Kornimate/medical-research-clean huggingface dataset:
safety of anticoagulant therapy after endoscopic treatment

Conditions: Cirrhosis; Portal Vein Thrombosis; Esophageal and Gastric Varices; Anticoagulant-induced Bleeding

Summary: the investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (nws) anticoagulation therapy after endoscopic therapy in pvt patients with cirrhosis and avb.

acute variceal bleeding is one of the most serious complications of liver cirrhosis and is associated with significant morbidity and mortality. portal vein thrombosis (pvt) aggravates portal hypertension and worsens hemorrhage, which increases the risk of endoscopic therapy, and pvt has been shown to be associated with a longer time to variceal eradication, a higher risk of variceal relapse and rebleeding. so, pvt should be treated earlier. data regarding the safety and initiation time of anticoagulant therapy in pvt patients with variceal bleeding after endoscopic therapy is lacking. aim of this study is to verify the efficacy and safety of nws anticoagulation therapy in pvt patients with cirrhosis and avb after endoscopic therapy and further to explored the appropriate initiation time of nws anticoagulation therapy after evl in these patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cirrhosis * portal hypertension with esophageal and gastric varices * diagnosis of pvt by imaging examination * undergo endoscopic therapy exclusion criteria: * older than 75 years * uncontrolled active bleeding * hepatocellular carcinoma or other extrahepatic malignancy * on-going or received antithrombotic/thrombolytic treatment * previous treatment with tipss * cavernous transformation of the portal vein * platelet count lower than 10\*10 \^ 9/l, creatinine more than 170 μmol/l * budd-chiari syndrome * pregnancy or breast-feeding period * severe cardiopulmonary diseases, severe systemic infection or sepsis * inability to sign informed consent

Keywords: endoscopic therapy endoscopic variceal band ligation warfarin nadroparin calcium
fluciclovine (18f) imaging of breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to find out what a new amino acid-based pet agent, fluciclovine (18f), can tell us about breast cancer biology (how it grows and develops), and quantify the differences in fluciclovine (18f) uptake between breast cancer subtypes. this will inform further work to investigate its use in breast cancer management.


Eligibility criteria:
inclusion criteria: 1. biopsy proven breast cancer (invasive ductal or ductal carcinoma in situ (dcis)) measuring ≥ 1.5cm * tumour size should be based on the longest diameter measured on ultrasound, mammogram or mri performed within 2 months prior to enrolment. 2. no prior treatment for breast cancer. 3. female, age \>= 40 years. 4. the patient is willing and able to comply with the protocol scheduled visits and examinations for the duration of the study. women of childbearing potential must follow contraception guidance given as standard of care at breast cancer diagnosis. 5. written (signed and dated) informed consent. exclusion criteria: 1. pregnant or breastfeeding women 2. major surgery or significant traumatic injury within four weeks prior to enrolment. 3. treatment with any other investigational agent, or participation in another interventional clinical study within 4 weeks prior to enrolment. 4. multifocal breast cancer (defined as more than two tumours, either unilateral or bilateral). 5. known hypersensitivity to fluciclovine (18f) or any of its constituents. 6. other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results. 7. any other active malignancy or any previous diagnosis of melanoma.
image biomarkers for progression of amd

Conditions: AMD

Summary: to study qualitatively and quantitatively the imaging biomarkers (ibs) on multi-modal imaging with novel technologies (mint), in order to understand their role in prediction of the age-related macular degeneration (amd) progression in eyes with and without treatment. the understanding of ibs will allow early detection of amd, prediction of its evolution, and guidance for the best options for stratified/individualized treatment of amd.

the qualitative studies will explore use of oct angiography (octa), swept source oct (ss-oct), ultra-wide field fluorescein angiography (uwf-fa), adaptive optic scanning laser ophthalmoscopy (ao-slo), fluorescence lifetime imaging ophthalmoscopy (flio), retro mode imaging (rmi) and other novel technologies for the retinal diagnosis. morphologic qualitative ibs described in the literature like macular neovascularization pattern, retinal tubulations, choriocapillary preservation, retinal pigment epithelium atrophy, drusen patterns, etc as well as other ibpamd original ibs classified in morphopathogenic categories like ibs related-to-mnv, ibs related-to-atrophy, ibs related-to macular chorio-retinal architecture, etc are analyzed in granular fashion by multi-modal imaging approach before and after different treatments for amd. the quantitative ibs assessment will be done in dual mode - classic and original to the ibpamd trial. the lesions are quantitatively assessed on one hand, by using the classic measurements of the greatest diameter, total lesions area, vessels density, fractal dimension, etc, based on the classic concept of measurements expressed in absolute values (mm, mm2 or pixels). the same lesions are quantitatively assessed by using the original ibpamd algorithm and software (site-app) that introduce a new concept in the quantification of the retinal lesions, the assessment of differences reported to the baseline.

Eligibility criteria:
inclusion criteria: * being male or female * at least 18 years of age * varied ethnic backgrounds (different ethnic groups have different structures of eye anatomy and we must be able to make ethnic subgroups to account for these differences) exclusion criteria: * vulnerable patients * patients under 18 * pregnant (we exclude pregnant women because pregnancy often can alter eye anatomy) * economically and educationally disadvantaged * decision impaired * homeless people.
post-operative pain in 2shape versus protaper next rotary systems

Conditions: Pulpitis

Summary: pain after endodontic treatment is considered the most disturbing problem facing both the patient and the dentist especially in cases of symptomatic pulpitis as the patient is expecting to relief the pain that already exists.therefore, this study aims to find a solution for the post-operative pain felt by the patient with symptomatic pulpitis in mandibular molars through comparing post-operative pain following use of 2shape and protaper next rotary systems.

root canal preparation is the most important step in endodontic treatment. for successful treatment, pulp tissue, dentin debris and microorganisms should be completely eradicated from the root canal system.however, it has been reported that all the instrumentation techniques (manual or mechanical) cause debris extrusion into the periradicular tissue resulting in periapical inflammation that causes post-operative pain and flare up. instrumentation technique and instrument design were found to be related to the amount of debris extruded which is the main cause of post-operative pain. it has been reported that rotary niti systems cause less debris extrusion than manual instrumentation. within niti systems, instrument design, taper and tip size were found to affect debris extrusion. therefore, new innovations in the instrument designs are introduced in order to reduce post-operative pain and flare up incidence. therefore, this study is established to compare the effect of 2 different rotary systems on postoperative pain in patients with symptomatic pulpitis. the aim of the present study is to assess the effect of rotary instrumentation using protaper next rotary system versus 2shape rotary system on postoperative pain and the number of analgesics taken by the patient following single visit root canal treatment in mandibular molars with symptomatic pulpitis. primary objective: comparing the intensity of post-operative pain using numerical rating scale (nrs) immediately after root canal treatment and post-appointment at 6, 12, 24, 48 and 72hours. secondary objectives: * the need for / and number of analgesic tablets taken within 3 days after end of endodontic treatment. * instrument separation during instrumentation.

Eligibility criteria:
inclusion criteria: * - medically free patients. * patients with symptomatic pulpitis in one of their mandibular molars. * patient's age ranges between 22 to 45 years with no sex predilection. * patients who can understand numerical analogue scales (nrs). * patients able to sign informed consent. exclusion criteria: * - patients having a systemic disorder. * presence of periapical lesion. * pregnant females. * patients who had taken analgesics during the last 12 hours preoperatively. * patients having active pain in more than one tooth. * non- educated patients.

Keywords: mandibular molars
barrett's dysplasia detection pilot trial using the nvisionvle® imaging system

Conditions: Barrett's Esophagus

Summary: the nvisionvle® dysplasia detection pilot study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of be with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for be surveillance by a standard procedure called egd (esophagogastroduodenoscopy) as well as an imaging procedure called vle (volumetric laser endomicroscopy).

the nvisionvle® dysplasia detection pilot study is a collection of data for research. participation is completely voluntary and does not affect the patient's medical care that chooses not to participate. the purpose of this study is to determine the performance of the nvisionvle® imaging system in determining features of dysplastic barrett's esophagus (be). this is done by the collection and analysis of the medical record information, imaging data, and pathology results. the information is then stored and may be used at a later time for various future analyses and publications. any future analyses involving this study will only use the information collected in this study. no further involvement or additional informed consent of participants will be needed if future analyses are performed. this study is designed for participants who have a prior biopsy-confirmed diagnosis of be with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for be surveillance by a standard procedure called egd (esophagogastroduodenoscopy) as well as an imaging procedure called vle (volumetric laser endomicroscopy). the nvisionvle® imaging system is cleared for use by the u.s. food and drug administration (fda). patients who undergo an endoscopic evaluation of the esophagus with the nvisionvle® imaging system at participating hospitals will be invited to participate in this study. the study is taking place at up to 4 hospitals, and as many as 100 patients may participate in this study.

Eligibility criteria:
inclusion criteria: * patients over the age of 18. * patients undergoing an upper endoscopy for be surveillance with prior biopsy-confirmed be with dysplasia (at least lgd). * ability to provide written, informed consent. * no significant esophagitis (la grade \< b, c and d). exclusion criteria: * patients who have achieved complete remission of intestinal metaplasia (cr-im) * patients without visible be at time of study egd. * patients for whom use of the nvisionvle device would be in conflict with the instructions for use (ifu). * prior esophageal or gastric surgical resection. * significant esophageal stricture requiring dilatation. * patients who require anticoagulation for whom biopsy would be contraindicated. * patients who are known to be pregnant.

Keywords: barrett's esophagus barrett's oct vle
using microbial genomics to elucidate the source of central-line associated bloodstream infections

Conditions: Laboratory-confirmed Bloodstream Infection; Central Line-associated Bloodstream Infections; Mucosal Barrier Injury

Summary: central line-associated bloodstream infections (clabsis) are the most common healthcare-associated infection in children and are associated with morbidity and mortality. this study will attempt to identify the source of bloodstream infections (bsis) in children with clabsi because we hypothesize that many of the bsis that are currently classified as clabsis are actually laboratory-confirmed bloodstream infections (lcbi) that may be a result of mucosal barrier injury (mbi), also known as mbi-lcbi. in order to study this, we will isolate bacteria from multiple body sites of children that have bsi in order to compare these bacteria to the strain growing in their blood using whole-genome dna sequencing. we will also evaluate biomarkers of mbi of the respiratory tract and gi tract.

this is a prospective cohort pilot study at boston children's hospital (bch) that will explore the source of presumed clabsi, which we believe may actually have multiple possible sources including mbi. we plan to enroll all inpatient children at bch who meet the centers for disease control and prevention (cdc) definition of mbi-lcbi as well as children who meet the criteria for clabsi without mbi. for all enrolled patients, we will collect samples from the oral cavity, respiratory tract, skin, and stool. these samples will be cultured in order to see if the same microbial species and strain(s) growing from the blood also grow from these other sites. cultures will then have isolated colonies selected for whole-genome dna sequencing to allow assessment of genomic diversity between body sites. stool and blood samples will be tested for markers of mbi. all patient enrollment and sample collection will be done at bch.

Eligibility criteria:
inclusion criteria: * hospitalized at boston children's hospital * central venous catheter of any type including peripherally inserted central catheters (picc) in any location. * laboratory-confirmed bloodstream infection (lcbi) diagnosed by a clinical blood culture growing certain gram-negative rods exclusion criteria: * patients with cdc-defined secondary bloodstream infections

Keywords: central line-associated bloodstream infections mucosal barrier injury laboratory-confirmed bloodstream infection
accuracy of computer guided surgery (vs) conventional model surgery in treatment of skeletal open bite

Conditions: Apertognathia

Summary: in patient with skeletal open bite, dose computer-aided surgery enhances the clinical outcomes and accuracy versus conventional model surgery

p adult patients with skeletal open bite. i computer guided surgery. c conventional articulating model surgery o outcome measure: outcome name measuring device measuring unit (mm) o1 accuracy computer guided: super-imposition of virtual surgery over the post- operative ct scan composite models ( millimeter mm) conventional : super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion ( millimeter mm) o2 anterior open bite closure standardized multi scan ct (millimeter mm)

Eligibility criteria:
inclusion criteria: * patients suffering from skeletal open bite caused by vertical posterior maxillary excess and/or short mandible ramus. * patients should be free from any systemic disease that may affect normal healing, and predictable outcome. * required two jaws orthographic surgery exclusion criteria: * patients with any systemic disease that may affect normal healing * intra-bony lesions or infections that may retard the osteotomy healing. * patient with bad oral hygiene. * uncontrolled diabetes mellitus.

Keywords: skeletal open bite
mmept for traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the primary purpose of this research is to increase adherence to outpatient rehabilitation of chronically underserved individuals with traumatic brain injury (tbi). the intervention will be a tbi rehabilitation-focused education tool suitable for use with a wide variety of patients, including those with poor literacy skills and those with limited english proficiency (lep), hereafter referred to as the multimedia multicultural educational program for tbi (mmept).


Eligibility criteria:
inclusion criteria: * a medically documented (e.g., ems report, hospital record, physician record) tbi as a result of a blow to the head requiring admission to an acute inpatient rehabilitation unit, meeting at least one of the following criteria for moderate to severe tbi: 1. pta \> 24 hours 2. trauma related intracranial neuroimaging abnormalities 3. loss of consciousness exceeding 30 minutes 4. gcs in emergency department of less than 13 (unless due to intubation, sedation or intoxication) * proficient in chinese (mandarin or cantonese), spanish or english, * willing to engage in the mmept and complete questionnaires, * agreeing to participate (i.e., completion of informed consent and hipaa documents). exclusion criteria: * preferred language (language with greatest proficiency) other than english, chinese or spanish, * in minimally conscious or vegetative state, * significant symptoms of receptive aphasia, and * any acute medical condition that, in the investigator's opinion, makes the person unsuitable or unable to participate. participants enrolled in the study who are ultimately not discharged to the community at the completion of acute inpatient rehabilitation will be removed from the study.
mindfulness surgical pain outcomes

Conditions: Post Surgical Pain; Surgery

Summary: this will be a prospective randomized study to evaluate novel, clinically feasible, easily deliverable, pragmatic ways of preemptively modifying known cpsp and behavioral risk factors for acute to chronic pain transitions in adolescents before surgery. in addition, it will provide mechanistic insights and build a strong foundation for future large scale interventional studies that can impact outcomes positively in children undergoing surgery.


Eligibility criteria:
inclusion criteria: 1. aged 10-18 years 2. english speaking 3. ability to provide assent/consent/parent permission 4. scheduled to undergo elective major musculoskeletal surgeries including spine fusion (idiopathic scoliosis only), abdominal surgeries, thoracic surgery including pectus repair, and major orthopedic joint surgeries. exclusion criteria: 1. previous exposure to psychological interventions 2. surgery within 1 year 3. developmental delay 4. chronic opioid use within 6 months prior to surgery 5. severe systemic disease
modulation of visual-spatial learning in patients with mild cognitive impairment (mci) by tdcs

Conditions: Mild Cognitive Impairment (MCI)

Summary: the aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (locato task) with anodal transcranial direct current stimulation (tdcs) leads to an improvement in learning and memory in patients with mild cognitive impairment (mci) and to examine the underlying neuronal mechanism.


Eligibility criteria:
inclusion criteria (mci patients): * right handedness * amnestic and amnestic plus mci with: 1. subjective memory impairment; 2. objective memory difficulties, at least 1 sd below gender, age and education adjusted standard values; 3. relatively normal performance in other cognitive domains; 4. no constraints in activities of daily livings 5. age: 50-90 years exclusion criteria: * severe internal or psychiatric disease * epilepsy * other severe neurological diseases, e.g. previous major stroke or brain tumor * dms-iv manifest dementia * contraindication for mrt (claustrophobia, metallic implants, tattoos)

Keywords: mild cognitive impairment (mci) tdcs locato task visual-spatial learning
investigation of the naída ci m90 sound processor in various acoustic scenarios

Conditions: Cochlear Hearing Loss

Summary: in this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of naída link m90 hearing aid and naída ci m90 sound processor on sound perception. this design was shown to be successful in previous studies for the evaluation of sound coding strategies. furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population that uses the investigational device is not large in general.


Eligibility criteria:
inclusion criteria: * ci users with a cii, hires90k (advantage) or hires ultra implant system * bilateral users: two implant systems * bimodal users: hearing aid contralateral * minimum of 18 years of age * minimum of six months experience with their implant system * minimum of six months experience with the naída ci q-series sound processor * ability to give feedback on sound quality * speech intelligibility with the hsm sentence test in noise at 10 db snr \> 10% as obtained during previous visits in the clinical routine * fluent in german language exclusion criteria: * difficulties additional to hearing impairment that would interfere with the study procedures * concurrent participation in other study * pregnant and breast-feeding women