Kornimate/medical-research-clean huggingface dataset:
topical tranexamic acid for bilateral breast reduction surgery

Conditions: Hematoma Postoperative; Tranexamic Acid

Summary: hematoma is a common complication of bilateral breast reduction (bbr) surgery. this can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. previous studies have shown correlation between the use of tranexamic acid (txa), an anti-fibrinolytic, and reduced post-surgical bleeding complication events. in this randomized control trial (rct) evaluation txa use in bbr, for which one breast will be randomized to have txa applied topically, while the other will have normal saline (ns) placebo applied. the primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical txa in bbr reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. the results of this study will be used to inform the design of a larger multicentered rct on txa in breast surgery.

the primary objective of this study is to investigate the use of topical application of tranexamic acid (txa) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing bilateral breast reduction (bbr). this project is designed as a single-center rct to evaluate the effectiveness of topical txa in this patient population. if enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed. one breast will have an intravenous form of txa applied topically to the surgical site. the other will be have a topical normal saline solution applied to the wound before closure (a placebo). the patients will have the standard number of drains and postoperative instructions for breast reduction. they will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. standard of care will be practiced with respect to all procedures and visits.

Eligibility criteria:
inclusion criteria: * are 18 years or older; * are undergoing bilateral breast reduction at either hamilton health sciences or st. joseph's hospital hamilton. exclusion criteria: * taking therapeutic anticoagulation; * taking antiplatelet drugs; * pregnant or breast feeding; * allergic to txa; * cannot provide informed consent; * have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.

Keywords: breast reduction
sentinel lymph node navigation surgery using near-infrared imaging in early esophageal cancer

Conditions: Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis

Summary: the esophageal squamous cell carcinoma (escc) has high prevalence and mortality in china, which become a severe challenge for public health. esophagectomy is the preferred choice for the patients who are diagnosed with escc in early stage .although three-field lymphadenectomy has improved patient survival and reduced tumor recurrence, surgery-related complications increased dramatically. it has become a research hotspot to find an effective detection method to identify the lymph node metastasis of escc and avoid ineffective expanded lymphadenectomy .the molecular imaging technology has been developed for intra-operative visualization and precise resection of the tumors. indocyanine green for injection (icg) has been used as a contrast agent in the near-infrared imaging system for the surgical navigation technology, which has a relatively positive effect in the clinical application of gastric cancer and liver cancer.there are few reports on the application of icg near-infrared imaging tracer lymph nodes in the surgery of escc. this study intends to identify the detection rate of sentinel lymph node (sln) and determine the accuracy of regional lymph node metastasis in escc by icg near-infrared imaging technique, which provides clinical evidence for subsequent precise resection of the lymph nodes. this will be one-arm prospective trial. the escc patients will be recruited with strict criteria. 84 patients will be enrolled between18 and 75 years old, without gender limit. the submucosal injection of icg will be performed preoperatively by gastroscopy on the superior and inferior edge of the esophageal tumor. nir fluorescence imaging will be performed intraoperatively to observe the lymph nodes. the luminescent lymph node is defined as sln. according to the standard procedure, 3 field lymphadenectomy will be performed, and all the resected lymph nodes will be subjected to pathological analysis including correlation study of fluorescence signal and tumor tissue in pathology slice. this clinical trial is anticipated to evaluate the detection rate of sln in escc with icg near-infrared fluorescence imaging and determine the accuracy of regional lymph node metastasis.


Eligibility criteria:
inclusion criteria: 1. 18 years old ≤ age ≤ 75 years old, gender is not limited; 2. patient who is diagnosed with escc and choose to proceed with surgery 3. patient with ctnm stage:t1-3n0-1m0 4. tumor located at the middle thoracic or lower thoracic esophagus 5. the main organ function is basically normal: karnofsky score \>70%; 6. laboratory blood tests meet surgical standards; exclusion criteria: 1. pregnancy or breastfeeding 2. history of iodide or seafood allergy, 3. patient with occult metastatic disease at the time of surgery 4. patient with mental disorder; 5. patient who is simultaneously involved in another clinical trial;
ed hypernatremia. prognostic factors and epidemiology.

Conditions: Hypernatremia

Summary: this study evaluate the 1-month mortality of patients who proceed a blood sample while in the ed with an hypernatremia (\>145 mmol/l). this prospective study will try to show several prognostic factors, and show the epidemiology of hypernatremia in this single center evaluation.


Eligibility criteria:
inclusion criteria: * natremia \> 145 mmol/l exclusion criteria: * age \< 18 years * refusal
effect of oral nutritional supplements to older patients discharged with a rehabilitation plan

Conditions: Nutritional Risk; Rehabilitation; Oral Nutritional Supplements

Summary: the purpose of the study is to investigate whether an extra intake of energy and protein in the form of nutritional drinks twice a day for 12 weeks can improve muscle strength, muscle mass, quality of life and the implementation of rehabilitation in elderly patients at nutritional risk who are discharged to municipal rehabilitation

the study is a single-blind randomised study where the subjects will be randomly divided into two groups. a group that must consume nutritional drinks in connection with their rehabilitation and a group that must do nothing extra. based on a statistical power calculation, we will include a total of 124 patients. in connection with the experiment, different data will be collected three times, in connection with the discharge from the hospital, after 6 weeks via the telephone and after 12 weeks. during a home visit. here, various questionnaires will have to be answered and data on muscle strength and muscle mass will be collected. further crp, vitamin d status and epa/dha content in blood will be assessed. in addition, data is collected from the patient's medical record about e.g. readmissions

Eligibility criteria:
inclusion criteria: * men and women aged ≥ 65 years old * independent stand function * able to speak and understand danish * at nutritional risk according to nrs-2002 * (expected to be) discharged with a new rehabilitation plan * admitted to the medical and orthopaedic departments of gentofte or herlev hospital exclusion criteria: * active cancer * renal insufficiency (egfr \< 27 ml/min/1.73m2) * cognitive impairment (not able to comprehend the purpose of the study/give informed consent) * terminal disease * exclusively receiving texture modified food, enteral or parenteral nutrition * planning to lose weight/go on a special diet * planned transfer to other hospitals/departments * pacemaker/other implanted electrical stimulants (due to bio-impedance analysis (bia) * taking fish-oil supplements as a medical prescription due to hypertriglyceridemia * taking fish-oil supplements for other reasons and do not wish to stop this during the study period

Keywords: muscle strenght quality of life body composition protein intake
continued anticonvulsants after resolution of neonatal seizures: a patient-centered comparative effectiveness study

Conditions: Neonatal Seizures

Summary: the purpose of this study is to examine whether the duration of treatment with phenobarbital has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family well-being, after neonatal seizures.


Eligibility criteria:
inclusion criteria: * neonates \<44 weeks corrected age at seizure onset * seizures due to acute brain injury * parent(s) who are english or spanish literate (with assistance of interpreter) exclusion criteria: * neonates at risk for adverse outcome independent of seizures and underlying brain injury * neonates with mild, temporary causes for seizures * newborns with neonatal-onset epilepsy syndromes * neonates who do not survive the initial hospital admission * neonates will not be excluded based on race, ethnicity, gender or gestational age

Keywords: phenobarbital eeg family impact neurodevelopment
the relationship between irriv and rfr under pathologic conditions

Conditions: Acute Kidney Injury

Summary: the assessment of renal functional reserve (rfr) has been proposed for the risk stratification of patients undergoing potentially nephrotoxic procedures. the present pilot study is designed to explore the correlation between irriv and rfr under pathologic conditions.

renal functional reserve (rfr) represents the capacity of the kidney to increase glomerular filtration rate (gfr) in response to certain physiological or pathological stimuli or conditions. rfr is calculated as the difference between the measured maximum gfr achieved through a renal stress test and the baseline gfr measured in rest conditions. in clinical practice, the most common renal stress test is performed as a standardized protein loading test. recently, in a pilot study, the investigators demonstrated a significant correlation between rfr and the intra-parenchymal renal resistive index variation (irriv) during an echo renal stress test in a cohort of healthy volunteers. irriv test has proven to be rapid, safe, bedside and easy to perform and it might represent a preliminary test in screening patients' rfr.the present pilot study is designed to explore the correlation between irriv and rfr under pathologic conditions.

Eligibility criteria:
inclusion criteria: * estimated gfr (ckd-epi) greater than or equal to 60 ml/min/1.73 m2 * scheduled cardiac surgery with cardiopulmonary bypass (coronary artery bypass, valve replacements, combined or other operations). exclusion criteria: * age less than 18 years old * pregnancy * ultrasound evidence of morphological kidney abnormalities and/or renal artery stenosis * nonsteroidal anti-inflammatory drugs (nsaids) * contrast media in the 2 days before the tests.
an investigational study to evaluate experimental medication bms-986036 in participants with different levels of kidney function

Conditions: NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

Summary: this is an investigational study to evaluate the experimental medication bms-986036 in participants with different levels of kidney function.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * bmi ≥ 25 and ≤ 40 kg/m2 exclusion criteria: * presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds) * any bone trauma (fracture) or bone surgery (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration * any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status * any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration * donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration * inability to tolerate subcutaneous injections other protocol defined inclusion/exclusion criteria could apply
anxiety and depression in patients hospitalizes for an acute exacerbation of copd

Conditions: Chronic Obstructive Pulmonary Disease; Anxiety; Depression

Summary: this study will try to elucidate wheter the impact of a psychiatric intervention in patients hospitalized because an acute exacerbation of copd and anxiety/depression and reconsulting at 1 and 6 month after discharge.


Eligibility criteria:
inclusion criteria: * men and women of any ethnic group * above 40 years old * diagnose with chronic obstructive pulmonary disease (copd) according to the ats/ers guidelines * acute exacerbation of copd according to the following criteria: a) cyanosis b) obnubilations or mental confusion d) respiratory rate above 25 per minute e) failure of ambulatory treatment f) co-morbidities that worsens respiratory condition g) dyspnea exclusion criteria: * less than 6 months expectancy of life * needing of mechanical ventilation * severe cardiovascular disease * pregnancy * previous diagnosis of depression/anxiety
addressing racial disparities in opioid overdose using peer recovery coach training and mhealth platform

Conditions: Opioid Use Disorder

Summary: the study aims to adapt an existing cultural structural humility (csh) training into a video format for peer recovery coaches (prcs) and refine an ai-driven texting tool to reinforce the training. after refining these tools using user-centered design, a pilot test will be conducted to assess their impact on the uptake of opioid treatment and social services. the study will also evaluate the feasibility and effectiveness of the intervention to inform future large-scale trials.

the purpose of this study is to adapt an evidence-supported, currently staff-led cultural structural humility (csh) training to an interactive video format (7 brief video modules) for prcs (aim 1) while concurrently, refining a validated ai-driven texting tool that will newly reinforce core csh training principles (aim 2) that focus upon cultural and structural determinants of health (csdh). after completing iterative refinement per user-centered design strategies based on the technology acceptance model (tam) for aim 1 and 2, the investigators will pilot test csh-trained prcs delivering telephone based care/services coordination combined with refined ai-driven texting to enhance uptake of moud services, and social services (aim 3). aim 3 is sized for feasibility testing, final 'de-bugging' of the platform, and informing study conceptualization for a future large-scale efficacy trial. in this r34, the intervention effects will be assessed on the primary clinical outcome (i.e., receipt of buprenorphine), secondary outcome (i.e., uptake of social services), and implementation of the proposed multimodal intervention platform per the re-aim framework.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * fluent in english * self-reported non-prescription opioid use \<30 days prior to consent * provision of informed consent * planned stay in nyc ≥3 months * black and/or latinx race/ethnicity * positive urine toxicology for opioids per emr records or study staff administered random saliva drug testing * diagnosis of oud per the diagnostic and statistical manual of mental disorders-5 (dsm-5) * self-reported interest in initiating buprenorphine in primary care, or elsewhere. exclusion criteria: * inability to comprehend text content written at a 3rd grade reading level * physical or visual disability preventing mobile phone use

Keywords: opioid use disorder peer recovery coach cultural structural humility mhealth people with opioid use disorder oud pwoud mhealth intervention
synthetic cartilage implant vs osteochondral autograft transfer for advanced 1st metatarsal phalangeal joint arthritis

Conditions: Metatarsophalangeal Joint Arthritis

Summary: this is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (mtp) arthritis. this data will allow for accurate comparisons between the two groups in regards to functional outcome, clinical outcome, pain relief, and complications.

first mtp joint arthritis or hallux rigidus is the most common arthritic condition of the foot. historically, there have been several options to treat this condition surgically, but the current standard for advanced hallux rigidus is first mtp anthrodesis. newer joint preserving procedures offer patients effective relief of pain and improving functional outcomes as well as maintaining, and potentially improving, range of motion for the first mtp joint. osteochondral autograft transfer has been shown to be an effective treatment for hallux rigidus, and involves harvesting a small cylindrical osteochondral graft from a site remote of the first mtp joint and transferring the graft to the head of the first metatarsal. a new synthetic cartilage implant, cartiva, has been shown to have equivalent functional outcomes, pain scores, and complications to anthrodesis, but the first mtp range of motion in the cartiva group was maintained or even improved in some patients. this is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (mtp) arthritis. the hypothesis is that clinical range of motion, pain scores, subjective clinical outcomes, and complications will not be clinically inferior with the synthetic cartilage implant group compared to the osteochondral autograft transfer group.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 80 years old * grade 2 or 3 hallux rigidus based on coughlin and shurnas classification * presence of good bone stock as determined on pre-operative x-rays not requiring bone grafting * capable of consenting for self exclusion criteria: * patients \<18 years of age * grade 1 or 4 hallux rigidus based on coughlin and shurnas classification * active bacterial infection of the foot * previous bilateral total knee arthroplasty * previous fracture or significant trauma to the ipsilateral knee * inflammatory anthropathy * gout * inadequate bone stock * previous anthrodesis or arthroplasty performed on the ipsilateral first mtp

Keywords: metatarsophalangeal joint arthritis synthetic cartilage implant cartiva osteochondral autograft transfer
treatment of knee osteoarthritis with autologous mesenchymal stromal cell product (regstem)

Conditions: Osteoarthritis,Knee

Summary: osteoarthritis (oa) is a common and incurable disease for the elderly in taiwan, so it is an important mission to develop a new treatment for oa. recently, cellular therapy is a new and popular medical treatment around the world, one of them is "mesenchymal stromal cells (mscs)". mscs are found in many tissues of human body and play an important role for repairing, regeneration, anti-inflammatory and chondrogenesis. so, msc product, regstem, for osteoarthritis treatment becomes a developing target for new generation drugs. this study is to isolate and expand mscs(regstem) from infrapatellar fat pad of subject. when the number of mscs expands to 1×10\^8, cell will be cryopreserved in the liquid nitrogen tank until all release tests passed. on the distribution day, cell will be thawed and injected into joint cavity of patient (5×10\^7). subjects will be monitored after msc product infusion of seven days, one month, six months and one year. the monitoring items include the changes of knee (by appearance, x-ray and mri of knee) and pain improvement (by questionnaire).


Eligibility criteria:
inclusion criteria: 1. subjects who understand and sign the informed consent form for this study 2. grade 2\~3 osteoarthritis according to the kellgren-lawrence grading scale with one-month x-ray 3. age is 50\~75 years old 4. postmenopausal women 5. vas scores in 50 to 90 mm exclusion criteria: 1. abnormal of liver and kidney: got and gpt \> 100 iu/l, bun \>22 mg/dl and creatinine \> 1.2 mg/dl. 2. positive serology for hiv, htlv-1/2 and syphilis 3. women who are pregnant or breast feeding 4. serious pre-existing medical conditions: coagulation disorders, cardiovascular diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic renal failure), liver diseases (cirrhosis), diabetes mellitus type i, cancer history. 5. other joint diseases: knee deformity (knee varus greater than 10 degree or valgus greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis, serious meniscal tear, other autoimmune arthritis. 6. skin inflammatory of knee 7. knee pain caused by referred pain from spine disease or hip joint disease. knee pain combined with pain from spine disease or hip disease. 8. immunosuppressive state 9. subjects who were injected with hyaluronic acid and prp in the past 6 months 10. body mass index (bmi) greater than 30 11. have a history of allergic reaction of any medication 12. participation in another clinical trial or treatment within 3 months 13. other pathologic conditions or circumstances that difficult participation in this study according to pi's evaluations
comparison of surgical,clinical and oncological outcomes between robotic-assisted and laparoscopic-assisted gastrectomy

Conditions: Gastric Cancer

Summary: the study aims to compare the clinical outcomes between robotic-assisted and laparoscopic-assisted gastrectomy for gastric cancer,and evaluate the the feasibility and safety of robotic gastrectomy. furthermore, the investigators can explore the patients who are more suitable for robotic gastrectomy.

this is a prospective study lasting 36 months. minimally invasive gastrectomy is accepted widely in asian countries. laparoscopic-assisted gastrectomy offers improved early postoperative outcomes and improved long-term oncologic outcomes,but it still has its own limitations.the advantages of robotic surgery include a 3d imagine, convenient movements of the robotic arm, no tremor, and ambidextrous capability. this study therefore aimed to compare the clinical results between robotic-assisted gastrectomy(rag) using the da vinci surgical system and conventional laparoscopic-assisted gastrectomy(lag) in gastric cancer patients.to evaluate the the feasibility and safety of robotic gastrectomy and explore the patients who are more suitable for robotic gastrectomy.

Eligibility criteria:
inclusion criteria: 1. pathologically proven gastric cancer(early or advanced). 2. age:older than 18 years old,younger than 80 years old. 3. ct1-4a(surgically resectable tumor),n0-3,m0 at preoperative evaluation according to the american joint committee on cancer(ajcc) cancer staging manual seventh edition 4. no obvious surgical contraindications. 5. american society of anesthesiology (asa) score class i, ii, or iii 6. written informed consent. exclusion criteria: 1. severe mental disorder 2. pregnancy 3. history of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. history of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection. 5. history of unstable angina or myocardial infarction within past six months 6. history of previous neoadjuvant chemotherapy or radiotherapy 7. history of other malignant disease within past 5 years. 8. enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 9. any accompanying surgical condition needed to be performed in the same time

Keywords: robotic-assisted gastrectomy laparoscopic-assisted gastrectomy gastric cancer