Kornimate/medical-research-clean huggingface dataset:
comparison of telavancin and vancomycin for complicated skin and skin structure infections with a focus on methicillin-resistant staphylococcus aureus

Conditions: Staphylococcal Skin Infection

Summary: study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.


Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of one of the following complicated skin and skin structure infections with methicillin resistant staphylococcus aureus (mrsa) either suspected or confirmed as the major cause of the infection: * major abscess requiring surgical incision and drainage * infected burn (see exclusion criteria for important qualifications) * deep/extensive cellulitis * infected ulcer (see exclusion criteria for important qualifications) * wound infections * patients must be expected to require at least 7 days of intravenous antibiotic treatment exclusion criteria: * received more than 24 hours of potentially effective systemic (iv, im or po) antibiotic therapy prior to randomization * burns involving \> 20% of body surface area or third-degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fascitis, gas gangrene, or mediastinitis.

Keywords: staph mrsa csssi
the observer variation of shear wave elastography

Conditions: Thyroid Nodular Disease

Summary: background: the main goal of diagnosing thyroid nodules is to differentiate the few malignant from the large background of benign lesion. currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic surgery is necessary. therefore there is a need to develope the available diagnostic tools for the pre-operative diagnostic work-up of thyroid nodules. the study will investigate a novel ultrasonographic technique called shear wave elastography (swe) in the pre-operative evaluation of thyroid nodules. hypothesis: 1) swe is a precise tool for evaluation of thyroid nodules in terms of inter- and intra-observer reliability and day-to-day variation. the study will be conducted as part of a larger phd study, and an evaluation of the diagnostic value of thyroid swe will be evaluated in a larger study. perspectives: an optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.


Eligibility criteria:
inclusion criteria: * patients with a thyroid nodule ≥1 cm in largest dimension (solitary or dominating nodule in multinodular goiter), * patients undergoing thyroid surgery. exclusion criteria: * nodules located in the isthmus of the thyroid
a prospective study of surgical results, complications and predictive values in chinese women breast reconstruction

Conditions: Breast Reconstruction; Flap Necrosis

Summary: this study prospectively evaluates and compares the effectiveness of icg fluorescence imaging and lsci in predicting the risk of necrosis following direct-to-implant breast reconstruction.

this study prospectively evaluates and compares the effectiveness of indocyanine green (icg) fluorescence imaging and laser speckle contrast imaging (lsci) in predicting the risk of necrosis following direct-to-implant breast reconstruction. the investigation includes both intraoperative and postoperative assessments of flap perfusion, with a focus on identifying specific thresholds for necrosis prediction. by analyzing the sensitivity, specificity, and predictive accuracy of each technique, the study aims to establish their respective strengths and limitations. additionally, the research aims to explore the feasibility of using these methods in different surgical stages, evaluating their consistency and reliability in monitoring the viability of the skin flap and nipple-areolar complex.

Eligibility criteria:
inclusion criteria: all patients presenting for implant-base reconstruction immediately after mastectomy exclusion criteria: delayed reconstruction, expander removal followed by prothesis implant, icg allergy or intolerance, autologous reconstruction

Keywords: lsci icg breast reconstruction implant-based breast reconstruction flap necrosis
augmented reality bci longitudinal study for persons with late stage als

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Summary: the goal of this study is refine the usability of a bci based communication platform. the study will take place in the greater los angeles area and will enroll up to 10 participants with late stage als. each subject will receive a cognixion axon-r augmented reality brain computer interface and associated communication software. the study duration is 3 months for each participant. the key questions that will be addressed in this study are: 1. how quickly can participants learn and gain confidence with a pure bci interface. 2. how effective are alternate input modalities including eye tracking for this use case. 3. identify the extent to which generative ai based personalization impacts the communication quality. key measures include: itr - information transfer rate sus - system usability scale


Eligibility criteria:
inclusion criteria: * must have someone (lar) who can consent to their participation and who will be present in the study alongside the participant * must have a designated individual who can be trained on the cognixion system * fluent in understanding english * 18 years or older * must have als and need an assistive communication device * must be able to engage in volitional eye opening and sustain eye opening independently for x duration * must have a way to communicate apart from using the cognixion device such as vocalizations, head nod, eye blinks, eyebrow raises, etc. at a minimum, reliable way of communicating "yes" and "no" exclusion criteria: * disruption in english comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia) * severely hearing impaired or deaf * sensitivity to flashing lights * history of epilepsy and/or seizures * vision disorders restricting the visual field such as glaucoma, diplopia (double vision), nystagmus (involuntary eye movements) * history of vertigo or other vestibular disorders * scalp that is prone to irritation, inflammation, injury, or infectious process

Keywords: usability study augmented reality brain computer interface amyotrophic lateral sclerosis als generative ai longitudinal study
powder topical rifampicin on reducing infections after neural tube defect surgery in infants

Conditions: Postoperative Infection Rates

Summary: the correct timing and technique of neural tube defect (ntd) repairs significantly decreases the morbidity and mortality of ntd cases. however, infections related to the surgery are still common. we investigated the effects of topical rifampicin (rif) combined with routine prophylaxis in newborns with open ntd.

the study will be conducted in the yuzuncu yil university neonatal intensive care unit, van, turkey. the data of 60 neonates diagnosed with open ntd, who will be underwent surgical intervention between august 2016 and december 2017, will be prospectively evaluated. these cases will be randomised.these neonates are going to divide into two groups: the experimental group and the control group. the experimental group will be consisted of 30 newborns diagnosed with open ntds, administered topical rif (10 mg/kg/day, 24 h infusion) and cefotaxime (50 mg/kg/day, two doses, iv), and the control group will be consisted of 30 newborns diagnosed with open ntds, administered cefotaxime (50 mg/kg/day, two doses). in this study, researchers will be investigated whether prophylactic topical rif applied on a pre-operative mesh in newborns with open ntd reduce the rate of ssis and meningitis/ vp shunt infections after surgery. for deep incisional primary ssis will be evaluated according to the diagnostic criteria of the united states (u.s.) centers for disease control and prevention (cdc) (1). the diagnosis of vp shunt infections will be made after extensive clinical and laboratory evaluations. the diagnosis of to make shunt infections, criteria of the hydrocephalus clinical research network (hcrn) will be taken into consideration (2). topical rif application procedure the ntd site will be covered with a sterile gauze dressing in the first hours of life after birth in all babies with open ntds. then, 10 mg/kg/day rif will be added to 24 ml of saline (0,9% nacl), and this will be applied to the mesh as an infusion at a 1cc/h speed . every day, the same dose of rif will be delivered to the mesh,changed daily, as a 24-hour infusion until the patient could be operated. after the patient is operated, the rif infusion delivered to the mesh will be stopped. the cefotaxime treatment will be continued until 72 hours post-op (3).

Eligibility criteria:
inclusion criteria: * newborns who have open ntds exclusion criteria: * healthy newborns

Keywords: topical rifampicin, neural tube defects, infection, newborn
special drug use-results surveillance of tafinlar/mekinist

Conditions: BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

Summary: this is a prospective, multicenter, single-arm, non-interventional and observational j-pms conducted by the central registration system and operated in electronic data capture.

in the post-marketing surveillance (pms), dabrafenib and trametinib are used as the marketed drugs. registration of the corresponding patients is to be conducted by the central registered system under current medical practice. target number of adult patient is 65 (as the number of patients in the effectiveness analysis set). target number of pediatric patient is not determined. estimated number of enrolled patients is approximately 20 (as the number of patients in the enrolled set) the observation period for pediatric patients will last after the start of treatment until 8 years (planned, november 2031) after the approval of additional indications, regardless of discontinuation of the product, in order to collect long-term information from as many patients as possible during the reexamination period. the duration of observation for adult patients will be 1 year after the start of treatment with the product.

Eligibility criteria:
inclusion criteria: 1. patients who have given written consent to cooperate in this surveillance 2. for patients aged \< 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment. 3. patients who start treatment with the product for braf-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications exclusion criteria: 1. patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance 2. patients with braf-mutation-positive malignant melanoma 3. patients with braf-mutation-positive non-small cell lung cancer 4. patients with braf-mutation-positive hairy cell leukemia

Keywords: tafinlar dabrafenib mekinist trametinib braf v600e mutation-positive unresectable advanced solid tumor japan recurrent
endoscopic ultrasonography-guided double ethanol lavage for pancreatic cysts: a prospective cohort study

Conditions: Pancreatic Mucinous-Cystic Neoplasm

Summary: due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in abdominal image. these lesions encompass a wide spectrum, ranging from benign to malignant. the diagnosing specific type of cystic lesion is limited in spite of recent advances of diagnostic modalities. surgical resection is generally recommended for malignant and potentially malignant lesions. however, surgical resection has significant morbidity and sometimes mortality. recently, a few study of eus-guided ethanol lavage for cystic tumors of the pancreas reported that complete resolution was achieved in only one-third of patients. ethanol lavage of pancreatic cysts may be alternative method to surgical resection. the purpose of this study is the double ethanol lavage is a safe and effective method for treatment in those with the indeterminate pancreas cysts.


Eligibility criteria:
inclusion criteria: * patients age 18 and older of any gender, ethnicity and race * voluntary enrollment and ability to give written informed consent * capable of safely undergoing endoscopy with deep sedation or general anesthesia * indeterminate cystic lesion which was diagnosed in cross-sectional image (ct and mri) * pancreatic cystic lesion having uni- or oligo-locular (defined as having 2-6 locules within a cyst) and 2\~4 cm in diameter exclusion criteria: * pancreatic cystic lesions which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., recent history of acute pancreatitis or parenchymal changes) * pancreatic cystic lesions having communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde cholangiopancreatography and magnetic resonance cholangiopancreatography * pancreatic cystic lesions having overt evidence of carcinomas, such as peripancreatic invasion * patients with a bleeding tendency (prothrombin time \> 1.5 international normalized ratio \[inr\] or platelet count \< 50,000/μl).

Keywords: cystic tumors of the pancreas endoscopic ultrasound ethanol
effectiveness study of videoconferencing on teaching parent training skills to parents of children with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to evaluate the effectiveness of group parent training taught through videoconferencing on adhd treatment via a comparison between participants using traditional face-to-face parent training sessions and a group using teleconferencing.

subjects with a primary diagnosis of adhd between the ages of 6 and 14 years were enrolled. all subjects were screened and assessed for psychiatric and learning disorders using structured interviews (dica, parent and child version, reich et al, 2000) based on dsm iv criteria and parent and teacher rating scales. mothers took the beck depression inventory (bdi) to assess for depression. parents or primary caregivers were randomized to two treatment arms (videoconference or face to face). ten sessions of weekly parent training through either videoconference or face-to-face delivery was conducted using dr. russell a. barkley's manual. a non-mandatory skill training and play group was offered to the children of both groups while parents attended the parent training group in order to provide child care for the parents during the training sessions. following outcomes will be measured to assess the effectiveness of the intervention: primary outcome acceptance of the parent and children on the mode the communication as well as parent training. secondary outcomes: 1. parent-child relations measured by the parent child relationship questionnaire (pcq) 2. the vanderbilt assessment scale (parent \& teacher versions), children global assessment scale (cgas), clinical global impression- severity score (cgi-s), and clinical global impression-improvement scores (cgi-i) assessed the severity of core symptoms of adhd and oppositional/aggressive symptoms. 3. the parent and teacher-rated versions of the social skills rating system (ssrs) assessed social skills.

Eligibility criteria:
inclusion criteria: * dsm-iv criteria for any subtype of adhd. * adhd must be the primary diagnosis if there is comorbidity. exclusion criteria: * subjects with significant medical conditions, which are not stable on current outpatient treatment regimen. * subjects with severe psychiatric disorders (i.e., bipolar disorder, autism, schizophrenia, major depression).

Keywords: adhd parent training videoconference
efficacy of surgical skin preparation solutions in hip arthroplasty surgery

Conditions: Arthroplasty, Hip Replacement; Infection, Postoperative Wound

Summary: this study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: chloraprep (chlorhexidine-alcohol) and duraprep (iodine-alcohol) at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.

post-operative infections, although rare, can lead to significant patient morbidity and cost. a potential risk factor for the development of post-operative wound infection is the amount of bacterial skin flora present at the operative site at the time of surgery. therefore, the use of an effective anti-microbial preoperative skin-preparation solution is essential in preventing the contamination of the surgical site and in turn the surgical wound. several different types of anti-microbial skin preparation solutions are presently used pre-operatively. however, there is currently no consensus on which solution is superior. previous studies have investigated the efficacy of commonly used solutions in the shoulder, foot and spine, however the bacterial flora from these areas are likely different from the hip region. thus the findings in the literature are not necessarily applicable to surgery involving the hip. because of the potentially devastating consequences of a surgical wound infection, ensuring effective skin preparation prior to surgery is critical. therefore the identification of a superior skin-preparation solution for the elimination of bacterial pathogens, specific to the hip region, could potentially have considerable impact on the clinical care of patients undergoing hip arthroplasty surgery. this study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: chloraprep (chlorhexidine-alcohol) and duraprep (iodine-alcohol), at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.the primary outcome is as follows: positive culture rates of residual bacteria following surgical skin preparation. secondary outcomes that will be evaluated is culture rates post-surgery (following skin closure) and acute (within 3 months) post-operative wound complications.

Eligibility criteria:
inclusion criteria: * has consented for primary total hip arthroplasty by any of the following orthopaedic surgeons: drs. kurt droll, dave puskas or claude cullinan * are capable of providing their own consent * are able to adequately communicate in english to undergo informed consent * has provided written, informed consent for the study exclusion criteria: * previous hip arthroplasty * evidence of an open wound at the incision site * evidence of an abrasion in the vicinity of the planned incision * evidence of an active infection at or near the surgical site * evidence of an active infection elsewhere in the body * are chronically immunosuppressed e.g. transplant * is deemed not suitable for the study in the opinion of an investigator

Keywords: antimicrobial skin solution skin preparation
evaluation of pku sphere

Conditions: Phenylketonurias

Summary: a prospective, open-label study of pku sphere in patients with pku following a phenylalanine restricted therapeutic diet.

the rationale for this study is to assess acceptability, adherence and metabolic control in individuals with pku consuming pku sphere, a gmp-based medical food. the sponsor developed pku sphere in response to growing interest in gmp medical foods for the purpose of improving adherence and quality of life by offering an alternative to amino acid based medical foods. pku sphere is a powdered, low phenylalanine medical food containing a balanced mix of casein glycomacropeptide (gmp) isolate, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and the long chain polyunsaturated fatty acid (lcp); docosahexaenoic acid (dha). pku sphere has been designed for use in the dietary management of phenylketonuria. it is available in two flavors, red berry and vanilla, packaged in individual serving sachets of 35g and containing 20g protein equivalent (pe).

Eligibility criteria:
inclusion criteria: * diagnosis of pku, identified by newborn screening (nbs) and treated since birth. * ages 3 years and above (this includes pregnant women who will be assessed on an individual basis by the co-principal investigators). * currently or previously consuming a low phenylalanine diet supplemented with a medical food designed for the dietary management of pku. * english as primary language. * willingly given, written, informed consent from the participant, 18 or more years, or from the parent/caregiver for participants \< 18 years. * willingly given, written assent (if appropriate) for those \< 18 years. exclusion criteria: * currently consuming 100% of the medical food component of the diet as pku sphere. * an inability, in the opinion of the investigator, to comply with the requirements of the protocol. * any other type of inherited metabolic disease.

Keywords: phenylketonuria gmp sphere child adult phenylalanine pku glycomacropeptide
novel method of surveillance in barrett's esophagus

Conditions: Barrett Esophagus

Summary: this study is being done to see how biomarkers (abnormalities in molecules of cells ) present in their barrett's esophagus agree with results from surveillance biopsies; and to compare three different brush devices used to collect cells to see which of these 3 brush devices obtains a higher number of cells.

during an endoscopy done for clinical surveillance of your barrett's esophagus participants are randomized to one of three brush devices by random chance like a flip of a coin. this is being done to see if one collects more cells than the others. a soft brush will be used to collect cells from the lining of the esophagus, this is known as brush cytology. with the endoscope positioned in your esophagus, samples (biopsies) of lining of the esophagus will then be taken to determine the nature of the barrett's mucosa in the same manner as for any patient undergoing routine surveillance endoscopy for barrett's esophagus. a part of the specimen will be used to store tissue samples that can later be used.

Eligibility criteria:
inclusion criteria: * patient age greater than 18 years of age * prior histological demonstration of barretts esophagus that is endoscopically visible with no dysplasia * low grade, high grade dysplasia or early esophageal cancer exclusion criteria: * none

Keywords: barrett's esophagus reflux dysplasia adenocarcinoma