Kornimate/medical-research-clean huggingface dataset:
cranioplasty using titanium mesh vs bone cement

Conditions: Bone Defects; Decompressive Craniectomy and Cranioplasty; Cranioplasty

Summary: the aim of this study is: to compare the surgical outcomes between titanium mesh and bone cement in cranioplasty. to assess the complication rates associated with each material. to evaluate patient satisfaction and aesthetic results post-surgery

cranioplasty is a common neurosurgical procedure performed to repair skull vault defects. the skull vault defects may result mostly after traumatic injuries as depressed skull fractures, tumor removal (infiltrating skull bones), decompressive craniectomies, congenital anomalies or inflammatory lesions. at present, there is no gold standard material for cranioplasty with the use of autologous bone as well as other synthetic materials as bone cement and titanium mesh. bone cement is malleable, lightweight, strong, and heat resistant, but it may cause burn injury during the process of its preparation and is used for relatively small defects. titanium mesh good mechanical strength, a low infection rate, and an acceptable cost but may cause metal allergy, tissue erosion, implant exposure, and deformity upon application of external force. cranioplasty not only provides brain protection and cosmetic aspects but also, decrease incidence of epilepsy, relief to psychological drawbacks and increases social performance, restoring the dynamics of csf.

Eligibility criteria:
* inclusion criteria: * patients requiring cranioplasty for a skull defect due to decompressive craniectomy, trauma, tumor resection, or congenital issues. * all ages . * both sex. * informed consent obtained from all participants. * patient fit for surgery. * exclusion criteria: * patients with active infection at the surgical site * patient unfit for surgery. * patient refuse consent

Keywords: cranioplasty titanium mesh bone cement traumatic brain injury
patients with diabetes mellitus on drug treatment on the list or already undergoing orthotopic liver transplantation

Conditions: Diabetes Mellitus Type 2; Liver Transplant

Summary: observational study through which we aim to collect information on metabolic compensation, the degree of satisfaction with hypoglycemic therapy, the onset of complications of diabetes or liver disease, evaluation of survival, in patients on the list for at least three months or already undergoing liver transplantation for at least three months


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * presence on the list for olt for at least 3 months or have already been submitted to olt for at least 3 months * age ≥ 18 years * signature of written informed consent to participate in the observational study, either by the participant or legal guardian exclusion criteria: - pregnancy or breastfeeding
cystatin sn binds to phytic acid and predicts non-heme iron bioavailability

Conditions: Iron-deficiency; Iron Deficiency Anemia

Summary: phytic acid is a known inhibitor of iron bioavailability, although long term studies have suggested possibly exaggerated findings compared to single meal studies, pointing to phytic acid adaptation over time. salivary proline-rich proteins have been found to reduce tannin-iron chelation, but studies have not explored changes in salivary proteins that may result in phytic acid adaptation. the primary objectives of this study are: 1) to determine whether phytic acid impacts iron bioavailability or status when consumed over time 2) to test whether salivary protein production may impact iron bioavailability with phytic acid supplementation, and 3) to explore in vitro phytic acid salivary binding. secondary objectives included assessment of the reliability of astringency as a measure of salivary protein production and iron absorption. the study was conducted in an iron absorption study of 7 women, aged 18-35 years old, to determine iron bioavailability with supplementation of 350 mg phytic acid before and after regular, three times daily supplementation for four weeks. direct iron absorption was measured using area under the curve. iron status was measured by changes in hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels. salivary samples were collected before and after supplement consumption during meal challenges, and analyzed on hplc and by elisa. astringency testing was conducted at the end of each meal challenge. in vitro saliva-phytic acid modeling was explored on hplc, maldi-tof, and elisa. iron absorption and status markers were analyzed by anova, and mixed-modeling followed by pairwise comparison by least significant differences. pearson's correlations were used to correlated salivary proteins and astringency with iron bioavailability. the present study will provide important information regarding the approximate influence of phytic acid consumption on iron bioavailability and storage over time in regards to salivary proteins. it will also give context to the role of salivary proteins with phytic acid consumption over time. data will also help to delineate possible physiological mechanisms underlying phytic acid adaptation and possible ways to detect individuals who better adapt than others.


Eligibility criteria:
inclusion criteria: * female, 18-35 years' old * non-obese bmi (18-29.9) * signed informed consent exclusion criteria: * oral disease * gastrointestinal disease * tobacco user * heavy alcohol user * pregnancy (assessed by pregnancy test) * lactation * medications affecting iron bioavailability * vitamin or mineral supplementation (other than vitamin b12)

Keywords: phytic acid cystatin salivary proline-rich protein antinutrient
tolerability and efficacy of rosuvastatin - fenofibrate combine therapy in korean patients with combined hyperlipidemia

Conditions: Hyperlipidemia

Summary: although the combination of statin and fenofibrate is one of the options for patients with combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. in this study we compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney, blood glucose control, and blood cell counts.


Eligibility criteria:
inclusion criteria: * mixed hyperlipidemia: total cholesterol levels higher than 220 mg/dl, triglyceride (tg) levels between 200 and 500 mg/dl, and low-density lipoprotein (ldl)-cholesterol levels higher than 130 mg/dl after 6-week diet/life style change * men and women who were between 20 and 70 years of age * having at least one history of: coronary artery disease, cerebrovascular disease or transient ischemic attack, peripheral vascular disease, or diabetes mellitus. * having risk factors at least two of: age ≥45 years in male or ≥55 years in female, elevated blood pressure (systolic blood pressure ≥130 mmhg or diastolic blood pressure ≥85 mmhg, or treatment of previously diagnosed hypertension), high-density lipoprotein (hdl)-cholesterol \<40 mg/dl, family history of coronary artery disease at age \<55 years in male or \<65 years in female, central obesity (waist circumference ≥90 cm for male or ≥80 cm for female), fasting plasma glucose ≥110 mg/dl, or left ventricular hypertrophy on electrocardiogram * written informed consent. exclusion criteria: * pregnant or breast-feeding * uncontrolled hypertension * uncontrolled diabetes mellitus * thyroid dysfunction * serum transaminase level \>2 times the upper limit of normal * history of gall bladder disease * chronic alcoholic * serum creatinine level \>1.5 mg/dl * history of myopathy * history of acute myocardial infarction or acute stroke within 3 months before the study began * acute or chronic infection or inflammation * history of cancer * history of adverse events associated with test drugs.

Keywords: rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase
custom pack in spine surgery

Conditions: Bone Diseases; Spine Cancer; Spine Osteoarthritis

Summary: recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs. nevertheless ,the studies available are sponsored by the industry and their results are very few. the aim of this study is to evaluate the correlation and reliability of spine surgery "custom pack" efficacy in adult patients obtained in the reduction of surgery time, relative risks, and materials wasted compared with the standard surgical field procedure practice .


Eligibility criteria:
inclusion criteria: * degenerative spinal disease from 2 to 4 levels, * oncologic spine disease with only decompression and stabilization. exclusion criteria: * revision surgeries, * minimally invasive interventions, * interventions that provide a dual access, and * patients who refuse consent to experimentation.
laparoscopic surgery: comparison of conventional trocars to the teleflex® minilap® system

Conditions: Gynecologic Surgeries

Summary: during laparoscopy, trocars are essential: they allow the passage of instruments through the wall. in gynecology, with exception, trocars 5mm (used for the passage of endo-scissors and forceps) and 10 to 12mm are used (especially for optics). trocars are responsible for complications, such as vascular wounds, digestive wounds, pain, infections or postoperative hernias, or aesthetic sequelae, and should be chosen with caution: most complications of laparoscopy are essentially due to their placement, and the complications at the introduction of the first trocar are the most frequent. the minilap® system developed by teleflex does not require trocars in the case of a single forceps, or a single 5mm trocar with the necessary forceps change (this is the percuvance® system). the aim of the latter is to make minimally invasive surgery even less invasive, thanks to a reduction in the number of trocars used (in many cases, elimination of two trocars), smaller incisions (percutaneous use of instruments, with a diameter of 2,4mm) thus reducing the complications


Eligibility criteria:
inclusion criteria: * bmi \<35kg / m2 * no history of multiple abdominopelvic surgery * without absolute contraindication to laparoscopy * in the context of ambulatory surgery * with precise laparoscopy of indication: * exploratory or diagnostic * exploration of infertility * performing a tubal permeability test * performing a salpingectomy * realization of a tubal sterilization * realization of a tubal plasty * performing an ovariectomy * performing a simple ovarian cystectomy * patient have been informed during her preoperative consultation and have signed the consent in a free and informed manner upon admission to hospital exclusion criteria: * performing an emergency surgery * carcinological surgery * performing a benign but complex surgery such as: * hysterectomy * prolapse cure * promontofixation * complex surgery of endometriosis * removal of large cyst from the ovary. * person unable to receive informed information and / or give consent. person deprived of liberty. * pregnant or nursing woman.

Keywords: laparoscopy trocar minilap surgery gynecology pain, scars scars
combination of nhf and nebulizer on lung function in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will prove to concept of effectiveness of nhf in combination with a nebulizer on reversibility of lung function in copd patients.

patients will inhale on day 1 with a nebulizer and on another day with combination of nebulizer an nhf in a randomised order.

Eligibility criteria:
inclusion criteria: * stable disease * copd exclusion criteria: * exacerbation * right heart decompensation * acute respiratory insufficiency * acute disease

Keywords: nhf nasal highflow
effectiveness of mobile application intervention in day surgery

Conditions: Pain; Fear; Stress; Anxiety

Summary: in finland about 50% of surgical operations for all under 16 years of age are made as day surgery which means that the patient comes to the hospital and is discharged on the day of the operation. day surgery will continue to grow in the next few years. its benefits include shorter hospitalization, family reunion and rapid recovery. the preschool children and their parents who come in for day surgery feel fear, anxiety and stress, which depend on the amount of knowledge and its quality. by developing the preparation of preschool children and their parents for day surgery, and by testing new methods more attention can be paid to the special features of day surgery, supporting the families, and increasing family involvement in the whole process. the purpose of this study is to describe and evaluate the effectiveness of a new mobile application intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. the aim is to produce new information and to develop day surgery of preschool children. the study consist of two phases. the first phase of the research is a systematic literature review and meta-analysis. the purpose of the review is to assess and describe the methods previously used in the preparation of parental day surgery and their effectiveness for preschool children fear and pain and parents' anxiety and stress. the second phase of the study is carried out as a randomized controlled trial (=rct). the parents of the preschool children are randomized to the mobile application group (n = 50-60) and the control group (n = 50-60). the sample size is based on power-analysis, with anxiety as the primary outcome. the material for the second phase of the study is collected at the day surgery department of the oulu university hospital. the study group is prepared for day surgery with a new mobile application and the control group according to the traditional preparing method. the study examines the effectiveness of a new intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. the collected data are analyzed using the mann-whitney, t-test, khi square test, and fisher's accurate test.


Eligibility criteria:
inclusion criteria: * asa 1 or 2 * elective day surgigal procedure in 3-4 weeks * parent able to use mobile intervention, understands finnish and willing to participate in preparing child for day surgery * general anaesthesia exclusion criteria: * inclusion criteria not met
a study of duvelisib in participants with refractory indolent non-hodgkin lymphoma

Conditions: Indolent Non-Hodgkin Lymphoma

Summary: this was a phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-hodgkin lymphoma (inhl) (follicular lymphoma \[fl\], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (rit).

this was an open-label, single-arm safety and efficacy study of duvelisib administered orally to participants who had been diagnosed with inhl whose disease was refractory to rituximab and to either chemotherapy or rit. approximately 120 participants received 25 milligrams of duvelisib twice daily over the course of 28-day treatment cycles for up to 13 cycles. after completing 13 treatment cycles of duvelisib, participants continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. however, to receive additional cycles of duvelisib beyond 13 cycles, participants must have had evidence of response (complete response \[cr\] or partial response \[pr\]) or stable disease according to the international working group criteria by the end of cycle 13.

Eligibility criteria:
inclusion criteria: * participants who had been diagnosed with inhl that had progressed. * participants must have exhibited lack of cr or progressive disease (pr) or progression within 6 months after the last dose of a chemotherapy induction regimen or rit. * participants must have had rituximab-refractory disease, defined as lack of cr or pr or pd within 6 months of last dose. * measurable disease with a lymph node or tumor mass ≥1.5 centimeters in at least one dimension by computed tomography (ct), positron emission tomography/ct or magnetic resonance imaging. * adequate renal and hepatic function. exclusion criteria: * candidate for potentially curative therapies in the opinion of the investigator. * previous treatment with a pi3k inhibitor or bruton's tyrosine kinase inhibitor. * prior history of allogeneic hematopoietic stem cell transplant. * prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug. * grade 3b fl and/or clinical evidence of transformation to a more aggressive subtype of lymphoma. * symptomatic central nervous system nhl. * ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment. * prior, current, or chronic hepatitis b or hepatitis c infection, positive result for hepatitis c virus antibodies, hepatitis b surface antigen, or hepatitis b core antibodies. * history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug.

Keywords: pi3k inhibitor
effect of cryotherapy on postoperative pain in vital pulp treatment of molar teeth

Conditions: Pulpitis - Irreversible

Summary: the goal of this clinical trial was to evaluate the effect of cryotherapy with salin solution on the intensity of postoperative pain after total pulpotomy procedures in molar teeth with symptomatic irreversible pulpitis. the main question it aims to answer is: - does controlled irrigation with cold saline in total pulpotomy reduce the severity of postoperative pain? in the cryotherapy group, unlike the control group, after hemostasis was achieved, the coronal pulp cavity was irrigated with 2 °c saline solution for 5 minutes.


Eligibility criteria:
inclusion criteria: teeth with * moderate or severe pain * diagnosed with symptomatic irreversible pulpitis * no tenderness to percussion and palpation * positive response to cold test and electric pulp test * no signs of periapical pathology exclusion criteria: teeth which * could not be restored or required post-core * had periapical lesions, * had poor periodontal status (pocket depth\> 4 mm), * had negative responses to pulp sensitivity tests, * had no pulp exposure after caries removing patients who * had no preoperative pain or had mild preoperative pain * had bleeding disorders * had systemic diseases such as immunosuppressive disease or diabetes

Keywords: cryotherapy vital pulp therapy irreversibl pulpitis postoperative pain total pulpotomy
allogenic adipose tissue-derived mesenchymal stromal cells for the treatment of primary progressive multiple sclerosis

Conditions: Multiple Sclerosis

Summary: in this study, we propose, for the first time, to test the safety and the potential efficacy of repeated allogenic adipose tissue-derived mesenchymal stromal cells it injections in primary progressive multiple sclerosis patients.

in this study, the investigators propose, for the first time, to test the safety and the potential efficacy of repeated allogenic adipose tissue-derived mesenchymal stromal cells (ascs) it injections in primary progressive multiple sclerosis (ppms) patients. in fact, even if autologous bone marrow-mesenchymal stromal cells (bm-msc) and ascs have already been infused intrathecally in multiple sclerosis, repeated injections of allogenic ascs have never been tested in this disease. the use of allogenic cells is driven by recent publications reporting decreased suppressive properties of autologous msc from ms patients. the hypothesis is that 3 repeated intrathecal (it) injections of allogenic ascs every 3 months will be safe and can lower disease progression in ppms patients. preamble of infusing ascs in the first patient, it's necessary to constitute and characterize the asc bank. asc will be obtained from allogeneic human mesenchymal stromal cells derived from adipose tissue of a living donor. once the bank is available, ms patients will be screened and included in rennes university hospital to received asc's infusions. ms patients will be followed for one year after inclusion

Eligibility criteria:
inclusion criteria: * patient with primary progressive ms according to the criteria of mc donald 2017 (thompson et al lancet neurol, 2017) * age between 18 and 55 years * edss score: 3 to 6 at inclusion * documented evidence of disability progression independent of relapse activity at any point in time over the 2 years prior to the screening visit * positive csf with oligoclonal bands * for women of childbearing potential (wocbp), effective contraception as per the cftg recommendations (version 1.1) * having signed a free, informed and written consent * affiliated to social security scheme exclusion criteria: * inflammatory activity during the past year (relapses or new t2 mri lesions) * disease modifying drugs during the past year * treatment with high dose corticosteroids during the 30 days preceding the inclusion * contra indication to lumbar puncture/intrathecal infusion: intracranial hypertension, puncture site infections, severe thrombocytopenia (\<50 g/l), anticoagulant or fibrinolytic treatment * participation in another therapeutic trial in the last 6 months * adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breastfeeding women, minors, persons unable to express their consent
chordate system s020 acute migraine clinical investigation

Conditions: Acute Migraine

Summary: the main purpose of the study is to evaluate the impact of treatment with the chordate system s020 (medical device) on acute migraine headache pain.

one single migraine attack will be treated either with the chordate system s020 or with chordate system in placebo mode. after a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). the subjects will record their response over the next 48 hours using a diary card. a follow-up visit will be scheduled 3 to 7 days after the treatment. in addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing aes.

Eligibility criteria:
inclusion criteria: * subjects with migraine, with or without aura according to international headache society (ihs) classification (international classification of headache disorders \[ichd\]-iii beta). * history of 1 to 6 migraine attacks per month for at least 12 previous months. * at least 50% of previous migraine attacks had moderate or severe pain intensity. * history of at least 48 hours of freedom from headache between migraine attacks. * the majority of the previous untreated migraine attacks lasted at least 8 hours. * migraine onset before the age of 50 years. exclusion criteria: * history (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind). * more than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation). * unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack. * treatment with botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit. * previously treated with an implantable stimulator or any implantable devices in the head and/or neck. * pronounced anterior septal nasal deviation.