do varying versions of hearing instrument features perform based on exposure to different environments? what is the hearing instrument user preference between varying versions of hearing instrument features? participants will be fit with hearing instruments in the lab, and asked to wear them for the duration of the study period in their home environment. participants will be asked to answer questionnaires throughout the study period.


Eligibility criteria:
inclusion criteria: * adult, age 18 - 95 years * n4 hearing loss * experienced hearing aid user * english fluency * cognitively able to complete complex listening tasks exclusion criteria: * normal hearing, or hearing loss outside the specified range * no hearing aid experience * unable to speak, read, or write english fluently * cognitive impairment * any other condition or situation that impacts eligibility to participate in or complete study tasks, at the discretion of the investigator
a randomised efficacy study of combination antimalarials to treat uncomplicated malaria

Conditions: Malaria

Summary: the purpose of this study is to compare the efficacy of sulfadoxine-pyrimethamine plus artesunate with that of sulfadoxine-pyrimethamine on its own for the treatment of uncomplicated malaria.

resistance of plasmodium falciparum to anti-malarial drugs is a serious impediment to malaria control. in the south east african combination anti-malarial therapy (seacat) evaluation, there is an evaluation of the phased introduction of combination anti-malarial therapy (cat) in mozambique, swaziland and south africa. in order to facilitate formulation of effective regional drug policy and provide a database for decision-making on the implementation of cat, it is essential that the in vivo response to cat be investigated. this will be achieved through the seacat 01 protocol which is a component of the seacat evaluation described in another file on this website. however, in selected mozambique sites where the intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (sp) with cat (artesunate, as, plus sp) will be conducted according to a specific amendment (amendment 4) to the seacat 01 protocol. amendment 4 is presented in this separate file on the website for clarity.

Eligibility criteria:
inclusion criteria: * male or female, older than 12 months. * weight \> 10 kg. * diagnoses of uncomplicated acute p. falciparum malaria parasitaemia of up to 500 000 asexual parasite/mcl blood with axillary temperature of greater than and equal to 37.50c or history of fever. * documented informed consent. * lives close enough to the health centre for reliable follow up. exclusion criteria: * has received anti-malarial treatment in the past 7 days. * is infected with other malarial species (such subjects will be excluded retrospectively). * severely ill (based on who criteria for severe malaria ) or if patient is considered, in the opinion of the investigator or designee, to have moderately severe malaria (e.g. prostrate, repeated vomiting, dehydrated). * has received cotrimoxazole or chloramphenicol in the past 7 days. * history of g6pd deficiency. * is pregnant. * has a history of allergy to any sulphonamide (for sp) or artemisinin derivative (for artesunate and co-artemether).

Keywords: malaria efficacy pharmacokinetic gametocyte molecular markers sulfadoxine-pyrimethamine artesunate artemisinin
a study of revlimid in the treatment of non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin's

Summary: subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. treatment will continue until disease progression, or unacceptable adverse events develop


Eligibility criteria:
key inclusion criteria * biopsy proven aggressive non-hodgkin's lymphoma * follicular center lymphoma grade 3. * diffuse large b-cell lymphoma. * mantle cell lymphoma. * transformed lymphoma. * relapsed or refractory to previous therapy for lymphoma * at least one prior combination chemotherapy regime * measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter * eastern cooperative oncology group (ecog) performance score of 0, 1 or 2 * willing to follow the pregnancy precautions key exclusion criteria * any of the following laboratory abnormalities. * absolute neutrophil count (anc) \< 1,500 cells/mm\^3 (1.5\*10\^9/l). * platelet count \< 60,000/mm\^3 (60\*10\^9/l). * calculated creatinine clearance of \<50ml/min * serum glutamic oxaloacetic transaminase/aspartate aminotransferase (sgot/ast) or serum glutamic pyruvic transaminase/alanine transaminase (sgpt/alt) 5.0 times upper limit of normal (uln). * serum total bilirubin \> 2.0 mg/dl (34 µmol/l)/conjugated bilirubin \>0.8mg/dl. * subjects who are candidates for and willing to undergo an autologous stem cell transplant. * history of active central nervous system (cns) lymphoma within the previous 6 months * history of other malignancies within the past year * positive human immunodeficiency virus (hiv) or active hepatitis b or c

Keywords: celgene revlimid cc-5013 non-hodgkin's lymphoma lenalidomide cc5013 nhl
italian validation of the revised mds-unified parkinson's disease rating scale

Conditions: Parkinson's Disease

Summary: the present study is part of an international program and deals with the translation and validation program for the italian version of the mds-updrs. the program will be articulated in three steps: * phase i: translation and back-translation of the mds-updrs in italian (completed) * phase ii: cognitive testing. this step is aimed at a preliminary testing of a subset of potentially culturally sensitive items in a limited set of pd patients (approximately 10). should this phase identify issues in the understanding and ease of use of some items a revised translation of some individual items might be envisaged. * phase iii: large validation testing: this phase will involve 350 pd patients from 12-14 italian pd centres. the iris protocol deals with phase ii and iii of the program.


Eligibility criteria:
inclusion criteria: * written and signed informed consent; * native italian-speaking patients or either sex; * patients suffering from parkinson's disease ranging from mild to severe, based on clinical judgement; * presence of a native italian-speaking caregiver. exclusion criteria: * patients with evidence of other central nervous system disorders; * patients with a degree of depression or dementia which may prevent and/or affect ratings.

Keywords: comparative fit index movement disorders' society unified parkinson's disease rating scale
warm ischemia or cold ischemia during surgery in treating patients with stage i kidney cancer

Conditions: Kidney Cancer; Long-term Effects Secondary to Cancer Therapy in Adults; Perioperative/Postoperative Complications; Urinary Complications

Summary: rationale: warm ischemia is the clamping of blood vessels without cooling the kidney. cold ischemia is the clamping of blood vessels with kidney cooling. it is not yet known whether warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage i kidney cancer. purpose: this randomized phase iii trial is studying warm ischemia to see how well it works compared with cold ischemia during surgery in treating patients with stage i kidney cancer.

objectives: primary * determine the effect of warm ischemia during partial nephrectomy on long-term renal function in patients with solitary stage i renal cortical tumor and normal contralateral kidney. secondary * determine to what degree the contralateral kidney compensates for the damage inflicted on the operated kidney during surgery. * determine the 1-year disease-specific and overall survival of these patients. outline: this is a multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo warm ischemia followed by partial nephrectomy. * arm ii: patients undergo cold ischemia followed by partial nephrectomy. blood and urine samples are collected periodically after nephrectomy to assess renal function. patients are followed at 1, 3, 6, 9 , and 12 months after nephrectomy.

Eligibility criteria:
disease characteristics: * diagnosis of solitary renal cortical tumor * tumor size ≤ 4 cm * candidate for open partial nephrectomy * expected ischemia time \< 45 minutes * normal renal function, defined as glomerular filtration rate (gfr) \> 60 ml/min * no evidence of distant metastasis * no evidence of local invasion of adjacent structures, including the adrenal gland * no evidence of tumor extension into the renal venous system * no evidence of ureteral obstruction on mag-3 renal scan * no family history of renal cancer patient characteristics: * ecog performance status 0 * life expectancy \> 5 years * no prior malignancy, except for non-melanomatous skin cancer prior concurrent therapy: * not specified

Keywords: perioperative/postoperative complications urinary complications long-term effects secondary to cancer therapy in adults stage i renal cell cancer
does tranexamic acid reduce the need for blood transfusions in patients undergoing hip fracture surgery?

Conditions: Hip Fracture

Summary: does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. in orthopedic surgery, tranexamic acid (txa) is the best studied of these medications and a recent cochrane database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. at mayo clinic rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the mayo clinic rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. a recent analysis of the mayo clinic rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. this raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

Eligibility criteria:
inclusion criteria * ao/ota (orthopedic trauma association) fracture classification 31b * surgically treated with either hemiarthroplasty or total hip arthroplasty * acute fracture treated within 72 hours of injury * low energy isolated injury * age greater than 18 years old exclusion criteria * transfusion received during admission, prior to surgery * creatinine clearance less than 30 ml/min * history of unprovoked venous thromboembolism (vte) and/or recurrent vte * known history of factor v leiden, protein c/s deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant * pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential) * history of cerebrovascular accident (cva), myocardial infarction (mi), or vte within the previous 30 days * coronary stent placement within the previous 6 months * disseminated intravascular coagulation * subarachnoid hemorrhage

Keywords: arbeitsgemeinschaft für osteosynthesefragen (ao) fracture orthopaedic trauma association (ota) fracture
determination of scapulothoracic and glenohumeral angles by imaging in patients after shoulder arthroplasty (scap-imag)

Conditions: Arthropathy Shoulder

Summary: the shoulder is a site particularly affected by osteoarthritis since it affects up to 7% of the population aged over 65. to deal with osteoarthritis, total shoulder prosthesis is an increasingly used solution. among the different types of total shoulder prostheses, the majority of surgical procedures involve the use of a reverse total shoulder prosthesis. this type of prosthesis modifies the anatomy of the shoulder in order to ensure better stability and mobility of the shoulder in patients while also compensating for potential significant lesions of certain deep muscles of the shoulder joint (i.e., rotator cuff). reverse prostheses have good short-term results but these are impaired in longer term with a constant functional score of around 70% at 10 years and a survival rate of 70% after 20 years. problems of bone conflicts between the scapula and the humerus can also be observed on these reverse total shoulder prostheses with variable rates from 4.6% to 47.3% depending on the position of the prosthesis. in order to minimize the risk of complications, several tools are available to surgeons to optimize the positioning of the prosthesis. planning software can be used to plan the kinematics of the shoulder after arthroplasty and quantify shoulder movements by 1/ estimating the scapulothoracic and glenohumeral angles, and 2/ determining the scapulohumeral rhythm (i.e., joint coordination index evaluating the relative contribution of these two joints to the total elevation of the arm). this prediction allows the surgeon to adapt the size, shape and position of the implants to each patient in order to ensure optimal shoulder kinematics, namely a maximum amplitude without bone conflicts (contacts) between the scapula and the humerus. the main objective of this study is to evaluate the influence of a reverse shoulder arthroplasty on shoulder kinematics at 2 years postoperatively in comparison with the non-operated contralateral limb.


Eligibility criteria:
inclusion criteria: * major * reverse total shoulder arthroplasty surgery performed by dr. lionel neyton (jean mermoz private hospital,69008 lyon) 24±3 months prior to inclusion in the study. * have had a ct scan of the operated shoulder prior to the operation * patient having signed informed consent * patient affiliated to a social security scheme or beneficiary of such a scheme, according to article l.1124-1 of the public health code exclusion criteria: * contraindication to the eos® examination * anthropometry incompatible with the production of eos images * pregnant, parturient, breastfeeding women * have a history of fracture at the level of the humerus, scapula or clavicle * have a history of surgery on the shoulder or contralateral upper limb to the limb with the prosthesis * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
the occurrence of the apoe4 allele in agitated in-patients with late-onset alzheimer's disease

Conditions: Alzheimer's Disease; Agitation

Summary: the purpose of this clinical research study is to determine if a specific genetic allele is involved with the development of agitation in patients with late-onset alzheimer's disease (ad). the study will compare the results of genetic testing between two groups: individuals with late-onset ad who show signs of agitation and individuals with late-onset ad who do not show signs of agitation.

agitation and other behavioral disturbances are a main cause in the need for increasing levels of care for the patient with alzheimer's disease (ad). and while the pathology of dementia has been studied in great detail, the etiology is considered multi-factorial. the hypothesis behind this clinical study is that the presence of the apo lipoprotein e4 (apo e4) allele will serve to predict which patients with late on-set ad are at greater risk to develop agitation.

Eligibility criteria:
inclusion criteria: * men and women who are at least 65 years of age * meet the dsm-iv-tr criteria for late-onset alzheimer's disease (ad) exclusion criteria: * unable to provide informed consent or do not have a legally acceptable caregiver and/or representative present or available to enter into the informed consent process on the study subject's behalf * diagnosis of a non-alzheimer's type of dementia * determined by the principal investigator (or his designee) that the study subject would be unsuitable for study participation

Keywords: alzheimer's disease agitation genetics apolipoprotein apoe4