Kornimate/medical-research-clean huggingface dataset:
predictive factor of overall survival among geriatric assessment tools and disease related factors in elderly patients with high risk myelodysplastic syndromes.

Conditions: Myelodysplastic Syndromes

Summary: no prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. the impact on overall survival of all of these factors was recognized in elderly people with cancer but remains unknown in high risk myelodysplastic syndromes (hr-mds). therefore this information could be crucial to better select geriatric assessment domains relevant for the prediction and to recommend simplified tool after stratification of geriatric assessment domains thanks to their predictive value. the main hypothesis is that patient-related factors will have a better capacity to predict survival and treatment tolerance than disease-related factors in hr-mds aged 75 and over and that the predictive value will be different among assessment tools which allows a selection of reduced number of tools for clinical use. to best knowledge estimation of predictive value of geriatric assessment tools remains unknown and explains why no standardization of practice exists. in testing all tools at the same cohort of patients allows to compare different tools and to define minimal and optimal geriatric assessment for hr-mds. to determine the best strategy of geriatric assessment will allow in a second time to measure the impact of the use of this geriatric standardized evaluation by comparing patients'care and prognosis according to the use or not by the doctors of the new scores. research outcomes are various medical, economic and ethic. medical because decision-making will be improved with simplified geriatric assessment; economic because a better knowledge of geriatric assessment will improve treatment toxicity prevention and decrease treatment costs. ethic will be associated with this project because a better knowledge of geriatric assessment tools to predict survival and tolerance treatment could improve the choice of best supportive care if prognosis markers are not favorable to active therapy. this project could induce important modification of practice in this area to an improved personalized treatment and simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.


Eligibility criteria:
inclusion criteria: * diagnosis of hr-mds inferior to 6 weeks, * no treatment received before inclusion, * ipss superior to 1 (intermediate 2 and high risk ipss categories), * social system affiliation, * informed consent signed. exclusion criteria: * patient eligibility to stem cell transplantation, * ipss inferior or egal 1 (low or intermediate 1 ipss), * concomitant investigational trial participation, which could interfere, * patients under legal protection.

Keywords: hematology elderly high risk myelodysplastic syndrome
wide margin vs. narrow margin in postneoadjuvant lumpectomy

Conditions: Breast Cancer

Summary: breast cancer patients often receive systemic drugs as the initial curative treatment of their disease. the initial systemic therapy leads to a variable degree of tumor shrinkage. at present, there is no evidence-based consensus among breast surgeons on the optimal extent of resection after considerable tumor shrinkage and whether resection margin should be designed according to the tumor extent before treatment or the extent after treatment. this trial will help determine the optimal extent of resection in tumors that exhibits a significant change in volume after primary systemic therapy.

primary systemic (neoadjuvant) therapy (nat) is a widely practised curative treatment for invasive breast cancer. neoadjuvant chemotherapy (before surgery) and adjuvant chemotherapy (after surgery) had equivalent survival rates in major randomized trials. in these studies, preoperative systemic therapy increased the patient's chance to achieve breast conservation. the down side was a clear trend towards increased ipsilateral breast tumor recurrence. preoperative chemotherapy leads to patchy, irregular cell death known as honeycomb effect and thus may lead to a misleading false negative resection margin of a tumorectomy operation. even with the advent of oncoplastic techniques which allowed larger resection volumes with satisfactory cosmetic results, rates of re-excision, mastectomy and local relapse did not differ from those after traditional lumpectomy operations. as of today, there is no consensus -based on evidence- on the optimal width of margin in patients who are offered breast conservative surgery (bcs) after systemic therapy. in view of the current uncertainty and lack of evidence, the present trial is designed to answer the following question (specific aim): does planning the resection margin according to the pre-treatment tumor extent improve the local recurrence rate in patients receiving breast conservative surgery after systemic therapy?

Eligibility criteria:
inclusion criteria: * biopsy-proven diagnosis of invasive adenocarcinoma of the breast. * tumor stage t 1-4b * nodal stage n 0-2 * asa (american society of anesthesiologists) class i-ii exclusion criteria: * patients opting for mastectomy. * patients advised for mastectomy by the treating physician. * patients opting for primary surgical treatment. * patients advised for primary surgical treatment by the treating physician. * metastatic patients. * multifocal tumors. * lobular neoplasia. * current pregnancy or pregnancy less than 6 months from the enrollment date. * active second cancer.

Keywords: resection margin neoadjuvant therapy breast conservative surgery locally advanced breast cancer
the efficacy of collaborative patient education on total knee arthroplasty

Conditions: Knee Arthritis

Summary: this project is about the integrated rehabilitation program for the patients receiving total knee arthroplasty. the investigators are monitoring the womac(western ontario and mcmaster university arthritis index)/ pain scores/anxiety scores/knee society scores in the treatment course between the intervention group and the control group.

this is a quasi-experimental design study. the participants received total knee arthroplasty by one single surgeon in two facilities within the same medical system (kaohsiung medical university affiliated hospitals). the intervention groups received integrated rehabilitation program including verbal one-on-one education, personalized post-operation rehabilitation during admission and scheduled post-operation follow up by a nurse case manager. the control group received the same surgery with traditional clinical pathway by the single surgeon in another affiliated hospital. we recorded the pain scores, state-trait anxiety inventory scores, womac(western ontario and mcmaster universities arthritis index) scores, american knee society scores for these participants.

Eligibility criteria:
inclusion criteria * patients over 65 years of age * patients scheduled to receive unilateral total knee arthroplasty due to advanced osteoarthritis * patients are able to understand the study and express opinions clearly * patients are willing to participate in this study and provide informed consents exclusion criteria * patients with inflammatory joint disease * patients with neurosensory system disease (such as stroke or parkinsonism) * patients have intellectual impairment, or dementia.

Keywords: integrated rehabilitation total knee arthroplasty personalized medicine
a trial evaluating compatibility and safety of fiasp and insulin aspart with an external continuous subcutaneous insulin infusion system in adult subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe and the united states of america (usa). the aim of this trial is to evaluate compatibility and safety of fiasp (faster-acting insulin aspart) and insulin aspart (novorapid®) with an external continuous subcutaneous insulin infusion (csii) system in adult subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * male or female, age at least 18 years at the time of signing inform consent * type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of screening (visit 1) * currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (visit 1) * using an external csii system for the previous 6 months prior to screening (visit 1) * hba1c (glycosylated haemoglobin) below or equal to 9.0% as assessed by central laboratory * body mass index (bmi) 20.0-35.0 kg/m\^2 exclusion criteria: * history of diabetic ketoacidosis (dka) episodes requiring hospitalization within 6 months prior to screening (visit 1) * history of abscess at the infusion site within 6 months prior to screening (visit 1) * hypoglycaemic unawareness as judged by the investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening (visit 1)
percutaneous needle electrolysis (pne) on the concha of the ear

Conditions: Headache

Summary: headache is a very frequent symptom among the world population, the adult population with an active headache disorder are 46% for headache in general, 11% for migraine, 42% for tension-type headache and 3% for chronic daily headache. there are different therapeutic approaches for the improvement of headache. transcutaneous stimulation of the auricular vagal nerve is being used for the treatment of headache due to the involvement of the vagus nerve in inflammation and pain modulation. on the other hand, galvanic current has shown a measurable effect by increasing parasympathetic activity. the objective of this clinical trial is to stimulate the auricular vagal nerve with galvanic current using a needle as an electrode that will be inserted into the concha of the ear. as a tool for measuring results, infrared thermography will be used to observe changes in facial skin temperature, since patients with high sympathetic activity present a characteristic pattern of "cold nose" and/or "cold patch". in addition, variables that record changes in autonomic activity such as skin conductance and heart rate variability will be collected.


Eligibility criteria:
inclusion criteria: * headache with a frequency of at least one monthly episode. * present the "cold nose" and/or "cold patch" pattern exclusion criteria: * do not present a "cold nose" and/or "cold patch" pattern * pregnant women * subjects with facial alterations that may affect facial vascularization (sinusitis, allergies...) * patients with belonephobia or allergy to metals or any material used in the procedure.
combined bipolar radiofrequency&pulsed dye laser treatment

Conditions: Port-Wine Stain

Summary: port wine stain birthmark is a congenital, progressive vascular malformation of human skin. however, even though the pulsed dye laser is considered as the treatment of choice for port wine stain birthmark the degree of fading can remain variable and unpredictable after laser treatment.

the researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of port wine stain birthmark. this investigational device is essentially a combination of two commercially available systems cleared for marketing (k044351 and k052324) provided by candela laser corporation.

Eligibility criteria:
inclusion criteria: 1. port wine stain suitable for comparison testing 2. age \> 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment 3. apparent good health as documented by medical history 4. ability to understand and carry out subject instructions exclusion criteria: 1. history of photodermatoses or skin cancer 2. any therapy within the previous two months to the proposed port wine stain treatment sites 3. current participation in any other investigational drug or device evaluation 4. concurrent use of known photosensitizing drugs 5. inability to understand and carry out instructions
valproic acid sodium salt in bipolar disorder

Conditions: Bipolar Disorder

Summary: * to determine the total and local gray matter volumes, and n-acetyl aspartate (naa) levels in patients with bipolar disorders who are within euthimic, depressive or manic/hypomanic period and who are not taking drug; * to investigate the neuroprotective effects of long-term (6 weeks) use of valproate on total and local gray matter volumes and naa levels. * to measure the brain electrical response to visual and auditory impulses before and after valproate treatment in patients within euthimic, depressive or manic/hypomanic period and who are not taking drug, and to compare the data with each other and with normal groups. * to determine the cognitive functions before and after the valproate treatment in the same patient group, to compare the data with each other and with age- and sex-paired normal controls; * to determine the relationship between these effects of valproate and clinical improvement; * to investigate the relationship between cognitive ability status and electrical activity of brain, to compare this with that in control group; to determine the relationship between the data and brain imaging (mri/mrs) findings in conjunction with localization


Eligibility criteria:
inclusion criteria: * diagnosis of type i or ii bipolar disorder according to dsm-iv after stratified scid i interview, * being currently euthimic (for at least one month), manic-hypomanic and having ymrs points of 15 or more, or being in depressive episode and having ham-d21 points of 15 or more * being not taking drugs for at least two weeks before participating in the study (except benzodiazepins) exclusion criteria: * female who are pregnant or planning to be pregnant, nursing * having known hypersensitivity to study drug * being given any psychotropic agent other than benzodiazepine within the last two weeks * active sustance or alcohol usage within the last two weeks, or substance addiction other than cafein or nicotine (within the last month) * having another axis i disorder such as comorbid dementia, delirium, obsessive compulsive disorder, eating disorder * having unstabilised hepatic or renal disorder, thyroid or blood disease * having history of cerebral surgery * existence of a degenerative neurologic disease or epilepsy * having pacemaker * having a prosthesis able to magnetic effect in eye, brain or sites near to these regions * homicide thougths or severe catatonia required to be hospitalized * having mixed episode the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a phase 2 study of amg 193 in participants with mtap-deleted advanced nsclc (mtapestry 201)

Conditions: MTAP-deleted NSCLC

Summary: the main objective of the study is to characterize safety and efficacy of 2 dose levels of amg 193 by investigator, and to evaluate amg 193 monotherapy efficacy by blinded independent central review (bicr).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic or unresectable locally advanced mtap-deleted (homozygous deletion of mtap) nsclc * participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease. * either an archival tissue sample or an archival block must be available. * life expectancy of greater than 3 months, in the opinion of the investigator. * participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible. * participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible. exclusion criteria: disease related • tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (egfr), alk receptor tyrosine kinase (alk), ros proto-oncogene 1 (ros1), neurotrophic tyrosine receptor kinase (ntrk), met proto-oncogene (met), b-raf proto-oncogene (braf), ret proto-oncogene (ret), human epidermal growth factor receptor 2 (her2/erbb2), kras proto-oncogene g12c (kras g12c). other medical conditions * major surgery within 28 days of study day 1. * untreated symptomatic central nervous system (cns) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

Keywords: oncology amg 193
inspiratory muscle training using the o2 trainer

Conditions: Inspiratory Muscle Training; Blood Pressure

Summary: this study aims to investigate the effects of resistive inspiratory training using the o2 trainer on cardiopulmonary outcomes in healthy individuals.


Eligibility criteria:
inclusion criteria: * age 18-65 * able to participate in training 5 days per week exclusion criteria: * previous ventilation * diagnosed chronic obstructive pulmonary disease (copd) * uncontrolled asthma * previous ear drum rupture * previous abdominal hernia * acute respiratory infection * currently pregnant

Keywords: maximal respiratory pressures
a study to evaluate the safety and efficacy of pac-14028 cream in atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the study is a phase ii, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. all subjects will receive bid topical applications of pac-14028 cream or vehicle or elidel cream for up to 4 weeks.


Eligibility criteria:
inclusion criteria: * male or female patients aged between 20 and 65 years old * patients with atopic dermatitis, diagnosed according to hanifin and rajka diagnostic criteria * scorad (scoring atopic dermatitis) score less than 40 exclusion criteria: * patients presenting symptoms of systemic infection at screening * patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration * patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration * pregnant women or breastfeeding women * women of childbearing potential or women who are planning a pregnancy during the study
comparison of serological test s for the virus chicken pox virus (vzv) and correlation with the patient's memory of the infection or vaccination

Conditions: Pregnancy

Summary: comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women. secondary goals : * correlation memory / immunity; * prevalence of vzv immunity in pregnant women; * evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory; * evaluation of acceptability of vaccination in the post partum period in non immune patients. methods not randomized prospective study, number of patients : 400 duration : 36 months inclusion criteria : pregnant women \>18years old, agree to participate (written consent) exclusion criteria: auto immune disease, hiv +, grafted patients


Eligibility criteria:
inclusion criteria: * pregnant women aged over 18 * affiliated to a social protection scheme or women benefiting from such a regime * women who gived a writing consent exclusion criteria: * women with a maternal disease: autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome, insulin dependent diabetes, autoimmune thyroiditis ..), it takes an immunosuppressive treatment or not. * hiv-positive women * garfted women whatever organ
comparison of the restoration of hip biomechanical parameters by ct measurement between the 3 surgical techniques: rsa/minihip/tha - hip replacement: 3d planning

Conditions: Coxarthrosis

Summary: the study will analyze hip biomechanical parameters using eos radiographic measurements pre- and post-operatively (3 months) and post-operatively (3 months) ct scans after total hip replacement (thr), neck-preserving thr of the minihip type or hip resurfacing (hr). clinical results will be assessed at 3 months and 1 year after surgery. to this end, two types of examination are carried out, both of which are used in current practice: * pre-operatively: eos radiography * post-operatively: eos radiograph and ct scan inclusion (m-3; m-1) : * patient information at pre-operative visit * non-opposition of patient, family member or legal guardian, if applicable * questionnaires and clinical examination (standard management) * eos during anesthetic consultation follow-up visit (m+3): - post-operative follow-up consultation eos and ct scan (1 week prior to visit) + questionnaire and clinical examination follow-up visit (m+12): - post-operative check-up, questionnaire and clinical examination


Eligibility criteria:
inclusion criteria: * male or female * age ≥ 18 years * planned surgery: total hip arthroplasty, minihip or rsa * absence of osteoarthritis or osteoarthritis ≤ stage 1 (tönnis classification) of contralateral hip (radiographic analysis) * patient having given his/her non-opposition to participate in the study * patient with social insurance * patient willing to comply with all study procedures and duration exclusion criteria: * patient with comorbidity(ies) likely to affect biomechanical parameter measurements or surgical conditions: * anomalies or anatomical changes of the hip, pelvis or lumbar spine (history of fracture, protrusion, scoliosis, history of orthopedic surgery, dysplasia, torsion disorder) * established genetic disease affecting the musculoskeletal system * severe or morbid obesity * neuromuscular pathologies affecting the limb girdles * severe osteoporosis * bone location of primary or metastatic cancer (spine, pelvis or femur) - inequality of lower limb length \> 2 cm. * minors * protected adults * pregnant or breast-feeding women * administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to participate.

Keywords: arthroplasty hip femoral offset resurfacing eos 3d