Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the potential of mesenchymal stromal cells to treat obliterative bronchiolitis after lung transplantation

Conditions: Bronchiolitis Obliterans; Lung Transplantation

Summary: the primary aim of this study is to establish the safety of infusions of mesenchymal stromal cells (msc) from related or unrelated human leukocyte antigen (hla) identical or hla mismatched donors in the management of bronchiolitis obliterans syndrome after lung transplantation.


Eligibility criteria:
inclusion criteria: 1. patients with single, bilateral or heart-lung allografts 2. patients with bronchiolitis obliterans syndrome (bos) grades 2 \& 3 (defined and graded according to international criteria (appendix 1)), with evidence of deterioration in allograft function (i.e. deteriorating fev1 or worsening bos grade) within the last 12 months. 3. patients with bos grade 1 and evidence of deterioration in allograft function (i.e. deteriorating fev1 or worsening bos grade) within the last 12 months and at least one of the following additional risk factors for subsequent death: * single lung transplant * rapid deterioration (\>20% fall in fev1 in the previous 12 months) * a pre-transplant diagnosis of usual interstitial pneumonia (pulmonary fibrosis) or pulmonary hypertension exclusion criteria: 1. patients with active infection, acute allograft rejection, or airway anastomotic complications 2. patients with \> 3 infective exacerbations of bos in the last 12 months 3. patients with a history of cytomegalovirus (cmv) pneumonitis 4. patients with poor performance status and/or not expected to survive 3 months 5. patients who are pregnant or breastfeeding 6. patients with an allergy to beef products. 7. any condition that in the opinion of the investigator may interfere with the safety of the patient, his / her completion of required follow-up visits or evaluation of the study objectives.

Keywords: mesenchymal stromal cells bronchiolitis obliterans lung transplant
effects of post-covid-19 on quadriceps femoral muscle-tendon unit

Conditions: Post-COVID-19; Healthy Participants

Summary: the physiological/biomechanical characteristics related to muscle and tendon architecture and their possible relationship with the loss of muscle strength and fatigue in patients who were infected with covid-19 are totally unknown. the aim of this study is to evaluate inflammatory markers, the isometric maximum voluntary force of the knee extensor torque, muscle fatigue, neuromuscular adaptations, muscle architecture, tendinous properties of quadriceps components, oxygen extraction, and body composition in participants after diagnosis with covid-19 who had moderate and severe levels of involvement compared to a healthy control group.

the groups will be composed of participants who had covid-19, except for the control group, which will be composed of healthy participants who did not have covid-19. participants will be divided into: (1) control group, (2) covid-19 positive participants who had moderate symptoms, (3) covid-19 positive participants who had severe symptoms. participants will be recruited from 21 days after the onset of symptoms, the period recommended by the scientific community that the patient no longer transmits severe acute respiratory syndrome coronavirus 2 (sars-cov-2). after recruitment, 4 evaluations will be carried out over 1 year.

Eligibility criteria:
inclusion criteria: * control group: - the control group will include healthy participants, aged 18 and 80 years, who had not tested positive for covid-19. * covid-19 positive participants who had moderate symptoms group: * female and male participants, aged between 18 and 80 years, who had molecular test (rt-pcr) or serological test, which assesses whether the samples are reactive to immunoglobulin m (igm) and immunoglobulin g (igg) antibodies, positive for covid-19; * presence of some of the following symptoms, without the need for hospitalization: dry cough, runny nose, sore throat, diffuse body pain, persistent hyperthermia, no hypoxemia. * covid-19 positive participants who had severe symptoms group: * female and male participants, aged between 18 and 80 years, who had molecular test (rt-pcr) or serological test (which assesses whether the samples are reactive to igm and igg antibodies) positive for covid-19; * presence of hypoxemia (peripheral oxygen saturation - spo2 ≤ 93%) requiring hospitalization with or without intubation, in addition to the symptoms described for the covid-19 positive participants who had moderate symptoms group. exclusion criteria: * body mass index (bmi) ≥ 35 kg/m2; * pregnancy; * pain, swelling, dermal damage, deformity, or amputation in the regions to be examined; * diagnosis of ankylosing spondylitis, rheumatoid arthritis, severe heart disease, advanced chronic obstructive pulmonary disease, cognitive impairment, chemical dependency, psychiatric illness, or behavioral that makes it difficult to cooperate with the procedures.

Keywords: covid-19 muscle tendon cytokines electrodiagnosis fatigue strength peripheral oxygen extraction
postoperative systemic corticosteroids when utilizing a steroid-eluting spacer following endoscopic sinus surgery

Conditions: Chronic Sinusitis; Endoscopic Sinus Surgery; Post-operative Care; Steroids; Drug-eluting Spacer

Summary: chronic rhinosinusitis (crs) is an inflammatory condition of the nose and sinuses. it affects about 5 to 10% of canadians. patients suffer from congestion in the nose and sinuses, nasal discharge, pressure in the face, and a reduced sense of smell. this affects people's enjoyment of life. medical management uses sprays or pills to treat these symptoms but for some patients sinus surgery is needed. this type of surgery is called endoscopic sinus surgery (ess). there is no single correct approach to take care of patients after sinus surgery. most experts would use a nasal spray and a short-course of oral steroid pills to reduce sinus swelling and minimize complications related to scarring. "steroid-eluting nasal spacers" are devices placed inside the sinus during surgery and slowly release topical steroids into the sinuses better than steroid sprays. these "spacers" have been shown to improve results following sinus surgery. when using these special "spacers", there may no longer be a need for oral steroid pills following surgery. this would help to avoid potential side effects associated with these medications. the purpose of this study is to find out whether taking oral (systemic) steroid pills following sinus surgery is necessary to improve surgical results, now that steroid-eluting nasal spacers are commonly used during surgery.


Eligibility criteria:
inclusion criteria: * adult ( \> 18 years of age) * crs defined by 2007 adult sinusitis guidelines19 * electing endoscopic sinus surgery for the indication medically refractory crs, as defined by having persistent symptoms despite the following "maximal medical therapy": 1. received 3 months of topical corticosteroid spray 2. received a 2 week course of a broad-spectrum antibiotic combined with a 2 week course of systemic corticosteroid * provide written informed consent * subject must be able to complete all study evaluations and hrqol questionnaires written in english exclusion criteria: * children (\< 18 years of age) * unable to complete questionnaires or clinical testing or cooperate with study evaluations in english. * unwilling to provide written, informed consent * patients who have not undergone previous "maximum" prescribed medical therapy * patients with suspected systemic inflammatory disease
aortic valve neocuspidization with glutaraldehyde-treated autologous pericardium (ozaki procedure)

Conditions: Aortic Valve Disease

Summary: the ozaki aortic valve reconstruction procedure uses autologous or bovine pericardium as an aortic cusp replacement without the use of struts and with use of the patient's own native aortic root. in this technique one can replace individual aortic cusps, 1, 2, or all 3 cusps. ideally the patient's autologous pericardium will be harvested and fixed in gluteraldehyde at the time and prepared for the patient's specific annular dimensions with the neoaortic root sizers. based on the measured size, one then uses a leaflet template to independently replace the cusps resulting in more effective preservation of the natural motion of the aortic valve annulus in coordination of the left ventricle, aortic annulus, sinus of valsalva, and aorta compared to stented bioprosthetic and/or mechanical aortic valve replacements. professor ozaki has now performed 1000 ozaki neoaortic valve reconstructive operations and has better than 95% freedom from re-operation at late follow-up. the objective of this study is to collect a large collection of prospective data from patients undergoing aortic neocuspidalization surgery for aortic valve insufficiency or stenosis isolated or combined with other procedures


Eligibility criteria:
inclusion criteria: * severe aortic valve stenosis or insufficiency * written informed consent * willingness to carry out the follow-up visits exclusion criteria: * other types of aortic valve surgery
single-cycle remote ischemic preconditioning and postconditioning for prevention of contrast-induced nephropathy

Conditions: Ischemic Reperfusion Injury

Summary: this trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty

randomized controlled trial

Eligibility criteria:
inclusion criteria: * the patient have indication for coronary angiography or angioplasty. * impaired renal function with reduced egfr \< 60 ml/min/1.73 m2 by ckd-epi equation. * written informed consent. exclusion criteria: * history of contrast allergy. * the patient had end-stage renal failure with the need for hemodialysis. * the patient take medications that affect the kidneys function within 48 hours before study. * the patient had acute kidney injury from any cause. * the patient was received contrast media within 2 weeks before study. * the patient had cardiac arrest or shock. * the patient had peripheral arterial disease (pad) * pregnancy * refused to study

Keywords: ischemic preconditioning postconditioning angioplasty angiography contrast-induced nephropathy
developing a communication intervention for people with memory challenges and their care partners

Conditions: Alzheimer Disease; Dementia

Summary: the proposed research is consistent with broader public health goals focused on improving communication regarding end-of-life care and the centers for medicare and medicaid services' (cms) call for increased patient engagement in advance care planning (acp) as part of standard care. the proposed study will address this public health issue by developing a communication-based intervention designed to improve alzheimer's disease and related dementias (adrd) patients' and care partners' engagement in acp, distress and care partner burden, and completion of advance directives and receipt of goal-concordant care at the end-of-life. therefore, this study is aligned with the national institute on aging's long-term goal to improve the quality of care for adrd patients and cms's goal to increase engagement in acp.

the goals of this study are to: (1) develop a communication-based intervention, called know the optimal way (know) for alzheimer's disease and related dementias (adrd) patients and care partners that includes theoretically grounded communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention; and (3) test the preliminary efficacy of the intervention on adrd patients' and care partners' preparedness for and engagement in advance care planning (acp), and completion of advance directives (primary outcomes) as well as patient-care partner concordance on the person with dementia (pwd)'s healthcare values, perceived need for acp, psychological distress, communication quality, and care partner burden (secondary outcomes).

Eligibility criteria:
patient inclusion criteria: 1. montreal cognitive assessment (moca) score of ≥11-21 2. score of ≥9 on the university of california-san diego brief assessment of capacity to consent, 3. score of ≥11 on the capacity to execute a health care proxy guideline, 4. identification of an informal cp. 5. age ≥ 65 6. impaired autonomy in memory function, adls, or iadls per the care partner's report. care partner inclusion criteria: 1. the person whom the patient indicates provides their informal (unpaid) care 2. moca score of ≥26 exclusion criteria for patient or care partner: * not fluent in english * ≤17 years of age * too ill or weak to complete the interviews (per the interviewer) * presence of significant sensory, language, or motor deficit (e.g., visual or hearing loss, paralysis, aphasia) * patient is in the late stage of dementia (i.e., severe cognitive impairment), is bed-bound, or has a nursing home admission planned within 12 months * has a diagnosis of major depressive disorder, bipolar disorder, current psychotic disorder or substance abuse disorder per self-report or the medical record * patient-care partner dyads who have completed advance directives, due to the lack of need for an intervention

Keywords: caregiving advance care planning communication
clinical trial of chemosensitivity test

Conditions: Gastric Cancer

Summary: to evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery

patients: clinical stage iii gastric cancer patients. informed consent will be obtained before surgery. eligible patients: surgical stage ii, iiia and iiib gastric cancer patients. chemosensitivity test: the surgical specimen will be sent mitsubishi bcl, co. ltd. to be tested by cd-dst chemosensitivity test and rt-pcr for thymidylate synthetase and dihydropyrimidine dehydrogenase mrna. the test results will be blinded for the doctors on duty. treatment: all the patients will be treated with s-1 at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest. the treatment will be continued until the recurrence or 1 year after operation. primary endpoint: 3-years disease-free survival rate secondary endpoint: 3-years overall survival rate and side effect (ctcae v3.0) evaluation of chemosensitivity test: the cutoff condition will be determined based on the accumulated data of cd-dst and mrnas. hypothesis: the responder detected by cd-dst and/or ts, dpd mrna will have a favorable survival outcome comparing with resistant cases.

Eligibility criteria:
inclusion criteria: * histologically proven gastric cancer * ps (ecog) 0 or 2 * d2 dissection, curability b or more * surgical stage iiia and iiib * negative peritoneal cytology * no previous radiotherapy, chemotherapy and hormone therapy * possible peroral intake at 6 pow * no severe surgical complication * normal bone marrow, liver and renal function * complete chemosensitivity test * written informed consent exclusion criteria: * multiple cancer * contraindication for s-1 * history of drug allergy (grade 3) * severe complication * watery diarrhea * pregnant * scirrhous gastric cancer * the other patients who was judged as inadequate for trial by doctor on duty

Keywords: gastric cancer s-1 chemosensitivity adjuvant
external validation of a septic arthritis prognosis score

Conditions: Arthritis

Summary: observational study

septic arthritis is a diagnostic emergency for acute arthritis because it is accompanied by an excess of mortality of 11% and frequent functional sequelae in about 50% of cases in the year. however, it remains rare with an estimated annual incidence of 1 to 5/100000, and a prevalence of about 10% in front of an acute arthritis table sent to an emergency department. the diagnosis is based on the bacteriological culture which finds the presence of a microorganism within the joint. however, only 80% of septic arthritis is bacteriologically documented due to low inoculum, the presence of fragile bacteria (neisseria sp) or especially untimely antibiotherapy prior to joint puncture. in addition, the bacteriological culture takes an average of 3 days to become positive, which may delay the implementation of appropriate antibiotic therapy. it is therefore essential that the clinician can rely on other clinical or biological parameters, reliable and fast for better diagnostic orientation. a first study: synolactates showed the interest of the measurement of glucose and synovial lactate for the diagnosis of septic arthritis with very good performances. a resas score (rennes septic arthritis score) was constructed from these results to assess the likelihood of septic arthritis.

Eligibility criteria:
inclusion criteria: * any acute arthritis less than or equal to 30 days; * achievement of a joint puncture in routine care as part of the diagnostic assessment of this acute arthritis; * affiliation to a social security scheme; * no one opposes his participation in the research. exclusion criteria: * age below 18 years; * major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.
effect of ripc on the prevention of pod in patients undergoing cardiac surgery

Conditions: Postoperative Delirium; Cardiac Surgery

Summary: postoperative delirium (pod) is one of the most frequent neurological complications in elderly patients and is closely associated with longer icu stay and hospitalization, deterioration of long-term neurocognitive function, and increased mortality. the incidence of pod is significantly higher in elderly patients undergoing cardiac surgery than in other populations. therefore, the prevention of pod is an important clinical problem to be solved urgently. in this study, we intend to observe the effect of ripc on the prevention and treatment of pod in patients undergoing cardiac surgery through a prospective randomized controlled trial.


Eligibility criteria:
inclusion criteria: * patients undergoing elective cardiac surgery; * age ≥ 18 yr; * any sex; * american society of anesthesiologists (asa) class ≥ii class; * new york heart association (nyha) ≥ii class. exclusion criteria: * emergency surgery; * a history of cardiovascular surgery; * peripheral vascular disease affecting the upper limbs; * acute myocardial infarction (mi) up to 14 days before surgery; * a history of severe injuries and operations within 3 months before cardiac surgery; * a history of cancer and chronic autoimmune diseases.
radicava® (edaravone) findings in biomarkers from als (refine-als)

Conditions: Amyotrophic Lateral Sclerosis; ALS

Summary: refine-als is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of edaravone effects in als. epigenetic and protein biomarkers will also be investigated.

treatment will be prescribed by hcps in accordance with their clinical judgement and the prescribing information for edaravone. the decision to prescribe edaravone to the participants should be made separately from the decision to enroll then in the study. there will be no randomized assignments to treatment and no restrictions on the use of commercially available medications (but those participating in an experimental study, even if taking edaravone, will be excluded). no experimental treatment is evaluated in this study. the intervention is limited to the collection of blood and urine samples for biomarker testing. during the estimated study period, eligible patients who are prescribed edaravone within the approved indication will be invited to participate in the study. an initial screening/baseline visit will be scheduled for participants who are considered for study participation. participants in this study will be followed from enrollment up to 24 weeks after treatment initiation (6 treatment cycles \[each cycle consisting of 28 days\], corresponding to a treatment period of approximately 24 weeks) or premature study discontinuation. throughout the study period, the investigators will record participant baseline and follow-up information and perform clinical and biomarker assessments.

Eligibility criteria:
inclusion criteria: * male and female aged 18 years or older at enrollment * sporadic or familial als diagnosed as possible, probable, probable-laboratory supported or definite as defined by the world federation of neurology revised el escorial criteria * decision made to prescribe edaravone prior to screening * participant will likely be able to obtain commercial edaravone and likely to complete 6 cycles of treatment, per site investigator estimation * participant either naïve to edaravone or who did not receive any edaravone does within 1 month prior to screening * signed informed consent by the subject, or a witness if a subject cannot read or write or is physically unable to talk or write, obtained before any study-related activities are undertaken exclusion criteria: * participant with a contraindication to edaravone * participant is participating in an interventional clinical trial

Keywords: biomarkers edaravone radicava® radicava ors® motor neuron disease