Kornimate/medical-research-clean huggingface dataset:
trial of docetaxel versus vinorelbine as 1st line treatment in elderly patients with non-small-cell lung cancer (nsclc)

Conditions: Non Small Cell Lung Cancer

Summary: this trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced nsclc.

docetaxel and vinorelbine are well known active agents in the treatment of nsclc. the standard treatment of elderly patients with advanced nsclc is monotherapy with a third generation agent. the role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Eligibility criteria:
inclusion criteria: * histologically- or cytologically- confirmed non-small-cell lung cancer * stage iiib/iv * no prior chemotherapy * existence of two-dimensional measurable disease. the measurable disease should not have been irradiated * life expectancy of more than 3 months * age ≥ 65 years * performance status (who) ≤ 3 * adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3) * adequate liver (bilirubin \< 1.5 times upper limit of normal and sgot/sgpt \< 2 times upper limit of normal), and renal function (creatinine \< 2 mg/dl) * informed consent exclusion criteria: * psychiatric illness or social situation that would preclude study compliance. * other concurrent uncontrolled illness * other invasive malignancy within the past 5 years except nonmelanoma skin cancer * no absence or irradiated and stable central nervous system metastatic disease. * no presence of a reliable care giver * other concurrent investigational agents

Keywords: cancer elderly chemotherapy docetaxel vinorelbine
gastric residuals in preterm infants

Conditions: Early Enteral Feeding Advancement; Nutrition; Preterm Infants

Summary: checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs the time to establish full gastric feeding in the early postnatal period.


Eligibility criteria:
inclusion criteria: * infants with a birth weight ≥ 1500g and \< 2000g * age ≤48 hours of life * informed, written parental consent exclusion criteria: * antenatally recognized gastrointestinal malformation * major congenital anomaly * chromosomal anomaly * nec stage ii * severe acidosis, asphyxia (ph \<7.0) * severe growth restriction below 3rd percentile
influence of the sensory profile of deaf children with autism spectrum disorders on the outcome of cochlear implantation

Conditions: Deafness

Summary: an unpublished study conducted at toulouse university hospital revealed that 30% of implanted children with autism spectrum disorders abandon their implant, while 70% of them keep it. the aim of this study is to evaluate the causes of this disparity, which is much greater than in children with cochlear implants without associated autism spectrum disorders. our problem is as follows: do the sensory hypersensitivity and hyposensitivity of deaf children with autism spectrum disorders have an effect on the expected results after a cochlear implantation from a language and auditory reaction point of view?

the present study will specifically focus on the sensory profile of these children with autism spectrum disorders, which could be the cause of these developmental difficulties in language and communication development.

Eligibility criteria:
inclusion criteria: * deaf child with cochlear implant * 15 months to 10 years old and 6 months old at the time of implantation * child with autism spectrum disorder (only for children group with autisme spectrum disorder) * no opposition from the legal representative of the authority to participate in the study exclusion criteria: * opposition by the legal representative of the child * child under legal protection
the role of "hypospadias objective scoring evaluation" (hose) and uroflowmetry in evaluation of successful hypospadias repair

Conditions: Hypospadias

Summary: hypospadias is a common anomaly of the male genitalia affecting 0.4-8.2 of 1000 live male babies and varies considerably in severity. the position of the urethral meatus can be classified as anterior or distal (glandular, coronal, or subcoronal; 60-65% of cases), middle (midpenile; 20-30% of cases), or posterior or proximal (posterior penile, penoscrotal, scrotal, or perineal; 10-15% of cases). the subcoronal position is the most common. most cases are mild and surgical correction is undertaken mostly for cosmetic reasons at the request of the parents or on advice of the pediatrician or surgeon. functional success of hypospadias repair depends on the creation of a uniform and adequate caliber urethra up to the meatus. accordingly, meatal stenosis and urethral stricture are the important complications of surgery, others include urethrocutaneous fistula, diverticula, skin flap necrosis and persistent chordee. although functional assessment of the repair is possible by observation of the urinary stream and voiding cystourethrography, uroflowmetry is considered to be a more objective tool, especially for the detection of a subclinical urethral stricture. reports of the results of hypospadias surgery commonly focus on the cosmetic results and incidence of obvious complications, as urethrocutaneous fistulas, and symptomatic urethral strictures. few have emphasized the role of uroflowmetry in the postoperative evaluation of children with hypospadias to detect asymptomatic strictures and, despite the simplicity and non-invasive nature of this test, it has not become standard or widely accepted. we evaluate auuh experience by use of 'hypospadias objective scoring evaluation' hose and uroflowmetry after hypospadias repair. the hose is a validated scoring system that incorporates the evaluation of meatal location and shape, urinary stream, straightness of erection, presence and complexity of urethral fistula. the minimum total score is 5, and the maximum total score is 16. the point score is graded as either acceptable or not.


Eligibility criteria:
inclusion criteria: 1. more than six months after last hypospadias repair. 2. toilet trained children. 3. patients less than 18 years old. 4. successful repair of hypospadias with hose score more than 10 decided by one of the experts in pediatric urology. exclusion criteria: 1. patient not welling to participate in our study. 2. within six months of last hypospadias repair. 3. patient had urethral intervention within 3 months. 4. children with any associated neurological or urological abnormality related to the bladder, which could potentially affect flow pattern.
making it work program for systemic sclerosis

Conditions: Scleroderma, Systemic

Summary: the purpose of this clinical trial is to see if an online intervention program for people with systemic sclerosis (scleroderma) helps keep people in the workforce and increase self-confidence in dealing with challenges at work. the program is called making it work systemic sclerosis. researchers will compare a group who gets the program to a group who will get the program at a later point in time (wait list control group) to see if self-confidence in dealing with work challenge gets better. people in the making it work group will complete questionnaires and attend one 2 hour meetings each week for 5 weeks and meet with an occupational therapist and vocational counselor. people in the wait list control group will complete the questionnaires and participate in the program at a later point in time.


Eligibility criteria:
inclusion criteria: * currently employed (full-time, part-time) * over 18 and less than or equal to 67 years of age * reside and work in the united states * self-report diagnosis with systemic sclerosis (scleroderma; systemic sclerosis) * report concerns about risk for job loss * possess sufficient spoken english to participate in a group * have device with audio and visual videoconferencing capabilities * be willing to participate in a 2.0 hour virtual meeting once a week for 5 weeks * be willing to complete assigned pre-meeting worksheets * be willing to meet virtually with both an occupational therapist and vocational counselor after the 5th weekly sessin. exclusion criteria: * not working (full-time, part-time, self-employed, contract work) * pregnant * less than 18 and over 67 years of age * do not work in the united states * do not report are not concerned about job loss * do not have a device with audio and visual videoconferencing capabilities * do note communicate sufficiently in english * are not able to participate in the program for 5 weeks * are not wiling to complete pre-meeting worksheets * not willing to meet with both an occupational therapist and vocational counselor.

Keywords: work
the ranibizumab plus transpupillary thermotherapy for neovascular age-related macular degeneration (amd) study

Conditions: Neovascular Age-related Macular Degeneration

Summary: neovascular age-related macular degeneration (amd) is the leading cause of severe vision loss in the western world. intravitreal ranibizumab has recently become the treatment of choice for neovascular (amd). limitations to ranibizumab however include the high cost for the drug and the need for frequent intravitreal re-injections. the investigators' hypothesis is that when ranibizumab is combined with transpupillary thermotherapy (ttt) the number of necessary retreatments with lucentis will be significantly reduced as compared to ranibizumab alone.

neovascular age-related macular degeneration (amd) is caused by an ingrowth of pathological vessels under the macula. experimental studies have demonstrated that vascular endothelial growth factor (vegf) is centrally involved in this process. for this reason, anti-vegf drugs, in particular ranibizumab, as become the treatment of choice for neovascular amd. ranibizumab use is limited by its high cost. also, ranibizumab requires repeated (sometimes up to monthly) intravitreal injections for many years. strategies to reduce the burden of this treatment on the patient as well as on the health care system will be critical. combination therapy is an attractive such possibility. transpupillary thermotherapy (ttt) is a technique by which vascular occlusion can be induced by delivering radiation at near infrared intensity to the target tissue through the pupil. several reports have indicated that ttt may be used to slow disease progression in patients with neovascular amd. in this study we examine whether combined ranibizumab and ttt will reduce the number of ranibizumab injections compared with ranibizumab alone (sham ttt). the study will go on for 2 years with an interim report after 1 year.

Eligibility criteria:
inclusion criteria: * patients with subfoveal neovascular amd with either classic/predominantly classic or occult lesions * visual acuity =\> 20/200 exclusion criteria: * subretinal fibrosis or atrophy under the fovea * patients previously treated for neovascular amd in the study eye

Keywords: amd macular degeneration anti-vegf laser treatment
comparison of evolut fx versus sapien 3 ultra resilia.

Conditions: Aortic Stenosis

Summary: to compare outcome in patients randomized to treatment with evolut fx versus sapien 3 ultra resilia.

the purpose of the "compare-tavi" organization is to ensure a continuous comparison of the tavi-valves implanted, and to monitor long-term valve performances. purpose of present study: to compare outcome in patients randomized to treatment with evolut fx versus sapien 3 ultra resilia. hypotheses: 1. evolut fx is non-inferior to edwards sapien 3 resilia with regard to the combined endpoint (death, stroke, moderate/severe aortic regurgitation, moderate/severe valve deterioration) between the two valves being compared. 2. there is no difference between valves in secondary safety and efficacy endpoints (see below) 3. there is no difference in aortic regurgitation fraction (arf) and effective orifice area (eoa) measured by cmr (cmr-substudy, n=166) 4. there is no difference in eoa measured invasively during dobutamine stress (hemodynamic substudy, n=440). 5. there is no difference in occurrence of hypoathenuated leaflet thickening (halt) measured by ct (ct-substudy, n=778).

Eligibility criteria:
inclusion criteria: 1. patient more than 18 years of age. 2. patient eligible for both evolut fx and edwards sapien 3 ultra resilia according to a tavi heart team conference. 3. the center experience for each of the valves considered should be more than 15 cases a year, and the treating physician should have implanted at least 15 of each valve used in the trial. 4. the center volume should be more than 75 cases a year. 5. the patient has given signed informed consent. 6. tavi performed via the femoral artery. exclusion criteria: none
extra corporeal shock wave versus phonophoresis in sub acromial impingement syndrome.

Conditions: Sub Acromial Impingement Syndrome

Summary: shoulder sub acromial impingement syndrome is an encroachment of subacrormial tissues, rotator cuff, subacrormial bursa, and the long head of the biceps tendon, as a result of narrowing of the subacrormial space. activities requiring repetitive or sustained use of the arms over head often predispose the rotator cuff tendon to injury. hence the objective of the study is to examine the influence of extra corporeal shock wave versus phonophoresis on pain severity and functional disability in patients with sub acromial impingement syndrome.

background: shoulder sub acromial impingement syndrome is an encroachment of subacrormial tissues, rotator cuff, subacrormial bursa, and the long head of the biceps tendon, as a result of narrowing of the subacrormial space. activities requiring repetitive or sustained use of the arms over head often predispose the rotator cuff tendon to injury. objective of the study: to examine the influence of extra corporeal shock wave versus phonophoresis on pain severity and functional disability in patients with sub acromial impingement syndrome. subjects and methods: thirty patients diagnosed as shoulder impingement syndrome stage ii neer classification due to mechanical causes. patients were randomly distributed into two equal groups. the first group consisted of 15 patients with a mean age of 45.46 (+ 8.64) received therapeutic exercises( stretching exercise of posterior shoulder capsule and strengthening exercises of shoulder muscles) and shockwave therapy (6000 shock, 2000/session, 3 sessions, 2 weeks a part, 0.22mj/mm2) years. the second group consisted of 15 patients with a mean age of 46.26 (+ 8.05) received same therapeutic exercises and phonophoresis (3 times per week, each other day, for 4 consecutive weeks). patients were evaluated pretreatment and post treatment for shoulder pain severity, shoulder functional disability, shoulder flexion, abduction and internal rotation motions.

Eligibility criteria:
inclusion criteria: * the patient reported a positive "neer sign" and" hawkins sign". * the patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and over head playing athletes). * the patient reported pain with palpation of the rotator cuff tendons. * the patient reported pain with resisted isometric abduction. exclusion criteria: * frozen shoulder. * rotator cuff tear. * glenohumeral or acromioclavicular arthritis. * implented pace maker. * pregnancy

Keywords: extra corporeal shock wave phonophoresis sub acromial impingement syndrome
3d printing models in surgical planning of osteotomies in kienbock´s disease stages ii-iii

Conditions: Kienbock Disease

Summary: ischemic necrosis of lunate bone, osteonecrosis or kienböck´s disease was described by kienböck in 1910. numerous surgical procedures for this disease had been proposed. these surgical options, that depends of the radiological stage and anatomical risk factors, can be classified into lunate unloading procedures, lunate revascularization, replacement procedures and salvage procedures. these procedures, except the salvage procedures, has been successful in reconstructing and maintaining the height of the carpus, avoiding progression of the disease and with reduction of the pain. the lunate unloading procedures are surgical treatments that make a radial osteotomy for modify differents anatomical risk factors associated with the osteonecrosis.

the anatomical factors associated with kienböck´s disease are morphology of the lunate type i by antuña-zapico, cubitus minus, radial inclination angle greater than 23º, and little coverage of the lunate by the radius. the types of radial osteotomy for kienböck´s disease stages ii, iiia, iiib or iiic, depends to the anatomy of the patient and its anatomical risk factors. for patients with cubitus minus the indication is usually a radial shortening osteotomy. for patients with zero variant and an increase in the radial inclination angle the indication is usually a closed wedge radial osteotomy. the dorsolateral biplane radial osteotomy is used for zero variant cases such as a modification of the technique proposed by nakamura et and miura et al. it decompresses the lunate on the frontal plane and reduces dorsal radiolunate impingement on hyperextension. dorsolateral radial osteotomy ensures a reduction of the radial inclination angle and a corresponding lunate decompression on the anteroposterior and sagittal plane.

Eligibility criteria:
inclusion criteria: * kienbock´s disease in the wrist estages ii, iiia, iiib or iiic by lichtman classification exclusion criteria: * pre-radiological stages-lichtman stage i * radiocarpal and midcarpal osteoarthrosis, lichtman stage iv * kienböck in children: less than 18 years * adults years greater than 85 years old

Keywords: lunatomalacia kienböck´s disease radial osteotomy biplane radial osteotomy
popliteal sciatic nerve block and adductor canal block

Conditions: Popliteal Sciatic Nerve Block; Adductor Canal Block

Summary: the goal of this observational study is to determine the effect of adding adductor canal block to popliteal sciatic nerve block on patient-surgeon satisfaction, intraoperative sedation need, tourniquet pain, return time of motor block, and postoperative pain in patients undergoing hallux valgus correction surgery. the main question it aims to answer are: * does peroperative pain decrease? * do patient-surgeon satisfaction increase? the patients were divided into two groups, the popliteal sciatic block (psb) group, and the popliteal sciatic block + adductor canal block (psb + acb) group.

patients were randomly assigned into 2 groups as popliteal sciatic nerve block (group psb), popliteal sciatic nerve + adductor canal block (group psb + acb). in this study, 52 patients scheduled for hallux valgus correction operations, in the american society of anesthesiologists i-iii groups, between the ages of 18-80, were enrolled. study was planned as a prospective, randomized and controlled trial. all patients were perfomed psb with 10 ml 0.5% bupivacaine and 10 ml 2% prilocaine in the prone position, using ultrasonography and nerve stimulator. 10 ml of 0.5% bupivacaine and 10 ml of 2% prilocaine were administered to the patients in the acb + psb group in the supine position, in addition to psb. patients with coagulopathy, infection at the region site of regional blockade, allergy of local anesthetic drugs, peripheral neuropathy and neurogenic disorders affecting the lower extremities, peripheral artery disease, mental retardation and those who did not give consent to study were excluded. all patients were sedated with 1-2 mg midazolam and 50 µg fentanyl. after the blocks were performed , sensory -motor block onset time, surgery-tourniquet time, tourniquet pain, motor block time, pain onset time, first analgesic administration time (nprs≥4) and analgesic administered were recorded. anesthesiologists evaluating these data were blinded to group distribution .

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 80 * american society of anesthesiologists asa i-iii exclusion criteria: * patients with coagulopathy * patient with wounds or infections in the region * patient with allergies to local anesthetic drugs * patient with significantly impaired peripheral neuropathy and neurogenic disorders affecting the lower extremity * patient with peripheral arterial disease * patient with mental retardation

Keywords: popliteal sciatic block, adductor canal block
cohort of stemi patients 2

Conditions: Myocardial Infarction

Summary: st-segment elevation myocardial infarction (stemi) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. however, the mechanism of myocardial infarction remains poorly understood. at present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (ofsep cohort). the purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of stemi defined by st segment elevation ≥ 0.2 mv in 2 contiguous leads on a 12-lead ecg. * management in primary act * prior oral informed consent followed by signed informed consent as soon as possible. exclusion criteria: * diagnosis of stemi not confirmed on angiography * inability to give the subject informed information * lack of coverage by a social security scheme * obvious contraindication to injected magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, or a metallic body (ferromagnetic), severe renal insufficiency (gfr\<30 ml/min), known allergy to the contrast medium ....) * pregnant woman or woman of childbearing age without effective contraception, breastfeeding woman. * deprivation of civil rights (curators, guardianship, safeguard of justice)

Keywords: myocardial infarction bio-collection imaging markers biomarkers stemi clinical outcomes