Kornimate/medical-research-clean huggingface dataset:
msc for treatment of cgvhd after allo-hsct

Conditions: Chronic Graft-versus-host Disease

Summary: the purpose of this study is to evaluate the efficacy of mesenchymal stem cells in patients with chronic graft-versus-host disease.

allogeneic hematopoietic stem cell transplantation(allo-hsct) can cure many hematologic diseases. although great progress has been made in the prevention and treatment of side effects associated with transplantation,chronic graft-versus-host disease(cgvhd) remains an important complication that occurs in about 50% patients. the mortality of cgvhd and its complication could reach up to 50%,and cgvhd seriously influence the quality of life. at present, the first line treatment of cgvhd remains in discussion. mesenchymal stem cells (mscs) are a form of multipotent adult stem cells that can be isolated from bone marrow (bm), adipose tissue, and cord blood. clinical applications of human mscs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating gvhd after allo-hsct and so on. however, the efficacy of treatment of cgvhd remains undetermined. in the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded mscs in treating patients with cgvhd.

Eligibility criteria:
inclusion criteria: * a patient age of 18-65 years * recipients of allogeneic hematopoietic stem cell transplantation patients with moderate/ severe cgvhd without systemic treatment * subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * primary disease relapse * expected lifetime less than 3 months * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: hematopoietic stem cell transplantation chronic graft-versus-host disease mesenchymal stem cells
effect of spinal cord stimulation (scs) on insulin secretion in humans

Conditions: Spinal Cord Stimulation; Insulin Secretion

Summary: this trial investigates the effect of burstdr and tonic spinal cord stimulation (scs) on glucose metabolism and heart rate variability in patients with neuropathic pain.

this study investigates the effect of spinal cord stimulation (burstdr stimulation versus tonic stimulation versus no stimulation) on glucose metabolism, insulin secretion and heart rate variability in patients with neuropathic pain. to assess insulin secretion, hyperglycaemic clamps are performed in 10 patients. three different stimulation conditions (burstdr, tonic and no stimulation) are tested in 10 hyperglycaemic clamps each. a total of 30 clamps are carried out.

Eligibility criteria:
inclusion criteria: * implanted burstdr spinal cord stimulating system * body mass index 18-25 kg/m2 exclusion criteria: * neurological and psychatric diseases * decompensated diabetes mellitus * hemoglobin \< 13 g/dl * thrombocytopenia
extended postoperative oral tranexamic acid in knee replacement

Conditions: Knee Osteoarthritis; Blood Loss; Pain, Postoperative

Summary: a comparison of outcomes between use of oral tranexamic acid as compared to oral placebo in the first days after total knee replacement will be made to determine impact on clinical indications and patient reported outcomes.

significant blood loss occurs during total knee arthroplasty (tka) which can lead to adverse outcomes including need for blood transfusion as well as increased local tissue swelling and ecchymosis which can inhibit post-operative recovery. tranexamic acid (txa), an inhibitor of fibrinolysis, has been shown to be a safe and effective drug for reducing blood loss during and after tka. the use of txa intraoperatively has been associated with higher postoperative hemoglobin levels and a reduction in postoperative blood transfusion rates. administration of txa in tka has also been associated with improved clinical outcome measures including decreased rate of periprosthetic joint infection, decreased length of stay, and increased postoperative range of motion and early ambulation distances. however, there remains a wide variance in the route of administration, dosage, and timing of txa use among treatment protocols in tka. previous studies have evaluated outcomes with the addition of post-operative txa dosing to standard pre-operative and intra-operative intravenous (iv) doses. this study will investigate patient outcomes following a standardized post-operative oral txa protocol as compared to oral placebo for three doses over day of surgery, postop day one and postop day two after tka. following written consent documentation, subjects will be randomized and blinded to randomization assignment until completion of study to either the oral txa group or oral placebo group. the study medication will be distributed with the subject's name with instructions for use in the post-anesthesia unit (pacu). the first dose will be administered in pacu with subsequent doses to be taken at home on postop day one and postop day two. tka will be completed in an ambulatory surgery center with discharge same day of surgery to home. outcome measures include: hemoglobin, visual analog score, koos jr (knee injury and osteoarthritis outcome score), range of motion, and incidence of treatment-emergent adverse event at postoperative (pod) day 3, pod week 2, pod week 6, and pod week 12. koos jr. will be collected at one year post-op.

Eligibility criteria:
inclusion criteria: * primary total knee replacement in ambulatory setting * willing to participate * physical therapy on site at campbell clinic wolf river * fluent in oral and written english exclusion criteria: * unwilling to participate * revision total knee replacement * preoperative use of anticoagulants other than 81 mg aspirin * previous history of thromboembolic event * previous history of cancer other than non-melanoma skin cancers
a study of vinflunine in patients with gastric cancer

Conditions: Stomach Cancer

Summary: the purpose of this study is to learn if vinflunine can shrink or slow the growth of cancer in patients with advanced or metastatic stomach cancer who have progressed on a prior treatment with a fluoropyrimidine or taxane-containing chemotherapy regimen. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment. * egoc performance status of 0,1 or 2 * men and women, 18 years of age and older exclusion criteria: * patients having received more than one previous systemic chemotherapy regimen in any setting. * major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks * unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis) * prior radiation to \>=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment * acute or chronic hepatitis * known hiv infection * a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval \>450 ms * a history of additional risk factors for torsade de pointes (e.g., heart failure hypokalemia, family history of long qt syndrome)

Keywords: locally advanced/metastatic gastric adenocarcinoma adenocarcinoma-gastroesophageal junction gastric adenocarcinoma
creating african-american wellness through exercise

Conditions: Depression

Summary: the purpose of this study is to pilot-test a culturally-tailored, community-based educational program for african-americans, focusing on how to use exercise and other self-management strategies to reduce depressive symptoms and improve health. this study will explore what type of additional support would encourage depressed african-americans to exercise regularly. the investigators hypothesize that participants will report greater frequency of exercise and lower depression scores at the end of the program than they did at baseline. however, this study is not adequately powered to test this hypothesis - the main goal is to assess feasibility, acceptability and satisfaction of the pilot intervention.

several studies have documented the effectiveness of exercise as a treatment for depression. however, these studies have used supervised exercise in medical school or university environments and have included mostly middle-class white populations. little is known regarding how to translate these findings to real world settings or to minority populations. exercise may be a particularly beneficial option for african-americans suffering from depression. african-americans face significant disparities in depression care. at least a part of these disparities are due to lack of trust in the healthcare system and negative attitudes toward antidepressants. our goal is to pilot-test a culturally-tailored, community-based exercise support program for depressed african-americans. we will recruit participants who screened positive for moderate depressive symptoms when they enrolled in the african-american health coalition's free exercise card program, but who are exercising less than 3 times per week. they will participate in a 6-week educational self-care group focusing on how to use exercise and other self-help tools to reduce depressive symptoms. participants will be encouraged to create action plans regarding exercise and other healthy lifestyle changes. groups will also provide culturally-tailored information about depression therapies, such as antidepressants and psychotherapy, and discuss strategies for obtaining quality health care.

Eligibility criteria:
inclusion criteria: * 18 years of age * african-american or of african-american descent * currently participating in the african-american health coalition free exercise-card program * experiencing moderate depressive symptoms, as indicated by a score of 10-20 on the depression scale of the patient health questionnaire (phq-9. * exercising less than three times per week (for a minimum of 30 minutes per session) over the past month exclusion criteria: * actively suicidal * if a health care provider, aahc staff member, or an investigator feel that participation in the program may endanger the participant's health or safety. * known mental or cognitive impairments * known condition that precludes their ability to feasibly participate in a support group session.

Keywords: depression african americans exercise culturally tailored intervention health disparities
symbicort in chronic obstruktive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e.general practitioners and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with copd.


Eligibility criteria:
inclusion criteria: * patients with copd treated with budesonide/formoterol exclusion criteria: * limitiations; possible risks; warnings; contraindications mentioned in the spc.

Keywords: treatment of copd documentation of relevant data related to the budesonide/formoterole therapy in patients with copd.
a novel probiotic-antibiotic combination to prevent recurrent urinary tract infections

Conditions: Recurrent Uti

Summary: patients with recurrent uti were randomized to receive either the probiotic sacchromyces boulardii at enrollment, and the intracellularly active ciprofloxacin with their first uti episode after enrollment, or they received standard of care treatment.

* at the time of consent, participants will be given 20 mg/kg of the antibiotic, ciprofloxacin. if the participant has symptoms of a uti or have a positive urine culture at enrollment, they will take the antibiotic every 12 hours for 14 days. if the participant does not have symptoms of a uti at enrollment, the antibiotic will be taken only if needed at home upon the first occurrence of a uti. * at the time of consent, participants will also be given 250 mg of the probiotic, s. boulardii, taken once daily for 6 months, irrespective of symptoms. - throughout the study, participants will receive their standard clinical care for recurrent uti treatment, which includes bowel and bladder dysfunction management and other prescribed non-antibiotic interventions at the managing provider's clinical discretion.

Eligibility criteria:
inclusion criteria: * a history of 3 or more uti episodes in the past 12 months, or 2 or more episodes in the past 6 months * no evidence of vesicoureteral reflux or only low-grade (grade 1-2) vesicoureteral reflux * no other genitourinary anatomical abnormality * not receiving prophylactic antibiotics at the time of enrollment * ages 2-17 years. exclusion criteria: * high grade (grade 3-5) vesicoureteral reflux * neurogenic bladder * anatomical abnormalities of the gastrointestinal tract * any history of urologic or gastrointestinal surgery * on prophylactic antibiotics * a urine culture positive for pathogens that are not susceptible to ciprofloxacin in the last 3 months * history of an allergic reaction to ciprofloxacin or other quinolones, or a history of severe adverse reactions * as stated on the package insert for ciprofloxacin, individuals with a known history of myasthenia gravis should avoid taking ciprofloxacin and therefore will be excluded from this study. * based on the black box warning for ciprofloxacin, individuals taking tizanidine as concomitant administration, or those taking other drugs known to interact with ciprofloxacin will be excluded from the study. * individuals with known qt prolongation, hypokalemia, or on other drugs that prolong the qt interval should also avoid taking ciprofloxacin and will be excluded from this study. * individuals under 2 years old. in the bfit clinic, because they do bladder, bowel movement, and constipation management, it is harder to manage if the patient is not potty trained. therefore, we are excluding participants under 2 years of age.
utility of trypsinogen -2 in early detection and follow up of post-pancreatectomy acute pancreatitis (ppap)

Conditions: Pancreatitis; Pancreatectomy

Summary: the goal of this study is to learn if urine trypsinogen can be used to diagnose post-pancreatectomy acute pancreatitis in patients undergoing pancreatectomy. participants will have their urine measured by dipsticks during and after their surgery.

patients will be identified utilizing preoperative scheduling and clinic visits. patients undergoing any pancreatectomy (such as: pancreatoduodenectomy, distal pancreatectomy, duodenal preserving pancreatic head resection) will be identified. these patients will be educated about possible enrollment in the prospective study in the preoperative clinic or in the surgery preoperative area. if enrolled, these patients will receive the standard of care postoperative laboratory tests. these include, but are not limited to, postoperative serum amylase, drain amylase, complete blood counts, and complete or basic metabolic panels. these patients will have standard of care pathologic review of their operative specimens. these patients will also have their urine tested for trp-2. this design will allow for the direct comparison of the trp-2 dipstick tests against the standard of care serum amylase tests. furthermore, the measuring of serum amylase will allow for the evaluation of post-pancreatectomy acute pancreatitis by the isgps definition.

Eligibility criteria:
inclusion criteria: * older than 18 years of age * undergoing elective pancreatectomy for any indication exclusion criteria: * younger than 18 years of age * pregnant women * prisoner

Keywords: pancreatectomy post-pancreatectomy acute pancreatitis ppap
assessing the impact of isha kriya meditation on anxiety and depression - a pilot study

Conditions: Anxiety; Depression

Summary: this study aims to assess the impact of isha kriya, a freely available guided meditation, on mental health - specifically anxiety and depression.

in 2019, over 15% of the population experienced symptoms of anxiety. this was highest amongst 18-29-year-olds. amongst these adults, 9.5% experienced mild, 3.4% experienced moderate, and 2.7% experienced severe symptoms of anxiety. about 1 in 6 adults is expected to suffer from depression at some point in their lives. due to the pandemic, rates of anxiety and depression increased significantly. in december 2020, 42% of people surveyed by the us census bureau had symptoms associated with anxiety or depression. this is compared to 11% of adults having similar symptoms from jan-june 2019. the rapidly diminishing mental health in the general population, especially since the covid-19 pandemic, has raised the concern for an emerging new pandemic: the mental health pandemic. mental health leaders and organizations are urging the federal and state authorities to make mental health a top priority and allocate resources to areas including early identification and prevention, establishing integrated health and mental health care to ensure "whole-person" well-being, assuring evidence-based standards of prevention, treatment and care. meditation has been shown to be effective in reducing symptoms associated with anxiety and depression. a recent study using a meditation called isha kriya showed improved perceived stress amongst operating room professionals in one sitting. isha kriya is a simple meditation practice (15minutes) that can be done by anyone over 12 years of age. it is offered free globally via in-person sessions, online webinars, and online videos. a meditation which is available electronically and freely could be an attractive option to include in prevention and treatment strategies for anxiety and depression. furthermore, such intervention is easily scalable and accessible to everyone with access to the internet and if found effective, can be a valuable resource for addressing disparities in access to mental health resources in minority and underserved populations. this study aims to assess the effectiveness of this meditation on reducing symptoms associated with anxiety and depression over 6 weeks.

Eligibility criteria:
inclusion criteria: * age 18-70 years * interest in isha kriya exclusion criteria: * low english proficiency * not currently residing in united states

Keywords: meditation anxiety depression isha kriya
remote psychological intervention for covid-19 survivors with aki and caregivers (repicov-aki)

Conditions: COVID-19; Anxiety; Depressive Symptoms; Acute Kidney Injury

Summary: the frequency of psychological conditions in recovered covid-19 patients with acute kidney injury (aki) and their informal primary caregivers (ipc) is unknown; as well as the effects of psychological therapy in this population. the present study was initiated to determine the effectiveness of a brief remote psychological intervention (brpi) to reduce anxious and depressive symptoms in survivors of aki. the investigator designed a single-case experimental design a-b with prospective follow-up. we used the patient health questionnaire-9 (phq-9) and the general anxiety disorder scale-7 (gad-7) to screen for depressive and anxiety symptoms, one week later after hospital discharge. those with moderate or severe symptoms received cognitive behavioral therapy (cbt) and were evaluated over time with the instruments and daily self-report of symptoms. the statistical analysis was conducted using statistical software.


Eligibility criteria:
inclusion criteria: * survivors of severe covid-19 who had aki during hospitalization * informal primary caregivers exclusion criteria: * they did not accept to participate in the study * they did not answer three attempted phone calls or text messages making it impossible to complete the intervention.
restor-mv: randomized evaluation of a surgical treatment for off-pump repair of the mitral valve

Conditions: Mitral Valve Regurgitation; Left Ventricular Dysfunction; Heart Failure

Summary: the purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart coapsys system (myocor, inc.) to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation.

patient clinical evaluations will consist of 3-month, 6-month, and 12-month follow up of the primary endpoints. additional follow up of 18-month, 24-month, and annually thereafter will also be included.

Eligibility criteria:
inclusion criteria: * grade 2, 3, or 4 functional mitral valve regurgitation per 2d echocardiography * patient undergoing concomitant coronary artery bypass graft surgery, either on-pump or off-pump * left ventricular ejection fraction greater than or equal to 25% * age between 18 and 80 years, inclusive * patient is willing and available to return for study follow up * ability of the patient or legal representative to understand and provide signed consent for participating in the study. exclusion criteria: * structural abnormality of the mitral valve (e.g. calcification or thickening of the valve leaflets, ruptured papillary muscle, ruptured chordae tendinae, mitral valve prolapse, mitral stenosis, etc.) * asymptomatic grade 2 mr (those with nyha class \ 40%) * organic valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring surgical intervention * transmural myocardial infarction within 30 day period prior to surgical placement of coapsys * nyha class iv * left ventricular end diastolic diameter \> 7.0 cm * cardiac surgery on an emergency or salvage basis * left atrial or left ventricular thrombus * left ventricular aneurysm * previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the coapsys * chronic renal failure requiring dialysis * open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis) * active infection * life expectancy of less than 24 months due to conditions other than their cardiac status * participation in another investigational drug or device protocol * abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures.

Keywords: functional mitral regurgitation (fmr) ischemic mitral regurgitation less invasive repair surgical mv repair mitral valve repair heart failure left ventricular dysfunction