Kornimate/medical-research-clean huggingface dataset:
management of traumatic bone defects in tibial plateau fractures with antibiotic-impregnated biodegradable calcium sulfate beads: a prospective clinical trial

Conditions: Tibial Fractures; Intra-Articular Fractures; Fracture Fixation, Internal

Summary: this is a prospective clinical trial of tibial plateau fractures treated with internal fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into various bead sizes for implantation into bone defects. the graft material chosen for this study is stimulan rapid cure (biocomposites, uk), which is approved for use as a bone void filler and may be mixed with a variety of antibiotics. the combination of stimulan + antibiotic in bead form is the "study device". our primary study aim is to look at resorption and remodeling of the study device into bone. another important aim of the study is to look at subsidence, or collapse, of the joint surface.


Eligibility criteria:
inclusion criteria: * adult (skeletally mature) men or women; * acute, closed, tibial plateau fractures, schatzker grade 1 through 5; * internal fixation and use of study device per protocol; * fracture repair within 30 days of injury; * signed informed consent to participate in study. exclusion criteria: * uncontrolled diabetes; * severe degenerative or metabolic bone disease; * malignancy; * severe vascular or neurologic disease; * alcoholism; * substance abuse; * use of systemic steroids; * immunosuppressive therapy; * hypercalcaemia; * renal-compromised patients; * osteomyelitis or chronic infection in the study limb; * women who are pregnant or breast-feeding.
mutation detection for vrl

Conditions: Vitreoretinal Lymphoma; Uveitis

Summary: vitreoretinal lymphoma (vrl) is a rare but aggressive masquerade syndrome, which would be easily confused with uveitis. the diagnostic gold standard remains the pathologic examination of ocular specimen with invasiveness and low sensitivity. to improve the safety and accuracy of vrl diagnosis, alternative techniques using intraocular fluid (iof) samples are emerging. in this study, we aimed to test the diagnostic value of mutation analysis for vrl

chest ct, urinalysis, kidney, and liver function were routinely checked. il-10/il-6 ratio, genetic mutation analysis and samples were igh gene rearrangements were reviewed and analyzed retrospectively. the diagnoses were identified after careful evaluation of treatment effects in follow-up. the diagnostic value including sensitivity, specificity, positive and negative predictive values, and test efficiency of genetic mutation analysis in diagnosing vrl were analyzed. furthermore, a validation group of patients including vrl and uveitis was selected to validate the diagnostic value of mutation analysis in the diagnosis of vrl. all the patients signed an informed consent and institutional review board approval was obtained. the study was performed in accordance with the tenets of the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * suspected vrl patients who had intraocular fluid for mutation test. and got a clear diagnose of vrl or uveitis afther having dianostic tests and follow-up treatment exclusion criteria: * suspected vrl patients who lost in follow-up without a definitive diagnose, or whoever reluctance to participate our study

Keywords: vitreoretinal lymphoma uveitis intraocular fluid mutation
unilateral pulmonary edema after minimal-invasive mitral valve surgery

Conditions: Pulmonary Edema

Summary: unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. the investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. this is a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure.

unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. the investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. after having studied the available literature on this particular topic the investigators have decided to prepare a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure focusing on radiological and clinical signs of unilateral pulmonary edema.

Eligibility criteria:
inclusion criteria: * \>= 18 years of age exclusion criteria: * urgent surgery

Keywords: minimal-invasive surgery, mitral valve
ofatumumab in aqp4-igg seropositive nmosd

Conditions: Neuromyelitis Optica Spectrum Disorder

Summary: this is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with aqp4-igg seropositive neuromyelitis optica spectrum disorder (nmosd) in china.

neuromyelitis optica spectrum disorder (nmosd) is a rare but severe demyelinating disorder that affects mainly adult patients. it is associated with a pathological b cell-mediated humoral immune response against the aquaporin-4 (aqp4) water channel. monoclonal antibodies against cd20 have been shown to be effective for prevention of relapses in patients with nmosd, and therefore been recommended as first-line therapy for this disorder. ofatumumab (ofa), a fully humanized anti-cd20 monoclonal antibody, has been approved for multiple sclerosis treatment. however, prospective multicenter studies are needed to determine the efficacy and safety of ofatumumab in treating nmosd.

Eligibility criteria:
inclusion criteria: * diagnosis of nmosd according to the 2015 international panel diagnostic criteria for nmosd with aqp4-igg. * clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months. * adults aged ≥18 years old. * expanded disability status scale (edss) score between 0 and 7.5 (inclusive). * provision of written informed consent to participate in this study. * only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month. * effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication. exclusion criteria: * progressive neurological deterioration unrelated to relapses of nmosd, or presence of neurological findings suspected with pml. * pregnant or breastfeeding patients and those with family planning during the study period. * patients participating in any other clinical therapeutic study at the screening or within 30 days of screening. * patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period. * presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression. * active infection at within 4 weeks before baseline. * positive for hbv or hcv. * evidence of latent or active tuberculosis (tb). * have received any live or live-attenuated vaccine within 6 weeks before baseline. * history of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ. * history of severe allergic reactions to biological agents. * inability to provide written informed consent.

Keywords: neuromyelitis optica spectrum disorder aquaporin 4 ofatumumab
a longitudinal observational study of the natural history and management of patients with hcc

Conditions: Hepatocellular Cancer

Summary: target-hcc is a longitudinal, observational study of patients being managed for hcc in usual clinical practice. target-hcc will create a research registry of participants with hcc within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.


Eligibility criteria:
inclusion criteria: 1. male or female patients, age ≥18 years 2. patients with a histological/cytological or radiological diagnosis of hcc (mixed hcc cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific hcc therapy may be included) exclusion criteria: 1. inability to provide written informed consent
u/s guided sapb versus conventional iv analgesics in postoperative pain management in mrm

Conditions: Injection Site Haematoma; Local Anesthetic Toxicity

Summary: the aim of this study is to compare the effect of ultra-sound guided serratus anterior plane block versus conventional iv analgesics in postoperative pain management in modified radical mastectomy (mrm)

all patients undergoing modified radical mastectomy were assigned to one of the following two groups:group a: serratus anterior plane block group (sapb group): this group consists of 20 patients who received ultra sound guided serratus anterior plane block just after induction of anesthesia and group b: iv analgesics group (control group): this group consists of 20 patients who did not receive any type of block.further evaluations were carried out by a different investigator who was unaware of the patients' grouping. the degree of post-operative pain was assessed at: just upon arrival to the pacu, 2, 4, 8, 12 and 24 hours using the vas score and the haemodynamic data and respiratory rate were measured during the first 24 hours after the end of the surgery. postoperative analgesia regimen was standard in both groups; patients from each groups received 1 gm of paracetamol q 8 hours. patients reporting vas ( visual analogue score) score greater than 40, mean arterial blood pressure, heart rate or respiratory rate \>20% from the baseline, were given pethidine (50 mg iv) as rescue analgesic. while, those reporting vas score less than 40 with mean arterial blood pressure, heart rate or respiratory rate \>20% from the baseline but still complaining; ketoralac (30 mg iv) was given with a maximum dose of 120 mg/ day.

Eligibility criteria:
inclusion criteria: * females aged between 20-60 years old. * preoperative physical status: asa (american society of anesthesiology) i \& ii. * body mass index (bmi) \< 35 kg/ m2. * candidate for unilateral modified radical mastectomy. * informed consent to participate in the study. exclusion criteria: * - females aged \ 60 years old. * preoperative physical status: asa iii \& iv. * morbid obese patients with bmi \> 35 kg/ m2. * refusal to participate in the study. * addiction to narcotics or psycho-active drugs. * psychological disorders. * contra-indications to regional anesthesia (coagulopathy, injection site infection or allergy to any of the study drugs)

Keywords: "sapb" "mrm" "pain management"
daily living activities in young adults with cerebral palsy

Conditions: Cerebral Palsy; Sensitivity; Motor Skills Disorders; Activity, Motor

Summary: this study explored the relationship between sensory function and occupational performance in young adults with cerebral palsy. using standardized assessments, researchers compared tactile sensitivity and discrimination between individuals with cp and neurotypical controls, and examined how these sensory variables relate to motor function, adls, and iadls.

background: sensory impairments are increasingly recognized as influential factors in the occupational performance of individuals with cerebral palsy (cp). although prior studies have explored this relationship in children, evidence in young adults remains limited. objective: this study aimed to compare tactile sensitivity and discrimination in young adults with cp and neurotypical individuals, and to examine their association with motor-related variables relevant to occupational performance: muscle tone, grip strength, manual dexterity, activities of daily living (adls), and instrumental activities of daily living (iadls). methods: a multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years. sensory and motor variables were assessed using the semmes-weinstein monofilaments, two-point discrimination test, modified ashworth scale, digital dynamometer, box and block test, functional independence measure, and the lawton and brody scale. conclusion: findings highlight the relevance of sensory function in the occupational performance of young adults with cp. these results underscore the need for occupational therapy interventions that integrate sensory assessments and target sensory-motor integration to improve functional independence and participation.

Eligibility criteria:
inclusion criteria: * young people and adults with a medical diagnosis of cp, who had a motor condition of hemiparesis, diparesis, or tetraparesis; * aged between 16 and 45 years * had a minimum score of 19 on the mini mental state examination cognitive assessment scale * authorized their participation in the study by signing an informed consent form. in cases between the ages of 16 and 18 years, informed consent was signed by the participants and their parents or legal guardians exclusion criteria: * any peripheral nerve injury * shoulder, elbow, wrist or hand injuries * individuals whose mother tongue was neither portuguese nor spanish
lower urinary tract symptoms in systemic sclerosis

Conditions: Urinary Symptoms; Systemic Sclerosis

Summary: urinary symptoms must be frequent in scleroderma. in one hand, mobility limitation by joint stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as narcotic medication use, puts patients at higher risk of secondary bladder filling and voiding dysfunction. in another hand, few case report and small sample observational studies have identified a specific sclerosis of the urinary tract. those two mechanisms must be more frequent in the diffuse cutaneous form of scleroderma (dcssc) compare to the limited one (lcssc). but prevalence or incidence is unknown. urinary symptoms are seldom reported by those suffering from them and are rarely part of a systemic evaluation. in a threatening disease, urinary symptoms assessment might seem to be of no priority. but luts have a real impact on many aspect of everyday living. furthermore urinary tract involvement might predispose to urinary tract infection due to flow limitation and stagnation. since it is an inner fibrosis it might be associated with a more aggressive form of disease conferring a greater loss of physical function, higher risk for hospital admission and death. thus, identifying urinary symptoms would permit to address specific rehabilitation or medication therapy, in order to minimize the consequences of the bothersome symptoms and identify those subjects at higher risk of urinary infection, aggressive disease/loss of function or death. this study will also give basement to build an interventional study directed toward luts treatment in this population. in this prospective cohort we would like to: * compare the prevalence of lower urinary tract symptoms (luts) in diffuse and limited forms of systemic sclerosis. * determine the prevalence (at inclusion) and incidence (in a two years period) of luts among patients suffering from systemic sclerosis. * evaluate the impact of luts symptoms on quality of life. * compare the discrimination ability of cochin-hand score and haq score to predict incontinence in this population. * evaluate the association between luts symptoms, hospital admission rate, urinary tract infection, mortality and loss of autonomy.


Eligibility criteria:
inclusion criteria: adult suffering from systemic sclerosis included in network of brescia (i), geneva (ch), padova (i) and paris (f). exclusion criteria: those unable to understand the rules and implications of the study, end of life patients, the pregnant women and anuric patients

Keywords: urinary symptoms systemic sclerosis severity index urinary tract infection mortality quality of life
assessing the gay male experience with anal cancer prevention strategies

Conditions: Anal Cancer

Summary: the purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (msm), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * current resident of the u.s. * engage in anoreceptive intercourse with male partners * fluent in english or spanish exclusion criteria: * under the age of 18 years old * not living in the united states * not born with sex assigned at birth as male * does not engage in sex with male partners
closed-loop control of overnight glucose levels (artificial pancreas) in children with type 1 diabetes in a diabetes camp

Conditions: Type 1 Diabetes

Summary: closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. a dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. the main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp. the investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (t1d) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia

closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. a dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. the investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. the investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp.

Eligibility criteria:
inclusion criteria: * males or females between the 8 and 17 years of old. * clinical diagnosis of type 1 diabetes for at least one year. the subject will have been on insulin pump therapy for at least 3 months. * hba1c ≤ 11.0%. exclusion criteria: * clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. * severe hypoglycemic episode within two weeks of inclusion in the study. a severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit. * current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). stable doses of inhaled steroids are acceptable. * known or suspected allergy to the trial products. * other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. * failure to comply with team's recommendations (e.g. not willing to use trial pump, etc).

Keywords: type 1 diabetes hypoglycemia insulin glucagon closed-loop system artificial pancreas
ridge preservation following tooth extraction

Conditions: Alveolar Bone Resorption; Tooth Extraction

Summary: an animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (tbs) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. the purpose of this randomized clinical trial is to investigate the effectiveness of tbs application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (arp) approach using allografts and a membrane.

the participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (tbs), and alveolar ridge preservation (arp) groups. the sockets in the non-intervention group will be filled with blood clots only. one tbs will be placed over the labial/buccal plate of the extraction socket in the tbs group on the same day of the extraction. allograft and resorbable collagen membrane will be used for the arp group.

Eligibility criteria:
inclusion criteria: * age ≥18 years * a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally * a tooth requiring extraction exclusion criteria: * thyroid dysfunctions * diabetes mellitus * history of a chronic use of corticosteroids (\>6 months) * history of oral/intravenous bisphosphonates within the past 2 years * smoking * history of other systemic conditions that could affect bone integrity.
mean arterial pressure reduction anesthesia induction using propofol bolus or tritiated target-infusion

Conditions: Hypotension on Induction; Hypnotic Intoxication

Summary: to compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

to compare mean arterial pressure, heart rate and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

Eligibility criteria:
inclusion criteria: * scheduled for general anesthesia; * no contraindication for propofol. exclusion criteria: * data loss; * protocol violation.
epidemiology and diagnosis of haemoptysis: a multicenter study

Conditions: Lung Cancer; Tuberculosis; Bronchiectasis; Pneumonia; Acute Bronchitis; Chronic Obstructive Pulmonary Disease; Cryptogenic Haemoptysis

Summary: haemoptysis is the coughing up of blood originating from the respiratory tract. it is a common and worrying clinical symptom which can be due to different aetiologies including lung cancer, tuberculosis, copd, bronchiectasis, pneumonia, acute bronchitis or unknown origin (cryptogenic haemoptysis). epidemiology and optimal diagnostic approach are largely unclear. aims of this study are to define current epidemiology and to provide the best diagnostic approach by providing a diagnostic algorithm.


Eligibility criteria:
inclusion criteria: * haemoptysis requiring a diagnosis exclusion criteria: * history of known bleeding lesions in the upper or lower airways

Keywords: haemoptysis hemoptysis airway bleeding