Kornimate/medical-research-clean huggingface dataset:
interference screw mectascrew-c postmarket study

Conditions: Anterior Cruciate Ligament Injuries; Posterior Cruciate Ligament Tear

Summary: an observational prospective study with the aim to analyze the presence at 6 months of a specific composite is (medacta mectascrew c) in the reconstructive treatment of ruptured acl or pcl by means of an autograft or allograft.

this is an observational prospective study with the aim to determine the presence of the composite is (mectascrew-c) at 6 months following acl or pcl reconstruction. patients with an acl or pcl tear scheduled for surgery at one of the eoc's hospitals will be enrolled in the study, after the subscription of informed consent. the injured ligament will be restored with an auto- or allograft that will be fixed with a composite is (mectascrew-c, 70% pldlla, 30% β-tcp, medacta international sa). the data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, in order to assess the functional outcomes (ikdc objective and subjective) and the knee stability (rom, pivot shift or reverse pivot shift test, anterior or posterior drawer test) of the patients. the treated knee will be also evaluated radiologically with an mri at 6 months to assess the is reabsorption. the results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms

Eligibility criteria:
inclusion criteria: * patients of both sexes aged 16-60 yrs * pre-operative mri confirming the acl or pcl rupture * scheduled for surgical reconstruction of acl or pcl * bmi\>18 and \<35 kg/m2 * ability to give informed consent by signature exclusion criteria: * age under 16 or over 60 yrs * degenerative osteopathies * local bone tumors * deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician * systemic diseases and metabolic disorders that may compromise the outcome of the surgery
the effect of bifocals in children with down syndrome

Conditions: Visual Acuity at Near; Accuracy of Accommodation; Prevention of Strabismus; Task Readiness

Summary: visual acuity at near improves in children with down syndrome using bifocals

the accommodation is consistently reduced in 50 to 100% of children with down syndrome and does not improve with age.

Eligibility criteria:
inclusion criteria: * diagnosed with down syndrome (ds) * accommodation lag \>0.5 dioptres for children with ds \ 0.75 dioptres for children older than age 12 or visual acuity at near is worse than at distance and \>0.1 * age range 2-14 years * speaks dutch as the first language * must be verbal or able to understand instructions * must be able to perform a task sitting on a chair and working at a table exclusion criteria: * visual acuity at near \< 0.1 * not able to do vision tests at age over 5 * has worn bifocals already * other significant eye diseases, such as keratoconus, cataract or high myopia (\>s-6.00). * diagnoses of any neurological, sensory or behavioural disorders such as autism, microcephaly or significant hearing loss. * prematurity, born premature after a pregnancy term less than 36 weeks * born after severe perinatal problems

Keywords: down syndrome visual functions bifocals children visual acuity at near
a trial of rigid versus semirigid thoracoscopy in the evaluation of exudative pleural effusions

Conditions: Pleurisy With Effusion

Summary: rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. the semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. the two devices have not been compared in a head-to-head trial in published literature. the investigators attempt to conduct a randomised comparative trial between the two devices.


Eligibility criteria:
inclusion criteria: * patients with an exudative (as defined by light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination exclusion criteria: * significant hypoxemia on room air * hemodynamic instability * significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina) * refractory cough * lack of pleural space due to adhesions * uncorrected coagulopathy

Keywords: pleural effusion semirigid thoracoscopy rigid thoracoscopy
impact of non-fasting on anxiety in cataract surgery

Conditions: Cataract Surgery

Summary: the aim of this prospective study was to investigate whether non-fasting recommendation could reduce preoperative anxiety level, incidence of anesthetist interventions, and number of surgical complications in elective cataract surgery patients.

fear of aspiration makes anesthetists reluctant to challenge standard pre-operative fasting guidelines recommending stopping eating solids and drinking clear fluid 6 hours and 2 hours, respectively before anesthesia. however, hunger and thirst exacerbates patients' anxiety, adversely impacts the patient's comfort and satisfaction, and enhances pain response leading to additional need for analgesia. patients undergoing non-invasive procedures requiring no or light sedation may benefit from non-fasting recommendations. the need for preoperative fasting in patients undergoing cataract surgery under topical anesthesia remains controversial. patients are not fasted before standard cataract surgery under local anesthesia in many cataract centers, in accordance with the uk national guideline published in 2012. however, this practice is not supported by a high level of evidence from prospective clinical trials. so far, the lack of international professional consensus on the matter, local practices are based on institutional recommendations obviating the need for starvation in routine cataract surgery under topical anesthesia.

Eligibility criteria:
inclusion criteria: * information and collection of patient consent * age greater than or equal to 18 years * affiliation to a social insurance * undergoing cataract surgery under topical anesthesia * intervention on the 1st eye exclusion criteria: * refusal to participate * language barrier incompatible with the performance of a reliable assessment * behavior disorders * anesthesia other than topical * voluntary control disorder * intervention on the 2nd eye * taking psychotropic drugs. * legal protection regime

Keywords: cataract surgery anxiety fasting
bilateral thoracoscopic splanchnicectomy for pain relief in patients with unresectable pancreatic cancer

Conditions: Unresectable Pancreatic Cancer

Summary: this study aims to compare the efficacy of bilateral thoracoscopic splanchnicectomy (bts) to conventional narcotic analgesia for control of abdominal pain in patients with pancreatic ductal adenocarcinoma not amenable to surgical resection.

all patients with unresectable pancreatic cancer will be considered for participation in this study. patients with locally advanced or metastatic cancer that meet inclusion criteria will be randomized into one of two arms, treatment with bts and narcotic analgesia or treatment with narcotic analgesia alone. after randomization a baseline pain score will be assessed using the visual analog pain scale. narcotic dosage and frequency will be evaluated at the time of enrollment. a pre-treatment quality of life score will be recorded using the sf-12® patient questionnaire. patients will also be queried about the presence of nausea and reflux. after all baseline assessments are complete patients will be taken to the or to undergo their assigned procedure. bts and infusaport placement will be performed on patients randomly selected for treatment with bts and narcotic analgesia. bts will be performed as described in the study procedure. patients chosen to be treated with narcotic analgesia alone will undergo infusaport placement only. an evaluation will be completed postoperatively in which the length of stay, post-op complications, and chest x-ray results will be recorded. follow-up assessments will be conducted 24-48 hours post-procedure and at the time of discharge. further follow-up assessments will be conducted 14 days, 30 days, and 90 days post-procedure during an office visit with the clinical research team or medical oncology.

Eligibility criteria:
inclusion criteria: 1. must be 18 years of age 2. diagnosed with stage iii/iv pancreatic cancer 3. willing and able to comply with the protocol requirements 4. able to comprehend and have signed the informed consent form (icf) to participate in the study exclusion criteria: 1. participating in another clinical trial for the treatment of cancer at the time of screening 2. pregnant or currently breast feeding
new magnesium sulphate protocol for pre-eclampsia

Conditions: Pre-eclampsia

Summary: there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol

the aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia. the study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:- * systolic blood pressure ≥ 160. * diastolic blood pressure ≥ 110. * proteinuria \> +2 by dip stick. * presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding). * fetal growth restriction (iugr). after obtaining an informed consent the patients will be subjected to the following: * careful history taking including age, parity, gestational age. * complete physical examination and assessment of the blood pressure. * urine analysis by dipstick. * all women will take initial mgso4 (6 grams of mgso4 on 250 ml ringer solutions over 20 minutes by iv drip) . using random number table, the sample size will be divided into three categories:- * category a : 80 patients given full dose of maintenance mgso4 (4 grams of mgso4 on 250 ml ringer solution over 4 hours every 4 hours by iv drip for 24 hours) in the postpartum period. * category b : 80 patients given abbreviated doses of mgso4 (4 grams of mgso4 on 250 ml ringer solution over 4 hours every 4 hours by iv drip only for 12 hours) in the postpartum period. * category c : 80 patients who will take only loading dose of mgso4 (6 grams of mgso4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate. inclusion criteria: * pregnant females ≥20 weeks of gestation. * pregnant females with criteria of severe pre-eclampsia. * single or multi-fetal pregnancy. * primigravida or multigravida. exclusion criteria: * pregnant females \< 20 weeks gestation. * pregnant females with history of epilepsy. * pregnant females with diabetes. * pregnant females with chronic hypertension. * pregnant females with renal disease.

Eligibility criteria:
inclusion criteria: * pregnant females ≥20 weeks of gestation. * pregnant females with criteria of severe pre-eclampsia. * single or multi-fetal pregnancy. * primigravida or multigravida. exclusion criteria: * pregnant females \< 20 weeks gestation. * pregnant females with history of epilepsy. * pregnant females with diabetes. * pregnant females with chronic hypertension. * pregnant females with renal disease.

Keywords: convulsion rate
evaluation of the effect of nurse coaching program on self-management and skin care behaviors in patients with diabetes

Conditions: Diabetes Mellitus Self Management Education; Diabetes Mellitus, Type II; Skin Care

Summary: this research will be conducted in a pre-test-post-test randomized controlled, single-blind experimental design to evaluate the effects of a nurse coaching program on self-management and skin care behaviors in patients with diabetes. the key question(s) it aims to answer are: * does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes? * does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes?

the study will be conducted in the internal medicine units of mut state hospital in the mut district of mersin between january 2025 and june 2025. an average of 100 patients with type 2 dm apply to the hospital per day. according to cohen's effect size coefficients; it was decided to include 21 people (n=42) in the groups, assuming that the evaluations to be made between two independent groups would have a large effect size (d=0.8; large) according to the calculations made. the consents of 42 type 2 dm patients who constitute the study group of the experimental research will be obtained. after the preliminary tests are performed, a series of random numbers will be generated by an independent statistician and 21 will be assigned to the intervention group and 21 to the control group using the simple randomization method. personal information form, diabetes self-management scale, and skin care behavior monitoring form will be used as data collection tools. in addition, the "diabetes education booklet" designed and prepared by the researchers will be used as an intervention material in the research study.the follow-up of the implementation process will be recorded with the msf and kbif prepared by the researcher.before starting the research, 3 measurements will be taken at week 6 and week 12. the data collection process of the research will be completed by using face-to-face training opportunities in the first 6 weeks and reminders (message, phone call, etc.) in the following periods. the control group will receive standard training and the same measurement tools will be used.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * having a type 2 dm diagnosis period of 6 months or more, * not having any psychiatric disorders or mental problems, * having hemoglobin a1c values \<8 mmol/ml, * individuals who can perform diabetes self-management behaviors and skin care behaviors (regular eating habits, physical activity, regular monitoring of blood sugar, compliance with treatment, ability to solve problems, coping strategies and minimizing risks). exclusion criteria: * exclusion criteria for the study; * having verbal communication problems, * having been diagnosed with type 1 diabetes mellitus, * having been diagnosed with gestational diabetes mellitus,

Keywords: diabetes mellitus self management education skin care tip ii diyabet mellitus
trendelenburg positioning and external cephalic version outcome

Conditions: Breech Presentation of Fetus With Successful Version

Summary: women at term (over 37 weeks) that are candidates for external cephalic version will be positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure. the control group will not be positioned differently than usual. we will evaluate external cephalic version success and compare the 2 groups.

this is a randomized controlled trial that is designed to compare external cephalic version success between women positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure and a control group of women that will lie on their back without special positioning. the women that are eligible for participation will receive a thorough explanation and will sign informed consent.

Eligibility criteria:
inclusion criteria: * women interested in having external cephalic version at a gestational age of 37+0/7 or more. exclusion criteria: * age 18 and under. * women with a body mass index 35 or higher. * women with a previous cesarean section. * women with premature rupture of membranes. * women with vaginal bleeding. * women with a previously failed external cephalic version.
deficient lower segment cesarean section scar, does the type of suture matter?

Conditions: 2 Arms, Conventional Suture, Barbed Suture

Summary: in recent years there has been a significant increase in cesarean sections. this is not without complication in subsequent pregnancies such as placenta previa, placenta accrete, scar pregnancy, dehiscence or uterine rupture. uterine rupture during trial of labor after cesarean section is an uncommon but potentially catastrophic, life threatening event. it is thus of importance if the investigators were able to predict the risk of uterine rupture. imaging studies including ultrasound, hysterography and sonohysterography have been used to evaluate the scar from a prior cesarean before pregnancy, there is no consensus as to which of them is the preferred method but it is known that cesarean section scars can be detected reliably by ultrasound imaging. previous studies have shown that sonographic lower uterine segment thickness is a strong predictor for uterine scar defect and could represent a high risk of uterine rupture during a trial of labor in women with prior cesarean section. there is a likely association between large defects in the scar after cesarean delivery detected by transvaginal ultrasonography in non pregnant women and uterine rupture or dehiscence in subsequent pregnancy. the knotless barbed suture was fda approved in 2004. knotless barbed sutures are monofilament sutures with barbs cut into them. these sutures self-anchor, maintaining tissue approximation without the need for surgical knots. the objective of this study is to determine whether there is a difference in the lower uterine segment thickness between uterine scars sutured with two types of sutures, to determine whether there is a difference in the size of the scar defects. methods: two hundred and two women will undergo transvaginal ultrasound examination 3 and 6 months after delivery: 101 women will have undergone cesarean section in which the vicryl suture was used, 101 women will have undergone cesarean section in which the kbs suture was used. the ultrasound examiner will be blinded to the use of the suture. the investigators will measure the myometrial thickness 3 months and 6 months after the delivery and compare the results between the 2 groups. the assumption is that the findings of the study will be useful in counseling concerning trial of labor after cesarean (tolac). to the best of the investigators' knowledge, there are no published data on the risk of uterine rupture predicted based on the myometrial thickness measured in the non-pregnant patient when the knotless barbed suture was used in the cesarean section. previous studies have examined the applicability of low uterine segment measurement in the third trimester in the prediction of a uterine defect during trial of labor


Eligibility criteria:
inclusion criteria: * post cesarean section exclusion criteria: * non low- transverse incision, after myomectomy, pregnancy

Keywords: conventional suture, barbed suture, niche, scar, cesarean section
stereotactic radiosurgery in treating patients with liver metastases, lung metastases, or other advanced solid tumors

Conditions: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less damage to normal tissue. purpose: phase ii trial to study the effectiveness of stereotactic radiosurgery in treating patients who have liver metastases, lung metastases, or other advanced solid tumors.

objectives: * determine the feasibility of fractionated stereotactic body radiosurgery in patients with advanced extracranial tumors. * assess the toxicities of this treatment regimen in these patients. * determine tumor response and cause of death in these patients treated with this regimen. outline: patients receive fractionated stereotactic body radiosurgery over 30 minutes for 5-10 days for a total of 3 treatments. patients are followed every 3 months. projected accrual: a total of 10-25 patients will be accrued within 2-3 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed malignancy * extracranial recurrent or metastatic disease or primary tumor not predicted to be controlled with standard radiotherapy * incurable with any standard therapy * no tumors involving critical structures (e.g., mucosal surfaces (bowel or bladder) or heart) * tumor visible by ct scan patient characteristics: age: * not specified performance status: * karnofsky 60-100% life expectancy: * not specified hematopoietic: * not specified hepatic: * bilirubin less than 2.0 times upper limit of normal (uln) * ast and alt less than 5 times uln renal: * creatinine less than 2.0 mg/dl pulmonary: * fev1 greater than 0.75 l other: * no unsuitable size or geometric proportion that would preclude stereotactic immobilization * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 14 days since prior anticancer biologic therapy and recovered chemotherapy: * at least 14 days since prior anticancer chemotherapy and recovered endocrine therapy: * at least 14 days since prior anticancer endocrine therapy and recovered radiotherapy: * see disease characteristics * at least 14 days since prior anticancer radiotherapy and recovered surgery: * not specified

Keywords: unspecified adult solid tumor, protocol specific lung metastases liver metastases
intradialytic parenteral nutrition in hemodialysis patients

Conditions: Malnutrition; Complication of Hemodialysis

Summary: malnutrition is a major cause of death in chronic hemodialysis patients. primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy. in cases where primary treatment of malnutrition is not effective, intradialytic parenteral nutrition (idpn)during dialysis therapy may be administered. using idpn aminoacids, carbohydrates and fatty acids as well as vitamins and trace elements can be given to the patients. effectiveness of idpn has to be verified.

25% of hemodialysis patients who are treated for more than 5 years suffer from protein malnutrition. 7% have a protein catabolic rate less than 0,6 g/kgbw and day. the conventional treatment of malnutrition include dietetic counseling, psychologic advice and giving additional oral nutrients.in many cases this kind of therapy is uneffective. if supplementary enteral nutrition is used, the additional intake of water has to be taken into consideration. idpn is a mode of treatment by which disadvantages of enteral nutrition and fluid overload of the patients can be avoided.during each dialysis session nutrients can be given and additional water simultaneously can be removed by ultrafiltration. some publications have shown that the catabolic state of the patients can be converted into an anabolic state. there are only small randomized studies showing the positive effect of idpn. in this german multicenter study malnourished hemodialysis patients are randomized into two groups. one group is treated with idpn during each dialysis session for 16 weeks followed by 12 weeks of follow-up without idpn. the control-group does not receive idpn. the parameters of metabolism are: albumin, prealbumin, transferrin, phase angle alpha (bioimpedance), proteincatabolic rate (formal urea kinetics), bmi and subjective global assessment (sga score).

Eligibility criteria:
inclusion criteria: * hemodialysis therapy more than 6 months * three times per week hemodialysis * albumin \< 35 g/l * prealbumin \< 250 mg/l * phase angle \< 4,5° * sga score grade b or c * informed consent exclusion criteria: * inadequate dialysis (kt/v \< 1,2) * chemotherapy or radiotherapy * cardiac pacemaker * acute bacterial infection * acute immunological disease * cancer disease * severe hepatic insufficiency * interferon therapy * hiv disease * severe diabetes mellitus

Keywords: chronic renal replacement therapy malnutrition anorexia parenteral nutrition