Kornimate/medical-research-clean huggingface dataset:
outcome of the anterior subcutaneous internal fixator (infix) for pelvic ring disruptions

Conditions: Pelvic Fracture

Summary: with a prospective case series study of 15 patients the aim of this study is to estimate the clinical outcomes in patients with unstable anterior pelvic ring fractures ( b\&c ) after treatment with (infix)

unstable pelvic ring fractures are usually associated with high energy trauma. they account for about 1.5-3.9% of all fractures, but they have a high rate of morbidity and mortality. although the posterior pelvic ring provides the main stability (60%), the anterior ring still account for 40% of stability fracture pelvis b \&c according to tiles classification require fixation of the anterior ring or anterior-posterior ring simultaneously. the external fixator is the most widely used treatment for initial and temporary stabilization of anterior pelvic ring injury, especially in emergency situations. it can be quickly placed and can easily stabilize the disrupted pelvic ring and decrease pelvic cavity haemorrhage. however, many clinical complications associated with the external fixator have been reported, including wound infection, loosening of the fixator, and impingement on the skin. moreover, the anterior pelvic external fixator limits patients' daily activities, such as sitting, lying in the lateral position, rolling over, and sexual intercourse recently, anterior subcutaneous internal fixator (infix) was proposed by several scholars to treat anterior pelvic ring injury. infix was invented based upon the same biomechanical principle as the traditional external fixator, but it is placed subcutaneously. it proved to be stiffer than the traditional external fixator, and at the same time eliminates the open pin tracts, which increased the infection rate and nursing care . infix was initially designed as an alternative to the external fixator, but recently its indications have been expanded and multiple complications have been reported.

Eligibility criteria:
inclusion criteria: * skeletally mature patient. * type b2 / b3 \& c1 pelvic fracture. * open book b1 fracture with urogenital disruption. * patient with fatty tissue that cover pubic bones enable insertion of the rod. * if there is a contraindication to anterior symphyseal plating. exclusion criteria: * associated comorbidities preventing surgery. * pelvic fracture associated with iliac bones fracture * combined pelvis and acetabulum fracture.

Keywords: pelvic ring fractures infix
ris international cohort

Conditions: Multiple Sclerosis; Radiologically Isolated Syndrome

Summary: the radiologically isolated syndrome (ris) corresponds to the discovery of white matter (wm) abnormalities suggestive of multiple sclerosis (ms) by their location, size, and appearance, on the brain or spinal cord magnetic resonance imaging (mri). this imaging is performed for a reason other than for suspicion of demyelinating disease in subjects without a history of neurological symptoms and a strict routine clinical neurological examination. it was defined and named in 2009 (okuda et al.) after publishing 3 case series (french, usa, turkey). the radiologically isolated syndrome consortium (risc) published a cohort of subjects with an extended follow-up after the first brain mri of ms, with 34% presenting an event (clinical conversion) at five years, 51.2 % of these subjects showed an event at ten years. the patients who offer a higher risk of developing a first clinical demyelinating event were identified such as male sex, young age, the presence of oligoclonal bands (bocs) in the cerebrospinal fluid (csf), the presence of infratentorial lesions and spinal cord lesions on the first mri suggestive of ris. the location and morphology of the lesions appear to be decisive for studying the risk of conversion. our first objective is to prospectively collect data to identify the subjects who present a higher risk of developing a first clinical demyelinating event and the progression of the disease in these subjects. among the objectives of this worldwide cohort is the analysis of (1) environmental factors (vit d, ebv, tobacco...), (2) mri biomarkers, including atrophy, central veins signs, paramagnetic rings, and dti. (3) digital biomarkers (4) oculography (5) biological markers to summarize, this cohort will allow for analyzing features in imaging, biology and the exploration of digital and oculographic characteristics to identify predictive factors of clinical evolution of a large cohort of subjects presenting wm abnormalities suggestive of multiple sclerosis.


Eligibility criteria:
inclusion criteria: * white matter t2 lesions suggestive of demyelination * asymptomatic * normal neurological exam exclusion criteria: * abnormal neurological exam, * suspicion of another disease explaining mri lesions.
motivob-(acceptance and commitment therapy group intervention for obesity)section

Conditions: Obesity

Summary: the purpose of the present study is to compare an acceptance and commitment therapy (act) group intervention and a cognitive behavioral therapy (cbt) group in a sample of obese individuals with respect to mid-term outcome.

effective weight-management programs often include a combination of physical activity, diet, and psychological intervention, in particular cognitive behavioral therapy (cbt). the effects of these programs are frequently not stable, and usually the maintenance of achieved weight-loss lasts only for a short period of time. acceptance and commitment therapy, act, keeps on gaining recognition in obesity treatment. the purpose of the study is to compare weight loss and indicator of psychological functioning in a population of obese subjects belonging to three different diagnostic categories: without ed, with ed nas and with bed. participants were exposed respectively to a cbt or an act treatment and were assessed three times: pre intervention, post intervention and follow-up. the investigators hypothesize that cbt and act are both effective in the post-intervention. act intervention should be more effective in the follow-up both for weight and psychological functioning, due to its focus on the flexible managing of the global context instead of the focus on the pathology itself, more typical in standard cbt treatment.

Eligibility criteria:
inclusion criteria: 1. between the ages of 18 and 70 years 2. obesity according to the who criteria (bmi ≥ 30) 3. fluency in spoken and written italian language 4. expression of written informed consent exclusion criteria: 1. other severe psychiatric disturbance different form eating disorders diagnosed by dsm-5 criteria (scid-structured clinical interview for dsm-iv-tr disorders i and ii and dsm 5 manual, administered by an independent clinical psychologist, were used as screening tools for psychiatric disorders) 2. concurrent severe medical condition not related to obesity

Keywords: act cbt obesity eating disorders health psychology
small doses of pituitrin versus norepinephrine for the management of vasoplegic syndrome in patients after cardiac surgery

Conditions: Postoperative Vasoplegic Syndrome

Summary: vasoplegic syndrome is a common complication after cardiac surgery. low dose vasopressin can up-regulate blood pressure and improve clinical outcomes compared with norepinephrine (mainly acute kidney injury anesthesiology 2017; 126:85-93). pituitrin is used as a substitute for vasopressin in our center, which contains both vasopressin and oxytocin. oxytocin may alleviate inflammatory process-associated kidney injury (peptides 2006;27:2249-57). therefore, the investigators hypothesize pituitrin may be preferable to norepinephrine in the renal protection of patients with vasoplegic syndrome after cardiac surgery. moreover, the serum levels of vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone will be measured.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed as vasoplegic syndrome(defined as mean arterial pressure less than 65 mmhg resistant to fluid challenge and cardiac index greater than 2.2 l/min · m2) within 24 hours after cardiac surgery. exclusion criteria: 1. age \ 75 years. 2. received renal replacement therapy before cardiac surgery. 3. diagnosed as endocrine disease before cardiac surgery. 4. diagnosed as sever peripheral vascular disease before cardiac surgery. 5. extracorporeal membrane oxygenation support before admission. 6. to receive heart transplantation. 7. infection on admission. 8. pregnant or maternal patients. 9. refusal of consent
msc for treatment of cmv infection

Conditions: Stem Cell Transplantation, Hematopoietic; CMV Infection; Hematological Diseases

Summary: the purpose of this study is to evaluate the efficacy of mesenchymal stem cells (msc) in the treatment of refractory cytomegalovirus (cmv) infection after allogeneic hematopoietic stem cell transplantation (allo-hsct).

viral infections are common complications after allo-hsct. with wide use of hla-mismatch, unrelated and cord blood donors as alternative sources of hematopoietic stem cells, and anti-thymocyte globulin (atg) as the standard prophylaxis of graft versus host disease (gvhd) in hla-mismatch and unrelated donor transplantation, allo-hsct recipients are at increasing risk for viral infections. till now, cmv remains one of the most important viruses and causes of death in the recipients of allo-hsct. approximately 75% of cmv-seropositive recipients develop cmv reactivation, and 20-30% of these patients develop cmv disease without intervention. ganciclovir is the first-line treatment of cmv diseases. however, bone marrow suppression, which is the main and common side effect, limits the utility of ganciclovir in allo-hsct recipients. besides, ganciclovir and other antiviral agents resistance has been reported up to 28%. since it has been known that specific immune response to cmv is important to control reactivation, cmv-specific ctl has been used in prophylaxis and treatment of cmv viremia in several studies. however, the production of ctl requires time. mesenchymal stem cells (msc) are a form of multipotent adult stem cells that can be isolated from bone marrow (bm), adipose tissue, and cord blood. in vivo experiment showed that mscs have antimicrobial activity. in this trial, we will use mscs in the recipients with refractory cmv infections.

Eligibility criteria:
inclusion criteria: * a patient age of 14-65 years * refractory cmv infection or cmv-associated diseases * subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: cmv infection mesenchymal stem cells allogeneic hematopoietic stem cell transplantation
gene-activated matrix for bone tissue repair in maxillofacial surgery

Conditions: Maxillofacial Bone Defects; Alveolar Bone Atrophy; Jaw Fractures; Maxillofacial Bone Deformities; Bone Neoplasm, Benign; Disorders of Teeth and Jaw

Summary: the purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("nucleostim") for regeneration of bone tissue in maxillofacial area. patients with congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy will be included into the study.

all patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. maxillofacial bone defects (formed after injuries, surgeries, excision of benign neoplasms and pseudotumors, teeth extraction, etc.) or areas of alveolar bone atrophy will be the filled by gene-activated matrix "nucleostim". safety and efficacy of implanted osteoplastic material will be assessed by physical examination, comprehensive laboratory tests, x-ray examination within 60 days after operation.

Eligibility criteria:
inclusion criteria: * obtained voluntary informed consent for participation in the clinical study; * congenital and acquired maxillofacial bone defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy. exclusion criteria: * not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study; * decompensated chronic visceral diseases; * clinically significant laboratory abnormalities; * hiv, hbv and hcv antibodies in serum; * alcohol consumption within 4 days prior the study; * history of drug addiction; * participation in other clinical studies (or administration of study products) within 3 months prior the study; * conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.); * malignancies including post-surgical period with chemo- and (or) radiation therapy); * vascular malformations; * pregnancy or lactation.

Keywords: maxillofacial bone defects alveolar ridge atrophy gene-activated matrix vegf gene dna plasmid bone gene therapy
the effect of nutritional formula supplementation on linear growth of growth hormone (gh) treated prepubertal children with idiopathic short stature (iss) after 2 years from the beginning of gh-therapy

Conditions: ISS- Idiopathic Short Stature

Summary: the proposed study is a double blind, randomized, placebo controlled study. the aim of the study is to evaluate the effect of combined growth hormone (gh) treatment \&nutritional formula supplementation versus gh \& placebo on growth parameters in 64 children with idiopathic short stature (iss) after the second year of gh treatment. participants will be randomly assigned either to the intervention group or the placebo control group. randomization for the two study groups will be made in a ratio of 1:1. both participants and study team will be blinded to the type of treatment that each patient will receive during the study. the randomization will be done according to gender. participants in the intervention groups will be treated with the study formula and participants in the control group will be treated with a placebo low caloric formula (powder added to water). the study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.


Eligibility criteria:
inclusion criteria: 1. gh treatment for at least 24 months due to idiopathic short stature (iss) 2. age 5-10 years inclusive. 3. tanner stage 1 (gonadarche). 4. bmi \<85 percentile for age and gender. exclusion criteria: 1. sga/ iugr 2. diagnosis of gh deficiency 3. any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardial, renal or pulmonary problems, metabolic disorders. 4. any known gastrointestinal problem including absorption problems. 5. any chronic treatment with medication that might affect appetite, weight or growth (for example ssri's, steroids). 6. any eating disorders and/or psychiatric disorder 7. milk or other food allergies
doors: a research study to understand how oral semaglutide works in people with type 2 diabetes who change from dipeptidyl peptidase-4 inhibitor (dpp4i) treatment to oral semaglutide in italy

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who change their treatment from dpp4i to oral semaglutide. participant will get oral semaglutide as prescribed by the study doctor. the study will last for about 5-6 months. participants will be asked to complete two questionnaires. one will be about eating behaviour and the other one will be diabetes related. participant will complete this questionnaire during the normal scheduled visit with study doctor. participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * the decision to switch from dpp4i treatment to commercially available oral semaglutide has been made by the participant/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the participant in this study * participant with last measurement of hba1c \>= 7.5% at informed consent and treatment initiation visit (v1) or less than or equal to (\<=) 90 days before informed consent and treatment initiation visit (v1) * treatment naïve to insulin. an exception is short-term insulin treatment for acute illness for a total of \< 14 days exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the informed consent and treatment initiation visit (v1) and throughout the duration of the study * participants with type-1 diabetes * participants who are pregnant or who become pregnant (or who plan to become pregnant) during the study period * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * age \< 18 years on the informed consent and treatment initiation visit (v1)
diagnostic accuracy of the central venous pressure (cvp) variation to predict fluid responsiveness in spontaneously breathing patients

Conditions: Breathing

Summary: volume expansion (ve) is often administered in intensive care (icu)-patient to improve arterial oxygen delivery. such effect is secondary to an increase in stroke volume and cardiac output. however, cardiac output increase in response to ve (fluid responsiveness) only occurs when the heart is preload-dependant. increasing evidence of the deleterious effects of inappropriate fluid administration encourages the development of variables predicting fluid responsiveness, but few have been validated in spontaneously breathing patients. central venous pressure (cvp) variation in spontaneously patients during standardized or unstandardized inspiratory maneuver may represent an easy tool to predict fluid responsiveness. the hypothesise is that inspiratory maneuver may increase cvp variation in fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.


Eligibility criteria:
inclusion criteria * spontaneous breathing without mechanical assistance * central venous catheter (superior vena cava) and monitoring of central venous pressure * urinary catheter and monitoring of intra-abdominal pressure exclusion criteria: * intolerance to ventilatory manœuvre including severe basal dyspnea/symptomatic heart failure (pulmonary edema) * contraindication to passive leg raising (intracranial hypertension) * passive leg raising unsuitable for measuring hemodynamic response : high grade aortic insufficiency/ poor echogenicity unsuitable to measure the velocity-time /integral of aortic blood flow/ pregnancy/abdominal hypertension with abdominal compartment syndrome/ lower leg amputation * necessity of urgent hemodynamic therapy (within 90 min) * modification of hemodynamic therapy during study protocol (vascular filling, increase catecholamine dose

Keywords: volume expansion fluid responsiveness critically ill patient spontaneously breathing patient central venous pressure variation
interest in the use of dressings with honey for wound healing after excision of pilonidal cyst

Conditions: Pilonidal Cysts

Summary: the management of pilonidal cysts is a skin excision and under deep skin. scarring requires regular dressings (daily for 15 days and then every 48 hours) until complete healing. this healing is obtained on average in 68 days. some patients have difficulties in healing with a final healing achieved on average in 95 days. some teams use honey to promote wound cavitary wounds (wound infection, pressure ulcers, varicose wound). the acceleration of wound healing is due to antibacterial properties and hyperosmolarity to reduce secretions. ) the use of honey in pilonidal cysts is not evaluated and may accelerate healing.


Eligibility criteria:
inclusion criteria: * cavity wound to 6 weeks of a pilonidal cyst excision * bloodless wound * pilonidal cyst not recurred * age : 18 years and older * signature of informed consent * in the capacity to understand the study exclusion criteria: * bleeding wound * refused to participate in protocol * patient immunocompromised * recurrent pilonidal cyst * patients on long-term corticosteroid * patient deprived of liberty, under guardianship * patient unable to understand the study * allergy or hypersensitivity to honey * allergy or hypersensitivity to hyaluronic acid * allergy or hypersensitivity to guar gum * allergy or hypersensitivity to pectin * known allergy to propolis (potentially present in honey) * sensitivity to zinc oxide * sensitivity known dressings used in this trial or any component * diabetes non-insulin or insulin

Keywords: pilonidal cysts cavity wound long healing honey
patient's quality of life assessment 5 to 10 years after hospitalization in intensive care unit for a severe bacterial infection

Conditions: Quality of Life; Sequela

Summary: the aim of this study is to assess patient's quality of life 5 to 10 years after a severe bacterial infection with hospitalization in a intensive unit care. the population is derived from the diabact iii study. the investigators will include every patient still alive. to evaluate our question, patients and their parents will answer quality of life questionnaires. the investigators will also have telephone interviews with the parents to know somatic and psychological effects on their child. the investigators will see if quality of life and sequelae differ depending on various studied factors.

the aim of this study is to assess patient's quality of life 5 to 10 years after hospitalization in intensive car unit for a severe bacterial infection. the population is derived from diabact iii study, and includes all patients still alive. to evaluate their quality of life, patients and parents will answer specific questionnaries. the pediatric quality of life inventory (pedsql) has various versions for children depending on their age, adults and parents. the investigators will get physical, emotional, social and academic scores. to assess somatic and psychological effect after the severe bacterial infection, the investigators will have telephone interviews with the parents, with many questions about organs disorders, specialized medical follow-up, medication, need physical or material assistance, financial and psychological family impact... the investigators will examine data from diabact iii study to assess determinants of the quality of life for these patients.

Eligibility criteria:
inclusion criteria: * every patients from diabact iii study still alive at the beginning of this study exclusion criteria: * patients who did not respond to the questionnaire * inability to contact the patient and family * no fixed postal address

Keywords: severe bacterial infection quality of life long term sequela pediatric intensive care unit children