Kornimate/medical-research-clean huggingface dataset:
adding adjuvant cisplatin and gemicitabine versus capecitabine in triple-negative breast cancer patients in non pcr after neoadjuvant standard chemotherapy

Conditions: Breast Cancer

Summary: in our study; investigator aim to show efficacy and toxicity of adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy to compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine

patients with operable, primary invasive non inflammatory early tnbc of stage i-iiib and pathologically verified residual cancer cells (no pathological complete response) after neoadjuvant chemotherapy then underwent adjuvant treatment with gemcitabine plus cisplatin patients will be followed up every 3 month in first year then every 6 month in the second year then followed up yearly study will be conducted at assiut university hospital with sample size calculation braca will be done

Eligibility criteria:
inclusion criteria: * age: 20 years and older. * patients with no clinical/radiologic distant metastasis. * tumor type: invasive ductal carcinoma or invaive lobular carcinoma. * tumor subtype: triple negative * patients had operable, primary invasive, noninflammatory early stage i-iiib tnbc (er and pr \<1%, her2 score: 0 or 1) * patients with a good performance status (0/1) * patients with adequate hematological, cardiac, renal, and hepatic function exclusion criteria: * patients who achieve pathologic complete response after neoadjuvant chemotherapy * inflammatory breast cancer * breast cancer patients with distant metastasis * patient with hormonal receptor positive /her2 +ve
early assessment of lymphoma treatment response using phased variant analysis with next-generation sequencing

Conditions: Lymphoma; Hodgkin Lymphoma; T-cell Lymphoma; Waldenstrom Macroglobulinaemia

Summary: lymphoma is a prevalent lymphoid malignancy globally and in taiwan. large b-cell lymphoma (lbcl) is the most common subtype of aggressive b-cell lymphoma. lbcl's aggressive nature manifests through extranodal involvement, severe symptoms, and relative refractoriness to therapies, leading to a 5-year overall survival rate of 60-70% across developed countries and poorer outcomes in high-risk patients with primary refractory disease. chemoimmunotherapy remains the primary treatment for lbcl, requiring comprehensive assessment through clinical and imaging examinations, biomarkers, and molecular testing. currently, computed tomography (ct) and positron emission tomography (pet) scans are the standard modalities for treatment response evaluation, though their radioactive nature calls for the development of safer alternatives. circulating tumor dna (ctdna) analysis has emerged as a promising field, providing insights into tumor molecular characteristics, clinical status, and treatment response by analyzing dna fragments released from tumor cells into the bloodstream. dynamic monitoring of ctdna during treatment can effectively gauge therapeutic efficacy-decreasing ctdna concentrations suggest successful treatment, while increasing levels may indicate treatment failure or tumor recurrence. the detection of ctdna has been much improved through advances in next-generation sequencing (ngs) technologies, particularly taking advantage of analyzing phased variants, consecutive gene mutations on the same chromosome, enhances the sensitivity and specificity.


Eligibility criteria:
inclusion criteria: * • pathology proven lymphoma * age ≥ 18 years old exclusion criteria: * none

Keywords: lymphoma ngs phased variant early response assessment early outcome
the gut and skin microbiome in vitiligo disease progression

Conditions: Vitiligo; Healthy

Summary: investigators plan to perform a pilot study that aims to characterize the microbiome of human vitiligo patients with both active and stable disease and compare this to the microbiome of age and sex matched controls. the investigators aim to answer the question whether the gut and skin microbiome of patients with vitiligo differs from the general population.


Eligibility criteria:
inclusion criteria: * patients with and/or without vitiligo lesional expansion over the past year. * age/sex-matched controls who do not have a diagnosis of vitiligo * subjects who are age 18-89 years of age at time of enrollment * subjects who are able and willing to give informed consent for this study and the dermatology tissue acquisition and biorepository (stu00009443) exclusion criteria: * subjects who are younger than 18 years of age or 90 years of age or older * subjects who are unable to give consent
metacognition in semantic dementia: comparison with alzheimer's disease

Conditions: Semantic Dementia; Alzheimer Disease; Healthy

Summary: this study aims at exploring patients' ability to monitor their own memory performance depending on their primary deficit and the type of memory involved in the criterion task. the goal is to evaluate if semantic dementia (sd) and alzheimer's disease (ad) differently affect patients' awareness of their memory abilities.

patients who will give their informed non-opposition will be included. participants will undergo 6 metacognitive tasks in which they will be tested on newly learnt information (i.e., episodic memory) or prior knowledge (i.e., semantic memory) and asked to evaluate their performance either prior or after the test. correlation between their evaluation and their actual performance will be measured. performance and correlations will be compared across groups.

Eligibility criteria:
inclusion criteria: * native french-speakers * normal or corrected-to-normal vision * for patients only : doctor-approved diagnosis of semantic dementia or alzheimer's disease * for healthy participants only: score above 27 on the mmse * non-opposition in participation exclusion criteria: * other neurological/ psychiatric disorder, or cognitive disorder that might affect general cognition * drug or alcohol abuse
comparison of the efficacy of the ultrasound with fluoroscopy in guidance of lumbar sympathetic block

Conditions: Complex Regional Pain Syndrome; Postherpetic Neuralgia; Diabetic Polyneuropathy; Peripheral Neuropathy

Summary: this study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar sympathetic block (lsb). the goals of the study are; 1) to show that us-guided lsb results in shorter performance time compared to fluoroscope-guided lsb, 2) to evaluate the efficacy and safety of us-guided lsb, and 3) to verify that us-guided lsb has similar success rates to fluoroscope-guided lsb. 50 patients who are supposed to undergo lsb due to sympathetically maintained pain, satisfy criteria of inclusion and exclusion, and voluntarily sign the informed consent will be enrolled.


Eligibility criteria:
inclusion criteria: * patients who have sympathetically-mediated pain and are supposed to undergo lsb procedure (e.g. pain with asymmetric skin temperature of lower limb in previous thermography, small fiber disorder in previous quantitative sudomotor axon reflex test (qsart), vascular insufficiency in lower extremities, diabetic polyneuropathy, postherpetic neuralgia, complex regional pain syndrome, cancer-related neuropathic pain such as chemotherapy-induced peripheral neuropathy, other lower extremity neuropathies, lower extremity crush injury etc.) * numeric rating scale (nrs) ≥ 4/10 * failure of previous conservative treatments, such as physiotherapy, oral medication, or other noninvasive treatment exclusion criteria: * previous lumbar sympathetic neurolysis * bleeding tendency * local infection * allergy to local anesthetics or contrast media * pregnancy * severe variation near procedure site-scoliosis, tumor, abdominal aneurysm, etc. * bmi ≥ 30 kg/m2 * cognitive dysfunction

Keywords: ultrasound lumbar sympathetic block
use of activated recombinant human factor vii in cardiac surgery

Conditions: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass

Summary: this trial is conducted in africa, asia, europe, south america and the united states of america (usa). the trial is planned to investigate the safety and efficacy of novoseven® in the management of post-operative bleeding in patients following cardiac surgery.


Eligibility criteria:
inclusion criteria: * post-operative bleeding according to pre-defined criteria for critical bleeding
pilot study: investigating mood changes after slow-wave enhancement

Conditions: Depressive Disorder, Major; Depression; Depression, Unipolar; Depressive Disorder

Summary: the aim of this pilot project proposal is to test the hypothesis that decreased sleep slow-wave activity (swa) observed in individuals with major depressive disorder (mdd) is related to mood dysfunction, and that manipulating swa may serve to improve mood by normalizing swa regulation. the investigators propose to enhance swa during nighttime sleep in a group of 20 antidepressant-free males and females age 25-50 with varying degrees of impairment in mood. each participant will undergo one baseline night of sleep in the laboratory and then will sleep with the smartsleep headband nightly for two weeks in their own home. for one week, slow-wave sleep will be enhanced. on the alternate week, sleep will not be changed. following the two weeks of sleeping with the device, participants will then spend another night in the sleep laboratory to assess changes in sleep. mood will be assessed by self-report and clinician-administered scales following the baseline night of sleep, virtually after the first experimental week, and at the conclusion of the study.


Eligibility criteria:
inclusion criteria: 1. age 25-50 years. 2. primary language is english. 3. normal cognition. 4. normal (or corrected-to-normal) vision and hearing. 5. current depression. 6. stable, normally-timed sleep-wake cycle as determined by interview, 1-week daily sleep log, and 1-week wrist actigraphic evidence, and defined by: 1. habitual nocturnal sleep duration between 6h and 9h. 2. habitual bedtime between 9pm-12am. 3. no evidence of habitual napping. exclusion criteria: 1. current or prior medical condition that could interfere with collection or interpretation of data, based on medical history. 2. history of stroke, epilepsy, brain scarring, or head injury causing unconsciousness. 3. independent/intrinsic sleep disorder other than insomnia based on history or polysomnogram. 4. recent use of psychoactive medications or medication thought to impact sleep or cns function, as determined by investigators (e.g. ssris, benzodiazepines, glutamate modulators, gabapentin). 5. history of or current psychiatric conditions that increase study risk or grossly impair cns function (e.g., current anorexia or bulimia, history of substance dependence or current substance abuse, lifetime history of psychosis). 6. lifetime history of electroconvulsive therapy. 7. pregnancy as determined by self-report. 8. travel beyond 2 time zones in the 2 months before study. 9. unwillingness to refrain from using alcohol or caffeine during the study.
the use of the internet to facilitate weight loss and maintenance.

Conditions: Obesity

Summary: this project is assessing the effectiveness of using the internet as a tool to facilitate the maintenance of weight lost in a behavioral weight control program. participants attend a standard behavioral weight control intervention via interactive television and after 6 months are randomly assigned to one of three groups; a control group, an in-person weight maintenance group and a maintenance group that meets over the internet. this research project is being conducted in vermont.


Eligibility criteria:
inclusion criteria: * bmi between 25 and 39.9 * internet connection exclusion criteria: * major medical problems * inability to walk for exercise

Keywords: obesity behavioral weight control internet
comparing of long bout and short bouts of similar volume of walking in obese on weight loss during a weight loss program

Conditions: Obesity; Overweight

Summary: the purpose of this present study is to determine if a daily walking program of 50 continuous minutes (long bout) or two 25-minute bouts (short bouts) in similar volume on body weight, abdominal fat mass deposition and cardiometabolic measures in overweight and obese women receiving a low calorie diet for 24 weeks.


Eligibility criteria:
inclusion criteria: * must have body mass index (bmi) between 27-35 kg/ m². * were sedentary (reported exercising \<20 min/d for the previous 6 month) and healthy * must be able to have moderate exercise. * must be interested to have weight loss. exclusion criteria: * participating in a research project involving weight loss or physical activity in the previous six months. * pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. * taking medication that could affect metabolism or change body weight. * report heart problems, chest pain, and cancer within the last five years. * smoking * menopause * diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Keywords: long bout physical activity short bout physical activity caloric restriction
novel inxn-4001 triple effector plasmid in heart failure

Conditions: Heart Failure; Cardiovascular Diseases; Heart-Assist Device

Summary: to evaluate the safety of retrograde coronary sinus infusion (rcsi) of a novel triple-effector plasmid (inxn-4001) in outpatient lvad recipients as assessed by incidence of all study intervention-related adverse events occurring up to 6 months post-rcsi (primary endpoints), and to evaluate general safety by assessing incidence of cardiac specific adverse events and the incidence of related serious adverse events at intervals up to 12 months post-infusion (or until cardiac transplantation or death).

this is a first-in-human, phase i, open label, safety study of inxn-4001 delivered via rcsi in patients with outpatient lvad. twelve stable patients with implanted lvad for mechanical support of end stage heart failure have been allocated into 2 cohorts (6 subjects each) to evaluate the safety of infusing the same amount of inxn-4001 (80mg) in 2 volumes (40ml and 80ml) at 20ml/min rate. ongoing safety assessments include clinical labs, physical exams, ecg and medical history collected during clinic visits at: pre-treatment, day 3, then 1, 3, 6, 9, and 12 months after dosing via rcsi. during visits, subjects complete the kccq questionnaire and are evaluated via 6-min walk test (6mwt) prior to and during an lvad wean interval. daily activity data is collected throughout the study using a wearable biosensor (actigraph).

Eligibility criteria:
inclusion criteria: * male and female adult patients with a stable lvad implanted for end-stage heart failure * must be managed in an outpatient setting and on stable medication regimen exclusion criteria: * women who are pregnant or nursing * patients who have been on another clinical trial for heart failure in the last 90 days, or have received any stem cell or gene therapy within the previous year. * patient is not able to complete a six minute walk test or unable to tolerate an lvad wean in the past 3 months * patient has an active infection requiring systemic antibiotics or an autoimmune disease requiring systemic immunosuppressants * patient has a history of arrhythmia, uncontrolled diabetes, diabetic retinopathy, systemic lupus erythematosus, macular degeneration, hyper-coagulation, or stroke * patient has had a myocardial infarction related to ischemia within the past 30 days * patient has had certain prior surgeries such as organ transplant, cardiac transplantation, left ventricle reduction surgery, or cardiomyoplasty * patient has infectious disease, such as hepatitis b or c, or human immunodeficiency virus (hiv) * patient has a history of cancer within the past 3 years

Keywords: retrograde coronary sinus infusion dna non-viral triple effector plasmid gene therapy regenerative medicine non-stem cell
study to identify and characterize the bacteria causing acute otitis media episodes in young children in taiwan

Conditions: Acute Otitis Media

Summary: the purpose of the study is to identify the bacterial aetiology of acute otitis media episodes in young children aged \>= 3 months to \< 5 years in taiwan


Eligibility criteria:
inclusion criteria: * age: \>= 3 months and \< 5 years at the time they are seen by the pediatrician or ear, nose and throat specialist. the subject becomes ineligible on the fifth birthday. * onset of signs and symptoms of acute otitis media within 72 hours: * one of the functional or general signs of otalgia (, conjunctivitis, fever and either * paradise's criteria or * spontaneous otorrhea of less than 1 day. * written informed consent obtained from parent or legally acceptable representative prior to study start. exclusion criteria: * hospitalized during the diagnosis of acute otitis media. * onset of otorrhea greater than 1 day prior to enrolment. * otitis externa, or otitis media with effusion. * presence of a transtympanic aerator. * systemic antibiotic treatment received for a disease other than acute otitis media in the 72 hours prior to enrolment. * receiving antimicrobial prophylaxis for recurrent acute otitis media. * provision of prescribing antibiotics by ear, nose and throat specialist and pediatricians for acute otitis media before sample collection. * intended or planned prescription of antibiotic by pediatrician or ear, nose and throat specialist prior to the completion of study specified procedures during the enrolment visit.

Keywords: non-typeable haemophilus influenzae acute otitis media streptococcus pneumoniae etiology
distribution and prognostic impact of oncogenic drivers in metastatic lung adenocarcinoma : a retrospective monocentric study in nancy university hospital center

Conditions: Adenocarcinoma of Lung Stage IV; Adenocarcinoma of Lung, Response to Tyrosine Kinase Inhibitor in, Somatic

Summary: the recent discovery of oncogenic drivers has revolutionized the management of advanced lung cancer by development of tyrosine kinase inhibitors targeted therapies. prevalence of daily tobacco use is evaluated at 31,3 % in grand-est region, the only french region with a statistically significative difference for smoking habits. this region shows a higher incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other french regions. the objectives of our studie were to estimate the distribution of oncogenic drivers and analyse their prognostic impacts in the nancy university hospital center metastatic lung adenocarcinoma's population.


Eligibility criteria:
inclusion criteria: * lung adenocarcinoma * patients diagnosed at a metastatic stage * patient who benefited an oncogenic driver research on their histologic samples * medical follow-up entirely done in nancy central hospital exclusion criteria: * patients with double histology * synchronous cancer * patients with surgical care
outcomes of different surgical procedures after high level resection for patients with small intestinal gangrene

Conditions: Small Bowel Gangrene; Mesenteric Artery Ischemia; Strangulated Hernia

Summary: in this cohort study, aim to evaluate and compare short-term postoperative outcomes of different surgical procedures for patients with intestinal gangrene who underwent high level small bowel resection (\< 150 cm from dj).

patients with intestinal gangrene have a high mortality rate depending on etiology, degree, and length of an ischemic part, associated comorbidity, and time between the onset of symptoms and final diagnosis. this overall mortality ranges from 50 to 80%. when intestinal gangrene is evident or suspected, surgical laparotomy is mandatory, where the affected segment is resected, and the remaining part is either anastomosed or diverted on the anterior abdominal wall as stoma. small bowel anastomoses performed in the emergency settings have a high risk of anastomotic leakage. the leak rate in these settings may reach 35% . intestinal gangrene is usually associated with peritonitis and sepsis. the performance of ostomy or intestinal anastomosis in cases of peritonitis or sepsis is a controversial theme. this controversy increases when proximal small bowel is involved . stomas avoid the risks of anastomotic leakage and re-operation and permit close examination of the bowel by inspection. however, creating stoma after proximal level of resection is associated with catastrophic sequels of high output fistula and short bowel syndrome. hence, most of the time the risk of a high jejunal anastomosis dehiscence is preferred to the metabolic complications associated with ostomy . a jejunostomy was defined as having less than 200 cm of proximal remaining small bowel. since most nutrients are absorbed within the first 100-150 cm of the jejunum, the severity of short bowel syndrome and dependence on tpn is markedly increased if a jejunostomy is created at less than 150 cm from dj . distal refeeding of chyme "re-feeding enteroclysis", by reinfusing the chyme collected from the proximal stoma into the downstream small bowel through the distal stoma, was used by some surgeons to alleviate the complications of jejunostomy before re-establishment of digestive continuity . however, this procedure can be technically demanding. on the other hand, some authors prefer to use prophylactic tube enterostomy with primary anastomosis in cases of high risk of anastomotic leak . the choice between these surgical technical varieties depends upon general health status of the patient, and local abdominal factors e.g. presence of peritoneal contamination, but mostly depends on surgeons' experience.

Eligibility criteria:
inclusion criteria: * 1) distance of proximal resection margin less than 150 cm from dj. 2) mesenteric vascular ischemia. 3) strangulating obstruction e.g. due to hernia, volvulus, band, etc. exclusion criteria: * 1) patients less than 18 years. 2) patients with malignant disease. 3) patients with almost all small bowel loops resected (\< 60 cm remaining).